Preferred Pharmaceuticals, Inc.
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Preferred Pharmaceuticals, Inc. Drugs
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![Budesonide Suspension [Preferred Pharmaceuticals Inc.]](https://www.recallguide.org/wp-content/themes/bootstrap/assets/img/drug-image-placeholder.jpg)
Budesonide Suspension
The recommended starting dose and highest recommended dose of budesonide inhalation suspension, based on prior asthma therapy, are listed in the following table.
Previous Therapy
Recommended Starting Dose
Highest Recommended Dose
Bronchodilators alone
0.5 mg total daily dose administered either once daily or twice daily in divided doses
0.5 mg total daily dose
Inhaled Corticosteroids
0.5 mg total daily dose administered either once daily or twice daily in divided doses
1 mg total daily dose
Oral Corticosteroids
1 mg total daily dose administered either as 0.5 mg twice daily or 1 mg once daily
1 mg total daily dose
2.1 Dosing Recommendations
Dosing recommendations based on previous therapy are as follows:
• Bronchodilators alone: 0.5 mg once daily or 0.25 mg twice daily • Inhaled corticosteroids: 0.5 mg once daily or 0.25 mg twice daily up to 0.5 mg twice daily • Oral corticosteroids: 0.5 mg twice daily or 1 mg once dailyIn symptomatic children not responding to non-steroidal therapy, a starting dose of 0.25 mg once daily may be considered. If once-daily treatment does not provide adequate control, the total daily dose should be increased and/or administered as a divided dose. In all patients, it is desirable to downward-titrate to the lowest effective dose once asthma stability is achieved.
2.2 Directions for Use
Budesonide inhalation suspension should be administered via jet nebulizer connected to an air compressor with an adequate air flow, equipped with a mouthpiece or suitable face mask. Ultrasonic nebulizers are not suitable for the adequate administration of budesonide inhalation suspension and, therefore, are NOT recommended.
The effects of mixing budesonide inhalation suspension with other nebulizable medications have not been adequately assessed. Budesonide inhalation suspension should be administered separately in the nebulizer [see PATIENT COUNSELING INFORMATION, Administration with a jet nebulizer (17.1)].
A Pari-LC-Jet Plus Nebulizer (with face mask or mouthpiece) connected to a Pari Master compressor was used to deliver budesonide inhalation suspension to each patient in 3 U.S. controlled clinical studies. The safety and efficacy of budesonide inhalation suspension delivered by other nebulizers and compressors have not been established.
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Bisoprolol Fumarate
The dose of BISOPROLOL FUMARATE must be individualized to the needs of the patient. The usual starting dose is 5 mg once daily. In some patients, 2.5 mg may be an appropriate starting dose (see Bronchospastic Disease in WARNINGS). If the antihypertensive effect of 5 mg is inadequate, the dose may be increased to 10 mg and then, if necessary, to 20 mg once daily.
Patients with Renal or Hepatic Impairment
In patients with hepatic impairment (hepatitis or cirrhosis) or renal dysfunction (creatinine clearance less than 40 mL/min), the initial daily dose should be 2.5 mg and caution should be used in dose-titration. Since limited data suggest that bisoprolol fumarate is not dialyzable, drug replacement is not necessary in patients undergoing dialysis.
Geriatric Patients
It is not necessary to adjust the dose in the elderly, unless there is also significant renal or hepatic dysfunction (see above and Geriatric Use in PRECAUTIONS).
Pediatric Patients
There is no pediatric experience with BISOPROLOL FUMARATE.
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Lisinopril
2.1 Hypertension
Initial Therapy in adults: The recommended initial dose is 10 mg once a day. Dosage should be adjusted according to blood pressure response. The usual dosage range is 20 mg to 40 mg per day administered in a single daily dose. Doses up to 80 mg have been used but do not appear to give greater effect.
Use with diuretics in adults
If blood pressure is not controlled with lisinopril tablets alone, a low dose of a diuretic may be added (e.g., hydrochlorothiazide, 12.5 mg). After the addition of a diuretic, it may be possible to reduce the dose of lisinopril tablets.
The recommended starting dose in adult patients with hypertension taking diuretics is 5 mg once per day.
Pediatric Patients 6 years of age and older with hypertension
For pediatric patients with glomerular filtration rate > 30 mL/min/1.73m2, the recommended starting dose is 0.07 mg per kg once daily (up to 5 mg total). Dosage should be adjusted according to blood pressure response up to a maximum of 0.61 mg per kg (up to 40 mg) once daily. Doses above 0.61 mg per kg (or in excess of 40 mg) have not been studied in pediatric patients [see Clinical Pharmacology (12.3)].
Lisinopril tablets are not recommended in pediatric patients < 6 years or in pediatric patients with glomerular filtration rate < 30 mL/min/1.73m2 [see Use in Specific Populations (8.4)and Clinical Studies (14.1)].
2.2 Heart Failure
The recommended starting dose for lisinopril tablets, when used with diuretics and (usually) digitalis as adjunctive therapy for systolic heart failure, is 5 mg once daily. The recommended starting dose in these patients with hyponatremia (serum sodium < 130 mEq/L) is 2.5 mg once daily. Increase as tolerated to a maximum of 40 mg once daily.
Diuretic dose may need to be adjusted to help minimize hypovolemia, which may contribute to hypotension [see Warnings and Precautions (5.4), and Drug Interactions (7.1)]. The appearance of hypotension after the initial dose of lisinopril tablets does not preclude subsequent careful dose titration with the drug, following effective management of the hypotension.
2.3 Reduction of Mortality in Acute Myocardial Infarction
In hemodynamically stable patients within 24 hours of the onset of symptoms of acute myocardial infarction, give lisinopril tablets 5 mg orally, followed by 5 mg after 24 hours, 10 mg after 48 hours and then 10 mg once daily. Dosing should continue for at least six weeks.
Initiate therapy with 2.5 mg in patients with a low systolic blood pressure (≤ 120 mmHg and > 100 mm Hg) during the first 3 days after the infarct [see Warnings and Precautions (5.4)]. If hypotension occurs (systolic blood pressure ≤ 100 mmHg) a daily maintenance dose of 5 mg may be given with temporary reductions to 2.5 mg if needed. If prolonged hypotension occurs (systolic blood pressure < 90 mmHg for more than 1 hour) lisinopril tablets should be withdrawn.
2.4 Dose in Patients with Renal Impairment
No dose adjustment of lisinopril tablets is required in patients with creatinine clearance > 30 mL/min. In patients with creatinine clearance ≥ 10 mL/min and ≤ 30 mL/min, reduce the initial dose of lisinopril tablets to half of the usual recommended dose i.e., hypertension, 5 mg; systolic heart failure, 2.5 mg and acute MI, 2.5 mg. Up titrate as tolerated to a maximum of 40 mg daily. For patients on hemodialysis or creatinine clearance < 10 mL/min, the recommended initial dose is 2.5 mg once daily [see Use in Specific Populations (8.7)and Clinical Pharmacology (12.3)].
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Phentermine Hydrochloride
Exogenous Obesity Dosage should be individualized to obtain an adequate response with the lowest effective dose.
The usual adult dose is 15 mg to 30 mg as prescribed by the physician, at approximately 2 hours after breakfast for appetite control. Administration of one 30 mg capsule daily has been found to be adequate in depression of the appetite for 12 to 14 hours. Phentermine is not recommended for use in pediatric patients ≤ 16 years of age.
Late evening medication should be avoided because of the possibility of resulting insomnia.
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Lisinopril
2.1 Hypertension
Initial Therapy in adults: The recommended initial dose is 10 mg once a day. Dosage should be adjusted according to blood pressure response. The usual dosage range is 20 mg to 40 mg per day administered in a single daily dose. Doses up to 80 mg have been used but do not appear to give greater effect.
Use with diuretics in adults
If blood pressure is not controlled with lisinopril tablets alone, a low dose of a diuretic may be added (e.g., hydrochlorothiazide, 12.5 mg). After the addition of a diuretic, it may be possible to reduce the dose of lisinopril tablets.
The recommended starting dose in adult patients with hypertension taking diuretics is 5 mg once per day.
Pediatric Patients 6 years of age and older with hypertension
For pediatric patients with glomerular filtration rate > 30 mL/min/1.73m2, the recommended starting dose is 0.07 mg per kg once daily (up to 5 mg total). Dosage should be adjusted according to blood pressure response up to a maximum of 0.61 mg per kg (up to 40 mg) once daily. Doses above 0.61 mg per kg (or in excess of 40 mg) have not been studied in pediatric patients [see Clinical Pharmacology (12.3)].
Lisinopril tablets are not recommended in pediatric patients < 6 years or in pediatric patients with glomerular filtration rate < 30 mL/min/1.73m2 [see Use in Specific Populations (8.4)and Clinical Studies (14.1)].
2.2 Heart Failure
The recommended starting dose for lisinopril tablets, when used with diuretics and (usually) digitalis as adjunctive therapy for systolic heart failure, is 5 mg once daily. The recommended starting dose in these patients with hyponatremia (serum sodium < 130 mEq/L) is 2.5 mg once daily. Increase as tolerated to a maximum of 40 mg once daily.
Diuretic dose may need to be adjusted to help minimize hypovolemia, which may contribute to hypotension [see Warnings and Precautions (5.4), and Drug Interactions (7.1)]. The appearance of hypotension after the initial dose of lisinopril tablets does not preclude subsequent careful dose titration with the drug, following effective management of the hypotension.
2.3 Reduction of Mortality in Acute Myocardial Infarction
In hemodynamically stable patients within 24 hours of the onset of symptoms of acute myocardial infarction, give lisinopril tablets 5 mg orally, followed by 5 mg after 24 hours, 10 mg after 48 hours and then 10 mg once daily. Dosing should continue for at least six weeks.
Initiate therapy with 2.5 mg in patients with a low systolic blood pressure (≤ 120 mmHg and > 100 mm Hg) during the first 3 days after the infarct [see Warnings and Precautions (5.4)]. If hypotension occurs (systolic blood pressure ≤ 100 mmHg) a daily maintenance dose of 5 mg may be given with temporary reductions to 2.5 mg if needed. If prolonged hypotension occurs (systolic blood pressure < 90 mmHg for more than 1 hour) lisinopril tablets should be withdrawn.
2.4 Dose in Patients with Renal Impairment
No dose adjustment of lisinopril tablets is required in patients with creatinine clearance > 30 mL/min. In patients with creatinine clearance ≥ 10 mL/min and ≤ 30 mL/min, reduce the initial dose of lisinopril tablets to half of the usual recommended dose i.e., hypertension, 5 mg; systolic heart failure, 2.5 mg and acute MI, 2.5 mg. Up titrate as tolerated to a maximum of 40 mg daily. For patients on hemodialysis or creatinine clearance < 10 mL/min, the recommended initial dose is 2.5 mg once daily [see Use in Specific Populations (8.7)and Clinical Pharmacology (12.3)].
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Azithromycin
2.1 Adult Patients
[See Indications and Usage (1.1) and Clinical Pharmacology (12.3)]
Infection* Recommended Dose/Duration of TherapyCommunity-acquired pneumonia
Pharyngitis/tonsillitis (second-line therapy)
Skin/skin structure (uncomplicated)
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5
Acute bacterial exacerbations of chronic obstructive pulmonary disease
500 mg once daily for 3 days
OR
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5
Acute bacterial sinusitis
500 mg once daily for 3 days
Genital ulcer disease (chancroid)
One single 1 gram dose
Non-gonococcal urethritis and cervicitis
One single 1 gram dose
Gonococcal urethritis and cervicitis
One single 2 gram dose
*DUE TO THE INDICATED ORGANISMS [see Indications and Usage (1.1)]
Azithromycin tablets can be taken with or without food.
2.2 Pediatric Patients1
Infection* Recommended Dose/Duration of TherapyAcute otitis media
30 mg/kg as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on Day 1 followed by 5 mg/kg/day on Days 2 through 5.
Acute bacterial sinusitis
10 mg/kg once daily for 3 days.
Community-acquired pneumonia
10 mg/kg as a single dose on Day 1 followed by 5 mg/kg once daily on Days 2 through 5.
Pharyngitis/tonsillitis
12 mg/kg once daily for 5 days.
*DUE TO THE INDICATED ORGANISMS [see Indications and Usage (1.2)]
1see dosing tables below for maximum doses evaluated by indication
Azithromycin can be taken with or without food.
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA, ACUTE BACTERIAL SINUSITIS, AND COMMUNITY‑ACQUIRED PNEUMONIA (Age 6 months and above, [see Use in Specific Populations (8.4)]) Based on Body Weight
OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5-Day Regimen)* Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5. Weight 100 mg/5 mL 200 mg/5 mL Total mL per Treatment Course Total mg per Treatment Course Kg Lbs. Day 1 Days 2-5 Day 1 Days 2-55
11
2.5 mL; (½ tsp)
1.25 mL; (¼ tsp)
7.5 mL
150 mg
10
22
5 mL; (1 tsp)
2.5 mL; (½ tsp)
15 mL
300 mg
20
44
5 mL; (1 tsp)
2.5 mL; (½ tsp)
15 mL
600 mg
30
66
7.5 mL; (1½ tsp)
3.75 mL; (¾ tsp)
22.5 mL
900 mg
40
88
10 mL; (2 tsp)
5 mL; (1 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL; (2½ tsp)
6.25 mL; (1¼ tsp)
37.5 mL
1500 mg
* Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established.
OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)* Dosing Calculated on 10 mg/kg/day. Weight 100 mg/5 mL 200 mg/5 mL Total mL per Treatment Course Total mg per Treatment Course Kg Lbs. Days 1-3 Days 1-35
11
2.5 mL; (1/2 tsp)
7.5 mL
150 mg
10
22
5 mL; (1 tsp)
15 mL
300 mg
20
44
5 mL (1 tsp)
15 mL
600 mg
30
66
7.5 mL (1½ tsp)
22.5 mL
900 mg
40
88
10 mL (2 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL (2 ½ tsp)
37.5 mL
1500 mg
*Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established.
OTITIS MEDIA: (1-Day Regimen) Dosing Calculated on 30 mg/kg as a single dose. Weight 200 mg/5 mL Total mL per Treatment Course Total mg per Treatment Course Kg Lbs. 1-Day Regimen5
11
3.75 mL;(3/4 tsp)
3.75 mL
150 mg
10
22
7.5 mL;(1½ tsp)
7.5 mL
300 mg
20
44
15 mL;(3 tsp)
15 mL
600 mg
30
66
22.5 mL;(4½ tsp)
22.5 mL
900 mg
40
88
30 mL;(6 tsp)
30 mL
1200 mg
50 and above
110 and above
37.5 mL;(7½ tsp)
37.5 mL
1500 mg
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/Tonsillitis: The recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS/TONSILLITIS (Age 2 years and above, [see Use in Specific Populations (8.4)]) Based on Body Weight
PHARYNGITIS/TONSILLITIS: (5-Day Regimen) Dosing Calculated on 12 mg/kg/day for 5 days. Weight 200 mg/5 mL Total mL per Treatment Course Total mg per Treatment Course Kg Lbs. Day 1-58
18
2.5 mL; (½ tsp)
12.5 mL
500 mg
17
37
5 mL; (1 tsp)
25 mL
1000 mg
25
55
7.5 mL; (1½ tsp)
37.5 mL
1500 mg
33
73
10 mL; (2 tsp)
50 mL
2000 mg
40
88
12.5 mL; (2½ tsp)
62.5 mL
2500 mg
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Sucralfate
Active Duodenal Ulcer
The recommended adult oral dosage for duodenal ulcer is 1 g four times per day on an empty stomach.
Antacids may be prescribed as needed for relief of pain but should not be taken within one-half hour before or after sucralfate.
While healing with sucralfate may occur during the first week or two, treatment should be continued for 4 to 8 weeks unless healing has been demonstrated by x-ray or endoscopic examination.
Maintenance Therapy
The recommended adult oral dosage is 1 g twice a day.
Elderly
In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy (see PRECAUTIONS, Geriatric Use).
Call your doctor for medical advice about side effects. You may report side effects to TEVA USA, PHARMACOVIGILANCE at tel: 1-888-838-2872, x6351 or drug.safety@tevapharm.com; or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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Hyoscyamine Sulfate
Dosage may be adjusted according to the conditions and severity of symptoms.
Adults and pediatric patients 12 years of age and older: 1 to 2 tablets every four hours or as needed. Do not exceed 12 tablets in 24 hours.
Pediatric patients 2 to under 12 years of age: 1/2 to 1 tablet every four hours or as needed. Do not exceed 6 tablets in 24 hours.
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Adacel Tdap Tdap
Dosage should be individualized for maximum beneficial effect. While the usual daily dosages given below will meet the needs of most patients, there will be some who require doses greater than 4 mg/day. In such cases, dosage should be increased cautiously to avoid adverse effects.Anxiety Disorders and Transient Symptoms of Anxiety: Treatment for patients with anxiety should be initiated with a dose of 0.25 to 0.5 mg given three times daily. The dose may be increased to achieve a maximum therapeutic effect, at intervals of 3 to 4 days, to a maximum daily dose of 4 mg, given in divided doses. The lowest possible effective dose should be employed and the need for continued treatment reassessed frequently. The risk of dependence may increase with dose and duration of treatment. In all patients, dosage should be reduced gradually when discontinuing therapy or when decreasing the daily dosage. Although there are no systematically collected data to support a specific discontinuation schedule, it is suggested that the daily dosage be decreased by no more than 0.5 mg every 3 days. Some patients may require an even slower dosage reduction. Panic Disorder: The successful treatment of many panic disorder patients has required the use of alprazolam tablets at doses greater than 4 mg daily. In controlled trials conducted to establish the efficacy of alprazolam tablets in panic disorder, doses in the range of 1 to 10 mg daily were used. The mean dosage employed was approximately 5 to 6 mg daily. Among the approximately 1700 patients participating in the panic disorder development program, about 300 received alprazolam tablets in dosages of greater than 7 mg/day, including approximately 100 patients who received maximum dosages of greater than 9 mg/day. Occasional patients required as much as 10 mg a day to achieve a successful response. Dose Titration: Treatment may be initiated with a dose of 0.5 mg three times daily. Depending on the response, the dose may be increased at intervals of 3 to 4 days in increments of no more than 1 mg per day. Slower titration to the dose levels greater than 4 mg/day may be advisable to allow full expression of the pharmacodynamic effect of alprazolam tablets. To lessen the possibility of interdose symptoms, the times of administration should be distributed as evenly as possible throughout the waking hours, that is, on a three or four times per day schedule. Generally, therapy should be initiated at a low dose to minimize the risk of adverse responses in patients especially sensitive to the drug. Dose should be advanced until an acceptable therapeutic response (ie, a substantial reduction in or total elimination of panic attacks) is achieved, intolerance occurs, or the maximum recommended dose is attained. Dose Maintenance: For patients receiving doses greater than 4 mg/day, periodic reassessment and consideration of dosage reduction is advised. In a controlled postmarketing dose-response study, patients treated with doses of alprazolam tablets greater than 4 mg/day for 3 months were able to taper to 50% of their total maintenance dose without apparent loss of clinical benefit. Because of the danger of withdrawal, abrupt discontinuation of treatment should be avoided. (See WARNINGS, PRECAUTIONS, DRUG ABUSE AND DEPENDENCE.) The necessary duration of treatment for panic disorder patients responding to alprazolam tablets is unknown. After a period of extended freedom from attacks, a carefully supervised tapered discontinuation may be attempted, but there is evidence that this may often be difficult to accomplish without recurrence of symptoms and/or the manifestation of withdrawal phenomena.Dose Reduction: Because of the danger of withdrawal, abrupt discontinuation of treatment should be avoided (see WARNINGS, PRECAUTIONS, DRUG ABUSE AND DEPENDENCE).In all patients, dosage should be reduced gradually when discontinuing therapy or when decreasing the daily dosage. Although there are no systematically collected data to support a specific discontinuation schedule, it is suggested that the daily dosage be decreased by no more than 0.5 mg every three days. Some patients may require an even slower dosage reduction.In any case, reduction of dose must be undertaken under close supervision and must be gradual. If significant withdrawal symptoms develop, the previous dosing schedule should be reinstituted and, only after stabilization, should a less rapid schedule of discontinuation be attempted. In a controlled postmarketing discontinuation study of panic disorder patients which compared this recommended taper schedule with a slower taper schedule, no difference was observed between the groups in the proportion of patients who tapered to zero dose; however, the slower schedule was associated with a reduction in symptoms associated with a withdrawal syndrome. It is suggested that the dose be reduced by no more than 0.5 mg every 3 days, with the understanding that some patients may benefit from an even more gradual discontinuation. Some patients may prove resistant to all discontinuation regimens.Dosing in Special Populations: In elderly patients, in patients with advanced liver disease or in patients with debilitating disease, the usual starting dose is 0.25 mg, given two or three times daily. This may be gradually increased if needed and tolerated. The elderly may be especially sensitive to the effects of benzodiazepines. If side effects occur at the recommended starting dose, the dose may be lowered.
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Fluconazole
Dosage and Administration in Adults
Single Dose
Vaginal candidiasis: The recommended dosage of fluconazole for vaginal candidiasis is 150 mg as a single oral dose.
Multiple Dose
SINCE ORAL ABSORPTION IS RAPID AND ALMOST COMPLETE, THE DAILY DOSE OF FLUCONAZOLE IS THE SAME FOR ORAL AND INTRAVENOUS ADMINISTRATION. In general, a loading dose of twice the daily dose is recommended on the first day of therapy to result in plasma concentrations close to steady-state by the second day of therapy.
The daily dose of fluconazole for the treatment of infections other than vaginal candidiasis should be based on the infecting organism and the patient’s response to therapy. Treatment should be continued until clinical parameters or laboratory tests indicate that active fungal infection has subsided. An inadequate period of treatment may lead to recurrence of active infection. Patients with AIDS and cryptococcal meningitis or recurrent oropharyngeal candidiasis usually require maintenance therapy to prevent relapse.
Oropharyngeal candidiasis: The recommended dosage of fluconazole for oropharyngeal candidiasis is 200 mg on the first day, followed by 100 mg once daily. Clinical evidence of oropharyngeal candidiasis generally resolves within several days, but treatment should be continued for at least 2 weeks to decrease the likelihood of relapse.
Esophageal candidiasis: The recommended dosage of fluconazole for esophageal candidiasis is 200 mg on the first day, followed by 100 mg once daily. Doses up to 400 mg/day may be used, based on medical judgment of the patient’s response to therapy. Patients with esophageal candidiasis should be treated for a minimum of three weeks and for at least two weeks following resolution of symptoms.
Systemic Candida infections: For systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia, optimal therapeutic dosage and duration of therapy have not been established. In open, noncomparative studies of small numbers of patients, doses of up to 400 mg daily have been used.
Urinary tract infections and peritonitis: For the treatment of Candida urinary tract infections and peritonitis, daily doses of 50 to 200 mg have been used in open, noncomparative studies of small numbers of patients.
Cryptococcal meningitis: The recommended dosage for treatment of acute cryptococcal meningitis is 400 mg on the first day, followed by 200 mg once daily. A dosage of 400 mg once daily may be used, based on medical judgment of the patient’s response to therapy. The recommended duration of treatment for initial therapy of cryptococcal meningitis is 10 to 12 weeks after the cerebrospinal fluid becomes culture negative. The recommended dosage of fluconazole for suppression of relapse of cryptococcal meningitis in patients with AIDS is 200 mg once daily.
Prophylaxis in patients undergoing bone marrow transplantation: The recommended fluconazole daily dosage for the prevention of candidiasis in patients undergoing bone marrow transplantation is 400 mg, once daily. Patients who are anticipated to have severe granulocytopenia (less than 500 neutrophils per cu mm) should start fluconazole prophylaxis several days before the anticipated onset of neutropenia, and continue for 7 days after the neutrophil count rises above 1000 cells per cu mm.
Dosage and Administration in Children
The following dose equivalency scheme should generally provide equivalent exposure in pediatric and adult patients:
Pediatric Patients Adults * Some older children may have clearances similar to that of adults. Absolute doses exceeding 600 mg/day are not recommended.3 mg/kg
100 mg
6 mg/kg
200 mg
12* mg/kg
400 mg
Experience with fluconazole in neonates is limited to pharmacokinetic studies in premature newborns. (See CLINICAL PHARMACOLOGY.) Based on the prolonged half-life seen in premature newborns (gestational age 26 to 29 weeks), these children, in the first two weeks of life, should receive the same dosage (mg/kg) as in older children, but administered every 72 hours. After the first two weeks, these children should be dosed once daily. No information regarding fluconazole pharmacokinetics in full-term newborns is available.
Dosage in Patients With Impaired Renal Function
Fluconazole is cleared primarily by renal excretion as unchanged drug. There is no need to adjust single dose therapy for vaginal candidiasis because of impaired renal function. In patients with impaired renal function who will receive multiple doses of fluconazole, an initial loading dose of 50 to 400 mg should be given. After the loading dose, the daily dose (according to indication) should be based on the following table:
Creatinine Clearance (mL/min) Percent of Recommended Dose> 50
100%
≤ 50 (no dialysis)
50%
Regular dialysis
100% after each dialysis
These are suggested dose adjustments based on pharmacokinetics following administration of multiple doses. Further adjustment may be needed depending upon clinical condition.
When serum creatinine is the only measure of renal function available, the following formula (based on sex, weight, and age of the patient) should be used to estimate the creatinine clearance in adults:
Males: Weight (kg) × (140-age) 72 × serum creatinine (mg/100 mL)
Females: 0.85 × above value
Although the pharmacokinetics of fluconazole has not been studied in children with renal insufficiency, dosage reduction in children with renal insufficiency should parallel that recommended for adults. The following formula may be used to estimate creatinine clearance in children:
K × linear length or height (cm) serum creatinine (mg/100 mL)(Where K=0.55 for children older than 1 year and 0.45 for infants.)
Administration
Fluconazole tablets are administered orally. Fluconazole tablets can be taken with or without food.
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Azithromycin
2.1 Adult Patients
[See Indications and Usage (1.1) and Clinical Pharmacology (12.3)]
Infection* Recommended Dose/Duration of TherapyCommunity-acquired pneumonia
Pharyngitis/tonsillitis (second-line therapy)
Skin/skin structure (uncomplicated)
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5
Acute bacterial exacerbations of chronic obstructive pulmonary disease
500 mg once daily for 3 days
OR
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5
Acute bacterial sinusitis
500 mg once daily for 3 days
Genital ulcer disease (chancroid)
One single 1 gram dose
Non-gonococcal urethritis and cervicitis
One single 1 gram dose
Gonococcal urethritis and cervicitis
One single 2 gram dose
*DUE TO THE INDICATED ORGANISMS [see Indications and Usage (1.1)]
Azithromycin tablets can be taken with or without food.
2.2 Pediatric Patients1
Infection* Recommended Dose/Duration of TherapyAcute otitis media
30 mg/kg as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on Day 1 followed by 5 mg/kg/day on Days 2 through 5.
Acute bacterial sinusitis
10 mg/kg once daily for 3 days.
Community-acquired pneumonia
10 mg/kg as a single dose on Day 1 followed by 5 mg/kg once daily on Days 2 through 5.
Pharyngitis/tonsillitis
12 mg/kg once daily for 5 days.
*DUE TO THE INDICATED ORGANISMS [see Indications and Usage (1.2)]
1see dosing tables below for maximum doses evaluated by indication
Azithromycin can be taken with or without food.
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA, ACUTE BACTERIAL SINUSITIS, AND COMMUNITY‑ACQUIRED PNEUMONIA (Age 6 months and above, [see Use in Specific Populations (8.4)]) Based on Body Weight
OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5-Day Regimen)* Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5. Weight 100 mg/5 mL 200 mg/5 mL Total mL per Treatment Course Total mg per Treatment Course Kg Lbs. Day 1 Days 2-5 Day 1 Days 2-55
11
2.5 mL; (½ tsp)
1.25 mL; (¼ tsp)
7.5 mL
150 mg
10
22
5 mL; (1 tsp)
2.5 mL; (½ tsp)
15 mL
300 mg
20
44
5 mL; (1 tsp)
2.5 mL; (½ tsp)
15 mL
600 mg
30
66
7.5 mL; (1½ tsp)
3.75 mL; (¾ tsp)
22.5 mL
900 mg
40
88
10 mL; (2 tsp)
5 mL; (1 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL; (2½ tsp)
6.25 mL; (1¼ tsp)
37.5 mL
1500 mg
* Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established.
OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)* Dosing Calculated on 10 mg/kg/day. Weight 100 mg/5 mL 200 mg/5 mL Total mL per Treatment Course Total mg per Treatment Course Kg Lbs. Days 1-3 Days 1-35
11
2.5 mL; (1/2 tsp)
7.5 mL
150 mg
10
22
5 mL; (1 tsp)
15 mL
300 mg
20
44
5 mL (1 tsp)
15 mL
600 mg
30
66
7.5 mL (1½ tsp)
22.5 mL
900 mg
40
88
10 mL (2 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL (2 ½ tsp)
37.5 mL
1500 mg
*Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established.
OTITIS MEDIA: (1-Day Regimen) Dosing Calculated on 30 mg/kg as a single dose. Weight 200 mg/5 mL Total mL per Treatment Course Total mg per Treatment Course Kg Lbs. 1-Day Regimen5
11
3.75 mL;(3/4 tsp)
3.75 mL
150 mg
10
22
7.5 mL;(1½ tsp)
7.5 mL
300 mg
20
44
15 mL;(3 tsp)
15 mL
600 mg
30
66
22.5 mL;(4½ tsp)
22.5 mL
900 mg
40
88
30 mL;(6 tsp)
30 mL
1200 mg
50 and above
110 and above
37.5 mL;(7½ tsp)
37.5 mL
1500 mg
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/Tonsillitis: The recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS/TONSILLITIS (Age 2 years and above, [see Use in Specific Populations (8.4)]) Based on Body Weight
PHARYNGITIS/TONSILLITIS: (5-Day Regimen) Dosing Calculated on 12 mg/kg/day for 5 days. Weight 200 mg/5 mL Total mL per Treatment Course Total mg per Treatment Course Kg Lbs. Day 1-58
18
2.5 mL; (½ tsp)
12.5 mL
500 mg
17
37
5 mL; (1 tsp)
25 mL
1000 mg
25
55
7.5 mL; (1½ tsp)
37.5 mL
1500 mg
33
73
10 mL; (2 tsp)
50 mL
2000 mg
40
88
12.5 mL; (2½ tsp)
62.5 mL
2500 mg
-
Ondansetron
Instructions for Use/Handling Ondansetron Orally Disintegrating Tablets
Do not attempt to push ondansetron orally disintegrating tablets, USP through the foil backing. With dry hands, PEEL BACK the foil backing of 1 blister and GENTLY remove the tablet. IMMEDIATELY place the ondansetron orally disintegrating tablet on top of the tongue where it will dissolve in seconds, then swallow with saliva. Administration with liquid is not necessary.
Prevention of Nausea and Vomiting Associated With Highly Emetogenic Cancer Chemotherapy
The recommended adult oral dosage of ondansetron hydrochloride is 24 mg given as three 8-mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥ 50 mg/m2. Multiday, single-dose administration of a 24 mg dosage has not been studied.
Pediatric Use
There is no experience with the use of a 24 mg dosage in pediatric patients.
Geriatric Use
The dosage recommendation is the same as for the general population.
Prevention of Nausea and Vomiting Associated With Moderately Emetogenic Cancer Chemotherapy
The recommended adult oral dosage is one 8-mg ondansetron orally disintegrating tablet, USP given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8-mg ondansetron orally disintegrating tablet, USP should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.
Pediatric Use
For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4-mg ondansetron orally disintegrating tablet, USP given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4-mg ondansetron orally disintegrating tablet, USP should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.
Geriatric Use
The dosage is the same as for the general population.
Prevention of Nausea and Vomiting Associated With Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions to the Abdomen
The recommended oral dosage is one 8 mg ondansetron orally disintegrating tablet, USP given 3 times a day.
For total body irradiation
One 8-mg ondansetron orally disintegrating tablet, USP should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.
For single high-dose fraction radiotherapy to the abdomen
One 8-mg ondansetron orally disintegrating tablet, USP should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.
For daily fractionated radiotherapy to the abdomen
One 8-mg ondansetron orally disintegrating tablet, USP should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.
Pediatric Use
There is no experience with the use of, ondansetron orally disintegrating tablets, USP, in the prevention of radiation-induced nausea and vomiting in pediatric patients.
Geriatric Use
The dosage recommendation is the same as for the general population.
Postoperative Nausea and Vomiting
The recommended dosage is 16 mg given as two 8-mg ondansetron orally disintegrating tablets, USP 1 hour before induction of anesthesia.
Pediatric Use
There is no experience with the use of ondansetron orally disintegrating tablets, USP in the prevention of postoperative nausea and vomiting in pediatric patients.
Geriatric Use
The dosage is the same as for the general population.
Dosage Adjustment for Patients With Impaired Renal Function
The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron.
Dosage Adjustment for Patients With Impaired Hepatic Function
In patients with severe hepatic impairment (Child-Pugh2 score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.
-
Celecoxib
Use lowest effective dose for the shortest duration consistent with treatment goals for the individual patient. These doses can be given without regard to timing of meals.
2.1 Osteoarthritis
For relief of the signs and symptoms of OA the recommended oral dose is 200 mg per day administered as a single dose or as 100 mg twice daily.
2.2 Rheumatoid Arthritis
For relief of the signs and symptoms of RA the recommended oral dose is 100 to 200 mg twice daily.
2.3 Juvenile Rheumatoid Arthritis
For the relief of the signs and symptoms of JRA the recommended oral dose for pediatric patients (age 2 years and older) is based on weight. For patients >10 kg to <25 kg the recommended dose is 50 mg twice daily. For patients >25 kg the recommended dose is 100 mg twice daily.
For patients who have difficulty swallowing capsules, the contents of a celecoxib capsule can be added to applesauce. The entire capsule contents are carefully emptied onto a level teaspoon of cool or room temperature applesauce and ingested immediately with water. The sprinkled capsule contents on applesauce are stable for up to 6 hours under refrigerated conditions (2-8° C/ 35-45° F).
2.4 Ankylosing Spondylitis
For the management of the signs and symptoms of AS, the recommended dose of celecoxib capsules is 200 mg daily in single (once per day) or divided (twice per day) doses. If no effect is observed after 6 weeks, a trial of 400 mg daily may be worthwhile. If no effect is observed after 6 weeks on 400 mg daily, a response is not likely and consideration should be given to alternate treatment options.
2.5 Management of Acute Pain and Treatment of Primary Dysmenorrhea
The recommended dose of celecoxib capsules is 400 mg initially, followed by an additional 200 mg dose if needed on the first day. On subsequent days, the recommended dose is 200 mg twice daily as needed.
2.6 Special Populations Hepatic insufficiency:
The daily recommended dose of celecoxib capsules in patients with moderate hepatic impairment (Child-Pugh Class B) should be reduced by 50%. The use of celecoxib in patients with severe hepatic impairment is not recommended [see Warnings and Precautions (5.5), Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
Poor Metabolizers of CYP2C9 Substrates:
Patients who are known or suspected to be poor CYP2C9 metabolizers based on genotype or previous history/experience with other CYP2C9 substrates (such as warfarin, phenytoin) should be administered celecoxib with caution. Consider starting treatment at half the lowest recommended dose in poor metabolizers (i.e. CYP2C9*3/*3). Consider using alternative management in JRA patients who are poor metabolizers. [see Use in Specific populations (8.8), and Clinical Pharmacology (12.5)].
-
Tramadol Hydrochloride And Acetaminophen
For the short-term (five days or less) management of acute pain, the recommended dose of tramadol hydrochloride and acetaminophen tablets is 2 tablets every 4 to 6 hours as needed for pain relief, up to a maximum of 8 tablets per day.
Individualization of Dose
In patients with creatinine clearances of less than 30 mL/min, it is recommended that the dosing interval of tramadol hydrochloride and acetaminophen tablets be increased not to exceed 2 tablets every 12 hours. Dose selection for an elderly patient should be cautious, in view of the potential for greater sensitivity to adverse events.
-
Metoprolol Tartrate
Hypertension
The dosage of metoprolol tartrate tablets should be individualized. Metoprolol tartrate tablets should be taken with or immediately following meals.
The usual initial dosage of Metoprolol tartrate tablets is 100 mg daily in single or divided doses, whether used alone or added to a diuretic. The dosage may be increased at weekly (or longer) intervals until optimum blood pressure reduction is achieved. In general, the maximum effect of any given dosage level will be apparent after 1 week of therapy. The effective dosage range of Metoprolol tartrate tablets is 100 to 450 mg per day. Dosages above 450 mg per day have not been studied. While once-daily dosing is effective and can maintain a reduction in blood pressure throughout the day, lower doses (especially 100 mg) may not maintain a full effect at the end of the 24-hour period, and larger or more frequent daily doses may be required. This can be evaluated by measuring blood pressure near the end of the dosing interval to determine whether satisfactory control is being maintained throughout the day. Beta1 selectivity diminishes as the dose of metoprolol is increased.
Angina Pectoris
The dosage of metoprolol tartrate tablets should be individualized. Metoprolol tartrate tablets should be taken with or immediately following meals.
The usual initial dosage of Metoprolol tartrate tablets is 100 mg daily, given in two divided doses. The dosage may be gradually increased at weekly intervals until optimum clinical response has been obtained or there is pronounced slowing of the heart rate. The effective dosage range of Metoprolol tartrate tablets is 100 to 400 mg per day. Dosages above 400 mg per day have not been studied. If treatment is to be discontinued, the dosage should be reduced gradually over a period of 1 to 2 weeks (see WARNINGS).
Myocardial Infarction
Early Treatment
During the early phase of definite or suspected acute myocardial infarction, treatment with metoprolol tartrate can be initiated as soon as possible after the patient’s arrival in the hospital. Such treatment should be initiated in a coronary care or similar unit immediately after the patient’s hemodynamic condition has stabilized.
Treatment in this early phase should begin with the intravenous administration of three bolus injections of 5 mg of metoprolol tartrate each; the injections should be given at approximately 2-minute intervals. During the intravenous administration of metoprolol, blood pressure, heart rate, and electrocardiogram should be carefully monitored.
In patients who tolerate the full intravenous dose (15 mg), metoprolol tartrate tablets, 50 mg every 6 hours, should be initiated 15 minutes after the last intravenous dose and continued for 48 hours. Thereafter, patients should receive a maintenance dosage of 100 mg twice daily (see Late Treatment below).
Patients who appear not to tolerate the full intravenous dose should be started on metoprolol tartrate tablets either 25 mg or 50 mg every 6 hours (depending on the degree of intolerance) 15 minutes after the last intravenous dose or as soon as their clinical condition allows. In patients with severe intolerance, treatment with metoprolol should be discontinued (see WARNINGS).
Late Treatment
Patients with contraindications to treatment during the early phase of suspected or definite myocardial infarction, patients who appear not to tolerate the full early treatment, and patients in whom the physician wishes to delay therapy for any other reason should be started on metoprolol tartrate tablets, 100 mg twice daily, as soon as their clinical condition allows. Therapy should be continued for at least 3 months. Although the efficacy of metoprolol beyond 3 months has not been conclusively established, data from studies with other beta blockers suggest that treatment should be continued for 1 to 3 years.
Special populations
Pediatric patients: No pediatric studies have been performed. The safety and efficacy of Metoprolol Tartrate in pediatric patients have not been established.
Renal impairment: No dose adjustment of Metoprolol Tartrate is required in patients with renal impairment.
Hepatic impairment: Metoprolol Tartrate blood levels are likely to increase substantially in patients with hepatic impairment. Therefore, Metoprolol Tartrate should be initiated at low doses with cautious gradual dose titration according to clinical response.
Geriatric patients (>65 years):In general, use a low initial starting dose in elderly patients given their greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Method of administration:For oral treatment, the tablets should be swallowed un-chewed with a glass of water. Metoprolol Tartrate should always be taken in standardized relation with meals. If the physician asks the patient to take Metoprolol Tartrate either before breakfast or with breakfast, then the patient should continue taking Metoprolol Tartrate with the same schedule during the course of therapy.
-
Metronidazole
Trichomoniasis In the Female One-day treatment − two grams of metronidazole tablets, given either as a single dose or in two divided doses of one gram each, given in the same day.
Seven-day course of treatment − 250 mg three times daily for seven consecutive days. There is some indication from controlled comparative studies that cure rates as determined by vaginal smears and signs and symptoms, may be higher after a seven-day course of treatment than after a one-day treatment regimen.
The dosage regimen should be individualized. Single-dose treatment can assure compliance, especially if administered under supervision, in those patients who cannot be relied on to continue the seven-day regimen. A seven-day course of treatment may minimize reinfection by protecting the patient long enough for the sexual contacts to obtain appropriate treatment. Further, some patients may tolerate one treatment regimen better than the other.
Pregnant patients should not be treated during the first trimester (see CONTRAINDICATIONS). In pregnant patients for whom alternative treatment has been inadequate, the one-day course of therapy should not be used, as it results in higher serum levels which can reach the fetal circulation (see PRECAUTIONS, Pregnancy).
When repeat courses of the drug are required, it is recommended that an interval of four to six weeks elapse between courses and that the presence of the trichomonad be reconfirmed by appropriate laboratory measures. Total and differential leukocyte counts should be made before and after re-treatment.
In the Male
Treatment should be individualized as it is for the female.
Amebiasis
Adults
For acute intestinal amebiasis (acute amebic dysentery): 750 mg orally three times daily for 5 to 10 days.
For amebic liver abscess: 500 mg or 750 mg orally three times daily for 5 to 10 days.
Pediatric patients
35 to 50 mg/kg/24 hours, divided into three doses, orally for 10 days.
Anaerobic Bacterial Infections
In the treatment of most serious anaerobic infections, intravenous metronidazole is usually administered initially.
The usual adult oral dosage is 7.5 mg/kg every six hours (approx. 500 mg for a 70 kg adult). A maximum of 4 g should not be exceeded during a 24-hour period.
The usual duration of therapy is 7 to 10 days; however, infections of the bone and joint, lower respiratory tract, and endocardium may require longer treatment.
Dosage Adjustments
Patients with Severe Hepatic Impairment
For patients with severe hepatic
impairment (Child-Pugh C), the dose of metronidazole should be reduced by 50% (see CLINICAL PHARMACOLOGY and PRECAUTIONS).
Patients Undergoing Hemodialysis:
Hemodialysis removes significant amounts of metronidazole and its metabolites from systemic circulation. The clearance of metronidazole will depend on the type of dialysis membrane used, the duration of the dialysis session, and other factors. If the administration of metronidazole cannot be separated from the hemodialysis session, supplementation of metronidazole dosage following the hemodialysis session should be considered, depending on the patient’s clinical situation (see CLINICAL PHARMACOLOGY).
-
Regular Strength Enteric Coated Aspirin
• drink a full glass of water with each dose • swallow whole, do not chew or crush • do not exceed recommended dose • adults and children 12 years and older: take 1-2 tablets every 4 hours, as needed, not more than 12 tablets in 24 hours, or as directed by a doctor • children under 12 years: ask a doctor
-
Eszopiclone
Use the lowest effective dose for the patient.
2.1 Dosage in Adults
The recommended starting dose is 1 mg. Dosing can be raised to 2 mg or 3 mg if clinically indicated. In some patients, the higher morning blood levels of eszopiclone following use of the 2 mg or 3 mg dose increase the risk of next day impairment of driving and other activities that require full alertness [see Warnings and Precautions (5.1)]. The total dose of eszopiclone should not exceed 3 mg, once daily immediately before bedtime [see Warnings and Precautions (5.6)].
2.2 Geriatric or Debilitated Patients
The total dose of eszopiclone should not exceed 2 mg in elderly or debilitated patients.
2.3 Patients with Severe Hepatic Impairment, or Taking Potent CYP3A4 Inhibitors
In patients with severe hepatic impairment, or in patients coadministered eszopiclone tablets with potent CYP3A4 inhibitors, the total dose of eszopiclone should not exceed 2 mg [see Warnings and Precautions (5.7)].
2.4 Use with CNS Depressants
Dosage adjustments may be necessary when eszopiclone tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.1)].
2.5 Administration with Food
Taking eszopiclone tablets with or immediately after a heavy, high-fat meal results in slower absorption and would be expected to reduce the effect of eszopiclone tablets on sleep latency [see Clinical Pharmacology (12.3)].
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Methimazole
Methimazole is administered orally. It is usually given in 3 equal doses at approximately 8-hour intervals.
Adults
The initial daily dosage is 15 mg for mild hyperthyroidism, 30 to 40 mg for moderately severe hyperthyroidism, and 60 mg for severe hyperthyroidism, divided into 3 doses at 8-hour intervals. The maintenance dosage is 5 to 15 mg daily.
Pediatric
Initially, the daily dosage is 0.4 mg/kg of body weight divided into 3 doses and given at 8-hour intervals. The maintenance dosage is approximately 1/2 of the initial dose.
-
Celecoxib
Use lowest effective dose for the shortest duration consistent with treatment goals for the individual patient.
These doses can be given without regard to timing of meals.
2.1 Osteoarthritis
For relief of the signs and symptoms of OA the recommended oral dose is 200 mg per day administered as a single dose or as 100 mg twice daily.
2.2 Rheumatoid Arthritis
For relief of the signs and symptoms of RA the recommended oral dose is 100 to 200 mg twice daily.
2.3 Juvenile Rheumatoid Arthritis
For the relief of the signs and symptoms of JRA the recommended oral dose for pediatric patients (age 2 years and older) is based on weight. For patients ≥10 kg to ≤25 kg the recommended dose is 50 mg twice daily. For patients >25 kg the recommended dose is 100 mg twice daily.
For patients who have difficulty swallowing capsules, the contents of a celecoxib capsule can be added to applesauce. The entire capsule contents are carefully emptied onto a level teaspoon of cool or room temperature applesauce and ingested immediately with water. The sprinkled capsule contents on applesauce are stable for up to 6 hours under refrigerated conditions (2–8° C/ 35–45° F).
2.4 Ankylosing Spondylitis
For the management of the signs and symptoms of AS, the recommended dose of celecoxib is 200 mg daily in single (once per day) or divided (twice per day) doses. If no effect is observed after 6 weeks, a trial of 400 mg daily may be worthwhile. If no effect is observed after 6 weeks on 400 mg daily, a response is not likely and consideration should be given to alternate treatment options.
2.5 Management of Acute Pain and Treatment of Primary Dysmenorrhea
The recommended dose of celecoxib is 400 mg initially, followed by an additional 200 mg dose if needed on the first day. On subsequent days, the recommended dose is 200 mg twice daily as needed.
2.6 Special Populations
Hepatic insufficiency: The daily recommended dose of celecoxib capsules in patients with moderate hepatic impairment (Child-Pugh Class B) should be reduced by 50%. The use of celecoxib in patients with severe hepatic impairment is not recommended [see Warnings and Precautions (5.5), Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
Poor Metabolizers of CYP2C9 Substrates: Patients who are known or suspected to be poor CYP2C9 metabolizers based on genotype or previous history/experience with other CYP2C9 substrates (such as warfarin, phenytoin) should be administered celecoxib with caution. Consider starting treatment at half the lowest recommended dose in poor metabolizers (i.e. CYP2C9*3/*3). Consider using alternative management in JRA patients who are poor metabolizers. [see Use in Specific populations (8.8), and Clinical Pharmacology (12.5)].
-
Isoniazid
(See also INDICATIONS AND USAGE):
NOTE--For preventive therapy of tuberculous infection and treatment of tuberculosis, it is recommended that physicians be familiar with the following publications: (1) the recommendations of the Advisory Council for the Elimination of Tuberculosis, published in the MMWR: vol 42; RR-4, 1993 and (2)Treatment of Tuberculosis and Tuberculosis Infection in Adults and Children, American Journal of Respiratory and Critical Care Medicine: vol 149; 1359-1374, 1994.
For Treatment of Tuberculosis
Isoniazid is used in conjunction with other effective anti-tuberculous agents. Drug susceptibility testing should be performed on the organisms initially isolated from all patients with newly diagnosed tuberculosis. If the bacilli becomes resistant, therapy must be changed to agents to which the bacilli are susceptible.
Usual Oral Dosage (depending on the regimen used):
Adults
5 mg/kg up to 300 mg daily in a single dose; or15 mg/kg up to 900 mg/day, two or three times/week
Children
10 mg/kg to15 mg/kg up to 300 mg daily in a single dose; or20 mg/kg to 40 mg/kg up to 900 mg/day, two or three times/week
Patients with Pulmonary Tuberculosis Without HIV Infection
There are 3 regimen options for the initial treatment of tuberculosis in children and adults:
Option 1: Daily isoniazid, rifampin and pyrazinamide for 8 weeks followed by 16 weeks of isoniazid and rifampin daily or 2 to 3 times weekly. Ethambutol or streptomycin should be added to the initial regimen until sensitivity to isoniazid and rifampin is demonstrated. The addition of a fourth drug is optional if the relative prevalence of isoniazid-resistant Mycobacterium tuberculosis isolates in the community is less than or equal to four percent.
Option 2: Daily isoniazid, rifampin, pyrazinamide and streptomycin or ethambutol for 2 weeks followed by twice weekly administration of the same drugs for 6 weeks, subsequently twice weekly isoniazid and rifampin for 16 weeks.
Option 3: Three times weekly with isoniazid, rifampin, pyrazinamide and ethambutol or streptomycin for 6 months.
*All regimens given twice weekly or 3 times weekly should be administered by directly observed therapy (see also Directly Observed Therapy (DOT)).
The above treatment guidelines apply only when the disease is caused by organisms that are susceptible to the standard antituberculous agents. Because of the impact of resistance to isoniazid and rifampin on the response to therapy, it is essential that physicians initiating therapy for tuberculosis be familiar with the prevalence of drug resistance in their communities. It is suggested that ethambutol not be used in children whose visual acuity cannot be monitored.
Patients with Pulmonary Tuberculosis and HIV Infection
The response of the immunologically impaired host to treatment may not be as satisfactory as that of a person with normal host responsiveness. For this reason, therapeutic decisions for the impaired host must be individualized. Since patients co-infected with HIV may have problems with malabsorption, screening of antimycobacterial drug levels, especially in patients with advanced HIV disease, may be necessary to prevent the emergence of MDRTB.
Patients with Extra Pulmonary Tuberculosis
The basic principles that underlie the treatment of pulmonary tuberculosis also apply to Extra pulmonary forms of the disease. Although there have not been the same kinds of carefully conducted controlled trials of treatment of Extra pulmonary tuberculosis as for pulmonary disease, increasing clinical experience indicates that a 6 to 9 month short-course regimen is effective. Because of the insufficient data, miliary tuberculosis, bone/joint tuberculosis and tuberculous meningitis in infants and children should receive 12 month therapy.
Bacteriologic evaluation of Extra pulmonary tuberculosis may be limited by the relative inaccessibility of the sites of disease. Thus, response to treatment often must be judged on the basis of clinical and radiographic findings.
The use of adjunctive therapies such as surgery and corticosteroids is more commonly required in Extra pulmonary tuberculosis than in pulmonary disease. Surgery may be necessary to obtain specimens for diagnosis and to treat such processes as constrictive pericarditis and spinal cord compression from Pott's Disease. Corticosteriods have been shown to be of benefit in preventing cardiac constriction from tuberculous pericarditis and in decreasing the neurologic sequelae of all stages of tuberculosis meningitis, especially when administered early in the course of the disease.
Pregnant Women with Tuberculosis
The options listed above must be adjusted for the pregnant patient. Streptomycin interferes with in utero development of the ear and may cause congenital deafness. Routine use of pyrazinamide is also not recommended in pregnancy because of inadequate teratogenicity data. The initial treatment regimen should consist of isoniazid and rifampin. Ethambutol should be included unless primary isoniazid resistance is unlikely (isoniazid resistance rate documented to be less than 4%).
Treatment of Patients with Multi-Drug Resistant Tuberculosis (MDRTB)
Multiple-drug resistant tuberculosis (i.e., resistance to at least isoniazid and rifampin) presents difficult treatment problems. Treatment must be individualized and based on susceptibility studies. In such cases, consultation with an expert in tuberculosis is recommended.
Directly Observed Therapy (DOT)
A major cause of drug-resistant tuberculosis is patient noncompliance with treatment. The use of DOT can help assure patient compliance with drug therapy. DOT is the observation of the patient by a health care provider or other responsible person as the patient ingests anti-tuberculosis medications. DOT can be achieved with daily, twice weekly or thrice weekly regimens and is recommended for all patients.
For Preventative Therapy of Tuberculosis
Before isoniazid preventive therapy is initiated, bacteriologically positive or radiographically progressive tuberculosis must be excluded. Appropriate evaluations should be performed if Extra pulmonary tuberculosis is suspected.
Adults over 30 Kg
300 mg per day in a single dose.
Infants and Children
10 mg/kg (up to 300 mg daily) in a single dose. In situations where adherence with daily preventative therapy cannot be assured, 20 mg/kg to 30 mg/kg (not to exceed 900 mg) twice weekly under the direct observation of a health care worker at the time of administration8.
Continuous administration of isoniazid for a sufficient period is an essential part of the regimen because relapse rates are higher if chemotherapy is stopped prematurely. In the treatment of tuberculosis, resistant organisms may multiply and the emergence of resistant organisms during the treatment may necessitate a change in the regimen.
For following patient compliance: the Potts-Cozart test9, a simple colorimetric6 method of checking for isoniazid in the urine, is a useful tool for assuring patient compliance, which is essential for effective tuberculosis control. Additionally, isoniazid test strips are also available to check patient compliance.
Concomitant administration of pyridoxine (B6) is recommended in the malnourished and in those predisposed to neuropathy (e.g., alcoholics and diabetics).
-
Good Sense Tussin Dm Cough And Chest Congestion
• do not take more than 6 doses in any 24-hour period • measure only with dosing cup provided • keep dosing cup with product • mL = milliliter • this adult product is not intended for use in children under 12 years of age
age
dose
adults and children
12 years and over
10 mL
every 4 hours
children under 12 years
do not use
-
Adult Low Dose Enteric Coated Aspirin
• drink a full glass of water with each dose • swallow whole, do not chew or crush • do not exceed recommended dose • adults and children 12 years and older: take 4-8 tablets every 4 hours, as needed, not more than 48 tablets in 24 hours, or as directed by a doctor • children under 12 years: ask a doctor
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Hydrochlorothiazide
Therapy should be individualized according to patient response. Use the smallest dosage necessary to achieve the required response.
Adults:For Edema: The usual adult dosage is 25 to 100 mg daily as a single or divided dose. Many patients with edema respond to intermittent therapy, i.e., administration on alternate days or on 3 to 5 days each week. With an intermittent schedule, excessive response and the resulting undesirable electrolyte imbalance are less likely to occur.
For Control of Hypertension: The usual initial dose in adults is 25 mg daily given as a single dose. The dose may be increased to 50 mg daily, given as a single or two divided doses. Doses above 50 mg are often associated with marked reductions in serum potassium (see also PRECAUTIONS).
Patients usually do not require doses in excess of 50 mg of hydrochlorothiazide daily when used concomitantly with other antihypertensive agents.
Infants and Children: For Diuresis and for Control of Hypertension: The usual pediatric dosage is 0.5 mg to 1 mg per pound (1 to 2 mg/kg) per day in single or two divided doses, not to exceed 37.5 mg per day in infants up to 2 years of age or 100 mg per day in children 2 to 12 years of age. In infants less than 6 months of age, doses up to 1.5 mg per pound (3 mg/kg) per day in two divided doses may be required (See PRECAUTIONS: Pediatric Use).
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![Tramadol Hydrochloride Tablet, Extended Release [Preferred Pharmaceuticals Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=94cc034e-e6c6-4bb2-b3b0-0a9a4a708add&name=tramadol-label-200mg.jpg)
Tramadol Hydrochloride
Tramadol hydrochloride extended-release tablets should not be used in patients with:
• creatinine clearance less than 30 mL/min, • severe hepatic impairment (Child-Pugh Class C)(See PRECAUTIONS, Use in Renal and Hepatic Disease).
Tramadol hydrochloride extended-release tablets must be swallowed whole and must not be chewed, crushed, or split (see WARNINGS, Misuse, Abuse and Diversion of Opioids and DRUG ABUSE AND ADDICTION).
Adults (18 years of age and over)
Patients Not Currently on Tramadol Immediate-Release Products
For patients not currently treated with tramadol immediate-release (IR) products, tramadol hydrochloride extended-release tablets should be initiated at a dose of 100 mg once daily and titrated up as necessary by 100 mg increments every five days to relief of pain and depending upon tolerability. Tramadol hydrochloride extended-release tablets should not be administered at a dose exceeding 300 mg per day.
Patients Currently on Tramadol Immediate-Release Products
For patients maintained on tramadol IR products, calculate the 24-hour tramadol immediate-release (IR) dose and initiate a total daily dose of tramadol hydrochloride extended-release tablets rounded down to the next lowest 100 mg increment. The dose may subsequently be individualized according to patient need. Due to limitations in flexibility of dose selection with tramadol hydrochloride extended-release tablets, some patients maintained on tramadol IR products may not be able to convert to tramadol hydrochloride extended-release tablets. Tramadol hydrochloride extended-release tablets should not be administered at a dose exceeding 300 mg per day. The concomitant use of tramadol hydrochloride extended-release tablets with other tramadol products is not recommended (see WARNINGS).
Individualization of Dose
Good pain management practice dictates that the dose be individualized according to patient need using the lowest beneficial dose. Start at the lowest possible dose and titrate upward as tolerated to achieve an adequate effect. Clinical studies of tramadol hydrochloride extended-release tablets have not demonstrated a clinical benefit at a total daily dose exceeding 300 mg.
In general, dosing of an elderly patient (over 65 years of age) should be initiated cautiously, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function and of concomitant disease or other drug therapy. Tramadol hydrochloride extended-release tablets should be administered with even greater caution in patients over 75 years, due to the greater frequency of adverse events seen in this population.
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Tramadol Hydrochloride
2.1 General Dosing Considerations
Tramadol Hydrochloride Extended-Release is an extended-release formulation intended for once a day dosing in adults aged 18 years and older. The capsules must be swallowed whole with liquid and must not be split, chewed, dissolved or crushed. Chewing, crushing, dissolving or splitting the capsule could result in the uncontrolled delivery of tramadol, in overdose and death [see WARNINGS AND PRECAUTIONS (5.11), DRUG ABUSE AND DEPENDENCE (9), AND OVERDOSE (10.1)].
Do not administer Tramadol Hydrochloride Extended-Release at a dose exceeding 300 mg per day. Do not use Tramadol Hydrochloride Extended-Release more than once daily or concomitantly with other tramadol products [see WARNINGS AND PRECAUTIONS (5.12)].
2.2 Patients Not Currently on Tramadol Immediate-Release Products
Initiate treatment with Tramadol Hydrochloride Extended-Release at a dose of 100 mg once daily and titrated up as necessary to 150 mg, 200 mg, and 300 mg every five days to achieve a balance between relief of pain and tolerability.
2.3 Patients Currently on Tramadol Immediate-Release Products
Calculate the 24-hour tramadol IR dose and initiate a total daily dose of Tramadol Hydrochloride Extended-Release rounded down to the next lowest 100 mg dose. The dose may subsequently be individualized according to patient need. Due to limitations in flexibility of dose selection with Tramadol Hydrochloride Extended-Release, some patients maintained on tramadol IR products may not be able to convert to Tramadol Hydrochloride Extended-Release.
2.4 Patients 65 Years of Age and Older
Dosing of an elderly patient (over 65 years of age) should be initiated cautiously, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function and of concomitant disease or other drug therapy. Tramadol Hydrochloride Extended-Release should be administered with even greater caution in patients over 75 years, due to the greater frequency of adverse events seen in this population.
2.5 Patients with Renal Impairment
The limited availability of dose strengths and once daily dosing of Tramadol Hydrochloride Extended-Release Capsules do not permit the dosing flexibility required for safe use in patients with severe renal impairment. Do not use Tramadol Hydrochloride Extended-Release in patients with creatinine clearance less than 30 mL/min [see USE IN SPECIFIC POPULATIONS (8.6) and CLINICAL PHARMACOLOGY (12.3)].
2.6 Patients with Hepatic Impairment
The limited availability of dose strengths and once daily dosing of Tramadol Hydrochloride Extended-Release capsules do not permit the dosing flexibility required for safe use in patients with severe hepatic impairment. Do not use Tramadol Hydrochloride Extended-Release in patients with severe hepatic impairment (Child-Pugh Class C) [see USE IN SPECIFIC POPULATIONS (8.7) and CLINICAL PHARMACOLOGY (12.3)].
2.7 Discontinuation of Treatment
Withdrawal symptoms may occur if Tramadol Hydrochloride Extended-Release is discontinued abruptly. Clinical experience with tramadol suggests that withdrawal symptoms may be reduced by tapering Tramadol Hydrochloride Extended-Release [see WARNINGS AND PRECAUTIONS (5.10) and DRUG ABUSE AND DEPENDENCE (9.3)].
2.8 Food Effects
Tramadol Hydrochloride Extended-Release may be taken without regard to food [see CLINICAL PHARMACOLOGY (12.3)].
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Venlafaxine Hydrochloride
Venlafaxine hydrochloride extended-release capsules should be administered in a single dose with food, either in the morning or in the evening at approximately the same time each day [see Clinical Pharmacology (12.3)]. Each capsule should be swallowed whole with fluid and not divided, crushed, chewed, or placed in water or it may be administered by carefully opening the capsule and sprinkling the entire contents on a spoonful of applesauce. This drug/food mixture should be swallowed immediately without chewing and followed with a glass of water to ensure complete swallowing of the pellets (spheroids).
2.1 Major Depressive Disorder
For most patients, the recommended starting dose for venlafaxine hydrochloride extended-release capsules is 75 mg per day, administered in a single dose. For some patients, it may be desirable to start at 37.5 mg per day for 4 to 7 days to allow new patients to adjust to the medication before increasing to 75 mg per day. Patients not responding to the initial 75 mg per day dose may benefit from dose increases to a maximum of 225 mg per day. Dose increases should be in increments of up to 75 mg per day, as needed, and should be made at intervals of not less than 4 days, since steady-state plasma levels of venlafaxine and its major metabolites are achieved in most patients by day 4 [see Clinical Pharmacology (12.3)]. In the clinical studies establishing efficacy, upward titration was permitted at intervals of 2 weeks or more.
It should be noted that, while the maximum recommended dose for moderately depressed outpatients is also 225 mg per day for venlafaxine hydrochloride tablets, more severely depressed inpatients in one study of the development program for that product responded to a mean dose of 350 mg per day (range of 150 to 375 mg per day). Whether or not higher doses of venlafaxine hydrochloride extended-release capsules are needed for more severely depressed patients is unknown; however, the experience with venlafaxine hydrochloride extended-release capsules doses higher than 225 mg per day is very limited.
2.3 Social Anxiety Disorder (Social Phobia)
The recommended dose is 75 mg per day, administered in a single dose. There was no evidence that higher doses confer any additional benefit.
2.4 Panic Disorder
The recommended starting dose is 37.5 mg per day of venlafaxine hydrochloride extended-release capsules for 7 days. Patients not responding to 75 mg per day may benefit from dose increases to a maximum of approximately 225 mg per day. Dose increases should be in increments of up to 75 mg per day, as needed, and should be made at intervals of not less than 7 days.
2.5 Switching Patients from Venlafaxine Hydrochloride Tablets
Depressed patients who are currently being treated at a therapeutic dose with venlafaxine hydrochloride tablets may be switched to venlafaxine hydrochloride extended-release capsules at the nearest equivalent dose (mg per day), e.g., 37.5 mg venlafaxine twice a day to 75 mg venlafaxine hydrochloride extended-release capsules once daily. However, individual dosage adjustments may be necessary.
2.6 Specific Populations
Patients with Hepatic Impairment
The total daily dose should be reduced by 50% in patients with mild (Child-Pugh=5 to 6) to moderate (Child-Pugh=7 to 9) hepatic impairment. In patients with severe hepatic impairment (Child-Pugh=10 to 15) or hepatic cirrhosis, it may be necessary to reduce the dose by 50% or more [See Use in Specific Populations (8.7)].
Patients with Renal Impairment
The total daily dose should be reduced by 25% to 50% in patients with mild (CLcr= 60 to 89 mL/min) or moderate (CLcr= 30 to 59 mL/min) renal impairment. In patients undergoing hemodialysis or with severe renal impairment (CLcr < 30 mL/min), the total daily dose should be reduced by 50% or more. Because there was much individual variability in clearance between patients with renal impairment, individualization of dosage may be desirable in some patients [see Use in Specific Populations (8.7)].
2.7 Maintenance Treatment
There is no body of evidence available from controlled studies to indicate how long patients with MDD, SAD, or PD should be treated with venlafaxine hydrochloride extended-release capsules.
It is generally agreed that acute episodes of MDD require several months or longer of sustained pharmacological therapy beyond response to the acute episode. Venlafaxine hydrochloride extended-release capsules/venlafaxine hydrochloride tablets have demonstrated continuation of response in clinical studies up to 52 weeks, at the same dose at which patients responded during the initial treatment [see Clinical Studies (14.1)]. It is not known whether or not the dose of venlafaxine hydrochloride needed for maintenance treatment is identical to the dose needed to achieve an initial response. Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment.
In patients with SAD, venlafaxine hydrochloride extended-release capsules have been shown to be effective in 6-month clinical studies. The need for continuing medication in patients with SAD who improve with venlafaxine hydrochloride extended-release capsules treatment should be periodically reassessed.
In a clinical study for PD, patients continuing venlafaxine hydrochloride extended-release capsules at the same dose at which they responded during the initial 12 weeks of treatment experienced a statistically significantly longer time to relapse than patients randomized to placebo [see Clinical Studies (14.4)]. The need for continuing medication in patients with PD who improve with venlafaxine hydrochloride treatment should be periodically reassessed.
2.8 Discontinuing venlafaxine hydrochloride extended-release capsules
A gradual reduction in the dose, rather than abrupt cessation, is recommended whenever possible. In clinical studies with venlafaxine hydrochloride extended-release capsules, tapering was achieved by reducing the daily dose by 75 mg at one-week intervals. Individualization of tapering may be necessary [see Warnings and Precautions (5.7)].
2.9 Switching Patients to or from a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders
At least 14 days should elapse between discontinuation of an MAOI (intended to treat psychiatric disorders) and initiation of therapy with venlafaxine hydrochloride extended-release capsules. In addition, at least 7 days should be allowed after stopping venlafaxine hydrochloride extended-release capsules before starting an MAOI intended to treat psychiatric disorders [see Contraindications (4.2), Warnings and Precautions (5.2), and Drug Interactions (7.2)].
Use of venlafaxine hydrochloride extended-release capsules with other MAOIs such as Linezolid or Intravenous Methylene Blue
Do not start venlafaxine hydrochloride extended-release capsules in a patient who is being treated with linezolid or intravenous methylene blue, because there is an increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization should be considered [see Contraindications 4.2)].
In some cases, a patient already receiving venlafaxine hydrochloride extended-release capsules therapy may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, venlafaxine hydrochloride extended-release capsules should be stopped promptly, and linezolid or intravenous methylene blue can be administered. Monitor the patient for symptoms of serotonin syndrome for 7 days or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with venlafaxine hydrochloride can be resumed 24 hours after the last dose of linezolid or intravenous methylene blue [see Warnings and Precautions (5.2)].
The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg concomitantly with venlafaxine hydrochloride is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use [see Warnings and Precautions (5.2)].
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![Acetaminophen, Caffeine, Dihydrocodeine Bitartrate Capsule [Preferred Pharmaceuticals Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=1002a53c-551c-48f3-b4a5-a0922e1e8ca7&name=labl1.jpg)
Acetaminophen
The usual adult dosage is two (2) Acetaminophen, Caffeine, and Dihydrocodeine Bitartrate capsules orally every four (4) hours, as needed. Dosage should be adjusted according to the severity of the pain and the response of the patient. No more than two (2) capsules should be taken in a 4-hour period. No more than five (5) doses, or ten (10) capsules should be taken in a 24-hour period.
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![Diclofenac Sodium Delayed Release (Diclofenac Sodium) Tablet, Delayed Release [Preferred Pharmaceuticals Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=c933eaad-ba53-4130-90db-a66f89dfc29f&name=dic05-0003-05.jpg)
Diclofenac Sodium Delayed Release
Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with diclofenac, the dose and frequency should be adjusted to suit an individual patient's needs.
For the relief of osteoarthritis, the recommended dosage is 100 to 150 mg/day in divided doses (50 mg b.i.d. or t.i.d., or 75 mg b.i.d.).
For the relief of rheumatoid arthritis, the recommended dosage is 150 to 200 mg/day in divided doses (50 mg t.i.d. or q.i.d., or 75 mg b.i.d.).
For the relief of ankylosing spondylitis, the recommended dosage is 100 to 125 mg/day, administered as 25 mg q.i.d., with an extra 25-mg dose at bedtime if necessary.
Different formulations of diclofenac (diclofenac sodium delayed-release tablets; diclofenac sodium extended-release tablets; diclofenac potassium immediate-release tablets) are not necessarily bioequivalent even if the milligram strength is the same.
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![Famotidine Tablet [Preferred Pharmaceuticals Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=97418bd4-f411-4bd6-b06d-b1eb00758b98&name=fam00-0002-04.jpg)
Famotidine
Duodenal Ulcer
Acute Therapy: The recommended adult oral dosage for active duodenal ulcer is 40 mg once a day at bedtime. Most patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. A regimen of 20 mg b.i.d. is also effective.
Maintenance Therapy: The recommended adult oral dose is 20 mg once a day at bedtime.
Benign Gastric Ulcer
Acute Therapy: The recommended adult oral dosage for active benign gastric ulcer is 40 mg once a day at bedtime.
Gastroesophageal Reflux Disease (GERD)
The recommended oral dosage for treatment of adult patients with symptoms of GERD is 20 mg b.i.d. for up to 6 weeks. The recommended oral dosage for the treatment of adult patients with esophagitis including erosions and ulcerations and accompanying symptoms due to GERD is 20 or 40 mg b.i.d. for up to 12 weeks (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies).
Dosage for Pediatric Patients <1 year of age Gastroesophageal Reflux Disease (GERD)
See PRECAUTIONS , Pediatric Patients <1 year of age.
The studies described in PRECAUTIONS , Pediatric Patients <1 year of age suggest the following starting doses in pediatric patients <1 year of age: Gastroesophageal Reflux Disease (GERD) - 0.5 mg/kg/dose of famotidine oral suspension for the treatment of GERD for up to 8 weeks once daily in patients <3 months of age and 0.5 mg/kg/dose twice daily in patients 3 months to <1 year of age. Patients should also be receiving conservative measures (e.g., thickened feedings). The use of intravenous famotidine in pediatric patients <1 year of age with GERD has not been adequately studied.
Dosage for Pediatric Patients 1-16 years of age
See PRECAUTIONS , Pediatric Patients 1-16 years of age .
The studies described in PRECAUTIONS , Pediatric Patients 1-16 years of age suggest the following starting doses in pediatric patients 1-16 years of age:
Peptic ulcer — 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.
Gastroesophageal Reflux Disease with or without esophagitis including erosions and ulcerations — 1.0 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.
While published uncontrolled studies suggest effectiveness of famotidine in the treatment of gastroesophageal reflux disease and peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or pH determination (gastric or esophageal) and endoscopy. Published uncontrolled clinical studies in pediatric patients 1-16 years of age have employed doses up to 1 mg/kg/day for peptic ulcer and 2 mg/kg/day for GERD with or without esophagitis including erosions and ulcerations.
Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas)
The dosage of famotidine in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose for pathological hypersecretory conditions is 20 mg q 6 h. In some patients, a higher starting dose may be required. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. Doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison Syndrome.
Concomitant Use of Antacids
Antacids may be given concomitantly if needed.
Dosage Adjustment for Patients with Moderate or Severe Renal Insufficiency
In adult patients with moderate (creatinine clearance <50 mL/min) or severe (creatinine clearance <10 mL/min) renal insufficiency, the elimination half-life of famotidine is increased. For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients. Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of famotidine may be reduced to half the dose or the dosing interval may be prolonged to 36-48 hours as indicated by the patient's clinical response.
Based on the comparison of pharmacokinetic parameters for famotidine in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.
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Nizatidine
Active Duodenal Ulcer
The recommended oral dosage of adults is 300 mg once daily at bedtime. An alternative dosage regimen is 150 mg twice daily.
Maintenance of Healed Duodenal Ulcer
The recommended oral dosage for adults is 150 mg once daily at bedtime.
Gastroesophageal Reflux Disease
The recommended oral dosage in adults for the treatment of erosions, ulcerations, and associated heartburn is 150 mg twice daily.
Active Benign Gastric Ulcer
The recommended oral dosage is 300 mg given either as 150 mg twice daily or 300 mg once daily at bedtime. Prior to treatment, care should be taken to exclude the possibility of malignant gastric ulceration.
Dosage Adjustment for Patients With Moderate to Severe Renal Insufficiency
The dose for patients with renal dysfunction should be reduced as follows:
Active Duodenal Ulcer, GERD, and Benign Gastric Ulcer
Ccr
Dose
20-50 mL/min
150 mg daily
<20 mL/min
150 mg every other day
Maintenance Therapy
Ccr
Dose
20-50 mL/min
150 mg every other day
<20 mL/min
150 mg every 3 days
Some elderly patients may have creatinine clearances of less than 50 mL/min, and, based on pharmacokinetic data in patients with renal impairment, the dose for such patients should be reduced accordingly. The clinical effects of this dosage reduction in patients with renal failure have not been evaluated.
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![Lisinopril Tablet [Preferred Pharmaceuticals Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=f517c327-3077-4ebd-befd-3b6f8075cf01&name=lisinopril-10mg-100.jpg)
Lisinopril
2.1 Hypertension
Initial Therapy in adults: The recommended initial dose is 10 mg once a day. Dosage should be adjusted according to blood pressure response. The usual dosage range is 20 to 40 mg per day administered in a single daily dose. Doses up to 80 mg have been used but do not appear to give greater effect.
Use with diuretics in adults
If blood pressure is not controlled with lisinopril alone, a low dose of a diuretic may be added (eg, hydrochlorothiazide, 12.5 mg). After the addition of a diuretic, it may be possible to reduce the dose of lisinopril.
The recommended starting dose in adult patients with hypertension taking diuretics is 5 mg once per day.
Pediatric Patients 6 years of age and older with hypertension
For pediatric patients with glomerular filtration rate > 30 mL/min/1.73m 2, the recommended starting dose is 0.07 mg per kg once daily (up to 5 mg total). Dosage should be adjusted according to blood pressure response up to a maximum of 0.61 mg per kg (up to 40 mg) once daily. Doses above 0.61 mg per kg (or in excess of 40 mg) have not been studied in pediatric patients [See Clinical Pharmacology (12.3)].
Lisinopril is not recommended in pediatric patients < 6 years or in pediatric patients with glomerular filtration rate < 30 mL/min/1.73m 2 [See Use in Specific Populations (8.4) and Clinical Studies (14.1)].
2.2 Heart Failure
The recommended starting dose for lisinopril, when used with diuretics and (usually) digitalis as adjunctive therapy for systolic heart failure, is 5 mg once daily. The recommended starting dose in these patients with hyponatremia (serum sodium < 130 mEq/L) is 2.5 mg once daily. Increase as tolerated to a maximum of 40 mg once daily.
Diuretic dose may need to be adjusted to help minimize hypovolemia, which may contribute to hypotension [See Warnings and Precautions (5.4), and Drug Interactions (7.1)]. The appearance of hypotension after the initial dose of lisinopril does not preclude subsequent careful dose titration with the drug, following effective management of the hypotension.
2.3 Reduction of Mortality in Acute Myocardial Infarction
In hemodynamically stable patients within 24 hours of the onset of symptoms of acute myocardial infarction, give lisinopril 5 mg orally, followed by 5 mg after 24 hours, 10 mg after 48 hours and then 10 mg once daily. Dosing should continue for at least six weeks.
Initiate therapy with 2.5 mg in patients with a low systolic blood pressure (≤ 120 mmHg and > 100 mm Hg) during the first 3 days after the infarct [See Warnings and Precautions (5.4)]. If hypotension occurs (systolic blood pressure ≤ 100 mmHg) a daily maintenance dose of 5 mg may be given with temporary reductions to 2.5 mg if needed. If prolonged hypotension occurs (systolic blood pressure < 90 mmHg for more than 1 hour) lisinopril should be withdrawn.
2.4 Dose in Patients with Renal Impairment
No dose adjustment of lisinopril is required in patients with creatinine clearance > 30 mL/min. In patients with creatinine clearance ≥ 10 mL/min and ≤ 30 mL/min, reduce the initial dose of lisinopril to half of the usual recommended dose i.e., hypertension, 5 mg; systolic heart failure, 2.5 mg and acute MI, 2.5 mg. Up titrate as tolerated to a maximum of 40 mg daily. For patients on hemodialysis or creatinine clearance < 10 mL/min, the recommended initial dose is 2.5 mg once daily [See Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].
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![Glyburide Tablet [Preferred Pharmaceuticals Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=1f497334-0400-4512-8809-b053f1267de5&name=ef6bcee2-figure-04.jpg)
Glyburide
Patients should be retitrated when transferred from glyburide tablets or other oral hypoglycemic agents.
There is no fixed dosage regimen for the management of diabetes mellitus with glyburide tablets or any other hypoglycemic agent. In addition to the usual monitoring of urinary glucose, the patient’s blood glucose must also be monitored periodically to determine the minimum effective dose for the patient; to detect primary failure, ie, inadequate lowering of blood glucose at the maximum recommended dose of medication; and to detect secondary failure, ie, loss of adequate blood glucose lowering response after an initial period of effectiveness. Glycosylated hemoglobin levels may also be of value in monitoring the patient’s response to therapy.
Short-term administration of glyburide tablets may be sufficient during periods of transient loss of control in patients usually controlled well on diet.
Usual Starting Dose
The usual starting dose of glyburide tablets is 2.5 to 5 mg daily, administered with breakfast or the first main meal. Those patients who may be more sensitive to hypoglycemic drugs should be started at 1.25 mg daily. (See PRECAUTIONS section for patients at increased risk.) Failure to follow an appropriate dosage regimen may precipitate hypoglycemia. Patients who do not adhere to their prescribed dietary and drug regimen are more prone to exhibit unsatisfactory response to therapy.
Transfer From Other Hypoglycemic Therapy Patients Receiving Other Oral Antidiabetic Therapy: Transfer of patients from other oral antidiabetic regimens to glyburide tablets should be done conservatively and the initial daily dose should be 2.5 to 5 mg. When transferring patients from oral hypoglycemic agents other than chlorpropamide to glyburide tablets, no transition period and no initial or priming dose are necessary. When transferring patients from chlorpropamide, particular care should be exercised during the first two weeks because the prolonged retention of chlorpropamide in the body and subsequent overlapping drug effects may provoke hypoglycemia.
Patients Receiving Insulin: Some Type II diabetic patients being treated with insulin may respond satisfactorily to glyburide tablets. If the insulin dose is less than 20 units daily, substitution of glyburide tablets 2.5 to 5 mg as a single daily dose may be tried. If the insulin dose is between 20 and 40 units daily, the patient may be placed directly on glyburide tablets 5 mg daily as a single dose. If the insulin dose is more than 40 units daily, a transition period is required for conversion to glyburide tablets. In these patients, insulin dosage is decreased by 50% and glyburide tablets 5 mg daily is started. Please refer to Titration to Maintenance Dose for further explanation.
Patients Receiving Colesevelam: When colesevelam is coadministered with glyburide, maximum plasma concentration and total exposure to glyburide is reduced. Therefore, glyburide tablets should be administered at least 4 hours prior to colesevelam.
Titration to Maintenance Dose
The usual maintenance dose is in the range of 1.25 to 20 mg daily, which may be given as a single dose or in divided doses (See Dosage Interval section). Dosage increases should be made in increments of no more than 2.5 mg at weekly intervals based upon the patient’s blood glucose response.
No exact dosage relationship exists between glyburide tablets and the other oral hypoglycemic agents. Although patients may be transferred from the maximum dose of other sulfonylureas, the maximum starting dose of 5 mg of glyburide tablets should be observed. A maintenance dose of 5 mg of glyburide tablets provides approximately the same degree of blood glucose control as 250 to 375 mg chlorpropamide, 250 to 375 mg tolazamide, 500 to 750 mg acetohexamide, or 1000 to 1500 mg tolbutamide.
When transferring patients receiving more than 40 units of insulin daily, they may be started on a daily dose of glyburide tablets 5 mg concomitantly with a 50% reduction in insulin dose. Progressive withdrawal of insulin and increase of glyburide tablets in increments of 1.25 to 2.5 mg every 2 to 10 days is then carried out. During this conversion period when both insulin and glyburide tablets are being used, hypoglycemia may rarely occur. During insulin withdrawal, patients should test their urine for glucose and acetone at least three times daily and report results to their physician. The appearance of persistent acetonuria with glycosuria indicates that the patient is a Type I diabetic who requires insulin therapy.
Concomitant Glyburide and Metformin Therapy
Glyburide tablets should be added gradually to the dosing regimen of patients who have not responded to the maximum dose of metformin monotherapy after four weeks (see Usual Starting Dose and Titration to Maintenance Dose). Refer to metformin package insert.
With concomitant glyburide and metformin therapy, the desired control of blood glucose may be obtained by adjusting the dose of each drug. However, attempts should be made to identify the optimal dose of each drug needed to achieve this goal. With concomitant glyburide and metformin therapy, the risk of hypoglycemia associated with sulfonylurea therapy continues and may be increased. Appropriate precautions should be taken (see PRECAUTIONS section).
Maximum Dose
Daily doses of more than 20 mg are not recommended.
Dosage Interval
Once-a-day therapy is usually satisfactory. Some patients, particularly those receiving more than 10 mg daily, may have a more satisfactory response with twice-a-day dosage.
Specific Patient Populations
Glyburide tablets is not recommended for use in pregnancy or for use in pediatric patients.
In elderly patients, debilitated or malnourished patients, and patients with impaired renal or hepatic function, the initial and maintenance dosing should be conservative to avoid hypoglycemic reactions. (See PRECAUTIONS section.)
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Lisinopril
2.1 Hypertension
Initial Therapy in adults: The recommended initial dose is 10 mg once a day. Dosage should be adjusted according to blood pressure response. The usual dosage range is 20 mg to 40 mg per day administered in a single daily dose. Doses up to 80 mg have been used but do not appear to give greater effect.
Use with diuretics in adults
If blood pressure is not controlled with lisinopril tablets alone, a low dose of a diuretic may be added (e.g., hydrochlorothiazide, 12.5 mg). After the addition of a diuretic, it may be possible to reduce the dose of lisinopril tablets.
The recommended starting dose in adult patients with hypertension taking diuretics is 5 mg once per day.
Pediatric Patients 6 years of age and older with hypertension
For pediatric patients with glomerular filtration rate > 30 mL/min/1.73m2, the recommended starting dose is 0.07 mg per kg once daily (up to 5 mg total). Dosage should be adjusted according to blood pressure response up to a maximum of 0.61 mg per kg (up to 40 mg) once daily. Doses above 0.61 mg per kg (or in excess of 40 mg) have not been studied in pediatric patients [see Clinical Pharmacology (12.3)].
Lisinopril tablets are not recommended in pediatric patients < 6 years or in pediatric patients with glomerular filtration rate < 30 mL/min/1.73m2 [see Use in Specific Populations (8.4)and Clinical Studies (14.1)].
2.2 Heart Failure
The recommended starting dose for lisinopril tablets, when used with diuretics and (usually) digitalis as adjunctive therapy for systolic heart failure, is 5 mg once daily. The recommended starting dose in these patients with hyponatremia (serum sodium < 130 mEq/L) is 2.5 mg once daily. Increase as tolerated to a maximum of 40 mg once daily.
Diuretic dose may need to be adjusted to help minimize hypovolemia, which may contribute to hypotension [see Warnings and Precautions (5.4), and Drug Interactions (7.1)]. The appearance of hypotension after the initial dose of lisinopril tablets does not preclude subsequent careful dose titration with the drug, following effective management of the hypotension.
2.3 Reduction of Mortality in Acute Myocardial Infarction
In hemodynamically stable patients within 24 hours of the onset of symptoms of acute myocardial infarction, give lisinopril tablets 5 mg orally, followed by 5 mg after 24 hours, 10 mg after 48 hours and then 10 mg once daily. Dosing should continue for at least six weeks.
Initiate therapy with 2.5 mg in patients with a low systolic blood pressure (≤ 120 mmHg and > 100 mm Hg) during the first 3 days after the infarct [see Warnings and Precautions (5.4)]. If hypotension occurs (systolic blood pressure ≤ 100 mmHg) a daily maintenance dose of 5 mg may be given with temporary reductions to 2.5 mg if needed. If prolonged hypotension occurs (systolic blood pressure < 90 mmHg for more than 1 hour) lisinopril tablets should be withdrawn.
2.4 Dose in Patients with Renal Impairment
No dose adjustment of lisinopril tablets is required in patients with creatinine clearance > 30 mL/min. In patients with creatinine clearance ≥ 10 mL/min and ≤ 30 mL/min, reduce the initial dose of lisinopril tablets to half of the usual recommended dose i.e., hypertension, 5 mg; systolic heart failure, 2.5 mg and acute MI, 2.5 mg. Up titrate as tolerated to a maximum of 40 mg daily. For patients on hemodialysis or creatinine clearance < 10 mL/min, the recommended initial dose is 2.5 mg once daily [see Use in Specific Populations (8.7)and Clinical Pharmacology (12.3)].
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![Rabeprazole Sodium Tablet, Delayed Release [Preferred Pharmaceuticals Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=0a00adf2-5c45-4eb1-a03e-8d37980f8633&name=image-06.jpg)
Rabeprazole Sodium
2.1 Healing of Erosive or Ulcerative GERD in Adults
The recommended adult oral dose is one rabeprazole sodium 20 mg delayed-release tablet to be taken once daily for four to eight weeks [see Indications and Usage (1.1)]. For those patients who have not healed after 8 weeks of treatment, an additional 8 week course of rabeprazole sodium delayed-release tablets may be considered.
2.2 Maintenance of Healing of Erosive or Ulcerative GERD in Adults
The recommended adult oral dose is one rabeprazole sodium 20 mg delayed-release tablet to be taken once daily. Controlled studies do not extend beyond 12 months [see Indications and Usage (1.2)].
2.3 Treatment of Symptomatic GERD in Adults
The recommended adult oral dose is one rabeprazole sodium 20 mg delayed-release tablet to be taken once daily for 4 weeks [see Indications and Usage (1.3)]. If symptoms do not resolve completely after 4 weeks, an additional course of treatment may be considered.
2.4 Healing of Duodenal Ulcers in Adults
The recommended adult oral dose is one rabeprazole sodium 20 mg delayed-release tablet to be taken once daily after the morning meal for a period up to four weeks [see Indications and Usage (1.5)]. Most patients with duodenal ulcer heal within four weeks. A few patients may require additional therapy to achieve healing.
2.5 Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence in Adults
TABLE 1: THREE DRUG REGIMEN* * It is important that patients comply with the full 7 day regimen [see Clinical Studies (14.5)].Rabeprazole Sodium Delayed-Release Tablet
20 mg
Twice Daily for 7 Days
Amoxicillin
1000 mg
Twice Daily for 7 Days
Clarithromycin
500 mg
Twice Daily for 7 Days
All three medications should be taken twice daily with the morning and evening meals.
2.6 Treatment of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome in Adults
The dosage of rabeprazole sodium delayed-release tablets in patients with pathologic hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Some patients may require divided doses. Doses up to 100 mg QD and 60 mg BID have been administered. Some patients with Zollinger-Ellison syndrome have been treated continuously with rabeprazole sodium delayed-release tablets for up to one year.
2.7 Short-Term Treatment of Symptomatic GERD in Adolescent Patients 12 Years of Age and Older
The recommended oral dose for adolescents 12 years of age and older is one 20 mg delayed-release tablet once daily for up to 8 weeks [see Use in Specific Populations (8.4) and Clinical Studies (14.7)].
2.9 Elderly, Renal, and Hepatic Impaired Patients
No dosage adjustment is necessary in elderly patients, in patients with renal disease, or in patients with mild to moderate hepatic impairment. Administration of rabeprazole to patients with mild to moderate liver impairment resulted in increased exposure and decreased elimination. Due to the lack of clinical data on rabeprazole in patients with severe hepatic impairment, caution should be exercised in those patients.
2.10 Administration Recommendations
TABLE 2: ADMINISTRATION RECOMMENDATIONSFormulation
Population
Instructions
Delayed-Release Tablet
Adults and adolescents 12 years of age and older
Swallow tablets whole. Do not chew, crush, or split tablets.
Tablets can be taken with or without food.
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![Lorazepam Tablet [Preferred Pharmaceuticals Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=e5fe4d74-82ef-4896-976b-204061103d69&name=1e9f779d-5859-4b11-9b7a-d3efcbe83693-02.jpg)
Lorazepam
Lorazepam is administered orally. For optimal results, dose, frequency of administration, and duration of therapy should be individualized according to patient response. To facilitate this, 0.5 mg, 1 mg, and 2 mg tablets are available.
The usual range is 2 to 6 mg/day given in divided doses, the largest dose being taken before bedtime, but the daily dosage may vary from 1 to 10 mg/day.
For anxiety, most patients require an initial dose of 2 to 3 mg/day given b.i.d. or t.i.d.
For insomnia due to anxiety or transient situational stress, a single daily dose of 2 to 4 mg may be given, usually at bedtime.
For elderly or debilitated patients, an initial dosage of 1 to 2 mg/day in divided doses is recommended, to be adjusted as needed and tolerated.
The dosage of lorazepam should be increased gradually when needed to help avoid adverse effects. When higher dosage is indicated, the evening dose should be increased before the daytime doses.
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![Acetaminophen And Codeine Phosphate Tablet [Preferred Pharmaceuticals Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=ea29d458-601b-4040-b17b-7f9087466247&name=image-03.jpg)
Acetaminophen And Codeine Phosphate
Dosage should be adjusted according to severity of pain and response of the patient.
The usual adult dosage is:
Single Doses (range)
Maximum 24 Hour Dose
Codeine Phosphate
15 mg to 60 mg
360 mg
Acetaminophen
300 mg to 1000 mg
4000 mg
The usual dose of codeine phosphate in children is 0.5 mg/kg.
Doses may be repeated up to every 4 hours.
The prescriber must determine the number of tablets per dose, and the maximum number of tablets per 24 hours based upon the above dosage guidance. This information should be conveyed in the prescription.
It should be kept in mind, however, that tolerance to codeine can develop with continued use and that the incidence of untoward effects is dose related. Adult doses of codeine higher than 60 mg fail to give commensurate relief of pain but merely prolong analgesia and are associated with an appreciably increased incidence of undesirable side effects. Equivalently high doses in children would have similar effects.
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![Hydroxyzine (Hydroxyzine Hydrochloride) Solution [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=84691197-2289-4f2b-b1fb-086b7d91a299&name=container.jpg)
Hydroxyzine
For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested: in adults, 50 to 100 mg four times daily.: children under 6 years, 50 mg daily in divided doses: children over 6 years: 50 to 100 mg daily in divided doses.
For use in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and in histamine-mediated pruritus: in adults, 25 mg three times to four times daily.; children under 6 years, 50 mg daily in divided doses and children over 6 years, 50 to 100 mg daily in divided doses.
As a sedative when used as a premedication and following general anesthesia: 50 to 100 mg in adults, and 0.6 mg/kg in children.
When treatment is initiated by the intramuscular route of administration, subsequent doses may be administered orally.
As with all medications, the dosage should be adjusted according to the patient’s response to therapy.
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![Lisinopril Tablet [Preferred Pharmaceuticals Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=4fa5ef1d-51a5-40c0-9cdc-edb26d7a3f93&name=74b1d819-7c65-42de-bfec-81393105b0c1-02.jpg)
Lisinopril
2.1 Hypertension
Initial Therapy in adults: The recommended initial dose is 10 mg once a day. Dosage should be adjusted according to blood pressure response. The usual dosage range is 20 mg to 40 mg per day administered in a single daily dose. Doses up to 80 mg have been used but do not appear to give greater effect.
Use with diuretics in adults
If blood pressure is not controlled with lisinopril tablets alone, a low dose of a diuretic may be added (e.g., hydrochlorothiazide, 12.5 mg). After the addition of a diuretic, it may be possible to reduce the dose of lisinopril tablets.
The recommended starting dose in adult patients with hypertension taking diuretics is 5 mg once per day.
Pediatric Patients 6 years of age and older with hypertension
For pediatric patients with glomerular filtration rate > 30 mL/min/1.73m2, the recommended starting dose is 0.07 mg per kg once daily (up to 5 mg total). Dosage should be adjusted according to blood pressure response up to a maximum of 0.61 mg per kg (up to 40 mg) once daily. Doses above 0.61 mg per kg (or in excess of 40 mg) have not been studied in pediatric patients [see Clinical Pharmacology (12.3)].
Lisinopril tablets are not recommended in pediatric patients < 6 years or in pediatric patients with glomerular filtration rate < 30 mL/min/1.73m2 [see Use in Specific Populations (8.4)and Clinical Studies (14.1)].
2.2 Heart Failure
The recommended starting dose for lisinopril tablets, when used with diuretics and (usually) digitalis as adjunctive therapy for systolic heart failure, is 5 mg once daily. The recommended starting dose in these patients with hyponatremia (serum sodium < 130 mEq/L) is 2.5 mg once daily. Increase as tolerated to a maximum of 40 mg once daily.
Diuretic dose may need to be adjusted to help minimize hypovolemia, which may contribute to hypotension [see Warnings and Precautions (5.4), and Drug Interactions (7.1)]. The appearance of hypotension after the initial dose of lisinopril tablets does not preclude subsequent careful dose titration with the drug, following effective management of the hypotension.
2.3 Reduction of Mortality in Acute Myocardial Infarction
In hemodynamically stable patients within 24 hours of the onset of symptoms of acute myocardial infarction, give lisinopril tablets 5 mg orally, followed by 5 mg after 24 hours, 10 mg after 48 hours and then 10 mg once daily. Dosing should continue for at least six weeks.
Initiate therapy with 2.5 mg in patients with a low systolic blood pressure (≤ 120 mmHg and > 100 mm Hg) during the first 3 days after the infarct [see Warnings and Precautions (5.4)]. If hypotension occurs (systolic blood pressure ≤ 100 mmHg) a daily maintenance dose of 5 mg may be given with temporary reductions to 2.5 mg if needed. If prolonged hypotension occurs (systolic blood pressure < 90 mmHg for more than 1 hour) lisinopril tablets should be withdrawn.
2.4 Dose in Patients with Renal Impairment
No dose adjustment of lisinopril tablets is required in patients with creatinine clearance > 30 mL/min. In patients with creatinine clearance ≥ 10 mL/min and ≤ 30 mL/min, reduce the initial dose of lisinopril tablets to half of the usual recommended dose i.e., hypertension, 5 mg; systolic heart failure, 2.5 mg and acute MI, 2.5 mg. Up titrate as tolerated to a maximum of 40 mg daily. For patients on hemodialysis or creatinine clearance < 10 mL/min, the recommended initial dose is 2.5 mg once daily [see Use in Specific Populations (8.7)and Clinical Pharmacology (12.3)].
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![Cefdinir Capsule [Preferred Pharmaceuticals Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=1165564d-025e-460d-a1bd-1ca5300ae3fe&name=cefdinir-capsules-figure-2.jpg)
Cefdinir
(see INDICATIONS AND USAGE for Indicated Pathogens)
The recommended dosage and duration of treatment for infections in adults and adolescents are described in the following chart; the total daily dose for all infections is 600 mg. Once-daily dosing for 10 days is as effective as BID dosing. Once-daily dosing has not been studied in pneumonia or skin infections; therefore, Cefdinir Capsules should be administered twice daily in these infections. Cefdinir Capsules may be taken without regard to meals.
Adults and Adolescents (Age 13 Years and Older)Type of Infection
Dosage
Duration
Community-Acquired Pneumonia
300 mg q12h
10 days
Acute Exacerbations of Chronic Bronchitis
300 mg q12h or600 mg q24h
5 to 10 days10 days
Acute Maxillary Sinusitis
300 mg q12h or600 mg q24h
10 days10 days
Pharyngitis/Tonsillitis
300 mg q12h or600 mg q24h
5 to 10 days10 days
Uncomplicated Skin and Skin Structure Infections
300 mg q12h
10 days
Patients With Renal Insufficiency
For adult patients with creatinine clearance <30 mL/min, the dose of cefdinir should be 300 mg given once daily.
Creatinine clearance is difficult to measure in outpatients. However, the following formula may be used to estimate creatinine clearance (CLcr) in adult patients. For estimates to be valid, serum creatinine levels should reflect steady-state levels of renal function.
Males: CLcr = (weight) (140 – age)
(72) (serum creatinine)
Females: CLcr = 0.85 x above value
where creatinine clearance is in mL/min, age is in years, weight is in kilograms, and serum creatinine is in mg/dL6.
The following formula may be used to estimate creatinine clearance in pediatric patients:
CLcr = K x body length or height
serum creatinine
where K = 0.55 for pediatric patients older than 1 year7 and 0.45 for infants (up to 1 year)8.
In the above equation, creatinine clearance is in mL/min/1.73 m2, body length or height is in centimeters, and serum creatinine is in mg/dL.
For pediatric patients with a creatinine clearance of <30 mL/min/1.73 m2, the dose of cefdinir should be 7 mg/kg (up to 300 mg) given once daily.
6 Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron 1976; 16:31-41. 7 Schwartz GJ, Haycock GB, Edelmann CM, Spitzer A. A simple estimate of glomerular filtration rate in children derived from body length and plasma creatinine. Pediatrics 1976; 58:259-63. 8 Schwartz GJ, Feld LG, Langford DJ. A simple estimate of glomerular filtration rate in full-term infants during the first year of life. J Pediatrics 1984; 104:849-54.Patients on Hemodialysis
Hemodialysis removes cefdinir from the body. In patients maintained on chronic hemodialysis, the recommended initial dosage regimen is a 300 mg or 7 mg/kg dose every other day. At the conclusion of each hemodialysis session, 300 mg (or 7 mg/kg) should be given. Subsequent doses (300 mg or 7 mg/kg) are then administered every other day.
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![Gabapentin Tablet [Preferred Pharmaceuticals Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=0c314060-3c64-4738-9fa3-94d4535a78c8&name=600mg-label.jpg)
Gabapentin
2.1 Administration Information
Administer gabapentin tablets orally with or without food.
Inform patients that, should they break the scored 600 mg or 800 mg gabapentin tablets tablet in order to administer a half-tablet, they should take the unused half-tablet as the next dose. Half tablets not used within 28 days of breaking the scored tablet should be discarded.
If the gabapentin tablets dose is reduced, discontinued, or substituted with an alternative medication, this should be done gradually over a minimum of 1 week (a longer period may be needed at the discretion of the prescriber).
2.2 Dosage for Postherpetic Neuralgia
In adults with postherpetic neuralgia, gabapentin tablets therapy may be initiated on Day 1 as a single 300 mg dose, on Day 2 as 600 mg/day (300 mg two times a day), and on Day 3 as 900 mg/day (300 mg three times a day). The dose can subsequently be titrated up as needed for pain relief to a dose of 1800 mg/day (600 mg three times a day). In clinical studies, efficacy was demonstrated over a range of doses from 1800 mg/day to 3600 mg/day with comparable effects across the dose range; however, in these clinical studies, the additional benefit of using doses greater than 1800 mg/day was not demonstrated.
2.3 Dosage for Epilepsy with Partial Onset Seizures
Patients 12 years of age and above
The starting dose is 300 mg three times a day. The effective dose of gabapentin tablets is 300 mg to 600 mg three times a day. Dosages up to 2400 mg/day have been well tolerated in long-term clinical studies. Doses of 3600 mg/day have also been administered to a small number of patients for a relatively short duration, and have been well tolerated. Gabapentin tablets should be administered three times a day using 600 mg or 800 mg tablets. The maximum time between doses should not exceed 12 hours.
Pediatric Patients Age 3 to 11 years
The starting dose range is 10 mg/kg/day to 15 mg/kg/day, given in three divided doses, and the effective dose reached by upward titration over a period of approximately 3 days. The effective dose of gabapentin tablets in patients 3 to 4 years of age is 40 mg/kg/day, given in three divided doses. The effective dose of gabapentin tablets in patients 5 to 11 years of age is 25 mg/kg/day to 35 mg/kg/day, given in three divided doses. Dosages up to 50 mg/kg/day have been well tolerated in a long-term clinical study. The maximum time interval between doses should not exceed 12 hours.
2.4 Dosage Adjustment in Patients Patients with Renal Impairment
Dosage adjustment in patients 12 years of age and older with renal function or undergoing hemodialysis is recommended, as follows (see dosing recommendations above for effective doses in each indication):
TABLE 1. Gabapentin Tablets Dosage Based on Renal Function
Renal Function Creatinine Clearance
(mL/min)
Total Daily Dose Range
(mg/day)
Dose Regimen
(mg)
≥60
900 to 3600
300 TID
400 TID
600 TID
800 TID
1200 TID
>30-59
400 to 1400
200 BID
300 BID
400 BID
500 BID
700 BID
>15-29
200 to 700
200 QD
300 QD
400 QD
500 QD
700 QD
15a
100 to 300
100 QD
125 QD
150 QD
200 QD
300 QD
Post-Hemodialysis Supplemental Dose (mg)b
Hemodialysis
125b
150b
200b
250b
350b
TID = Three times a day; BID = Two times a day; QD = Single daily dose
a For patients with creatinine clearance <15 mL/min, reduce daily dose in proportion to creatinine clearance (e.g., patients with a creatinine clearance of 7.5 mL/min should receive one-half the daily dose that patients with a creatinine clearance of 15 mL/min receive).
b Patients on hemodialysis should receive maintenance doses based on estimates of creatinine clearance as indicated in the upper portion of the table and a supplemental post-hemodialysis dose administered after each 4 hours of hemodialysis as indicated in the lower portion of the table.
Creatinine clearance (CLCr) is difficult to measure in outpatients. In patients with stable renal function, creatinine clearance can be reasonably well estimated using the equation of Cockcroft and Gault:
The use of gabapentin tablets in patients less than 12 years of age with compromised renal function has not been studied.
2.5 Dosage in Elderly
Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and dose should be adjusted based on creatinine clearance values in these patients.
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![Naproxen Tablet [Preferred Pharmaceuticals Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=476725b3-1d1f-4d48-9cfe-29a4b0b3c42a&name=3466d710-figure-03.jpg)
Naproxen
Carefully consider the potential benefits and risks of naproxen tablets and other treatment options before deciding to use naproxen tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with naproxen tablets, the dose and frequency should be adjusted to suit an individual patient’s needs.
Different dose strengths and formulations (ie, tablets, suspension) of the drug are not necessarily bioequivalent. This difference should be taken into consideration when changing formulation.
Although naproxen tablets, naproxen suspension, naproxen delayed-release tablets and naproxen sodium tablets all circulate in the plasma as naproxen, they have pharmacokinetic differences that may affect onset of action. Onset of pain relief can begin within 1 hour in patients taking naproxen.
The recommended strategy for initiating therapy is to choose a formulation and a starting dose likely to be effective for the patient and then adjust the dosage based on observation of benefit and/or adverse events. A lower dose should be considered in patients with renal or hepatic impairment or in elderly patients (see WARNINGS and PRECAUTIONS).
Geriatric Patients
Studies indicate that although total plasma concentration of naproxen is unchanged, the unbound plasma fraction of naproxen is increased in the elderly. Caution is advised when high doses are required and some adjustment of dosage may be required in elderly patients. As with other drugs used in the elderly, it is prudent to use the lowest effective dose.
Patients with Moderate to Severe Renal Impairment
Naproxen-containing products are not recommended for use in patients with moderate to severe and severe renal impairment (creatinine clearance <30 mL/min) (see WARNINGS: Renal Effects).
Rheumatoid Arthritis, Osteoarthritis and Ankylosing Spondylitis
Naproxen Tablets
250 mgor 375 mgor 500 mg
twice dailytwice dailytwice daily
During long-term administration, the dose of naproxen may be adjusted up or down depending on the clinical response of the patient. A lower daily dose may suffice for long-term administration. The morning and evening doses do not have to be equal in size and the administration of the drug more frequently than twice daily is not necessary.
In patients who tolerate lower doses well, the dose may be increased to naproxen 1500 mg/day for limited periods of up to 6 months when a higher level of anti-inflammatory/analgesic activity is required. When treating such patients with naproxen 1500 mg/day, the physician should observe sufficient increased clinical benefits to offset the potential increased risk. The morning and evening doses do not have to be equal in size and administration of the drug more frequently than twice daily does not generally make a difference in response (see CLINICAL PHARMACOLOGY).
Juvenile Arthritis
The recommended total daily dose of naproxen is approximately 10 mg/kg given in 2 divided doses (i.e., 5 mg/kg given twice a day). Naproxen tablets are not well suited to this dosage so use of naproxen oral suspension is recommended for this indication.
Management of Pain, Primary Dysmenorrhea, and Acute Tendonitis and Bursitis
Because the sodium salt of naproxen is more rapidly absorbed, naproxen sodium is recommended for the management of acute painful conditions when prompt onset of pain relief is desired. Naproxen may also be used. The recommended starting dose of Naproxen is 500 mg, followed by 500 mg every 12 hours or 250 mg every 6 to 8 hours as required. The initial total daily dose should not exceed 1250 mg of naproxen. Thereafter, the total daily dose should not exceed 1000 mg of naproxen.
Acute Gout
The recommended starting dose is 750 mg of naproxen tablets followed by 250 mg every 8 hours until the attack has subsided.
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![Buspirone Hydrochloride Tablet [Preferred Pharmaceuticals Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=b4b3d24e-88b2-40da-b9c0-c3cb7ead8680&name=buspironhcltablets-figure-04.jpg)
Buspirone Hydrochloride
The recommended initial dose is 15 mg daily (7.5 mg b.i.d.). To achieve an optimal therapeutic response, at intervals of 2 to 3 days the dosage may be increased 5 mg per day, as needed. The maximum daily dosage should not exceed 60 mg per day. In clinical trials allowing dose titration, divided doses of 20 mg to 30 mg per day were commonly employed.
The bioavailability of buspirone is increased when given with food as compared to the fasted state (see CLINICAL PHARMACOLOGY). Consequently, patients should take buspirone in a consistent manner with regard to the timing of dosing; either always with or always without food.
When buspirone is to be given with a potent inhibitor of CYP3A4, the dosage recommendations described in the PRECAUTIONS: Drug Interactionssection should be followed.
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![Methocarbamol Tablet [Preferred Pharmaceuticals Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=8974533c-9834-4d84-96e3-45dfbccca660&name=8abf52d1-f208-4ba0-821c-8417308a985a-03.jpg)
Methocarbamol
Methocarbamol tablets, USP, 500 mg – Adults:
Initial dosage: 3 tablets q.i.d.
Maintenance dosage: 2 tablets q.i.d.
Methocarbamol tablets, USP: 750 mg – Adults:
Initial dosage: 2 tablets q.i.d.
Maintenance dosage: 1 tablet q.4h. or 2 tablets t.i.d.
Six grams a day are recommended for the first 48 to 72 hours of treatment. (For severe conditions 8 grams a day may be administered). Thereafter, the dosage can usually be reduced to approximately 4 grams a day.
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![Promethazine Hydrochloride Tablet [Preferred Pharmaceuticals Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=521414ca-57f5-4855-a951-b99ac161b13f&name=d4c70548-figure-02.jpg)
Promethazine Hydrochloride
Promethazine Hydrochloride Tablets, USP are contraindicated for children under 2 years of age (see WARNINGS: Black Box Warning and Use in Pediatric Patients).
Allergy: The average oral dose is 25 mg taken before retiring; however, 12.5 mg may be taken before meals and on retiring, if necessary. Single 25 mg doses at bedtime or 6.25 to 12.5 mg taken three times daily will usually suffice. After initiation of treatment, in children or adults, dosage should be adjusted to the smallest amount adequate to relieve symptoms. The administration of promethazine HCl in 25 mg doses will control minor transfusion reactions of an allergic nature.
Motion Sickness: The average adult dose is 25 mg taken twice daily. The initial dose should be taken one-half to one hour before anticipated travel and be repeated eight to twelve hours later if necessary. On succeeding days of travel, it is recommended that 25 mg be given on arising and again before the evening meal. For children, promethazine hydrochloride tablets, syrup, or rectal suppositories, 12.5 to 25 mg, twice daily, may be administered.
Nausea and Vomiting: Antiemetics should not be used in vomiting of unknown etiology in children and adolescents (see WARNINGS: Use in Pediatric Patients).
The average effective dose of promethazine HCl for the active therapy of nausea and vomiting in children or adults is 25 mg. When oral medication cannot be tolerated, the dose should be given parenterally or by rectal suppository. 12.5 to 25 mg doses may be repeated, as necessary, at four- to six-hour intervals.
For nausea and vomiting in children, the usual dose is 0.5 mg per pound of body weight, and the dose should be adjusted to the age and weight of the patient and the severity of the condition being treated.
For prophylaxis of nausea and vomiting, as during surgery and the postoperative period, the average dose is 25 mg repeated at four- to six-hour intervals, as necessary.
Sedation: This product relieves apprehension and induces a quiet sleep from which the patient can be easily aroused. Administration of 12.5 to 25 mg Promethazine HCl by the oral route or by rectal suppository at bedtime will provide sedation in children. Adults usually require 25 to 50 mg for nighttime, presurgical, or obstetrical sedation.
Pre- and Postoperative Use: Promethazine HCl in 12.5 to 25 mg doses for children and 50 mg doses for adults the night before surgery relieves apprehension and produces a quiet sleep.
For preoperative medication, children require doses of 0.5 mg per pound of body weight in combination with an appropriately reduced dose of narcotic or barbiturate and the appropriate dose of an atropine-like drug. Usual adult dosage is 50 mg Promethazine HCl with an appropriately reduced dose of narcotic or barbiturate and the required amount of a belladonna alkaloid.
Postoperative sedation and adjunctive use with analgesics may be obtained by the administration of 12.5 to 25 mg in children and 25 to 50 mg doses in adults. Promethazine hydrochloride tablets are contraindicated for children under 2 years of age.
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![Rizatriptan Tablet, Film Coated [Preferred Pharmaceuticals Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=6261cbf2-8f30-4297-a963-01faa32708ef&name=RizatriptanBenzoateODT10mg,Macleods.jpg)
Rizatriptan
2.1 Dosing Information in Adults
The recommended starting dose of rizatriptan benzoate tablets is either 5 mg or 10 mg for the acute treatment of migraines in adults. The 10 mg dose may provide a greater effect than the 5 mg dose, but may have a greater risk of adverse reactions [see Clinical Studies (14.1)]. Redosing in Adults: Although the effectiveness of a second dose or subsequent doses has not been established in placebo-controlled trials, if the migraine headache returns, a second dose may be administered 2 hours after the first dose. The maximum daily dose should not exceed 30 mg in any 24-hour period. The safety of treating, on average, more than four headaches in a 30-day period has not been established.
2.2 Dosing Information in Pediatric Patients (Age 6 to 17 Years)
Information related to usage of rizatriptan benzoate in pediatric patients (6 to 17 years old) is approved for Merck & Co., Inc.’s Rizatriptan Benzoate Tablets. However, due to Merck & Co., Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric patient (6 to 17 years old) usage information.
2.4 Dosage Adjustment for Patients on Propranolol
Adult Patients: In adult patients taking propranolol, only the 5 mg dose of rizatriptan benzoate tablets is recommended, up to a maximum of three doses in any 24-hour period (15 mg) [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)].
Pediatric Patients:Dosage adjustment information of rizatriptan benzoate for pediatric patients (6 to 17 years old) taking propranolol is approved for Merck & Co., Inc.’s Rizatriptan Benzoate Tablets. However, due to Merck & Co., Inc.’s marketing exclusivity rights, this drug product is not labeled with that dosage adjustment information.
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![Doxycycline Hyclate Tablet, Film Coated [Preferred Pharmaceuticals Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=0edea3e4-91be-46c1-8941-4496039e63d2&name=doxycycline-02.jpg)
Doxycycline Hyclate
THE USUAL DOSAGE AND FREQUENCY OF ADMINISTRATION OF DOXYCYCLINE DIFFERS FROM THAT OF THE OTHER TETRACYCLINES. EXCEEDING THE RECOMMENDED DOSAGE MAY RESULT IN AN INCREASED INCIDENCE OF SIDE EFFECTS.
Adults: The usual dose of oral doxycycline is 200 mg on the first day of treatment (administered 100 mg every 12 hours) followed by a maintenance dose of 100 mg/day.
In the management of more severe infections (particularly chronic infections of the urinary tract), 100 mg every 12 hours is recommended.
For children above eight years of age: The recommended dosage schedule for children weighing 100 pounds or less is 2 mg/lb of body weight divided into two doses on the first day of treatment, followed by 1 mg/lb of body weight given as a single daily dose or divided into two doses, on subsequent days. For more severe infections, up to 2 mg/lb of body weight may be used. For children over 100 lb the usual adult dose should be used.
The therapeutic antibacterial serum activity will usually persist for 24 hours following recommended dosage.
When used in streptococcal infections, therapy should be continued for 10 days.
Administration of adequate amounts of fluid along with capsule and tablet forms of drugs in the tetracycline class is recommended to wash down the drugs and reduce the risk of esophageal irritation and ulceration. (See ADVERSE REACTIONS.)
If gastric irritation occurs, it is recommended that doxycycline be given with food or milk. The absorption of doxycycline is not markedly influenced by simultaneous ingestion of food or milk.
Studies to date have indicated that administration of doxycycline at the usual recommended doses does not lead to excessive accumulation of doxycycline in patients with renal impairment.
Uncomplicated gonococcal infections in adults (except anorectal infections in men): 100 mg, by mouth, twice a day for 7 days. As an alternate single visit dose, administer 300 mg stat followed in one hour by a second 300 mg dose. The dose may be administered with food, including milk or carbonated beverage, as required.
Uncomplicated urethral, endocervical, or rectal infection in adults caused by Chlamydia trachomatis: 100 mg, by mouth twice a day for 7 days.
Nongonococcal urethritis (NGU) caused by C. trachomatis or U. urealyticum: 100 mg by mouth, twice a day for 7 days.
Syphilis - early: Patients who are allergic to penicillin should be treated with doxycycline 100 mg, by mouth, twice a day for 2 weeks.
Syphilis of more than one year's duration: Patients who are allergic to penicillin should be treated with doxycycline 100 mg, by mouth, twice a day for 4 weeks.
Acute epididymo-orchitis caused by N. gonorrhoeae: 100 mg, by mouth, twice a day for at least 10 days.
Acute epididymo-orchitis caused by C. trachomatis: 100 mg, by mouth, twice a day for at least 10 days.
For prophylaxis of malaria: For adults, the recommended dose is 100 mg daily. For children over 8 years of age, the recommended dose is 2 mg/kg given once daily up to the adult dose. Prophylaxis should begin 1-2 days before travel to the malarious area. Prophylaxis should be continued daily during travel in the malarious area and for 4 weeks after the traveler leaves the malarious area.
Inhalational anthrax (post-exposure)
ADULTS: 100 mg of doxycycline, by mouth, twice a day for 60 days. CHILDREN: weighing less than 100 lb (45 kg); 1 mg/lb (2.2 mg/kg) of body weight by mouth, twice a day for 60 days. Children weighing 100 lb or more should receive the adult dose. -
![Eszopiclone Tablet, Film Coated [Preferred Pharmaceuticals Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=4377297a-b91f-45f9-8088-d62b8ca80af9&name=eszopiclone-label-3mg.jpg)
Eszopiclone
Use the lowest effective dose for the patient.
2.1 Dosage in Adults
The recommended starting dose is 1 mg. Dosing can be raised to 2 mg or 3 mg if clinically indicated. In some patients, the higher morning blood levels of eszopiclone tablets following use of the 2 mg or 3 mg dose increase the risk of next day impairment of driving and other activities that require full alertness [see Warnings and Precautions (5.1)]. The total dose of eszopiclone tablets should not exceed 3 mg, once daily immediately before bedtime [see Warnings and Precautions (5.6)].
2.2 Geriatric or Debilitated Patients
The total dose of eszopiclone tablets should not exceed 2 mg in elderly or debilitated patients.
2.3 Patients with Severe Hepatic Impairment, or Taking Potent CYP3A4 Inhibitors
In patients with severe hepatic impairment, or in patients coadministered eszopiclone tablets with potent CYP3A4 inhibitors, the total dose of eszopiclone tablets should not exceed 2 mg [see Warning and Precautions (5.7)].
2.4 Use with CNS Depressants
Dosage adjustments may be necessary when eszopiclone tablets is combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.1)].
2.5 Administration with Food
Taking eszopiclone tablets with or immediately after a heavy, high-fat meal results in slower absorption and would be expected to reduce the effect of eszopiclone tablets on sleep latency [see Clinical Pharmacology (12.3)].
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![Sertraline Hydrochloride Tablet [Legacy Pharmaceutical Packaging, Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=f8bf8cf0-df94-4fe1-afc4-a105bbd337df&name=hydrochlorothiazide-capsule-2.jpg)
Sertraline Hydrochloride
For Control of Hypertension: The adult initial dose of hydrochlorothiazide is one capsule given once daily whether given alone or in combination with other antihypertensives. Total daily doses greater than 50 mg are not recommended.
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Modesa
Dosage should be adjusted according to the severity of the pain and the response of the patient. However, it should be kept in mind that tolerance to hydrocodone can develop with continued use and that the incidence of untoward effects is dose related.
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 5 mg/325 mg
The usual adult dosage is one or two tablets every four to six hours as needed for pain. The total daily dosage should not exceed 12 tablets.
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg/325 mg
The usual adult dosage is one tablet every four to six hours as needed for pain. The total daily dosage should not exceed 6 tablets.
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg
The usual adult dosage is one tablet every four to six hours as needed for pain. The total daily dosage should not exceed 6 tablets.
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 5 mg/325 mg
The usual adult dosage is one or two tablets every four to six hours as needed for pain. The total daily dosage should not exceed 12 tablets.
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg/325 mg
The usual adult dosage is one tablet every four to six hours as needed for pain. The total daily dosage should not exceed 6 tablets.
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg
The usual adult dosage is one tablet every four to six hours as needed for pain. The total daily dosage should not exceed 6 tablets.
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![Amoxicillin And Clavulanate Potassium Powder, For Suspension [Preferred Pharmaceuticals Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=b8cf1f1d-6013-49ab-ae4f-1d22ddf2e03e&name=amoxicillin-03.jpg)
Amoxicillin And Clavulanate Potassium
Amoxicillin and Clavulanate Potassium for Oral Suspension 600 mg/42.9 mg per 5 mL, does not contain the same amount of clavulanic acid (as the potassium salt) as any of the other suspensions of amoxicillin and clavulanate potassium. Amoxicillin and Clavulanate Potassium for Oral Suspension 600 mg/42.9 mg per 5 mL contains 42.9 mg of clavulanic acid per 5 mL, whereas the 200 mg/28.5 mg per 5 mL suspension of amoxicillin and clavulanate potassium contains 28.5 mg of clavulanic acid per 5 mL and the 400 mg/57 mg per 5 mL suspension contains 57 mg of clavulanic acid per 5 mL. Therefore, the 200 mg/28.5 mg per 5 mL and 400 mg/57 mg per 5 mL suspensions of amoxicillin and clavulanate potassium should not be substituted for Amoxicillin and Clavulanate Potassium for Oral Suspension 600 mg/42.9 mg per 5 mL, as they are not interchangeable.
Dosage
Pediatric patients 3 months and older
Based on the amoxicillin component (600 mg/5 mL), the recommended dose of Amoxicillin and Clavulanate Potassium for Oral Suspension 600 mg/42.9 mg per 5 mL is 90 mg/kg/day divided every 12 hours, administered for 10 days (see chart below).
Body Weight (kg) Volume of Amoxicillin and Clavulanate Potassium for Oral Suspension 600 mg/42.9 mg per 5 mL Providing 90 mg/kg/day8
3 mL twice daily
12
4.5 mL twice daily
16
6 mL twice daily
20
7.5 mL twice daily
24
9 mL twice daily
28
10.5 mL twice daily
32
12 mL twice daily
36
13.5 mL twice daily
Pediatric patients weighing 40 kg and more
Experience with Amoxicillin and Clavulanate Potassium for Oral Suspension 600 mg/42.9 mg per 5 mL formulation in this group is not available.
Adults
Experience with Amoxicillin and Clavulanate Potassium for Oral Suspension 600 mg/42.9 mg per 5 mL formulation in adults is not available and adults who have difficulty swallowing should not be given Amoxicillin and Clavulanate Potassium for Oral Suspension 600 mg/42.9 mg per 5 mL in place of the 500 mg/125 mg or 875 mg/125 mg tablet of amoxicillin and clavulanate potassium.
Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals. (See WARNINGS.)
Directions for Mixing Oral Suspension
Prepare a suspension at time of dispensing as follows: Tap bottle until all the powder flows freely. Add approximately 2/3 of the total amount of water for reconstitution (see table below) and shake vigorously to suspend powder. Add remainder of the water and again shake vigorously.
Amoxicillin and Clavulanate Potassium for Oral Suspension 600 mg/42.9 mg per 5 mL Bottle Size Amount of Water Required for Reconstitution75 mL
67 mL
125 mL
110 mL
Each teaspoonful (5 mL) will contain 600 mg amoxicillin as the trihydrate and 42.9 mg of clavulanic acid as the potassium salt.
NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING.
Administration
To minimize the potential for gastrointestinal intolerance, Amoxicillin and Clavulanate Potassium for Oral Suspension 600 mg/42.9 mg per 5 mL should be taken at the start of a meal. Absorption of clavulanate potassium may be enhanced when Amoxicillin and Clavulanate Potassium for Oral Suspension, USP 600 mg/42.9 mg per 5 mL is administered at the start of a meal.
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![Neomycin And Polymyxin B Sulfates And Dexamethasone Ointment [Preferred Pharmaceuticals Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=42da5857-e274-416d-bcd4-4ff33ea9eef0&name=722cb3be-8e7a-443f-8770-2aa147b8a131-04.jpg)
Neomycin And Polymyxin B Sulfates And Dexamethasone Ointment
Apply a small amount into the conjunctival sac(s) up to three or four times daily.
How to Apply neomycin and polymyxin B sulfates and dexamethasone ophthalmic ointment:
1. Tilt your head back. 2. Place a finger on your cheek just under your eye and gently pull down until a "V" pocket is formed between your eyeball and your lower lid. 3. Place a small amount (about 1/2 inch) of neomycin and polymyxin B sulfates and dexamethasone ophthalmic ointment in the "V" pocket. Do not let the tip of the tube touch your eye. 4. Look downward before closing your eye.Not more than 8 g should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in PRECAUTIONS above.
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![Penicillin V Potassium Tablet, Film Coated [Preferred Pharmaceuticals Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=8e7827a9-e247-4b11-8bb7-f18ec1d9d2dd&name=2710-1.jpg)
Penicillin V Potassium
The dosage of Penicillin V should be determined according to the sensitivity of the causative microorganism and the severity of infection, and adjusted to the clinical response of the patient. The usual dosage recommendations for adults and children 12 years and over are as follows: Streptococcal Infections - mild to moderately severe - of the upper respiratory tract and including scarlet fever and erysipelas: 125 to 250 mg (200,000 to 400,000 units) every 6 to 8 hours for 10 days. Pneumococcal Infections - mild to moderately severe - of the respiratory tract, including otitis media: 250 to 500 mg (400,000 to 800,000 units) every 6 hours until the patient has been afebrile for at least 2 days. Staphylococcal Infections - mild infections of skin and soft tissue (culture and sensitive tests should be performed): 250 to 500 mg (400,000 to 800,000 units) every 6 to 8 hours. Fusospirochetosis (Vincent’s infection) of the oropharynx. Mild to moderately severe infections: 250 to 500 mg (400,000 to 800,000 units) every 6 to 8 hours. For the prevention of recurrence following rheumatic fever and/or chorea: 125 mg to 250 mg (200,000 to 400,000 units) twice daily on a continuing basis. For prophylaxis against bacterial endocarditis1 in patients with congenital heart disease or rheumatic or other acquired valvular heart disease when undergoing dental procedures or surgical procedures of the upper respiratory tract: 2 gram of penicillin V (1 gram for children under 60 lbs.) 1 hour before the procedure, and then, 1 gram (500 mg for children under 60 lbs.) 6 hours later.
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![Rabeprazole Sodium Tablet, Delayed Release [Preferred Pharmaceuticals Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=4ba56c0d-ec48-4fe0-a0c2-6edb820a4695&name=rabeprazoletab-figure-08.jpg)
Rabeprazole Sodium
2.1 Healing of Erosive or Ulcerative GERD in Adults
The recommended adult oral dose is one rabeprazole sodium 20 mg delayed-release tablet to be taken once daily for four to eight weeks [see Indications and Usage (1.1)]. For those patients who have not healed after 8 weeks of treatment, an additional 8-week course of rabeprazole sodium delayed-release tablets may be considered.
2.2 Maintenance of Healing of Erosive or Ulcerative GERD in Adults
The recommended adult oral dose is one rabeprazole sodium 20 mg delayed-release tablet to be taken once daily [see Indications and Usage (1.2)].
2.3 Treatment of Symptomatic GERD in Adults
The recommended adult oral dose is one rabeprazole sodium 20 mg delayed-release tablet to be taken once daily for 4 weeks [see Indications and Usage (1.3)]. If symptoms do not resolve completely after 4 weeks, an additional course of treatment may be considered. The recommended adolescent dosing is one rabeprazole sodium 20 mg delayed-release tablet to be taken once daily for 8 weeks.
2.4 Healing of Duodenal Ulcers in Adults
The recommended adult oral dose is one rabeprazole sodium 20 mg delayed-release tablet to be taken once daily after the morning meal for a period up to four weeks [see Indications and Usage (1.5)]. Most patients with duodenal ulcer heal within four weeks. A few patients may require additional therapy to achieve healing.
2.5 Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence in Adults
TABLE 1
THREE DRUG REGIMEN a All three medications should be taken twice daily with the morning and evening meals. aIt is important that patients comply with the full 7-day regimen [see Clinical Studies (14.5)].Rabeprazole sodium delayed-release tablet
20 mg
Twice Daily for 7 Days
Amoxicillin
1000 mg
Twice Daily for 7 Days
Clarithromycin
500 mg
Twice Daily for 7 Days
2.6 Treatment of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome in Adults
The dosage of rabeprazole sodium delayed-release tablets in patients with pathologic hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Some patients may require divided doses. Doses up to 100 mg QD and 60 mg BID have been administered. Some patients with Zollinger-Ellison syndrome have been treated continuously with rabeprazole sodium delayed-release tablets for up to one year.
2.7 Short-term Treatment of Symptomatic GERD in Adolescent Patients 12 Years of Age and Older
The recommended oral dose for adolescents 12 years of age and older is one 20 mg delayed-release tablet once daily for up to 8 weeks [see Use in Specific Populations (8.4) and Clinical Studies (14.7)].
2.9 Elderly, Renal and Hepatic Impaired Patients
No dosage adjustment is necessary in elderly patients, in patients with renal disease or in patients with mild to moderate hepatic impairment. Administration of rabeprazole to patients with mild to moderate liver impairment resulted in increased exposure and decreased elimination. Due to the lack of clinical data on rabeprazole in patients with severe hepatic impairment, caution should be exercised in those patients.
2.10 Administration Recommendations
TABLE 2
Administration RecommendationsFormulation
Population
Instructions
Delayed-release tablet
Adults and adolescents 12 years of age and older
Swallow tablets whole. Do not chew, crush or split tablets.Tablets can be taken with or without food.
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![Dicyclomine Hydrochloride Tablet [Preferred Pharmaceuticals Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=cfc33579-95e6-49f5-bce9-e185f9ca994a&name=3ff9e059-9575-4ce1-957f-112cfd8a6f04-02.jpg)
Dicyclomine Hydrochloride
DOSAGE MUST BE ADJUSTED TO INDIVIDUAL PATIENT NEEDS. (See CLINICAL PHARMACOLOGY.)
Adults
The only oral dose clearly shown to be effective is 160 mg per day (in 4 equally divided doses). Since this dose is associated with a significant incidence of side effects, it is prudent to begin with 80 mg per day (in 4 equally divided doses). Depending upon the patient's response during the first week of therapy, the dose should be increased to 160 mg per day unless side effects limit dosage escalation.
If efficacy is not achieved within 2 weeks or side effects require doses below 80 mg per day, the drug should be discontinued. Documented safety data are not available for doses above 80 mg daily for periods longer than 2 weeks.
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![Lidopro Patch (Lidocaine, Menthol, And Methyl Salicylate) Patch [Preferred Pharmaceuticals Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=142e5b26-ca69-4546-b43d-88fb0e0bb385&name=image-01.jpg)
Lidopro Patch
Adults 18 years and older:
• Apply patch to affected area 1 to 2 times daily or as directed.
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![Lubrifresh P.m. (White Petrolatum Mineral Oil) Ointment [Preferred Pharmaceuticals Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=4677b689-d98d-47a4-9c3d-595a9f03f626&name=image-01.jpg)
Lubrifresh P.m.
pull down the lower lid of the affected eye (s) apply a small amount (1/4 inch) of ointment to the inside of eyelid apply one or more times daily or as directed by a doctor
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![All Day Relief (Naproxen Sodium Tablet, Coated) Tablet [Preferred Pharmaceuticals Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=1812c18f-5472-4900-bb59-4e5bd80f3311&name=image-01.jpg)
All Day Relief
• do not more than directed • the smallest effective dose should be used • do not take longer than 10 days, unless directred by a doctor (see Warnings) • drink a full glass of water with each doseAdults and children 12 years and older:
• take 1 tablet every 8 to12 hours while symptoms last • for first dose you may take 2 tablets within the first hour • do not exceed 2 tablets in any 8 to 12 hour period • do not exceed 3 tablets in a 24 hours periodchildren under 12 years:
• ask a doctor -
![Glyburide And Metformin Hydrochloride Tablet, Film Coated [Preferred Pharmaceuticals Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=635c56bf-e16c-4722-98e5-ff4e0076fb85&name=glymet-fig3.jpg)
Glyburide And Metformin Hydrochloride
General Considerations
Dosage of glyburide and metformin hydrochloride tablets must be individualized on the basis of both effectiveness and tolerance while not exceeding the maximum recommended daily dose of 20 mg glyburide/2000 mg metformin. Glyburide and metformin hydrochloride tablets should be given with meals and should be initiated at a low dose, with gradual dose escalation as described below, in order to avoid hypoglycemia (largely due to glyburide), reduce GI side effects (largely due to metformin), and permit determination of the minimum effective dose for adequate control of blood glucose for the individual patient.With initial treatment and during dose titration, appropriate blood glucose monitoring should be used to determine the therapeutic response to glyburide and metformin hydrochloride tablets and to identify the minimum effective dose for the patient. Thereafter, HbA1c should be measured at intervals of approximately 3 months to assess the effectiveness of therapy. The therapeutic goal in all patients with type 2 diabetes is to decrease FPG, PPG, and HbA1c to normal or as near normal as possible. Ideally, the response to therapy should be evaluated using HbA1c (glycosylated hemoglobin), which is a better indicator of long-term glycemic control than FPG alone.No studies have been performed specifically examining the safety and efficacy of switching to glyburide and metformin hydrochloride tablets therapy in patients taking concomitant glyburide (or other sulfonylurea) plus metformin. Changes in glycemic control may occur in such patients, with either hyperglycemia or hypoglycemia possible. Any change in therapy of type 2 diabetes should be undertaken with care and appropriate monitoring.
Glyburide and Metformin Hydrochloride Tablets in Patients with Inadequate Glycemic Control on Diet and Exercise
Recommended starting dose: 1.25 mg/250 mg once or twice daily with meals. For patients with type 2 diabetes whose hyperglycemia cannot be satisfactorily managed with diet and exercise alone, the recommended starting dose of glyburide and metformin hydrochloride tablets is 1.25 mg/250 mg once a day with a meal. As initial therapy in patients with baseline HbA1c >9% or an FPG >200 mg/dL, a starting dose of glyburide and metformin hydrochloride tablets 1.25 mg/250 mg twice daily with the morning and evening meals may be used. Dosage increases should be made in increments of 1.25 mg/250 mg per day every 2 weeks up to the minimum effective dose necessary to achieve adequate control of blood glucose. In clinical trials of glyburide and metformin hydrochloride tablets as initial therapy, there was no experience with total daily doses >10 mg/2000 mg per day. Glyburide and metformin hydrochloride tablet 5 mg/500 mg should not be used as initial therapy due to an increased risk of hypoglycemia.
Glyburide and Metformin Hydrochloride Tablets Use in Patients with Inadequate Glycemic Control on a Sulfonylurea and/or Metformin
Recommended starting dose: 2.5 mg/500 mg or 5 mg/500 mg twice daily with meals. For patients not adequately controlled on either glyburide (or another sulfonylurea) or metformin alone, the recommended starting dose of glyburide and metformin hydrochloride tablets is 2.5 mg/500 mg or 5 mg/500 mg twice daily with the morning and evening meals. In order to avoid hypoglycemia, the starting dose of glyburide and metformin hydrochloride tablets should not exceed the daily doses of glyburide or metformin already being taken. The daily dose should be titrated in increments of no more than 5 mg/500 mg up to the minimum effective dose to achieve adequate control of blood glucose or to a maximum dose of 20 mg/2000 mg per day.For patients previously treated with combination therapy of glyburide (or another sulfonylurea) plus metformin, if switched to glyburide and metformin hydrochloride tablets, the starting dose should not exceed the daily dose of glyburide (or equivalent dose of another sulfonylurea) and metformin already being taken. Patients should be monitored closely for signs and symptoms of hypoglycemia following such a switch and the dose of glyburide and metformin hydrochloride tablets should be titrated as described above to achieve adequate control of blood glucose.
Addition of Thiazolidinediones to Glyburide and Metformin Hydrochloride Tablets Therapy
For patients not adequately controlled on glyburide and metformin hydrochloride tablets, a thiazolidinedione can be added to glyburide and metformin hydrochloride tablets therapy. When a thiazolidinedione is added to glyburide and metformin hydrochloride tablets therapy, the current dose of glyburide and metformin hydrochloride tablets can be continued and the thiazolidinedione initiated at its recommended starting dose. For patients needing additional glycemic control, the dose of the thiazolidinedione can be increased based on its recommended titration schedule. The increased glycemic control attainable with glyburide and metformin hydrochloride tablets plus a thiazolidinedione may increase the potential for hypoglycemia at any time of day. In patients who develop hypoglycemia when receiving glyburide and metformin hydrochloride tablets and a thiazolidinedione, consideration should be given to reducing the dose of the glyburide component of glyburide and metformin hydrochloride tablets. As clinically warranted, adjustment of the dosages of the other components of the antidiabetic regimen should also be considered.
Patients Receiving Colesevelam
When colesevelam is coadministered with glyburide, maximum plasma concentration and total exposure to glyburide is reduced. Therefore, glyburide and metformin hydrochloride tablets should be administered at least 4 hours prior to colesevelam.
Specific Patient Populations
Glyburide and metformin hydrochloride tablets are not recommended for use during pregnancy. The initial and maintenance dosing of glyburide and metformin hydrochloride tablets should be conservative in patients with advanced age, due to the potential for decreased renal function in this population. Any dosage adjustment requires a careful assessment of renal function. Generally, elderly, debilitated, and malnourished patients should not be titrated to the maximum dose of glyburide and metformin hydrochloride tablets to avoid the risk of hypoglycemia. Monitoring of renal function is necessary to aid in prevention of metformin-associated lactic acidosis, particularly in the elderly. (See WARNINGS.)
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![Hydrochlorothiazide Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=21ee06e3-8a86-428f-844b-aa6fd19c840b&name=hctztablets-figure-03.jpg)
Hydrochlorothiazide
Therapy should be individualized according to patient response. Use the smallest dosage necessary to achieve the required response.
Adults
For Edema
The usual adult dosage is 25 to 100 mg daily as a single or divided dose. Many patients with edema respond to intermittent therapy, i.e., administration on alternate days or on 3 to 5 days each week. With an intermittent schedule, excessive response and the resulting undesirable electrolyte imbalance are less likely to occur.
For Control of Hypertension
The usual initial dose in adults is 25 mg daily given as a single dose. The dose may be increased to 50 mg daily, given as a single or two divided doses. Doses above 50 mg are often associated with marked reductions in serum potassium (see also PRECAUTIONS).
Patients usually do not require doses in excess of 50 mg of hydrochlorothiazide daily when used concomitantly with other antihypertensive agents.
Infants and Children
For Diuresis and for Control of Hypertension
The usual pediatric dosage is 0.5 to 1 mg per pound (1 to 2 mg/kg) per day in single or two divided doses, not to exceed 37.5 mg per day in infants up to 2 years of age or 100 mg per day in children 2 to 12 years of age. In infants less than 6 months of age, doses up to 1.5 mg per pound (3 mg/kg) per day in two divided doses may be required. (See PRECAUTIONS, Pediatric Use).
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![Valacyclovir Hydrochloride Tablet, Film Coated [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=fc20acce-c989-42d3-8508-3230a9c8f9a5&name=image2.jpg)
Valacyclovir Hydrochloride
Valacyclovir tablets, USP may be given without regard to meals. Valacyclovir oral suspension (25 mg/mLor 50 mg/mL) may be prepared extemporaneously from valacyclovir tablets, USP 500 mg for use in pediatric patients for whoma solid dosage form is not appropriate [see Dosage and Administration (2.3)].
2.1 Adult Dosing Recommendations
Cold Sores (Herpes Labialis): The recommended dosage of valacyclovir hydrochloride for treatment of cold sores is 2 grams twice daily for 1 day taken 12 hours apart. Therapy should be initiated at the earliest symptom of a cold sore (e.g., tingling, itching, or burning).Genital Herpes: Initial Episode: The recommended dosage of valacyclovir hydrochloride for treatment of initial genital herpes is 1 gram twice daily for 10 days. Therapy was most effective when administered within 48 hours of the onset of signs and symptoms.Recurrent Episodes: The recommended dosage of valacyclovir hydrochloride for treatment of recurrent genital herpes is 500 mg twice daily for 3 days. Initiate treatment at the first sign or symptom of an episode.Suppressive Therapy: The recommended dosage of valacyclovir hydrochloride for chronic suppressive therapy of recurrent genital herpes is 1 gram once daily in patients with normal immune function. In patients with a history of 9 or fewer recurrences per year, an alternative dose is 500 mg once daily.In HIV‑infected patients with a CD4+ cell count >100 cells/mm3, the recommended dosage of valacyclovir hydrochloride for chronic suppressive therapy of recurrent genital herpes is 500 mg twice daily.Reduction of Transmission: The recommended dosage of valacyclovir hydrochloride for reduction of transmission of genital herpes in patients with a history of 9 or fewer recurrences per year is 500 mg once daily for the source partner.Herpes Zoster: The recommended dosage of valacyclovir hydrochloride for treatment of herpes zoster is 1 gram 3 times daily for 7 days. Therapy should be initiated at the earliest sign or symptom of herpes zoster and is most effective when started within 48 hours of the onset of rash.
2.2 Pediatric Dosing Recommendations
Cold Sores (Herpes Labialis): The recommended dosage of valacyclovir hydrochloride for the treatment of cold sores in pediatric patients ≥12 years of age is 2 grams twice daily for 1 day taken 12 hours apart. Therapy should be initiated at the earliest symptom of a cold sore (e.g., tingling, itching, or burning).Chickenpox:The recommended dosage of valacyclovir hydrochloride for treatment of chickenpox in immunocompetent pediatric patients 2 to <18 years of age is 20 mg/kg administered 3 times daily for 5 days. The total dose should not exceed 1 gram 3 times daily. Therapy should be initiated at the earliest sign or symptom[see Use in Specific Populations(8.4),Clinical Pharmacology (12.3), Clinical Studies (14.4)].
2.3 Extemporaneous Preparation of Oral Suspension
Ingredients and Preparation per USP-NF: valacyclovir hydrochloride 500 mg, cherry flavor, and Suspension Structured Vehicle USP-NF (SSV). Valacyclovir oral suspension (25 mg/mL or 50 mg/mL) should be prepared in lots of 100 mL. Prepare Suspension at Time of Dispensing as Follows:
Prepare SSV accordingto the USP-NF. Using a pestle and mortar, grind the required number of valacyclovir tablets, USP 500 mg until a fine powder is produced (5 valacyclovir tablets, USP for 25 mg/mL suspension; 10 valacyclovir tablets, USP for 50 mg/mL suspension). Gradually add approximately 5 mL aliquots of SSV to the mortar and triturate the powder until a paste has been produced. Ensure that the powder has been adequately wetted. Continue to add approximately 5 mL aliquots of SSV to the mortar, mixing thoroughly between additions, until a concentrated suspension is produced, to a minimum total quantity of 20 mL SSV and a maximum total quantity of 40 mL SSV for both the 25 mg/mL and 50mg/mL suspensions. Transfer the mixture to a suitable 100 mL measuring flask. Transfer the cherry flavor* to the mortar and dissolve in approximately 5 mL of SSV. Once dissolved, add to the measuring flask. Rinse the mortar at least 3 times with approximately 5 mL aliquots of SSV, transferring the rinsing to the measuring flask between additions. Make the suspension to volume (100 mL) with SSV and shake thoroughly to mix. Transfer the suspension to an amber glass medicine bottle with a child-resistant closure. The prepared suspension should be labeled with the following information “Shake well before using. Store suspension between 2°C to 8°C (36°F to 46°F) in a refrigerator. Discard after 28 days.” *The amount of cherry flavor added is as instructed by the suppliers of the cherry flavor.2.4 Patients With Renal Impairment
Dosage recommendations for adult patients with reduced renal function are provided in Table 1 [see Use in Specific Populations (8.5, 8.6), Clinical Pharmacology (12.3)]. Data are not available for the use of valacyclovir hydrochloride in pediatric patients with a creatinine clearance <50 mL/min/1.73 m2. Table 1.Valacyclovir Hydrochloride Dosage Recommendations for Adults With Renal Impairment
Indications
Normal Dosage Regimen (Creatinine Clearance ≥ 50 mL/min)
Creatinine Clearance (mL/min)
30-49
10-29
<10
Cold sores (Herpes labialis)
Do not exceed 1 day of treatment.
Two 2 gram doses taken 12 hours apart
Two 1 gram doses taken 12 hours apart
Two 500 mg doses taken 12 hours apart
500 mg single dose
Genital herpes: Initial episode
1 gram every 12 hours
no reduction
1 gram every 24 hours
500 mg every 24 hours
Genital herpes: Recurrent episode
500 mg every 12 hours
no reduction
500 mg every 24 hours
500 mg every 24 hours
Genital herpes: Suppressive therapy
Immunocompetent patients
1 gram every 24 hours
no reduction
500 mg every 24 hours
500 mg every 24 hours
Alternate dose for immunocompetent patients with ≤ 9 recurrences/year
500 mg every 24 hours
no reduction
500 mg every 48 hours
500 mg every 48 hours
HIV‑infected patients
500 mg every 12 hours
no reduction
500 mg every 24 hours
500 mg every 24 hours
Herpes zoster
1 gram every 8 hours
1 gram every 12 hours
1 gram every 24 hours
500 mg every 24 hours
Hemodialysis: Patients requiring hemodialysis should receive the recommended dose of valacyclovir hydrochloride after hemodialysis. During hemodialysis, the half‑life of acyclovir after administration of valacyclovir hydrochloride is approximately 4 hours. About one third of acyclovir in the body is removed by dialysis during a 4‑hour hemodialysis session.Peritoneal Dialysis: There is no information specific to administration of valacyclovir hydrochloride in patients receiving peritoneal dialysis. The effect of chronic ambulatory peritoneal dialysis (CAPD) and continuous arteriovenous hemofiltration/dialysis (CAVHD) on acyclovir pharmacokinetics has been studied. The removal of acyclovir after CAPD and CAVHD is less pronounced than with hemodialysis, and the pharmacokinetic parameters closely resemble those observed in patients with end‑stage renal disease (ESRD) not receiving hemodialysis. Therefore, supplemental doses of valacyclovir hydrochloride should not be required following CAPD or CAVHD.
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Carisoprodol
The recommended dose of CARISOPRODOL is 350 mg three times a day and at bedtime. The recommended maximum duration of CARISOPRODOL use is up to two or three weeks.
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Cyclobenzaprine Hydrochloride
For most patients, the recommended dose of cyclobenzaprine hydrochloride tablets is 5 mg three times a day. Based on individual patient response, the dose may be increased to either 7.5 or 10 mg three times a day. Use of cyclobenzaprine hydrochloride tablets for periods longer than two or three weeks is not recommended. (see INDICATIONS AND USAGE).
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).
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Cyclobenzaprine Hydrochloride
For most patients, the recommended dose of cyclobenzaprine hydrochloride tablets USP is 5 mg three times a day. Based on individual patient response, the dose may be increased to 10 mg three times a day. Use of cyclobenzaprine hydrochloride tablets USP for periods longer than two or three weeks is not recommended. (see INDICATIONS AND USAGE).
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).
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Albuterol Sulfate Solution
Adults and Children 2 to 12 Years of Age:
The usual dosage for adults and for children weighing at least 15 kg is 2.5 mg of albuterol (one vial) administered three to four times daily by nebulization. Children weighing < 15 kg who require < 2.5 mg/dose (i.e., less than a full vial) should use albuterol inhalation solution, 0.5% instead of albuterol inhalation solution, 0.083%. More frequent administration or higher doses are not recommended. To administer 2.5 mg of albuterol, administer the entire contents of one sterile unit dose vial (3 mL of 0.083% inhalation solution) by nebulization. The flow rate is regulated to suit the particular nebulizer so that albuterol inhalation solution will be delivered over approximately 5 to 15 minutes.
The use of albuterol sulfate inhalation solution can be continued as medically indicated to control recurring bouts of bronchospasm. During this time most patients gain optimum benefit from regular use of the inhalation solution.
If a previously effective dosage regimen fails to provide the usual relief, medical advice should be sought immediately, as this is often a sign of seriously worsening asthma that would require reassessment of therapy.
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Cetirizine Hydrochloride Solution
Cetirizine Hydrochloride Oral Solution, USP can be taken without regard to food consumption.
Children 2 to 5 Years for Chronic Urticaria: The recommended initial dose of Cetirizine Hydrochloride Oral Solution, USP in children aged 2 to 5 years is 2.5 mg (½ teaspoonful) syrup once daily. The dosage in this age group can be increased to a maximum dose of 5 mg per day given as 1 teaspoonful syrup once a day, or one ½ teaspoonful syrup given every 12 hours.
Children 6 months to < 2 years for Perennial Allergic Rhinitis and Chronic Urticaria: The recommended dose of Cetirizine Hydrochloride Oral Solution, USP in children 6 months to 23 months of age is 2.5 mg (½ teaspoonful) once daily. The dose in children 12 to 23 months of age can be increased to a maximum dose of 5 mg per day, given as ½ teaspoonful (2.5 mg) every 12 hours.
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Levothyroxine Sodium
General Principles
The goal of replacement therapy is to achieve and maintain a clinical and biochemical euthyroid state. The goal of suppressive therapy is to inhibit growth and/or function of abnormal thyroid tissue. The dose of levothyroxine sodium tablets that is adequate to achieve these goals depends on a variety of factors including the patient’s age, body weight, cardiovascular status, concomitant medical conditions, including pregnancy, concomitant medications, and the specific nature of the condition being treated (see WARNINGS and PRECAUTIONS). Hence, the following recommendations serve only as dosing guidelines. Dosing must be individualized and adjustments made based on periodic assessment of the patient’s clinical response and laboratory parameters (see PRECAUTIONS: Laboratory Tests).
Levothyroxine sodium tablets should be taken in the morning on an empty stomach, at least one-half hour before any food is eaten. Levothyroxine sodium tablets should be taken at least 4 hours apart from drugs that are known to interfere with its absorption (see PRECAUTIONS: Drug Interactions).
Due to the long half-life of levothyroxine, the peak therapeutic effect at a given dose of levothyroxine sodium may not be attained for 4 to 6 weeks.
Caution should be exercised when administering levothyroxine sodium tablets to patients with underlying cardiovascular disease, to the elderly, and to those with concomitant adrenal insufficiency (see PRECAUTIONS).
Specific Patient Populations
Hypothyroidism in Adults and in Children in Whom Growth and Puberty are Complete
(see WARNINGS and PRECAUTIONS: Laboratory Tests)
Therapy may begin at full replacement doses in otherwise healthy individuals less than 50 years old and in those older than 50 years who have been recently treated for hyperthyroidism or who have been hypothyroid for only a short time (such as a few months). The average full replacement dose of levothyroxine sodium is approximately 1.7 mcg/kg/day (e.g., 100 to 125 mcg/day for a 70 kg adult). Older patients may require less than 1 mcg/kg/day. Levothyroxine sodium doses greater than 200 mcg/day are seldom required. An inadequate response to daily doses ≥ 300 mcg/day is rare and may indicate poor compliance, malabsorption, and/or drug interactions.
For most patients older than 50 years or for patients under 50 years of age with underlying cardiac disease, an initial starting dose of 25 to 50 mcg/day of levothyroxine sodium is recommended, with gradual increments in dose at 6 to 8 week intervals, as needed. The recommended starting dose of levothyroxine sodium in elderly patients with cardiac disease is 12.5 to 25 mcg/day, with gradual dose increments at 4 to 6 week intervals. The levothyroxine sodium dose is generally adjusted in 12.5 mcg to 25 mcg increments until the patient with primary hypothyroidism is clinically euthyroid and the serum TSH has normalized.
In patients with severe hypothyroidism, the recommended initial levothyroxine sodium dose is 12.5 to 25 mcg/day with increases of 25 mcg/day every 2 to 4 weeks, accompanied by clinical and laboratory assessment, until the TSH level is normalized.
In patients with secondary (pituitary) or tertiary (hypothalamic) hypothyroidism, the levothyroxine sodium dose should be titrated until the patient is clinically euthyroid and the serum free-T4 level is restored to the upper half of the normal range.
Pediatric Dosage - Congenital or Acquired Hypothyroidism
(see PRECAUTIONS: Laboratory Tests)
General Principles
In general, levothyroxine therapy should be instituted at full replacement doses as soon as possible. Delays in diagnosis and institution of therapy may have deleterious effects on the child’s intellectual and physical growth and development.
Undertreatment and overtreatment should be avoided (see PRECAUTIONS: Pediatric Use).
Levothyroxine sodium tablets may be administered to infants and children who cannot swallow intact tablets by crushing the tablet and suspending the freshly crushed tablet in a small amount (5 to 10 mL or 1 to 2 teaspoons) of water. This suspension can be administered by spoon or by dropper. DO NOT STORE THE SUSPENSION. Foods that decrease absorption of levothyroxine, such as soybean infant formula, should not be used for administering levothyroxine sodium tablets (see PRECAUTIONS: Drug-Food Interactions).
Newborns
The recommended starting dose of levothyroxine sodium in newborn infants is 10 to 15 mcg/kg/day. A lower starting dose (e.g., 25 mcg/day) should be considered in infants at risk for cardiac failure, and the dose should be increased in 4 to 6 weeks as needed based on clinical and laboratory response to treatment. In infants with very low (< 5 mcg/dL) or undetectable serum T4 concentrations, the recommended initial starting dose is 50 mcg/day of levothyroxine sodium.
Infants and Children
Levothyroxine therapy is usually initiated at full replacement doses, with the recommended dose per body weight decreasing with age (see Table 3). However, in children with chronic or severe hypothyroidism, an initial dose of 25 mcg/day of levothyroxine sodium is recommended with increments of 25 mcg every 2 to 4 weeks until the desired effect is achieved.
Hyperactivity in an older child can be minimized if the starting dose is one-fourth of the recommended full replacement dose, and the dose is then increased on a weekly basis by an amount equal to one-fourth the full recommended replacement dose until the full recommended replacement dose is reached.
Table 3: Levothyroxine Sodium Dosing Guidelines for Pediatric Hypothyroidism * The dose should be adjusted based on clinical response and laboratory parameters (see PRECAUTIONS: Laboratory Tests and PRECAUTIONS: Pediatric Use).AGE
Daily Dose Per Kg Body Weight*
0 to 3 months
10 to 15 mcg/kg/day
3 to 6 months
8 to 10 mcg/kg/day
6 to 12 months
6 to 8 mcg/kg/day
1 to 5 years
5 to 6 mcg/kg/day
6 to 12 years
4 to 5 mcg/kg/day
> 12 years but growth and puberty incomplete
2 to 3 mcg/kg/day
Growth and puberty complete
1.7 mcg/kg/day
Pregnancy
Pregnancy may increase levothyroxine requirements (see PRECAUTIONS: Pregnancy).
Subclinical Hypothyroidism
If this condition is treated, a lower levothyroxine sodium dose (e.g., 1 mcg/kg/day) than that used for full replacement may be adequate to normalize the serum TSH level. Patients who are not treated should be monitored yearly for changes in clinical status and thyroid laboratory parameters.
TSH Suppression in Well Differentiated Thyroid Cancer and Thyroid Nodules
The target level for TSH suppression in these conditions has not been established with controlled studies. In addition, the efficacy of TSH suppression for benign nodular disease is controversial. Therefore, the dose of levothyroxine sodium tablets used for TSH suppression should be individualized based on the specific disease and the patient being treated.
In the treatment of well differentiated (papillary and follicular) thyroid cancer, levothyroxine is used as an adjunct to surgery and radioiodine therapy. Generally, TSH is suppressed to < 0.1 mU/L, and this usually requires a levothyroxine sodium dose of greater than 2 mcg/kg/day. However, in patients with high risk tumors, the target level for TSH suppression may be < 0.01 mU/L.
In the treatment of benign nodules and nontoxic multinodular goiter, TSH is generally suppressed to a higher target (e.g., 0.1 to 0.5 mU/L for nodules and 0.5 to 1.0 mU/L for multinodular goiter) than that used for the treatment of thyroid cancer. Levothyroxine sodium is contraindicated if the serum TSH is already suppressed due to the risk of precipitating overt thyrotoxicosis (see CONTRAINDICATIONS, WARNINGS and PRECAUTIONS).
Myxedema Coma
Myxedema coma is a life-threatening emergency characterized by poor circulation and hypometabolism, and may result in unpredictable absorption of levothyroxine sodium from the gastrointestinal tract. Therefore, oral thyroid hormone drug products are not recommended to treat this condition. Thyroid hormone products formulated for intravenous administration should be administered.
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Doxycycline Hyclate
THE USUAL DOSAGE AND FREQUENCY OF ADMINISTRATION OF DOXYCYCLINE DIFFERS FROM THAT OF THE OTHER TETRACYCLINES. EXCEEDING THE RECOMMENDED DOSAGE MAY RESULT IN AN INCREASED INCIDENCE OF SIDE EFFECTS. Adults: The usual dose of oral doxycycline is 200 mg on the first day of treatment (administered 100 mg every 12 hours) followed by a maintenance dose of 100 mg/day.
In the management of more severe infections (particularly chronic infections of the urinary tract), 100 mg every 12 hours is recommended.
For children above eight years of age: The recommended dosage schedule for children weighing 100 pounds or less is 2 mg/lb of body weight divided into two doses on the first day of treatment, followed by 1 mg/lb of body weight given as a single daily dose or divided into two doses, on subsequent days. For more severe infections, up to 2 mg/lb of body weight may be used. For children over 100 lb the usual adult dose should be used.
The therapeutic antibacterial serum activity will usually persist for 24 hours following recommended dosage.
When used in streptococcal infections, therapy should be continued for 10 days.
Administration of adequate amounts of fluid along with capsule and tablet forms of drugs in the tetracycline class is recommended to wash down the drugs and reduce the risk of esophageal irritation and ulceration. (See ADVERSE REACTIONS.)
If gastric irritation occurs, it is recommended that doxycycline be given with food or milk. The absorption of doxycycline is not markedly influenced by simultaneous ingestion of food or milk.
Studies to date have indicated that administration of doxycycline at the usual recommended doses does not lead to excessive accumulation of doxycycline in patients with renal impairment.
Uncomplicated gonococcal infections in adults (except anorectal infections in men): 100 mg, by mouth, twice a day for 7 days. As an alternate single visit dose, administer 300 mg stat followed in one hour by a second 300 mg dose. The dose may be administered with food, including milk or carbonated beverage, as required.
Uncomplicated urethral, endocervical, or rectal infection in adults caused by Chlamydia trachomatis: 100 mg, by mouth twice a day for 7 days.
Nongonococcal urethritis (NGU) caused by C. trachomatis or U. urealyticum: 100 mg by mouth, twice a day for 7 days.
Syphilis – early: Patients who are allergic to penicillin should be treated with doxycycline 100 mg, by mouth, twice a day for 2 weeks.
Syphilis of more than one year's duration: Patients who are allergic to penicillin should be treated with doxycycline 100 mg, by mouth, twice a day for 4 weeks.
Acute epididymo-orchitis caused by N. gonorrhoeae: 100 mg, by mouth, twice a day for at least 10 days.
Acute epididymo-orchitis caused by C. trachomatis: 100 mg, by mouth, twice a day for at least 10 days.
For prophylaxis of malaria: For adults, the recommended dose is 100 mg daily. For children over 8 years of age, the recommended dose is 2 mg/kg given once daily up to the adult dose. Prophylaxis should begin 1–2 days before travel to the malarious area. Prophylaxis should be continued daily during travel in the malarious area and for 4 weeks after the traveler leaves the malarious area.
Inhalational anthrax (post-exposure):
ADULTS: 100 mg of doxycycline, by mouth, twice a day for 60 days. CHILDREN: weighing less than 100 lb (45 kg); 1 mg/lb (2.2 mg/kg) of body weight by mouth, twice a day for 60 days. Children weighing 100 lb or more should receive the adult dose. -
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Fluconazole
Dosage and Administration in Adults
Single Dose
Vaginal candidiasis: The recommended dosage of fluconazole for vaginal candidiasis is 150 mg as a single oral dose.
Multiple Dose
SINCE ORAL ABSORPTION IS RAPID AND ALMOST COMPLETE, THE DAILY DOSE OF FLUCONAZOLE IS THE SAME FOR ORAL AND INTRAVENOUS ADMINISTRATION. In general, a loading dose of twice the daily dose is recommended on the first day of therapy to result in plasma concentrations close to steady-state by the second day of therapy.
The daily dose of fluconazole for the treatment of infections other than vaginal candidiasis should be based on the infecting organism and the patient’s response to therapy. Treatment should be continued until clinical parameters or laboratory tests indicate that active fungal infection has subsided. An inadequate period of treatment may lead to recurrence of active infection. Patients with AIDS and cryptococcal meningitis or recurrent oropharyngeal candidiasis usually require maintenance therapy to prevent relapse.
Oropharyngeal candidiasis: The recommended dosage of fluconazole for oropharyngeal candidiasis is 200 mg on the first day, followed by 100 mg once daily. Clinical evidence of oropharyngeal candidiasis generally resolves within several days, but treatment should be continued for at least 2 weeks to decrease the likelihood of relapse.
Esophageal candidiasis: The recommended dosage of fluconazole for esophageal candidiasis is 200 mg on the first day, followed by 100 mg once daily. Doses up to 400 mg/day may be used, based on medical judgment of the patient’s response to therapy. Patients with esophageal candidiasis should be treated for a minimum of three weeks and for at least two weeks following resolution of symptoms.
Systemic Candida infections: For systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia, optimal therapeutic dosage and duration of therapy have not been established. In open, noncomparative studies of small numbers of patients, doses of up to 400 mg daily have been used.
Urinary tract infections and peritonitis: For the treatment of Candida urinary tract infections and peritonitis, daily doses of 50 to 200 mg have been used in open, noncomparative studies of small numbers of patients.
Cryptococcal meningitis: The recommended dosage for treatment of acute cryptococcal meningitis is 400 mg on the first day, followed by 200 mg once daily. A dosage of 400 mg once daily may be used, based on medical judgment of the patient’s response to therapy. The recommended duration of treatment for initial therapy of cryptococcal meningitis is 10 to 12 weeks after the cerebrospinal fluid becomes culture negative. The recommended dosage of fluconazole for suppression of relapse of cryptococcal meningitis in patients with AIDS is 200 mg once daily.
Prophylaxis in patients undergoing bone marrow transplantation: The recommended fluconazole daily dosage for the prevention of candidiasis in patients undergoing bone marrow transplantation is 400 mg, once daily. Patients who are anticipated to have severe granulocytopenia (less than 500 neutrophils per cu mm) should start fluconazole prophylaxis several days before the anticipated onset of neutropenia, and continue for 7 days after the neutrophil count rises above 1000 cells per cu mm.
Dosage and Administration in Children
The following dose equivalency scheme should generally provide equivalent exposure in pediatric and adult patients:
Pediatric Patients Adults * Some older children may have clearances similar to that of adults. Absolute doses exceeding 600 mg/day are not recommended.3 mg/kg
100 mg
6 mg/kg
200 mg
12* mg/kg
400 mg
Experience with fluconazole in neonates is limited to pharmacokinetic studies in premature newborns. (See CLINICAL PHARMACOLOGY.) Based on the prolonged half-life seen in premature newborns (gestational age 26 to 29 weeks), these children, in the first two weeks of life, should receive the same dosage (mg/kg) as in older children, but administered every 72 hours. After the first two weeks, these children should be dosed once daily. No information regarding fluconazole pharmacokinetics in full-term newborns is available.
Dosage in Patients With Impaired Renal Function
Fluconazole is cleared primarily by renal excretion as unchanged drug. There is no need to adjust single dose therapy for vaginal candidiasis because of impaired renal function. In patients with impaired renal function who will receive multiple doses of fluconazole, an initial loading dose of 50 to 400 mg should be given. After the loading dose, the daily dose (according to indication) should be based on the following table:
Creatinine Clearance (mL/min) Percent of Recommended Dose> 50
100%
≤ 50 (no dialysis)
50%
Regular dialysis
100% after each dialysis
These are suggested dose adjustments based on pharmacokinetics following administration of multiple doses. Further adjustment may be needed depending upon clinical condition.
When serum creatinine is the only measure of renal function available, the following formula (based on sex, weight, and age of the patient) should be used to estimate the creatinine clearance in adults:
Males: Weight (kg) × (140-age) 72 × serum creatinine (mg/100 mL)
Females: 0.85 × above value
Although the pharmacokinetics of fluconazole has not been studied in children with renal insufficiency, dosage reduction in children with renal insufficiency should parallel that recommended for adults. The following formula may be used to estimate creatinine clearance in children:
K × linear length or height (cm) serum creatinine (mg/100 mL)(Where K=0.55 for children older than 1 year and 0.45 for infants.)
Administration
Fluconazole tablets are administered orally. Fluconazole tablets can be taken with or without food.
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Eszopiclone
Use the lowest effective dose for the patient.
2.1 Dosage in Adults
The recommended starting dose is 1 mg. Dosing can be raised to 2 mg or 3 mg if clinically indicated. In some patients, the higher morning blood levels of eszopiclone tablets following use of the 2 mg or 3 mg dose increase the risk of next day impairment of driving and other activities that require full alertness [see Warnings and Precautions (5.1)]. The total dose of eszopiclone tablets should not exceed 3 mg, once daily immediately before bedtime [see Warnings and Precautions (5.6)].
2.2 Geriatric or Debilitated Patients
The total dose of eszopiclone tablets should not exceed 2 mg in elderly or debilitated patients.
2.3 Patients with Severe Hepatic Impairment, or Taking Potent CYP3A4 Inhibitors
In patients with severe hepatic impairment, or in patients coadministered eszopiclone tablets with potent CYP3A4 inhibitors, the total dose of eszopiclone tablets should not exceed 2 mg [see Warning and Precautions (5.7)].
2.4 Use with CNS Depressants
Dosage adjustments may be necessary when eszopiclone tablets is combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.1)].
2.5 Administration with Food
Taking eszopiclone tablets with or immediately after a heavy, high-fat meal results in slower absorption and would be expected to reduce the effect of eszopiclone tablets on sleep latency [see Clinical Pharmacology (12.3)].
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Atorvastatin Calcium
2.1 Hyperlipidemia (Heterozygous Familial and Nonfamilial) and Mixed Dyslipidemia (Fredrickson Types IIa and IIb)
The recommended starting dose of atorvastatin calcium tablets is 10 or 20 mg once daily. Patients who require a large reduction in LDL-C (more than 45%) may be started at 40 mg once daily. The dosage range of atorvastatin calcium tablets is 10 to 80 mg once daily. Atorvastatin calcium tablets can be administered as a single dose at any time of the day, with or without food. The starting dose and maintenance doses of atorvastatin calcium tablets should be individualized according to patient characteristics such as goal of therapy and response (see current NCEP Guidelines). After initiation and/or upon titration of atorvastatin calcium tablets, lipid levels should be analyzed within 2 to 4 weeks and dosage adjusted accordingly.
2.2 Heterozygous Familial Hypercholesterolemia in Pediatric Patients (10-17 years of age)
The recommended starting dose of atorvastatin calcium tablets is 10 mg/day; the maximum recommended dose is 20 mg/day (doses greater than 20 mg have not been studied in this patient population). Doses should be individualized according to the recommended goal of therapy [see current NCEP Pediatric Panel Guidelines, Clinical Pharmacology (12), and Indications and Usage (1.2)]. Adjustments should be made at intervals of 4 weeks or more.
2.3 Homozygous Familial Hypercholesterolemia
The dosage of atorvastatin calcium tablets in patients with homozygous FH is 10 to 80 mg daily. Atorvastatin calcium tablets should be used as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) in these patients or if such treatments are unavailable.
2.4 Concomitant Lipid-Lowering Therapy
Atorvastatin calcium tablets may be used with bile acid resins. The combination of HMG-CoA reductase inhibitors (statins) and fibrates should generally be used with caution [see Warnings and Precautions, Skeletal Muscle (5.1), Drug Interactions (7)].
2.5 Dosage in Patients with Renal Impairment
Renal disease does not affect the plasma concentrations nor LDL-C reduction of atorvastatin calcium tablets; thus, dosage adjustment in patients with renal dysfunction is not necessary [see Warnings and Precautions, Skeletal Muscle (5.1), Clinical Pharmacology, Pharmacokinetics (12.3)].
2.6 Dosage in Patients Taking Cyclosporine, Clarithromycin, Itraconazole, or Certain Protease Inhibitors
In patients taking cyclosporine or the HIV protease inhibitors (tipranavir plus ritonavir) or the hepatitis C protease inhibitor (telaprevir), therapy with atorvastatin calcium tablets should be avoided. In patients with HIV taking lopinavir plus ritonavir, caution should be used when prescribing atorvastatin calcium tablets and the lowest dose necessary employed. In patients taking clarithromycin, itraconazole, or in patients with HIV taking a combination of saquinavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, or fosamprenavir plus ritonavir, therapy with atorvastatin calcium tablets should be limited to 20 mg, and appropriate clinical assessment is recommended to ensure that the lowest dose necessary of atorvastatin calcium is employed. In patients taking the HIV protease inhibitor nelfinavir or the hepatitis C protease inhibitor boceprevir, therapy with atorvastatin calcium tablets should be limited to 40 mg, and appropriate clinical assessment is recommended to ensure that the lowest dose necessary of atorvastatin calcium tablets is employed [see Warnings and Precautions, Skeletal Muscle (5.1), Drug Interactions (7)].
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![Alprazolam Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=ca6b7023-f245-4405-a8ab-1b9296c74ef7&name=eba936b6-7a9f-46af-abee-5762e03c5801-04.jpg)
Alprazolam
Dosage should be individualized for maximum beneficial effect. While the usual daily dosages given below will meet the needs of most patients, there will be some who require doses greater than 4 mg/day. In such cases, dosage should be increased cautiously to avoid adverse effects.
Anxiety Disorders and Transient Symptoms of Anxiety
Treatment for patients with anxiety should be initiated with a dose of 0.25 to 0.5 mg given three times daily. The dose may be increased to achieve a maximum therapeutic effect, at intervals of 3 to 4 days, to a maximum daily dose of 4 mg, given in divided doses. The lowest possible effective dose should be employed and the need for continued treatment reassessed frequently. The risk of dependence may increase with dose and duration of treatment.
In all patients, dosage should be reduced gradually when discontinuing therapy or when decreasing the daily dosage. Although there are no systematically collected data to support a specific discontinuation schedule, it is suggested that the daily dosage be decreased by no more than 0.5 mg every 3 days. Some patients may require an even slower dosage reduction.
Panic Disorder
The successful treatment of many panic disorder patients has required the use of ALPRAZOLAM at doses greater than 4 mg daily. In controlled trials conducted to establish the efficacy of ALPRAZOLAM in panic disorder, doses in the range of 1 to 10 mg daily were used. The mean dosage employed was approximately 5 to 6 mg daily. Among the approximately 1700 patients participating in the panic disorder development program, about 300 received ALPRAZOLAM in dosages of greater than 7 mg/day, including approximately 100 patients who received maximum dosages of greater than 9 mg/day. Occasional patients required as much as 10 mg a day to achieve a successful response.
Dose Titration
Treatment may be initiated with a dose of 0.5 mg three times daily. Depending on the response, the dose may be increased at intervals of 3 to 4 days in increments of no more than 1 mg per day. Slower titration to the dose levels greater than 4 mg/day may be advisable to allow full expression of the pharmacodynamic effect of ALPRAZOLAM. To lessen the possibility of interdose symptoms, the times of administration should be distributed as evenly as possible throughout the waking hours, that is, on a three or four times per day schedule.
Generally, therapy should be initiated at a low dose to minimize the risk of adverse responses in patients especially sensitive to the drug. Dose should be advanced until an acceptable therapeutic response (ie, a substantial reduction in or total elimination of panic attacks) is achieved, intolerance occurs, or the maximum recommended dose is attained.
Dose Maintenance
For patients receiving doses greater than 4 mg/day, periodic reassessment and consideration of dosage reduction is advised. In a controlled postmarketing dose-response study, patients treated with doses of ALPRAZOLAM greater than 4 mg/day for 3 months were able to taper to 50% of their total maintenance dose without apparent loss of clinical benefit. Because of the danger of withdrawal, abrupt discontinuation of treatment should be avoided. (See WARNINGS, PRECAUTIONS, DRUG ABUSE AND DEPENDENCE.)
The necessary duration of treatment for panic disorder patients responding to ALPRAZOLAM is unknown. After a period of extended freedom from attacks, a carefully supervised tapered discontinuation may be attempted, but there is evidence that this may often be difficult to accomplish without recurrence of symptoms and/or the manifestation of withdrawal phenomena.
Dose Reduction
Because of the danger of withdrawal, abrupt discontinuation of treatment should be avoided (see WARNINGS, PRECAUTIONS, DRUG ABUSE AND DEPENDENCE).
In all patients, dosage should be reduced gradually when discontinuing therapy or when decreasing the daily dosage. Although there are no systematically collected data to support a specific discontinuation schedule, it is suggested that the daily dosage be decreased by no more than 0.5 mg every three days. Some patients may require an even slower dosage reduction.
In any case, reduction of dose must be undertaken under close supervision and must be gradual. If significant withdrawal symptoms develop, the previous dosing schedule should be reinstituted and, only after stabilization, should a less rapid schedule of discontinuation be attempted. In a controlled postmarketing discontinuation study of panic disorder patients which compared this recommended taper schedule with a slower taper schedule, no difference was observed between the groups in the proportion of patients who tapered to zero dose; however, the slower schedule was associated with a reduction in symptoms associated with a withdrawal syndrome. It is suggested that the dose be reduced by no more than 0.5 mg every 3 days, with the understanding that some patients may benefit from an even more gradual discontinuation. Some patients may prove resistant to all discontinuation regimens.
Dosing in Special Populations
In elderly patients, in patients with advanced liver disease or in patients with debilitating disease, the usual starting dose is 0.25 mg, given two or three times daily. This may be gradually increased if needed and tolerated. The elderly may be especially sensitive to the effects of benzodiazepines. If side effects occur at the recommended starting dose, the dose may be lowered.
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Dry Scalp Care
Amoxicillin and clavulanate potassium may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when amoxicillin and clavulanate potassium is administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium should be taken at the start of a meal.
2.1 Adults
The usual adult dose is one amoxicillin and clavulanate potassium tablet, 500 mg/125 mg every 12 hours or one amoxicillin and clavulanate potassium tablet, 250 mg/125 mg every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one amoxicillin and clavulanate potassium tablet, 875 mg/125 mg every 12 hours or one amoxicillin and clavulanate potassium tablet, 500 mg/125 mg every 8 hours. Adults who have difficulty swallowing may be given the 125 mg/5 mL or 250 mg/5 mL suspension in place of the 500 mg/125 mg tablet. The 200 mg/5 mL suspension or the 400 mg/5 mL suspension may be used in place of the 875 mg/125 mg tablet.
Two 250 mg/125 mg tablets of amoxicillin and clavulanate potassium should not be substituted for one 500 mg/125 mg tablet of amoxicillin and clavulanate potassium. Since both the 250 mg/125 mg and 500 mg/125 mg tablets of amoxicillin and clavulanate potassium contain the same amount of clavulanic acid (125 mg, as the potassium salt), two 250 mg/125 mg tablets are not equivalent to one 500 mg/125 mg tablet of amoxicillin and clavulanate potassium.
The 250 mg/125 mg tablet of amoxicillin and clavulanate potassium and the 250 mg/62.5 mg chewable tablet should not be substituted for each other, as they are not interchangeable. The 250 mg/125 mg tablet of amoxicillin and clavulanate potassium and the 250 mg/62.5 mg chewable tablet do not contain the same amount of clavulanic acid (as the potassium salt). The 250 mg/125 mg tablet of amoxicillin and clavulanate potassium contains 125 mg of clavulanic acid, whereas the 250 mg/62.5 mg chewable tablet contains 62.5 mg of clavulanic acid.
2.2 Pediatric Patients
Based on the amoxicillin component, amoxicillin and clavulanate potassium should be dosed as follows:
Neonates and Infants Aged < 12 weeks (< 3 months)
The recommended dose of amoxicillin and clavulanate potassium is 30 mg/kg/day divided every 12 hours, based on the amoxicillin component. Experience with the 200 mg/28.5 mg/5 mL formulation in this age group is limited, and thus, use of the 125 mg/31.25 mg/5 mL oral suspension is recommended.
Patients Aged 12 weeks (3 months) and Older
See dosing regimens provided in Table 1. The every 12 hour regimen is recommended as it is associated with significantly less diarrhea [see Clinical Studies (14.2)].
Table 1: Dosing in Patients Aged 12 weeks (3 months) and Older
* Each strength of suspension of amoxicillin and clavulanate potassium is available as a chewable tablet for use by older children. † Duration of therapy studied and recommended for acute otitis media is 10 days.INFECTION
DOSING REGIMEN
Every 12 hours
Every 8 hours
200 mg/28.5 mg/5 mL or
400 mg/57 mg/5 mL oral suspension*
125 mg/31.25 mg/5 mL or 250 mg/62.5 mg/5 mL oral suspension*
Otitis media†, sinusitis, lower respiratory tract infections, and more severe infections
45 mg/kg/day every 12 hours
40 mg/kg/day every 8 hours
Less severe infections
25 mg/kg/day every 12 hours
20 mg/kg/day every 8 hours
Patients Weighing 40 kg or More
Pediatric patients weighing 40 kg or more should be dosed according to adult recommendations.
The 250 mg/125 mg tablet of amoxicillin and clavulanate potassium should not be used until the child weighs at least 40 kg, due to the different amoxicillin to clavulanic acid ratios in the 250 mg/125 mg tablet of amoxicillin and clavulanate potassium (250/125) versus the 250 mg/62.5 mg chewable tablet of amoxicillin and clavulanate potassium (250/62.5).
2.3 Patients with Renal Impairment
Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Renal impairment patients with a glomerular filtration rate of < 30 mL/min should not receive the 875 mg/125 mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg/125 mg or 250 mg/125 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection.
Hemodialysis patients should receive 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.
2.4 Directions for Mixing Oral Suspension
Prepare a suspension at time of dispensing as follows: Tap bottle until all the powder flows freely. Add approximately 2/3 of the total amount of water for reconstitution (see Table 2 below) and shake vigorously to suspend powder. Add remainder of the water and again shake vigorously.
Table 2: Amount of Water for Mixing Oral Suspension
Strength
Bottle Size
Amount of Water for Reconstitution
Contents of Each Teaspoonful (5 mL)
200 mg/28.5 mg/5 mL
50 mL
75 mL
100 mL
47 mL
70 mL
93 mL
200 mg amoxicillin and 28.5 mg of clavulanic acid as the potassium salt
400 mg/57 mg/5 mL
50 mL
75 mL
100 mL
45 mL
67 mL
89 mL
400 mg amoxicillin and 57 mg of clavulanic acid as the potassium salt
Note: Shake oral suspension well before using. Reconstituted suspension must be stored under refrigeration and discarded after 10 days.
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![Gabapentin Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=d2aa2a6a-5e7a-4f29-82e7-a85f5ecc4b1b&name=c13551d6-figure-06.jpg)
Gabapentin
Gabapentin tablets USP are given orally with or without food. Patients should be informed that, should they break the scored 600 or 800 mg tablet in order to administer a half-tablet, they should take the unused half-tablet as the next dose. Half-tablets not used within several days of breaking the scored tablet should be discarded.
If gabapentin tablets USP dose is reduced, discontinued or substituted with an alternative medication, this should be done gradually over a minimum of 1 week (a longer time period may be needed at the discretion of the prescriber).
Postherpetic Neuralgia
In adults with postherpetic neuralgia, gabapentin therapy may be initiated as a single 300 mg dose on Day 1, 600 mg/day on Day 2 (divided BID), and 900 mg/day on Day 3 (divided TID). The dose can subsequently be titrated up as needed for pain relief to a daily dose of 1800 mg (divided TID). In clinical studies, efficacy was demonstrated over a range of doses from 1800 mg/day to 3600 mg/day with comparable effects across the dose range. Additional benefit of using doses greater than 1800 mg/day was not demonstrated.
Epilepsy
Gabapentin tablets USP, are recommended for add-on therapy in patients 3 years of age and older. Effectiveness in pediatric patients below the age of 3 years has not been established.
Patients >12 Years of Age: The effective dose of gabapentin is 900 to 1800 mg/day and given in divided doses (three times a day) using 300 or 400 mg capsules, or 600 or 800 mg tablets. The starting dose is 300 mg three times a day. If necessary, the dose may be increased using 300 or 400 mg capsules, or 600 or 800 mg tablets three times a day up to 1800 mg/day. Dosages up to 2400 mg/day have been well tolerated in long-term clinical studies. Doses of 3600 mg/day have also been administered to a small number of patients for a relatively short duration, and have been well tolerated. The maximum time between doses in the TID schedule should not exceed 12 hours.
Pediatric Patients Age 3 to 12 Years: The starting dose should range from 10 to 15 mg/kg/day in 3 divided doses, and the effective dose reached by upward titration over a period of approximately 3 days. The effective dose of gabapentin in patients 5 years of age and older is 25 to 35 mg/kg/day and given in divided doses (three times a day). The effective dose in pediatric patients ages 3 and 4 years is 40 mg/kg/day and given in divided doses (three times a day) (see CLINICAL PHARMACOLOGY, Pediatrics). Gabapentin may be administered as the oral solution, capsule, or tablet, or using combinations of these formulations. Dosages up to 50 mg/kg/day have been well tolerated in a long-term clinical study. The maximum time interval between doses should not exceed 12 hours.
It is not necessary to monitor gabapentin plasma concentrations to optimize gabapentin therapy. Further, because there are no significant pharmacokinetic interactions among gabapentin and other commonly used antiepileptic drugs, the addition of gabapentin does not alter the plasma levels of these drugs appreciably.
If gabapentin tablets are discontinued and/or an alternate anticonvulsant medication is added to the therapy, this should be done gradually over a minimum of 1 week.
Dosage in Renal Impairment
Creatinine clearance is difficult to measure in outpatients. In patients with stable renal function, creatinine clearance (CCr) can be reasonably well estimated using the equation of Cockcroft and Gault:
for females CCr = (0.85)(140-age)(weight)/[(72)(SCr)]
for males CCr = (140-age)(weight)/[(72)(SCr)]
where age is in years, weight is in kilograms and SCr is serum creatinine in mg/dL.
Dosage adjustment in patients ≥ 12 years of age with compromised renal function or undergoing hemodialysis is recommended as follows (see dosing recommendations above for effective doses in each indication).
TABLE 6. Gabapentin Dosage Based on Renal Function Renal Function Creatinine Clearance (mL/min) Total Daily Dose Range (mg/day) Dose Regimen(mg) a For patients with creatinine clearance <15 mL/min, reduce daily dose in proportion to creatinine clearance (e.g., patients with creatinine clearance of 7.5 mL/min should receive one-half the daily dose that patients with a creatinine clearance of 15 mL/min receive). b Patients on Hemodialysis should receive maintenance doses based on estimates of creatinine clearance as indicated in the upper portion of the table and a supplemental post-hemodialysis dose administered after each 4 hours of hemodialysis as indicated in the lower portion of the table.≥ 60
900-3600
300 TID
400 TID
600 TID
800 TID
1200 TID
> 30-59
400-1400
200 BID
300 BID
400 BID
500 BID
700 BID
> 15-29
200-700
200 QD
300 QD
400 QD
500 QD
700 QD
15a
100-300
100 QD
125 QD
150 QD
200 QD
300 QD
Post-Hemodialysis Supplemental Dose (mg)b
Hemodialysis
125b
150b
200b
250b
350b
The use of gabapentin tablets USP in patients < 12 years of age with compromised renal function has not been studied.
Dosage in Elderly
Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and dose should be adjusted based on creatinine clearance values in these patients.
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Orphenadrine Citrate
Adults-Two tablets per day; one in the morning and one in the evening.
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![Eszopiclone Tablet, Film Coated [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=5e638ca7-6df0-404c-8e8c-97f7a71c3278&name=image-03.jpg)
Eszopiclone
Use the lowest effective dose for the patient.
2.1 Dosage in Adults
The recommended starting dose is 1 mg. Dosing can be raised to 2 mg or 3 mg if clinically indicated. In some patients, the higher morning blood levels of eszopiclone following use of the 2 mg or 3 mg dose increase the risk of next day impairment of driving and other activities that require full alertness [see Warnings and Precautions (5.1)]. The total dose of eszopiclone should not exceed 3 mg, once daily immediately before bedtime [see Warnings and Precautions (5.6)].
2.2 Geriatric or Debilitated Patients
The total dose of eszopiclone should not exceed 2 mg in elderly or debilitated patients.
2.3 Patients with Severe Hepatic Impairment, or Taking Potent CYP3A4 Inhibitors
In patients with severe hepatic impairment, or in patients coadministered eszopiclone tablets with potent CYP3A4 inhibitors, the total dose of eszopiclone should not exceed 2 mg [see Warnings and Precautions (5.7)].
2.4 Use with CNS Depressants
Dosage adjustments may be necessary when eszopiclone tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.1)].
2.5 Administration with Food
Taking eszopiclone tablets with or immediately after a heavy, high-fat meal results in slower absorption and would be expected to reduce the effect of eszopiclone tablets on sleep latency [see Clinical Pharmacology (12.3)].
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Hydroxyzine Hydrochloride
For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested: Adults, 50-100 mg q.i.d.; children under 6 years, 50 mg daily in divided doses; children over 6 years, 50-100 mg daily in divided doses.
For use in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses and in histamine-mediated pruritus: adults, 25 mg t.i.d. or q.i.d.; children under 6 years, 50 mg daily in divided doses; children over 6 years, 50-100 mg daily in divided doses.
As a sedative when used as a premedication and following general anesthesia: 50-100 mg for adults and 0.6 mg/kg of body weight in children.
When treatment is initiated by the intramuscular route of administration, subsequent doses may be administered orally.
As with all potent medication, the dosage should be adjusted according to the patient’s response to therapy.
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Mirtazapine
Initial Treatment
The recommended starting dose for mirtazapine tablets is 15 mg/day, administered in a single dose, preferably in the evening prior to sleep. In the controlled clinical trials establishing the efficacy of mirtazapine in the treatment of major depressive disorder, the effective dose range was generally 15 to 45 mg/day. While the relationship between dose and satisfactory response in the treatment of major depressive disorder for mirtazapine tablets has not been adequately explored, patients not responding to the initial 15 mg dose may benefit from dose increases up to a maximum of 45 mg/day. Mirtazapine tablets has an elimination half-life of approximately 20 to 40 hours; therefore, dose changes should not be made at intervals of less than one to two weeks in order to allow sufficient time for evaluation of the therapeutic response to a given dose.
Elderly and Patients with Renal or Hepatic Impairment
The clearance of mirtazapine is reduced in elderly patients and in patients with moderate to severe renal or hepatic impairment. Consequently, the prescriber should be aware that plasma mirtazapine levels may be increased in these patient groups, compared to levels observed in younger adults without renal or hepatic impairment (see PRECAUTIONS and CLINICAL PHARMACOLOGY).
Maintenance/Extended Treatment
It is generally agreed that acute episodes of depression require several months or longer of sustained pharmacological therapy beyond response to the acute episode. Systematic evaluation of mirtazapine tablets has demonstrated that its efficacy in major depressive disorder is maintained for periods of up to 40 weeks following 8 to 12 weeks of initial treatment at a dose of 15 to 45 mg/day (see CLINICAL PHARMACOLOGY). Based on these limited data, it is unknown whether or not the dose of mirtazapine tablets needed for maintenance treatment is identical to the dose needed to achieve an initial response. Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment.
Switching a Patient To or From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders
At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with mirtazapine tablets. Conversely, at least 14 days should be allowed after stopping mirtazapine tablets before starting an MAOI intended to treat psychiatric disorders (see CONTRAINDICATIONS).
Use of Mirtazapine Tablets With Other MAOIs, Such as Linezolid or Methylene Blue
Do not start mirtazapine tablets in a patient who is being treated with linezolid or intravenous methylene blue because there is an increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered (see CONTRAINDICATIONS).
In some cases, a patient already receiving therapy with mirtazapine may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, Mirtazapine tablets should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for 2 weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with mirtazapine tablets may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue (see WARNINGS).
The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with mirtazapine tablets is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use (see WARNINGS).
Discontinuation of Mirtazapine Tablets, USP Treatment
Symptoms associated with the discontinuation or dose reduction of mirtazapine tablets have been reported. Patients should be monitored for these and other symptoms when discontinuing treatment or during dosage reduction. A gradual reduction in the dose over several weeks, rather than abrupt cessation, is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, dose titration should be managed on the basis of the patient’s clinical response (see PRECAUTIONS and ADVERSE REACTIONS).
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Lorazepam
Lorazepam is administered orally. For optimal results, dose, frequency of administration, and duration of therapy should be individualized according to patient response. To facilitate this, 0.5 mg, 1 mg, and 2 mg tablets are available.
The usual range is 2 to 6 mg/day given in divided doses, the largest dose being taken before bedtime, but the daily dosage may vary from 1 to 10 mg/day.
For anxiety, most patients require an initial dose of 2 to 3 mg/day given b.i.d. or t.i.d.
For insomnia due to anxiety or transient situational stress, a single daily dose of 2 to 4 mg may be given, usually at bedtime.
For elderly or debilitated patients, an initial dosage of 1 to 2 mg/day in divided doses is recommended, to be adjusted as needed and tolerated.
The dosage of lorazepam should be increased gradually when needed to help avoid adverse effects. When higher dosage is indicated, the evening dose should be increased before the daytime doses.
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![Eszopiclone Tablet, Film Coated [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=4dac2083-aef8-4515-ac52-5d2829397d4a&name=eszopiclone-tablets-figure-1.jpg)
Eszopiclone
Use the lowest effective dose for the patient.
2.1 Dosage in Adults
The recommended starting dose is 1 mg. Dosing can be raised to 2 mg or 3 mg if clinically indicated. In some patients, the higher morning blood levels of eszopiclone tablets following use of the 2 mg or 3 mg dose increase the risk of next day impairment of driving and other activities that require full alertness [see Warnings and Precautions (5.1)]. The total dose of eszopiclone tablets should not exceed 3 mg, once daily immediately before bedtime [see Warnings and Precautions (5.6)].
2.2 Geriatric or Debilitated Patients
The total dose of eszopiclone tablets should not exceed 2 mg in elderly or debilitated patients.
2.3 Patients with Severe Hepatic Impairment, or Taking Potent CYP3A4 Inhibitors
In patients with severe hepatic impairment, or in patients coadministered eszopiclone tablets with potent CYP3A4 inhibitors, the total dose of eszopiclone tablets should not exceed 2 mg [see Warning and Precautions (5.7)].
2.4 Use with CNS Depressants
Dosage adjustments may be necessary when eszopiclone tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.1)].
2.5 Administration with Food
Taking eszopiclone tablets with or immediately after a heavy, high-fat meal results in slower absorption and would be expected to reduce the effect of eszopiclone on sleep latency [see Clinical Pharmacology (12.3)].
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![Viscum Pini 50mg Liquid [Uriel Pharmacy Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=032ea0f7-3304-4778-b3a6-6125ea7537ab&name=bb91223e-ffa5-4a3a-b191-fe121250c20c-03.jpg)
Viscum Pini 50mg
Hypertension
Adults
The recommended initial dose for patients not receiving a diuretic is 10 mg once a day. The usual maintenance dosage range is 20-40 mg per day administered as a single dose or in two equally divided doses. A dose of 80 mg gives an increased response, but experience with this dose is limited. The divided regimen was more effective in controlling trough (pre-dosing) blood pressure than the same dose given as a once-daily regimen. Dosage adjustment should be based on measurement of peak (2-6 hours after dosing) and trough responses. If a once-daily regimen does not give adequate trough response, an increase in dosage or divided administration should be considered. If blood pressure is not controlled with benazepril hydrochloride tablets alone, a diuretic can be added.
Total daily doses above 80 mg have not been evaluated.
Concomitant administration of benazepril hydrochloride tablets with potassium supplements, potassium salt substitutes, or potassium-sparing diuretics can lead to increases of serum potassium (see PRECAUTIONS).
In patients who are currently being treated with a diuretic, symptomatic hypotension occasionally can occur following the initial dose of benazepril hydrochloride tablets. To reduce the likelihood of hypotension, the diuretic should, if possible, be discontinued two to three days prior to beginning therapy with benazepril hydrochloride tablets (see WARNINGS). Then, if blood pressure is not controlled with benazepril hydrochloride tablets alone, diuretic therapy should be resumed.
If the diuretic cannot be discontinued, an initial dose of 5 mg benazepril should be used to avoid excessive hypotension.
Pediatrics
In children, doses of benazepril hydrochloride between 0.1 and 0.6 mg/kg once daily have been studied, and doses greater than 0.1 mg/kg were shown to reduce blood pressure (see Pharmacodynamics). Based on this, the recommended starting dose of benazepril hydrochloride is 0.2 mg/kg once per day as monotherapy. Doses above 0.6 mg/kg (or in excess of 40 mg daily) have not been studied in pediatric patients.
For pediatric patients who cannot swallow tablets, or for whom the calculated dosage (mg/kg) does not correspond to the available tablet strengths for benazepril hydrochloride tablets, follow the suspension preparation instructions below to administer benazepril hydrochloride tablets as a suspension.
Treatment with benazepril hydrochloride tablets is not advised for children below the age of 6 years (see PRECAUTIONS, Pediatric Use) and in pediatric patients with glomerular filtration rate <30 mL, as there are insufficient data available to support a dosing recommendation in these groups.
For Hypertensive Patients with Renal Impairment
For patients with a creatinine clearance <30 mL/min/1.73 m2 (serum creatinine >3 mg/dL), the recommended initial dose is 5 mg benazepril hydrochloride tablet once daily. Dosage may be titrated upward until blood pressure is controlled or to a maximum total daily dose of 40 mg (see WARNINGS).
Preparation of Suspension (for 150 mL of a 2 mg/mL suspension)
Add 75 mL of Ora-Plus®* oral suspending vehicle to an amber polyethylene terephthalate (PET) bottle containing fifteen benazepril hydrochloride 20 mg tablets, and shake for at least 2 minutes. Allow the suspension to stand for a minimum of 1 hour. After the standing time, shake the suspension for a minimum of 1 additional minute. Add 75 mL of Ora-Sweet®* oral syrup vehicle to the bottle and shake the suspension to disperse the ingredients. The suspension should be refrigerated at 2-8°C (36-46°F) and can be stored for up to 30 days in the PET bottle with a child-resistant screw-cap closure. Shake the suspension before each use.
*Ora-Plus® and Ora-Sweet® are registered trademarks of Paddock Laboratories, Inc. Ora-Plus® contains carrageenan, citric acid, methylparaben, microcrystalline cellulose, carboxymethylcellulose sodium, potassium sorbate, simethicone, sodium phosphate monobasic, xanthan gum, and water. Ora-Sweet® contains citric acid, berry citrus flavorant, glycerin, methylparaben, potassium sorbate, sodium phosphate monobasic, sorbitol, sucrose, and water.
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![Lidocaine And Prilocaine Cream [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=809985d1-7899-4431-8a34-1babb20e5ff2&name=a3873b70-figure-05.jpg)
Lidocaine And Prilocaine
Adult Patients-Intact Skin: A thick layer of lidocaine and prilocaine cream is applied to intact skin and covered with an occlusive dressing (see INSTRUCTIONS FOR APPLICATION).
Minor Dermal Procedures: For minor procedures such as intravenous cannulation and venipuncture, apply 2.5 grams of lidocaine and prilocaine cream (1/2 the 5 g tube) over 20 to 25 cm2 of skin surface for at least 1 hour. In controlled clinical trials using lidocaine and prilocaine cream, two sites were usually prepared in case there was a technical problem with cannulation or venipuncture at the first site.
Major Dermal Procedures: For more painful dermatological procedures involving a larger skin area such as split thickness skin graft harvesting, apply 2 grams of lidocaine and prilocaine cream per 10 cm2 of skin and allow to remain in contact with the skin for at least 2 hours.
Adult Male Genital Skin: As an adjunct prior to local anesthetic infiltration, apply a thick layer of lidocaine and prilocaine cream (1 g/10 cm2) to the skin surface for 15 minutes. Local anesthetic infiltration should be performed immediately after removal of lidocaine and prilocaine cream.
Dermal analgesia can be expected to increase for up to 3 hours under occlusive dressing and persist for 1 to 2 hours after removal of the cream. The amount of lidocaine and prilocaine absorbed during the period of application can be estimated from the information in TABLE 2, ** footnote, in Individualization of Dose.
Adult Female Patients-Genital Mucous Membranes: For minor procedures on the female external genitalia, such as removal of condylomata acuminata, as well as for use as pretreatment for anesthetic infiltration, apply a thick layer (5 to 10 grams) of lidocaine and prilocaine cream for 5 to 10 minutes.
Occlusion is not necessary for absorption, but may be helpful to keep the cream in place. Patients should be lying down during the lidocaine and prilocaine cream application, especially if no occlusion is used. The procedure or the local anesthetic infiltration should be performed immediately after the removal of lidocaine and prilocaine cream.
Pediatric Patients-Intact Skin: The following are the maximum recommended doses, application areas and application times for lidocaine and prilocaine cream based on a child's age and weight:
Age and Body Weight Requirements
Maximum Total Dose of Lidocaine and Prilocaine Cream
Maximum Application Area
Maximum Application Time
0 up to 3 months or < 5 kg
1 g
10 cm2
1 hour
3 up to 12 months and > 5 kg
2 g
20 cm2
4 hours
1 to 6 years and > 10 kg
10 g
100 cm2
4 hours
7 to 12 years and > 20 kg
20 g
200 cm2
4 hours
Please note: If a patient greater than 3 months old does not meet the minimum weight requirement, the maximum total dose of lidocaine and prilocaine cream should be restricted to that which corresponds to the patient's weight (see INSTRUCTIONS FOR APPLICATION).
Practitioners should carefully instruct caregivers to avoid application of excessive amounts of lidocaine and prilocaine cream (see PRECAUTIONS).
When applying lidocaine and prilocaine cream to the skin of young children, care must be taken to maintain careful observation of the child to prevent accidental ingestion of lidocaine and prilocaine cream, or the occlusive dressing. A secondary protective covering to prevent inadvertent disruption of the application site may be useful.
Lidocaine and prilocaine cream should not be used in neonates with a gestational age less than 37 weeks nor in infants under the age of twelve months who are receiving treatment with methemoglobin-inducing agents (see Methemoglobinemia subsection of WARNINGS).
When lidocaine and prilocaine cream is used concomitantly with other products containing local anesthetic agents, the amount absorbed from all formulations must be considered (see Individualization of Dose). The amount absorbed in the case of lidocaine and prilocaine cream is determined by the area over which it is applied and the duration of application under occlusion (see TABLE 2, ** footnote, in Individualization of Dose).
Although the incidence of systemic adverse reactions with lidocaine and prilocaine cream is very low, caution should be exercised, particularly when applying it over large areas and leaving it on for longer than 2 hours. The incidence of systemic adverse reactions can be expected to be directly proportional to the area and time of exposure (see Individualization of Dose).
INSTRUCTIONS FOR APPLICATION
To measure 1 gram of lidocaine and prilocaine cream, the cream should be gently squeezed out of the tube as a narrow strip that is 1.5 inches (3.8 cm) long and 0.2 inches (5 mm) wide. The strip of lidocaine and prilocaine cream should be contained within the lines of the diagram shown below.
≈ 1 g strip
1.5 x 0.2 inches
Use the number of strips that equals your dose, like the examples in the table below.
Dosing Information
1 gram =
1 strip
2 grams =
2 strips
2.5 grams =
2.5 strips
For adult and pediatric patients, apply ONLY as prescribed by your physician.
If your child is below the age of 3 months or small for their age, please inform your doctor before applying lidocaine and prilocaine cream, which can be harmful, if applied over too much skin at one time in young children.
When applying lidocaine and prilocaine cream to the intact skin of young children, it is important that they be carefully observed by an adult in order to prevent the accidental ingestion of or eye contact with lidocaine and prilocaine cream.
Lidocaine and prilocaine cream must be applied to intact skin at least 1 hour before the start of a routine procedure and for 2 hours before the start of a painful procedure. A protective covering of the cream is not necessary for absorption but may be helpful to keep the cream in place. If using a protective covering, your doctor will remove it, wipe off the lidocaine and prilocaine cream, and clean the entire area with an antiseptic solution before the procedure.
The duration of effective skin anesthesia will be at least 1 hour after removal of the protective covering.
PRECAUTIONS:
1. Do not apply near eyes or on open wounds.
2. Keep out of reach of children.
3. If your child becomes very dizzy, excessively sleepy, or develops duskiness of the face or lips after applying lidocaine and prilocaine cream, remove the cream and contact your physician at once.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
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![Gabapentin Capsule [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=66944a90-fc9b-497d-8340-f25d5ef50139&name=gabapentin-capsules-usp-7.jpg)
Gabapentin
Gabapentin capsules, USP are given orally with or without food. Gabapentin capsules, USP should be swallowed whole with plenty of water.
If gabapentin capsules, USP dose is reduced, discontinued, or substituted with an alternative medication, this should be done gradually over a minimum of 1 week (a longer period may be needed at the discretion of the prescriber).
2.1 Postherpetic Neuralgia
In adults with postherpetic neuralgia, gabapentin capsules, USP therapy may be initiated on Day 1 as a single 300 mg dose, on Day 2 as 600 mg/day (300 mg two times a day), and on Day 3 as 900 mg/day (300 mg three times a day). The dose can subsequently be titrated up as needed for pain relief to a dose of 1800 mg/day (600 mg three times a day). In clinical studies, efficacy was demonstrated over a range of doses from 1800 mg/day to 3600 mg/day with comparable effects across the dose range; however, in these clinical studies, the additional benefit of using doses greater than 1800 mg/day was not demonstrated.
2.2 Epilepsy with Partial Onset Seizures
Gabapentin capsules, USP are recommended for add-on therapy in patients 3 years of age and older. Effectiveness in pediatric patients below the age of 3 years has not been established.
Patients 12 years of age and above: The starting dose is 300 mg three times a day. The effective dose of gabapentin capsules, USP is 300 mg to 600 mg three times a day. Dosages up to 2400 mg/day have been well tolerated in long-term clinical studies. Doses of 3600 mg/day have also been administered to a small number of patients for a relatively short duration, and have been well tolerated. Gabapentin capsules, USP should be administered three times a day using 300 mg or 400 mg capsules. The maximum time between doses should not exceed 12 hours.
Pediatric Patients Age 3 to 11 years: The starting dose range is 10 mg/kg/day to 15 mg/kg/day, given in three divided doses, and the effective dose reached by upward titration over a period of approximately 3 days. The effective dose of gabapentin capsules, USP in patients 3 to 4 years of age is 40 mg/kg/day, given in three divided doses. The effective dose of gabapentin capsules, USP in patients 5 to 11 years of age is 25 mg/kg/day to 35 mg/kg/day, given in three divided doses. Gabapentin capsules, USP may be administered as the oral solution, capsule, or tablet, or using combinations of these formulations. Dosages up to 50 mg/kg/day have been well tolerated in a long-term clinical study. The maximum time interval between doses should not exceed 12 hours.
It is not necessary to monitor gabapentin plasma concentrations to optimize gabapentin capsules, USP therapy. Further, because there are no significant pharmacokinetic interactions among gabapentin capsules, USP and other commonly used antiepileptic drugs, the addition of gabapentin capsules, USP does not alter the plasma levels of these drugs appreciably.
If gabapentin capsules, USP are discontinued and/or an alternate anticonvulsant medication is added to the therapy, this should be done gradually over a minimum of 1 week.
2.3 Patients with Renal Impairment
Dosage adjustment in patients 12 years of age and older with compromised renal function or undergoing hemodialysis is recommended, as follows (see dosing recommendations above for effective doses in each indication):
TABLE 1. Gabapentin Capsules, USP Dosage Based on Renal Function
Renal Function Creatinine Clearance (mL/min)
Total Daily Dose Range (mg/day)
Dose Regimen (mg)
≥ 60
900 to 3600
300 TID
400 TID
600 TID
800 TID
1200 TID
>30 to 59
400 to 1400
200 BID
300 BID
400 BID
500 BID
700 BID
>15 to 29
200 to 700
200 QD
300 QD
400 QD
500 QD
700 QD
15a
100 to 300
100 QD
125 QD
150 QD
200 QD
300 QD
Post-Hemodialysis Supplemental Dose (mg)b
Hemodialysis
125b
150b
200b
250b
350b
TID = Three times a day; BID = Two times a day; QD = Single daily dose
a For patients with creatinine clearance <15 mL/min, reduce daily dose in proportion to creatinine clearance (e.g., patients with a creatinine clearance of 7.5 mL/min should receive one-half the daily dose that patients with a creatinine clearance of 15 mL/min receive).
b Patients on hemodialysis should receive maintenance doses based on estimates of creatinine clearance as indicated in the upper portion of the table and a supplemental post-hemodialysis dose administered after each 4 hours of hemodialysis as indicated in the lower portion of the table.
Creatinine clearance (CLCr) is difficult to measure in outpatients. In patients with stable renal function, creatinine clearance can be reasonably well estimated using the equation of Cockcroft and Gault:
The use of gabapentin capsules, USP in patients less than 12 years of age with compromised renal function has not been studied.
2.4 Dosage in Elderly
Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and dose should be adjusted based on creatinine clearance values in these patients.
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![Amoxicillin And Clavulanate Potassium Tablet, Film Coated [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=65d26fac-c971-4d6c-887d-3a74f25c5237&name=acee535d-927a-4f86-8f8f-d9377ade1613-04.jpg)
Amoxicillin And Clavulanate Potassium
Amoxicillin and clavulanate potassium may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when amoxicillin and clavulanate potassium is administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium should be taken at the start of a meal.
2.1 Adults
The usual adult dose is one 500-mg tablet of amoxicillin and clavulanate potassium every 12 hours or one 250mg tablet of amoxicillin and clavulanate potassium every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one 875-mg tablet of amoxicillin and clavulanate potassium every 12 hours or one 500-mg tablet of amoxicillin and clavulanate potassium every 8 hours. Adults who have difficulty swallowing may be given the 125 mg/5 mL or 250 mg/5 mL suspension in place of the 500-mg tablet. The 200 mg/5 mL suspension or the 400 mg/5 mL suspension may be used in place of the 875-mg tablet.
Two 250-mg tablets of amoxicillin and clavulanate potassium should not be substituted for one 500-mg tablet of amoxicillin and clavulanate potassium. Since both the 250-mg and 500-mg tablets of amoxicillin and clavulanate potassium contain the same amount of clavulanic acid (125 mg, as the potassium salt), two 250-mg tablets are not equivalent to one 500-mg tablet of amoxicillin and clavulanate potassium.
The 250-mg tablet of amoxicillin and clavulanate potassium and the 250-mg chewable tablet should not be substituted for each other, as they are not interchangeable. The 250-mg tablet of amoxicillin and clavulanate potassium and the 250-mg chewable tablet do not contain the same amount of clavulanic acid (as the potassium salt). The 250-mg tablet of amoxicillin and clavulanate potassium contains 125 mg of clavulanic acid, whereas the 250-mg chewable tablet contains 62.5 mg of clavulanic acid.
2.2 Pediatric Patients
Based on the amoxicillin component, amoxicillin and clavulanate potassium should be dosed as follows:
Neonates and Infants Aged <12 weeks (<3 months): The recommended dose of Amoxicillin and clavulanate potassium is 30 mg/kg/day divided every 12 hours, based on the amoxicillin component. Experience with the 200 mg/5 mL formulation in this age group is limited, and thus, use of the 125 mg/5 mL oral suspension is recommended.
Patients Aged 12 weeks (3 months) and Older: See dosing regimens provided in Table 1. The every 12 hour regimen is recommended as it is associated with significantly less diarrhea [see Clinical Studies (14.2)]. However, the every 12 hour suspension (200 mg/5 mL and 400 mg/5 mL) and chewable tablets (200 mg and 400 mg) contain aspartame and should not be used by phenylketonurics. [see Warnings and Precautions (5.6)]
Table 1. Dosing in Patients Aged 12 weeks (3 months) and Older * Each strength of suspension of amoxicillin and clavulanate potassium is available as a chewable tablet for use by older children. † Duration of therapy studied and recommended for acute otitis media is 10 days.DOSING REGIMEN
Every 12 hours
Every 8 hours
INFECTION
200 mg/5 mL or400 mg/5 mLoral suspension*
125 mg/5 mL or250 mg/5 mLoral suspension*
Otitis media†, sinusitis, lower respiratory tract infections, and more severe infections
45 mg/kg/dayevery 12 hours
40 mg/kg/dayevery 8 hours
Less severe infections
25 mg/kg/dayevery 12 hours
20 mg/kg/dayevery 8 hours
Patients Weighing 40 kg or More: Pediatric patients weighing 40 kg or more should be dosed according to adult recommendations.
The 250-mg tablet of amoxicillin and clavulanate potassium should not be used until the child weighs at least 40 kg, due to the different amoxicillin to clavulanic acid ratios in the 250-mg tablet of amoxicillin and clavulanate potassium (250 mg/125 mg) versus the 250-mg chewable tablet of amoxicillin and clavulanate potassium (250 mg/62.5 mg).
2.3 Patients with Renal Impairment
Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Renal impairment patients with a glomerular filtration rate of <30 mL/min should not receive the 875-mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.
Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.
2.4 Directions for Mixing Oral Suspension
Prepare a suspension at time of dispensing as follows: Tap bottle until all the powder flows freely. Add approximately 2/3 of the total amount of water for reconstitution (see Table 2 below) and shake vigorously to suspend powder. Add remainder of the water and again shake vigorously.
Table 2. Amount of Water for Mixing Oral SuspensionStrength
Bottle Size
Amount of Water for Reconstitution
Contents of Each Teaspoonful (5 mL)
200 mg/5 mL
100 mL
88 mL
200 mg amoxicillin and 28.5 mg of clavulanic acid as the potassium salt
400 mg/5 mL
100 mL
84 mL
400 mg amoxicillin and 57 mg of clavulanic acid as the potassium salt
Note: Shake oral suspension well before using. Reconstituted suspension must be stored under refrigeration and discarded after 10 days.
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![Ketorolac Tromethamine Solution [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=3296f699-bc21-4847-8944-b34ce5e8d61b&name=ket02-0000-03.jpg)
Ketorolac Tromethamine Solution
The recommended dose of Ketorolac Tromethamine Ophthalmic Solution is one drop (0.25 mg) four times a day for relief of ocular itching due to seasonal allergic conjunctivitis.
For the treatment of postoperative inflammation in patients who have undergone cataract extraction, one drop of Ketorolac Tromethamine Ophthalmic Solution should be applied to the affected eye(s) four times daily beginning 24 hours after cataract surgery and continuing through the first 2 weeks of the postoperative period.
Ketorolac Tromethamine Ophthalmic Solution has been safely administered in conjunction with other ophthalmic medications such as antibiotics, beta blockers, carbonic anhydrase inhibitors, cycloplegics, and mydriatics.
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![Clonidine Hydrochloride Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=0f794bcd-d5d0-4fa7-981d-406524726496&name=clonidinehydrochloride-figure-03.jpg)
Clonidine Hydrochloride
Adults
The dose of clonidine hydrochloride tablets must be adjusted according to the patient's individual blood pressure response. The following is a general guide to its administration.
Initial Dose
0.1 mg tablet twice daily (morning and bedtime). Elderly patients may benefit from a lower initial dose.
Maintenance Dose
Further increments of 0.1 mg per day may be made at weekly intervals if necessary until the desired response is achieved. Taking the larger portion of the oral daily dose at bedtime may minimize transient adjustment effects of dry mouth and drowsiness. The therapeutic doses most commonly employed have ranged from 0.2 mg to 0.6 mg per day given in divided doses. Studies have indicated that 2.4 mg is the maximum effective daily dose, but doses as high as this have rarely been employed.
Renal Impairment
Patients with renal impairment may benefit from a lower initial dose. Patients should be carefully monitored. Since only a minimal amount of clonidine is removed during routine hemodialysis, there is no need to give supplemental clonidine following dialysis.
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![Amlodipine Besylate Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=ce43d286-53e8-4109-8516-cb73231f8214&name=8352ab43-figure-06.jpg)
Amlodipine Besylate
2.1. Adults
The usual initial antihypertensive oral dose of amlodipine besylate tablets is 5 mg once daily with a maximum dose of 10 mg once daily.
Small, fragile, or elderly patients, or patients with hepatic insufficiency may be started on 2.5 mg once daily and this dose may be used when adding amlodipine besylate tablets to other antihypertensive therapy.
Adjust dosage according to each patient’s need. In general, titration should proceed over 7 to 14 days so that the physician can fully assess the patient’s response to each dose level. Titration may proceed more rapidly, however, if clinically warranted, provided the patient is assessed frequently.
The recommended dose for chronic stable or vasospastic angina is 5 to10 mg, with the lower dose suggested in the elderly and in patients with hepatic insufficiency. Most patients will require 10 mg for adequate effect [see Adverse Reactions (6)].
The recommended dose range for patients with coronary artery disease is 5 to10 mg once daily. In clinical studies, the majority of patients required 10 mg [see Clinical Studies (14.4)].
2.2. Children
The effective antihypertensive oral dose in pediatric patients ages 6 to 17 years is 2.5 mg to 5 mg once daily. Doses in excess of 5 mg daily have not been studied in pediatric patients [see Clinical Pharmacology (12.4), Clinical Studies (14.1)].
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![Erythromycin Ointment [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=ee3d806e-65ce-42e1-b170-7b35bcb7b06a&name=afcc9f01-dd91-468e-8f58-896b68c0d2ff-02.jpg)
Erythromycin Ointment
In the treatment of superficial ocular infections, erythromycin ophthalmic ointment approximately 1 cm in length should be applied directly to the infected eye(s) up to six times daily, depending on the severity of the infection.
For prophylaxis of neonatal gonococcal or chlamydial ophthalmia, a ribbon of ointment approximately 1 cm in length should be instilled into each lower conjunctival sac. The ointment should not be flushed from the eye following instillation. A new tube should be used for each infant.
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![Prednisone Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=9e2422b7-aafc-4e81-8c15-ed7db01b76bb&name=175_label.jpg)
Prednisone
The initial dosage of prednisone Tablets, USP may vary from 5 mg to 60 mg prednisone per day depending on the specific disease entity being treated. In situations of less severity lower doses will generally suffice while in selected patients higher initial doses may be required. The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time there is a lack of satisfactory clinical response, Prednisone should be discontinued and the patient transferred to other appropriate therapy. IT SHOULD BE EMPHASIZED THAT DOSAGE REQUIREMENTS ARE VARIABLE AND MUST BE INDIVIDUALIZED ON THE BASIS OF THE DISEASE UNDER TREATMENT AND THE RESPONSE OF THE PATIENT. After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. It should be kept in mind that constant monitoring is needed in regard to drug dosage. Included in the situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient’s individual drug responsiveness, and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment; in this latter situation it may be necessary to increase the dosage of Prednisone for a period of time consistent with the patient’s condition. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.
Multiple Sclerosis
In the treatment of acute exacerbations of multiple sclerosis daily doses of 200 mg of prednisolone for a week followed by 80 mg every other day for 1 month have been shown to be effective. (Dosage range is the same for prednisone and prednisolone.)
ADT ® (Alternate Day Therapy)
ADT is a corticosteroid dosing regimen in which twice the usual daily dose of corticoid is administered every other morning. The purpose of this mode of therapy is to provide the patient requiring long-term pharmacologic dose treatment with the beneficial effects of corticoids while minimizing certain undesirable effects, including pituitary-adrenal suppression, the Cushingoid state, corticoid withdrawal symptoms, and growth suppression in children. The rationale for this treatment schedule is based on two major premises: (a) the anti-inflammatory or therapeutic effect of corticoids persists longer than their physical presence and metabolic effects and (b) administration of the corticosteroid every other morning allows for re-establishment of more nearly normal hypothalamic-pituitary-adrenal (HPA) activity on the off-steroid day.
A brief review of the HPA physiology may be helpful in understanding this rationale. Acting primarily through the hypothalamus a fall in free cortisol stimulates the pituitary gland to produce increasing amounts of corticotropin (ACTH) while a rise in free cortisol inhibits ACTH secretion. Normally the HPA system is characterized by diurnal (circadian) rhythm. Serum levels of ACTH rise from a low point about 10 pm to a peak level about 6 am. Increasing levels of ACTH stimulate adrenocortical activity resulting in a rise in plasma cortisol with maximal levels occurring between 2 am and 8 am. This rise in cortisol dampens ACTH production and in turn adrenocortical activity. There is a gradual fall in plasma corticoids during the day with lowest levels occurring about midnight.
The diurnal rhythm of the HPA axis is lost in Cushing’s disease, a syndrome of adrenocortical hyperfunction characterized by obesity with centripetal fat distribution, thinning of the skin with easy bruisability, muscle wasting with weakness, hypertension, latent diabetes, osteoporosis, electrolyte imbalance, etc. The same clinical findings of hyperadrenocorticism may be noted during long-term pharmacologic dose corticoid therapy administered in conventional daily divided doses. It would appear, then, that a disturbance in the diurnal cycle with maintenance of elevated corticoid values during the night may play a significant role in the development of undesirable corticoid effects. Escape from these constantly elevated plasma levels for even short periods of time may be instrumental in protecting against undesirable pharmacologic effects.
During conventional pharmacologic dose corticosteroid therapy, ACTH production is inhibited with subsequent suppression of cortisol production by the adrenal cortex. Recovery time for normal HPA activity is variable depending upon the dose and duration of treatment. During this time the patient is vulnerable to any stressful situation. Although it has been shown that there is considerably less adrenal suppression following a single morning dose of prednisolone (10 mg) as opposed to a quarter of that dose administered every 6 hours, there is evidence that some suppressive effect on adrenal activity may be carried over into the following day when pharmacologic doses are used. Further, it has been shown that a single dose of certain corticosteroids will produce adrenocortical suppression for two or more days. Other corticoids, including methylprednisolone, hydrocortisone, prednisone, and prednisolone, are considered to be short acting (producing adrenocortical suppression for 1 ¼ to 1 ½ days following a single dose) and thus are recommended for alternate day therapy.
The following should be kept in mind when considering alternate day therapy:
1) Basic principles and indications for corticosteroid therapy should apply. The benefits of ADT should not encourage the indiscriminate use of steroids.2) ADT is a therapeutic technique primarily designed for patients in whom long-term pharmacologic corticoid therapy is anticipated.3) In less severe disease processes in which corticoid therapy is indicated, it may be possible to initiate treatment with ADT. More severe disease states usually will require daily divided high dose therapy for initial control of the disease process. The initial suppressive dose level should be continued until satisfactory clinical response is obtained, usually four to ten days in the case of many allergic and collagen diseases. It is important to keep the period of initial suppressive dose as brief as possible particularly when subsequent use of alternate day therapy is intended. Once control has been established, two courses are available: (a) change to ADT and then gradually reduce the amount of corticoid given every other day or (b) following control of the disease process reduce the daily dose of corticoid to the lowest effective level as rapidly as possible and then change over to an alternate day schedule. Theoretically, course (a) may be preferable.4) Because of the advantages of ADT, it may be desirable to try patients on this form of therapy who have been on daily corticoids for long periods of time (eg, patients with rheumatoid arthritis). Since these patients may already have a suppressed HPA axis, establishing them on ADT may be difficult and not always successful. However, it is recommended that regular attempts be made to change them over. It may be helpful to triple or even quadruple the daily maintenance dose and administer this every other day rather than just doubling the daily dose if difficulty is encountered. Once the patient is again controlled, an attempt should be made to reduce this dose to a minimum.5) As indicated above, certain corticosteroids, because of their prolonged suppressive effect on adrenal activity, are not recommended for alternate day therapy (eg; dexamethasone and betamethasone).6) The maximal activity of the adrenal cortex is between 2 am and 8 am, and it is minimal between 4 pm and midnight. Exogenous corticosteroids suppress adrenocortical activity the least, when given at the time of maximal activity (am).7) In using ADT it is important, as in all therapeutic situations to individualize and tailor the therapy to each patient. Complete control of symptoms will not be possible in all patients. An explanation of the benefits of ADT will help the patient to understand and tolerate the possible flare-up in symptoms which may occur in the latter part of the off-steroid day. Other symptomatic therapy may be added or increased at this time if needed.8) In the event of an acute flare-up of the disease process, it may be necessary to return to a full suppressive daily divided corticoid dose for control. Once control is again established alternate day therapy may be re-instituted.9) Although many of the undesirable features of corticosteroid therapy can be minimized by ADT, as in any therapeutic situation, the physician must carefully weigh the benefit-risk ratio for each patient in whom corticoid therapy is being considered.
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![Amoxicillin And Clavulanate Potassium Powder, For Suspension [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=0a9c9126-ac36-4f49-8f23-bbdc874f81ce&name=600-mg-75-ml-label.jpg)
Amoxicillin And Clavulanate Potassium
Amoxicillin and Clavulanate Potassium, 600 mg/42.9 mg per 5 mL, does not contain the same amount of clavulanic acid (as the potassium salt) as any of the other suspensions of AMOXICILLIN AND CLAVULANATE POTASSIUM. Amoxicillin and Clavulanate Potassium 600 mg/42.9 mg per 5 mL contains 42.9 mg of clavulanic acid per 5 mL, whereas the 200 mg/5 mL suspension of AMOXICILLIN AND CLAVULANATE POTASSIUM contains 28.5 mg of clavulanic acid per 5 mL and the 400 mg/5 mL suspension contains 57 mg of clavulanic acid per 5 mL. Therefore, the 200 mg/28.5 mg/5 mL and 400 mg/57 mg/5 mL suspensions of AMOXICILLIN AND CLAVULANATE POTASSIUM should not be substituted for Amoxicillin and Clavulanate Potassium 600 mg/42.9 mg per 5 mL as they are not interchangeable.
Dosage:
Pediatric patients 3 months and older:
Based on the amoxicillin component (600 mg/5 mL), the recommended dose of Amoxicillin and Clavulanate Potassium 600 mg/42.9 mg per 5 mL is 90 mg/kg/day divided every 12 hours, administered for 10 days (see chart below).
Body Weight (kg) Volume of Amoxicillin and Clavulanate Potassium 600 mg/42.9 mg per 5 mL providing 90 mg/kg/day8
3.0 mL twice daily
12
4.5 mL twice daily
16
6.0 mL twice daily
20
7.5 mL twice daily
24
9.0 mL twice daily
28
10.5 mL twice daily
32
12.0 mL twice daily
36
13.5 mL twice daily
Pediatric patients weighing 40 kg and more:
Experience with Amoxicillin and Clavulanate Potassium (600 mg/5 mL formulation) in this group is not available.
Adults:
Experience with Amoxicillin and Clavulanate Potassium (600 mg/5 mL formulation) in adults is not available and adults who have difficulty swallowing should not be given Amoxicillin and Clavulanate Potassium (600 mg/5 mL) in place of the 500-mg or 875-mg tablet of AMOXICILLIN AND CLAVULANATE POTASSIUM.
Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals. (See WARNINGS.)
Directions for Mixing Oral Suspension:
Prepare a suspension at time of dispensing as follows: Tap bottle until all the powder flows freely. Add approximately 2/3 of the total amount of water for reconstitution (see table below) and shake vigorously to suspend powder. Add remainder of the water and again shake vigorously.
Amoxicillin and Clavulanate Potassium (600 mg/5 mL Suspension)Bottle Size
Amount of WaterRequired for Reconstitution
75 mL
70 mL
125 mL
110 mL
200 mL
180 mL
Each teaspoonful (5 mL) will contain 600 mg amoxicillin as the trihydrate and 42.9 mg of clavulanic acid as the potassium salt.
NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING.
Information for the Pharmacist:
For patients who wish to alter the taste of Amoxicillin and Clavulanate Potassium 600 mg/42.9 mg per 5 mL, immediately after reconstitution 1 drop of FLAVORx™ (apple, banana cream, bubble gum, cherry, or watermelon flavor) may be added for every 5 mL of Amoxicillin and Clavulanate Potassium 600 mg/42.9 mg per 5 mL. The resulting suspension is stable for 10 days under refrigeration. Stability of Amoxicillin and Clavulanate Potassium 600 mg/42.9 mg per 5 mL when mixed with other flavors distributed by FLAVORx has not been evaluated for flavors other than the 5 flavors listed above.
Administration:
To minimize the potential for gastrointestinal intolerance, Amoxicillin and Clavulanate Potassium 600 mg/42.9 mg per 5 mL should be taken at the start of a meal. Absorption of clavulanate potassium may be enhanced when Amoxicillin and Clavulanate Potassium 600 mg/42.9 mg per 5 mL is administered at the start of a meal.
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![Escitalopram Tablet, Film Coated [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=494a5d1a-0226-4408-9bdb-6fd093f0efce&name=image-09.jpg)
Escitalopram
Escitalopram tablets should be administered once daily, in the morning or evening, with or without food.
2.1 Major Depressive Disorder
Initial Treatment
Adolescents
The recommended dose of escitalopram tablets is 10 mg once daily. A flexible-dose trial of escitalopram tablets (10 to 20 mg/day) demonstrated the effectiveness of escitalopram tablets [see Clinical Studies (14.1)]. If the dose is increased to 20 mg, this should occur after a minimum of three weeks.
Adults
The recommended dose of escitalopram tablets is 10 mg once daily. A fixed-dose trial of escitalopram tablets demonstrated the effectiveness of both 10 mg and 20 mg of escitalopram tablets, but failed to demonstrate a greater benefit of 20 mg over 10 mg [see Clinical Studies (14.1)]. If the dose is increased to 20 mg, this should occur after a minimum of one week.
Maintenance Treatment
It is generally agreed that acute episodes of major depressive disorder require several months or longer of sustained pharmacological therapy beyond response to the acute episode. Systematic evaluation of continuing escitalopram tablets 10 or 20 mg/day in adult patients with major depressive disorder who responded while taking escitalopram tablets during an 8 week, acute-treatment phase demonstrated a benefit of such maintenance treatment [see Clinical Studies (14.1)]. Nevertheless, the physician who elects to use escitalopram tablets for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient. Patients should be periodically reassessed to determine the need for maintenance treatment.
2.2 Generalized Anxiety Disorder
Initial Treatment
Adults
The recommended starting dose of escitalopram tablets is 10 mg once daily. If the dose is increased to 20 mg, this should occur after a minimum of one week.
Maintenance Treatment
Generalized anxiety disorder is recognized as a chronic condition. The efficacy of escitalopram tablets in the treatment of GAD beyond 8 weeks has not been systematically studied. The physician who elects to use escitalopram tablets for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
2.3 Special Populations
10 mg/day is the recommended dose for most elderly patients and patients with hepatic impairment.
No dosage adjustment is necessary for patients with mild or moderate renal impairment. Escitalopram tablets should be used with caution in patients with severe renal impairment.
2.4 Discontinuation of Treatment With Escitalopram Tablets
Symptoms associated with discontinuation of escitalopram tablets and other SSRIs and SNRIs have been reported [see Warnings and Precautions (5.3)]. Patients should be monitored for these symptoms when discontinuing treatment. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate.
2.5 Switching a Patient To or From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders
At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with escitalopram tablets. Conversely, at least 14 days should be allowed after stopping escitalopram tablets before starting an MAOI intended to treat psychiatric disorders [see Contraindications (4.1)].
2.6 Use of Escitalopram Tablets With Other MAOIs Such as Linezolid or Methylene Blue
Do not start escitalopram tablets in a patient who is being treated with linezolid or intravenous methylene blue because there is an increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered [see Contraindications (4.1)].
In some cases, a patient already receiving escitalopram tablets therapy may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, escitalopram tablets should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for 2 weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with escitalopram tablets may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue [see Warnings and Precautions (5.2)].
The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with escitalopram tablets is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use [see Warnings and Precautions (5.2)].
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![Duloxetine Delayed-release (Duloxetine Hydrochloride) Capsule, Delayed Release Pellets [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=49821f58-a5a6-47c5-96d1-f673ef2f4bd5&name=duloxetine-08.jpg)
Duloxetine Delayed-release
Duloxetine Delayed-release Capsules should be swallowed whole and should not be chewed or crushed, nor should the capsule be opened and its contents sprinkled on food or mixed with liquids. All of these might affect the enteric coating. Duloxetine Delayed-release Capsules can be given without regard to meals.
2.1Initial Treatment
Major Depressive Disorder — Duloxetine Delayed-release Capsules should be administered at a total dose of 40 mg/day (given as 20 mg twice daily) to 60 mg/day (given either once daily or as 30 mg twice daily). For some patients, it may be desirable to start at 30 mg once daily for 1 week, to allow patients to adjust to the medication before increasing to 60 mg once daily. While a 120 mg/day dose was shown to be effective, there is no evidence that doses greater than 60 mg/day confer any additional benefits. The safety of doses above 120 mg/day has not been adequately evaluated [see Clinical Studies (14.1)].
Generalized Anxiety Disorder — For most patients, the recommended starting dose for Duloxetine Delayed-release Capsules is 60 mg administered once daily. For some patients, it may be desirable to start at 30 mg once daily for 1 week, to allow patients to adjust to the medication before increasing to 60 mg once daily. While a 120 mg once daily dose was shown to be effective, there is no evidence that doses greater than 60 mg/day confer additional benefit. Nevertheless, if a decision is made to increase the dose beyond 60 mg once daily, dose increases should be in increments of 30 mg once daily. The safety of doses above 120 mg once daily has not been adequately evaluated [see Clinical Studies (14.2)].
Diabetic Peripheral Neuropathic Pain — The recommended dose for Duloxetine Delayed-release Capsules is 60 mg administered once daily. There is no evidence that doses higher than 60 mg confer additional significant benefit and the higher dose is clearly less well tolerated [see Clinical Studies (14.3)]. For patients for whom tolerability is a concern, a lower starting dose may be considered.
Since diabetes is frequently complicated by renal disease, a lower starting dose and gradual increase in dose should be considered for patients with renal impairment [see Dosage and Administration (2.3), Use in Specific Populations (8.10), and Clinical Pharmacology (12.3)].
Chronic Musculoskeletal Pain — The recommended dose for Duloxetine Delayed-release Capsules is 60 mg once daily. Dosing may be started at 30 mg for one week, to allow patients to adjust to the medication before increasing to 60 mg once daily. There is no evidence that higher doses confer additional benefit, even in patients who do not respond to a 60 mg dose, and higher doses are associated with a higher rate of adverse reactions [see Clinical Studies (14.5)].
2.2Maintenance/Continuation/Extended Treatment
Major Depressive Disorder — It is generally agreed that acute episodes of major depression require several months or longer of sustained pharmacologic therapy. Maintenance of efficacy in MDD was demonstrated with Duloxetine Delayed-release Capsules as monotherapy. Duloxetine Delayed-release Capsules should be administered at a total dose of 60 mg once daily. Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment [see Clinical Studies (14.1)].
Generalized Anxiety Disorder — It is generally agreed that episodes of generalized anxiety disorder require several months or longer of sustained pharmacological therapy. Maintenance of efficacy in GAD was demonstrated with Duloxetine Delayed-release Capsules as monotherapy. Duloxetine Delayed-release Capsules should be administered in a dose range of 60-120 mg once daily. Patients should be periodically reassessed to determine the continued need for maintenance treatment and the appropriate dose for such treatment [see Clinical Studies (14.2)].
Diabetic Peripheral Neuropathic Pain — As the progression of diabetic peripheral neuropathy is highly variable and management of pain is empirical, the effectiveness of Duloxetine Delayed-release Capsules must be assessed individually. Efficacy beyond 12 weeks has not been systematically studied in placebo-controlled trials.
Chronic Musculoskeletal Pain — The efficacy of Duloxetine Delayed-release Capsules has not been established in placebo-controlled studies beyond 13 weeks.
2.3Dosing in Special Populations
Hepatic Insufficiency — It is recommended that Duloxetine Delayed-release Capsules should ordinarily not be administered to patients with any hepatic insufficiency [see Warnings and Precautions (5.13) and Use in Specific Populations (8.9)].
Severe Renal Impairment — Duloxetine Delayed-release Capsules are not recommended for patients with end-stage renal disease or severe renal impairment (estimated creatinine clearance <30 mL/min) [see Warnings and Precautions (5.13) and Use in Specific Populations (8.10)].
Elderly Patients — No dose adjustment is recommended for elderly patients on the basis of age. As with any drug, caution should be exercised in treating the elderly. When individualizing the dosage in elderly patients, extra care should be taken when increasing the dose [see Use in Specific Populations (8.5)].
Pregnant Women — There are no adequate and well-controlled studies in pregnant women; therefore, Duloxetine Delayed-release Capsules should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus [see Use in Specific Populations (8.1)].
Nursing Mothers — Because the safety of duloxetine in infants is not known, nursing while on Duloxetine Delayed-release Capsules is not recommended [see Use in Specific Populations (8.3)].
2.4Discontinuing Duloxetine Delayed-release Capsules
Symptoms associated with discontinuation of Duloxetine Delayed-release Capsules and other SSRIs and SNRIs have been reported. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible [see Warnings and Precautions (5.7)].
2.5Switching a Patient To or From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders
At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with Duloxetine Delayed-release Capsules. Conversely, at least 5 days should be allowed after stopping Duloxetine Delayed-release Capsules before starting an MAOI intended to treat psychiatric disorders [see Contraindications (4.1)].
2.6Use of Duloxetine Delayed-release Capsules with Other MAOIs such as Linezolid or Methylene Blue
Do not start Duloxetine Delayed-release Capsules in a patient who is being treated with linezolid or intravenous methylene blue because there is an increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered [see Contraindications (4.1)]
In some cases, a patient already receiving Duloxetine Delayed-release Capsules therapy may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, Duloxetine Delayed-release Capsules should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for 5 days or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with Duloxetine Delayed-release Capsules may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue [see Warnings and Precautions (5.4)].
The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with Duloxetine Delayed-release Capsules is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use [see Warnings and Precautions (5.4)].
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![Smart Sense Ultra Strength (Camphor, Menthol, Methyl Salicylate) Cream [Kmart Corporation]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=da0a8f1e-44ad-4487-9bdc-ddbce9a23321&name=image-02.jpg)
Smart Sense Ultra Strength
Major Depressive Disorder
Usual Initial Dosage
Paroxetine tablets should be administered as a single daily dose with or without food, usually in the morning. The recommended initial dose is 20 mg/day. Patients were dosed in a range of 20 to 50 mg/day in the clinical trials demonstrating the effectiveness of paroxetine tablets in the treatment of major depressive disorder. As with all drugs effective in the treatment of major depressive disorder, the full effect may be delayed. Some patients not responding to a 20 mg dose may benefit from dose increases, in 10 mg/day increments, up to a maximum of 50 mg/day. Dose changes should occur at intervals of at least 1 week.
Maintenance Therapy
There is no body of evidence available to answer the question of how long the patient treated with paroxetine tablets should remain on it. It is generally agreed that acute episodes of major depressive disorder require several months or longer of sustained pharmacologic therapy. Whether the dose needed to induce remission is identical to the dose needed to maintain and/or sustain euthymia is unknown.
Systematic evaluation of the efficacy of paroxetine tablets has shown that efficacy is maintained for periods of up to 1 year with doses that averaged about 30 mg.
Obsessive Compulsive Disorder
Usual Initial Dosage
Paroxetine tablets should be administered as a single daily dose with or without food, usually in the morning. The recommended dose of paroxetine tablets in the treatment of OCD is 40 mg daily. Patients should be started on 20 mg/day and the dose can be increased in 10 mg/day increments. Dose changes should occur at intervals of at least 1 week. Patients were dosed in a range of 20 to 60 mg/day in the clinical trials demonstrating the effectiveness of paroxetine tablets in the treatment of OCD. The maximum dosage should not exceed 60 mg/day.
Maintenance Therapy
Long-term maintenance of efficacy was demonstrated in a 6-month relapse prevention trial. In this trial, patients with OCD assigned to paroxetine demonstrated a lower relapse rate compared to patients on placebo (see CLINICAL PHARMACOLOGY: Clinical Trials). OCD is a chronic condition, and it is reasonable to consider continuation for a responding patient. Dosage adjustments should be made to maintain the patient on the lowest effective dosage, and patients should be periodically reassessed to determine the need for continued treatment.
Panic Disorder
Usual Initial Dosage
Paroxetine tablets should be administered as a single daily dose with or without food, usually in the morning. The target dose of paroxetine tablets in the treatment of panic disorder is 40 mg/day. Patients should be started on 10 mg/day. Dose changes should occur in 10 mg/day increments and at intervals of at least 1 week. Patients were dosed in a range of 10 to 60 mg/day in the clinical trials demonstrating the effectiveness of paroxetine tablets. The maximum dosage should not exceed 60 mg/day.
Maintenance Therapy
Long-term maintenance of efficacy was demonstrated in a 3-month relapse prevention trial. In this trial, patients with panic disorder assigned to paroxetine demonstrated a lower relapse rate compared to patients on placebo (see CLINICAL PHARMACOLOGY: Clinical Trials). Panic disorder is a chronic condition, and it is reasonable to consider continuation for a responding patient. Dosage adjustments should be made to maintain the patient on the lowest effective dosage, and patients should be periodically reassessed to determine the need for continued treatment.
Generalized Anxiety Disorder
Usual Initial Dosage
Paroxetine tablets should be administered as a single daily dose with or without food, usually in the morning. In clinical trials the effectiveness of paroxetine tablets was demonstrated in patients dosed in a range of 20 to 50 mg/day. The recommended starting dosage and the established effective dosage is 20 mg/day. There is not sufficient evidence to suggest a greater benefit to doses higher than 20 mg/day. Dose changes should occur in 10 mg/day increments and at intervals of at least 1 week.
Maintenance Therapy
Systematic evaluation of continuing paroxetine tablets for periods of up to 24 weeks in patients with Generalized Anxiety Disorder who had responded while taking paroxetine tablets during an 8-week acute treatment phase has demonstrated a benefit of such maintenance (see CLINICAL PHARMACOLOGY: Clinical Trials). Nevertheless, patients should be periodically reassessed to determine the need for maintenance treatment.
Special Populations
Treatment of Pregnant Women During the Third Trimester
Neonates exposed to paroxetine tablets and other SSRIs or SNRIs, late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding (see WARNINGS: Usage in Pregnancy). When treating pregnant women with paroxetine during the third trimester, the physician should carefully consider the potential risks and benefits of treatment.
Dosage for Elderly or Debilitated Patients, and Patients With Severe Renal or Hepatic Impairment
The recommended initial dose is 10 mg/day for elderly patients, debilitated patients, and/or patients with severe renal or hepatic impairment. Increases may be made if indicated. Dosage should not exceed 40 mg/day.
Switching a Patient to or From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders
At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with paroxetine tablets. Conversely, at least 14 days should be allowed after stopping paroxetine tablets before starting an MAOI intended to treat psychiatric disorders (see CONTRAINDICATIONS).
Use of Paroxetine Tablets With Other MAOIs, Such as Linezolid or Methylene Blue
Do not start paroxetine tablets in a patient who is being treated with linezolid or intravenous methylene blue because there is increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered (see CONTRAINDICATIONS).In some cases, a patient already receiving therapy with paroxetine tablets may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, paroxetine tablets should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for 2 weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with paroxetine tablets may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue (see WARNINGS).The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with paroxetine tablets is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use (see WARNINGS).
Discontinuation of Treatment With Paroxetine Tablets
Symptoms associated with discontinuation of paroxetine tablets have been reported (see PRECAUTIONS: Discontinuation of Treatment With Paroxetine Tablets). Patients should be monitored for these symptoms when discontinuing treatment, regardless of the indication for which paroxetine tablets is being prescribed. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate.
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![Ipratropium Bromide And Albuterol Sulfate Solution [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=8a1cb095-c3c6-4629-9a88-aeae949541ef&name=ipratropium-bromide-and-albuterol-sulfate-inhalati-7.jpg)
Ipratropium Bromide And Albuterol Sulfate Solution
The recommended dose of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution is one 3 mL vial administered 4 times per day via nebulization with up to 2 additional 3 mL doses allowed per day, if needed. Safety and efficacy of additional doses or increased frequency of administration of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution beyond these guidelines has not been studied and the safety and efficacy of extra doses of albuterol sulfate or ipratropium bromide in addition to the recommended doses of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution have not been studied.
The use of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution can be continued as medically indicated to control recurring bouts of bronchospasm. If a previously effective regimen fails to provide the usual relief, medical advice should be sought immediately, as this is often a sign of worsening COPD, which would require reassessment of therapy.
A Pari-LC-Plus™ nebulizer (with face mask or mouthpiece) connected to a PRONEB™ compressor was used to deliver Ipratropium Bromide and Albuterol Sulfate Inhalation Solution to each patient in one U.S. clinical study. The safety and efficacy of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution delivered by other nebulizers and compressors have not been established.
Ipratropium Bromide and Albuterol Sulfate Inhalation Solution should be administered via jet nebulizer connected to an air compressor with an adequate air flow, equipped with a mouthpiece or suitable face mask.
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![Brain Support (Acetylcholine Chloride, Adrenalinum, Dopamine Hydrochloride, Gaba (Gamma Aminobutyric Acid), Norepinephrine, Octopamine, Serotonin (Hydrochloride), Taurine, Adenosinum Cyclophosphoricum, Cerebrum (Suis), Diencephalon (Suis), Pineal Gland (Suis), Thalamus Opticus (Suis)) Liquid [Dr.donna Resivo Dc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=1d9fa4b9-3ec2-4ea2-a05a-ca46cc529167&name=L401-01-GCP.jpg)
Brain Support
• adults and children 12 years and older: take 1-2 softgel daily until first bowel movement; 1 softgel daily thereafter, or as directed by doctor
• children under 12: consult a doctor
• do not exceed recommended dose
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![Gabapentin Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=6dcaf09c-d3fb-4528-b7de-97dfbbd36594&name=c13551d6-figure-07.jpg)
Gabapentin
Gabapentin tablets USP are given orally with or without food. Patients should be informed that, should they break the scored 600 or 800 mg tablet in order to administer a half-tablet, they should take the unused half-tablet as the next dose. Half-tablets not used within several days of breaking the scored tablet should be discarded.
If gabapentin tablets USP dose is reduced, discontinued or substituted with an alternative medication, this should be done gradually over a minimum of 1 week (a longer time period may be needed at the discretion of the prescriber).
Postherpetic Neuralgia
In adults with postherpetic neuralgia, gabapentin therapy may be initiated as a single 300 mg dose on Day 1, 600 mg/day on Day 2 (divided BID), and 900 mg/day on Day 3 (divided TID). The dose can subsequently be titrated up as needed for pain relief to a daily dose of 1800 mg (divided TID). In clinical studies, efficacy was demonstrated over a range of doses from 1800 mg/day to 3600 mg/day with comparable effects across the dose range. Additional benefit of using doses greater than 1800 mg/day was not demonstrated.
Epilepsy
Gabapentin tablets USP, are recommended for add-on therapy in patients 3 years of age and older. Effectiveness in pediatric patients below the age of 3 years has not been established.
Patients >12 Years of Age: The effective dose of gabapentin is 900 to 1800 mg/day and given in divided doses (three times a day) using 300 or 400 mg capsules, or 600 or 800 mg tablets. The starting dose is 300 mg three times a day. If necessary, the dose may be increased using 300 or 400 mg capsules, or 600 or 800 mg tablets three times a day up to 1800 mg/day. Dosages up to 2400 mg/day have been well tolerated in long-term clinical studies. Doses of 3600 mg/day have also been administered to a small number of patients for a relatively short duration, and have been well tolerated. The maximum time between doses in the TID schedule should not exceed 12 hours.
Pediatric Patients Age 3 to 12 Years: The starting dose should range from 10 to 15 mg/kg/day in 3 divided doses, and the effective dose reached by upward titration over a period of approximately 3 days. The effective dose of gabapentin in patients 5 years of age and older is 25 to 35 mg/kg/day and given in divided doses (three times a day). The effective dose in pediatric patients ages 3 and 4 years is 40 mg/kg/day and given in divided doses (three times a day) (see CLINICAL PHARMACOLOGY, Pediatrics). Gabapentin may be administered as the oral solution, capsule, or tablet, or using combinations of these formulations. Dosages up to 50 mg/kg/day have been well tolerated in a long-term clinical study. The maximum time interval between doses should not exceed 12 hours.
It is not necessary to monitor gabapentin plasma concentrations to optimize gabapentin therapy. Further, because there are no significant pharmacokinetic interactions among gabapentin and other commonly used antiepileptic drugs, the addition of gabapentin does not alter the plasma levels of these drugs appreciably.
If gabapentin tablets are discontinued and/or an alternate anticonvulsant medication is added to the therapy, this should be done gradually over a minimum of 1 week.
Dosage in Renal Impairment
Creatinine clearance is difficult to measure in outpatients. In patients with stable renal function, creatinine clearance (CCr) can be reasonably well estimated using the equation of Cockcroft and Gault:
for females CCr = (0.85)(140-age)(weight)/[(72)(SCr)]
for males CCr = (140-age)(weight)/[(72)(SCr)]
where age is in years, weight is in kilograms and SCr is serum creatinine in mg/dL.
Dosage adjustment in patients ≥ 12 years of age with compromised renal function or undergoing hemodialysis is recommended as follows (see dosing recommendations above for effective doses in each indication).
TABLE 6. Gabapentin Dosage Based on Renal Function Renal Function Creatinine Clearance (mL/min) Total Daily Dose Range (mg/day) Dose Regimen(mg) a For patients with creatinine clearance <15 mL/min, reduce daily dose in proportion to creatinine clearance (e.g., patients with creatinine clearance of 7.5 mL/min should receive one-half the daily dose that patients with a creatinine clearance of 15 mL/min receive). b Patients on Hemodialysis should receive maintenance doses based on estimates of creatinine clearance as indicated in the upper portion of the table and a supplemental post-hemodialysis dose administered after each 4 hours of hemodialysis as indicated in the lower portion of the table.≥ 60
900-3600
300 TID
400 TID
600 TID
800 TID
1200 TID
> 30-59
400-1400
200 BID
300 BID
400 BID
500 BID
700 BID
> 15-29
200-700
200 QD
300 QD
400 QD
500 QD
700 QD
15a
100-300
100 QD
125 QD
150 QD
200 QD
300 QD
Post-Hemodialysis Supplemental Dose (mg)b
Hemodialysis
125b
150b
200b
250b
350b
The use of gabapentin tablets USP in patients < 12 years of age with compromised renal function has not been studied.
Dosage in Elderly
Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and dose should be adjusted based on creatinine clearance values in these patients.
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![Sinus Congestion Pe (Guaifenesin And Phenylephrine Hcl) Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=31257238-a0b0-4f2c-98ea-c24b8a6dc30a&name=image-01.jpg)
Sinus Congestion Pe
• adults and children 12 years of age and older: take 1 tablet every 4 hours, with a full glass of water, while symptoms persist. Do not exceed 6 tablets in 24 hours. • children under 12 years of age: do not use
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![Zolpidem Tartrate Tablet, Film Coated [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=b2d67196-f997-49de-8a89-0622c65f794e&name=65732383-d311-4c3b-9dd4-446c30a72970-02.jpg)
Zolpidem Tartrate
2.1 Dosage in Adults
Use the lowest effective dose for the patient. The recommended initial dose is 5 mg for women and either 5 mg or 10 mg for men, taken only once per night immediately before bedtime with at least 7 to 8 hours remaining before the planned time of awakening. If the 5 mg dose is not effective, the dose can be increased to 10 mg. In some patients, the higher morning blood levels following use of the 10 mg dose increase the risk of next day impairment of driving and other activities that require full alertness [see Warnings and Precautions (5.1)]. The total dose of zolpidem tartrate tablets should not exceed 10 mg once daily immediately before bedtime.
The recommended initial doses for women and men are different because zolpidem clearance is lower in women.
2.2 Special Populations
Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate tablets in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.1) and Use in Specific Populations (8.5)].
2.3 Use with CNS Depressants
Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.1)].
2.4 Administration
The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.
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![Zolpidem Tartrate Tablet, Film Coated [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=68ee4878-5a63-4ea8-a1b6-88fec4001d83&name=zolpidem-fig1.jpg)
Zolpidem Tartrate
2.1 Dosage in Adults
Use the lowest effective dose for the patient. The recommended initial dose is 5 mg for women and either 5 or 10 mg for men, taken only once per night immediately before bedtime with at least 7 to 8 hours remaining before the planned time of awakening. If the 5 mg dose is not effective, the dose can be increased to 10 mg. In some patients, the higher morning blood levels following use of the 10 mg dose increase the risk of next day impairment of driving and other activities that require full alertness [see Warnings and Precautions (5.1)]. The total dose of zolpidem tartrate tablets should not exceed 10 mg once daily immediately before bedtime.The recommended initial doses for women and men are different because zolpidem clearance is lower in women.
2.2 Special Populations
Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate tablets in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.1); Use in Specific Populations (8.5)].
2.3 Use with CNS Depressants
Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.1)].
2.4 Administration
The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.
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![Antipyrine And Benzocaine Liquid [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=dd455461-10ff-4302-897e-f1860ca79f38&name=antipyrine-03.jpg)
Antipyrine And Benzocaine
Acute otitis media
Instill Antipyrine and Benzocaine Otic Solution, permitting the solution to run along the wall of the ear canal until it is filled. Avoid touching the ear with dropper. Then moisten a cotton pledget with Antipyrine and Benzocaine Otic Solution and insert into meatus. Repeat every one to two hours until pain and congestion are relieved.
Removal of Cerumen
Before: Instill Antipyrine and Benzocaine Otic Solution three times daily for two or three days to help detach cerumen from wall of ear canal and facilitate removal.
After: Antipyrine and Benzocaine Otic Solution is useful for drying out the ear canal or relieving discomfort.
Before and after removal of cerumen, a cotton pledget moistened with Antipyrine and Benzocaine Otic Solution should be inserted into the meatus following instillation.
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![Vitamin D (Ergocalciferol) Capsule [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=3d741db6-e6cc-4df6-a21d-4d0dcf768122&name=ergocalciferol-3.jpg)
Vitamin D
THE RANGE BETWEEN THERAPEUTIC AND TOXIC DOSES IS NARROW.
Vitamin D Resistant Rickets: 12,000 to 500,000 USP units daily.
Hypoparathyroidism: 50,000 to 200,000 USP units daily concomitantly with calcium lactate 4g, six times per day.
DOSAGE MUST BE INDIVIDUALIZED UNDER CLOSE MEDICAL SUPERVISION.
Calcium intake should be adequate. Blood calcium and phosphorus determinations must be made every 2 weeks or more frequently if necessary. X-rays of the bones should be taken every month until condition is corrected and stabilized.
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![Metaxalone Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=ae9d3f6f-8967-4e72-b1d0-e19afd1d1da5&name=metaxalone-tablets-3.jpg)
Metaxalone
The recommended dose for adults and children over 12 years of age is one 800 mg tablet three to four times a day.
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Lidocaine
Dosage should be individualized for maximum beneficial effect. While the usual daily dosages given below will meet the needs of most patients, there will be some who require doses greater than 4 mg/day. In such cases, dosage should be increased cautiously to avoid adverse effects.
Anxiety Disorders and Transient Symptoms of Anxiety
Treatment for patients with anxiety should be initiated with a dose of 0.25 to 0.5 mg given three times daily. The dose may be increased to achieve a maximum therapeutic effect, at intervals of 3 to 4 days, to a maximum daily dose of 4 mg, given in divided doses. The lowest possible effective dose should be employed and the need for continued treatment reassessed frequently. The risk of dependence may increase with dose and duration of treatment.
In all patients, dosage should be reduced gradually when discontinuing therapy or when decreasing the daily dosage. Although there are no systematically collected data to support a specific discontinuation schedule, it is suggested that the daily dosage be decreased by no more than 0.5 mg every 3 days. Some patients may require an even slower dosage reduction.
Panic Disorder
The successful treatment of many panic disorder patients has required the use of ALPRAZOLAM at doses greater than 4 mg daily. In controlled trials conducted to establish the efficacy of ALPRAZOLAM in panic disorder, doses in the range of 1 to 10 mg daily were used. The mean dosage employed was approximately 5 to 6 mg daily. Among the approximately 1700 patients participating in the panic disorder development program, about 300 received ALPRAZOLAM in dosages of greater than 7 mg/day, including approximately 100 patients who received maximum dosages of greater than 9 mg/day. Occasional patients required as much as 10 mg a day to achieve a successful response.
Dose Titration
Treatment may be initiated with a dose of 0.5 mg three times daily. Depending on the response, the dose may be increased at intervals of 3 to 4 days in increments of no more than 1 mg per day. Slower titration to the dose levels greater than 4 mg/day may be advisable to allow full expression of the pharmacodynamic effect of ALPRAZOLAM. To lessen the possibility of interdose symptoms, the times of administration should be distributed as evenly as possible throughout the waking hours, that is, on a three or four times per day schedule.
Generally, therapy should be initiated at a low dose to minimize the risk of adverse responses in patients especially sensitive to the drug. Dose should be advanced until an acceptable therapeutic response (ie, a substantial reduction in or total elimination of panic attacks) is achieved, intolerance occurs, or the maximum recommended dose is attained.
Dose Maintenance
For patients receiving doses greater than 4 mg/day, periodic reassessment and consideration of dosage reduction is advised. In a controlled postmarketing dose-response study, patients treated with doses of ALPRAZOLAM greater than 4 mg/day for 3 months were able to taper to 50% of their total maintenance dose without apparent loss of clinical benefit. Because of the danger of withdrawal, abrupt discontinuation of treatment should be avoided. (See WARNINGS, PRECAUTIONS, DRUG ABUSE AND DEPENDENCE.)
The necessary duration of treatment for panic disorder patients responding to ALPRAZOLAM is unknown. After a period of extended freedom from attacks, a carefully supervised tapered discontinuation may be attempted, but there is evidence that this may often be difficult to accomplish without recurrence of symptoms and/or the manifestation of withdrawal phenomena.
Dose Reduction
Because of the danger of withdrawal, abrupt discontinuation of treatment should be avoided (see WARNINGS, PRECAUTIONS, DRUG ABUSE AND DEPENDENCE).
In all patients, dosage should be reduced gradually when discontinuing therapy or when decreasing the daily dosage. Although there are no systematically collected data to support a specific discontinuation schedule, it is suggested that the daily dosage be decreased by no more than 0.5 mg every three days. Some patients may require an even slower dosage reduction.
In any case, reduction of dose must be undertaken under close supervision and must be gradual. If significant withdrawal symptoms develop, the previous dosing schedule should be reinstituted and, only after stabilization, should a less rapid schedule of discontinuation be attempted. In a controlled postmarketing discontinuation study of panic disorder patients which compared this recommended taper schedule with a slower taper schedule, no difference was observed between the groups in the proportion of patients who tapered to zero dose; however, the slower schedule was associated with a reduction in symptoms associated with a withdrawal syndrome. It is suggested that the dose be reduced by no more than 0.5 mg every 3 days, with the understanding that some patients may benefit from an even more gradual discontinuation. Some patients may prove resistant to all discontinuation regimens.
Dosing in Special Populations
In elderly patients, in patients with advanced liver disease or in patients with debilitating disease, the usual starting dose is 0.25 mg, given two or three times daily. This may be gradually increased if needed and tolerated. The elderly may be especially sensitive to the effects of benzodiazepines. If side effects occur at the recommended starting dose, the dose may be lowered.
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![Amoxicillin And Clavulanate Potassium Tablet, Film Coated [Preferred Pharmaceuticals, Inc.]](http://www.recallguide.org/wp-content/themes/recallguide/assets/img/drug-image-placeholder.jpg)
Amoxicillin And Clavulanate Potassium
Since both amoxicillin and clavulanate potassium tablets USP, 250 mg/125 mg and 500 mg/125 mg, contain the same amount of clavulanic acid (125 mg, as the potassium salt), two amoxicillin and clavulanate potassium tablets USP, 250 mg/125 mg are not equivalent to one amoxicillin and clavulanate potassium tablet USP, 500 mg/125 mg. Therefore, two amoxicillin and clavulanate potassium tablets USP, 250 mg/125 mg should not be substituted for one amoxicillin and clavulanate potassium tablet USP, 500 mg/125 mg.
Dosage
Adults
The usual adult dose is one amoxicillin and clavulanate potassium tablet USP, 500 mg/125 mg every 12 hours or one amoxicillin and clavulanate potassium tablet USP, 250 mg/125 mg every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one amoxicillin and clavulanate potassium tablet USP, 875 mg/125 mg every 12 hours or one amoxicillin and clavulanate potassium tablet USP, 500 mg/125 mg every 8 hours.
Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of < 30 mL/min. should not receive the amoxicillin and clavulanate potassium tablets USP, 875 mg/125 mg. Patients with a glomerular filtration rate of 10 to 30 mL/min. should receive amoxicillin and clavulanate potassium tablets USP, 500 mg/125 mg or 250 mg/125 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/min. glomerular filtration rate should receive amoxicillin and clavulanate potassium tablets USP, 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection.
Hemodialysis patients should receive amoxicillin and clavulanate potassium tablets USP, 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.
Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals (see WARNINGS).
Pediatric Patients
Pediatric patients weighing 40 kg or more should be dosed according to the adult recommendations.
Due to the different amoxicillin to clavulanic acid ratios in the amoxicillin and clavulanate potassium tablets USP, 250 mg/125 mg versus the amoxicillin and clavulanate potassium chewable tablets USP, 250 mg/62.5 mg, the amoxicillin and clavulanate potassium tablets USP, 250 mg/125 mg should not be used until the pediatric patient weighs at least 40 kg or more.
Administration
Amoxicillin and clavulanate potassium tablets USP may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when amoxicillin and clavulanate potassium tablets USP are administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium tablets USP should be taken at the start of a meal.
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![Allergy Multi-symptom (Acetaminophen, Cholrpheniramine Maleate, Phenylephrine Hcl) Tablet, Film Coated [Fred’s, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=4104aad8-ded6-4e46-a5c1-4b7120180941&name=image-01.jpg)
Allergy Multi-symptom
take with a full glass of water adults and children 12 years of age and over: 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours. children under 12 years: do not use
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![Dendracin Neurodendraxcin (Methyl Salicylate, Menthol And Capsaicin) Lotion [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=a851ed45-38bc-499f-836b-b472f4c86ec1&name=image-01.jpg)
Dendracin Neurodendraxcin
Use only as directed. Shake before each use. Prior to first use, rub small amount to check for sensitivity. Gently rub over painful areas. Dry before contact with clothes or bedding to avoid staining. Wash hands after use. Do not use more than 4 times daily or if pregnant or nursing. If swallowed, call poison control. If placed into eyes, rinse with cold water and call a doctor.
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![Penicillin V Potassium Tablet, Film Coated [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=ceaa15a7-a440-4d91-912f-e8d3dd6dd4aa&name=43063557.jpg)
Penicillin V Potassium
The dosage of Penicillin V should be determined according to the sensitivity of the causative microorganism and the severity of infection, and adjusted to the clinical response of the patient.The usual dosage recommendations for adults and children 12 years and over are as follows:Streptococcal Infections Mild to moderately severe - of the upper respiratory tract and including scarlet fever and erysipelas: 125 to 250 mg (200,000 to 400,000 units) every 6 to 8 hours for 10 days.Pneumococcal Infections Mild to moderately severe - of the respiratory tract, including otitis media: 250 to 500 mg (400,000 to 800,000 units) every 6 hours until the patient has been afebrile for at least 2 days.Staphylococcal Infections Mild infections of skin and soft tissue (culture and sensitive tests should be performed): 250 to 500 mg (400,000 to 800,000 units) every 6 to 8 hours.Fusospirochetosis (Vincent’s infection) of the oropharynx. Mild to moderately severe infections: 250 to 500 mg (400,000 to 800,000 units) every 6 to 8 hours.For the prevention of recurrence following rheumatic fever and/or chorea: 125 mg to 250 mg (200,000 to 400,000 units) twice daily on a continuing basis.For prophylaxis against bacterial endocarditis1 in patients with congenital heart disease or rheumatic or other acquired valvular heart disease when undergoing dental procedures or surgical procedures of the upper respiratory tract: 2 gram of penicillin V (1 gram for children under 60 lbs.) 1 hour before the procedure, and then, 1 gram (500 mg for children under 60 lbs.) 6 hours later.
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![Diclofenac Sodium And Misoprostol Tablet, Delayed Release [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=ab5dc1b9-dc3f-4c06-9839-46515a9a05f5&name=diclo-miso-dr-tabs-2.jpg)
Diclofenac Sodium And Misoprostol
Carefully consider the potential benefits and risks of diclofenac sodium and misoprostol delayed-release tablets and other treatment options before deciding to use diclofenac sodium and misoprostol delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with diclofenac sodium and misoprostol delayed-release tablets, the dose and frequency should be adjusted to suit an individual patient’s needs.
For the relief of rheumatoid arthritis and osteoarthritis, the recommended dose is given below.
Diclofenac sodium and misoprostol delayed-release tablets are administered as diclofenac sodium and misoprostol delayed-release tablets (50 mg diclofenac sodium/0.2 mg misoprostol) or as diclofenac sodium and misoprostol delayed-release tablets (75 mg diclofenac sodium/0.2 mg misoprostol).
Note: See SPECIAL DOSING CONSIDERATIONS section below.
Osteoarthritis: The recommended dosage for maximal GI mucosal protection is diclofenac sodium and misoprostol delayed-release tablets 50 mg/0.2 mg tid. For patients who experience intolerance, diclofenac sodium and misoprostol delayed-release tablets 75 mg/0.2 mg bid or diclofenac sodium and misoprostol delayed-release tablets 50 mg/0.2 mg bid can be used, but are less effective in preventing ulcers. This fixed combination product, diclofenac sodium and misoprostol delayed-release tablets, is not recommended for patients who would not receive the appropriate dose of both ingredients. Doses of the components delivered with these regimens are as follows:
OA regimen
Diclofenac sodium (mg/day)
Misoprostol (mcg/day)
Diclofenac Sodium and Misoprostol Delayed-Release Tablets 50 mg/0.2 mg
tidbid
150100
600400
Diclofenac Sodium and Misoprostol Delayed-Release Tablets 75 mg/0.2 mg
bid
150
400
Rheumatoid Arthritis: The recommended dosage is diclofenac sodium and misoprostol delayed-release tablets 50 mg/0.2 mg tid or qid. For patients who experience intolerance, diclofenac sodium and misoprostol delayed-release tablets 75 mg/0.2 mg bid or diclofenac sodium and misoprostol delayed-release tablets 50 mg/0.2 mg bid can be used, but are less effective in preventing ulcers. This fixed combination product, diclofenac sodium and misoprostol delayed-release tablets, is not recommended for patients who would not receive the appropriate dose of both ingredients. Doses of the components delivered with these regimens are as follows:
RA regimen
Diclofenac sodium (mg/day)
Misoprostol (mcg/day)
Diclofenac Sodium and Misoprostol Delayed-Release Tablets 50 mg/0.2 mg
qidtidbid
200150100
800600400
Diclofenac Sodium and Misoprostol Delayed-Release Tablets 75 mg/0.2 mg
bid
150
400
SPECIAL DOSING CONSIDERATIONS: Diclofenac sodium and misoprostol delayed-release tablets contain misoprostol, which provides protection against gastric and duodenal ulcers (see CLINICAL STUDIES). For gastric ulcer prevention, the0.2 mg qid and tid regimens are therapeutically equivalent, but more protective than the bid regimen. For duodenal ulcer prevention, the qid regimen is more protective than the tid or bid regimens. However, the qid regimen is less well tolerated than the tid regimen because of usually self-limited diarrhea related to the misoprostol dose (see ADVERSE REACTIONS — Gastrointestinal), and the bid regimen may be better tolerated than tid in some patients.
Dosages may be individualized using the separate products (misoprostol and diclofenac), after which the patient may be changed to the appropriate dose of diclofenac sodium and misoprostol delayed-release tablets. If clinically indicated, misoprostol co-therapy with diclofenac sodium and misoprostol delayed-release tablets, or use of the individual components to optimize the misoprostol dose and/or frequency of administration, may be appropriate. The total dose of misoprostol should not exceed 800 mcg/day, and no more than 200 mcg of misoprostol should be administered at any one time. Doses of diclofenac higher than 150 mg/day in osteoarthritis or higher than 225 mg/day in rheumatoid arthritis are not recommended.
For additional information, it may be helpful to refer to the package inserts for Cytotec® tablets and Voltaren® tablets.
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![Metoprolol Tartrate Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=4a4935af-b3b5-489d-a7b4-1c117ee3ae12&name=metoprolol-fig1.jpg)
Metoprolol Tartrate
Hypertension
The dosage of metoprolol tartrate tablets should be individualized. Metoprolol tartrate tablets should be taken with or immediately following meals.
The usual initial dosage of Metoprolol tartrate tablets is 100 mg daily in single or divided doses, whether used alone or added to a diuretic. The dosage may be increased at weekly (or longer) intervals until optimum blood pressure reduction is achieved. In general, the maximum effect of any given dosage level will be apparent after 1 week of therapy. The effective dosage range of Metoprolol tartrate tablets is 100 to 450 mg per day. Dosages above 450 mg per day have not been studied. While once-daily dosing is effective and can maintain a reduction in blood pressure throughout the day, lower doses (especially 100 mg) may not maintain a full effect at the end of the 24-hour period, and larger or more frequent daily doses may be required. This can be evaluated by measuring blood pressure near the end of the dosing interval to determine whether satisfactory control is being maintained throughout the day. Beta1 selectivity diminishes as the dose of metoprolol is increased.
Angina Pectoris
The dosage of metoprolol tartrate tablets should be individualized. Metoprolol tartrate tablets should be taken with or immediately following meals.
The usual initial dosage of Metoprolol tartrate tablets is 100 mg daily, given in two divided doses. The dosage may be gradually increased at weekly intervals until optimum clinical response has been obtained or there is pronounced slowing of the heart rate. The effective dosage range of Metoprolol tartrate tablets is 100 to 400 mg per day. Dosages above 400 mg per day have not been studied. If treatment is to be discontinued, the dosage should be reduced gradually over a period of 1 to 2 weeks (see WARNINGS).
Myocardial Infarction
Early Treatment
During the early phase of definite or suspected acute myocardial infarction, treatment with metoprolol tartrate can be initiated as soon as possible after the patient’s arrival in the hospital. Such treatment should be initiated in a coronary care or similar unit immediately after the patient’s hemodynamic condition has stabilized.
Treatment in this early phase should begin with the intravenous administration of three bolus injections of 5 mg of metoprolol tartrate each; the injections should be given at approximately 2-minute intervals. During the intravenous administration of metoprolol, blood pressure, heart rate, and electrocardiogram should be carefully monitored.
In patients who tolerate the full intravenous dose (15 mg), metoprolol tartrate tablets, 50 mg every 6 hours, should be initiated 15 minutes after the last intravenous dose and continued for 48 hours. Thereafter, patients should receive a maintenance dosage of 100 mg twice daily (see Late Treatment below).
Patients who appear not to tolerate the full intravenous dose should be started on metoprolol tartrate tablets either 25 mg or 50 mg every 6 hours (depending on the degree of intolerance) 15 minutes after the last intravenous dose or as soon as their clinical condition allows. In patients with severe intolerance, treatment with metoprolol should be discontinued (see WARNINGS).
Late Treatment
Patients with contraindications to treatment during the early phase of suspected or definite myocardial infarction, patients who appear not to tolerate the full early treatment, and patients in whom the physician wishes to delay therapy for any other reason should be started on metoprolol tartrate tablets, 100 mg twice daily, as soon as their clinical condition allows. Therapy should be continued for at least 3 months. Although the efficacy of metoprolol beyond 3 months has not been conclusively established, data from studies with other beta blockers suggest that treatment should be continued for 1 to 3 years.
Special populations
Pediatric patients: No pediatric studies have been performed. The safety and efficacy of Metoprolol Tartrate in pediatric patients have not been established.
Renal impairment: No dose adjustment of Metoprolol Tartrate is required in patients with renal impairment.
Hepatic impairment: Metoprolol Tartrate blood levels are likely to increase substantially in patients with hepatic impairment. Therefore, Metoprolol Tartrate should be initiated at low doses with cautious gradual dose titration according to clinical response.
Geriatric patients (>65 years): In general, use a low initial starting dose in elderly patients given their greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Method of administration:
For oral treatment, the tablets should be swallowed un-chewed with a glass of water. Metoprolol Tartrate should always be taken in standardized relation with meals. If the physician asks the patient to take Metoprolol Tartrate either before breakfast or with breakfast, then the patient should continue taking Metoprolol Tartrate with the same schedule during the course of therapy.
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![Simethicone Capsule, Liquid Filled [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=8e1781a6-b01b-4030-a52e-f6e7e3b043bc&name=image-01.jpg)
Simethicone
• swallow one or two softgels as needed after a meal • do not exceed two softgels per day except under the advice and supervision of a physician
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![Colgate Advanced Whitening Fluoride (Sodium Fluoride) Paste, Dentifrice [Mission Hills S.a De C.v]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=366e4040-638d-49cb-b569-c8f2ac2552e0&name=image-01.jpg)
Colgate Advanced Whitening Fluoride
adults and children 6 years and over
2 teaspoonfuls (TSP) daily; do not take more than 2 teaspoonfuls (TSP) in 24 hours
children 2 to under 6 years of age
1 teaspoonful (TSP) daily; do not take more than 1 teaspoonful (TSP) in 24 hours
children under 2 years of age
ask a doctor
consumers with liver or kidney disease
ask a doctor
-
![Phentermine Hydrochloride Tablet Phentermine Hydrochloride Capsule [A-s Medication Solutions Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=1cab271a-1c2e-4cd3-8447-e290964413ff&name=image-01.jpg)
Phentermine Hydrochloride
adults and children 6 years and over
1 tablet daily; not more than 1 tablet in 24 hours
children under 6 years of age
ask a doctor
consumers with liver or kidney disease
ask a doctor
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![Amrutanjan Relief Strong Pain Balm (Menthol, Methyl Salicylate) Ointment [Amrutanjan Health Care Limited]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=2072dce3-940f-4cce-a726-203e6b616a66&name=image-03.jpg)
Amrutanjan Relief Strong Pain Balm
2.1 Adult Patients
[See Indications and Usage (1.1) and Clinical Pharmacology (12.3)]
Infection*
Recommended Dose/Duration of Therapy
Community-acquired pneumonia Pharyngitis/tonsillitis (second-line therapy) Skin/skin structure (uncomplicated)
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5
Acute bacterial exacerbations of chronic obstructive pulmonary disease
500 mg once daily for 3 days
OR
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5
Acute bacterial sinusitis
500 mg-once daily for 3 days
Genital ulcer disease (chancroid)
One single 1 gram dose
Non-gonococcal urethritis and cervicitis
One single 1 gram dose
Gonococcal urethritis and cervicitis
One single 2 gram dose
*DUE TO THE INDICATED ORGANISMS [see Indications and Usage (1.1)]
Azithromycin tablets can be taken with or without food.
2.2 Pediatric Patients1
Infection*
Recommended Dose/Duration of Therapy
Acute otitis media
30 mg/kg as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on Day 1 followed by 5 mg/kg/day on Days 2 through 5.
Acute bacterial sinusitis
10 mg/kg once daily for 3 days.
Community-acquired pneumonia
10 mg/kg as a single dose on Day 1 followed by 5 mg/kg once daily on Days 2 through 5.
Pharyngitis/tonsillitis
12 mg/kg once daily for 5 days.
*DUE TO THE INDICATED ORGANISMS [see Indications and Usage (1.2)]
1 see dosing tables below for maximum doses evaluated by indication
Azithromycin for oral suspension can be taken with or without food.
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA, ACUTE BACTERIAL SINUSITIS, AND COMMUNITY-ACQUIRED PNEUMONIA
(Age 6 months and above, [see Use in Specific Populations (8.4)])
Based on Body Weight
OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5 Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1and 5 mg/kg/day Days 2 to 5.
Weight
100 mg/5 mL
200 mg/5 mL
Total mL perTreatmentCourse
Total mg perTreatmentCourse
Kg
Lbs.
Day 1
Days 2 to 5
Day 1
Days 2 to 5
5
11
2.5 mL (½ tsp)
1.25 mL (¼ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
2.5 mL (½ tsp)
15 mL
300 mg
20
44
5 mL (1 tsp)
2.5 mL (½ tsp)
15 mL
600 mg
30
66
7.5 mL (1½ tsp)
3.75 mL (¾ tsp)
22.5 mL
900 mg
40
88
10 mL (2 tsp)
5 mL (1 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL (2½ tsp)
6.25 mL (1¼ tsp)
37.5 mL
1500 mg
* Effectiveness of the 3 day or 1 day regimen in pediatric patients with community-acquired pneumonia has not been established.
OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3 Day Regimen)*
Dosing Calculated on 10 mg/kg/day
Weight
100 mg/5 mL
200 mg/5 mL
Total mL perTreatmentCourse
Total mg perTreatmentCourse
Kg
Lbs.
Days 1 to 3
Days 1 to 3
5
11
2.5 mL (½ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
15 mL
300 mg
20
44
5 mL
(1 tsp)
15 mL
600 mg
30
66
7.5 mL
(1 ½ tsp)
22.5 mL
900 mg
40
88
10 mL
(2 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL
(2 ½ tsp)
37.5 mL
1500 mg
*Effectiveness of the 5 day or 1 day regimen in pediatric patients with acute bacterial sinusitis has not been established.
OTITIS MEDIA: (1 Day Regimen)
Dosing Calculated on 30 mg/kg as a single dose
Weight
200 mg/5 mL
Total mL perTreatment Course
Total mg perTreatment Course
Kg
Lbs.
1 Day Regimen
5
11
3.75 mL
(3/4 tsp)
3.75 mL
150 mg
10
22
7.5 mL
(1 ½ tsp)
7.5 mL
300 mg
20
44
15 mL
(3 tsp)
15 mL
600 mg
30
66
22.5 mL
(4 ½ tsp)
22.5 mL
900 mg
40
88
30 mL
(6 tsp)
30 mL
1200 mg
50 and above
110 and above
37.5 mL
(7 ½ tsp)
37.5 mL
1500 mg
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/Tonsillitis: The recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS/TONSILLITIS
(Age 2 years and above, [see Use in Specific Populations (8.4)])
Based on Body Weight
PHARYNGITIS/TONSILLITIS: (5 Day Regimen)
Dosing Calculated on 12 mg/kg/day for 5 days.
Weight
200 mg/5 mL
Total mL per TreatmentCourse
Total mg per TreatmentCourse
Kg
Lbs.
Day 1 to 5
8
18
2.5 mL
(½ tsp)
12.5 mL
500 mg
17
37
5 mL
(1 tsp)
25 mL
1000 mg
25
55
7.5 mL
(1½ tsp)
37.5 mL
1500 mg
33
73
10 mL
(2 tsp)
50 mL
2000 mg
40
88
12.5 mL
(2½ tsp)
62.5 mL
2500 mg
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![Celecoxib Capsule [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=25161c1b-ee50-4e13-b22a-85306366b11f&name=celecoxib-04.jpg)
Celecoxib
Use lowest effective dose for the shortest duration consistent with treatment goals for the individual patient.
These doses can be given without regard to timing of meals.
2.1 Osteoarthritis
For relief of the signs and symptoms of OA the recommended oral dose is 200 mg per day administered as a single dose or as 100 mg twice daily.
2.2 Rheumatoid Arthritis
For relief of the signs and symptoms of RA the recommended oral dose is 100 to 200 mg twice daily.
2.3 Juvenile Rheumatoid Arthritis
For the relief of the signs and symptoms of JRA the recommended oral dose for pediatric patients (age 2 years and older) is based on weight. For patients ≥10 kg to ≤25 kg the recommended dose is 50 mg twice daily. For patients >25 kg the recommended dose is 100 mg twice daily.
For patients who have difficulty swallowing capsules, the contents of a celecoxib capsule can be added to applesauce. The entire capsule contents are carefully emptied onto a level teaspoon of cool or room temperature applesauce and ingested immediately with water. The sprinkled capsule contents on applesauce are stable for up to 6 hours under refrigerated conditions (2–8° C/ 35–45° F).
2.4 Ankylosing Spondylitis
For the management of the signs and symptoms of AS, the recommended dose of celecoxib is 200 mg daily in single (once per day) or divided (twice per day) doses. If no effect is observed after 6 weeks, a trial of 400 mg daily may be worthwhile. If no effect is observed after 6 weeks on 400 mg daily, a response is not likely and consideration should be given to alternate treatment options.
2.5 Management of Acute Pain and Treatment of Primary Dysmenorrhea
The recommended dose of celecoxib is 400 mg initially, followed by an additional 200 mg dose if needed on the first day. On subsequent days, the recommended dose is 200 mg twice daily as needed.
2.6 Special Populations
Hepatic insufficiency: The daily recommended dose of celecoxib capsules in patients with moderate hepatic impairment (Child-Pugh Class B) should be reduced by 50%. The use of celecoxib in patients with severe hepatic impairment is not recommended [see Warnings and Precautions (5.5), Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
Poor Metabolizers of CYP2C9 Substrates: Patients who are known or suspected to be poor CYP2C9 metabolizers based on genotype or previous history/experience with other CYP2C9 substrates (such as warfarin, phenytoin) should be administered celecoxib with caution. Consider starting treatment at half the lowest recommended dose in poor metabolizers (i.e. CYP2C9*3/*3). Consider using alternative management in JRA patients who are poor metabolizers. [see Use in Specific populations (8.8), and Clinical Pharmacology (12.5)].
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![Inosal 40 Number 3 (Bryonia Alba, Pulsatilla Nigricans) Pellet [Paramesh Banerji Life Sciences Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=0f09bcda-5041-48f6-8107-2785875efd51&name=label.jpg)
Inosal 40 Number 3
One to two drops in the conjunctival sac(s). In severe disease, drops may be used hourly, being tapered to discontinuation as the inflammation subsides. In mild disease, drops may be used up to four to six times daily.
Not more than 20 mL should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in PRECAUTIONS above.
FOR TOPICAL OPHTHALMIC USE ONLY.
-
![Promethazine Hydrochloride Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=01377b4c-e5be-41b7-877f-3102b40bda91&name=d4c70548-figure-03.jpg)
Promethazine Hydrochloride
Promethazine Hydrochloride Tablets, USP are contraindicated for children under 2 years of age (see WARNINGS: Black Box Warning and Use in Pediatric Patients).
Allergy: The average oral dose is 25 mg taken before retiring; however, 12.5 mg may be taken before meals and on retiring, if necessary. Single 25 mg doses at bedtime or 6.25 to 12.5 mg taken three times daily will usually suffice. After initiation of treatment, in children or adults, dosage should be adjusted to the smallest amount adequate to relieve symptoms. The administration of promethazine HCl in 25 mg doses will control minor transfusion reactions of an allergic nature.
Motion Sickness: The average adult dose is 25 mg taken twice daily. The initial dose should be taken one-half to one hour before anticipated travel and be repeated eight to twelve hours later if necessary. On succeeding days of travel, it is recommended that 25 mg be given on arising and again before the evening meal. For children, promethazine hydrochloride tablets, syrup, or rectal suppositories, 12.5 to 25 mg, twice daily, may be administered.
Nausea and Vomiting: Antiemetics should not be used in vomiting of unknown etiology in children and adolescents (see WARNINGS: Use in Pediatric Patients).
The average effective dose of promethazine HCl for the active therapy of nausea and vomiting in children or adults is 25 mg. When oral medication cannot be tolerated, the dose should be given parenterally or by rectal suppository. 12.5 to 25 mg doses may be repeated, as necessary, at four- to six-hour intervals.
For nausea and vomiting in children, the usual dose is 0.5 mg per pound of body weight, and the dose should be adjusted to the age and weight of the patient and the severity of the condition being treated.
For prophylaxis of nausea and vomiting, as during surgery and the postoperative period, the average dose is 25 mg repeated at four- to six-hour intervals, as necessary.
Sedation: This product relieves apprehension and induces a quiet sleep from which the patient can be easily aroused. Administration of 12.5 to 25 mg Promethazine HCl by the oral route or by rectal suppository at bedtime will provide sedation in children. Adults usually require 25 to 50 mg for nighttime, presurgical, or obstetrical sedation.
Pre- and Postoperative Use: Promethazine HCl in 12.5 to 25 mg doses for children and 50 mg doses for adults the night before surgery relieves apprehension and produces a quiet sleep.
For preoperative medication, children require doses of 0.5 mg per pound of body weight in combination with an appropriately reduced dose of narcotic or barbiturate and the appropriate dose of an atropine-like drug. Usual adult dosage is 50 mg Promethazine HCl with an appropriately reduced dose of narcotic or barbiturate and the required amount of a belladonna alkaloid.
Postoperative sedation and adjunctive use with analgesics may be obtained by the administration of 12.5 to 25 mg in children and 25 to 50 mg doses in adults. Promethazine hydrochloride tablets are contraindicated for children under 2 years of age.
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![Lansoprazole Capsule, Delayed Release [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=4d1d6d87-f71a-4f91-bffd-f7b93e9d0e24&name=Container1.jpg)
Lansoprazole
Lansoprazole is available as a capsule, and is available in 15 mg and 30 mg strengths. Directions for use specific to the route and available methods of administration is presented below. Lansoprazole delayed-release capsules should be taken before eating. Lansoprazole delayed-release capsule products SHOULD NOT BE CRUSHED OR CHEWED. In the clinical trials, antacids were used concomitantly with lansoprazole delayed-release capsules.
2.1Recommended Dose
Indication Recommended Dose FrequencyDuodenal Ulcers
Short-Term Treatment
15 mg
Once daily for 4 weeks
Maintenance of Healed
15 mg
Once daily
H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence
Triple Therapy:
Lansoprazole delayed-release capsules
30 mg
Twice daily (q12h) for 10 or 14 days
Amoxicillin
1 gram
Twice daily (q12h) for 10 or 14 days
Clarithromycin
500 mg
Twice daily (q12h) for 10 or 14 days
Dual Therapy:
Lansoprazole delayed-release capsules
30 mg
Three times daily (q8h) for 14 days
Amoxicillin
1 gram
Three times daily (q8h) for 14 days
Benign Gastric Ulcer
Short-Term Treatment
30 mg
Once daily for up to 8 weeks
NSAID-associated Gastric Ulcer
Healing
30 mg
Once daily for 8 weeks
Risk Reduction
15 mg
Once daily for up to 12 weeks
Gastroesophageal Reflux Disease (GERD)
Short-Term Treatment of Symptomatic GERD
15 mg
Once daily for up to 8 weeks
Short -Term Treatment of Erosive Esophagitis
30 mg
Once daily for up to 8 weeks
Pediatric
(1 to 11 years of age)Short-Term Treatment of Symptomatic GERD and Short-Term Treatment of Erosive Esophagitis
≤ 30 kg
15 mg
Once daily for up to 12 weeks
> 30 kg
30 mg
Once daily for up to 12 weeks
(12 to 17 years of age)Short-Term Treatment of Symptomatic GERD
Nonerosive GERD
15 mg
Once daily for up to 8 weeks
Erosive Esophagitis
30 mg
Once daily for up to 8 weeks
Maintenance of Healing of Erosive Esophagitis
15 mg
Once daily
Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome
60 mg
Once daily
Patients should be instructed that if a dose is missed, it should be taken as soon as possible. However, if the next scheduled dose is due, the patient should not take the missed dose, and should be instructed to take the next dose on time. Patients should be instructed not to take 2 doses at one time to make up for a missed dose.
2.2Special Populations
Renal impairment patients and geriatric patients do not require dosage adjustment. However, consider dose adjustment in patients with severe liver impairment. [See Use in Specific Populations (8.5, 8.6 and 8.7]
2.3Important Administration Information
Administration Options
Lansoprazole Delayed-Release Capsules - Oral Administration
• Lansoprazole delayed-release capsules should be swallowed whole. • Alternatively, for patients who have difficulty swallowing capsules, lansoprazole delayed-release capsules can be opened and administered as follows: • Open capsule. • Sprinkle intact granules on one tablespoon of either applesauce, ENSURE ® pudding, cottage cheese, yogurt or strained pears. • Swallow immediately. • Lansoprazole Delayed-Release Capsules may also be emptied into a small volume of either apple juice, orange juice or tomato juice and administered as follows: • Open capsule. • Sprinkle intact granules into a small volume of either apple juice, orange juice or tomato juice (60 mL – approximately 2 ounces). • Mix briefly. • Swallow immediately. • To ensure complete delivery of the dose, the glass should be rinsed with two or more volumes of juice and the contents swallowed immediately.Lansoprazole Delayed-Release Capsules - Nasogastric Tube (≥ 16 French) Administration
• For patients who have a nasogastric tube in place, lansoprazole delayed-release capsules can be administered as follows: 1. Open capsule. 2. Mix intact granules into 40 mL of apple juice. DO NOT USE OTHER LIQUIDS. 3. Inject through the nasogastric tube into the stomach. 4. Flush with additional apple juice to clear the tube.USE IN OTHER FOODS AND LIQUIDS HAS NOT BEEN STUDIED CLINICALLY AND IS THEREFORE NOT RECOMMENDED.
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![Lansoprazole Capsule, Delayed Release Pellets [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=1b083d0d-fd7d-49ff-9656-cf4f141fee18&name=6065e4e0-5302-4ebc-99e1-d01d86b6efc3-05.jpg)
Lansoprazole
Lansoprazole delayed-release capsules are available as capsules in 15 mg and 30 mg strengths. Directions for use specific to the route and available methods of administration is presented below. Lansoprazole delayed-release capsules should be taken before eating. Lansoprazole delayed-release capsules SHOULD NOT BE CRUSHED OR CHEWED. In the clinical trials, antacids were used concomitantly with lansoprazole.
2.1 Recommended Dose
* Please refer to amoxicillin and clarithromycin full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally-impaired patients. † Controlled studies did not extend beyond indicated duration. ‡ For patients who do not heal with lansoprazole for 8 weeks (5% to 10%), it may be helpful to give an additional 8 weeks of treatment. If there is a recurrence of erosive esophagitis, an additional 8 week course of lansoprazole may be considered. § The lansoprazole dose was increased (up to 30 mg twice daily) in some pediatric patients after 2 or more weeks of treatment if they remained symptomatic. For pediatric patients unable to swallow an intact capsule please see Administration Options. ¶ Varies with individual patient. Recommended adult starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Dosages up to 90 mg twice daily have been administered. Daily dose of greater than 120 mg should be administered in divided doses. Some patients with Zollinger-Ellison Syndrome have been treated continuously with lansoprazole for more than 4 years.Indication
Recommended
Frequency
Dose
Duodenal Ulcers
Short-Term Treatment
15 mg
Once daily for 4 weeks
Maintenance of Healed
15 mg
Once daily
H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence*
Triple Therapy:
Lansoprazole Delayed-release Capsules
30 mg
Twice daily (q12h) for 10 or 14 days
Amoxicillin
1 gram
Twice daily (q12h) for 10 or 14 days
Clarithromycin
500 mg
Twice daily (q12h) for 10 or 14 days
Dual Therapy:
Lansoprazole Delayed-release Capsules
30 mg
Three times daily (q8h) for 14 days
Amoxicillin
1 gram
Three times daily (q8h) for 14 days
Benign Gastric Ulcer
Short-Term Treatment
30 mg
Once daily for up to 8 weeks
NSAID-associated Gastric Ulcer
Healing
30 mg
Once daily for 8 weeks†
Risk Reduction
15 mg
Once daily for up to 12 weeks†
Gastroesophageal Reflux Disease (GERD)
Short-Term Treatment of Symptomatic GERD
15 mg
Once daily for up to 8 weeks
Short -Term Treatment of Erosive Esophagitis
30 mg
Once daily for up to 8 weeks‡
Pediatric
(1 to 11 years of age)
Short-Term Treatment of Symptomatic GERD and Short-Term Treatment of Erosive Esophagitis
≤ 30 kg
15 mg
Once daily for up to 12 weeks§
> 30 kg
30 mg
Once daily for up to 12 weeks§
(12 to 17 years of age)
Short-Term Treatment of Symptomatic GERD
Nonerosive GERD
15 mg
Once daily for up to 8 weeks
Erosive Esophagitis
30 mg
Once daily for up to 8 weeks
Maintenance of Healing of Erosive Esophagitis
15 mg
Once daily
Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome
60 mg
Once daily¶
Patients should be instructed that if a dose is missed, it should be taken as soon as possible. However, if the next scheduled dose is due, the patient should not take the missed dose and should be instructed to take the next dose on time. Patients should be instructed not to take two doses at one time to make up for a missed dose.
2.2 Special Populations
Renal impairment patients and geriatric patients do not require dosage adjustment. However, consider dose adjustment in patients with severe liver impairment. [See Use in Specific Populations (8.5, 8.6 and 8.7).]
2.3 Important Administration Information
Administration Options
Lansoprazole Delayed-release Capsules -Oral Administration
• Lansoprazole delayed-release capsules should be swallowed whole. • Alternatively, for patients who have difficulty swallowing capsules, lansoprazole delayed-release capsules can be opened and administered as follows: • Open capsule. • Sprinkle intact pellets on one tablespoon of either applesauce, ENSURE ® pudding, cottage cheese, yogurt or strained pears. • Swallow immediately. • Lansoprazole delayed-release capsules may also be emptied into a small volume of either apple juice, orange juice or tomato juice and administered as follows: • Open capsule. • Sprinkle intact pellets into a small volume of either apple juice, orange juice or tomato juice (60 mL – approximately 2 ounces). • Mix briefly. • Swallow immediately. • To ensure complete delivery of the dose, the glass should be rinsed with two or more volumes of juice and the contents swallowed immediately.Lansoprazole Delayed-release Capsules -Nasogastric Tube (≥ 16 French) Administration
• For patients who have a nasogastric tube in place, lansoprazole delayed-release capsules can be administered as follows: • Open capsule. • Mix intact pellets into 40 mL of apple juice. DO NOT USE OTHER LIQUIDS. • Inject through the nasogastric tube into the stomach. • Flush with additional apple juice to clear the tube.USE IN OTHER FOODS AND LIQUIDS HAS NOT BEEN STUDIED CLINICALLY AND IS THEREFORE NOT RECOMMENDED.
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![Levofloxacin Tablet, Film Coated [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=7d3f1001-b111-4038-82ad-a0465f8e854a&name=container3.jpg)
Levofloxacin
2.1 Dosage in Adult Patients with Normal Renal Function
The usual dose of levofloxacin tablets are 250 mg, 500 mg, or 750 mg administered orally every 24 hours, as indicated by infection and described in Table 1.
These recommendations apply to patients with creatinine clearance ≥ 50 mL/min. For patients with creatinine clearance <50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].
Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50 mL/min)
Type of Infection*
Dosed Every 24 hours
Duration (days)†
Nosocomial Pneumonia
750 mg
7 to 14
Community Acquired Pneumonia ‡
500 mg
7 to 14
Community Acquired Pneumonia§
750 mg
5
Acute Bacterial Sinusitis
750 mg
5
500 mg
10 to 14
Acute Bacterial Exacerbation of Chronic Bronchitis
500 mg
7
Complicated Skin and Skin Structure Infections (SSSI)
750 mg
7 to 14
Uncomplicated SSSI
500 mg
7 to 10
Chronic Bacterial Prostatitis
500 mg
28
Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)¶
750 mg
5
Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)#
250 mg
10
Uncomplicated Urinary Tract Infection
250 mg
3
Inhalational Anthrax (Post-Exposure), adult and pediatric patients > 50 kg Þ,ß Pediatric patients < 50 kg and ≥ 6 months of age Þ,ß
500 mg see Table 2 below (2.2)
60 ß 60 ß
Plague, adult and pediatric patients > 50 kgà Pediatric patients < 50 kg and ≥ 6 months of age
500 mgsee Table 2 below (2.2)
10 to 1410 to 14
1* Due to the designated pathogens [see Indications and Usage (1)].
†Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
‡ Due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [see Indications and Usage (1.2)].
§Due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see Indications and Usage (1.3)].
¶This regimen is indicated for cUTI due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and AP due to E. coli, including cases with concurrent bacteremia.
#This regimen is indicated for cUTI due to Enterococcus faecalis, Enterococcus cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa; and for AP due to E. coli.
ÞDrug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)].
ßThe safety of levofloxacin in adults for durations of therapy beyond 28 days or in pediatric patients for durations beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk.
à Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Higher doses of levofloxacin typically used for treatment of pneumonia can be used for treatment of plague, if clinically indicated.
2.2 Dosage in Pediatric Patients
The dosage in pediatric patients ≥ 6 months of age is described below in Table 2.
Table 2: Dosage in Pediatric Patients ≥ 6 months of age
Type of Infection*
Dose
Freq. Once every
Duration†
Inhalational Anthrax (post-exposure) ‡,§
Pediatric patients > 50 kg
500 mg
24 hr
60 days§
Pediatric patients < 50 kg and ≥ 6 months of age
8 mg/kg (not to exceed 250 mg per dose)
12 hr
60 days§
Plague¶
Pediatric patients > 50 kg
500 mg
24 hr
10 to 14 days
Pediatric patients < 50 kg and ≥ 6 months of age
8 mg/kg (not to exceed 250 mg per dose)
12 hr
10 to 14 days
*Due to Bacillus anthracis [see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage (1.14)].
†Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
‡Drug administration should begin as soon as possible after suspected or confirmed exposure toaerosolizedB. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrationsachieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)]
§The safety of levofloxacin in pediatric patients for durations of therapy beyond 14 days has not beenstudied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk.
¶ Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis.
2.3 Dosage Adjustment in Adults with Renal Impairment
Administer levofloxacin with caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced.
No adjustment is necessary for patients with a creatinine clearance ≥ 50 mL/min.
In patients with impaired renal function (creatinine clearance <50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [seeUse in Specific Populations (8.6)].
Table 3 shows how to adjust dose based on creatinine clearance.
Table 3: Dosage Adjustment in Adult Patients with Renal Impairment (creatinine clearance <50 mL/min)
Dosage in Normal Renal Function Every 24 hours
Creatinine Clearance 20 to 49 mL/min
Creatinine Clearance 10 to 19 mL/min
Hemodialysis or Chronic Ambulatory Peritoneal Dialysis (CAPD)
750 mg
750 mg every 48 hours
750 mg initial dose, then 500 mg every 48 hours
750 mg initial dose, then 500 mg every 48 hours
500 mg
500 mg initial dose, then
250 mg every 24 hours
500 mg initial dose, then
250 mg every 48 hours
500 mg initial dose, then
250 mg every 48 hours
250 mg
No dosage adjustment required
250 mg every 48 hours. If treating uncomplicated UTI, then no dosage adjustment is required
No information on dosing adjustment is available
2.4 Drug Interaction With Chelation Agents:
Antacids, Sucralfate, Metal Cations, Multivitamins
Levofloxacin tablets should be administered at least two hours before or two hours after antacids containing magnesium, aluminum, as well as sucralfate, metal cations such as iron, and multivitamin preparations with zinc or didanosine chewable/buffered tablets or the pediatric powder for oral solution [seeDrugInteractions (7.1) and Patient Counseling Information (17.2)]
2.5 Administration Instructions
Food and Levofloxacin Tablets
Levofloxacin tablets can be administered without regard to food.
Hydration for Patients Receiving Levofloxacin Tablets
Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [seeAdverse Reactions (6.1) and Patient Counseling Information (17.2)].
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![Symlinpen (Pramlintide Acetate) Injection [Astrazeneca Pharmaceuticals Lp]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=6d757241-53f8-4498-999a-87dfe3cb4d17&name=naproxen-tablets-usp-3.jpg)
Symlinpen
Carefully consider the potential benefits and risks of naproxen tablets, USP and other treatment options before deciding to use naproxen tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with naproxen tablets, USP, the dose and frequency should be adjusted to suit an individual patient’s needs.
Different dose strengths and formulations (i.e., tablets, suspension) of the drug are not necessarily bioequivalent. This difference should be taken into consideration when changing formulation.
Although naproxen tablets, USP, naproxen suspension, naproxen delayed-release tablets, and naproxen sodium tablets all circulate in the plasma as naproxen, they have pharmacokinetic differences that may affect onset of action. Onset of pain relief can begin within 1 hour in patients taking naproxen.
The recommended strategy for initiating therapy is to choose a formulation and a starting dose likely to be effective for the patient and then adjust the dosage based on observation of benefit and/or adverse events. A lower dose should be considered in patients with renal or hepatic impairment or in elderly patients (see WARNINGS and PRECAUTIONS).
Geriatric Patients
Studies indicate that although total plasma concentration of naproxen is unchanged, the unbound plasma fraction of naproxen is increased in the elderly. Caution is advised when high doses are required and some adjustment of dosage may be required in elderly patients. As with other drugs used in the elderly, it is prudent to use the lowest effective dose.
Patients With Moderate to Severe Renal Impairment
Naproxen-containing products are not recommended for use in patients with moderate to severe and severe renal impairment (creatinine clearance <30 mL/min) (see WARNINGS: Renal Effects).
Rheumatoid Arthritis, Osteoarthritis and Ankylosing Spondylitis
Naproxen Tablets, USP
250 mg or 375 mg or 500 mg
twice daily twice daily twice daily
During long-term administration, the dose of naproxen may be adjusted up or down depending on the clinical response of the patient. A lower daily dose may suffice for long-term administration. The morning and evening doses do not have to be equal in size and the administration of the drug more frequently than twice daily is not necessary.
In patients who tolerate lower doses well, the dose may be increased to naproxen 1500 mg/day for limited periods of up to 6 months when a higher level of anti-inflammatory/ analgesic activity is required. When treating such patients with naproxen 1500 mg/day, the physician should observe sufficient increased clinical benefits to offset the potential increased risk. The morning and evening doses do not have to be equal in size and administration of the drug more frequently than twice daily does not generally make a difference in response (see CLINICAL PHARMACOLOGY).
Acute Gout
The recommended starting dose is 750 mg of naproxen tablets, USP followed by 250 mg every 8 hours until the attack has subsided.
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![Phentermine Hydrochloride Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=7ffdb948-0b7f-4404-a858-127ddadd74f1&name=phentermine-hydrochloride-tablets-usp-2.jpg)
Phentermine Hydrochloride
Exogenous Obesity
Dosage should be individualized to obtain an adequate response with the lowest effective dose.
The usual adult dose is one tablet (37.5 mg) daily, as prescribed by the physician, administered before breakfast or 1 to 2 hours after breakfast. The dosage may be adjusted to the patient’s need. For some patients, half tablet (18.75 mg) daily may be adequate, while in some cases it may be desirable to give half tablets (18.75 mg) two times a day. Phentermine is not recommended for use in pediatric patients ≤ 16 years of age.
Late evening medication should be avoided because of the possibility of resulting insomnia.
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![Sleep Aid Maximum Strength Nighttime (Diphenhydramine Hcl) Capsule, Liquid Filled [Winco Foods, Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=84065605-11a6-465c-a86c-ce0d7829091c&name=image-02.jpg)
Sleep Aid Maximum Strength Nighttime
For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested: in adults, 50-100 mg q.i.d.: children under 6 years, 50 mg daily in divided doses: children over 6 years: 50-100 mg daily in divided doses.
For use in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and in histamine-mediated pruritus: in adults, 25 mg t.i.d. or q.i.d.; children under 6 years, 50 mg daily in divided doses and children over 6 years, 50-100 mg daily in divided doses.
As a sedative when used as a premedication and following general anesthesia: 50-100 mg in adults, and 0.6 mg/kg in children.
When treatment is initiated by the intramuscular route of administration, subsequent doses may be administered orally.
As with all medications, the dosage should be adjusted according to the patient’s response to therapy.
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![Tramadol Hydrochloride And Acetaminophen Tablet, Film Coated [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=04d7d345-eed9-4d25-b6c4-517ecb35d6b7&name=d0ea9c69-687a-4af1-a9c8-3a870f6c524c-03.jpg)
Tramadol Hydrochloride And Acetaminophen
For the short-term (5 days or less) management of acute pain, the recommended dose of tramadol hydrochloride and acetaminophen tablets is two tablets every 4 to 6 hours as needed for pain relief, up to a maximum of eight tablets per day.
Individualization of Dose
In patients with creatinine clearances of less than 30 mL/min, it is recommended that the dosing interval of tramadol hydrochloride and acetaminophen tablets be increased not to exceed two tablets every 12 hours. Dose selection for an elderly patient should be cautious, in view of the potential for greater sensitivity to adverse events.
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![Good Neighbor Pharmacy Sinus Relief (Acetaminophen, Guaifenesin, Phenylephrine Hcl) Capsule, Coated [Amerisource Bergen]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=cbec80f7-a85d-475d-bdbd-f940d7faadea&name=budesonide-inhalation-suspension-0-25-and-0-5mg-9.jpg)
Good Neighbor Pharmacy Sinus Relief
The recommended starting dose and highest recommended dose of budesonide inhalation suspension, based on prior asthma therapy, are listed in the following table.
Previous Therapy
Recommended Starting Dose
Highest Recommended Dose
Bronchodilators alone
0.5 mg total daily dose administeredtwice daily in divided doses
0.5 mg total daily dose
Inhaled Corticosteroids
0.5 mg total daily dose administeredtwice daily in divided doses
1 mg total daily dose
Oral Corticosteroids
1 mg total daily dose administeredas 0.5 mg twice daily
1 mg total daily dose
2.1 Dosing Recommendations
Dosing recommendations based on previous therapy are as follows:
• Bronchodilators alone: 0.25 mg twice daily • Inhaled corticosteroids: 0.25 mg twice daily up to 0.5 mg twice daily • Oral corticosteroids: 0.5 mg twice dailyIn all patients, it is desirable to downward-titrate to the lowest effective dose once asthma stability is achieved.
2.2 Directions for Use
Budesonide inhalation suspension should be administered via jet nebulizer connected to an air compressor with an adequate air flow, equipped with a mouthpiece or suitable face mask. Ultrasonic nebulizers are not suitable for the adequate administration of budesonide inhalation suspension and, therefore, are NOT recommended.
The effects of mixing budesonide inhalation suspension with other nebulizable medications have not been adequately assessed. Budesonide inhalation suspension should be administered separately in the nebulizer [see Patient Counseling Information, Administration with a jet nebulizer (17.1)].
A Pari-LC-Jet Plus Nebulizer (with face mask or mouthpiece) connected to a Pari Master compressor was used to deliver budesonide inhalation suspension to each patient in 3 U.S. controlled clinical studies. The safety and efficacy of budesonide inhalation suspension delivered by other nebulizers and compressors have not been established.
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![Proctosol-hc (Hydrocortisone) Cream [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=e79c9247-0e11-425c-9301-c63a2364a370&name=proctolabel1.jpg)
Proctosol-hc
Apply to the affected area as a thin film from two to four times daily depending on the severity of the condition.
Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions.
If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.
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![Bupropion Hydrochloride Tablet, Film Coated, Extended Release [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=aff1aa12-5f9d-4ba8-875b-cf804f371111&name=bupropion-hydrochloride-3.jpg)
Bupropion Hydrochloride
General Dosing Considerations: It is particularly important to administer bupropion hydrochloride extended-release tablets (SR) in a manner most likely to minimize the risk of seizure (see WARNINGS). Gradual escalation in dosage is also important if agitation, motor restlessness, and insomnia, often seen during the initial days of treatment, are to be minimized. If necessary, these effects may be managed by temporary reduction of dose or the short-term administration of an intermediate to long-acting sedative hypnotic. A sedative hypnotic usually is not required beyond the first week of treatment. Insomnia may also be minimized by avoiding bedtime doses. If distressing, untoward effects supervene, dose escalation should be stopped. Bupropion hydrochloride extended-release tablets (SR) should be swallowed whole and not crushed, divided, or chewed, as this may lead to an increased risk of adverse effects including seizures.
Initial Treatment: The usual adult target dose for bupropion hydrochloride extended-release tablets (SR) is 300 mg/day, given as 150 mg twice daily. Dosing with bupropion hydrochloride extended-release tablets (SR) should begin at 150 mg/day given as a single daily dose in the morning. If the 150 mg initial dose is adequately tolerated, an increase to the 300 mg/day target dose, given as 150 mg twice daily, may be made as early as day 4 of dosing. There should be an interval of at least 8 hours between successive doses.
Increasing the Dosage Above 300 mg/day: As with other antidepressants, the full antidepressant effect of bupropion hydrochloride extended-release tablets (SR) may not be evident until 4 weeks of treatment or longer. An increase in dosage to the maximum of 400 mg/day, given as 200 mg twice daily, may be considered for patients in whom no clinical improvement is noted after several weeks of treatment at 300 mg/day.
Maintenance Treatment: It is generally agreed that acute episodes of depression require several months or longer of sustained pharmacological therapy beyond response to the acute episode. In a study in which patients with major depressive disorder, recurrent type, who had responded during 8 weeks of acute treatment with bupropion hydrochloride extended-release tablets (SR) were assigned randomly to placebo or to the same dose of bupropion hydrochloride extended-release tablets (SR) (150 mg twice daily) during 44 weeks of maintenance treatment as they had received during the acute stabilization phase, longer-term efficacy was demonstrated (see CLINICAL TRIALS under CLINICAL PHARMACOLOGY). Based on these limited data, it is unknown whether or not the dose of bupropion hydrochloride extended-release tablets (SR) needed for maintenance treatment is identical to the dose needed to achieve an initial response. Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment.
Dosage Adjustment for Patients with Impaired Hepatic Function: Bupropion hydrochloride extended-release tablets (SR) should be used with extreme caution in patients with severe hepatic cirrhosis. The dose should not exceed 100 mg every day or 150 mg every other day in these patients. Bupropion hydrochloride extended-release tablets (SR) should be used with caution in patients with hepatic impairment (including mild-to-moderate hepatic cirrhosis) and a reduced frequency and/or dose should be considered in patients with mild-to-moderate hepatic cirrhosis (see CLINICAL PHARMACOLOGY, WARNINGS, and PRECAUTIONS).
Dosage Adjustment for Patients with Impaired Renal Function: Bupropion hydrochloride extended-release tablets (SR) should be used with caution in patients with renal impairment and a reduced frequency and/or dose should be considered (see CLINICAL PHARMACOLOGY and PRECAUTIONS).
Switching a Patient To or From a Monoamine Oxidase Inhibitor (MAOI) Antidepressant: At least 14 days should elapse between discontinuation of an MAOI intended to treat depression and initiation of therapy with bupropion hydrochloride extended-release tablets (SR). Conversely, at least 14 days should be allowed after stopping bupropion hydrochloride extended-release tablets (SR) before starting an MAOI antidepressant (seeCONTRAINDICATIONS and DRUG INTERACTIONS).
Use of Bupropion Hydrochloride Extended-Release Tablets (SR) With Reversible MAOIs Such as Linezolid or Methylene Blue: Do not start bupropion hydrochloride extended-release tablets (SR) in a patient who is being treated with a reversible MAOI such as linezolid or intravenous methylene blue. Drug interactions can increase the risk of hypertensive reactions. In a patient who requires more urgent treatment of a psychiatric condition, non-pharmacological interventions, including hospitalization, should be considered (see CONTRAINDICATIONS and DRUG INTERACTIONS).
In some cases, a patient already receiving therapy with bupropion hydrochloride extended-release tablets (SR) may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of hypertensive reactions in a particular patient, bupropion hydrochloride extended-release tablets (SR) should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for 2 weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with bupropion hydrochloride extended-release tablets (SR) may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue.
The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with bupropion hydrochloride extended-release tablets (SR) is unclear. The clinician should, nevertheless, be aware of the possibility of a drug interaction with such use (see CONTRAINDICATIONS and DRUG INTERACTIONS).
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![Estradiol Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=7bc58020-727f-483e-95de-15cbe327c673&name=estradiol-tablets-usp-3.jpg)
Estradiol
When estrogen is prescribed for a postmenopausal woman with a uterus, a progestin should also be initiated to reduce the risk of endometrial cancer. A woman without a uterus does not need progestin. Use of estrogen, alone or in combination with a progestin, should be with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Patients should be reevaluated periodically as clinically appropriate (e.g., 3-month to 6-month intervals) to determine if treatment is still necessary (see BOXED WARNINGS and WARNINGS). For women who have a uterus, adequate diagnostic measures, such as endometrial sampling, when indicated, should be undertaken to rule out malignancy in cases of undiagnosed persistent or recurring abnormal vaginal bleeding.
Patients should be started at the lowest dose for the indication.
1. For treatment of moderate to severe vasomotor symptoms, vulval and vaginal atrophy associated with the menopause, the lowest dose and regimen that will control symptoms should be chosen and medication should be discontinued as promptly as possible.
Attempts to discontinue or taper medication should be made at 3-month to 6-month intervals. The usual initial dosage range is 1 to 2 mg daily of estradiol adjusted as necessary to control presenting symptoms. The minimal effective dose for maintenance therapy should be determined by titration. Administration should be cyclic (e.g., 3 weeks on and 1 week off).
2. For treatment of female hypoestrogenism due to hypogonadism, castration or primary ovarian failure.
Treatment is usually initiated with a dose of 1 to 2 mg daily of estradiol, adjusted as necessary to control presenting symptoms; the minimal effective dose for maintenance therapy should be determined by titration.
3. For treatment of breast cancer, for palliation only, in appropriately selected women and men with metastatic disease.
Suggested dosage is 10 mg three times daily for a period of at least three months.
4. For treatment of advanced androgen-dependent carcinoma of the prostate, for palliation only.
Suggested dosage is 1 to 2 mg three times daily. The effectiveness of therapy can be judged by phosphatase determinations as well as by symptomatic improvement of the patient.
5. For prevention of osteoporosis.
When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should be considered only for women at significant risk of osteoporosis and for whom non-estrogen medications are not considered to be appropriate.
The lowest effective dose of estradiol tablets has not been determined.
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![Finasteride Tablet, Film Coated [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=142b1561-4310-494e-8a82-662c12de2cd1&name=finasteride-30tab.jpg)
Finasteride
Finasteride tablets may be administered with or without meals.
The recommended dose of finasteride tablets is one tablet (1 mg) taken once daily.
In general, daily use for three months or more is necessary before benefit is observed. Continued use is recommended to sustain benefit, which should be re-evaluated periodically. Withdrawal of treatment leads to reversal of effect within 12 months.
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![Tramadol Hydrochloride And Acetaminophen Tablet, Film Coated [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=27a9570c-78cd-45f1-87b5-83eea59d5099&name=UltracetSun.jpg)
Tramadol Hydrochloride And Acetaminophen
For the short-term (five days or less) management of acute pain, the recommended dose of tramadol hydrochloride and acetaminophen is 2 tablets every 4 to 6 hours as needed for pain relief, up to a maximum of 8 tablets per day.
Individualization of Dose
In patients with creatinine clearances of less than 30 mL/min, it is recommended that the dosing interval of tramadol hydrochloride and acetaminophen tablets be increased not to exceed 2 tablets every 12 hours. Dose selection for an elderly patient should be cautious, in view of the potential for greater sensitivity to adverse events.
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![Duloxetine (Duloxetine Hydrochloride) Capsule, Delayed Release [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=076af3a1-bbf6-407c-90c2-51a61eace283&name=duloxetine-fig8.jpg)
Duloxetine
Duloxetine delayed-release capsules should be swallowed whole and should not be chewed or crushed, nor should the capsule be opened and its contents sprinkled on food or mixed with liquids. All of these might affect the enteric coating. Duloxetine delayed-release capsules can be given without regard to meals.
2.1 Initial Treatment
Major Depressive Disorder — Duloxetine delayed-release capsules should be administered at a total dose of 40 mg/day (given as 20 mg twice daily) to 60 mg/day (given either once daily or as 30 mg twice daily). For some patients, it may be desirable to start at 30 mg once daily for 1 week, to allow patients to adjust to the medication before increasing to 60 mg once daily. While a 120 mg/day dose was shown to be effective, there is no evidence that doses greater than 60 mg/day confer any additional benefits. The safety of doses above 120 mg/day has not been adequately evaluated [see Clinical Studies (14.1)].Generalized Anxiety Disorder — For most patients, the recommended starting dose for duloxetine delayed-release capsules is 60 mg administered once daily. For some patients, it may be desirable to start at 30 mg once daily for 1 week, to allow patients to adjust to the medication before increasing to 60 mg once daily. While a 120 mg once daily dose was shown to be effective, there is no evidence that doses greater than 60 mg/day confer additional benefit. Nevertheless, if a decision is made to increase the dose beyond 60 mg once daily, dose increases should be in increments of 30 mg once daily. The safety of doses above 120 mg once daily has not been adequately evaluated [see Clinical Studies (14.2)].Diabetic Peripheral Neuropathic Pain — The recommended dose for duloxetine delayed-release capsules is 60 mg administered once daily. There is no evidence that doses higher than 60 mg confer additional significant benefit and the higher dose is clearly less well tolerated [see Clinical Studies (14.3)]. For patients for whom tolerability is a concern, a lower starting dose may be considered. Since diabetes is frequently complicated by renal disease, a lower starting dose and gradual increase in dose should be considered for patients with renal impairment [see Dosage and Administration (2.3), Use in Specific Populations (8.10), and Clinical Pharmacology (12.3)]. Chronic Musculoskeletal Pain — The recommended dose for duloxetine delayed-release capsules is 60 mg once daily. Dosing may be started at 30 mg for one week, to allow patients to adjust to the medication before increasing to 60 mg once daily. There is no evidence that higher doses confer additional benefit, even in patients who do not respond to a 60 mg dose, and higher doses are associated with a higher rate of adverse reactions [see Clinical Studies (14.5)].
2.2 Maintenance/Continuation/Extended Treatment
Major Depressive Disorder — It is generally agreed that acute episodes of major depression require several months or longer of sustained pharmacologic therapy. Maintenance of efficacy in MDD was demonstrated with duloxetine delayed-release capsules as monotherapy. Duloxetine delayed-release capsules should be administered at a total dose of 60 mg once daily. Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment [see Clinical Studies (14.1)].Generalized Anxiety Disorder — It is generally agreed that episodes of generalized anxiety disorder require several months or longer of sustained pharmacological therapy. Maintenance of efficacy in GAD was demonstrated with duloxetine delayed-release capsules as monotherapy. Duloxetine delayed-release capsules should be administered in a dose range of 60 to 120 mg once daily. Patients should be periodically reassessed to determine the continued need for maintenance treatment and the appropriate dose for such treatment [see Clinical Studies (14.2)]. Diabetic Peripheral Neuropathic Pain — As the progression of diabetic peripheral neuropathy is highly variable and management of pain is empirical, the effectiveness of duloxetine delayed-release capsules must be assessed individually. Efficacy beyond 12 weeks has not been systematically studied in placebo-controlled trials.Chronic Musculoskeletal Pain — The efficacy of duloxetine delayed-release capsules has not been established in placebo-controlled studies beyond 13 weeks.
2.3 Dosing in Special Populations
Hepatic Insufficiency — It is recommended that duloxetine delayed-release capsules should ordinarily not be administered to patients with any hepatic insufficiency [see Warnings and Precautions (5.14) and Use in Specific Populations (8.9)].Severe Renal Impairment — Duloxetine delayed-release capsules are not recommended for patients with end-stage renal disease or severe renal impairment (estimated creatinine clearance <30 mL/min) [see Warnings and Precautions (5.14) and Use in Specific Populations (8.10)].Elderly Patients — No dose adjustment is recommended for elderly patients on the basis of age. As with any drug, caution should be exercised in treating the elderly. When individualizing the dosage in elderly patients, extra care should be taken when increasing the dose [see Use in Specific Populations (8.5)].Pregnant Women — There are no adequate and well-controlled studies in pregnant women; therefore, duloxetine delayed-release capsules should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus [see Use in Specific Populations (8.1)].Nursing Mothers — Because the safety of duloxetine in infants is not known, nursing while on duloxetine delayed-release capsules is not recommended [see Use in Specific Populations (8.3)].
2.4 Discontinuing Duloxetine Delayed-Release Capsules
Symptoms associated with discontinuation of duloxetine delayed-release capsules and other SSRIs and SNRIs have been reported. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible [see Warnings and Precautions (5.7)].
2.5 Switching a Patient To or From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders
At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with duloxetine delayed-release capsules. Conversely, at least 5 days should be allowed after stopping duloxetine delayed-release capsules before starting an MAOI intended to treat psychiatric disorders [see Contraindications (4.1)].
2.6 Use of Duloxetine Delayed-Release Capsules with Other MAOIs such as Linezolid or Methylene Blue
Do not start duloxetine delayed-release capsules in a patient who is being treated with linezolid or intravenous methylene blue because there is an increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered [see Contraindications (4.1)]. In some cases, a patient already receiving duloxetine delayed-release capsules therapy may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, duloxetine delayed-release capsules should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for 5 days or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with duloxetine delayed-release capsules may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue [see Warnings and Precautions (5.4)].
The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with duloxetine delayed-release capsules is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use [see Warnings and Precautions (5.4)].
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![Duloxetine Capsule, Delayed Release Pellets [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=e89e6f78-1769-42de-828b-376893a40710&name=container2.jpg)
Duloxetine
Duloxetine delayed-release capsules should be swallowed whole and should not be chewed or crushed, nor should the capsule be opened and its contents sprinkled on food or mixed with liquids. All of these might affect the enteric coating. Duloxetine delayed-release capsules should be given without regard to meals.
2.1 Initial Treatment
Major Depressive Disorder - Duloxetine delayed-release capsules should be administered at a total dose of 40 mg/day (given as 20 mg twice daily) to 60 mg/day (given either once daily or as 30 mg twice daily). For some patients, it may be desirable to start at 30 mg once daily for 1 week, to allow patients to adjust to the medication before increasing to 60 mg once daily. While a 120 mg/day dose was shown to be effective, there is no evidence that doses greater than 60 mg/day confer any additional benefits. The safety of doses above 120 mg/day has not been adequately evaluated [see Clinical Studies (14.1)].
Generalized Anxiety Disorder - For most patients, the recommended starting dose for duloxetine delayed-release capsules are 60 mg administered once daily. For some patients, it may be desirable to start at 30 mg once daily for 1 week, to allow patients to adjust to the medication before increasing to 60 mg once daily. While a 120 mg once daily dose was shown to be effective, there is no evidence that doses greater than 60 mg/day confer additional benefit. Nevertheless, if a decision is made to increase the dose beyond 60 mg once daily, dose increases should be in increments of 30 mg once daily. The safety of doses above 120 mg once daily has not been adequately evaluated [see Clinical Studies (14.2)]
Diabetic Peripheral Neuropathic Pain - The recommended dose for duloxetine delayed-release capsules is 60 mg administered once daily. There is no evidence that doses higher than 60 mg confer additional significant benefit and the higher dose is clearly less well tolerated [see Clinical Studies (14.3)]. For patients for whom tolerability is a concern, a lower starting dose may be considered.
Since diabetes is frequently complicated by renal disease, a lower starting dose and gradual increase in dose should be considered for patients with renal impairment [seeDosage and Administration (2.3), Use In Specific Population (8.10), and Clinical Pharmacology (12.3)].
Chronic Musculoskeletal Pain — The recommended dose for duloxetine delayed-release capsules is 60 mg once daily. Dosing may be started at 30 mg for one week, to allow patients to adjust to the medication before increasing to 60 mg once daily. There is no evidence that higher doses confer additional benefit, even in patients who do not respond to a 60 mg dose, and higher doses are associated with a higher rate of adverse reactions [see Clinical Studies (14.5)].
2.2 Maintenance/Continuation/Extended Treatment
Major Depressive Disorder — It is generally agreed that acute episodes of major depression require several months or longer of sustained pharmacologic therapy. Maintenance of efficacy in MDD was demonstrated with duloxetine delayed-release capsules as monotherapy. Duloxetine delayed-release capsules should be administered at a total dose of 60 mg once daily. Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment [see Clinical Studies (14.1)].
Generalized Anxiety Disorder — It is generally agreed that episodes of generalized anxiety disorder require several months or longer of sustained pharmacological therapy. Maintenance of efficacy in GAD was demonstrated with duloxetine as monotherapy. Duloxetine delayed-release capsules should be administered in a dose range of 60 to 120 mg once daily. Patients should be periodically reassessed to determine the continued need for maintenance treatment and the appropriate dose for such treatment [see Clinical Studies (14.2)].
Diabetic Peripheral Neuropathic Pain — As the progression of diabetic peripheral neuropathy is highly variable and management of pain is empirical, the effectiveness of duloxetine delayed-release capsules must be assessed individually. Efficacy beyond 12 weeks has not been systematically studied in placebo-controlled trials.
Chronic Musculoskeletal Pain — The efficacy of duloxetine delayed-release capsules has not been established in placebo-controlled studies beyond 13 weeks.
2.3 Dosing in Special Populations
Hepatic Insufficiency —It is recommended that duloxetine delayed-release capsules should ordinarily not be administered to patients with any hepatic insufficiency [see Warnings and Precautions (5.14) and Use In Specific Populations (8.9)].
Severe Renal Impairment — Duloxetine delayed-release capsules are not recommended for patients with end-stage renal disease or severe renal impairment (estimated creatinine clearance <30 mL/min) [see Warnings and Precautions (5.14) and Use In Specific Populations (8.10)].
Elderly Patients — No dose adjustment is recommended for elderly patients on the basis of age. As with any drug, caution should be exercised in treating the elderly. When individualizing the dosage in elderly patients, extra care should be taken when increasing the dose [see Use In Specific Populations (8.5)].
Pregnant Women — There are no adequate and well-controlled studies in pregnant women; therefore, duloxetine delayed-release capsules should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus [see Use In Specific Populations (8.1)].
Nursing Mothers — Because the safety of duloxetine in infants is not known, nursing while on duloxetine delayed-release capsules are not recommended [see Use In Specific Populations (8.3)].
2.4 Discontinuing Duloxetine
Symptoms associated with discontinuation of duloxetine delayed-release capsules and other SSRIs and SNRIs have been reported. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible [see WARNINGS AND PRECAUTIONS (5.7)].
2.5 Switching a Patient To or From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders
At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with duloxetine delayed-release capsules. Conversely, at least 5 days should be allowed after stopping duloxetine delayed-release capsules before starting an MAOI intended to treat psychiatric disorders [see CONTRAINDICATIONS (4.1)].
2.6 Use of Duloxetine with Other MAOIs such as Linezolid or Methylene Blue
Do not start duloxetine in a patient who is being treated with linezolid or intravenous methylene blue because there is an increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered [see CONTRAINDICATIONS (4.1)].
In some cases, a patient already receiving duloxetine therapy may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, duloxetine should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for 5 days or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with duloxetine may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue [see WARNINGS AND PRECAUSTIONS (5.4)].
The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with duloxetine is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use [see WARNINGS AND PRECAUSTIONS (5.4)].
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![Betamethasone Valerate Cream [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=7ca0e960-8ec1-4715-b961-7d7e5d0bd9fa&name=cde26ab8-figure-02.jpg)
Betamethasone Valerate
Betamethasone Valerate Cream 0.1% and Betamethasone Valerate Ointment 0.1% are generally applied to the affected area as a thin film one to three times daily depending on the severity of the condition. Dosage once or twice a day is often effective. Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.
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![Buspirone Hcl (Buspirone Hydrochloride) Tablet [Cardinal Health]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=c6a3322d-943c-4f7a-9975-94d3fa38b12c&name=image-02.jpg)
Buspirone Hcl
(1 capsule = 2 mg)
Patients should receive appropriate fluid and electrolyte replacement as needed.
Acute Diarrhea
Adults
The recommended initial dose is 4 mg (two capsules) followed by 2 mg (one capsule) after each unformed stool. Daily dosage should not exceed 16 mg (eight capsules). Clinical improvement is usually observed within 48 hours.
Children
In children 2 to 5 years of age (20 kg or less), the non-prescription liquid formulation (loperamide hydrochloride for oral solution, 1 mg/5 mL) should be used; for ages 6 to 12, either loperamide hydrochloride capsules or loperamide hydrochloride for oral solution may be used. For children 2 to 12 years of age, the following schedule for capsules or liquid will usually fulfill initial dosage requirements:
Recommended First Day Dosage Schedule
Two to five years: 1 mg t.i.d. (3 mg daily dose) (13 to 20 kg)
Six to eight years: 2 mg b.i.d. (4 mg daily dose) (20 to 30 kg)
Eight to twelve years: 2 mg t.i.d. (6 mg daily dose) (greater than 30 kg)
Recommended Subsequent Daily Dosage
Following the first treatment day, it is recommended that subsequent loperamide hydrochloride doses (1 mg/10 kg body weight) be administered only after a loose stool. Total daily dosage should not exceed recommended dosages for the first day.
Chronic Diarrhea
Children
Although loperamide hydrochloride has been studied in a limited number of children with chronic diarrhea; the therapeutic dose for the treatment of chronic diarrhea in a pediatric population has not been established.
Adults
The recommended initial dose is 4 mg (two capsules) followed by 2 mg (one capsule) after each unformed stool until diarrhea is controlled, after which the dosage of loperamide hydrochloride capsules should be reduced to meet individual requirements. When the optimal daily dosage has been established, this amount may then be administered as a single dose or in divided doses.
The average daily maintenance dosage in clinical trials was 4 to 8 mg (two to four capsules). A dosage of 16 mg (eight capsules) was rarely exceeded. If clinical improvement is not observed after treatment with 16 mg per day for at least 10 days, symptoms are unlikely to be controlled by further administration. Loperamide hydrochloride capsules administration may be continued if diarrhea cannot be adequately controlled with diet or specific treatment.
Children Under 2 Years
The use of loperamide hydrochloride in children under 2 years is not recommended. There have been rare reports of paralytic ileus associated with abdominal distention. Most of these reports occurred in the setting of acute dysentery, overdose, and with very young children less than two years of age.
Elderly
No formal pharmacokinetic studies were conducted in elderly subjects. However, there were no major differences reported in the drug disposition in elderly patients with diarrhea relative to young patients. No dosage adjustment is required for the elderly.
Renal Impairment
No pharmacokinetic data are available in patients with renal impairment. Since the metabolites and the unchanged drug are mainly excreted in the feces, no dosage adjustment is required for patients with renal impairment (see PRECAUTIONS).
Hepatic Impairment
Although no pharmacokinetic data are available in patients with hepatic impairment, loperamide hydrochloride should be used with caution in such patients because of reduced first pass metabolism (see PRECAUTIONS).
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![Methocarbamol Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=89719699-695b-4592-bfef-0cdc300d9e3b&name=8abf52d1-f208-4ba0-821c-8417308a985a-02.jpg)
Methocarbamol
Methocarbamol tablets, USP, 500 mg – Adults:
Initial dosage: 3 tablets q.i.d.
Maintenance dosage: 2 tablets q.i.d.
Methocarbamol tablets, USP: 750 mg – Adults:
Initial dosage: 2 tablets q.i.d.
Maintenance dosage: 1 tablet q.4h. or 2 tablets t.i.d.
Six grams a day are recommended for the first 48 to 72 hours of treatment. (For severe conditions 8 grams a day may be administered). Thereafter, the dosage can usually be reduced to approximately 4 grams a day.
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![Methocarbamol Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=6424580d-31af-4ba6-9755-283de288b63d&name=750mg30s.jpg)
Methocarbamol
Methocarbamol Tablets USP 500 mg – Adults:Initial dosage: 3 tablets q.i.d.Maintenance dosage: 2 tablets q.i.d.Methocarbamol Tablets USP 750 mg – Adults:Initial dosage: 2 tablets q.i.d.Maintenance dosage: 1 tablet q.4h. or 2 tablets t.i.d.Six grams a day are recommended for the first 48 to 72 hours of treatment. (For severe conditions 8 grams a day may be administered). Thereafter, the dosage can usually be reduced to approximately 4 grams a day.
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![Isoniazid Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=e199dbfa-6d79-4c20-9984-9cd0c1907510&name=e52d3ab7-6583-4026-b79e-7cf9c50617cb-03.jpg)
Isoniazid
-
NOTE -- For preventive therapy of tuberculous infection and treatment of tuberculosis, it is recommended that physicians be familiar with the following publications: (1) the recommen- dations of the Advisory Council for the Elimination of Tuberculosis, published in the MMWR: vol 42; RR-4, 1993 and (2) Treatment of Tuberculosis and Tuberculosis Infection in Adults and Children, American Journal of Respiratory and Critical Care Medicine: vol 149; 1359-1374, 1994.
For Treatment of Tuberculosis
Isoniazid is used in conjunction with other effective anti-tuberculosis agents. Drug susceptibility testing should be performed on the organisms initially isolated from all patients with newly diagnosed tuberculosis. If the bacilli becomes resistant, therapy must be changed to agents to which the bacilli are susceptible.
Usual Oral Dosage (depending on the regimen used):
Adults: 5 mg/kg up to 300 mg daily in a single dose; or 15 mg/kg up to 900 mg/day, two or
three times/week
Children: 10 - 15 mg/kg up to 300 mg daily in a single dose; or 20-40 mg/kg up to 900
mg/day, two or three times/week
Patients with Pulmonary Tuberculosis Without HIV Infection
There are 3 regimen options for the initial treatment of tuberculosis in children and adults:
Option 1: Daily isoniazid, rifampin, and pyrazinamide for 8 weeks followed by 16 weeks of
isoniazid and rifampin daily or 2 to 3 times weekly. Ethambutol or streptomycin
should be added to the initial regimen until sensitivity to isoniazid and rifampin is
demonstrated. The addition of a fourth drug is optional if the relative prevalence of
isoniazid-resistant Mycobacteriumtuberculosis isolates in the community is less
than or equal to four percent.
Option 2: Daily isoniazid, rifampin, pyrazinamide, and streptomycin or ethambutol for 2
weeks followed by twice weekly administration of the same drugs for 6 weeks,
subsequently twice weekly isoniazid and rifampin for 16 weeks.
Option 3: Three times weekly with isoniazid, rifampin, pyrazinamide, and ethambutol or
streptomycin for 6 months.
* All regimen given twice weekly or 3 times weekly should be administered by directly observed therapy (see also Directly Observed Therapy).
The above treatment guidelines apply only when the disease is caused by organisms that are sus- ceptible to the standard antituberculous agents. Because of the impact of resistance to isoniazid and rifampin on the response to therapy, it is essential that physicians initiating therapy for tu- berculosis be familiar with the prevalence of drug resistance in their communities. It is suggested that ethambutol not be used in children whose visual acuity cannot be monitored.
Patients with Pulmonary Tuberculosis and HIV Infection
The response of the immunologically impaired host to treatment may not be as satisfactory as that of a person with normal host responsiveness. For this reason, therapeutic decisions for the impaired host must be individualized. Since patients co-infected with HIV may have problems with malabsorption, screening of antimycobacterial drug levels, especially in patients with ad- vanced HIV disease, may be necessary to prevent the emergence of MDRTB.
Patients with Extra Pulmonary Tuberculosis
The basic principles that underlie the treatment of pulmonary tuberculosis also apply to Extra pulmonary forms of the disease. Although there have not been the same kinds of carefully conducted controlled trials of treatment of Extra pulmonary tuberculosis as for pulmonary disease, increasing clinical experience indicates that a 6 to 9 month short-course regimen is effective. Because of the insufficient data, military tuberculosis, bone/joint tuberculosis, and tuberculous meningitis in infants and children should receive 12 month therapy.
Bacteriologic evaluation of Extra pulmonary tuberculosis may be limited by the relative in accessibility of the sites of disease. Thus, response to treatment often must be judged on the basis of clinical and radiographic findings.
The use of adjunctive therapies such as surgery and corticosteroids is more commonly required in Extra pulmonary tuberculosis than in pulmonary disease. Surgery may be necessary to obtain specimens for diagnosis and to treat such processes as constrictive pericarditis and spinal cord compression from Pott’s Disease. Corticosteroids have been shown to be of benefit in preventing cardiac constriction from tuberculous pericarditis and in decreasing the neurologic sequelae of all stages of tuberculosis meningitis, especially when administered early in the course of the disease.
Pregnant Women with Tuberculosis
The options listed above must be adjusted for the pregnant patient. Streptomycin interferes with in utero development of the ear and may cause congenital deafness. Routine use of pyrazinamide is also not recommended in pregnancy because of inadequate teratogenicity data. The initial treatment regimen should consist of isoniazid and rifampin. Ethambutol should be included unless primary isoniazid resistance is unlikely (isoniazid resistance rate documented to be less than 4%).
Treatment of Patients with Multi-Drug Resistant Tuberculosis (MDRTB)
Multiple-drug resistant tuberculosis (i.e., resistance to at least isoniazid and rifampin) presents difficult treatment problems. Treatment must be individualized and based on susceptibility studies. In such cases, consultation with an expert in tuberculosis is recommended.
Directly Observed Therapy (DOT)
A major cause of drug-resistant tuberculosis is patient noncompliance with treatment. The use of DOT can help assure patient compliance with drug therapy. DOT is the observation of the pa- tient by a health care provider or other responsible person as the patient ingests anti-tuberculosis medications. DOT can be achieved with daily, twice weekly or thrice weekly regimens, and is recommended for all patients.
For Preventative Therapy of Tuberculosis
Before isoniazid preventive therapy is initiated, bacteriologically positive or radiographically progressive tuberculosis must be excluded. Appropriate evaluations should be performed if Extra pulmonary tuberculosis is suspected.
Adults over 30 Kg: 300 mg per day in a single dose.
Infants and Children: 10 mg/kg (up to 300 mg daily) in a single dose. In situations where adherence with daily preventative therapy cannot be assured, 20-30 mg/kg (not to exceed 900 mg) twice weekly under the direct observation of a health care worker at the time of admin- istration8.
Continuous administration of isoniazid for a sufficient period is an essential part of the regimen because relapse rates are higher if chemotherapy is stopped prematurely. In the treatment of tu- berculosis, resistant organisms may multiply and the emergence of resistant organisms during the treatment may necessitate a change in the regimen.
For following patient compliance: the Potts-Cozart test9, a simple colorimetric6 method of checking for isoniazid in the urine, is a useful tool for assuring patient compliance, which is essential for effective tuberculosis control. Additionally, isoniazid test strips are also available
to check patient compliance.
Concomitant administration of pyridoxine (B6) is recommended in malnourished and in those predisposed to neuropathy (e.g., alcoholics and diabetics).
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![Bupropion Tablet, Extended Release [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=f9378e0d-f502-4f8c-b953-713e4b36cf02&name=bupropionxltablets-figure-02.jpg)
Bupropion
General Dosing Considerations
It is particularly important to administer bupropion hydrochloride extended-release tablets (XL) in a manner most likely to minimize the risk of seizure (see WARNINGS). Gradual escalation in dosage is also important if agitation, motor restlessness, and insomnia, often seen during the initial days of treatment, are to be minimized. If necessary, these effects may be managed by temporary reduction of dose or the short-term administration of an intermediate to long-acting sedative hypnotic. A sedative hypnotic usually is not required beyond the first week of treatment. Insomnia may also be minimized by avoiding bedtime doses. If distressing, untoward effects supervene, dose escalation should be stopped. bupropion hydrochloride extended-release tablets (XL) should be swallowed whole and not crushed, divided, or chewed, as this may lead to an increased risk of adverse effects including seizures. Bupropion hydrochloride extended-release tablets (XL) may be taken without regard to meals.
Major Depressive Disorder
Initial Treatment
The usual adult target dose for bupropion hydrochloride extended-release tablets (XL) is 300 mg/day, given once daily in the morning. Dosing with bupropion hydrochloride extended-release tablets (XL) should begin at 150 mg/day given as a single daily dose in the morning. If the 150-mg initial dose is adequately tolerated, an increase to the 300-mg/day target dose, given as once daily, may be made as early as day 4 of dosing. There should be an interval of at least 24 hours between successive doses.
Increasing the Dosage Above 300 mg/day
As with other antidepressants, the full antidepressant effect of bupropion hydrochloride extended-release tablets (XL) may not be evident until 4 weeks of treatment or longer. An increase in dosage to the maximum of 450 mg/day, given as a single dose, may be considered for patients in whom no clinical improvement is noted after several weeks of treatment at 300 mg/day.
Maintenance Treatment
It is generally agreed that acute episodes of depression require several months or longer of sustained pharmacological therapy beyond response to the acute episode. It is unknown whether or not the dose of bupropion hydrochloride extended-release tablets (XL) needed for maintenance treatment is identical to the dose needed to achieve an initial response. Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment.
Seasonal Affective Disorder
For the prevention of seasonal major depressive episodes associated with seasonal affective disorder, bupropion hydrochloride extended-release tablets (XL) should generally be initiated in the autumn prior to the onset of depressive symptoms. Treatment should continue through the winter season and should be tapered and discontinued in early spring. The timing of initiation and duration of treatment should be individualized based on the patient's historical pattern of seasonal major depressive episodes. Patients whose seasonal depressive episodes are infrequent or not associated with significant impairment should not generally be treated prophylactically.
Dosing with bupropion hydrochloride extended-release tablets (XL) should begin at 150 mg/day given as a single daily dose in the morning. If the 150-mg initial dose is adequately tolerated, the dose of bupropion hydrochloride extended-release tablets (XL) should be increased to the 300-mg/day dose after 1 week. If the 300-mg dose is not adequately tolerated, the dose can be reduced to 150 mg/day. The usual adult target dose for bupropion hydrochloride extended-release tablets (XL) is 300 mg/day, given once daily in the morning.
For patients taking 300 mg/day during the autumn-winter season, the dose should be tapered to 150 mg/day for 2 weeks prior to discontinuation.
Doses of bupropion hydrochloride extended-release tablets (XL) above 300 mg/day have not been studied for the prevention of seasonal major depressive episodes.
Switching Patients from bupropion hydrochloride tablets or from bupropion hydrochloride sustained-release tablets:
When switching patients from bupropion hydrochloride tablets to bupropion hydrochloride extended-release tablets (XL) or from bupropion hydrochloride sustained-Release Tablets to bupropion hydrochloride extended-release tablets (XL), give the same total daily dose when possible. Patients who are currently being treated with bupropion hydrochloride tablets at 300 mg/day (for example, 100 mg 3 times a day) may be switched to bupropion hydrochloride extended-release tablets (XL) 300 mg once daily. Patients who are currently being treated with bupropion hydrochloride sustained-ralease Tablets at 300 mg/day (for example, 150 mg twice daily) may be switched to bupropion hydrochloride extended-release tablets (XL) 300 mg once daily.
Dosage Adjustment for Patients With Impaired Hepatic Function
Bupropion hydrochloride extended-release tablets (XL) should be used with extreme caution in patients with severe hepatic cirrhosis. The dose should not exceed 150 mg every other day in these patients. Bupropion hydrochloride extended-release tablets (XL) should be used with caution in patients with hepatic impairment (including mild to moderate hepatic cirrhosis) and a reduced frequency and/or dose should be considered in patients with mild to moderate hepatic cirrhosis (see CLINICAL PHARMACOLOGY, WARNINGS, and PRECAUTIONS).
Dosage Adjustment for Patients With Impaired Renal Function
Bupropion hydrochloride extended-release tablets (XL) should be used with caution in patients with renal impairment and a reduced frequency and/or dose should be considered (see CLINICAL PHARMACOLOGY and PRECAUTIONS).
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![Nystatin Cream [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=28051258-478b-4c8e-ab48-3c3f40de2321&name=NystatinCreamUSP100,000unitspergram.jpg)
Nystatin
Adults and Pediatric Patients (Neonates and Older): Apply liberally to affected area twice daily or as indicated until healing is complete.
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![Docqlace (Docusate Sodium) Capsule [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=55038df8-077c-416c-ba5e-aa7fad9f390b&name=image-01.jpg)
Docqlace
doses may be taken as a single daily dose or in divided doses
adults and children 12 years and over
take 1-3 softgels daily
children 2 to under 12 years of age
take 1 softgel daily
children under 2 years
ask a doctor
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![Aurophen Childrens Pain And Fever (Acetaminophen) Suspension [Aurohealth Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=4b6ef4cb-4993-494a-bf52-901e545d1a81&name=ondansetronod-fig1.jpg)
Aurophen Childrens Pain And Fever
Instructions for Use/Handling Ondansetron Orally Disintegrating Tablets Do not attempt to push ondansetron orally disintegrating tablets through the foil backing. With dry hands, remove the tablet from the bottle or PEEL BACK the foil backing of 1 blister and GENTLY remove the tablet. IMMEDIATELY place the ondansetron orally disintegrating tablet on top of the tongue where it will dissolve in seconds, then swallow with saliva. Administration with liquid is not necessary.Prevention of Nausea and Vomiting Associated With Highly Emetogenic Cancer Chemotherapy The recommended adult oral dosage of ondansetron orally disintegrating tablets is 24 mg given as three 8 mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥50 mg/m2. Multiday, single-dose administration of a 24 mg dosage has not been studied.Pediatric Use There is no experience with the use of a 24 mg dosage in pediatric patients.Geriatric Use The dosage recommendation is the same as for the general population.Prevention of Nausea and Vomiting Associated With Moderately Emetogenic Cancer Chemotherapy The recommended adult oral dosage is one 8 mg ondansetron orally disintegrating tablet given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8 mg ondansetron orally disintegrating tablet should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.Pediatric UseFor pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4 mg ondansetron orally disintegrating tablet given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4 mg ondansetron orally disintegrating tablet should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.Geriatric Use The dosage is the same as for the general population. Prevention of Nausea and Vomiting Associated With Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions to the Abdomen The recommended oral dosage is one 8 mg ondansetron orally disintegrating tablet given 3 times a day.For total body irradiation, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.For single high-dose fraction radiotherapy to the abdomen, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.For daily fractionated radiotherapy to the abdomen, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.Pediatric UseThere is no experience with the use of ondansetron orally disintegrating tablets in the prevention of radiation-induced nausea and vomiting in pediatric patients.Geriatric UseThe dosage recommendation is the same as for the general population.Postoperative Nausea and Vomiting The recommended dosage is 16 mg given as two 8 mg ondansetron orally disintegrating tablets 1 hour before induction of anesthesia.Pediatric UseThere is no experience with the use of ondansetron orally disintegrating tablets in the prevention of postoperative nausea and vomiting in pediatric patients.Geriatric UseThe dosage is the same as for the general population.Dosage Adjustment for Patients With Impaired Renal Function The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron.Dosage Adjustment for Patients With Impaired Hepatic Function In patients with severe hepatic impairment (Child-Pugh2 score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.
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![Ciprofloxacin Tablet, Film Coated [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=7feaf530-8124-4171-a5d8-18f1f7dcf30d&name=ciprofloxacin-tablets-usp-5.jpg)
Ciprofloxacin
Adults
Ciprofloxacin tablets should be administered orally to adults as described in the Dosage Guidelines table.
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient’s host-defense mechanisms, and the status of renal function and hepatic function.
The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, polymeric phosphate binders (for example, sevelamer, lanthanum carbonate) or sucralfate, Videx® (didanosine) chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.
ADULT DOSAGE GUIDELINES
Infection
Severity
Dose
Frequency
Usual Durations†
Urinary Tract
Acute Uncomplicated
250 mg
q 12 h
3 days
Mild/Moderate
250 mg
q 12 h
7 to 14 days
Severe/Complicated
500 mg
q 12 h
7 to 14 days
Chronic Bacterial Prostatitis
Mild/Moderate
500 mg
q 12 h
28 days
Lower Respiratory Tract
Mild/Moderate
500 mg
q 12 h
7 to 14 days
Severe/Complicated
750 mg
q 12 h
7 to 14 days
Acute Sinusitis
Mild/Moderate
500 mg
q 12 h
10 days
Skin andSkin Structure
Mild/Moderate
500 mg
q 12 h
7 to 14 days
Severe/Complicated
750 mg
q 12 h
7 to 14 days
Bone and Joint
Mild/Moderate
500 mg
q 12 h
≥ 4 to 6 weeks
Severe/Complicated
750 mg
q 12 h
≥ 4 to 6 weeks
Intra-Abdominal*
Complicated
500 mg
q 12 h
7 to 14 days
Infectious Diarrhea
Mild/Moderate/Severe
500 mg
q 12 h
5 to 7 days
Typhoid Fever
Mild/Moderate
500 mg
q 12 h
10 days
Urethral and Cervical Gonococcal Infections
Uncomplicated
250 mg
single dose
single dose
Inhalational anthrax (post-exposure)**
500 mg
q h 12
60 days
* Used in conjunction with metronidazole
† Generally ciprofloxacin tablets should be continued for at least 2 days after the signs and symptoms of infection have disappeared, except for inhalational anthrax (post-exposure).
** Drug administration should begin as soon as possible after suspected or confirmed exposure.
This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.6 For a discussion of ciprofloxacin serum concentrations in various human populations, see Inhalational Anthrax, Additional Information.
Conversion of IV to Oral Dosing in Adults: Patients whose therapy is started with ciprofloxacin hydrochloride I.V. may be switched to ciprofloxacin tablets when clinically indicated at the discretion of the physician (See CLINICAL PHARMACOLOGY and table below for the equivalent dosing regimens).
Equivalent AUC Dosing Regimens
Ciprofloxacin Oral Dosage
Equivalent Ciprofloxacin IV Dosage
250 mg Tablet q 12 h
200 mg IV q 12 h
500 mg Tablet q 12 h
400 mg IV q 12 h
750 mg Tablet q 12 h
400 mg IV q 8 h
Adults with Impaired Renal Function: Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:
RECOMMENDED STARTING AND MAINTENANCE DOSES
FOR PATIENTS WITH IMPAIRED RENAL FUNCTION
Creatinine Clearance (mL/min)
Dose
> 50
See Usual Dosage.
30 to 50
250 to 500 mg q 12 h
5 to 29
250 to 500 mg q 18 h
Patients on hemodialysis or Peritoneal dialysis
250 to 500 mg q 24 h (after dialysis)
When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
Men: Creatinine clearance (mL/min) =
Weight (kg) x (140 - age)
72 x serum creatinine (mg/dL)
Women: 0.85 x the value calculated for men.
The serum creatinine should represent a steady state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored.
Pediatrics
Ciprofloxacin tablets should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS and CLINICAL STUDIES.)
Dosing and initial route of therapy (that is, IV or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg IV every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
PEDIATRIC DOSAGE GUIDELINES
Infection
Route of Administration
Dose (mg/kg)
Frequency
Total Duration
ComplicatedUrinary TractorPyelonephritis(patients from1 to 17 years ofage)
Oral
10 mg/kg to 20 mg/kg(maximum 750 mg per dose; not to be exceeded even in patients weighing > 51 kg)
Every 12 hours
10 to 21 days*
Inhalational Anthrax (Post-Exposure)**
Oral
15 mg/kg(maximum 500 mg per dose)
Every 12 hours
60 days
* The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days).
** Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.6 For a discussion of ciprofloxacin serum concentrations in various human populations, see Inhalational Anthrax In Adults and Pediatrics, Additional Information.
Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (that is, creatinine clearance of < 50 mL/min/1.73m2).
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![Spironolactone Tablet, Film Coated [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=3befad3c-b6fb-495a-a4d0-9893ec13e4c4&name=spironolactone-05.jpg)
Spironolactone
Primary hyperaldosteronism. Spironolactone may be employed as an initial diagnostic measure to provide presumptive evidence of primary hyperaldosteronism while patients are on normal diets.
Long test: Spironolactone is administered at a daily dosage of 400 mg for three to four weeks. Correction of hypokalemia and of hypertension provides presumptive evidence for the diagnosis of primary hyperaldosteronism.
Short test: Spironolactone is administered at a daily dosage of 400 mg for four days. If serum potassium increases during spironolactone administration but drops when spironolactone is discontinued, a presumptive diagnosis of primary hyperaldosteronism should be considered.
After the diagnosis of hyperaldosteronism has been established by more definitive testing procedures, spironolactone may be administered in doses of 100 to 400 mg daily in preparation for surgery. For patients who are considered unsuitable for surgery, spironolactone may be employed for long-term maintenance therapy at the lowest effective dosage determined for the individual patient.
Edema in adults (congestive heart failure, hepatic cirrhosis, or nephrotic syndrome). An initial daily dosage of 100 mg of spironolactone administered in either single or divided doses is recommended, but may range from 25 to 200 mg daily. When given as the sole agent for diuresis, spironolactone should be continued for at least five days at the initial dosage level, after which it may be adjusted to the optimal therapeutic or maintenance level administered in either single or divided daily doses. If, after five days, an adequate diuretic response to spironolactone has not occurred, a second diuretic that acts more proximally in the renal tubule may be added to the regimen. Because of the additive effect of spironolactone when administered concurrently with such diuretics, an enhanced diuresis usually begins on the first day of combined treatment; combined therapy is indicated when more rapid diuresis is desired. The dosage of spironolactone should remain unchanged when other diuretic therapy is added.
Essential hypertension. For adults, an initial daily dosage of 50 to 100 mg of spironolactone administered in either single or divided doses is recommended. Spironolactone may also be given with diuretics that act more proximally in the renal tubule or with other antihypertensive agents. Treatment with spironolactone should be continued for at least two weeks since the maximum response may not occur before this time. Subsequently, dosage should be adjusted according to the response of the patient.
Hypokalemia. Spironolactone in a dosage ranging from 25 mg to 100 mg daily is useful in treating a diuretic-induced hypokalemia, when oral potassium supplements or other potassium-sparing regimens are considered inappropriate.
Severe heart failure in conjunction with standard therapy (NYHA class III – IV). Treatment should be initiated with spironolactone 25 mg once daily if the patient's serum potassium is ≤5.0 mEq/L and the patient's serum creatinine is ≤2.5 mg/dL. Patients who tolerate 25 mg once daily may have their dosage increased to 50 mg once daily as clinically indicated. Patients who do not tolerate 25 mg once daily may have their dosage reduced to 25 mg every other day. See Warnings: Hyperkalemia in patients with severe heart failure for advice on monitoring serum potassium and serum creatinine.
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![Eszopiclone Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=0755ade3-edbc-4b34-b261-99b15b759599&name=image-02.jpg)
Eszopiclone
Use the lowest effective dose for the patient.
2.1 Dosage in Adults
The recommended starting dose is 1 mg. Dosing can be raised to 2 mg or 3 mg if clinically indicated. In some patients, the higher morning blood levels of eszopiclone following use of the 2 mg or 3 mg dose increase the risk of next day impairment of driving and other activities that require full alertness [see Warnings and Precautions (5.1)]. The total dose of eszopiclone should not exceed 3 mg, once daily immediately before bedtime [see Warnings and Precautions (5.6)].
2.2 Geriatric or Debilitated Patients
Thetotal doseof eszopiclone should not exceed 2 mgin elderly ordebilitated patients.
2.3 Patients with Severe Hepatic Impairment, or Taking Potent CYP3A4 Inhibitors
In patients with severe hepatic impairment, or in patients coadministered eszopiclone with potent CYP3A4 inhibitors, the total dose of eszopiclone should not exceed 2 mg [see Warning and Precautions (5.7)].
2.4 Use with CNS Depressants
Dosage adjustments may be necessary when eszopiclone is combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.1)].
2.5 Administration with Food
Taking eszopiclone with or immediately after a heavy, high-fat meal results in slower absorption and would be expected to reduce the effect of eszopiclone on sleep latency [see Clinical Pharmacology (12.3)].
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![Lidocaine Hydrochloride Solution [Cardinal Health]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=03646015-2d86-4d6d-958f-94687899b838&name=gabapentin-fig6.jpg)
Lidocaine Hydrochloride Solution
Gabapentin tablets are given orally with or without food. Patients should be informed that, should they break the scored 600 mg or 800 mg tablet in order to administer a half-tablet, they should take the unused half-tablet as the next dose. Half-tablets not used within 28 days of breaking the scored tablet should be discarded.If gabapentin tablets dose is reduced, discontinued, or substituted with an alternative medication, this should be done gradually over a minimum of 1 week (a longer period may be needed at the discretion of the prescriber).
2.1 Postherpetic Neuralgia
In adults with postherpetic neuralgia, gabapentin tablets therapy may be initiated on Day 1 as a single 300 mg dose, on Day 2 as 600 mg/day (300 mg two times a day), and on Day 3 as 900 mg/day (300 mg three times a day). The dose can subsequently be titrated up as needed for pain relief to a dose of 1800 mg/day (600 mg three times a day). In clinical studies, efficacy was demonstrated over a range of doses from 1800 mg/day to 3600 mg/day with comparable effects across the dose range; however, in these clinical studies, the additional benefit of using doses greater than 1800 mg/day was not demonstrated.
2.2 Epilepsy with Partial Onset Seizures
Gabapentin tablets are recommended for add-on therapy in patients 3 years of age and older. Effectiveness in pediatric patients below the age of 3 years has not been established.Patients 12 years of age and above: The starting dose is 300 mg three times a day. The effective dose of gabapentin tablets is 300 mg to 600 mg three times a day. Dosages up to 2400 mg/day have been well tolerated in long-term clinical studies. Doses of 3600 mg/day have also been administered to a small number of patients for a relatively short duration, and have been well tolerated. Gabapentin tablets should be administered three times a day using 600 mg or 800 mg tablets. The maximum time between doses should not exceed 12 hours.Pediatric Patients Age 3 to 11 years: The starting dose range is 10 mg/kg/day to 15 mg/kg/day, given in three divided doses, and the effective dose reached by upward titration over a period of approximately 3 days. The effective dose of gabapentin tablets in patients 3 to 4 years of age is 40 mg/kg/day, given in three divided doses. The effective dose of gabapentin tablets in patients 5 to 11 years of age is 25 mg/kg/day to 35 mg/kg/day, given in three divided doses. Dosages up to 50 mg/kg/day have been well tolerated in a long-term clinical study. The maximum time interval between doses should not exceed 12 hours.It is not necessary to monitor gabapentin plasma concentrations to optimize gabapentin tablets therapy. Further, because there are no significant pharmacokinetic interactions among gabapentin tablets and other commonly used antiepileptic drugs, the addition of gabapentin tablets does not alter the plasma levels of these drugs appreciably.If gabapentin tablets are discontinued and/or an alternate anticonvulsant medication is added to the therapy, this should be done gradually over a minimum of 1 week.
2.3 Patients with Renal Impairment
Dosage adjustment in patients 12 years of age and older with compromised renal function or undergoing hemodialysis is recommended, as follows (see dosing recommendations above for effective doses in each indication):
TABLE 1. Gabapentin Tablets Dosage Based on Renal Function
TID = Three times a day; BID = Two times a day; QD = Single daily dosea For patients with creatinine clearance <15 mL/min, reduce daily dose in proportion to creatinine clearance (e.g., patients with a creatinine clearance of 7.5 mL/min should receive one-half the daily dose that patients with a creatinine clearance of 15 mL/min receive).b Patients on hemodialysis should receive maintenance doses based on estimates of creatinine clearance as indicated in the upper portion of the table and a supplemental post-hemodialysis dose administered after each 4 hours of hemodialysis as indicated in the lower portion of the table.Renal Function Creatinine Clearance (mL/min)
Total Daily Dose Range (mg/day)
Dose Regimen (mg)
≥ 60
900 to 3600
300 TID
400 TID
600 TID
800 TID
1200 TID
>30 to 59
400 to 1400
200 BID
300 BID
400 BID
500 BID
700 BID
>15 to 29
200 to 700
200 QD
300 QD
400 QD
500 QD
700 QD
15a
100 to 300
100 QD
125 QD
150 QD
200 QD
300 QD
Post-Hemodialysis Supplemental Dose (mg)b
Hemodialysis
125b
150b
200b
250b
350b
Creatinine clearance (CLCr) is difficult to measure in outpatients. In patients with stable renal function, creatinine clearance can be reasonably well estimated using the equation of Cockcroft and Gault:The use of gabapentin tablets in patients less than 12 years of age with compromised renal function has not been studied.
2.4 Dosage in Elderly
Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and dose should be adjusted based on creatinine clearance values in these patients.
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![Phazyme (Simethicone) Capsule, Gelatin Coated [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=990ebac2-e65d-409f-b979-36f52b13e26e&name=image-01.jpg)
Phazyme
• swallow one or two softgels as needed after a meal • do not exceed two softgels per day except under the advice and supervision of a physician
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![Fluconazole Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=82af879c-9ecf-4f9a-b00f-779ab4104a2f&name=fluconazole-fig5.jpg)
Fluconazole
Dosage and Administration in Adults
Single Dose
Vaginal candidiasis: The recommended dosage of fluconazole for vaginal candidiasis is 150 mg as a single oral dose.
Multiple Dose
SINCE ORAL ABSORPTION IS RAPID AND ALMOST COMPLETE, THE DAILY DOSE OF FLUCONAZOLE IS THE SAME FOR ORAL AND INTRAVENOUS ADMINISTRATION. In general, a loading dose of twice the daily dose is recommended on the first day of therapy to result in plasma concentrations close to steady-state by the second day of therapy.The daily dose of fluconazole for the treatment of infections other than vaginal candidiasis should be based on the infecting organism and the patient’s response to therapy. Treatment should be continued until clinical parameters or laboratory tests indicate that active fungal infection has subsided. An inadequate period of treatment may lead to recurrence of active infection. Patients with AIDS and cryptococcal meningitis or recurrent oropharyngeal candidiasis usually require maintenance therapy to prevent relapse.Oropharyngeal candidiasis: The recommended dosage of fluconazole for oropharyngeal candidiasis is 200 mg on the first day, followed by 100 mg once daily. Clinical evidence of oropharyngeal candidiasis generally resolves within several days, but treatment should be continued for at least 2 weeks to decrease the likelihood of relapse.Esophageal candidiasis: The recommended dosage of fluconazole for esophageal candidiasis is 200 mg on the first day, followed by 100 mg once daily. Doses up to 400 mg/day may be used, based on medical judgment of the patient’s response to therapy. Patients with esophageal candidiasis should be treated for a minimum of three weeks and for at least two weeks following resolution of symptoms.Systemic Candida infections: For systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia, optimal therapeutic dosage and duration of therapy have not been established. In open, noncomparative studies of small numbers of patients, doses of up to 400 mg daily have been used.Urinary tract infections and peritonitis: For the treatment of Candida urinary tract infections and peritonitis, daily doses of 50 to 200 mg have been used in open, noncomparative studies of small numbers of patients.Cryptococcal meningitis: The recommended dosage for treatment of acute cryptococcal meningitis is 400 mg on the first day, followed by 200 mg once daily. A dosage of 400 mg once daily may be used, based on medical judgment of the patient’s response to therapy. The recommended duration of treatment for initial therapy of cryptococcal meningitis is 10 to 12 weeks after the cerebrospinal fluid becomes culture negative. The recommended dosage of fluconazole for suppression of relapse of cryptococcal meningitis in patients with AIDS is 200 mg once daily.Prophylaxis in patients undergoing bone marrow transplantation: The recommended fluconazole daily dosage for the prevention of candidiasis in patients undergoing bone marrow transplantation is 400 mg, once daily. Patients who are anticipated to have severe granulocytopenia (less than 500 neutrophils per cu mm) should start fluconazole prophylaxis several days before the anticipated onset of neutropenia, and continue for 7 days after the neutrophil count rises above 1000 cells per cu mm.
Dosage and Administration in Children
The following dose equivalency scheme should generally provide equivalent exposure in pediatric and adult patients:
Pediatric Patients Adults * Some older children may have clearances similar to that of adults. Absolute doses exceeding 600 mg/day are not recommended.3 mg/kg
100 mg
6 mg/kg
200 mg
12* mg/kg
400 mg
Experience with fluconazole in neonates is limited to pharmacokinetic studies in premature newborns. (See CLINICAL PHARMACOLOGY.) Based on the prolonged half-life seen in premature newborns (gestational age 26 to 29 weeks), these children, in the first two weeks of life, should receive the same dosage (mg/kg) as in older children, but administered every 72 hours. After the first two weeks, these children should be dosed once daily. No information regarding fluconazole pharmacokinetics in full-term newborns is available.Oropharyngeal candidiasis: The recommended dosage of fluconazole for oropharyngeal candidiasis in children is 6 mg/kg on the first day, followed by 3 mg/kg once daily. Treatment should be administered for at least 2 weeks to decrease the likelihood of relapse.Esophageal candidiasis: For the treatment of esophageal candidiasis, the recommended dosage of fluconazole in children is 6 mg/kg on the first day, followed by 3 mg/kg once daily. Doses up to 12 mg/kg/day may be used, based on medical judgment of the patient’s response to therapy.Patients with esophageal candidiasis should be treated for a minimum of three weeks and for at least 2 weeks following the resolution of symptoms.Systemic Candida infections: For the treatment of candidemia and disseminated Candida infections, daily doses of 6 to 12 mg/kg/day have been used in an open, noncomparative study of a small number of children.Cryptococcal meningitis: For the treatment of acute cryptococcal meningitis, the recommended dosage is 12 mg/kg on the first day, followed by 6 mg/kg once daily. A dosage of 12 mg/kg once daily may be used, based on medical judgment of the patient’s response to therapy. The recommended duration of treatment for initial therapy of cryptococcal meningitis is 10 to 12 weeks after the cerebrospinal fluid becomes culture negative. For suppression of relapse of cryptococcal meningitis in children with AIDS, the recommended dose of fluconazole is 6 mg/kg once daily.
Dosage In Patients With Impaired Renal Function
Fluconazole is cleared primarily by renal excretion as unchanged drug. There is no need to adjust single dose therapy for vaginal candidiasis because of impaired renal function. In patients with impaired renal function who will receive multiple doses of fluconazole, an initial loading dose of 50 to 400 mg should be given. After the loading dose, the daily dose (according to indication) should be based on the following table:
Creatinine Clearance (mL/min) Percent of Recommended Dose>50
100%
≤50 (no dialysis)
50%
Regular dialysis
100% after each dialysis
These are suggested dose adjustments based on pharmacokinetics following administration of multiple doses. Further adjustment may be needed depending upon clinical condition.When serum creatinine is the only measure of renal function available, the following formula (based on sex, weight, and age of the patient) should be used to estimate the creatinine clearance in adults: Males: Weight (kg) x (140-age) ————————————— 72 x serum creatinine (mg/100 mL) Females: 0.85 × above valueAlthough the pharmacokinetics of fluconazole has not been studied in children with renal insufficiency, dosage reduction in children with renal insufficiency should parallel that recommended for adults. The following formula may be used to estimate creatinine clearance in children: K x linear length or height (cm) ————————————— serum creatinine (mg/100 mL) (Where K=0.55 for children older than 1 year and 0.45 for infants.)
Administration
Fluconazole tablets are administered orally. Fluconazole tablets can be taken with or without food.
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![Baclofen Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=58416ceb-994f-4571-afbd-c2171823f528&name=baclofen-tablets-usp-2.jpg)
Baclofen
The determination of optimal dosage requires individual titration. Start therapy at a low dosage and increase gradually until optimum effect is achieved (usually between 40 to 80 mg daily).
The following dosage titration schedule is suggested:
5 mg t.i.d. for 3 days 10 mg t.i.d. for 3 days 15 mg t.i.d. for 3 days 20 mg t.i.d. for 3 days
Thereafter additional increases may be necessary but the total daily dose should not exceed a maximum of 80 mg daily (20 mg q.i.d.).
The lowest dose compatible with an optimal response is recommended. If benefits are not evident after a reasonable trial period, patients should be slowly withdrawn from the drug (see WARNINGS, Abrupt Drug Withdrawal).
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![Clonidine Hydrochloride Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=a49142e8-e6aa-4904-9632-4a690ae953f0&name=clonid-2.jpg)
Clonidine Hydrochloride
Adults
The dose of clonidine hydrochloride tablets, USP must be adjusted according to the patient’s individual blood pressure response. The following is a general guide to its administration.
Initial Dose
0.1 mg tablet twice daily (morning and bedtime). Elderly patients may benefit from a lower initial dose.
Maintenance Dose
Further increments of 0.1 mg per day may be made at weekly intervals if necessary until the desired response is achieved. Taking the larger portion of the oral daily dose at bedtime may minimize transient adjustment effects of dry mouth and drowsiness. The therapeutic doses most commonly employed have ranged from 0.2 mg to 0.6 mg per day given in divided doses. Studies have indicated that 2.4 mg is the maximum effective daily dose, but doses as high as this have rarely been employed.
Renal Impairment
Patients with renal impairment may benefit from a lower initial dose. Patients should be carefully monitored. Since only a minimal amount of clonidine is removed during routine hemodialysis, there is no need to give supplemental clonidine following dialysis.
Adults
The dose of clonidine hydrochloride tablets, USP must be adjusted according to the patient’s individual blood pressure response. The following is a general guide to its administration.
Initial Dose
0.1 mg tablet twice daily (morning and bedtime). Elderly patients may benefit from a lower initial dose.
Maintenance Dose
Further increments of 0.1 mg per day may be made at weekly intervals if necessary until the desired response is achieved. Taking the larger portion of the oral daily dose at bedtime may minimize transient adjustment effects of dry mouth and drowsiness. The therapeutic doses most commonly employed have ranged from 0.2 mg to 0.6 mg per day given in divided doses. Studies have indicated that 2.4 mg is the maximum effective daily dose, but doses as high as this have rarely been employed.
Renal Impairment
Patients with renal impairment may benefit from a lower initial dose. Patients should be carefully monitored. Since only a minimal amount of clonidine is removed during routine hemodialysis, there is no need to give supplemental clonidine following dialysis.
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![Clindamycin Hydrochloride Capsule [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=e4505f39-ebb0-4a0b-b91e-17fc42466c21&name=d481dcde-72eb-454b-af7a-46f4383f1959-02.jpg)
Clindamycin Hydrochloride
If significant diarrhea occurs during therapy, this antibiotic should be discontinued (see WARNING box).
Adults: Serious infections—150 to 300 mg every 6 hours. More severe infections - 300 to 450 mg every 6 hours. Pediatric Patients: Serious infections - 8 to 16 mg/kg/day (4 to 8 mg/lb/day) divided into three or four equal doses. More severe infections - 16 to 20 mg/kg/day (8 to 10 mg/lb/day) divided into three or four equal doses.
To avoid the possibility of esophageal irritation, clindamycin hydrochloride capsules should be taken with a full glass of water.
Serious infections due to anaerobic bacteria are usually treated with clindamycin injection. However, in clinically appropriate circumstances, the physician may elect to initiate treatment or continue treatment with clindamycin hydrochloride capsules.
In cases of β-hemolytic streptococcal infections, treatment should continue for at least 10 days.
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![Clindamycin Hydrochloride Capsule [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=192643cb-325b-4951-925f-ee2bc3e21983&name=be37162b-f1f3-47d8-9b3b-3b1ee7b39779-04.jpg)
Clindamycin Hydrochloride
If significant diarrhea occurs during therapy, this antibiotic should be discontinued (see WARNING box).
Adults:Serious infections–150 to 300 mg every 6 hours. More severe infections–300 to 450 mg every 6 hours.
Pediatric Patients:Serious infections–8 to 16 mg/kg/day (4 to 8 mg/lb/day) divided into three or four equal doses. More severeinfections–16 to 20 mg/kg/day (8 to 10 mg/lb/day) divided into three or four equal doses.
To avoid the possibility of esophageal irritation, clindamycin hydrochloride capsules should be taken with a full glass of water.
Serious infections due to anaerobic bacteria are usually treated with clindamycin phosphate sterile solution. However, in clinically appropriate circumstances, the physician may elect to initiate treatment or continue treatment with clindamycin hydrochloride capsules.
In cases of β-hemolytic streptococcal infections, treatment should continue for at least 10 days.
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![Ondansetron Tablet, Orally Disintegrating [Bluepoint Laboratories]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=fac9b9c0-7ea2-4986-9552-dc46a32b7c99&name=doxycycline-hyclate-capsules-3.jpg)
Ondansetron
THE USUAL DOSAGE AND FREQUENCY OF ADMINISTRATION OF DOXYCYCLINE DIFFERS FROM THAT OF THE OTHER TETRACYCLINES. EXCEEDING THE RECOMMENDED DOSAGE MAY RESULT IN AN INCREASED INCIDENCE OF SIDE EFFECTS. Adults: The usual dose of oral doxycycline is 200 mg on the first day of treatment (administered 100 mg every 12 hours) followed by a maintenance dose of 100 mg/day.
In the management of more severe infections (particularly chronic infections of the urinary tract), 100 mg every 12 hours is recommended.
For children above eight years of age: The recommended dosage schedule for children weighing 100 pounds or less is 2 mg/lb of body weight divided into two doses on the first day of treatment, followed by 1 mg/lb of body weight given as a single daily dose or divided into two doses, on subsequent days. For more severe infections up to 2 mg/lb of body weight may be used. For children over 100 lb the usual adult dose should be used.
The therapeutic antibacterial serum activity will usually persist for 24 hours following recommended dosage.
When used in streptococcal infections, therapy should be continued for 10 days.
Administration of adequate amounts of fluid along with capsule and tablet forms of drugs in the tetracycline class is recommended to wash down the drugs and reduce the risk of esophageal irritation and ulceration (See ADVERSE REACTIONS).
If gastric irritation occurs, it is recommended that doxycycline be given with food or milk. The absorption of doxycycline is not markedly influenced by simultaneous ingestion of food or milk.
Studies to date have indicated that administration of doxycycline at the usual recommended doses does not lead to excessive accumulation of doxycycline in patients with renal impairment.
Uncomplicated gonococcal infections in adults (except anorectal infections in men): 100 mg, by mouth, twice a day for 7 days. As an alternate single visit dose, administer 300 mg stat followed in one hour by a second 300 mg dose. The dose may be administered with food, including milk or carbonated beverage, as required.
Uncomplicated urethral, endocervical, or rectal infection in adults caused by Chlamydiatrachomatis: 100 mg, by mouth, twice a day for 7 days.
Nongonococcal urethritis (NGU) caused by C. trachomatis or U. urealyticum: 100 mg, by mouth, twice a day for 7 days.
Syphilis - early: Patients who are allergic to penicillin should be treated with doxycycline 100 mg, by mouth, twice a day for 2 weeks.
Syphilis of more than one year’s duration: Patients who are allergic to penicillin should be treated with doxycycline 100 mg, by mouth, twice a day for 4 weeks.
Acute epididymo-orchitis caused by N. gonorrhoeae: 100 mg, by mouth, twice a day for at least 10 days.
Acute epididymo-orchitis caused by C. trachomatis: 100 mg, by mouth, twice a day for at least 10 days.
For prophylaxis of malaria: For adults, the recommended dose is 100 mg daily. For children over 8 years of age, the recommended dose is 2 mg/kg given once daily up to the adult dose. Prophylaxis should begin 1 to 2 days before travel to the malarious area. Prophylaxis should be continued daily during travel in the malarious area and for 4 weeks after the traveler leaves the malarious area.
Inhalational anthrax (post-exposure):
ADULTS: 100 mg of doxycycline, by mouth, twice a day for 60 days.
CHILDREN: weighing less than 100 lb (45 kg); 1 mg/lb (2.2 mg/kg) of body weight, by mouth, twice a day for 60 days. Children weighing 100 lb or more should receive the adult dose.
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![Clindamycin Phosphate Cream [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=dfa15be0-7f3b-4cc5-90b4-9471851af410&name=clindamycin-phosphate-vaginal-cream-09.jpg)
Clindamycin Phosphate
The recommended dose is one applicatorful of clindamycin phosphate vaginal cream 2%, (5 grams containing approximately 100 mg of clindamycin phosphate) intravaginally, preferably at bedtime, for 3 or 7 consecutive days in non-pregnant patients and for 7 consecutive days in pregnant patients. (See CLINICAL STUDIES.)
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![Atenolol Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=b2d04a26-408f-4d18-82e8-66fe4092a78d&name=a89b06fa-6d67-4563-b42e-dfef72e534a4-03.jpg)
Atenolol
Hypertension
The initial dose of atenolol is 50 mg given as one tablet a day either alone or added to diuretic therapy. The full effect of this dose will usually be seen within one to two weeks. If an optimal response is not achieved, the dosage should be increased to atenolol 100 mg given as one tablet a day. Increasing the dosage beyond 100 mg a day is unlikely to produce any further benefit.
Atenolol may be used alone or concomitantly with other antihypertensive agents including thiazide-type diuretics, hydralazine, prazosin, and alpha-methyldopa.
Angina Pectoris
The initial dose of atenolol is 50 mg given as one tablet a day. If an optimal response is not achieved within one week, the dosage should be increased to atenolol 100 mg given as one tablet a day. Some patients may require a dosage of 200 mg once a day for optimal effect.
Twenty-four hour control with once daily dosing is achieved by giving doses larger than necessary to achieve an immediate maximum effect. The maximum early effect on exercise tolerance occurs with doses of 50 to 100 mg, but at these doses the effect at 24 hours is attenuated, averaging about 50% to 75% of that observed with once a day oral doses of 200 mg.
Acute Myocardial Infarction
In patients with definite or suspected acute myocardial infarction, treatment with atenolol I.V. injection should be initiated as soon as possible after the patient’s arrival in the hospital and after eligibility is established. Such treatment should be initiated in a coronary care or similar unit immediately after the patient’s hemodynamic condition has stabilized. Treatment should begin with the intravenous administration of 5 mg atenolol over 5 minutes followed by another 5 mg intravenous injection 10 minutes later. Atenolol I.V. injection should be administered under carefully controlled conditions including monitoring of blood pressure, heart rate, and electrocardiogram. Dilutions of atenolol I.V. injection in Dextrose Injection USP, Sodium Chloride Injection USP, or Sodium Chloride and Dextrose Injection may be used. These admixtures are stable for 48 hours if they are not used immediately.
In patients who tolerate the full intravenous dose (10 mg), atenolol tablets 50 mg should be initiated 10 minutes after the last intravenous dose followed by another 50 mg oral dose 12 hours later. Thereafter, atenolol can be given orally either 100 mg once daily or 50 mg twice a day for a further 6 to 9 days or until discharge from the hospital. If bradycardia or hypotension requiring treatment or any other untoward effects occur, atenolol should be discontinued. (See full prescribing information prior to initiating therapy with atenolol tablets).
Data from other beta blocker trials suggest that if there is any question concerning the use of IV beta blocker or clinical estimate that there is a contraindication, the IV beta blocker may be eliminated and patients fulfilling the safety criteria may be given atenolol tablets 50 mg twice daily or 100 mg once a day for at least seven days (if the IV dosing is excluded).
Although the demonstration of efficacy of atenolol is based entirely on data from the first seven postinfarction days, data from other beta blocker trials suggest that treatment with beta blockers that are effective in the post-infarction setting may be continued for one to three years if there are no contraindications.
Atenolol is an additional treatment to standard coronary care unit therapy.
Elderly Patients or Patients with Renal Impairment
Atenolol is excreted by the kidneys; consequently dosage should be adjusted in cases of severe impairment of renal function. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Evaluation of patients with hypertension or myocardial infarction should always include assessment of renal function. Atenolol excretion would be expected to decrease with advancing age.
No significant accumulation of atenolol occurs until creatinine clearance falls below 35 mL/min/1.73m2. Accumulation of atenolol and prolongation of its half-life were studied in subjects with creatinine clearance between 5 and 105 mL/min. Peak plasma levels were significantly increased in subjects with creatinine clearances below 30 mL/min.
The following maximum oral dosages are recommended for elderly, renally-impaired patients and for patients with renal impairment due to other causes:
Creatinine Clearance
(mL/min/1.73m2)
Atenolol
Elimination
Half-Life (h)
Maximum Dosage
15-35
16-27
50 mg daily
< 15
> 27
25 mg daily
Some renally-impaired or elderly patients being treated for hypertension may require a lower starting dose of atenolol: 25 mg given as one tablet a day. If this 25 mg dose is used, assessment of efficacy must be made carefully. This should include measurement of blood pressure just prior to the next dose (“trough” blood pressure) to ensure that the treatment effect is present for a full 24 hours.
Although a similar dosage reduction may be considered for elderly and/or renally-impaired patients being treated for indications other than hypertension, data are not available for these patient populations.
Patients on hemodialysis should be given 25 mg or 50 mg after each dialysis; this should be done under hospital supervision as marked falls in blood pressure can occur.
Cessation of Therapy in Patients with Angina Pectoris
If withdrawal of atenolol therapy is planned, it should be achieved gradually and patients should be carefully observed and advised to limit physical activity to a minimum.
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![Tramadol Hydrochloride Tablet, Extended Release [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=acdb92ef-d91b-463c-9abb-a10b2b55cee6&name=tramadol-label-200mg.jpg)
Tramadol Hydrochloride
Tramadol hydrochloride extended-release tablets should not be used in patients with:
• creatinine clearance less than 30 mL/min, • severe hepatic impairment (Child-Pugh Class C)(See PRECAUTIONS, Use in Renal and Hepatic Disease).
Tramadol hydrochloride extended-release tablets must be swallowed whole and must not be chewed, crushed, or split (see WARNINGS, Misuse, Abuse and Diversion of Opioids and DRUG ABUSE AND ADDICTION).
Adults (18 years of age and over)
Patients Not Currently on Tramadol Immediate-Release Products
For patients not currently treated with tramadol immediate-release (IR) products, tramadol hydrochloride extended-release tablets should be initiated at a dose of 100 mg once daily and titrated up as necessary by 100 mg increments every five days to relief of pain and depending upon tolerability. Tramadol hydrochloride extended-release tablets should not be administered at a dose exceeding 300 mg per day.
Patients Currently on Tramadol Immediate-Release Products
For patients maintained on tramadol IR products, calculate the 24-hour tramadol immediate-release (IR) dose and initiate a total daily dose of tramadol hydrochloride extended-release tablets rounded down to the next lowest 100 mg increment. The dose may subsequently be individualized according to patient need. Due to limitations in flexibility of dose selection with tramadol hydrochloride extended-release tablets, some patients maintained on tramadol IR products may not be able to convert to tramadol hydrochloride extended-release tablets. Tramadol hydrochloride extended-release tablets should not be administered at a dose exceeding 300 mg per day. The concomitant use of tramadol hydrochloride extended-release tablets with other tramadol products is not recommended (see WARNINGS).
Individualization of Dose
Good pain management practice dictates that the dose be individualized according to patient need using the lowest beneficial dose. Start at the lowest possible dose and titrate upward as tolerated to achieve an adequate effect. Clinical studies of tramadol hydrochloride extended-release tablets have not demonstrated a clinical benefit at a total daily dose exceeding 300 mg.
In general, dosing of an elderly patient (over 65 years of age) should be initiated cautiously, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function and of concomitant disease or other drug therapy. Tramadol hydrochloride extended-release tablets should be administered with even greater caution in patients over 75 years, due to the greater frequency of adverse events seen in this population.
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![Citalopram Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=22e98bda-195f-4301-b0ea-ae99edf68ed5&name=84bfabf8-figure-04.jpg)
Citalopram
Citalopram tablets, USP should be administered once daily, in the morning or evening, with or without food.
Initial Treatment
Citalopram tablets, USP should be administered at an initial dose of 20 mg once daily, with an increase to a maximum dose of 40 mg/day at an interval of no less than one week. Doses above 40 mg/day are not recommended due to the risk of QT prolongation. Additionally, the only study pertinent to dose response for effectiveness did not demonstrate an advantage for the 60 mg/day dose over the 40 mg/day dose.
Special Populations
20 mg/day is the maximum recommended dose for patients who are greater than 60 years of age, patients with hepatic impairment, and for CYP2C19 poor metabolizers or those patients taking cimetidine or another CYP2C19 inhibitor. (see WARNINGS)
No dosage adjustment is necessary for patients with mild or moderate renal impairment. Citalopram should be used with caution in patients with severe renal impairment.
Treatment of Pregnant Women During the Third Trimester
Neonates exposed to citalopram and other SSRIs or SNRIs, late in the third trimester, have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding (see PRECAUTIONS). When treating pregnant women with citalopram tablets, USP during the third trimester, the physician should carefully consider the potential risks and benefits of treatment. The physician may consider tapering citalopram tablets, USP in the third trimester.
Maintenance Treatment
It is generally agreed that acute episodes of depression require several months or longer of sustained pharmacologic therapy. Systematic evaluation of citalopram in two studies has shown that its antidepressant efficacy is maintained for periods of up to 24 weeks following 6 or 8 weeks of initial treatment (32 weeks total). In one study, patients were assigned randomly to placebo or to the same dose of citalopram (20 to 60 mg/day) during maintenance treatment as they had received during the acute stabilization phase, while in the other study, patients were assigned randomly to continuation of citalopram 20 or 40 mg/day, or placebo, for maintenance treatment. In the latter study, the rates of relapse to depression were similar for the two dose groups (see Clinical Trials under CLINICAL PHARMACOLOGY). Based on these limited data, it is not known whether the dose of citalopram needed to maintain euthymia is identical to the dose needed to induce remission. If adverse reactions are bothersome, a decrease in dose to 20 mg/day can be considered.
Discontinuation of Treatment with Citalopram tablets, USP
Symptoms associated with discontinuation of citalopram and other SSRIs and SNRIs have been reported (see PRECAUTIONS). Patients should be monitored for these symptoms when discontinuing treatment. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate.
Switching Patients To or From a Monoamine Oxidase Inhibitor
At least 14 days should elapse between discontinuation of an MAOI and initiation of Citalopram therapy. Similarly, at least 14 days should be allowed after stopping Citalopram before starting an MAOI (see CONTRAINDICATIONS and WARNINGS).
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![Voltaren (Diclofenac Sodium) Gel [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=9c4c44f5-33fd-4829-829f-caa132e90475&name=cb5c1a7d-a475-47f0-942f-d83adfcfd0af-01.jpg)
Voltaren
2.1 Dosing Card [See the Medication Guide – Patient Instructions for Use]
The proper amount of Voltaren® Gel should be measured using the dosing card supplied in the drug product carton. The dosing card is made of polypropylene, like the tube cap containing Voltaren® Gel, but without the white colorant. The dosing card should be used for each application of drug product. The gel should be applied within the oblong area of the dosing card up to the 2 gram or 4 gram line (2 g for each elbow, wrist, or hand, and 4 g for each knee, ankle, or foot). The dosing card containing Voltaren® Gel can be used to apply the gel. The hands should then be used to gently rub the gel into the skin. After using the dosing card, hold with fingertips, rinse, and dry. It treatment site is the hands, patients should wait at least one (1) hour to wash their hands
2.2 Lower extremities, including the knees, ankles, and feet
Apply the gel (4 g) to the affected foot or knee or ankle, 4 times daily. Voltaren® Gel should be gently massaged into the skin ensuring application to the entire affected foot or knee or ankle. The entire foot includes the sole, top of the foot and the toes. Do not apply more than 16 g daily to any single joint of the lower extremities.
2.3 Upper extremities including the elbows, wrists and hands
Apply the gel (2 g) to the affected hand or elbow or wrist, 4 times daily. Voltaren® Gel should be gently massaged into the skin ensuring application to the entire affected hand or elbow or wrist. The entire hand includes the palm, back of the hands, and the fingers. Do not apply more than 8 g daily to any single joint of the upper extremities.
Total dose should not exceed 32 g per day, over all affected joints.
2.4 Special Precautions
• Showering/bathing should be avoided for at least 1 hour after the application. Patient should wash his/her hands after use, unless the hands are the treated joint. If Voltaren® Gel is applied to the hand(s) for treatment; patient should not wash the treated hand(s) for at least 1 hour after the application. • Voltaren® Gel should not be applied to open wounds. • Contact of Voltaren® Gel with eyes and mucous membranes should be avoided. • External heat and/or occlusive dressings should not be applied to treated joints. • Exposure of the treated joint(s) to sunlight should be avoided. • Voltaren® Gel should not be used concomitantly with sunscreens, cosmetics, lotions, moisturizers, insect repellants, or other topical medications on the same skin sites has not been evaluated. • Concomitant use of Voltaren® Gel with oral non-steroidal anti-inflammatory drugs (NSAIDs) has not been evaluated, and may increase adverse NSAIDs effects. • Wearing of clothing or gloves should be avoided for at least 10 minutes after applying Voltaren® Gel. -
![Eszopiclone Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=77d38000-3d3d-4d05-a74a-2fcc11849ae7&name=image-04.jpg)
Eszopiclone
Use the lowest effective dose for the patient.
2.1 Dosage in Adults
The recommended starting dose is 1 mg. Dosing can be raised to 2 mg or 3 mg if clinically indicated. In some patients, the higher morning blood levels of eszopiclone following use of the 2 mg or 3 mg dose increase the risk of next day impairment of driving and other activities that require full alertness [see Warnings and Precautions (5.1)]. The total dose of eszopiclone should not exceed 3 mg, once daily immediately before bedtime [see Warnings and Precautions (5.6)].
2.2 Geriatric or Debilitated Patients
Thetotal doseof eszopiclone should not exceed 2 mgin elderly ordebilitated patients.
2.3 Patients with Severe Hepatic Impairment, or Taking Potent CYP3A4 Inhibitors
In patients with severe hepatic impairment, or in patients coadministered eszopiclone with potent CYP3A4 inhibitors, the total dose of eszopiclone should not exceed 2 mg [see Warning and Precautions (5.7)].
2.4 Use with CNS Depressants
Dosage adjustments may be necessary when eszopiclone is combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.1)].
2.5 Administration with Food
Taking eszopiclone with or immediately after a heavy, high-fat meal results in slower absorption and would be expected to reduce the effect of eszopiclone on sleep latency [see Clinical Pharmacology (12.3)].
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![Methylprednisolone Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=33d17918-0658-4783-8045-cdeb51dc0e08&name=methylprednisolone-tablets-4mg-2.jpg)
Methylprednisolone
The initial dosage of MethylPREDNISolone Tablets may vary from 4 mg to 48 mg of methylprednisolone per day depending on the specific disease entity being treated. In situations of less severity lower doses will generally suffice while in selected patients higher initial doses may be required. The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time there is a lack of satisfactory clinical response, MethylPREDNISolone should be discontinued and the patient transferred to other appropriate therapy.
IT SHOULD BE EMPHASIZED THAT DOSAGE REQUIREMENTS ARE VARIABLE AND MUST BE INDIVIDUALIZED ON THE BASIS OF THE DISEASE UNDER TREATMENT AND THE RESPONSE OF THE PATIENT. After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. It should be kept in mind that constant monitoring is needed in regard to drug dosage. Included in the situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient's individual drug responsiveness, and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment; in this latter situation it may be necessary to increase the dosage of MethylPREDNISolone for a period of time consistent with the patient's condition. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.
Multiple Sclerosis:
In treatment of acute exacerbations of multiple sclerosis daily doses of 200 mg of prednisolone for a week followed by 80 mg every other day for 1 month have been shown to be effective (4 mg of methylprednisolone is equivalent to 5 mg of prednisolone).
Alternate Day Therapy:
Alternate day therapy is a corticosteroid dosing regimen in which twice the usual daily dose of corticoid is administered every other morning. The purpose of this mode of therapy is to provide the patient requiring long-term pharmacologic dose treatment with the beneficial effects of corticoids while minimizing certain undesirable effects, including pituitary-adrenal suppression, the Cushingoid state, corticoid withdrawal symptoms, and growth suppression in children.
The rationale for this treatment schedule is based on two major premises: (a) the anti-inflammatory or therapeutic effect of corticoids persists longer than their physical presence and metabolic effects and (b) administration of the corticosteroid every other morning allows for reestablishment of more nearly normal hypothalamic-pituitary-adrenal (HPA) activity on the off-steroid day.
A brief review of the HPA physiology may be helpful in understanding this rationale. Acting primarily through the hypothalamus a fall in free cortisol stimulates the pituitary gland to produce increasing amounts of corticotropin (ACTH) while a rise in free cortisol inhibits ACTH secretion. Normally the HPA system is characterized by diurnal (circadian) rhythm. Serum levels of ACTH rise from a low point about 10 pm to a peak level about 6 am. Increasing levels of ACTH stimulate adrenal cortical activity resulting in a rise in plasma cortisol with maximal levels occurring between 2 am and 8 am. This rise in cortisol dampens ACTH production and in turn adrenal cortical activity. There is a gradual fall in plasma corticoids during the day with lowest levels occurring about midnight.
The diurnal rhythm of the HPA axis is lost in Cushing's disease, a syndrome of adrenal cortical hyperfunction characterized by obesity with centripetal fat distribution, thinning of the skin with easy bruisability, muscle wasting with weakness, hypertension, latent diabetes, osteoporosis, electrolyte imbalance, etc. The same clinical findings of hyperadrenocorticism may be noted during long-term pharmacologic dose corticoid therapy administered in conventional daily divided doses. It would appear, then, that a disturbance in the diurnal cycle with maintenance of elevated corticoid values during the night may play a significant role in the development of undesirable corticoid effects. Escape from these constantly elevated plasma levels for even short periods of time may be instrumental in protecting against undesirable pharmacologic effects.
During conventional pharmacologic dose corticosteroid therapy, ACTH production is inhibited with subsequent suppression of cortisol production by the adrenal cortex. Recovery time for normal HPA activity is variable depending upon the dose and duration of treatment. During this time the patient is vulnerable to any stressful situation. Although it has been shown that there is considerably less adrenal suppression following a single morning dose of prednisolone (10 mg) as opposed to a quarter of that dose administered every six hours, there is evidence that some suppressive effect on adrenal activity may be carried over into the following day when pharmacologic doses are used. Further, it has been shown that a single dose of certain corticosteroids will produce adrenal cortical suppression for two or more days. Other corticoids, including methylprednisolone, hydrocortisone, prednisone, and prednisolone, are considered to be short acting (producing adrenal cortical suppression for 1¼ to 1½ days following a single dose) and thus are recommended for alternate day therapy.
The following should be kept in mind when considering alternate day therapy:
1. Basic principles and indications for corticosteroid therapy should apply. The benefits of alternate day therapy should not encourage the indiscriminate use of steroids. 2. Alternate day therapy is a therapeutic technique primarily designed for patients in whom long-term pharmacologic corticoid therapy is anticipated. 3. In less severe disease processes in which corticoid therapy is indicated, it may be possible to initiate treatment with alternate day therapy. More severe disease states usually will require daily divided high dose therapy for initial control of the disease process. The initial suppressive dose level should be continued until satisfactory clinical response is obtained, usually four to ten days in the case of many allergic and collagen diseases. It is important to keep the period of initial suppressive dose as brief as possible particularly when subsequent use of alternate day therapy is intended. Once control has been established, two courses are available: (a) change to alternate day therapy and then gradually reduce the amount of corticoid given every other day or (b) following control of the disease process reduce the daily dose of corticoid to the lowest effective level as rapidly as possible and then change over to an alternate day schedule. Theoretically, course (a) may be preferable. 4. Because of the advantages of alternate day therapy, it may be desirable to try patients on this form of therapy who have been on daily corticoids for long periods of time (eg, patients with rheumatoid arthritis). Since these patients may already have a suppressed HPA axis, establishing them on alternate day therapy may be difficult and not always successful. However, it is recommended that regular attempts be made to change them over. It may be helpful to triple or even quadruple the daily maintenance dose and administer this every other day rather than just doubling the daily dose if difficulty is encountered. Once the patient is again controlled, an attempt should be made to reduce this dose to a minimum. 5. As indicated above, certain corticosteroids, because of their prolonged suppressive effect on adrenal activity, are not recommended for alternate day therapy (eg, dexamethasone and betamethasone). 6. The maximal activity of the adrenal cortex is between 2 am and 8 am, and it is minimal between 4 pm and midnight. Exogenous corticosteroids suppress adrenocortical activity the least, when given at the time of maximal activity (am). 7. In using alternate day therapy it is important, as in all therapeutic situations to individualize and tailor the therapy to each patient. Complete control of symptoms will not be possible in all patients. An explanation of the benefits of alternate day therapy will help the patient to understand and tolerate the possible flare-up in symptoms which may occur in the latter part of the off-steroid day. Other symptomatic therapy may be added or increased at this time if needed. 8. In the event of an acute flare-up of the disease process, it may be necessary to return to a full suppressive daily divided corticoid dose for control. Once control is again established alternate day therapy may be reinstituted. 9. Although many of the undesirable features of corticosteroid therapy can be minimized by alternate day therapy, as in any therapeutic situation, the physician must carefully weigh the benefit-risk ratio for each patient in whom corticoid therapy is being considered.Multiple Sclerosis:
In treatment of acute exacerbations of multiple sclerosis daily doses of 200 mg of prednisolone for a week followed by 80 mg every other day for 1 month have been shown to be effective (4 mg of methylprednisolone is equivalent to 5 mg of prednisolone).
Alternate Day Therapy:
Alternate day therapy is a corticosteroid dosing regimen in which twice the usual daily dose of corticoid is administered every other morning. The purpose of this mode of therapy is to provide the patient requiring long-term pharmacologic dose treatment with the beneficial effects of corticoids while minimizing certain undesirable effects, including pituitary-adrenal suppression, the Cushingoid state, corticoid withdrawal symptoms, and growth suppression in children.
The rationale for this treatment schedule is based on two major premises: (a) the anti-inflammatory or therapeutic effect of corticoids persists longer than their physical presence and metabolic effects and (b) administration of the corticosteroid every other morning allows for reestablishment of more nearly normal hypothalamic-pituitary-adrenal (HPA) activity on the off-steroid day.
A brief review of the HPA physiology may be helpful in understanding this rationale. Acting primarily through the hypothalamus a fall in free cortisol stimulates the pituitary gland to produce increasing amounts of corticotropin (ACTH) while a rise in free cortisol inhibits ACTH secretion. Normally the HPA system is characterized by diurnal (circadian) rhythm. Serum levels of ACTH rise from a low point about 10 pm to a peak level about 6 am. Increasing levels of ACTH stimulate adrenal cortical activity resulting in a rise in plasma cortisol with maximal levels occurring between 2 am and 8 am. This rise in cortisol dampens ACTH production and in turn adrenal cortical activity. There is a gradual fall in plasma corticoids during the day with lowest levels occurring about midnight.
The diurnal rhythm of the HPA axis is lost in Cushing's disease, a syndrome of adrenal cortical hyperfunction characterized by obesity with centripetal fat distribution, thinning of the skin with easy bruisability, muscle wasting with weakness, hypertension, latent diabetes, osteoporosis, electrolyte imbalance, etc. The same clinical findings of hyperadrenocorticism may be noted during long-term pharmacologic dose corticoid therapy administered in conventional daily divided doses. It would appear, then, that a disturbance in the diurnal cycle with maintenance of elevated corticoid values during the night may play a significant role in the development of undesirable corticoid effects. Escape from these constantly elevated plasma levels for even short periods of time may be instrumental in protecting against undesirable pharmacologic effects.
During conventional pharmacologic dose corticosteroid therapy, ACTH production is inhibited with subsequent suppression of cortisol production by the adrenal cortex. Recovery time for normal HPA activity is variable depending upon the dose and duration of treatment. During this time the patient is vulnerable to any stressful situation. Although it has been shown that there is considerably less adrenal suppression following a single morning dose of prednisolone (10 mg) as opposed to a quarter of that dose administered every six hours, there is evidence that some suppressive effect on adrenal activity may be carried over into the following day when pharmacologic doses are used. Further, it has been shown that a single dose of certain corticosteroids will produce adrenal cortical suppression for two or more days. Other corticoids, including methylprednisolone, hydrocortisone, prednisone, and prednisolone, are considered to be short acting (producing adrenal cortical suppression for 1¼ to 1½ days following a single dose) and thus are recommended for alternate day therapy.
The following should be kept in mind when considering alternate day therapy:
1. Basic principles and indications for corticosteroid therapy should apply. The benefits of alternate day therapy should not encourage the indiscriminate use of steroids. 2. Alternate day therapy is a therapeutic technique primarily designed for patients in whom long-term pharmacologic corticoid therapy is anticipated. 3. In less severe disease processes in which corticoid therapy is indicated, it may be possible to initiate treatment with alternate day therapy. More severe disease states usually will require daily divided high dose therapy for initial control of the disease process. The initial suppressive dose level should be continued until satisfactory clinical response is obtained, usually four to ten days in the case of many allergic and collagen diseases. It is important to keep the period of initial suppressive dose as brief as possible particularly when subsequent use of alternate day therapy is intended. Once control has been established, two courses are available: (a) change to alternate day therapy and then gradually reduce the amount of corticoid given every other day or (b) following control of the disease process reduce the daily dose of corticoid to the lowest effective level as rapidly as possible and then change over to an alternate day schedule. Theoretically, course (a) may be preferable. 4. Because of the advantages of alternate day therapy, it may be desirable to try patients on this form of therapy who have been on daily corticoids for long periods of time (eg, patients with rheumatoid arthritis). Since these patients may already have a suppressed HPA axis, establishing them on alternate day therapy may be difficult and not always successful. However, it is recommended that regular attempts be made to change them over. It may be helpful to triple or even quadruple the daily maintenance dose and administer this every other day rather than just doubling the daily dose if difficulty is encountered. Once the patient is again controlled, an attempt should be made to reduce this dose to a minimum. 5. As indicated above, certain corticosteroids, because of their prolonged suppressive effect on adrenal activity, are not recommended for alternate day therapy (eg, dexamethasone and betamethasone). 6. The maximal activity of the adrenal cortex is between 2 am and 8 am, and it is minimal between 4 pm and midnight. Exogenous corticosteroids suppress adrenocortical activity the least, when given at the time of maximal activity (am). 7. In using alternate day therapy it is important, as in all therapeutic situations to individualize and tailor the therapy to each patient. Complete control of symptoms will not be possible in all patients. An explanation of the benefits of alternate day therapy will help the patient to understand and tolerate the possible flare-up in symptoms which may occur in the latter part of the off-steroid day. Other symptomatic therapy may be added or increased at this time if needed. 8. In the event of an acute flare-up of the disease process, it may be necessary to return to a full suppressive daily divided corticoid dose for control. Once control is again established alternate day therapy may be reinstituted. 9. Although many of the undesirable features of corticosteroid therapy can be minimized by alternate day therapy, as in any therapeutic situation, the physician must carefully weigh the benefit-risk ratio for each patient in whom corticoid therapy is being considered. -
![Australian Dream Pain Relieving Arthritis (Histamine Dihydrochloride) Cream [Nature’s Health Connection]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=b9abd5ce-6aca-4fda-8f46-0bb5b7fdd5da&name=ondansetronod-fig3.jpg)
Australian Dream Pain Relieving Arthritis
Instructions for Use/Handling Ondansetron Orally Disintegrating Tablets Do not attempt to push ondansetron orally disintegrating tablets through the foil backing. With dry hands, remove the tablet from the bottle or PEEL BACK the foil backing of 1 blister and GENTLY remove the tablet. IMMEDIATELY place the ondansetron orally disintegrating tablet on top of the tongue where it will dissolve in seconds, then swallow with saliva. Administration with liquid is not necessary.Prevention of Nausea and Vomiting Associated With Highly Emetogenic Cancer Chemotherapy The recommended adult oral dosage of ondansetron orally disintegrating tablets is 24 mg given as three 8 mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥50 mg/m2. Multiday, single-dose administration of a 24 mg dosage has not been studied.Pediatric Use There is no experience with the use of a 24 mg dosage in pediatric patients.Geriatric Use The dosage recommendation is the same as for the general population.Prevention of Nausea and Vomiting Associated With Moderately Emetogenic Cancer Chemotherapy The recommended adult oral dosage is one 8 mg ondansetron orally disintegrating tablet given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8 mg ondansetron orally disintegrating tablet should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.Pediatric UseFor pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4 mg ondansetron orally disintegrating tablet given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4 mg ondansetron orally disintegrating tablet should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.Geriatric Use The dosage is the same as for the general population. Prevention of Nausea and Vomiting Associated With Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions to the Abdomen The recommended oral dosage is one 8 mg ondansetron orally disintegrating tablet given 3 times a day.For total body irradiation, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.For single high-dose fraction radiotherapy to the abdomen, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.For daily fractionated radiotherapy to the abdomen, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.Pediatric UseThere is no experience with the use of ondansetron orally disintegrating tablets in the prevention of radiation-induced nausea and vomiting in pediatric patients.Geriatric UseThe dosage recommendation is the same as for the general population.Postoperative Nausea and Vomiting The recommended dosage is 16 mg given as two 8 mg ondansetron orally disintegrating tablets 1 hour before induction of anesthesia.Pediatric UseThere is no experience with the use of ondansetron orally disintegrating tablets in the prevention of postoperative nausea and vomiting in pediatric patients.Geriatric UseThe dosage is the same as for the general population.Dosage Adjustment for Patients With Impaired Renal Function The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron.Dosage Adjustment for Patients With Impaired Hepatic Function In patients with severe hepatic impairment (Child-Pugh2 score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.
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![Pink Bismuth (Bismuth Subsalicylate) Tablet, Chewable [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=c069d188-5a79-4885-835b-afb69eaf8a48&name=pinkbismuth.jpg)
Pink Bismuth
Adults and Children 12 years and over: 525mg (2 tablets) every 1/2 to 1 hour or 1050mg (4 tablets) every hours as needed. Do not exceed 4200mg (16 tablets) in 24 hours. Use until diarrhea stops but not more than 2 days. Children under 12 years ask a doctor
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![Lisinopril And Hydrochlorothiazide (Lisinopril And Hydrochlorothiazide) Tablet [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=e7d690ab-d74a-4ee5-8927-e939a9d78453&name=515f735c-5dba-43d9-8a58-97a319cafd56-03.jpg)
Lisinopril And Hydrochlorothiazide
Lisinopril is an effective treatment of hypertension in once-daily doses of 10 to 80 mg, while hydrochlorothiazide is effective in doses of 12.5 to 50 mg. In clinical trials of lisinopril/hydrochlorothiazide combination therapy using lisinopril doses of 10 to 80 mg and hydrochlorothiazide doses of 6.25 to 50 mg, the antihypertensive response rates generally increased with increasing dose of either component.
The side effects (see WARNINGS) of lisinopril are generally rare and apparently independent of dose; those of hydrochlorothiazide are a mixture of dose-dependent phenomena (primarily hypokalemia) and dose-independent phenomena (e.g., pancreatitis), the former much more common than the latter. Therapy with any combination of lisinopril and hydrochlorothiazide will be associated with both sets of dose-independent side effects, but addition of lisinopril in clinical trials blunted the hypokalemia normally seen with diuretics.
To minimize dose-independent side effects, it is usually appropriate to begin combination therapy only after a patient has failed to achieve the desired effect with monotherapy.
Dose Titration Guided by Clinical Effect
A patient whose blood pressure is not adequately controlled with either lisinopril or hydrochlorothiazide monotherapy may be switched to lisinopril and hydrochlorothiazide tablets 10 mg/12.5 mg or lisinopril and hydrochlorothiazide tablets 20 mg/12.5 mg. Further increases of either or both components could depend on clinical response. The hydrochlorothiazide dose should generally not be increased until 2-3 weeks have elapsed. Patients whose blood pressures are adequately controlled with 25 mg of daily hydrochlorothiazide, but who experience significant potassium loss with this regimen, may achieve similar or greater blood pressure control with less potassium loss if they are switched to lisinopril and hydrochlorothiazide tablets 10 mg/12.5 mg. Dosage higher than lisinopril 80 mg and hydrochlorothiazide 50 mg should not be used.
Replacement Therapy
The combination may be substituted for the titrated individual components.
Use in Renal Impairment
The usual regimens of therapy with lisinopril and hydrochlorothiazide tablets need not be adjusted as long as the patient’s creatinine clearance is >30 mL/min/1.73 m2 (serum creatinine approximately ≤3 mg/dL or 265 µmol/L). In patients with more severe renal impairment, loop diuretics are preferred to thiazides, so lisinopril and hydrochlorothiazide tablets are not recommended (see WARNINGS, Anaphylactoid reactions during membrane exposure).
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![Tears Renewed Lubricant (Dextran 70) Solution [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=8cb4d4b4-44e5-4584-a4a4-940ad50b2f9d&name=tearsrenewed.jpg)
Tears Renewed Lubricant
Use as directed by your doctor or pharmacist
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![Skelaxin (Metaxalone) Tablet [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=d8684144-6c2d-4664-943a-2d3d2b46b1fc&name=metalaxone.jpg)
Skelaxin
The recommended dose for adults and children over 12 years of age is one 800 mg tablet three to four times a day.
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![Q-tapp Dm Elixir (Brompheniramine Maleate And Pseudoephedrine Hydrochloride And Dextromethorphan Hydrobromide) Elixir [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=0654b093-2067-492f-a0bc-647dac430bde&name=container.jpg)
Q-tapp Dm Elixir
do not take more than 4 doses in any 24-hour Adults and children 12 years and over 20 mL (4 tsp) every 4 to 6 hours Children 6 years to under 12 years 10 mL (2 tsp) every 4 to 6 hours Children under 6 years DO NOT USE Other information each tsp contains: sodium 2 mg Store at room temperature 20°-25°C (68°-77°F).
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![Alcohol Safeguard (Carboneum Sulphuratum, Carduus Marianus, Ceanothus Americanus, Hepar Suis, Pancreas Suis, Quercus Glandium Spitirus, Ranunculus Bulbosus,) Spray [Liddell Laboratories, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=b1a95331-12d0-42e8-bb46-ed12d3c212d5&name=promethazine-25mg.jpg)
Alcohol Safeguard
Promethazine hydrochloride tablets are contraindicated for children under 2 years of age (see WARNINGS: Black Box Warning and Use in Pediatric Patients).
Allergy
The average oral dose is 25 mg taken before retiring; however, 12.5 mg may be taken before meals and on retiring, if necessary. Single 25 mg doses at bedtime or 6.25 to 12.5 mg taken three times daily will usually suffice. After initiation of treatment in children or adults, dosage should be adjusted to the smallest amount adequate to relieve symptoms. The administration of promethazine HCl in 25 mg doses will control minor transfusion reactions of an allergic nature.
Motion Sickness
The average adult dose is 25 mg taken twice daily. The initial dose should be taken one-half to one hour before anticipated travel and be repeated eight to twelve hours later, if necessary. On succeeding days of travel, it is recommended that 25 mg be given on arising and again before the evening meal. For children, promethazine hydrochloride tablets 12.5 to 25 mg, twice daily, may be administered.
Nausea and Vomiting
Antiemetics should not be used in vomiting of unknown etiology in children and adolescents (see WARNINGS: Use in Pediatric Patients).
The average effective dose of promethazine HCl for the active therapy of nausea and vomiting in children or adults is 25 mg. When oral medication cannot be tolerated, the dose should be given parenterally (promethazine injection) or by rectal suppository. 12.5 mg to 25 mg doses may be repeated, as necessary, at four-to six-hour intervals.
For nausea and vomiting in children, the usual dose is 0.5 mg per pound of body weight, and the dose should be adjusted to the age and weight of the patient and the severity of the condition being treated.
For prophylaxis of nausea and vomiting, as during surgery and the postoperative period, the average dose is 25 mg repeated at four-to six-hour intervals, as necessary.
Sedation
This product relieves apprehension and induces a quiet sleep from which the patient can be easily aroused. Administration of 12.5 to 25 mg promethazine HCl by the oral route or by rectal suppository at bedtime will provide sedation in children. Adults usually require 25 to 50 mg for nighttime, presurgical, or obstetrical sedation.
Pre- and Postoperative Use
Promethazine HCl in 12.5 to 25 mg doses for children and 50 mg doses for adults the night before surgery relieves apprehension and produces a quiet sleep.
For preoperative medication, children require doses of 0.5 mg per pound of body weight in combination with an appropriately reduced dose of narcotic or barbiturate and the appropriate dose of an atropine-like drug.
Usual adult dosage is 50 mg promethazine HCl with an appropriately reduced dose of narcotic or barbiturate and the required amount of a belladonna alkaloid.
Postoperative sedation and adjunctive use with analgesics may be obtained by the administration of 12.5 to 25 mg in children and 25 to 50 mg doses in adults.
Promethazine hydrochloride tablets are contraindicated for children under 2 years of age.
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![Leucovorin Calcium Injection, Powder, Lyophilized, For Solution [App Pharmaceuticals, Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=2d97832e-c6c7-4a06-b83a-f8369c04f51e&name=e6cab8f5-5983-4fa9-9891-3cd8e1b554c9-02.jpg)
Leucovorin Calcium
A small amount of Mupirocin Ointment USP, 2% should be applied to the affected area 3 times daily. The area treated may be covered with a gauze dressing if desired. Patients not showing a clinical response within 3 to 5 days should be re-evaluated.
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![Sumatriptan Succinate Tablet [Preferred Pharmaceuticals, Inc]](http://recallguide.cwdevelopsp.com/wp-content/themes/recallguide/assets/img/drug-image-placeholder.jpg)
Sumatriptan Succinate
In controlled clinical trials, single doses of 25, 50, or 100 mg of sumatriptan succinate tablets were effective for the acute treatment of migraine in adults. There is evidence that doses of 50 and 100 mg may provide a greater effect than 25 mg (see CLINICALTRIALS). There is also evidence that doses of 100 mg do not provide a greater effect than 50 mg. Individuals may vary in response to doses of sumatriptan succinate tablets. The choice of dose should therefore be made on an individual basis, weighing the possible benefit of a higher dose with the potential for a greater risk of adverse events.
If the headache returns or the patient has a partial response to the initial dose, the dose may be repeated after 2 hours, not to exceed a total daily dose of 200 mg. If a headache returns following an initial treatment with sumatriptan succinate injection, additional single sumatriptan succinate tablets (up to 100 mg/day) may be given with an interval of at least 2 hours between tablet doses. The safety of treating an average of more than 4 headaches in a 30-day period has not been established.
Because of the potential of MAO-A inhibitors to cause unpredictable elevations in the bioavailability of oral sumatriptan, their combined use is contraindicated (see CONTRAINDICATIONS).
Hepatic disease/functional impairment may also cause unpredictable elevations in the bioavailability of orally administered sumatriptan. Consequently, if treatment is deemed advisable in the presence of liver disease, the maximum single dose should in general not exceed 50 mg (see CLINICALPHARMACOLOGYfor the basis of this recommendation).
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![Naproxen Sodium (Naproxen Sodium) Tablet [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=c469dded-01b1-46ed-bd20-e5a4eca7a938&name=0dd2d4b5-figure-04.jpg)
Naproxen Sodium
Carefully consider the potential benefits and risks of naproxen sodium tablets and other treatment options before deciding to use naproxen sodium tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with naproxen sodium tablets, the dose and frequency should be adjusted to suit an individual patient's needs.
Different dose strengths and formulations (i.e., tablets, suspension) of the drug are not necessarily bioequivalent. The difference should be taken into consideration when changing formulation.
Although naproxen tablets, naproxen suspension, naproxen delayed-release tablets, and naproxen sodium tablets all circulate in the plasma as naproxen, they have pharmacokinetic differences that may affect onset of action. Onset of pain relief can begin within 30 minutes in patients taking naproxen sodium and within 1 hour in patients taking naproxen. Because naproxen delayed-release tablets dissolve in the small intestine rather than in the stomach, the absorption of the drug is delayed compared to the other naproxen formulations (see CLINICAL PHARMACOLOGY).
The recommended strategy for initiating therapy is to choose a formulation and a starting dose likely to be effective for the patient and then adjust the dosage based on observation of benefit and/or adverse events. A lower dose should be considered in patients with renal or hepatic impairment or in elderly patients (see WARNINGS and PRECAUTIONS).
Geriatric Patients
Studies indicate that although total plasma concentration of naproxen is unchanged, the unbound plasma fraction of naproxen is increased in the elderly. Caution is advised when high doses are required and some adjustment of dosage may be required in elderly patients. As with other drugs used in the elderly, it is prudent to use the lowest effective dose.
Patients With Moderate to Severe Renal Impairment
Naproxen-containing products are not recommended for use in patients with moderate to severe and severe renal impairment (creatinine clearance <30 mL/min) (see WARNINGS: Renal Effects).
Rheumatoid Arthritis, Osteoarthritis and Ankylosing Spondylitis
During long-term administration, the dose of naproxen may be adjusted up or down depending on the clinical response of the patient. A lower daily dose may suffice for long-term administration. The morning and evening doses do not have to be equal in size and the administration of the drug more frequently than twice daily is not necessary.
In patients who tolerate lower doses well, the dose may be increased to naproxen sodium 1650 mg/day for limited periods of up to 6 months when a higher level of antiinflammatory/analgesic activity is required. When treating such patients with naproxen sodium 1650 mg/day, the physician should observe sufficient increased clinical benefits to offset the potential increased risk. The morning and evening doses do not have to be equal in size and administration of the drug more frequently than twice daily does not generally make a difference in response (see CLINICAL PHARMACOLOGY).
Juvenile Arthritis
For the relief of juvenile arthritis, the recommended dose is approximately 10 mg/kg given orally in 2 divided doses (i.e., 5 mg/kg given twice a day). Naproxen sodium tablets are not well suited to this dosage so use of naproxen oral suspension is recommended for this indication.
Management of Pain, Primary Dysmenorrhea, and Acute Tendonitis and Bursitis:
The recommended starting dose is 550 mg of naproxen sodium followed by 550 mg every 12 hours or 275 mg every 6 to 8 hours as required. The initial total daily dose should not exceed 1375 mg of naproxen sodium. Thereafter, the total daily dose should not exceed 1100 mg of naproxen sodium. Because the sodium salt of naproxen is more rapidly absorbed, naproxen sodium tablets are recommended for the management of acute painful conditions when prompt onset of pain relief is desired.
Acute Gout: The recommended starting dose is 825 mg of naproxen sodium tablets followed by 275 mg every 8 hours until the attack has subsided.
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![Sulfasalazine Tablet [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=57d4e53a-d3d6-4f40-8e9b-04b34bd49156&name=MM3.jpg)
Sulfasalazine
The dosage of sulfasalazine tablets should be adjusted to each individual’s response and tolerance.
Initial TherapyAdults: 3 to 4 g daily in evenly divided doses with dosage intervals not exceeding eight hours. In some cases, it is advisable to initiate therapy with a smaller dosage, e.g. 1 to 2 g daily, to reduce possible gastrointestinal intolerance. If daily doses exceeding 4 g are required to achieve desired effects, the increased risk of toxicity should be kept in mind.
Children, six years of age and older: 40 to 60 mg/kg body weight in each 24hour period, divided into 3 to 6 doses.
Maintenance Therapy:
Adults: 2 g daily.
Children, six years of age and older: 30 mg/kg body weight in each 24-hour period, divided into 4 doses.
The response of acute ulcerative colitis to sulfasalazine tablets can be evaluated by clinical criteria, including the presence of fever, weight changes, and degree and frequency of diarrhea and bleeding, as well as by sigmoidoscopy and the evaluation of biopsy samples. It is often necessary to continue medication even when clinical symptoms, including diarrhea, have been controlled. When endoscopic examination confirms satisfactory improvement, the dosage of sulfasalazine should be reduced to a maintenance level. If diarrhea recurs, dosage should be increased to previously effective levels. If symptoms of gastric intolerance (anorexia, nausea, vomiting, etc.) occur after the first few doses of sulfasalazine, they are probably due to increased serum levels of total sulfapyridine and may be alleviated by halving the daily dose of sulfasalazine and subsequently increasing it gradually over several days. If gastric intolerance continues, the drug should be stopped for 5 to 7 days, then reintroduced at a lower daily dose. Some patients may be sensitive to treatment with sulfasalazine. Various desensitization-like regimens have been reported to be effective in 34 of 53 patients,4 7 of 8 patients,5 and 19 of 20 patients.6 These regimens suggest starting with a total daily dose of 50 to 250 mg sulfasalazine initially, and doubling it every 4 to 7 days until the desired therapeutic level is achieved. If the symptoms of sensitivity recur, sulfasalazine should be discontinued. Desensitization should not be attempted in patients who have a history of agranulocytosis, or who have experienced an anaphylactoid reaction while previously receiving sulfasalazine.
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![Degree Clean Antiperspirant And Deodorant (Aluminum Zirconium Tetrachlorohydrex Gly) Stick [Conopco Inc. D/b/a Unilever]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=94a85fdc-6b17-4af8-a0c9-a7cda7c5a686&name=tramadol-hcl-tablets-usp-4.jpg)
Degree Clean Antiperspirant And Deodorant
Adults (17 years of age and over)
For patients with moderate to moderately severe chronic pain not requiring rapid onset of analgesic effect, the tolerability of tramadol hydrochloride tablets, USP can be improved by initiating therapy with a titration regimen: The total daily dose may be increased by 50 mg as tolerated every 3 days to reach 200 mg/day (50 mg q.i.d.). After titration, tramadol hydrochloride tablets, USP 50 to 100 mg can be administered as needed for pain relief every 4 to 6 hours not to exceed 400 mg/day.
For the subset of patients for whom rapid onset of analgesic effect is required and for whom the benefits outweigh the risk of discontinuation due to adverse events associated with higher initial doses, tramadol hydrochloride tablets, USP 50 mg to 100 mg can be administered as needed for pain relief every four to six hours, not to exceed 400 mg per day.
Individualization of Dose
Good pain management practice dictates that the dose be individualized according to patient need using the lowest beneficial dose. Studies with tramadol in adults have shown that starting at the lowest possible dose and titrating upward will result in fewer discontinuations and increased tolerability.
• In all patients with creatinine clearance less than 30 mL/min, it is recommended that the dosing interval of tramadol hydrochloride tablets be increased to 12 hours, with a maximum daily dose of 200 mg. Since only 7% of an administered dose is removed by hemodialysis, dialysis patients can receive their regular dose on the day of dialysis. • The recommended dose for adult patients with cirrhosis is 50 mg every 12 hours. • In general, dose selection for an elderly patient over 65 years old should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function and of concomitant disease or other drug therapy. For elderly patients over 75 years old, total dose should not exceed 300 mg/day. -
![Nasal (Oxymetazoline Hydrochloride) Spray [Meijer Distribution Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=6270ee8b-fa2c-4f06-8eaf-fc81716d9921&name=image-01.jpg)
Nasal
• drink plenty of clear fluids to help prevent dehydration caused by diarrhea • find right dose on chart. If possible, use weight to dose; otherwise use age. • shake well before using • only use attached measuring cup to dose product
adults and children
12 years and over
30 mL (6 tsp) after the first loose stool; 15 mL (3 tsp) after each subsequent loose stool; but no more than 60 mL (12 tsp) in 24 hours
children 9-11 years
(60-95 lbs)
15 mL (3 tsp) after the first loose stool; 7.5 mL (1 1/2 tsp) after each subsequent loose stool; but no more than 45 mL (9 tsp) in 24 hours
children 6-8 years
(48-59 lbs)
15 mL (3 tsp) after the first loose stool; 7.5 mL (1 1/2 tsp) after each subsequent loose stool; but no more than 30 mL (6 tsp) in 24 hours
children under
6 years
(up to 47 lbs)
ask a doctor
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![Q-tussin (Guaifenesin) Solution [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=36231ec1-97c0-4931-a689-ac74268a6bb7&name=q-tussin-1.jpg)
Q-tussin
do not take more than 6 doses in any 24-hour period this adult product is not intended for use in children under 12 years of age
age (yr)
dose (tsp)
adults and children12 years and over
2 - 4 teaspoonsevery 4 hours
children under12 years
do not use
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![Qdryl Allergy (Diphenhydramine Hydrochloride) Solution [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=7169248d-ee02-45bd-b689-14bcbb078df6&name=q-dryl-allergy-cherry-flavor-2.jpg)
Qdryl Allergy
use an accurate measuring device to administer this medication take every 4 to 6 hours children under 2 years do not use
children 2 to 5 years
ask a doctorchildren 6 years to under 12 years
5 mL (1 tsp) to 10 mL (2 tsp); not more than 60 mL (12 tsp) in 24 hours
adults and children 12 years and over
10 mL (2 tsp) to 20 mL (4 tsp); not more than 120 mL (24 tsp) in 24 hours -
![Terbinafine Hydrochloride Tablet [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=5831d093-9a92-43c2-a384-1ba1537dbcf7&name=terbinafine-01.jpg)
Terbinafine Hydrochloride
Fingernail onychomycosis: One 250 mg tablet once daily for 6 weeks.
Toenail onychomycosis: One 250 mg tablet once daily for 12 weeks.
The optimal clinical effect is seen some months after mycological cure and cessation of treatment. This is related to the period required for outgrowth of healthy nail.
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![Nitroglycerin Tablet [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=43a04d8f-9dc1-4760-98fc-8f976ddc8a4b&name=78fd9e96-6bfc-4c36-b1da-3a63473aade9-05.jpg)
Nitroglycerin
One tablet should be dissolved under the tongue or in the buccal pouch at the first sign of an acute anginal attack. The dose may be repeated approximately every five minutes, until relief is obtained. If the pain persists after a total of 3 tablets in a 15-minute period, prompt medical attention is recommended. Nitroglycerin tablets USP may be used prophylactically 5 to 10 minutes prior to engaging in activities which might precipitate an acute attack.
During administration the patient should rest, preferably in the sitting position.
No dosage adjustment is required in patients with renal failure.
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![Promethazine Dm (Dextromethorphan Hydrobromide And Promethazine Hydrochloride) Syrup [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=43dd6bbb-89ee-4a0d-bb62-ebd7e70c3d9b&name=promethazinedmsyrp-3.jpg)
Promethazine Dm
Promethazine hydrochloride and dextromethorphan hydrobromide syrup is contraindicated for children under 2 years of age (see WARNINGS –Black Box Warning and Use In Pediatric Patients).
The average effective dose is given in the following table:
Adults
1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 30 mL in 24 hours.
Children 6 Years To Under 12 Years
½ to 1 teaspoonful (2.5 to 5 mL) every 4 to 6 hours, not to exceed 20 mL in 24 hours.
Children 2 Years To Under 6 Years
¼ to ½ teaspoonful (1.25 to 2.5 mL) every 4 to 6 hours, not to exceed 10 mL in 24 hours.
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![Siltussin Sa (Guaifenesin) Liquid [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=264abf3d-c466-4209-b911-29ce18b0b816&name=containerlabel.jpg)
Siltussin Sa
do not take more than 6 doses in any 24-hour period repeat dose every 4 hours adults and children 12 years and over 2-4 teaspoonfuls children under 12 years DO NOT USE Other information Store at room temperature 20°-25°C (68°-77°F). Do not accept if imprinted tamperevident safety seal around cap is broken or missing.
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![Siltussin Dm (Guaifenesin And Dextromethorphan Hydrobromide) Liquid [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=9dc928f7-d07e-4b1e-ae12-18a2fbd3226b&name=container.jpg)
Siltussin Dm
do not take more than 6 doses in any 24-hour period. This adult product is not intended for use in children under 12 years of age Adults and children 12 years and over 2 teaspoonfuls (10 mL)every 4 hours Children under 12 years DO NOT USE
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![Promethazine Vc (Promethazinehydrochloride And Phenylephrine Hydrochloride) Syrup [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=b00b296d-6c34-48c8-9cfb-71ccc5c9a908&name=promethazinevcsyrp-3.jpg)
Promethazine Vc
Promethazine hydrochloride and phenylephrine hydrochloride syrup is contraindicated for children under 2 years of age (see WARNINGS – Black Box Warning and Use In Pediatric Patients).
The recommended doses are given in the following table:
Adults And Children 12 Years And Over
1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 6 teaspoonsful (30 mL) in 24 hours.
Children 6 To Under 12 Years Of Age
½ to 1 teaspoonful (2.5 to 5 mL) every 4 to 6 hours, not to exceed 6 teaspoonsful (30 mL) in 24 hours.
Children 2 To Under 6 Years Of Age
¼ to ½ teaspoonful (1.25 to 2.5 mL) every 4 to 6 hours.
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![Q Tussin Dm (Dextromethorphan Hbr And Guaifenesin) Syrup [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=7e2ca78a-5479-48e3-9497-8884d24236e7&name=q-tussin-dm-0855-1.jpg)
Q Tussin Dm
do not take more than 6 doses in any 24-hour period this adult product is not intended for use in children under 12 years of age
age (yr)
dose (tsp)
adults and children12 years and over
2 teaspoonsevery 4 hours
children under12 years
do not use
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![Spironolactone Tablet [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=7a0bba98-8f39-4020-b2a5-c487278a057a&name=25mgpackagelabel.jpg)
Spironolactone
Primary Hyperaldosteronism: Spironolactone may be employed as an initial diagnostic measure to provide presumptive evidence of primary hyperaldosteronism while patients are on normal diets.
Long Test:Spironolactone is administered at a daily dosage of 400 mg for three to four weeks. Correction of hypokalemia and of hypertension provides presumptive evidence for the diagnosis of primary hyperaldosteronism.
Short Test: Spironolactone is administered at a daily dosage of 400 mg for four days. If serum potassium increases during spironolactone administration but drops when spironolactone is discontinued, a presumptive diagnosis of primary hyperaldosteronism should be considered.
After the diagnosis of hyperaldosteronism has been established by more definitive testing procedures, spironolactone may be administered in doses of 100 to 400 mg daily in preparation for surgery. For patients who are considered unsuitable for surgery, spironolactone may be employed for long-term maintenance therapy at the lowest effective dosage determined for the individual patient.
Edema In Adults (Congestive Heart Failure, Hepatic Cirrhosis, Or Nephrotic Syndrome). An initial daily dosage of 100 mg of spironolactone administered in either single or divided doses is recommended, but may range from 25 to 200 mg daily. When given as the sole agent for diuresis, spironolactone should be continued for at least five days at the initial dosage level, after which it may be adjusted to the optimal therapeutic or maintenance level administered in either single or divided daily doses. If, after five days, an adequate diuretic response to spironolactone has not occurred, a second diuretic which acts more proximally in the renal tubule may be added to the regimen. Because of the additive effect of spironolactone when administered concurrently with such diuretics, an enhanced diuresis usually begins on the first day of combined treatment; combined therapy is indicated when more rapid diuresis is desired. The dosage of spironolactone should remain unchanged when other diuretic therapy is added.
Essential Hypertension: For adults, an initial daily dosage of 50 to 100 mg of spironolactone administered in either single or divided doses is recommended. Spironolactone may also be given with diuretics which act more proximally in the renal tubule or with other antihypertensive agents. Treatment with spironolactone should be continued for at least two weeks, since the maximum response may not occur before this time. Subsequently, dosage should be adjusted according to the response of the patient.
Hypokalemia: Spironolactone in a dosage ranging from 25 mg to 100 mg daily is useful in treating a diuretic-induced hypokalemia, when oral potassium supplements or other potassium-sparing regimens are considered inappropriate.
Severe heart failure (NYHA class III – IV): Treatment should be initiated with spironolactone 25 mg once daily if the patient’s serum potassium is ≤5.0 mEq/L and the patient’s serum creatinine is ≤ 2.5 mg/dL. Patients who tolerate 25 mg once daily may have their dosage increased to 50 mg once daily as clinically indicated. Patients who do not tolerate 25 mg once-daily dose may have their dosage reduced to 25 mg every other day. See WARNINGS: Hyperkalemia in patients with severe heart failure for advice on monitoring serum potassium and serum creatinine.
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![Mupirocin Ointment [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=2289900b-889b-4536-9ed0-3bddb20c9387&name=mupirocin-02.jpg)
Mupirocin Ointment
A small amount of mupirocin ointment should be applied to the affected area 3 times daily. The area treated may be covered with a gauze dressing if desired. Patients not showing a clinical response within 3 to 5 days should be re-evaluated.
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![Orphenadrine Citrate Tablet, Extended Release [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=0f50125a-6d89-4b2b-b48b-daac6129182c&name=7b76c8a7-dd0c-481c-8299-26dfd38ce066-02.jpg)
Orphenadrine Citrate
Adults
Two tablets per day; one in the morning and one in the evening.
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![Healthy Accents Milk Of Magnesia (Magnesium Hydroxide) Liquid [Dza Brands Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=db142333-5880-44ed-9fc7-db21bff3c66e&name=image-07.jpg)
Healthy Accents Milk Of Magnesia
Carefully consider the potential benefits and risks of naproxen, naproxen sodium and other treatment options before deciding to use naproxen tablets and naproxen sodium tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with naproxen or naproxen sodium, the dose and frequency should be adjusted to suit an individual patient's needs.
Different dose strengths and formulations (ie, tablets, suspension) of the drug are not necessarily bioequivalent. This difference should be taken into consideration when changing formulation.
Although naproxen and naproxen sodium circulate in the plasma as naproxen, they have pharmacokinetic differences that may affect onset of action. Onset of pain relief can begin within 30 minutes in patients taking naproxen sodium and within 1 hour in patients taking naproxen.
The recommended strategy for initiating therapy is to choose a formulation and a starting dose likely to be effective for the patient and then adjust the dosage based on observation of benefit and/or adverse events. A lower dose should be considered in patients with renal or hepatic impairment or in elderly patients (see WARNINGS and PRECAUTIONS).
Geriatric Patients
Studies indicate that although total plasma concentration of naproxen is unchanged, the unbound plasma fraction of naproxen is increased in the elderly. Caution is advised when high doses are required and some adjustment of dosage may be required in elderly patients. As with other drugs used in the elderly, it is prudent to use the lowest effective dose.
Patients With Moderate to Severe Renal Impairment
Naproxen-containing products are not recommended for use in patients with moderate to severe and severe renal impairment (creatinine clearance <30 mL/min) (see WARNINGS: Renal Effects).
Rheumatoid Arthritis, Osteoarthritis and Ankylosing SpondylitisNaproxen
250 mg
or 375 mg
or 500 mg
twice daily
twice daily
twice daily
Naproxen sodium
275 mg (naproxen 250 mg with 25 mg sodium)
550 mg (naproxen 500 mg with 50 mg sodium)
twice daily
twice daily
During long-term administration, the dose of naproxen may be adjusted up or down depending on the clinical response of the patient. A lower daily dose may suffice for long-term administration. The morning and evening doses do not have to be equal in size and the administration of the drug more frequently than twice daily is not necessary.
In patients who tolerate lower doses well, the dose may be increased to naproxen 1500 mg/day for limited periods of up to 6 months when a higher level of anti-inflammatory/analgesic activity is required. When treating such patients with naproxen 1500 mg/day, the physician should observe sufficient increased clinical benefits to offset the potential increased risk. The morning and evening doses do not have to be equal in size and administration of the drug more frequently than twice daily does not generally make a difference in response (see CLINICAL PHARMACOLOGY).
Juvenile Arthritis
The recommended total daily dose of naproxen is approximately 10 mg/kg given in 2 divided doses (ie, 5 mg/kg given twice a day).
Management of Pain, Primary Dysmenorrhea, and Acute Tendonitis and Bursitis
The recommended starting dose is 550 mg of naproxen sodium as naproxen sodium tablet followed by 550 mg every 12 hours or 275 mg every 6 to 8 hours as required. The initial total daily dose should not exceed 1375 mg of naproxen sodium. Thereafter, the total daily dose should not exceed 1100 mg of naproxen sodium. Because the sodium salt of naproxen is more rapidly absorbed, naproxen sodium tablets are recommended for the management of acute painful conditions when prompt onset of pain relief is desired. Naproxen may also be used for initial treatment of acute pain because absorption of naproxen is delayed compared to other naproxen-containing products (see CLINICAL PHARMACOLOGY, INDICATIONS AND USAGE).
Acute Gout
The recommended starting dose is 750 mg of naproxen followed by 250 mg every 8 hours until the attack has subsided. Naproxen sodium may also be used at a starting dose of 825 mg followed by 275 mg every 8 hours.
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![Levothyroxine Sodium Tablet [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=f887a801-744c-43c2-81d6-6433b1089667&name=levothyroxine-sodium-tablets-usp-7.jpg)
Levothyroxine Sodium
General Principles:
The goal of replacement therapy is to achieve and maintain a clinical and biochemical euthyroid state. The goal of suppressive therapy is to inhibit growth and/or function of abnormal thyroid tissue. The dose of Levothyroxine Sodium Tablets, USP that is adequate to achieve these goals depends on a variety of factors including the patient's age, body weight, cardiovascular status, concomitant medical conditions, including pregnancy, concomitant medications, and the specific nature of the condition being treated (see WARNINGS and PRECAUTIONS). Hence, the following recommendations serve only as dosing guidelines. Dosing must be individualized and adjustments made based on periodic assessment of the patient's clinical response and laboratory parameters (see PRECAUTIONS, Laboratory Tests).
Levothyroxine Sodium Tablets, USP should be taken in the morning on an empty stomach, at least one-half hour to one hour before any food is eaten. Levothyroxine Sodium Tablets, USP should be taken at least 4 hours apart from drugs that are known to interfere with its absorption (see PRECAUTIONS, Drug Interactions).
Due to the long half-life of levothyroxine, the peak therapeutic effect at a given dose of levothyroxine sodium may not be attained for 4-6 weeks.
Caution should be exercised when administering Levothyroxine Sodium Tablets, USP to patients with underlying cardiovascular disease, to the elderly, and to those with concomitant adrenal insufficiency (see PRECAUTIONS).
Specific Patient Populations:
Hypothyroidism in Adults and in Children in Whom Growth and Puberty are Complete (see WARNINGS and PRECAUTIONS, Laboratory Tests).
Therapy may begin at full replacement doses in otherwise healthy individuals less than 50 years old and in those older than 50 years who have been recently treated for hyperthyroidism or who have been hypothyroid for only a short time (such as a few months). The average full replacement dose of levothyroxine sodium is approximately 1.7 mcg/kg/day (e.g., 100-125 mcg/day for a 70 kg adult). Older patients may require less than 1 mcg/kg/day. Levothyroxine sodium doses greater than 200 mcg/day are seldom required. An inadequate response to daily doses ≥ 300 mcg/day is rare and may indicate poor compliance, malabsorption, and/or drug interactions.
For most patients older than 50 years or for patients under 50 years of age with underlying cardiac disease, an initial starting dose of 25-50 mcg/day of levothyroxine sodium is recommended, with gradual increments in dose at 6-8 week intervals, as needed. The recommended starting dose of levothyroxine sodium in elderly patients with cardiac disease is 12.5-25 mcg/day, with gradual dose increments at 4-6 week intervals. The levothyroxine sodium dose is generally adjusted in 12.5-25 mcg increments until the patient with primary hypothyroidism is clinically euthyroid and the serum TSH has normalized.
In patients with severe hypothyroidism, the recommended initial levothyroxine sodium dose is 12.5-25 mcg/day with increases of 25 mcg/day every 2-4 weeks, accompanied by clinical and laboratory assessment, until the TSH level is normalized.
In patients with secondary (pituitary) or tertiary (hypothalamic) hypothyroidism, the levothyroxine sodium dose should be titrated until the patient is clinically euthyroid and the serum free-T4 level is restored to the upper half of the normal range.
Pediatric Dosage - Congenital or Acquired Hypothyroidism (see PRECAUTIONS, Laboratory Tests)
General Principles
In general, levothyroxine therapy should be instituted at full replacement doses as soon as possible. Delays in diagnosis and institution of therapy may have deleterious effects on the child's intellectual and physical growth and development.
Undertreatment and overtreatment should be avoided (see PRECAUTIONS, Pediatric Use).
Levothyroxine Sodium Tablets, USP may be administered to infants and children who cannot swallow intact tablets by crushing the tablet and suspending the freshly crushed tablet in a small amount (5-10 mL or 1-2 teaspoons) of water. This suspension can be administered by spoon or dropper. DO NOT STORE THE SUSPENSION. Foods that decrease absorption of levothyroxine, such as soybean infant formula, should not be used for administering levothyroxine sodium tablets. (see PRECAUTIONS, Drug-Food Interactions).
Newborns
The recommended starting dose of levothyroxine sodium in newborn infants is 10-15 mcg/kg/day. A lower starting dose (e.g., 25 mcg/day) should be considered in infants at risk for cardiac failure, and the dose should be increased in 4-6 weeks as needed based on clinical and laboratory response to treatment. In infants with very low (< 5 mcg/dL) or undetectable serum T4 concentrations, the recommended initial starting dose is 50 mcg/day of levothyroxine sodium.
Infants and Children
Levothyroxine therapy is usually initiated at full replacement doses, with the recommended dose per body weight decreasing with age (see TABLE 3). However, in children with chronic or severe hypothyroidism, an initial dose of 25 mcg/day of levothyroxine sodium is recommended with increments of 25 mcg every 2-4 weeks until the desired effect is achieved.
Hyperactivity in an older child can be minimized if the starting dose is one-fourth of the recommended full replacement dose, and the dose is then increased on a weekly basis by an amount equal to one-fourth the full-recommended replacement dose until the full recommended replacement dose is reached.
Table 3: Levothyroxine Sodium Dosing Guidelines for Pediatric Hypothyroidism a. The dose should be adjusted based on clinical response and laboratory parameters (see PRECAUTlONS, Laboratory Tests and Pediatric Use).AGE
Daily Dose Per Kg Body Weighta
0-3 months
10-15 mcg/kg/day
3-6 months
8-10 mcg/kg/day
6-12 months
6-8 mcg/kg/day
1-5 years
5-6 mcg/kg/day
6-12 years
4-5 mcg/kg/day
>12 years but growth and puberty incomplete
2-3 mcg/kg/day
Growth and puberty complete
1.7 mcg/kg/day
Pregnancy- Pregnancy may increase levothyroxine requirements (see PREGNANCY).
Subclinical Hypothyroidism- If this condition is treated, a lower levothyroxine sodium dose (e.g., 1 mcg/kg/day) than that used for full replacement may be adequate to normalize the serum TSH level. Patients who are not treated should be monitored yearly for changes in clinical status and thyroid laboratory parameters.
TSH Suppression in Well-differentiated Thyroid Cancer and Thyroid Nodules- The target level for TSH suppression in these conditions has not been established with controlled studies. In addition, the efficacy of TSH suppression for benign nodular disease is controversial. Therefore, the dose of Levothyroxine Sodium Tablets, USP used for TSH suppression should be individualized based on the specific disease and the patient being treated.
In the treatment of well differentiated (papillary and follicular) thyroid cancer, levothyroxine is used as an adjunct to surgery and radioiodine therapy. Generally, TSH is suppressed to <0.1 mU/L, and this usually requires a levothyroxine sodium dose of greater than 2 mcg/kg/day. However, in patients with high-risk tumors, the target level for TSH suppression may be <0.01 mU/L.
In the treatment of benign nodules and nontoxic multinodular goiter, TSH is generally suppressed to a higher target (e.g., 0.1-0.5 mU/L for nodules and 0.5-1.0 mU/L for multinodular goiter) than that used for the treatment of thyroid cancer. Levothyroxine sodium is contraindicated if the serum TSH is already suppressed due to the risk of precipitating overt thyrotoxicosis (see CONTRAINDICATIONS, WARNINGS and PRECAUTIONS).
Myxedema Coma - Myxedema coma is a life-threatening emergency characterized by poor circulation and hypometabolism, and may result in unpredictable absorption of levothyroxine sodium from the gastrointestinal tract. Therefore, oral thyroid hormone drug products are not recommended to treat this condition. Thyroid hormone products formulated for intravenous administration should be administered.
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![Levothyroxine Sodium Tablet [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=6977f0ea-3343-4f99-bcc6-85acfeb69710&name=levothyroxine-sodium-tablets-usp-12.jpg)
Levothyroxine Sodium
General Principles:
The goal of replacement therapy is to achieve and maintain a clinical and biochemical euthyroid state. The goal of suppressive therapy is to inhibit growth and/or function of abnormal thyroid tissue. The dose of Levothyroxine Sodium Tablets, USP that is adequate to achieve these goals depends on a variety of factors including the patient's age, body weight, cardiovascular status, concomitant medical conditions, including pregnancy, concomitant medications, and the specific nature of the condition being treated (see WARNINGS and PRECAUTIONS). Hence, the following recommendations serve only as dosing guidelines. Dosing must be individualized and adjustments made based on periodic assessment of the patient's clinical response and laboratory parameters (see PRECAUTIONS, Laboratory Tests).
Levothyroxine Sodium Tablets, USP should be taken in the morning on an empty stomach, at least one-half hour to one hour before any food is eaten. Levothyroxine Sodium Tablets, USP should be taken at least 4 hours apart from drugs that are known to interfere with its absorption (see PRECAUTIONS, Drug Interactions).
Due to the long half-life of levothyroxine, the peak therapeutic effect at a given dose of levothyroxine sodium may not be attained for 4-6 weeks.
Caution should be exercised when administering Levothyroxine Sodium Tablets, USP to patients with underlying cardiovascular disease, to the elderly, and to those with concomitant adrenal insufficiency (see PRECAUTIONS).
Specific Patient Populations:
Hypothyroidism in Adults and in Children in Whom Growth and Puberty are Complete (see WARNINGS and PRECAUTIONS, Laboratory Tests).
Therapy may begin at full replacement doses in otherwise healthy individuals less than 50 years old and in those older than 50 years who have been recently treated for hyperthyroidism or who have been hypothyroid for only a short time (such as a few months). The average full replacement dose of levothyroxine sodium is approximately 1.7 mcg/kg/day (e.g., 100-125 mcg/day for a 70 kg adult). Older patients may require less than 1 mcg/kg/day. Levothyroxine sodium doses greater than 200 mcg/day are seldom required. An inadequate response to daily doses ≥ 300 mcg/day is rare and may indicate poor compliance, malabsorption, and/or drug interactions.
For most patients older than 50 years or for patients under 50 years of age with underlying cardiac disease, an initial starting dose of 25-50 mcg/day of levothyroxine sodium is recommended, with gradual increments in dose at 6-8 week intervals, as needed. The recommended starting dose of levothyroxine sodium in elderly patients with cardiac disease is 12.5-25 mcg/day, with gradual dose increments at 4-6 week intervals. The levothyroxine sodium dose is generally adjusted in 12.5-25 mcg increments until the patient with primary hypothyroidism is clinically euthyroid and the serum TSH has normalized.
In patients with severe hypothyroidism, the recommended initial levothyroxine sodium dose is 12.5-25 mcg/day with increases of 25 mcg/day every 2-4 weeks, accompanied by clinical and laboratory assessment, until the TSH level is normalized.
In patients with secondary (pituitary) or tertiary (hypothalamic) hypothyroidism, the levothyroxine sodium dose should be titrated until the patient is clinically euthyroid and the serum free-T4 level is restored to the upper half of the normal range.
Pediatric Dosage - Congenital or Acquired Hypothyroidism (see PRECAUTIONS, Laboratory Tests)
General Principles
In general, levothyroxine therapy should be instituted at full replacement doses as soon as possible. Delays in diagnosis and institution of therapy may have deleterious effects on the child's intellectual and physical growth and development.
Undertreatment and overtreatment should be avoided (see PRECAUTIONS, Pediatric Use).
Levothyroxine Sodium Tablets, USP may be administered to infants and children who cannot swallow intact tablets by crushing the tablet and suspending the freshly crushed tablet in a small amount (5-10 mL or 1-2 teaspoons) of water. This suspension can be administered by spoon or dropper. DO NOT STORE THE SUSPENSION. Foods that decrease absorption of levothyroxine, such as soybean infant formula, should not be used for administering levothyroxine sodium tablets. (see PRECAUTIONS, Drug-Food Interactions).
Newborns
The recommended starting dose of levothyroxine sodium in newborn infants is 10-15 mcg/kg/day. A lower starting dose (e.g., 25 mcg/day) should be considered in infants at risk for cardiac failure, and the dose should be increased in 4-6 weeks as needed based on clinical and laboratory response to treatment. In infants with very low (< 5 mcg/dL) or undetectable serum T4 concentrations, the recommended initial starting dose is 50 mcg/day of levothyroxine sodium.
Infants and Children
Levothyroxine therapy is usually initiated at full replacement doses, with the recommended dose per body weight decreasing with age (see TABLE 3). However, in children with chronic or severe hypothyroidism, an initial dose of 25 mcg/day of levothyroxine sodium is recommended with increments of 25 mcg every 2-4 weeks until the desired effect is achieved.
Hyperactivity in an older child can be minimized if the starting dose is one-fourth of the recommended full replacement dose, and the dose is then increased on a weekly basis by an amount equal to one-fourth the full-recommended replacement dose until the full recommended replacement dose is reached.
Table 3: Levothyroxine Sodium Dosing Guidelines for Pediatric Hypothyroidism a. The dose should be adjusted based on clinical response and laboratory parameters (see PRECAUTlONS, Laboratory Tests and Pediatric Use).AGE
Daily Dose Per Kg Body Weighta
0-3 months
10-15 mcg/kg/day
3-6 months
8-10 mcg/kg/day
6-12 months
6-8 mcg/kg/day
1-5 years
5-6 mcg/kg/day
6-12 years
4-5 mcg/kg/day
>12 years but growth and puberty incomplete
2-3 mcg/kg/day
Growth and puberty complete
1.7 mcg/kg/day
Pregnancy- Pregnancy may increase levothyroxine requirements (see PREGNANCY).
Subclinical Hypothyroidism- If this condition is treated, a lower levothyroxine sodium dose (e.g., 1 mcg/kg/day) than that used for full replacement may be adequate to normalize the serum TSH level. Patients who are not treated should be monitored yearly for changes in clinical status and thyroid laboratory parameters.
TSH Suppression in Well-differentiated Thyroid Cancer and Thyroid Nodules- The target level for TSH suppression in these conditions has not been established with controlled studies. In addition, the efficacy of TSH suppression for benign nodular disease is controversial. Therefore, the dose of Levothyroxine Sodium Tablets, USP used for TSH suppression should be individualized based on the specific disease and the patient being treated.
In the treatment of well differentiated (papillary and follicular) thyroid cancer, levothyroxine is used as an adjunct to surgery and radioiodine therapy. Generally, TSH is suppressed to <0.1 mU/L, and this usually requires a levothyroxine sodium dose of greater than 2 mcg/kg/day. However, in patients with high-risk tumors, the target level for TSH suppression may be <0.01 mU/L.
In the treatment of benign nodules and nontoxic multinodular goiter, TSH is generally suppressed to a higher target (e.g., 0.1-0.5 mU/L for nodules and 0.5-1.0 mU/L for multinodular goiter) than that used for the treatment of thyroid cancer. Levothyroxine sodium is contraindicated if the serum TSH is already suppressed due to the risk of precipitating overt thyrotoxicosis (see CONTRAINDICATIONS, WARNINGS and PRECAUTIONS).
Myxedema Coma - Myxedema coma is a life-threatening emergency characterized by poor circulation and hypometabolism, and may result in unpredictable absorption of levothyroxine sodium from the gastrointestinal tract. Therefore, oral thyroid hormone drug products are not recommended to treat this condition. Thyroid hormone products formulated for intravenous administration should be administered.
-
![Levothyroxine Sodium Tablet [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=48428150-629d-4745-9238-18c52cb2adf8&name=levothyroxine-sodium-tablets-usp-10.jpg)
Levothyroxine Sodium
General Principles:
The goal of replacement therapy is to achieve and maintain a clinical and biochemical euthyroid state. The goal of suppressive therapy is to inhibit growth and/or function of abnormal thyroid tissue. The dose of Levothyroxine Sodium Tablets, USP that is adequate to achieve these goals depends on a variety of factors including the patient's age, body weight, cardiovascular status, concomitant medical conditions, including pregnancy, concomitant medications, and the specific nature of the condition being treated (see WARNINGS and PRECAUTIONS). Hence, the following recommendations serve only as dosing guidelines. Dosing must be individualized and adjustments made based on periodic assessment of the patient's clinical response and laboratory parameters (see PRECAUTIONS, Laboratory Tests).
Levothyroxine Sodium Tablets, USP should be taken in the morning on an empty stomach, at least one-half hour to one hour before any food is eaten. Levothyroxine Sodium Tablets, USP should be taken at least 4 hours apart from drugs that are known to interfere with its absorption (see PRECAUTIONS, Drug Interactions).
Due to the long half-life of levothyroxine, the peak therapeutic effect at a given dose of levothyroxine sodium may not be attained for 4-6 weeks.
Caution should be exercised when administering Levothyroxine Sodium Tablets, USP to patients with underlying cardiovascular disease, to the elderly, and to those with concomitant adrenal insufficiency (see PRECAUTIONS).
Specific Patient Populations:
Hypothyroidism in Adults and in Children in Whom Growth and Puberty are Complete (see WARNINGS and PRECAUTIONS, Laboratory Tests).
Therapy may begin at full replacement doses in otherwise healthy individuals less than 50 years old and in those older than 50 years who have been recently treated for hyperthyroidism or who have been hypothyroid for only a short time (such as a few months). The average full replacement dose of levothyroxine sodium is approximately 1.7 mcg/kg/day (e.g., 100-125 mcg/day for a 70 kg adult). Older patients may require less than 1 mcg/kg/day. Levothyroxine sodium doses greater than 200 mcg/day are seldom required. An inadequate response to daily doses ≥ 300 mcg/day is rare and may indicate poor compliance, malabsorption, and/or drug interactions.
For most patients older than 50 years or for patients under 50 years of age with underlying cardiac disease, an initial starting dose of 25-50 mcg/day of levothyroxine sodium is recommended, with gradual increments in dose at 6-8 week intervals, as needed. The recommended starting dose of levothyroxine sodium in elderly patients with cardiac disease is 12.5-25 mcg/day, with gradual dose increments at 4-6 week intervals. The levothyroxine sodium dose is generally adjusted in 12.5-25 mcg increments until the patient with primary hypothyroidism is clinically euthyroid and the serum TSH has normalized.
In patients with severe hypothyroidism, the recommended initial levothyroxine sodium dose is 12.5-25 mcg/day with increases of 25 mcg/day every 2-4 weeks, accompanied by clinical and laboratory assessment, until the TSH level is normalized.
In patients with secondary (pituitary) or tertiary (hypothalamic) hypothyroidism, the levothyroxine sodium dose should be titrated until the patient is clinically euthyroid and the serum free-T4 level is restored to the upper half of the normal range.
Pediatric Dosage - Congenital or Acquired Hypothyroidism (see PRECAUTIONS, Laboratory Tests)
General Principles
In general, levothyroxine therapy should be instituted at full replacement doses as soon as possible. Delays in diagnosis and institution of therapy may have deleterious effects on the child's intellectual and physical growth and development.
Undertreatment and overtreatment should be avoided (see PRECAUTIONS, Pediatric Use).
Levothyroxine Sodium Tablets, USP may be administered to infants and children who cannot swallow intact tablets by crushing the tablet and suspending the freshly crushed tablet in a small amount (5-10 mL or 1-2 teaspoons) of water. This suspension can be administered by spoon or dropper. DO NOT STORE THE SUSPENSION. Foods that decrease absorption of levothyroxine, such as soybean infant formula, should not be used for administering levothyroxine sodium tablets. (see PRECAUTIONS, Drug-Food Interactions).
Newborns
The recommended starting dose of levothyroxine sodium in newborn infants is 10-15 mcg/kg/day. A lower starting dose (e.g., 25 mcg/day) should be considered in infants at risk for cardiac failure, and the dose should be increased in 4-6 weeks as needed based on clinical and laboratory response to treatment. In infants with very low (< 5 mcg/dL) or undetectable serum T4 concentrations, the recommended initial starting dose is 50 mcg/day of levothyroxine sodium.
Infants and Children
Levothyroxine therapy is usually initiated at full replacement doses, with the recommended dose per body weight decreasing with age (see TABLE 3). However, in children with chronic or severe hypothyroidism, an initial dose of 25 mcg/day of levothyroxine sodium is recommended with increments of 25 mcg every 2-4 weeks until the desired effect is achieved.
Hyperactivity in an older child can be minimized if the starting dose is one-fourth of the recommended full replacement dose, and the dose is then increased on a weekly basis by an amount equal to one-fourth the full-recommended replacement dose until the full recommended replacement dose is reached.
Table 3: Levothyroxine Sodium Dosing Guidelines for Pediatric Hypothyroidism a. The dose should be adjusted based on clinical response and laboratory parameters (see PRECAUTlONS, Laboratory Tests and Pediatric Use).AGE
Daily Dose Per Kg Body Weighta
0-3 months
10-15 mcg/kg/day
3-6 months
8-10 mcg/kg/day
6-12 months
6-8 mcg/kg/day
1-5 years
5-6 mcg/kg/day
6-12 years
4-5 mcg/kg/day
>12 years but growth and puberty incomplete
2-3 mcg/kg/day
Growth and puberty complete
1.7 mcg/kg/day
Pregnancy- Pregnancy may increase levothyroxine requirements (see PREGNANCY).
Subclinical Hypothyroidism- If this condition is treated, a lower levothyroxine sodium dose (e.g., 1 mcg/kg/day) than that used for full replacement may be adequate to normalize the serum TSH level. Patients who are not treated should be monitored yearly for changes in clinical status and thyroid laboratory parameters.
TSH Suppression in Well-differentiated Thyroid Cancer and Thyroid Nodules- The target level for TSH suppression in these conditions has not been established with controlled studies. In addition, the efficacy of TSH suppression for benign nodular disease is controversial. Therefore, the dose of Levothyroxine Sodium Tablets, USP used for TSH suppression should be individualized based on the specific disease and the patient being treated.
In the treatment of well differentiated (papillary and follicular) thyroid cancer, levothyroxine is used as an adjunct to surgery and radioiodine therapy. Generally, TSH is suppressed to <0.1 mU/L, and this usually requires a levothyroxine sodium dose of greater than 2 mcg/kg/day. However, in patients with high-risk tumors, the target level for TSH suppression may be <0.01 mU/L.
In the treatment of benign nodules and nontoxic multinodular goiter, TSH is generally suppressed to a higher target (e.g., 0.1-0.5 mU/L for nodules and 0.5-1.0 mU/L for multinodular goiter) than that used for the treatment of thyroid cancer. Levothyroxine sodium is contraindicated if the serum TSH is already suppressed due to the risk of precipitating overt thyrotoxicosis (see CONTRAINDICATIONS, WARNINGS and PRECAUTIONS).
Myxedema Coma - Myxedema coma is a life-threatening emergency characterized by poor circulation and hypometabolism, and may result in unpredictable absorption of levothyroxine sodium from the gastrointestinal tract. Therefore, oral thyroid hormone drug products are not recommended to treat this condition. Thyroid hormone products formulated for intravenous administration should be administered.
-
![Levothyroxine Sodium Tablet [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=1ad32038-f484-4469-93fe-d3da81d8b9ea&name=levothyroxine-sodium-tablets-usp-6.jpg)
Levothyroxine Sodium
General Principles:
The goal of replacement therapy is to achieve and maintain a clinical and biochemical euthyroid state. The goal of suppressive therapy is to inhibit growth and/or function of abnormal thyroid tissue. The dose of Levothyroxine Sodium Tablets, USP that is adequate to achieve these goals depends on a variety of factors including the patient's age, body weight, cardiovascular status, concomitant medical conditions, including pregnancy, concomitant medications, and the specific nature of the condition being treated (see WARNINGS and PRECAUTIONS). Hence, the following recommendations serve only as dosing guidelines. Dosing must be individualized and adjustments made based on periodic assessment of the patient's clinical response and laboratory parameters (see PRECAUTIONS, Laboratory Tests).
Levothyroxine Sodium Tablets, USP should be taken in the morning on an empty stomach, at least one-half hour to one hour before any food is eaten. Levothyroxine Sodium Tablets, USP should be taken at least 4 hours apart from drugs that are known to interfere with its absorption (see PRECAUTIONS, Drug Interactions).
Due to the long half-life of levothyroxine, the peak therapeutic effect at a given dose of levothyroxine sodium may not be attained for 4-6 weeks.
Caution should be exercised when administering Levothyroxine Sodium Tablets, USP to patients with underlying cardiovascular disease, to the elderly, and to those with concomitant adrenal insufficiency (see PRECAUTIONS).
Specific Patient Populations:
Hypothyroidism in Adults and in Children in Whom Growth and Puberty are Complete (see WARNINGS and PRECAUTIONS, Laboratory Tests).
Therapy may begin at full replacement doses in otherwise healthy individuals less than 50 years old and in those older than 50 years who have been recently treated for hyperthyroidism or who have been hypothyroid for only a short time (such as a few months). The average full replacement dose of levothyroxine sodium is approximately 1.7 mcg/kg/day (e.g., 100-125 mcg/day for a 70 kg adult). Older patients may require less than 1 mcg/kg/day. Levothyroxine sodium doses greater than 200 mcg/day are seldom required. An inadequate response to daily doses ≥ 300 mcg/day is rare and may indicate poor compliance, malabsorption, and/or drug interactions.
For most patients older than 50 years or for patients under 50 years of age with underlying cardiac disease, an initial starting dose of 25-50 mcg/day of levothyroxine sodium is recommended, with gradual increments in dose at 6-8 week intervals, as needed. The recommended starting dose of levothyroxine sodium in elderly patients with cardiac disease is 12.5-25 mcg/day, with gradual dose increments at 4-6 week intervals. The levothyroxine sodium dose is generally adjusted in 12.5-25 mcg increments until the patient with primary hypothyroidism is clinically euthyroid and the serum TSH has normalized.
In patients with severe hypothyroidism, the recommended initial levothyroxine sodium dose is 12.5-25 mcg/day with increases of 25 mcg/day every 2-4 weeks, accompanied by clinical and laboratory assessment, until the TSH level is normalized.
In patients with secondary (pituitary) or tertiary (hypothalamic) hypothyroidism, the levothyroxine sodium dose should be titrated until the patient is clinically euthyroid and the serum free-T4 level is restored to the upper half of the normal range.
Pediatric Dosage - Congenital or Acquired Hypothyroidism (see PRECAUTIONS, Laboratory Tests)
General Principles
In general, levothyroxine therapy should be instituted at full replacement doses as soon as possible. Delays in diagnosis and institution of therapy may have deleterious effects on the child's intellectual and physical growth and development.
Undertreatment and overtreatment should be avoided (see PRECAUTIONS, Pediatric Use).
Levothyroxine Sodium Tablets, USP may be administered to infants and children who cannot swallow intact tablets by crushing the tablet and suspending the freshly crushed tablet in a small amount (5-10 mL or 1-2 teaspoons) of water. This suspension can be administered by spoon or dropper. DO NOT STORE THE SUSPENSION. Foods that decrease absorption of levothyroxine, such as soybean infant formula, should not be used for administering levothyroxine sodium tablets. (see PRECAUTIONS, Drug-Food Interactions).
Newborns
The recommended starting dose of levothyroxine sodium in newborn infants is 10-15 mcg/kg/day. A lower starting dose (e.g., 25 mcg/day) should be considered in infants at risk for cardiac failure, and the dose should be increased in 4-6 weeks as needed based on clinical and laboratory response to treatment. In infants with very low (< 5 mcg/dL) or undetectable serum T4 concentrations, the recommended initial starting dose is 50 mcg/day of levothyroxine sodium.
Infants and Children
Levothyroxine therapy is usually initiated at full replacement doses, with the recommended dose per body weight decreasing with age (see TABLE 3). However, in children with chronic or severe hypothyroidism, an initial dose of 25 mcg/day of levothyroxine sodium is recommended with increments of 25 mcg every 2-4 weeks until the desired effect is achieved.
Hyperactivity in an older child can be minimized if the starting dose is one-fourth of the recommended full replacement dose, and the dose is then increased on a weekly basis by an amount equal to one-fourth the full-recommended replacement dose until the full recommended replacement dose is reached.
Table 3: Levothyroxine Sodium Dosing Guidelines for Pediatric Hypothyroidism a. The dose should be adjusted based on clinical response and laboratory parameters (see PRECAUTlONS, Laboratory Tests and Pediatric Use).AGE
Daily Dose Per Kg Body Weighta
0-3 months
10-15 mcg/kg/day
3-6 months
8-10 mcg/kg/day
6-12 months
6-8 mcg/kg/day
1-5 years
5-6 mcg/kg/day
6-12 years
4-5 mcg/kg/day
>12 years but growth and puberty incomplete
2-3 mcg/kg/day
Growth and puberty complete
1.7 mcg/kg/day
Pregnancy- Pregnancy may increase levothyroxine requirements (see PREGNANCY).
Subclinical Hypothyroidism- If this condition is treated, a lower levothyroxine sodium dose (e.g., 1 mcg/kg/day) than that used for full replacement may be adequate to normalize the serum TSH level. Patients who are not treated should be monitored yearly for changes in clinical status and thyroid laboratory parameters.
TSH Suppression in Well-differentiated Thyroid Cancer and Thyroid Nodules- The target level for TSH suppression in these conditions has not been established with controlled studies. In addition, the efficacy of TSH suppression for benign nodular disease is controversial. Therefore, the dose of Levothyroxine Sodium Tablets, USP used for TSH suppression should be individualized based on the specific disease and the patient being treated.
In the treatment of well differentiated (papillary and follicular) thyroid cancer, levothyroxine is used as an adjunct to surgery and radioiodine therapy. Generally, TSH is suppressed to <0.1 mU/L, and this usually requires a levothyroxine sodium dose of greater than 2 mcg/kg/day. However, in patients with high-risk tumors, the target level for TSH suppression may be <0.01 mU/L.
In the treatment of benign nodules and nontoxic multinodular goiter, TSH is generally suppressed to a higher target (e.g., 0.1-0.5 mU/L for nodules and 0.5-1.0 mU/L for multinodular goiter) than that used for the treatment of thyroid cancer. Levothyroxine sodium is contraindicated if the serum TSH is already suppressed due to the risk of precipitating overt thyrotoxicosis (see CONTRAINDICATIONS, WARNINGS and PRECAUTIONS).
Myxedema Coma - Myxedema coma is a life-threatening emergency characterized by poor circulation and hypometabolism, and may result in unpredictable absorption of levothyroxine sodium from the gastrointestinal tract. Therefore, oral thyroid hormone drug products are not recommended to treat this condition. Thyroid hormone products formulated for intravenous administration should be administered.
-
![Levothyroxine Sodium Tablet [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=05897f7a-4d31-497f-aa9e-52708b361640&name=levothyroxine-sodium-tablets-usp-8.jpg)
Levothyroxine Sodium
General Principles:
The goal of replacement therapy is to achieve and maintain a clinical and biochemical euthyroid state. The goal of suppressive therapy is to inhibit growth and/or function of abnormal thyroid tissue. The dose of Levothyroxine Sodium Tablets, USP that is adequate to achieve these goals depends on a variety of factors including the patient's age, body weight, cardiovascular status, concomitant medical conditions, including pregnancy, concomitant medications, and the specific nature of the condition being treated (see WARNINGS and PRECAUTIONS). Hence, the following recommendations serve only as dosing guidelines. Dosing must be individualized and adjustments made based on periodic assessment of the patient's clinical response and laboratory parameters (see PRECAUTIONS, Laboratory Tests).
Levothyroxine Sodium Tablets, USP should be taken in the morning on an empty stomach, at least one-half hour to one hour before any food is eaten. Levothyroxine Sodium Tablets, USP should be taken at least 4 hours apart from drugs that are known to interfere with its absorption (see PRECAUTIONS, Drug Interactions).
Due to the long half-life of levothyroxine, the peak therapeutic effect at a given dose of levothyroxine sodium may not be attained for 4-6 weeks.
Caution should be exercised when administering Levothyroxine Sodium Tablets, USP to patients with underlying cardiovascular disease, to the elderly, and to those with concomitant adrenal insufficiency (see PRECAUTIONS).
Specific Patient Populations:
Hypothyroidism in Adults and in Children in Whom Growth and Puberty are Complete (see WARNINGS and PRECAUTIONS, Laboratory Tests).
Therapy may begin at full replacement doses in otherwise healthy individuals less than 50 years old and in those older than 50 years who have been recently treated for hyperthyroidism or who have been hypothyroid for only a short time (such as a few months). The average full replacement dose of levothyroxine sodium is approximately 1.7 mcg/kg/day (e.g., 100-125 mcg/day for a 70 kg adult). Older patients may require less than 1 mcg/kg/day. Levothyroxine sodium doses greater than 200 mcg/day are seldom required. An inadequate response to daily doses ≥ 300 mcg/day is rare and may indicate poor compliance, malabsorption, and/or drug interactions.
For most patients older than 50 years or for patients under 50 years of age with underlying cardiac disease, an initial starting dose of 25-50 mcg/day of levothyroxine sodium is recommended, with gradual increments in dose at 6-8 week intervals, as needed. The recommended starting dose of levothyroxine sodium in elderly patients with cardiac disease is 12.5-25 mcg/day, with gradual dose increments at 4-6 week intervals. The levothyroxine sodium dose is generally adjusted in 12.5-25 mcg increments until the patient with primary hypothyroidism is clinically euthyroid and the serum TSH has normalized.
In patients with severe hypothyroidism, the recommended initial levothyroxine sodium dose is 12.5-25 mcg/day with increases of 25 mcg/day every 2-4 weeks, accompanied by clinical and laboratory assessment, until the TSH level is normalized.
In patients with secondary (pituitary) or tertiary (hypothalamic) hypothyroidism, the levothyroxine sodium dose should be titrated until the patient is clinically euthyroid and the serum free-T4 level is restored to the upper half of the normal range.
Pediatric Dosage - Congenital or Acquired Hypothyroidism (see PRECAUTIONS, Laboratory Tests)
General Principles
In general, levothyroxine therapy should be instituted at full replacement doses as soon as possible. Delays in diagnosis and institution of therapy may have deleterious effects on the child's intellectual and physical growth and development.
Undertreatment and overtreatment should be avoided (see PRECAUTIONS, Pediatric Use).
Levothyroxine Sodium Tablets, USP may be administered to infants and children who cannot swallow intact tablets by crushing the tablet and suspending the freshly crushed tablet in a small amount (5-10 mL or 1-2 teaspoons) of water. This suspension can be administered by spoon or dropper. DO NOT STORE THE SUSPENSION. Foods that decrease absorption of levothyroxine, such as soybean infant formula, should not be used for administering levothyroxine sodium tablets. (see PRECAUTIONS, Drug-Food Interactions).
Newborns
The recommended starting dose of levothyroxine sodium in newborn infants is 10-15 mcg/kg/day. A lower starting dose (e.g., 25 mcg/day) should be considered in infants at risk for cardiac failure, and the dose should be increased in 4-6 weeks as needed based on clinical and laboratory response to treatment. In infants with very low (< 5 mcg/dL) or undetectable serum T4 concentrations, the recommended initial starting dose is 50 mcg/day of levothyroxine sodium.
Infants and Children
Levothyroxine therapy is usually initiated at full replacement doses, with the recommended dose per body weight decreasing with age (see TABLE 3). However, in children with chronic or severe hypothyroidism, an initial dose of 25 mcg/day of levothyroxine sodium is recommended with increments of 25 mcg every 2-4 weeks until the desired effect is achieved.
Hyperactivity in an older child can be minimized if the starting dose is one-fourth of the recommended full replacement dose, and the dose is then increased on a weekly basis by an amount equal to one-fourth the full-recommended replacement dose until the full recommended replacement dose is reached.
Table 3: Levothyroxine Sodium Dosing Guidelines for Pediatric Hypothyroidism a. The dose should be adjusted based on clinical response and laboratory parameters (see PRECAUTlONS, Laboratory Tests and Pediatric Use).AGE
Daily Dose Per Kg Body Weighta
0-3 months
10-15 mcg/kg/day
3-6 months
8-10 mcg/kg/day
6-12 months
6-8 mcg/kg/day
1-5 years
5-6 mcg/kg/day
6-12 years
4-5 mcg/kg/day
>12 years but growth and puberty incomplete
2-3 mcg/kg/day
Growth and puberty complete
1.7 mcg/kg/day
Pregnancy- Pregnancy may increase levothyroxine requirements (see PREGNANCY).
Subclinical Hypothyroidism- If this condition is treated, a lower levothyroxine sodium dose (e.g., 1 mcg/kg/day) than that used for full replacement may be adequate to normalize the serum TSH level. Patients who are not treated should be monitored yearly for changes in clinical status and thyroid laboratory parameters.
TSH Suppression in Well-differentiated Thyroid Cancer and Thyroid Nodules- The target level for TSH suppression in these conditions has not been established with controlled studies. In addition, the efficacy of TSH suppression for benign nodular disease is controversial. Therefore, the dose of Levothyroxine Sodium Tablets, USP used for TSH suppression should be individualized based on the specific disease and the patient being treated.
In the treatment of well differentiated (papillary and follicular) thyroid cancer, levothyroxine is used as an adjunct to surgery and radioiodine therapy. Generally, TSH is suppressed to <0.1 mU/L, and this usually requires a levothyroxine sodium dose of greater than 2 mcg/kg/day. However, in patients with high-risk tumors, the target level for TSH suppression may be <0.01 mU/L.
In the treatment of benign nodules and nontoxic multinodular goiter, TSH is generally suppressed to a higher target (e.g., 0.1-0.5 mU/L for nodules and 0.5-1.0 mU/L for multinodular goiter) than that used for the treatment of thyroid cancer. Levothyroxine sodium is contraindicated if the serum TSH is already suppressed due to the risk of precipitating overt thyrotoxicosis (see CONTRAINDICATIONS, WARNINGS and PRECAUTIONS).
Myxedema Coma - Myxedema coma is a life-threatening emergency characterized by poor circulation and hypometabolism, and may result in unpredictable absorption of levothyroxine sodium from the gastrointestinal tract. Therefore, oral thyroid hormone drug products are not recommended to treat this condition. Thyroid hormone products formulated for intravenous administration should be administered.
-
![Prednisone Tablet [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=a1769552-f230-40e0-8f05-5b3b356437b6&name=prednisonetab-6.jpg)
Prednisone
Gastric irritation may be reduced if taken before, during, or immediately after meals or with food or milk.
The maximal activity of the adrenal cortex is between 2 am and 8 am, and it is minimal between 4 pm and midnight. Exogenous corticosteroids suppress adrenocorticoid activity the least when given at the time of maximal activity (am) for single dose administration. Therefore, it is recommended that prednisone be administered in the morning prior to 9 am and when large doses are given, administration of antacids between meals to help prevent peptic ulcers. Multiple dose therapy should be evenly distributed in evenly spaced intervals throughout the day.
Dietary salt restriction may be advisable in patients.
Do not stop taking this medicine without first talking to your doctor. Avoid abrupt withdraw of therapy.
The initial dosage of PredniSONE Tablets may vary from 5 mg to 60 mg per day, depending on the specific disease entity being treated. In situations of less severity lower doses will generally suffice, while in selected patients higher initial doses may be required. The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time there is a lack of satisfactory clinical response, PredniSONE should be discontinued and the patient transferred to other appropriate therapy. IT SHOULD BE EMPHASIZED THAT DOSAGE REQUIREMENTS ARE VARIABLE AND MUST BE INDIVIDUALIZED ON THE BASIS OF THE DISEASE UNDER TREATMENT AND THE RESPONSE OF THE PATIENT. After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small increments at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. It should be kept in mind that constant monitoring is needed in regard to drug dosage. Included in the situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient's individual drug responsiveness, and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment; in this latter situation, it may be necessary to increase the dosage of PredniSONE for a period of time consistent with the patient's condition. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.
Multiple Sclerosis
In the treatment of acute exacerbations of multiple sclerosis daily doses of 200 mg of prednisolone for a week followed by 80 mg every other day for 1 month have been shown to be effective. (Dosage range is the same for prednisone and prednisolone.)
Alternate Day Therapy
Alternate day therapy is a corticosteroid dosing regimen in which twice the usual daily dose of corticoid is administered every other morning. The purpose of this mode of therapy is to provide the patient requiring long-term pharmacologic dose treatment with the beneficial effects of corticoids while minimizing certain undesirable effects, including pituitary-adrenal suppression, the Cushingoid state, corticoid withdrawal symptoms, and growth suppression in children.
The rationale for this treatment schedule is based on two major premises: (a) the anti-inflammatory or therapeutic effect of corticoids persists longer than their physical presence and metabolic effects and (b) administration of the corticosteroid every other morning allows for re-establishment of more nearly normal hypothalamic-pituitary-adrenal (HPA) activity on the off-steroid day.
A brief review of the HPA physiology may be helpful in understanding this rationale. Acting primarily through the hypothalamus a fall in free cortisol stimulates the pituitary gland to produce increasing amounts of corticotropin (ACTH) while a rise in free cortisol inhibits ACTH secretion. Normally the HPA system is characterized by diurnal (circadian) rhythm. Serum levels of ACTH rise from a low point about 10 pm to a peak level about 6 am. Increasing levels of ACTH stimulate adrenocortical activity resulting in a rise in plasma cortisol with maximal levels occurring between 2 am and 8 am. This rise in cortisol dampens ACTH production and in turn adrenocortical activity. There is a gradual fall in plasma corticoids during the day with lowest levels occurring about midnight.
The diurnal rhythm of the HPA axis is lost in Cushing's disease, a syndrome of adrenocortical hyperfunction characterized by obesity with centripetal fat distribution, thinning of the skin with easy bruisability, muscle wasting with weakness, hypertension, latent diabetes, osteoporosis, electrolyte imbalance, etc. The same clinical findings of hyperadrenocorticism may be noted during long-term pharmacologic dose corticoid therapy administered in conventional daily divided doses. It would appear, then, that a disturbance in the diurnal cycle with maintenance of elevated corticoid values during the night may play a significant role in the development of undesirable corticoid effects. Escape from these constantly elevated plasma levels for even short periods of time may be instrumental in protecting against undesirable pharmacologic effects.
During conventional pharmacologic dose corticosteroid therapy, ACTH production is inhibited with subsequent suppression of cortisol production by the adrenal cortex. Recovery time for normal HPA activity is variable depending upon the dose and duration of treatment. During this time the patient is vulnerable to any stressful situation. Although it has been shown that there is considerably less adrenal suppression following a single morning dose of prednisolone (10 mg) as opposed to a quarter of that dose administered every 6 hours, there is evidence that some suppressive effect on adrenal activity may be carried over into the following day when pharmacologic doses are used. Further, it has been shown that a single dose of certain corticosteroids will produce adrenocortical suppression for two or more days. Other corticoids, including methylprednisolone, hydrocortisone, prednisone, and prednisolone, are considered to be short acting (producing adrenocortical suppression for 1¼ to 1½ days following a single dose) and thus are recommended for alternate day therapy.
The following should be kept in mind when considering alternate day therapy:
Basic principles and indications for corticosteroid therapy should apply. The benefits of alternate day therapy should not encourage the indiscriminate use of steroids. Alternate day therapy is a therapeutic technique primarily designed for patients in whom long-term pharmacologic corticoid therapy is anticipated. In less severe disease processes in which corticoid therapy is indicated, it may be possible to initiate treatment with alternate day therapy. More severe disease states usually will require daily divided high dose therapy for initial control of the disease process. The initial suppressive dose level should be continued until satisfactory clinical response is obtained, usually four to ten days in the case of many allergic and collagen diseases. It is important to keep the period of initial suppressive dose as brief as possible particularly when subsequent use of alternate day therapy is intended. Once control has been established, two courses are available: (a) change to alternate day therapy and then gradually reduce the amount of corticoid given every other day or (b) following control of the disease process reduce the daily dose of corticoid to the lowest effective level as rapidly as possible and then change over to an alternate day schedule. Theoretically, course (a) may be preferable. Because of the advantages of alternate day therapy, it may be desirable to try patients on this form of therapy who have been on daily corticoids for long periods of time (e.g., patients with rheumatoid arthritis). Since these patients may already have a suppressed HPA axis, establishing them on alternate day therapy may be difficult and not always successful. However, it is recommended that regular attempts be made to change them over. It may be helpful to triple or even quadruple the daily maintenance dose and administer this every other day rather than just doubling the daily dose if difficulty is encountered. Once the patient is again controlled, an attempt should be made to reduce this dose to a minimum. As indicated above, certain corticosteroids, because of their prolonged suppressive effect on adrenal activity, are not recommended for alternate day therapy (e.g., dexamethasone and betamethasone). The maximal activity of the adrenal cortex is between 2 am and 8 am, and it is minimal between 4 pm and midnight. Exogenous corticosteroids suppress adrenocortical activity the least, when given at the time of maximal activity (am). In using alternate day therapy it is important, as in all therapeutic situations to individualize and tailor the therapy to each patient. Complete control of symptoms will not be possible in all patients. An explanation of the benefits of alternate day therapy will help the patient to understand and tolerate the possible flare-up in symptoms which may occur in the latter part of the off-steroid day. Other symptomatic therapy may be added or increased at this time if needed. In the event of an acute flare-up of the disease process, it may be necessary to return to a full suppressive daily divided corticoid dose for control. Once control is again established alternate day therapy may be re-instituted. Although many of the undesirable features of corticosteroid therapy can be minimized by alternate day therapy, as in any therapeutic situation, the physician must carefully weigh the benefit-risk ratio for each patient in whom corticoid therapy is being considered.Multiple Sclerosis
In the treatment of acute exacerbations of multiple sclerosis daily doses of 200 mg of prednisolone for a week followed by 80 mg every other day for 1 month have been shown to be effective. (Dosage range is the same for prednisone and prednisolone.)
Alternate Day Therapy
Alternate day therapy is a corticosteroid dosing regimen in which twice the usual daily dose of corticoid is administered every other morning. The purpose of this mode of therapy is to provide the patient requiring long-term pharmacologic dose treatment with the beneficial effects of corticoids while minimizing certain undesirable effects, including pituitary-adrenal suppression, the Cushingoid state, corticoid withdrawal symptoms, and growth suppression in children.
The rationale for this treatment schedule is based on two major premises: (a) the anti-inflammatory or therapeutic effect of corticoids persists longer than their physical presence and metabolic effects and (b) administration of the corticosteroid every other morning allows for re-establishment of more nearly normal hypothalamic-pituitary-adrenal (HPA) activity on the off-steroid day.
A brief review of the HPA physiology may be helpful in understanding this rationale. Acting primarily through the hypothalamus a fall in free cortisol stimulates the pituitary gland to produce increasing amounts of corticotropin (ACTH) while a rise in free cortisol inhibits ACTH secretion. Normally the HPA system is characterized by diurnal (circadian) rhythm. Serum levels of ACTH rise from a low point about 10 pm to a peak level about 6 am. Increasing levels of ACTH stimulate adrenocortical activity resulting in a rise in plasma cortisol with maximal levels occurring between 2 am and 8 am. This rise in cortisol dampens ACTH production and in turn adrenocortical activity. There is a gradual fall in plasma corticoids during the day with lowest levels occurring about midnight.
The diurnal rhythm of the HPA axis is lost in Cushing's disease, a syndrome of adrenocortical hyperfunction characterized by obesity with centripetal fat distribution, thinning of the skin with easy bruisability, muscle wasting with weakness, hypertension, latent diabetes, osteoporosis, electrolyte imbalance, etc. The same clinical findings of hyperadrenocorticism may be noted during long-term pharmacologic dose corticoid therapy administered in conventional daily divided doses. It would appear, then, that a disturbance in the diurnal cycle with maintenance of elevated corticoid values during the night may play a significant role in the development of undesirable corticoid effects. Escape from these constantly elevated plasma levels for even short periods of time may be instrumental in protecting against undesirable pharmacologic effects.
During conventional pharmacologic dose corticosteroid therapy, ACTH production is inhibited with subsequent suppression of cortisol production by the adrenal cortex. Recovery time for normal HPA activity is variable depending upon the dose and duration of treatment. During this time the patient is vulnerable to any stressful situation. Although it has been shown that there is considerably less adrenal suppression following a single morning dose of prednisolone (10 mg) as opposed to a quarter of that dose administered every 6 hours, there is evidence that some suppressive effect on adrenal activity may be carried over into the following day when pharmacologic doses are used. Further, it has been shown that a single dose of certain corticosteroids will produce adrenocortical suppression for two or more days. Other corticoids, including methylprednisolone, hydrocortisone, prednisone, and prednisolone, are considered to be short acting (producing adrenocortical suppression for 1¼ to 1½ days following a single dose) and thus are recommended for alternate day therapy.
The following should be kept in mind when considering alternate day therapy:
Basic principles and indications for corticosteroid therapy should apply. The benefits of alternate day therapy should not encourage the indiscriminate use of steroids. Alternate day therapy is a therapeutic technique primarily designed for patients in whom long-term pharmacologic corticoid therapy is anticipated. In less severe disease processes in which corticoid therapy is indicated, it may be possible to initiate treatment with alternate day therapy. More severe disease states usually will require daily divided high dose therapy for initial control of the disease process. The initial suppressive dose level should be continued until satisfactory clinical response is obtained, usually four to ten days in the case of many allergic and collagen diseases. It is important to keep the period of initial suppressive dose as brief as possible particularly when subsequent use of alternate day therapy is intended. Once control has been established, two courses are available: (a) change to alternate day therapy and then gradually reduce the amount of corticoid given every other day or (b) following control of the disease process reduce the daily dose of corticoid to the lowest effective level as rapidly as possible and then change over to an alternate day schedule. Theoretically, course (a) may be preferable. Because of the advantages of alternate day therapy, it may be desirable to try patients on this form of therapy who have been on daily corticoids for long periods of time (e.g., patients with rheumatoid arthritis). Since these patients may already have a suppressed HPA axis, establishing them on alternate day therapy may be difficult and not always successful. However, it is recommended that regular attempts be made to change them over. It may be helpful to triple or even quadruple the daily maintenance dose and administer this every other day rather than just doubling the daily dose if difficulty is encountered. Once the patient is again controlled, an attempt should be made to reduce this dose to a minimum. As indicated above, certain corticosteroids, because of their prolonged suppressive effect on adrenal activity, are not recommended for alternate day therapy (e.g., dexamethasone and betamethasone). The maximal activity of the adrenal cortex is between 2 am and 8 am, and it is minimal between 4 pm and midnight. Exogenous corticosteroids suppress adrenocortical activity the least, when given at the time of maximal activity (am). In using alternate day therapy it is important, as in all therapeutic situations to individualize and tailor the therapy to each patient. Complete control of symptoms will not be possible in all patients. An explanation of the benefits of alternate day therapy will help the patient to understand and tolerate the possible flare-up in symptoms which may occur in the latter part of the off-steroid day. Other symptomatic therapy may be added or increased at this time if needed. In the event of an acute flare-up of the disease process, it may be necessary to return to a full suppressive daily divided corticoid dose for control. Once control is again established alternate day therapy may be re-instituted. Although many of the undesirable features of corticosteroid therapy can be minimized by alternate day therapy, as in any therapeutic situation, the physician must carefully weigh the benefit-risk ratio for each patient in whom corticoid therapy is being considered. -
![Q-tapp (Brompheniramine Maleate And Pseudoephedrine Hydrochloride) Elixir [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=12789360-0d40-4cf3-99a3-271920752a55&name=container.jpg)
Q-tapp
Do not take more than 4 doses in any 24-hour Adults and children 12 years and over 20 mL (4 tsp) every 4 to 6 hours Children 6 years to under 12 years 10 mL (2 tsp) every 4 to 6 hours Children under 6 years DO NOT USE Other information each tsp contains: sodium 2 mg Store at room temperature 20°-25°C (68°-77°F).
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![Levothyroxine Sodium Tablet [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=3218d7d0-08c8-4e96-a717-94a8cbad2092&name=levothyroxine-sodium-tablets-usp-2.jpg)
Levothyroxine Sodium
General Principles:
The goal of replacement therapy is to achieve and maintain a clinical and biochemical euthyroid state. The goal of suppressive therapy is to inhibit growth and/or function of abnormal thyroid tissue. The dose of Levothyroxine Sodium Tablets, USP that is adequate to achieve these goals depends on a variety of factors including the patient's age, body weight, cardiovascular status, concomitant medical conditions, including pregnancy, concomitant medications, and the specific nature of the condition being treated (see WARNINGS and PRECAUTIONS). Hence, the following recommendations serve only as dosing guidelines. Dosing must be individualized and adjustments made based on periodic assessment of the patient's clinical response and laboratory parameters (see PRECAUTIONS, Laboratory Tests).
Levothyroxine Sodium Tablets, USP should be taken in the morning on an empty stomach, at least one-half hour to one hour before any food is eaten. Levothyroxine Sodium Tablets, USP should be taken at least 4 hours apart from drugs that are known to interfere with its absorption (see PRECAUTIONS, Drug Interactions).
Due to the long half-life of levothyroxine, the peak therapeutic effect at a given dose of levothyroxine sodium may not be attained for 4-6 weeks.
Caution should be exercised when administering Levothyroxine Sodium Tablets, USP to patients with underlying cardiovascular disease, to the elderly, and to those with concomitant adrenal insufficiency (see PRECAUTIONS).
Specific Patient Populations:
Hypothyroidism in Adults and in Children in Whom Growth and Puberty are Complete (see WARNINGS and PRECAUTIONS, Laboratory Tests).
Therapy may begin at full replacement doses in otherwise healthy individuals less than 50 years old and in those older than 50 years who have been recently treated for hyperthyroidism or who have been hypothyroid for only a short time (such as a few months). The average full replacement dose of levothyroxine sodium is approximately 1.7 mcg/kg/day (e.g., 100-125 mcg/day for a 70 kg adult). Older patients may require less than 1 mcg/kg/day. Levothyroxine sodium doses greater than 200 mcg/day are seldom required. An inadequate response to daily doses ≥ 300 mcg/day is rare and may indicate poor compliance, malabsorption, and/or drug interactions.
For most patients older than 50 years or for patients under 50 years of age with underlying cardiac disease, an initial starting dose of 25-50 mcg/day of levothyroxine sodium is recommended, with gradual increments in dose at 6-8 week intervals, as needed. The recommended starting dose of levothyroxine sodium in elderly patients with cardiac disease is 12.5-25 mcg/day, with gradual dose increments at 4-6 week intervals. The levothyroxine sodium dose is generally adjusted in 12.5-25 mcg increments until the patient with primary hypothyroidism is clinically euthyroid and the serum TSH has normalized.
In patients with severe hypothyroidism, the recommended initial levothyroxine sodium dose is 12.5-25 mcg/day with increases of 25 mcg/day every 2-4 weeks, accompanied by clinical and laboratory assessment, until the TSH level is normalized.
In patients with secondary (pituitary) or tertiary (hypothalamic) hypothyroidism, the levothyroxine sodium dose should be titrated until the patient is clinically euthyroid and the serum free-T4 level is restored to the upper half of the normal range.
Pediatric Dosage - Congenital or Acquired Hypothyroidism (see PRECAUTIONS, Laboratory Tests)
General Principles
In general, levothyroxine therapy should be instituted at full replacement doses as soon as possible. Delays in diagnosis and institution of therapy may have deleterious effects on the child's intellectual and physical growth and development.
Undertreatment and overtreatment should be avoided (see PRECAUTIONS, Pediatric Use).
Levothyroxine Sodium Tablets, USP may be administered to infants and children who cannot swallow intact tablets by crushing the tablet and suspending the freshly crushed tablet in a small amount (5-10 mL or 1-2 teaspoons) of water. This suspension can be administered by spoon or dropper. DO NOT STORE THE SUSPENSION. Foods that decrease absorption of levothyroxine, such as soybean infant formula, should not be used for administering levothyroxine sodium tablets. (see PRECAUTIONS, Drug-Food Interactions).
Newborns
The recommended starting dose of levothyroxine sodium in newborn infants is 10-15 mcg/kg/day. A lower starting dose (e.g., 25 mcg/day) should be considered in infants at risk for cardiac failure, and the dose should be increased in 4-6 weeks as needed based on clinical and laboratory response to treatment. In infants with very low (< 5 mcg/dL) or undetectable serum T4 concentrations, the recommended initial starting dose is 50 mcg/day of levothyroxine sodium.
Infants and Children
Levothyroxine therapy is usually initiated at full replacement doses, with the recommended dose per body weight decreasing with age (see TABLE 3). However, in children with chronic or severe hypothyroidism, an initial dose of 25 mcg/day of levothyroxine sodium is recommended with increments of 25 mcg every 2-4 weeks until the desired effect is achieved.
Hyperactivity in an older child can be minimized if the starting dose is one-fourth of the recommended full replacement dose, and the dose is then increased on a weekly basis by an amount equal to one-fourth the full-recommended replacement dose until the full recommended replacement dose is reached.
Table 3: Levothyroxine Sodium Dosing Guidelines for Pediatric Hypothyroidism a. The dose should be adjusted based on clinical response and laboratory parameters (see PRECAUTlONS, Laboratory Tests and Pediatric Use).AGE
Daily Dose Per Kg Body Weighta
0-3 months
10-15 mcg/kg/day
3-6 months
8-10 mcg/kg/day
6-12 months
6-8 mcg/kg/day
1-5 years
5-6 mcg/kg/day
6-12 years
4-5 mcg/kg/day
>12 years but growth and puberty incomplete
2-3 mcg/kg/day
Growth and puberty complete
1.7 mcg/kg/day
Pregnancy- Pregnancy may increase levothyroxine requirements (see PREGNANCY).
Subclinical Hypothyroidism- If this condition is treated, a lower levothyroxine sodium dose (e.g., 1 mcg/kg/day) than that used for full replacement may be adequate to normalize the serum TSH level. Patients who are not treated should be monitored yearly for changes in clinical status and thyroid laboratory parameters.
TSH Suppression in Well-differentiated Thyroid Cancer and Thyroid Nodules- The target level for TSH suppression in these conditions has not been established with controlled studies. In addition, the efficacy of TSH suppression for benign nodular disease is controversial. Therefore, the dose of Levothyroxine Sodium Tablets, USP used for TSH suppression should be individualized based on the specific disease and the patient being treated.
In the treatment of well differentiated (papillary and follicular) thyroid cancer, levothyroxine is used as an adjunct to surgery and radioiodine therapy. Generally, TSH is suppressed to <0.1 mU/L, and this usually requires a levothyroxine sodium dose of greater than 2 mcg/kg/day. However, in patients with high-risk tumors, the target level for TSH suppression may be <0.01 mU/L.
In the treatment of benign nodules and nontoxic multinodular goiter, TSH is generally suppressed to a higher target (e.g., 0.1-0.5 mU/L for nodules and 0.5-1.0 mU/L for multinodular goiter) than that used for the treatment of thyroid cancer. Levothyroxine sodium is contraindicated if the serum TSH is already suppressed due to the risk of precipitating overt thyrotoxicosis (see CONTRAINDICATIONS, WARNINGS and PRECAUTIONS).
Myxedema Coma - Myxedema coma is a life-threatening emergency characterized by poor circulation and hypometabolism, and may result in unpredictable absorption of levothyroxine sodium from the gastrointestinal tract. Therefore, oral thyroid hormone drug products are not recommended to treat this condition. Thyroid hormone products formulated for intravenous administration should be administered.
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![Ketorolac Tromethamine Tablet, Film Coated [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=153d3376-4e38-4f5e-8bf7-4b77bcbb2ebe&name=8d49fd63-db80-46fb-892c-0662d748550d-02.jpg)
Ketorolac Tromethamine
Carefully consider the potential benefits and risks of ketorolac tromethamine tablets and other treatment options before deciding to use ketorolac tromethamine tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. In adults, the combined duration of use of IV or IM dosing of ketorolac tromethamine and ketorolac tromethamine tablets is not to exceed 5 days. In adults, the use of ketorolac tromethamine tablets is only indicated as continuation therapy to IV or IM dosing of ketorolac tromethamine.
Transition from IV or IM dosing of ketorolac tromethamine (single- or multiple-dose) to multiple-dose ketorolac tromethamine tablets:
Patients age 17 to 64: 20 mg PO once followed by 10 mg q4 to 6 hours prn not > 40 mg/day
Patients age ≥ 65, renally impaired, and/or weight < 50 kg (110 lbs): 10 mg PO once followed by 10 mg q4 to 6 hours prn not> 40 mg/day
Note:
Oral formulation should not be given as an initial dose.
Use minimum effective dose for the individual patient.
Do not shorten dosing interval of 4 to 6 hours.
Total duration of treatment in adult patients: the combined duration of use of IV or IM dosing of ketorolac tromethamine and ketorolac tromethamine tablets is not to exceed 5 days.
The following table summarizes ketorolac tromethamine tablet dosing instructions in terms of age group:
Table 4: Summary of Dosing InstructionsPatient Population
Ketorolac Tromethamine Tablets (following IV or IM dosing of ketorolac tromethamine)
Age < 17 years
Oral not approved
Adult Age 17 to 64 years
20 mg once, then 10 mg q4 to 6 hours prn not > 40 mg/day
Adult Age ≥ 65 years, renally impaired, and/or weight < 50 kg
10 mg once, then 10 mg q4 to 6 hours prn not > 40 mg/day
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![Medroxyprogesterone Acetate Injection, Suspension [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=91b3473d-b95b-4b7d-a1d4-3ff2cb75a9b9&name=medroxyprogesterone-04.jpg)
Medroxyprogesterone Acetate
2.1 Prevention of Pregnancy
Both the 1 mL vial and the 1 mL prefilled syringe of Medroxyprogesterone Acetate Injectable Suspension, USP should be vigorously shaken just before use to ensure that the dose being administered represents a uniform suspension.
The recommended dose is 150 mg of Medroxyprogesterone Acetate Injectable Suspension, USP every 3 months (13 weeks) administered by deep IM injection in the gluteal or deltoid muscle. Medroxyprogesterone Acetate Injectable Suspension, USP should not be used as a long-term birth control method (i.e. longer than 2 years) unless other birth control methods are considered inadequate. Dosage does not need to be adjusted for body weight [See Clinical Studies (14.1)].
To ensure the patient is not pregnant at the time of the first injection, the first injection should be given ONLY during the first 5 days of a normal menstrual period; ONLY within the first 5-days postpartum if not breast-feeding; and if exclusively breast-feeding, ONLY at the sixth postpartum week. If the time interval between injections is greater than 13 weeks, the physician should determine that the patient is not pregnant before administering the drug. The efficacy of Medroxyprogesterone Acetate Injectable Suspension, USP depends on adherence to the dosage schedule of administration.
2.2 Switching from other Methods of Contraception
When switching from other contraceptive methods, Medroxyprogesterone Acetate Injectable Suspension, USP should be given in a manner that ensures continuous contraceptive coverage based upon the mechanism of action of both methods, (e.g., patients switching from oral contraceptives should have their first injection of Medroxyprogesterone Acetate Injectable Suspension, USP on the day after the last active tablet or at the latest, on the day following the final inactive tablet).
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![Gentamicin Injection, Solution [App Pharmaceuticals, Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=ce06497d-12a6-4e79-967e-378b3a7dd61d&name=acetam-4.jpg)
Gentamicin
Dosage should be adjusted according to severity of pain and response of the patient. The usual adult dosage is:
Single Doses (range)
Maximum 24 Hour Dose
Codeine Phosphate
15 mg to 60 mg
360 mg
Acetaminophen
300 mg to 1000 mg
4000 mg
The usual dose of codeine phosphate in children is 0.5 mg/kg.
Doses may be repeated up to every 4 hours.
The prescriber must determine the number of tablets per dose, and the maximum number of tablets per 24 hours based upon the above dosage guidance. This information should be conveyed in the prescription.
It should be kept in mind, however, that tolerance to codeine can develop with continued use and that the incidence of untoward effects is dose related. Adult doses of codeine higher than 60 mg fail to give commensurate relief of pain but merely prolong analgesia and are associated with an appreciably increased incidence of undesirable side effects. Equivalently high doses in children would have similar effects.
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![Care One Ibuprofen (Ibuprofen) Suspension/ Drops [American Sales Company]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=3e1cfe73-1d7f-4807-a26d-0d4c2b4894d9&name=390ccf7a-2bf5-4ba0-9bc4-d0293520e05b-04.jpg)
Care One Ibuprofen
Adult Patients − Intact Skin
A thick layer of lidocaine 2.5% and prilocaine 2.5% cream is applied to intact skin and covered with an occlusive dressing (see INSTRUCTIONS FOR APPLICATION: ). Minor Dermal Procedures: For minor procedures such as intravenous cannulation and venipuncture, apply 2.5 grams of lidocaine 2.5% and prilocaine 2.5% cream (1/2 the 5 g tube) over 20 to 25 cm 2 of skin surface for at least 1 hour. In controlled clinical trials using lidocaine 2.5% and prilocaine 2.5% cream, two sites were usually prepared in case there was a technical problem with cannulation or venipuncture at the first site. Major Dermal Procedures: For more painful dermatological procedures involving a larger skin area such as split thickness skin graft harvesting, apply 2 grams of lidocaine 2.5% and prilocaine 2.5% cream per 10 cm 2 of skin and allow to remain in contact with the skin for at least 2 hours. Adult Male Genital Skin: As an adjunct prior to local anesthetic infiltration, apply a thick layer of lidocaine 2.5% and prilocaine 2.5% cream (1 g/10 cm 2) to the skin surface for 15 minutes. Local anesthetic infiltration should be performed immediately after removal of lidocaine 2.5% and prilocaine 2.5% cream.Dermal analgesia can be expected to increase for up to 3 hours under occlusive dressing and persist for 1 to 2 hours after removal of the cream. The amount of lidocaine and prilocaine absorbed during the period of application can be estimated from the information in Table 2, ** footnote, in Individualization of Dose.
Adult Female Patients − Genital Mucous Membranes
For minor procedures on the female external genitalia, such as removal of condylomata acuminata, as well as for use as pretreatment for anesthetic infiltration, apply a thick layer (5-10 grams) of lidocaine 2.5% and prilocaine 2.5% cream for 5 to 10 minutes.
Occlusion is not necessary for absorption, but may be helpful to keep the cream in place. Patients should be lying down during the lidocaine 2.5% and prilocaine 2.5% cream application, especially if no occlusion is used. The procedure or the local anesthetic infiltration should be performed immediately after the removal of lidocaine 2.5% and prilocaine 2.5% cream.
Pediatric Patients − Intact Skin
The following are the maximum recommended doses, application areas and application times for lidocaine 2.5% and prilocaine 2.5% cream based on a child’s age and weight:
Age and Body Weight Requirements Maximum Total Dose of lidocaine 2.5% and prilocaine 2.5% cream Maximum Application Area Maximum Application Time0 up to 3 months or < 5 kg
1 g
10 cm2
1 hour
3 up to 12 months and > 5 kg
2 g
20 cm2
4 hours
1 to 6 years and > 10 kg
10 g
100 cm2
4 hours
7 to 12 years and > 20 kg
20 g
200 cm2
4 hours
Please note: If a patient greater than 3 months old does not meet the minimum weight requirement, the maximum total dose of lidocaine 2.5% and prilocaine 2.5% cream should be restricted to that which corresponds to the patient’s weight. (see INSTRUCTIONS FOR APPLICATION).
Practitioners should carefully instruct caregivers to avoid application of excessive amounts of lidocaine 2.5% and prilocaine 2.5% cream (see PRECAUTIONS).
When applying lidocaine 2.5% and prilocaine 2.5% cream to the skin of young children, care must be taken to maintain careful observation of the child to prevent accidental ingestion of lidocaine 2.5% and prilocaine 2.5% cream or the occlusive dressing. A secondary protective covering to prevent inadvertent disruption of the application site may be useful.
Lidocaine 2.5% and prilocaine 2.5% cream should not be used in neonates with a gestational age less than 37 weeks nor in infants under the age of 12 months who are receiving treatment with methemoglobin-inducing agents (see Methemoglobinemia subsection of WARNINGS).
When lidocaine 2.5% and prilocaine 2.5% cream (lidocaine 2.5% and prilocaine 2.5%) is used concomitantly with other products containing local anesthetic agents, the amount absorbed from all formulations must be considered (see Individualization of Dose). The amount absorbed in the case of lidocaine 2.5% and prilocaine 2.5% cream is determined by the area over which it is applied and the duration of application under occlusion (see Table 2, ** footnote, in Individualization of Dose).
Although the incidence of systemic adverse reactions with lidocaine 2.5% and prilocaine 2.5% cream is very low, caution should be exercised, particularly when applying it over large areas and leaving it on for longer than 2 hours. The incidence of systemic adverse reactions can be expected to be directly proportional to the area and time of exposure (see Individualization of Dose).
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![Fluticasone Propionate Spray, Metered [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=3e710670-b72c-4a84-8c52-3ebae8783a32&name=3e710670-b72c-4a84-8c52-3ebae8783a32-07.jpg)
Fluticasone Propionate Spray
Patients should use Fluticasone Propionate Nasal Spray, USP, at regular intervals for optimal effect.
Adults
The recommended starting dosage in adults is 2 sprays (50 mcg of fluticasone propionate each) in each nostril once daily (total daily dose, 200 mcg). The same dosage divided into 100 mcg given twice daily (e.g., 8 a.m. and 8 p.m.) is also effective. After the first few days, patients may be able to reduce their dosage to 100 mcg (1 spray in each nostril) once daily for maintenance therapy. Some patients (12 years of age and older) with seasonal allergic rhinitis may find as-needed use of 200 mcg once daily effective for symptom control (see CLINICAL TRIALS). Greater symptom control may be achieved with scheduled regular use.
Adolescents and Children (4 Years of Age and Older)
Patients should be started with 100 mcg (1 spray in each nostril once daily). Patients not adequately responding to 100 mcg may use 200 mcg (2 sprays in each nostril). Once adequate control is achieved, the dosage should be decreased to 100 mcg (1 spray in each nostril) daily.
The maximum total daily dosage should not exceed 2 sprays in each nostril (200 mcg/day). (See CLINICAL TRIALS: Individualization of Dosage).
Fluticasone Propionate Nasal Spray, USP, is not recommended for children under 4 years of age.
Directions for Use
Illustrated patient’s instructions for proper use accompany each package of Fluticasone Propionate Nasal Spray, USP.
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![Miconazole 1 (Miconazole Nitrate) Kit [H E B]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=64ea4cd0-ba01-4c3a-8ef2-41d7b3073f8f&name=prednisonetab-8.jpg)
Miconazole 1
Gastric irritation may be reduced if taken before, during, or immediately after meals or with food or milk.
The maximal activity of the adrenal cortex is between 2 am and 8 am, and it is minimal between 4 pm and midnight. Exogenous corticosteroids suppress adrenocorticoid activity the least when given at the time of maximal activity (am) for single dose administration. Therefore, it is recommended that prednisone be administered in the morning prior to 9 am and when large doses are given, administration of antacids between meals to help prevent peptic ulcers. Multiple dose therapy should be evenly distributed in evenly spaced intervals throughout the day.
Dietary salt restriction may be advisable in patients.
Do not stop taking this medicine without first talking to your doctor. Avoid abrupt withdraw of therapy.
The initial dosage of PredniSONE Tablets may vary from 5 mg to 60 mg per day, depending on the specific disease entity being treated. In situations of less severity lower doses will generally suffice, while in selected patients higher initial doses may be required. The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time there is a lack of satisfactory clinical response, PredniSONE should be discontinued and the patient transferred to other appropriate therapy. IT SHOULD BE EMPHASIZED THAT DOSAGE REQUIREMENTS ARE VARIABLE AND MUST BE INDIVIDUALIZED ON THE BASIS OF THE DISEASE UNDER TREATMENT AND THE RESPONSE OF THE PATIENT. After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small increments at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. It should be kept in mind that constant monitoring is needed in regard to drug dosage. Included in the situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient's individual drug responsiveness, and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment; in this latter situation, it may be necessary to increase the dosage of PredniSONE for a period of time consistent with the patient's condition. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.
Multiple Sclerosis
In the treatment of acute exacerbations of multiple sclerosis daily doses of 200 mg of prednisolone for a week followed by 80 mg every other day for 1 month have been shown to be effective. (Dosage range is the same for prednisone and prednisolone.)
Alternate Day Therapy
Alternate day therapy is a corticosteroid dosing regimen in which twice the usual daily dose of corticoid is administered every other morning. The purpose of this mode of therapy is to provide the patient requiring long-term pharmacologic dose treatment with the beneficial effects of corticoids while minimizing certain undesirable effects, including pituitary-adrenal suppression, the Cushingoid state, corticoid withdrawal symptoms, and growth suppression in children.
The rationale for this treatment schedule is based on two major premises: (a) the anti-inflammatory or therapeutic effect of corticoids persists longer than their physical presence and metabolic effects and (b) administration of the corticosteroid every other morning allows for re-establishment of more nearly normal hypothalamic-pituitary-adrenal (HPA) activity on the off-steroid day.
A brief review of the HPA physiology may be helpful in understanding this rationale. Acting primarily through the hypothalamus a fall in free cortisol stimulates the pituitary gland to produce increasing amounts of corticotropin (ACTH) while a rise in free cortisol inhibits ACTH secretion. Normally the HPA system is characterized by diurnal (circadian) rhythm. Serum levels of ACTH rise from a low point about 10 pm to a peak level about 6 am. Increasing levels of ACTH stimulate adrenocortical activity resulting in a rise in plasma cortisol with maximal levels occurring between 2 am and 8 am. This rise in cortisol dampens ACTH production and in turn adrenocortical activity. There is a gradual fall in plasma corticoids during the day with lowest levels occurring about midnight.
The diurnal rhythm of the HPA axis is lost in Cushing's disease, a syndrome of adrenocortical hyperfunction characterized by obesity with centripetal fat distribution, thinning of the skin with easy bruisability, muscle wasting with weakness, hypertension, latent diabetes, osteoporosis, electrolyte imbalance, etc. The same clinical findings of hyperadrenocorticism may be noted during long-term pharmacologic dose corticoid therapy administered in conventional daily divided doses. It would appear, then, that a disturbance in the diurnal cycle with maintenance of elevated corticoid values during the night may play a significant role in the development of undesirable corticoid effects. Escape from these constantly elevated plasma levels for even short periods of time may be instrumental in protecting against undesirable pharmacologic effects.
During conventional pharmacologic dose corticosteroid therapy, ACTH production is inhibited with subsequent suppression of cortisol production by the adrenal cortex. Recovery time for normal HPA activity is variable depending upon the dose and duration of treatment. During this time the patient is vulnerable to any stressful situation. Although it has been shown that there is considerably less adrenal suppression following a single morning dose of prednisolone (10 mg) as opposed to a quarter of that dose administered every 6 hours, there is evidence that some suppressive effect on adrenal activity may be carried over into the following day when pharmacologic doses are used. Further, it has been shown that a single dose of certain corticosteroids will produce adrenocortical suppression for two or more days. Other corticoids, including methylprednisolone, hydrocortisone, prednisone, and prednisolone, are considered to be short acting (producing adrenocortical suppression for 1¼ to 1½ days following a single dose) and thus are recommended for alternate day therapy.
The following should be kept in mind when considering alternate day therapy:
Basic principles and indications for corticosteroid therapy should apply. The benefits of alternate day therapy should not encourage the indiscriminate use of steroids. Alternate day therapy is a therapeutic technique primarily designed for patients in whom long-term pharmacologic corticoid therapy is anticipated. In less severe disease processes in which corticoid therapy is indicated, it may be possible to initiate treatment with alternate day therapy. More severe disease states usually will require daily divided high dose therapy for initial control of the disease process. The initial suppressive dose level should be continued until satisfactory clinical response is obtained, usually four to ten days in the case of many allergic and collagen diseases. It is important to keep the period of initial suppressive dose as brief as possible particularly when subsequent use of alternate day therapy is intended. Once control has been established, two courses are available: (a) change to alternate day therapy and then gradually reduce the amount of corticoid given every other day or (b) following control of the disease process reduce the daily dose of corticoid to the lowest effective level as rapidly as possible and then change over to an alternate day schedule. Theoretically, course (a) may be preferable. Because of the advantages of alternate day therapy, it may be desirable to try patients on this form of therapy who have been on daily corticoids for long periods of time (e.g., patients with rheumatoid arthritis). Since these patients may already have a suppressed HPA axis, establishing them on alternate day therapy may be difficult and not always successful. However, it is recommended that regular attempts be made to change them over. It may be helpful to triple or even quadruple the daily maintenance dose and administer this every other day rather than just doubling the daily dose if difficulty is encountered. Once the patient is again controlled, an attempt should be made to reduce this dose to a minimum. As indicated above, certain corticosteroids, because of their prolonged suppressive effect on adrenal activity, are not recommended for alternate day therapy (e.g., dexamethasone and betamethasone). The maximal activity of the adrenal cortex is between 2 am and 8 am, and it is minimal between 4 pm and midnight. Exogenous corticosteroids suppress adrenocortical activity the least, when given at the time of maximal activity (am). In using alternate day therapy it is important, as in all therapeutic situations to individualize and tailor the therapy to each patient. Complete control of symptoms will not be possible in all patients. An explanation of the benefits of alternate day therapy will help the patient to understand and tolerate the possible flare-up in symptoms which may occur in the latter part of the off-steroid day. Other symptomatic therapy may be added or increased at this time if needed. In the event of an acute flare-up of the disease process, it may be necessary to return to a full suppressive daily divided corticoid dose for control. Once control is again established alternate day therapy may be re-instituted. Although many of the undesirable features of corticosteroid therapy can be minimized by alternate day therapy, as in any therapeutic situation, the physician must carefully weigh the benefit-risk ratio for each patient in whom corticoid therapy is being considered.Multiple Sclerosis
In the treatment of acute exacerbations of multiple sclerosis daily doses of 200 mg of prednisolone for a week followed by 80 mg every other day for 1 month have been shown to be effective. (Dosage range is the same for prednisone and prednisolone.)
Alternate Day Therapy
Alternate day therapy is a corticosteroid dosing regimen in which twice the usual daily dose of corticoid is administered every other morning. The purpose of this mode of therapy is to provide the patient requiring long-term pharmacologic dose treatment with the beneficial effects of corticoids while minimizing certain undesirable effects, including pituitary-adrenal suppression, the Cushingoid state, corticoid withdrawal symptoms, and growth suppression in children.
The rationale for this treatment schedule is based on two major premises: (a) the anti-inflammatory or therapeutic effect of corticoids persists longer than their physical presence and metabolic effects and (b) administration of the corticosteroid every other morning allows for re-establishment of more nearly normal hypothalamic-pituitary-adrenal (HPA) activity on the off-steroid day.
A brief review of the HPA physiology may be helpful in understanding this rationale. Acting primarily through the hypothalamus a fall in free cortisol stimulates the pituitary gland to produce increasing amounts of corticotropin (ACTH) while a rise in free cortisol inhibits ACTH secretion. Normally the HPA system is characterized by diurnal (circadian) rhythm. Serum levels of ACTH rise from a low point about 10 pm to a peak level about 6 am. Increasing levels of ACTH stimulate adrenocortical activity resulting in a rise in plasma cortisol with maximal levels occurring between 2 am and 8 am. This rise in cortisol dampens ACTH production and in turn adrenocortical activity. There is a gradual fall in plasma corticoids during the day with lowest levels occurring about midnight.
The diurnal rhythm of the HPA axis is lost in Cushing's disease, a syndrome of adrenocortical hyperfunction characterized by obesity with centripetal fat distribution, thinning of the skin with easy bruisability, muscle wasting with weakness, hypertension, latent diabetes, osteoporosis, electrolyte imbalance, etc. The same clinical findings of hyperadrenocorticism may be noted during long-term pharmacologic dose corticoid therapy administered in conventional daily divided doses. It would appear, then, that a disturbance in the diurnal cycle with maintenance of elevated corticoid values during the night may play a significant role in the development of undesirable corticoid effects. Escape from these constantly elevated plasma levels for even short periods of time may be instrumental in protecting against undesirable pharmacologic effects.
During conventional pharmacologic dose corticosteroid therapy, ACTH production is inhibited with subsequent suppression of cortisol production by the adrenal cortex. Recovery time for normal HPA activity is variable depending upon the dose and duration of treatment. During this time the patient is vulnerable to any stressful situation. Although it has been shown that there is considerably less adrenal suppression following a single morning dose of prednisolone (10 mg) as opposed to a quarter of that dose administered every 6 hours, there is evidence that some suppressive effect on adrenal activity may be carried over into the following day when pharmacologic doses are used. Further, it has been shown that a single dose of certain corticosteroids will produce adrenocortical suppression for two or more days. Other corticoids, including methylprednisolone, hydrocortisone, prednisone, and prednisolone, are considered to be short acting (producing adrenocortical suppression for 1¼ to 1½ days following a single dose) and thus are recommended for alternate day therapy.
The following should be kept in mind when considering alternate day therapy:
Basic principles and indications for corticosteroid therapy should apply. The benefits of alternate day therapy should not encourage the indiscriminate use of steroids. Alternate day therapy is a therapeutic technique primarily designed for patients in whom long-term pharmacologic corticoid therapy is anticipated. In less severe disease processes in which corticoid therapy is indicated, it may be possible to initiate treatment with alternate day therapy. More severe disease states usually will require daily divided high dose therapy for initial control of the disease process. The initial suppressive dose level should be continued until satisfactory clinical response is obtained, usually four to ten days in the case of many allergic and collagen diseases. It is important to keep the period of initial suppressive dose as brief as possible particularly when subsequent use of alternate day therapy is intended. Once control has been established, two courses are available: (a) change to alternate day therapy and then gradually reduce the amount of corticoid given every other day or (b) following control of the disease process reduce the daily dose of corticoid to the lowest effective level as rapidly as possible and then change over to an alternate day schedule. Theoretically, course (a) may be preferable. Because of the advantages of alternate day therapy, it may be desirable to try patients on this form of therapy who have been on daily corticoids for long periods of time (e.g., patients with rheumatoid arthritis). Since these patients may already have a suppressed HPA axis, establishing them on alternate day therapy may be difficult and not always successful. However, it is recommended that regular attempts be made to change them over. It may be helpful to triple or even quadruple the daily maintenance dose and administer this every other day rather than just doubling the daily dose if difficulty is encountered. Once the patient is again controlled, an attempt should be made to reduce this dose to a minimum. As indicated above, certain corticosteroids, because of their prolonged suppressive effect on adrenal activity, are not recommended for alternate day therapy (e.g., dexamethasone and betamethasone). The maximal activity of the adrenal cortex is between 2 am and 8 am, and it is minimal between 4 pm and midnight. Exogenous corticosteroids suppress adrenocortical activity the least, when given at the time of maximal activity (am). In using alternate day therapy it is important, as in all therapeutic situations to individualize and tailor the therapy to each patient. Complete control of symptoms will not be possible in all patients. An explanation of the benefits of alternate day therapy will help the patient to understand and tolerate the possible flare-up in symptoms which may occur in the latter part of the off-steroid day. Other symptomatic therapy may be added or increased at this time if needed. In the event of an acute flare-up of the disease process, it may be necessary to return to a full suppressive daily divided corticoid dose for control. Once control is again established alternate day therapy may be re-instituted. Although many of the undesirable features of corticosteroid therapy can be minimized by alternate day therapy, as in any therapeutic situation, the physician must carefully weigh the benefit-risk ratio for each patient in whom corticoid therapy is being considered. -
![Flurazepam (Flurazepam Hydrochloride) Capsule [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=d3d33307-05c1-4573-9804-93087189ae80&name=d3d33307-05c1-4573-9804-93087189ae80-02.jpg)
Flurazepam
Dosage should be individualized for maximal beneficial effects. The usual adult dosage is 30 mg before retiring. In some patients, 15 mg may suffice. In elderly and/or debilitated patients, 15 mg is usually sufficient for a therapeutic response and it is therefore recommended that therapy be initiated with this dosage.
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![Metaxalone Tablet [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=665bf04b-9732-4e24-944b-6599ba2730de&name=665bf04b-9732-4e24-944b-6599ba2730de-02.jpg)
Metaxalone
Methimazole is administered orally. It is usually given in 3 equal doses at approximately 8-hour intervals.
Adults
The initial daily dosage is 15 mg for mild hyperthyroidism, 30 to 40 mg for moderately severe hyperthyroidism, and 60 mg for severe hyperthyroidism, divided into 3 doses at 8- hour intervals. The maintenance dosage is 5 to 15 mg daily.
Pediatric
Initially, the daily dosage is 0.4 mg/kg of body weight divided into 3 doses and given at 8-hour intervals. The maintenance dosage is approximately 1/2 of the initial dose.
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![Ondansetron Tablet, Orally Disintegrating [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=7c45c2a6-0565-44e6-b538-a15a1bf72007&name=7c45c2a6-0565-44e6-b538-a15a1bf72007-02.jpg)
Ondansetron
Instructions for Use/Handling Ondansetron Orally Disintegrating Tablets:
Do not attempt to push ondansetron disintegrating tablets through the foil backing. With dry hands, PEEL BACK the foil backing of 1 blister and GENTLY remove the tablet. IMMEDIATELY place the ondansetron orally disintegrating tablet on top of the tongue where it will dissolve in seconds, then swallow with saliva. Administration with liquid is not necessary.
Prevention of Nausea and Vomiting Associated With Highly Emetogenic Cancer Chemotherapy:
The recommended adult oral dosage of ondansetron is 24 mg given as three 8 mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥50 mg/m2. Multiday, single-dose administration of a 24 mg dosage has not been studied.
Pediatric Use: There is no experience with the use of a 24 mg dosage in pediatric patients.
Geriatric Use: The dosage recommendation is the same as for the general population.
Prevention of Nausea and Vomiting Associated With Moderately Emetogenic Cancer Chemotherapy:
The recommended adult oral dosage is one 8 mg ondansetron orally disintegrating tablet given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8 mg ondansetron orally disintegrating tablet should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.
Pediatric Use: For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4 mg ondansetron orally disintegrating tablet given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4 mg ondansetron orally disintegrating tablet should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.
Geriatric Use: The dosage is the same as for the general population.
Prevention of Nausea and Vomiting Associated With Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions to the Abdomen:
The recommended oral dosage is one 8 mg ondansetron orally disintegrating tablets given 3 times a day.
For total body irradiation, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.
For single high-dose fraction radiotherapy to the abdomen, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.
For daily fractionated radiotherapy to the abdomen, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.
Pediatric Use: There is no experience with the use of ondansetron orally disintegrating tablets, in the prevention of radiation-induced nausea and vomiting in pediatric patients.
Geriatric Use: The dosage recommendation is the same as for the general population.
Postoperative Nausea and Vomiting:
The recommended dosage is 16 mg given as two 8 mg ondansetron orally disintegrating tablets 1 hour before induction of anesthesia.
Pediatric Use: There is no experience with the use of ondansetron orally disintegrating tablets in the prevention of postoperative nausea and vomiting in pediatric patients.
Geriatric Use: The dosage is the same as for the general population.
Dosage Adjustment for Patients with Impaired Renal Function:
The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron.
Dosage Adjustment for Patients With Impaired Hepatic Function:
In patients with severe hepatic impairment (Child-Pugh2 score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.
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![Next Choice (Levonorgestrel) Tablet [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=4a38f753-a2bf-40af-b638-00c3e409fb98&name=4a38f753-a2bf-40af-b638-00c3e409fb98-02.jpg)
Next Choice
Take one levonorgestrel tablet orally as soon as possible within 72 hours after unprotected intercourse or a known or suspected contraceptive failure. Efficacy is better if the tablet is taken as soon as possible after unprotected intercourse. The second tablet should be taken 12 hours after the first dose. Next ChoiceTM can be used at any time during the menstrual cycle.
If vomiting occurs within two hours of taking either dose of medication, consideration should be given to repeating the dose.
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![Medroxyprogesterone Acetate Tablet [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=37275fd0-eb24-40a4-a93f-b818bb98414e&name=b5c4f918-796b-4542-976f-8166f3375771-04.jpg)
Medroxyprogesterone Acetate
Secondary Amenorrhea
Medroxyprogesterone Acetate Tablets USP may be given in dosages of 5 or 10 mg daily for 5 to 10 days. A dose for inducing an optimum secretory transformation of an endometrium that has been adequately primed with either endogenous or exogenous estrogen is 10 mg of medroxyprogesterone acetate daily for 10 days. In cases of secondary amenorrhea, therapy may be started at any time. Progestin withdrawal bleeding usually occurs within three to seven days after discontinuing medroxyprogesterone acetate therapy.
Abnormal Uterine Bleeding Due to Hormonal Imbalance in the Absence of Organic Pathology
Beginning on the calculated 16th or 21st day of the menstrual cycle, 5 or 10 mg of medroxyprogesterone acetate may be given daily for 5 to 10 days. To produce an optimum secretory transformation of an endometrium that has been adequately primed with either endogenous or exogenous estrogen, 10 mg of medroxyprogesterone acetate daily for 10 days beginning on the 16th day of the cycle is suggested. Progestin withdrawal bleeding usually occurs within three to seven days after discontinuing therapy with medroxyprogesterone acetate. Patients with a past history of recurrent episodes of abnormal uterine bleeding may benefit from planned menstrual cycling with medroxyprogesterone acetate.
Reduction of Endometrial Hyperplasia in Postmenopausal Women Receiving Daily 0.625 mg Conjugated Estrogens
When estrogen is prescribed for a postmenopausal woman with a uterus, a progestin should also be initiated to reduce the risk of endometrial cancer. A woman without a uterus does not need progestin. Use of estrogen, alone or in combination with a progestin, should be with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Patients should be re-evaluated periodically as clinically appropriate (for example, 3-month to 6-month intervals) to determine if treatment is still necessary (see WARNINGS). For women who have a uterus, adequate diagnostic measures, such as endometrial sampling, when indicated, should be undertaken to rule out malignancy in cases of undiagnosed persistent or recurring abnormal vaginal bleeding.
Medroxyprogesterone Acetate Tablets USP may be given in dosages of 5 or 10 mg daily for 12 to 14 consecutive days per month, in postmenopausal women receiving daily 0.625 mg conjugated estrogens, either beginning on the 1st day of the cycle or the 16th day of the cycle.
Patients should be started at the lowest dose.
The lowest effective dose of medroxyprogesterone acetate has not been determined.
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![Triamcinolone Acetonide Cream [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=dec1337a-0ff1-44c0-9f7c-7e5ef18d6fbd&name=dec1337a-0ff1-44c0-9f7c-7e5ef18d6fbd-01.jpg)
Triamcinolone Acetonide
Apply triamcinolone acetonide cream 0.025% to the affected area two to four times daily. Rub in gently.
Apply the 0.1% triamcinolone acetonide cream to the affected area two to three times daily. Rub in gently.
Occlusive Dressing Technique
Occlusive dressings may be used for the management of psoriasis or other recalcitrant conditions. Gently rub a small amount of cream into the lesion until it disappears. Reapply the preparation leaving a thin coating on the lesion, cover with a pliable nonporous film, and seal the edges. If needed, additional moisture may be provided by covering the lesion with a dampened clean cotton cloth before the nonporous film is applied or by briefly wetting the affected area with water immediately prior to applying the medication. The frequency of changing dressings is best determined on an individual basis. It may be convenient to apply triamcinolone acetonide cream under an occlusive dressing in the evening and to remove the dressing in the morning (i.e., 12-hour occlusion). When utilizing the 12-hour occlusion regimen, additional cream should be applied, without occlusion, during the day. Reapplication is essential at each dressing change.
If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.
Occlusive Dressing Technique
Occlusive dressings may be used for the management of psoriasis or other recalcitrant conditions. Gently rub a small amount of cream into the lesion until it disappears. Reapply the preparation leaving a thin coating on the lesion, cover with a pliable nonporous film, and seal the edges. If needed, additional moisture may be provided by covering the lesion with a dampened clean cotton cloth before the nonporous film is applied or by briefly wetting the affected area with water immediately prior to applying the medication. The frequency of changing dressings is best determined on an individual basis. It may be convenient to apply triamcinolone acetonide cream under an occlusive dressing in the evening and to remove the dressing in the morning (i.e., 12-hour occlusion). When utilizing the 12-hour occlusion regimen, additional cream should be applied, without occlusion, during the day. Reapplication is essential at each dressing change.
If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.
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![Oxaprozin Tablet, Film Coated [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=03dc63f5-78cc-495a-a80b-fb77aeed8815&name=03dc63f5-78cc-495a-a80b-fb77aeed8815-02.jpg)
Oxaprozin
Carefully consider the potential benefits and risks of oxaprozin and other treatment options before deciding to use oxaprozin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with oxaprozin, the dose and frequency should be adjusted to suit an individual patient’s needs.
Rheumatoid Arthritis
For relief of the signs and symptoms of rheumatoid arthritis, the usual recommended dose is 1200 mg (two 600-mg tablets) given orally once a day (see Individualization of Dosage).
Osteoarthritis
For relief of the signs and symptoms of osteoarthritis, the usual recommended dose is 1200 mg (two 600-mg tablets) given orally once a day (see Individualization of Dosage).
Juvenile Rheumatoid Arthritis
For the relief of the signs and symptoms of JRA in patients 6-16 years of age, the recommended dose given orally once per day should be based on body weight of the patient as given in Table 3 (see also Individualization of Dosage).
Table 3
Body Weight Range (kg) Dose (mg) 22–31 600 32–54 900 ≥55 1200(see CLINICAL PHARMACOLOGY, Special Populations, Pediatric Patients)
Individualization of Dosage
As with other NSAIDs, the lowest dose should be sought for each patient. Therefore, after observing the response to initial therapy with oxaprozin, the dose and frequency should be adjusted to suit an individual patient’s needs. In osteoarthritis and rheumatoid arthritis and juvenile rheumatoid arthritis, the dosage should be individualized to the lowest effective dose of oxaprozin to minimize adverse effects. The maximum recommended total daily dose of oxaprozin tablets in adults is 1800 mg (26 mg/kg, whichever is lower) in divided doses. In children, doses greater than 1200 mg have not been studied.
Patients of low body weight should initiate therapy with 600 mg once daily. Patients with severe renal impairment or on dialysis should also initiate therapy with 600 mg once daily. If there is insufficient relief of symptoms in such patients, the dose may be cautiously increased to 1200 mg, but only with close monitoring (see CLINICAL PHARMACOLOGY, Special Populations).
In adults, in cases where a quick onset of action is important, the pharmacokinetics of oxaprozin allow therapy to be started with a one-time loading dose of 1200 to 1800 mg (not to exceed 26 mg/kg). Doses larger than 1200 mg/day on a chronic basis should be reserved for patients who weigh more than 50 kg, have normal renal and hepatic function, are at low risk of peptic ulcer, and whose severity of disease justifies maximal therapy. Physicians should ensure that patients are tolerating doses in the 600 to 1200 mg/day range without gastroenterologic, renal, hepatic, or dermatologic adverse effects before advancing to the larger doses. Most patients will tolerate once-a-day dosing with oxaprozin, although divided doses may be tried in patients unable to tolerate single doses.
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![Tobramycin Solution [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=f25741dd-a1d5-43fd-a21f-746d53f97c24&name=f25741dd-a1d5-43fd-a21f-746d53f97c24-02.jpg)
Tobramycin Solution
In mild to moderate disease, instill one or two drops into the affected eye(s) every four hours. In severe infections, instill two drops into the eye(s) hourly until improvement, following which treatment should be reduced prior to discontinuation.
DO NOT USE IF IMPRINTED NECKBAND IS NOT INTACT.
FOR OPHTHALMIC USE ONLY
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![Sulfacetamide Sodium Solution/ Drops [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=cf0cc763-49b5-435d-852b-e7617c8d3286&name=cf0cc763-49b5-435d-852b-e7617c8d3286-03.jpg)
Sulfacetamide Sodium Solution Drops
For conjunctivitis and other superficial ocular infections:
Instill one or two drops into the conjunctival sac(s) of the affected eye(s) every two to three hours initially. Dosages may be tapered by increasing the time interval between doses as the condition responds. The usual duration of treatment is seven to ten days.
For Trachoma:
Instill two drops into the conjunctival sac(s) of the affected eye(s) every two hours. Topical administration must be accompanied by systemic administration.
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![Ranitidine Tablet [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=1d6b4ff2-eb02-419a-8d82-75e42780514a&name=1d6b4ff2-eb02-419a-8d82-75e42780514a-02.jpg)
Ranitidine
Active Duodenal Ulcer: The current recommended adult dosage of Ranitidine Tablets, USP for duodenal ulcer is 150 mg twice daily. An alternative dosage of 300 mg once daily after the evening meal or at bedtime can be used for patients in whom dosing convenience is important. The advantages of one treatment regimen compared to the other in a particular patient population have yet to be demonstrated (see Clinical Trials: Active Duodenal Ulcer). Smaller doses have been shown to be equally effective in inhibiting gastric acid secretion in US studies, and several foreign trials have shown that 100 mg twice daily is as effective as the 150-mg dose.
Antacid should be given as needed for relief of pain (see CLINICAL PHARMACOLOGY: Pharmacokinetics).
Maintenance of Healing of Duodenal Ulcers: The current recommended adult oral dosage is 150 mg at bedtime.
Pathological Hypersecretory Conditions (such as Zollinger-Ellison syndrome):
The current recommended adult oral dosage is 150 mg twice a day. In some patients it may be necessary to administer Ranitidine Tablets, USP 150-mg doses more frequently. Dosages should be adjusted to individual patient needs, and should continue as long as clinically indicated. Dosages up to 6 g/day have been employed in patients with severe disease.
Benign Gastric Ulcer: The current recommended adult oral dosage is 150 mg twice a day.
Maintenance of Healing of Gastric Ulcers: The current recommended adult oral dosage is 150 mg at bedtime.
GERD: The current recommended adult oral dosage is 150 mg twice a day.
Erosive Esophagitis: The current recommended adult oral dosage is 150 mg four times a day.
Maintenance of Healing of Erosive Esophagitis: The current recommended adult oral dosage is 150 mg twice a day.
Pediatric Use: The safety and effectiveness of Ranitidine Tablets, USP have been established in the age-group of 1 month to 16 years. There is insufficient information about the pharmacokinetics of Ranitidine Tablets, USP in neonatal patients (less than 1 month of age) to make dosing recommendations.
The following 3 subsections provide dosing information for each of the pediatric indications.
Treatment of Duodenal and Gastric Ulcers: The recommended oral dose for the treatment of active duodenal and gastric ulcers is 2 to 4 mg/kg twice daily to a maximum of 300 mg/day. This recommendation is derived from adult clinical studies and pharmacokinetic data in pediatric patients.
Maintenance of Healing of Duodenal and Gastric Ulcers: The recommended oral dose for the maintenance of healing of duodenal and gastric ulcers is 2 to 4 mg/kg once daily to a maximum of 150 mg/day. This recommendation is derived from adult clinical studies and pharmacokinetic data in pediatric patients.
Treatment of GERD and Erosive Esophagitis: Although limited data exist for these conditions in pediatric patients, published literature supports a dosage of 5 to 10 mg/kg per day, usually given as two divided doses.
Dosage Adjustment for Patients With Impaired Renal Function: On the basis of experience with a group of subjects with severely impaired renal function treated with Ranitidine Tablets, USP, the recommended dosage in patients with a creatinine clearance <50 mL/min is 150 mg every 24 hours. Should the patient's condition require, the frequency of dosing may be increased to every 12 hours or even further with caution. Hemodialysis reduces the level of circulating ranitidine. Ideally, the dosing schedule should be adjusted so that the timing of a scheduled dose coincides with the end of hemodialysis.
Elderly patients are more likely to have decreased renal function, therefore caution should be exercised in dose selection, and it may be useful to monitor renal function (see CLINICAL PHARMACOLOGY: Pharmacokinetics: Geriatrics and PRECAUTIONS: Geriatric Use).
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![Pred Mild (Prednisolone Acetate) Suspension/ Drops [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=90fba723-51b1-4404-a30b-816f35001d91&name=90fba723-51b1-4404-a30b-816f35001d91-02.jpg)
Pred Mild
Shake well before using. Instill one to two drops into the conjunctival sac two to four times daily. During the initial 24 to 48 hours, the dosing frequency may be increased if necessary. Care should be taken not to discontinue therapy prematurely.
If signs and symptoms fail to improve after 2 days, the patient should be re-evaluated (see PRECAUTIONS).
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![Anucort-hc (Hydrocortisone Acetate) Suppository [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=e6ab3ac4-e84b-42f0-9f98-ae39a0c35616&name=e6ab3ac4-e84b-42f0-9f98-ae39a0c35616-02.jpg)
Anucort-hc
For rectal administration. Detach one suppository from strip of suppositories. Hold suppository upright. Separate tabs at top opening and pull downward from the pointed end. Continue pulling downward to almost the full length of the suppository. Carefully remove the suppository from the pocket. Avoid excessive handling of the suppository which is designed to melt at body temperature. Insert suppository into the rectum with with gentle pressure, pointed end first. Insert one suppository in the rectum twice daily, morning and night for two weeks, in nonspecific proctitis. In more severe cases, one suppository three times a day or two suppositories twice daily. In factitial proctitis, the recommended duration of therapy is six to eight weeks or less, according to the response of the individual case.
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![Medrox (Methyl Salicylate, Menthol, Capsaicin) Ointment [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=e14a98fd-3b83-46dc-a5e0-17cd55dcafa1&name=e14a98fd-3b83-46dc-a5e0-17cd55dcafa1-01.jpg)
Medrox
Apply product directly to affected area. Product may be used as necessary, but should not be used more than four times per day.
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![Artificial Tears (Polyvinyl Alcohol) Solution/ Drops [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=95cd5442-e62d-4dee-9da3-d8b6868dfe68&name=95cd5442-e62d-4dee-9da3-d8b6868dfe68-01.jpg)
Artificial Tears
instill 1 to 2 drops in the affected eye(s) as needed.
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![Naproxen Sodium Tablet, Film Coated [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=a92bf444-0ae7-4365-831e-9fd37d59d5fa&name=426231be-c09f-494d-a8e0-b1654eaa5f65-02.jpg)
Naproxen Sodium
• do not take more than directed • the smallest effective dose should be used • drink a full glass of water with each dose
Adults and children 12 years and older:
• take 1 caplet every 8 to 12 hours while symptoms last • for the first dose you may take 2 caplets within the first hour • do not exceed 2 caplets in any 8- to 12-hour period • do not exceed 3 caplets in a 24-hour periodChildren under 12 years:
• ask a doctor -
![Dg Health Pain Relief Pm (Acetaminophen, Diphenhydramine Hcl) Tablet, Film Coated [Dolgencorp Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=d00a5f80-aa50-4b0b-82d2-63ba33a56b2f&name=4165adea-6467-4085-9cbf-aedff4baeae6-02.jpg)
Dg Health Pain Relief Pm
Nystatin Ointment USP should be applied liberally to affected areas twice a day or as indicated until healing is complete. Nystatin cream is usually preferred to nystatin ointment in candidiasis involving intertriginous areas; very moist lesions, however, are best treated with nystatin topical powder.
This preparation does not stain skin or mucous membranes and provides a simple, convenient means of treatment.
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![Tretinoin Cream [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=e3d00b1d-0c68-44cc-ab5b-d76547283090&name=e3d00b1d-0c68-44cc-ab5b-d76547283090-02.jpg)
Tretinoin
Tretinoin gel or cream should be applied once a day, before retiring, to the skin where acne lesions appear, using enough to cover the entire affected area lightly. Gel: Excessive application results in "pilling" of the gel, which minimizes the likelihood of over application by the patient.
Application may cause a transitory feeling of warmth or slight stinging. In cases where it has been necessary to temporarily discontinue therapy or to reduce the frequency of application, therapy may be resumed or frequency of application increased when the patients become able to tolerate the treatment.
Alterations of vehicle, drug concentration, or dose frequency should be closely monitored by careful observation of the clinical therapeutic response and skin tolerance.
During the early weeks of therapy, an apparent exacerbation of inflammatory lesions may occur. This is due to the action of the medication on deep, previously unseen lesions and should not be considered a reason to discontinue therapy.
Therapeutic results should be noticed after two to three weeks but more than six weeks of therapy may be required before definite beneficial effects are seen.
Once the acne lesions have responded satisfactorily, it may be possible to maintain the improvement with less frequent applications, or other dosage forms.
Patients treated with tretinoin preparations may use cosmetics, but the areas to be treated should be cleansed thoroughly before the medication is applied (see Precautions).
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![Nizatidine Capsule [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=b616ab13-ff66-420a-8ee2-3a6351b51d06&name=b616ab13-ff66-420a-8ee2-3a6351b51d06-03.jpg)
Nizatidine
Active Duodenal Ulcer
The recommended oral dosage of adults is 300 mg once daily at bedtime. An alternative dosage regimen is 150 mg twice daily.
Maintenance of Healed Duodenal Ulcer
The recommended oral dosage for adults is 150 mg once daily at bedtime.
Gastroesophageal Reflux Disease
The recommended oral dosage in adults for the treatment of erosions, ulcerations, and associated heartburn is 150 mg twice daily.
Active Benign Gastric Ulcer
The recommended oral dosage is 300 mg given either as 150 mg twice daily or 300 mg once daily at bedtime. Prior to treatment, care should be taken to exclude the possibility of malignant gastric ulceration.
Dosage Adjustment for Patients With Moderate to Severe Renal Insufficiency
The dose for patients with renal dysfunction should be reduced as follows:
Active Duodenal Ulcer, GERD, and Benign Gastric Ulcer Ccr Dose 20-50 mL/min 150 mg daily <20 mL/min 150 mg every other day Maintenance Therapy Ccr Dose 20-50 mL/min 150 mg every other day <20 mL/min 150 mg every 3 daysSome elderly patients may have creatinine clearances of less than 50 mL/min, and, based on pharmacokinetic data in patients with renal impairment, the dose for such patients should be reduced accordingly. The clinical effects of this dosage reduction in patients with renal failure have not been evaluated.
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![Terazosin Hydrochloride Capsule [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=9d8fd052-b478-447e-a884-74fcd21275bb&name=9d8fd052-b478-447e-a884-74fcd21275bb-05.jpg)
Terazosin Hydrochloride
If the administration of terazosin hydrochloride capsule is discontinued for several days, therapy should be reinstituted using the initial dosing regimen.
Benign Prostatic Hyperplasia:
Initial Dose:
1 mg at bedtime is the starting dose for all patients, and this dose should not be exceeded as an initial dose. Patients should be closely followed during initial administration in order to minimize the risk of severe hypotensive response.
Subsequent Doses:
The dose should be increased in a stepwise fashion to 2 mg, 5 mg, or10 mg once daily to achieve the desired improvement of symptoms and/or flow rates. Doses of 10 mg once daily are generally required for the clinical response. Therefore, treatment with 10 mg for a minimum of 4-6weeksmay be required to assess whether a beneficial response has been achieved. Some patients may not achieve a clinical response despite appropriate titration. Although some additional patients responded at a 20 mg daily dose, there was an insufficient number of patients studied to draw definitive conclusions about this dose. There are insufficient data to support the use of higher doses for those patients who show inadequate or no response to 20mg daily. If terazosin administration is discontinued for several days or longer, therapy should be reinstituted using the initial dosing regimen.
Use with Other Drugs:
Caution should be observed when terazosin hydrochloride is administered concomitantly with other antihypertensive agents, especially the calcium channel blocker verapamil, to avoid the possibility of developing significant hypotension. When using terazosin hydrochloride and other antihypertensive agents concomitantly, dosage reduction and retitration of either agent may be necessary (see Precautions).
Hypotension has been reported when terazosin hydrochloride has been used with phosphodiesterase-5 (PDE-5) inhibitors.
Hypertension:
The dose of terazosin hydrochloride and the dose interval (12 or 24 hours) should be adjusted according to the patient’s individual blood pressure response. The following is a guide to its administration:
Initial Dose:
1 mg at bedtime is the starting dose for all patients, and this dose should not be exceeded. This initial dosing regimen should be strictly observed to minimize the potential for severe hypotensive effects.
Subsequent Doses:
The dose may be slowly increased to achieve the desired blood pressure response. The usual recommended dose range is 1 mg to 5 mg administered once a day; however, some patients may benefit from doses as high as 20 mg per day. Doses over 20 mg do not appear to provide further blood pressure effect and doses over 40 mg have not been studied. Blood pressure should be monitored at the end of the dosing interval to be sure control is maintained throughout the interval. It may also be helpful to measure blood pressure 2-3 hours after dosing to see if the maximum and minimum responses are similar, and to evaluate symptoms such as dizziness or palpitations which can result from excessive hypotensive response. If response is substantially diminished at 24 hours an increased dose or use of a twice daily regimen can be considered. If terazosin administration is discontinued for several days or longer, therapy should be reinstituted using the initial dosing regimen. In clinical trials, except for the initial dose, the dose was given in the morning.
Use with other Drugs: (see above).
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![Neomycin And Polymyxin B Sulfates And Dexamethasone Ointment [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=8e467d61-e26f-410e-b582-465432f087c1&name=8e467d61-e26f-410e-b582-465432f087c1-02.jpg)
Neomycin And Polymyxin B Sulfates And Dexamethasone Ointment
Apply a small amount into the conjunctival sac(s) up to three or four times daily.
How to Apply Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment:
1. Tilt your head back.
2. Place a finger on your cheek just under your eye and gently pull down until a "V" pocket is formed between your eyeball and your lower lid.
3. Place a small amount (about 1/2 inch) of Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment in the "V" pocket. Do not let the tip of the tube touch your eye.
4. Look downward before closing your eye.
Not more than 8 g should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in PRECAUTIONS above.
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![Lisinopril Tablet [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=631825ef-67f4-473a-a2b8-90cb3edfc4df&name=631825ef-67f4-473a-a2b8-90cb3edfc4df-02.jpg)
Lisinopril
Hypertension
Initial Therapy: In patients with uncomplicated essential hypertension not on diuretic therapy, the recommended initial dose is 10 mg once a day. Dosage should be adjusted according to blood pressure response. The usual dosage range is 20 to 40 mg per day administered in a single daily dose. The antihypertensive effect may diminish toward the end of the dosing interval regardless of the administered dose, but most commonly with a dose of 10 mg daily. This can be evaluated by measuring blood pressure just prior to dosing to determine whether satisfactory control is being maintained for 24 hours. If it is not, an increase in dose should be considered. Doses up to 80 mg have been used but do not appear to give greater effect. If blood pressure is not controlled with Lisinopril tablet alone, a low dose of a diuretic may be added. Hydrochlorothiazide, 12.5 mg has been shown to provide an additive effect. After the addition of a diuretic, it may be possible to reduce the dose of Lisinopril tablet.
Diuretic Treated Patients: In hypertensive patients who are currently being treated with a diuretic, symptomatic hypotension may occur occasionally following the initial dose of Lisinopril tablet. The diuretic should be discontinued, if possible, for two to three days before beginning therapy with Lisinopril tablet to reduce the likelihood of hypotension (See WARNINGS). The dosage of Lisinopril tablet should be adjusted according to blood pressure response. If the patient's blood pressure is not controlled with Lisinopril tablet alone, diuretic therapy may be resumed as described above.
If the diuretic cannot be discontinued, an initial dose of 5 mg should be used under medical supervision for at least two hours and until blood pressure has stabilized for at least an additional hour (See WARNINGS and PRECAUTIONS, Drug Interactions).
Concomitant administration of Lisinopril tablet with potassium supplements, potassium salt substitutes, or potassium-sparing diuretics may lead to increases of serum potassium (See PRECAUTIONS).
Dosage Adjustment in Renal Impairment: The usual dose of Lisinopril tablet (10 mg) is recommended for patients with creatinine clearance >30 mL/min (serum creatinine of up to approximately 3 mg/dL). For patients with creatinine clearance ≥10 mL/min ≤30 mL/min (serum creatinine ≥3 mg/dL), the first dose is 5 mg once daily. For patients with creatinine clearance <10 mL/min (usually on hemodialysis) the recommended initial dose is 2.5 mg. The dosage may be titrated upward until blood pressure is controlled or to a maximum of 40 mg daily.
* See WARNINGS, Anaphylactoid Reactions During Membrane Exposure. ** Dosage or dosing interval should be adjusted depending on the blood pressure response.Renal Status
Creatinine ClearancemL/min
Initial Dosemg/day
Normal Renal Functionto Mild Impairment
>30
10
Moderate to Severe Impairment
≥10 ≤30
5
Dialysis Patients*
<10
2.5**
Heart Failure
Lisinopril tablet is indicated as adjunctive therapy with diuretics and (usually) digitalis. The recommended starting dose is 5 mg once a day. When initiating treatment with lisinopril in patients with heart failure, the initial dose should be administered under medical observation, especially in those patients with low blood pressure (systolic blood pressure below 100 mmHg). The mean peak blood pressure lowering occurs six to eight hours after dosing. Observation should continue until blood pressure is stable. The concomitant diuretic dose should be reduced, if possible, to help minimize hypovolemia which may contribute to hypotension (See WARNINGS and PRECAUTIONS, Drug Interactions). The appearance of hypotension after the initial dose of Lisinopril tablet does not preclude subsequent careful dose titration with the drug, following effective management of the hypotension.
The usual effective dosage range is 5 to 40 mg per day administered as a single daily dose. The dose of Lisinopril tablet can be increased by increments of no greater than 10 mg, at intervals of no less than 2 weeks to the highest tolerated dose, up to a maximum of 40 mg daily. Dose adjustment should be based on the clinical response of individual patients.
Dosage Adjustment in Patients with Heart Failure and Renal Impairment or Hyponatremia: In patients with heart failure who have hyponatremia (serum sodium <130 mEq/L) or moderate to severe renal impairment (creatinine clearance ≤30 mL/min or serum creatinine >3 mg/dL), therapy with Lisinopril tablet should be initiated at a dose of 2.5 mg once a day under close medical supervision (See WARNINGS and PRECAUTIONS, Drug Interactions).
Acute Myocardial Infarction
In hemodynamically stable patients within 24 hours of the onset of symptoms of acute myocardial infarction, the first dose of Lisinopril tablet is 5 mg given orally, followed by 5 mg after 24 hours, 10 mg after 48 hours and then 10 mg of Lisinopril tablet once daily. Dosing should continue for six weeks. Patients should receive, as appropriate, the standard recommended treatments such as thrombolytics, aspirin, and beta-blockers.
Patients with a low systolic blood pressure (≤120 mmHg) when treatment is started or during the first 3 days after the infarct should be given a lower 2.5 mg oral dose of Lisinopril tablet (see WARNINGS). If hypotension occurs (systolic blood pressure ≤100 mmHg) a daily maintenance dose of 5 mg may be given with temporary reductions to 2.5 mg if needed. If prolonged hypotension occurs (systolic blood pressure <90 mmHg for more than 1 hour) Lisinopril tablet should be withdrawn. For patients who develop symptoms of heart failure, see DOSAGE AND ADMINISTRATION, Heart Failure.
Dosage Adjustment in Patients With Myocardial Infarction with Renal Impairment: In acute myocardial infarction, treatment with Lisinopril tablet should be initiated with caution in patients with evidence of renal dysfunction, defined as serum creatinine concentration exceeding 2 mg/dL. No evaluation of dosing adjustments in myocardial infarction patients with severe renal impairment has been performed.
Use in Elderly
In general, the clinical response was similar in younger and older patients given similar doses of Lisinopril tablet. Pharmacokinetic studies, however indicate that maximum blood levels and area under the plasma concentration time curve (AUC) are doubled in older patients, so that dosage adjustments should be made with particular caution.
Pediatric Hypertensive Patients ≥6 Years of age
The usual recommended starting dose is 0.07 mg/kg once daily (up to 5 mg total). Dosage should be adjusted according to blood pressure response. Doses above 0.61 mg/kg (or in excess of 40 mg) have not been studied in pediatric patients (See CLINICAL PHARMACOLOGY, Pharmacokinetics and Metabolism and Pharmacodynamics and Clinical Effects).
Lisinopril tablet is not recommend in pediatric patients <6 years or in pediatric patients with glomerular filtration rate <30 mL/min/1.73m2 (see CLINICAL PHARMACOLOGY, Pharmacokinetics and Metabolism and Pharmacodynamics and Clinical Effects and PRECAUTIONS).
Preparation of Suspension (for 200 mL of a 1.0 mg/mL suspension): Add 10 mL of Purified Water USP to a polyethylene terephthalate (PET) bottle containing ten 20 mg tablets of Lisinopril tablet and shake for at least one minute. Add 30 mL of Bicitra®† diluent and 160 mL of Ora Sweet SFTM†† to the concentrate in the PET bottle and gently shake for several seconds to disperse the ingredients. The suspension should be stored at or below 25°C (77°F) and can be stored for up to four weeks. Shake the suspension before each use.
† Registered trademark of Alza Corporation
†† Trademark of Paddock Laboratories, Inc.
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![Terbinafine Hydrochloride Cream [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=6016e546-6c02-4af0-888c-c0899865c5f0&name=6016e546-6c02-4af0-888c-c0899865c5f0-03.jpg)
Terbinafine Hydrochloride
• adults and children 12 years and older ∘ use the tip of the cap to break the seal and open the tube ∘ wash the affected skin with soap and water and dry completely before applying ∘ for athlete's foot wear well-fitting, ventilated shoes. Change shoes and socks at least once daily. ▪ between the toes only: apply twice a day (morning and night) for 1 week or as directed by a doctor. ▪ on the bottom or sides of the foot: apply twice a day (morning and night) for 2 weeks or as directed by a doctor. ∘ for jock itch and ringworm: apply once a day (morning or night) for 1 week or as directed by a doctor. ∘ wash hands after each use • children under 12 years: ask a doctor
1 week between the toes2 weeks on the bottom or sides of the foot
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![Polymyxin B Sulfate And Trimethoprim Sulfate (Polymyxin B Sulfate, Trimethoprim Sulfate) Solution/ Drops [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=394ee5cc-9b4c-42eb-b519-08931a1a8c39&name=394ee5cc-9b4c-42eb-b519-08931a1a8c39-04.jpg)
Polymyxin B Sulfate And Trimethoprim Sulfate
In mild to moderate infections, instill one drop in the affected eye(s) every three hours (maximum of 6 doses per day) for a period of 7 to 10 days.
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![Good Sense Tussin Cf Cough And Cold (Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride) Liquid [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=1b0ea019-4a51-4eb4-a22e-379785a1b84c&name=1b0ea019-4a51-4eb4-a22e-379785a1b84c-01.jpg)
Good Sense Tussin Cf Cough And Cold
• do not take more than 6 doses in any 24-hour period • this adult product is not intended for use in children under 12 years of age • mL = milliliter; tsp = teaspoonful
age
dose
adults and children 12 years and over
10 mL (2 tsp) every 4 hours
children under 12 years
do not use
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![Thermazene (Silver Sulfadiazine) Cream [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=62016bd1-2502-4bca-8274-2caa24fc0c06&name=62016bd1-2502-4bca-8274-2caa24fc0c06-01.jpg)
Thermazene
Prompt institution of appropriate regimens for care of the burned patient is of prime importance and includes the control of shock and pain. The burn wounds are then cleansed and debrided; Thermazene Cream is then applied under sterile conditions. The burn areas should be covered with Thermazene Cream at all times. The cream should be applied once to twice daily to a thickness of approximately one sixteenth of an inch. Whenever necessary, the cream should be reapplied to any areas from which it has been removed due to patient activity. Administration may be accomplished in minimal time because dressings are not required. However, if individual patient requirements make dressings necessary, they may be used. Reapply immediately after hydrotherapy. Treatment with Thermazene Cream should be continued until satisfactory healing has occurred or until the burn site is ready for grafting. The drug should not be withdrawn from the therapeutic regimen while there remains the possibility of infection except if a significant adverse reaction occurs.
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![Emetrol Cherry (Phosphorated Carbohydrate) Solution [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=d0ce87b8-d484-4307-95a9-05705a6caf85&name=d0ce87b8-d484-4307-95a9-05705a6caf85-01.jpg)
Emetrol Cherry
For maximum effectiveness never dilute or drink fluids of any kind immediately before or after taking this product adults and children 12 years of age and over: one to two tablespoons children 2 to under 12: one or two teaspoons repeat dose every 15 minutes or until distress subsides do not take more than 5 doses in 1 hour without consulting a doctor
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![Triple Antibiotic (Bacitracin Zinc Neomycin Sulfate Polymyxin B Sulfate) Ointment [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=149065ec-0c18-43e7-89de-6540bf48207b&name=149065ec-0c18-43e7-89de-6540bf48207b-01.jpg)
Triple Antibiotic
clean affected area apply a small amount (equal to the surface area of the tip of a finger) on the area 1 to 3 times daily may be covered with a sterile bandage
Other Information
Store at controlled room temperature 59º - 86ºF (15º - 30ºC). Protect from freezing. -
![Ibuprofen Childrens (Ibuprofen) Suspension [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=72923be6-d49c-4ea9-8e20-f9beec10b86e&name=72923be6-d49c-4ea9-8e20-f9beec10b86e-01.jpg)
Ibuprofen Childrens
this product does not contain directions or complete warnings for adult use do not give more than directed do not give longer than 10 days, unless directed by a doctor (see Warnings) shake well before using find right dose on chart. If possible, use weight to dose; otherwise use age. use only enclosed measuring cup if needed, repeat dose every 6-8 hours do not use more than 4 times a day replace original bottle cap to maintain child resistance wash dosage cup after each use
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![Triamterene And Hydrochlorothiazide Tablet [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=6e55081c-2531-43a2-9c9c-a56ea72e0e16&name=6e55081c-2531-43a2-9c9c-a56ea72e0e16-03.jpg)
Triamterene And Hydrochlorothiazide
The usual dose of Triamterene and Hydrochlorothiazide Tablets 37.5 mg/25 mg is one or two tablets daily, given as a single dose, with appropriate monitoring of serum potassium (see WARNINGS). The usual dose of Triamterene and Hydrochlorothiazide Tablets 75 mg/50 mg is one tablet daily, with appropriate monitoring of serum potassium (see WARNINGS). There is no experience with the use of more than one 75 mg/50 mg (75 mg triamterene and 50 mg hydrochlorothiazide) tablet daily or more than two 37.5 mg/25 mg (37.5 mg triamterene and 25 mg hydrochlorothiazide) tablets daily. Clinical experience with the administration of two 37.5 mg/25 mg tablets daily in divided doses (rather than as a single dose) suggests an increased risk of electrolyte imbalance and renal dysfunction.
Patients receiving 50 mg of hydrochlorothiazide who become hypokalemic may be transferred to this 75 mg/50 mg product directly. Patients receiving 25 mg hydrochlorothiazide who become hypokalemic may be transferred to this 37.5 mg/25 mg product directly.
In patients requiring hydrochlorothiazide therapy and in whom hypokalemia cannot be risked, therapy may be initiated with 37.5 mg/25 mg of triamterene and hydrochlorothiazide. If an optimal blood pressure response is not obtained with 37.5 mg/25 mg of triamterene and hydrochlorothiazide, the dose should be increased to two 37.5 mg/25 mg tablets daily as a single dose, or one 75 mg/50 mg tablet daily. If blood pressure still is not controlled, another antihypertensive agent may be added (see PRECAUTIONS: Drug Interactions).
Clinical studies have shown that patients taking less bioavailable formulations of triamterene and hydrochlorothiazide in daily doses of 25 mg to 50 mg hydrochlorothiazide and 50 mg to 100 mg triamterene may be safely changed to one triamterene and hydrochlorothiazide 37.5 mg/25 mg tablet daily. All patients changed from less bioavailable formulations to this product should be monitored clinically and for serum potassium after the transfer.
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![Lidocaine Hydrochloride Solution [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=5aa18b0b-4688-493a-a5ae-cb056ea6c0e3&name=LisinoprilHCTZ20-12.5.jpg.jpg)
Lidocaine Hydrochloride Solution
Lisinopril monotherapy is an effective treatment of hypertension in once-daily doses of 10 to 80 mg, while hydrochlorothiazide monotherapy is effective in doses of 12.5 to 50 mg per day. In clinical trials of lisinopril/hydrochlorothiazide combination therapy using lisinopril doses of 10 to 80 mg and hydrochlorothiazide doses of 6.25 to 50 mg, the antihypertensive response rates generally increased with increasing dose of either component.
The side effects (see WARNINGS) of lisinopril are generally rare and apparently independent of dose; those of hydrochlorothiazide are a mixture of dose-dependent phenomena (primarily hypokalemia) and dose-independent phenomena (e.g., pancreatitis), the former much more common than the latter. Therapy with any combination of lisinopril and hydrochlorothiazide may be associated with either or both dose-independent or dose-dependent side effects, but addition of lisinopril in clinical trials blunted the hypokalemia normally seen with diuretics.
To minimize dose-dependent side effects, it is usually appropriate to begin combination therapy only after a patient has failed to achieve the desired effect with monotherapy.
Dose Titration Guided by Clinical Effect
A patient whose blood pressure is not adequately controlled with either lisinopril or hydrochlorothiazide monotherapy may be switched to lisinopril and hydrochlorothiazide tablets 10 mg/12.5 mg or lisinopril and hydrochlorothiazide tablets 20 mg/12.5 mg, depending on current monotherapy dose. Further increases of either or both components should depend on clinical response with blood pressure measured at the interdosing interval to ensure that there is an adequate antihypertensive effect at that time. The hydrochlorothiazide dose should generally not be increased until 2 to 3 weeks have elapsed. After addition of the diuretic it may be possible to reduce the dose of lisinopril. Patients whose blood pressures are adequately controlled with 25 mg of daily hydrochlorothiazide, but who experience significant potassium loss with this regimen, may achieve similar or greater blood pressure control without electrolyte disturbance if they are switched to lisinopril and hydrochlorothiazide tablets 10 mg/12.5 mg.
In patients who are currently being treated with a diuretic, symptomatic hypotension occasionally may occur following the initial dose of lisinopril. The diuretic should, if possible, be discontinued for two to three days before beginning therapy with lisinopril to reduce the likelihood of hypotension (See WARNINGS). If the patient's blood pressure is not controlled with lisinopril alone, diuretic therapy may be resumed.
If the diuretic cannot be discontinued, an initial dose of 5 mg of lisinopril should be used under medical supervision for at least two hours and until blood pressure has stabilized for at least an additional hour (See WARNINGS and PRECAUTIONS, Drug Interactions).
Concomitant administration of lisinopril and hydrochlorothiazide with potassium supplements, potassium salt substitutes or potassium-sparing diuretics may lead to increases of serum potassium (See PRECAUTIONS).
Replacement Therapy
The combination may be substituted for the titrated individual components.
Use in Renal Impairment
Regimens of therapy with lisinopril and hydrochlorothiazide tablets need not take account of renal function as long as the patient's creatinine clearance is >30 mL/min/1.7 m2 (serum creatinine roughly ≤3 mg/dL or 265 µmol/L). In patients with more severe renal impairment, loop diuretics are preferred to thiazides, so lisinopril and hydrochlorothiazide tablets are not recommended (see WARNINGS, Anaphylactoid Reactions During Membrane Exposure).
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![Buminate (Albumin Human) Injection, Solution [Baxter Healthcare Corporation]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=b722a6c8-c44b-4ec7-9402-02dc7e965753&name=levothyroxine-sodium-tablets-usp-11.jpg)
Buminate
General Principles:
The goal of replacement therapy is to achieve and maintain a clinical and biochemical euthyroid state. The goal of suppressive therapy is to inhibit growth and/or function of abnormal thyroid tissue. The dose of Levothyroxine Sodium Tablets, USP that is adequate to achieve these goals depends on a variety of factors including the patient's age, body weight, cardiovascular status, concomitant medical conditions, including pregnancy, concomitant medications, and the specific nature of the condition being treated (see WARNINGS and PRECAUTIONS). Hence, the following recommendations serve only as dosing guidelines. Dosing must be individualized and adjustments made based on periodic assessment of the patient's clinical response and laboratory parameters (see PRECAUTIONS, Laboratory Tests).
Levothyroxine Sodium Tablets, USP should be taken in the morning on an empty stomach, at least one-half hour to one hour before any food is eaten. Levothyroxine Sodium Tablets, USP should be taken at least 4 hours apart from drugs that are known to interfere with its absorption (see PRECAUTIONS, Drug Interactions).
Due to the long half-life of levothyroxine, the peak therapeutic effect at a given dose of levothyroxine sodium may not be attained for 4-6 weeks.
Caution should be exercised when administering Levothyroxine Sodium Tablets, USP to patients with underlying cardiovascular disease, to the elderly, and to those with concomitant adrenal insufficiency (see PRECAUTIONS).
Specific Patient Populations:
Hypothyroidism in Adults and in Children in Whom Growth and Puberty are Complete (see WARNINGS and PRECAUTIONS, Laboratory Tests).
Therapy may begin at full replacement doses in otherwise healthy individuals less than 50 years old and in those older than 50 years who have been recently treated for hyperthyroidism or who have been hypothyroid for only a short time (such as a few months). The average full replacement dose of levothyroxine sodium is approximately 1.7 mcg/kg/day (e.g., 100-125 mcg/day for a 70 kg adult). Older patients may require less than 1 mcg/kg/day. Levothyroxine sodium doses greater than 200 mcg/day are seldom required. An inadequate response to daily doses ≥ 300 mcg/day is rare and may indicate poor compliance, malabsorption, and/or drug interactions.
For most patients older than 50 years or for patients under 50 years of age with underlying cardiac disease, an initial starting dose of 25-50 mcg/day of levothyroxine sodium is recommended, with gradual increments in dose at 6-8 week intervals, as needed. The recommended starting dose of levothyroxine sodium in elderly patients with cardiac disease is 12.5-25 mcg/day, with gradual dose increments at 4-6 week intervals. The levothyroxine sodium dose is generally adjusted in 12.5-25 mcg increments until the patient with primary hypothyroidism is clinically euthyroid and the serum TSH has normalized.
In patients with severe hypothyroidism, the recommended initial levothyroxine sodium dose is 12.5-25 mcg/day with increases of 25 mcg/day every 2-4 weeks, accompanied by clinical and laboratory assessment, until the TSH level is normalized.
In patients with secondary (pituitary) or tertiary (hypothalamic) hypothyroidism, the levothyroxine sodium dose should be titrated until the patient is clinically euthyroid and the serum free-T4 level is restored to the upper half of the normal range.
Pediatric Dosage - Congenital or Acquired Hypothyroidism (see PRECAUTIONS, Laboratory Tests)
General Principles
In general, levothyroxine therapy should be instituted at full replacement doses as soon as possible. Delays in diagnosis and institution of therapy may have deleterious effects on the child's intellectual and physical growth and development.
Undertreatment and overtreatment should be avoided (see PRECAUTIONS, Pediatric Use).
Levothyroxine Sodium Tablets, USP may be administered to infants and children who cannot swallow intact tablets by crushing the tablet and suspending the freshly crushed tablet in a small amount (5-10 mL or 1-2 teaspoons) of water. This suspension can be administered by spoon or dropper. DO NOT STORE THE SUSPENSION. Foods that decrease absorption of levothyroxine, such as soybean infant formula, should not be used for administering levothyroxine sodium tablets. (see PRECAUTIONS, Drug-Food Interactions).
Newborns
The recommended starting dose of levothyroxine sodium in newborn infants is 10-15 mcg/kg/day. A lower starting dose (e.g., 25 mcg/day) should be considered in infants at risk for cardiac failure, and the dose should be increased in 4-6 weeks as needed based on clinical and laboratory response to treatment. In infants with very low (< 5 mcg/dL) or undetectable serum T4 concentrations, the recommended initial starting dose is 50 mcg/day of levothyroxine sodium.
Infants and Children
Levothyroxine therapy is usually initiated at full replacement doses, with the recommended dose per body weight decreasing with age (see TABLE 3). However, in children with chronic or severe hypothyroidism, an initial dose of 25 mcg/day of levothyroxine sodium is recommended with increments of 25 mcg every 2-4 weeks until the desired effect is achieved.
Hyperactivity in an older child can be minimized if the starting dose is one-fourth of the recommended full replacement dose, and the dose is then increased on a weekly basis by an amount equal to one-fourth the full-recommended replacement dose until the full recommended replacement dose is reached.
Table 3: Levothyroxine Sodium Dosing Guidelines for Pediatric Hypothyroidism a. The dose should be adjusted based on clinical response and laboratory parameters (see PRECAUTlONS, Laboratory Tests and Pediatric Use).AGE
Daily Dose Per Kg Body Weighta
0-3 months
10-15 mcg/kg/day
3-6 months
8-10 mcg/kg/day
6-12 months
6-8 mcg/kg/day
1-5 years
5-6 mcg/kg/day
6-12 years
4-5 mcg/kg/day
>12 years but growth and puberty incomplete
2-3 mcg/kg/day
Growth and puberty complete
1.7 mcg/kg/day
Pregnancy- Pregnancy may increase levothyroxine requirements (see PREGNANCY).
Subclinical Hypothyroidism- If this condition is treated, a lower levothyroxine sodium dose (e.g., 1 mcg/kg/day) than that used for full replacement may be adequate to normalize the serum TSH level. Patients who are not treated should be monitored yearly for changes in clinical status and thyroid laboratory parameters.
TSH Suppression in Well-differentiated Thyroid Cancer and Thyroid Nodules- The target level for TSH suppression in these conditions has not been established with controlled studies. In addition, the efficacy of TSH suppression for benign nodular disease is controversial. Therefore, the dose of Levothyroxine Sodium Tablets, USP used for TSH suppression should be individualized based on the specific disease and the patient being treated.
In the treatment of well differentiated (papillary and follicular) thyroid cancer, levothyroxine is used as an adjunct to surgery and radioiodine therapy. Generally, TSH is suppressed to <0.1 mU/L, and this usually requires a levothyroxine sodium dose of greater than 2 mcg/kg/day. However, in patients with high-risk tumors, the target level for TSH suppression may be <0.01 mU/L.
In the treatment of benign nodules and nontoxic multinodular goiter, TSH is generally suppressed to a higher target (e.g., 0.1-0.5 mU/L for nodules and 0.5-1.0 mU/L for multinodular goiter) than that used for the treatment of thyroid cancer. Levothyroxine sodium is contraindicated if the serum TSH is already suppressed due to the risk of precipitating overt thyrotoxicosis (see CONTRAINDICATIONS, WARNINGS and PRECAUTIONS).
Myxedema Coma - Myxedema coma is a life-threatening emergency characterized by poor circulation and hypometabolism, and may result in unpredictable absorption of levothyroxine sodium from the gastrointestinal tract. Therefore, oral thyroid hormone drug products are not recommended to treat this condition. Thyroid hormone products formulated for intravenous administration should be administered.
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![Verapamil Hydrochloride Tablet, Film Coated, Extended Release [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=af1249b0-e889-4f02-bdc2-54862de0545e&name=af1249b0-e889-4f02-bdc2-54862de0545e-03.jpg)
Verapamil Hydrochloride
Essential Hypertension
The dose of verapamil hydrochloride extended-release should be individualized by titration and the drug should be administered with food. Initiate therapy with 180 mg of sustained-release verapamil HCl, verapamil hydrochloride extended-release, given in the morning. Lower, initial doses of 120 mg a day may be warranted in patients who may have an increased response to verapamil (e.g., the elderly or small people etc.). Upward titration should be based on therapeutic efficacy and safety evaluated weekly and approximately 24 hours after the previous dose. The antihypertensive effects of verapamil hydrochloride extended-release are evident within the first week of therapy.
If adequate response is not obtained with 180 mg of verapamil hydrochloride extended-release tablets, the dose may be titrated upward in the following manner:
1. 240 mg each morning. 2. 180 mg each morning plus 180 mg each evening, or 240 mg each morning plus 120 mg each evening. 3. 240 mg every twelve hours.When switching from immediate release verapamil hydrochloride to verapamil hydrochloride extended-release, the total daily dose in milligrams may remain the same.
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![Allopurinol Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=7a072f02-05ac-4ce0-8fa4-04a2ad8986fb&name=7a072f02-05ac-4ce0-8fa4-04a2ad8986fb-03.jpg)
Allopurinol
The dosage of allopurinol to accomplish full control of gout and to lower serum uric acid to normal or near-normal levels varies with the severity of the disease. The average is 200 to 300 mg per day for patients with mild gout and 400 to 600 mg per day for those with moderately severe tophaceous gout. The appropriate dosage may be administered in divided doses or as a single equivalent dose with the 300 mg tablet. Dosage requirements in excess of 300 mg should be administered in divided doses. The minimal effective dosage is 100 to 200 mg daily and the maximal recommended dosage is 800 mg daily. To reduce the possibility of flare-up of acute gouty attacks, it is recommended that the patient start with a low dose of allopurinol (100 mg daily) and increase at weekly intervals by 100 mg until a serum uric acid level of 6 mg/dL or less is attained but without exceeding the maximal recommended dosage.
Normal serum urate levels are usually achieved in one to three weeks. The upper limit of normal is about 7 mg/dL for men and postmenopausal women and 6 mg/dL for premenopausal women. Too much reliance should not be placed on a single serum uric acid determination since, for technical reasons, estimation of uric acid may be difficult. By selecting the appropriate dosage and, in certain patients, using uricosuric agents concurrently, it is possible to reduce serum uric acid to normal or, if desired, to as low as 2 to 3 mg/dL and keep it there indefinitely.
While adjusting the dosage of allopurinol in patients who are being treated with colchicine and/or anti-inflammatory agents, it is wise to continue the latter therapy until serum uric acid has been normalized and there has been freedom from acute gouty attacks for several months.
In transferring a patient from a uricosuric agent to allopurinol, the dose of the uricosuric agent should be gradually reduced over a period of several weeks and the dose of allopurinol gradually increased to the required dose needed to maintain a normal serum uric acid level.
It should also be noted that allopurinol is generally better tolerated if taken following meals. A fluid intake sufficient to yield a daily urinary output of at least 2 liters and the maintenance of a neutral or, preferably, slightly alkaline urine are desirable.
Since allopurinol and its metabolites are primarily eliminated only by the kidney, accumulation of the drug can occur in renal failure, and the dose of allopurinol should consequently be reduced. With a creatinine clearance of 10 to 20 mL/min, a daily dosage of 200 mg of allopurinol is suitable. When the creatinine clearance is less than 10 mL/min the daily dosage should not exceed 100 mg. With extreme renal impairment (creatinine clearance less than 3 mL/min) the interval between doses may also need to be lengthened.
The correct size and frequency of dosage for maintaining the serum uric acid just within the normal range is best determined by using the serum uric acid level as an index.
For the prevention of uric acid nephropathy during the vigorous therapy of neoplastic disease, treatment with 600 to 800 mg daily for two or three days is advisable together with a high fluid intake. Otherwise similar considerations to the above recommendations for treating patients with gout govern the regulation of dosage for maintenance purposes in secondary hyperuricemia.
The dose of allopurinol recommended for management of recurrent calcium oxalate stones in hyperuricosuric patients is 200 to 300 mg/day in divided doses or as the single equivalent. This dose may be adjusted up or down depending upon the resultant control of the hyperuricosuria based upon subsequent 24 hour urinary urate determinations. Clinical experience suggests that patients with recurrent calcium oxalate stones may also benefit from dietary changes such as the reduction of animal protein, sodium, refined sugars, oxalate-rich foods, and excessive calcium intake as well as an increase in oral fluids and dietary fiber.
Children, 6 to 10 years of age, with secondary hyperuricemia associated with malignancies may be given 300 mg allopurinol daily while those under 6 years are generally given 150 mg daily. The response is evaluated after approximately 48 hours of therapy and a dosage adjustment is made if necessary.
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![Sumatriptan Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=a3735b57-ecc7-43e2-859a-c43e2502779b&name=carton25mg.jpg)
Sumatriptan
2.1 Dosing Information
The recommended dose of sumatriptan tablets is 25 mg, 50 mg, or 100 mg. Doses of 50 mg and 100 mg may provide a greater effect than the 25 mg dose, but doses of 100 mg may not provide a greater effect than the 50 mg dose. Higher doses may have a greater risk of adverse reactions [see Clinical Studies (14)].
If the migraine has not resolved by 2 hours after taking sumatriptan tablets, or returns after a transient improvement, a second dose may be administered at least 2 hours after the first dose. The maximum daily dose is 200 mg in a 24-hour period.
Use after sumatriptan injection: If the migraine returns following an initial treatment with sumatriptan succinate injection, additional single sumatriptan tablets (up to 100 mg/day) may be given with an interval of at least 2 hours between tablet doses.
The safety of treating an average of more than 4 headaches in a 30-day period has not been established.
2.2 Dosing in Patients With Hepatic Impairment
If treatment is deemed advisable in the presence of mild to moderate hepatic impairment, the maximum single dose should not exceed 50 mg [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
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![Propranolol Hydrochloride Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=299c10c0-f54c-40f0-b84c-8b9a70cae004&name=299c10c0-f54c-40f0-b84c-8b9a70cae004-03.jpg)
Propranolol Hydrochloride
General
Because of the variable bioavailability of propranolol, the dose should be individualized based on response.
Hypertension
The usual initial dosage is 40 mg propranolol hydrochloride twice daily, whether used alone or added to a diuretic. Dosage may be increased gradually until adequate blood pressure control is achieved. The usual maintenance dosage is 120 mg to 240 mg per day. In some instances a dosage of 640 mg a day may be required. The time needed for full antihypertensive response to a given dosage is variable and may range from a few days to several weeks.
While twice-daily dosing is effective and can maintain a reduction in blood pressure throughout the day, some patients, especially when lower doses are used, may experience a modest rise in blood pressure toward the end of the 12-hour dosing interval. This can be evaluated by measuring blood pressure near the end of the dosing interval to determine whether satisfactory control is being maintained throughout the day. If control is not adequate, a larger dose, or 3-times-daily therapy may achieve better control.
Angina Pectoris
Total daily doses of 80 mg to 320 mg propranolol hydrochloride when administered orally, twice a day, three times a day, or four times a day, have been shown to increase exercise tolerance and to reduce ischemic changes in the ECG. If treatment is to be discontinued, reduce dosage gradually over a period of several weeks. (See WARNINGS)
Atrial Fibrillation
The recommended dose is 10 mg to 30 mg propranolol hydrochloride three or four times daily before meals and at bedtime.
Myocardial Infarction
In the Beta-Blocker Heart Attack Trial (BHAT), the initial dose was 40 mg t.i.d., with titration after 1- month to 60 mg to 80 mg t.i.d. as tolerated. The recommended daily dosage is 180 mg to 240 mg propranolol hydrochloride per day in divided doses. Although a t.i.d. regimen was used in BHAT and a q.i.d. regimen in the Norwegian Multicenter Trial, there is a reasonable basis for the use of either a t.i.d. or b.i.d. regimen (see PHARMACODYNAMICS AND CLINICAL EFFECTS). The effectiveness and safety of daily dosages greater than 240 mg for prevention of cardiac mortality have not been established. However, higher dosages may be needed to effectively treat coexisting diseases such as angina or hypertension (see above).
Migraine
The initial dose is 80 mg propranolol hydrochloride daily in divided doses. The usual effective dose range is 160 mg to 240 mg per day. The dosage may be increased gradually to achieve optimum migraine prophylaxis. If a satisfactory response is not obtained within four to six weeks after reaching the maximum dose, propranolol hydrochloride therapy should be discontinued. It may be advisable to withdraw the drug gradually over a period of several weeks.
Essential Tremor
The initial dosage is 40 mg propranolol hydrochloride twice daily. Optimum reduction of essential tremor is usually achieved with a dose of 120 mg per day. Occasionally, it may be necessary to administer 240 mg to 320 mg per day.
Hypertrophic Subaortic Stenosis
The usual dosage is 20 mg to 40 mg propranolol hydrochloride three or four times daily before meals and at bedtime.
Pheochromocytoma
The usual dosage is 60 mg propranolol hydrochloride daily in divided doses for three days prior to surgery as adjunctive therapy to alpha-adrenergic blockade. For the management of inoperable tumors, the usual dosage is 30 mg daily in divided doses as adjunctive therapy to alpha-adrenergic blockade.
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![Pediatric Cough And Cold Medicine (Chlorpheniramine Maleate And Pseudoephedrine Hydrochloride And Dextromethorphan Hydrobromide) Liquid [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=b2718aa0-6714-4974-b8e1-7ddc117b7fe7&name=image-01.jpg)
Pediatric Cough And Cold Medicine
• Dose may be repeated every 4 to 6 hours or as directed by a doctor • Do not exceed 4 doses in 24 - hour period.
AGE
DOSE
Children 6 to under 11 years
2 teaspoonfuls (TSP)
Children under 6 years
DO NOT USE
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![Prochlorperazine Maleate Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=15453da2-c60b-42ca-a997-8ec7bc7dcade&name=15453da2-c60b-42ca-a997-8ec7bc7dcade-02.jpg)
Prochlorperazine Maleate
(For children’s dosage and administration, see below.) Dosage should be increased more gradually in debilitated or emaciated patients.
Elderly Patients: In general, dosages in the lower range are sufficient for most elderly patients. Since they appear to be more susceptible to hypotension and neuromuscular reactions, such patients should be observed closely. Dosage should be tailored to the individual, response carefully monitored and dosage adjusted accordingly. Dosage should be increased more gradually in elderly patients.
1.To Control Severe Nausea and Vomiting: Adjust dosage to the response of the individual. Begin with the lowest recommended dosage.Oral Dosage-Tablets: Usually one 5mg or 10mg tablet 3 or 4 times daily. Daily dosages above 40 mgs should be used only in resistant cases.
2.In Adult Psychiatric Disorders: Adjust dosage to the response of the individual and according to the severity of the condition. Begin with the lowest recommended dose. Although response ordinarily is seen within a day or 2, longer treatment is usually required before maximal improvement is seen.Oral Dosage: Non-Psychotic Anxiety--Usual dosage is 5 mg 3 or4 times daily. Do not administer in doses of more than 20mg per day or for longer than 12 weeks.
Psychotic Disorders including Schizophrenia--Inrelatively mild conditions, as seen in private psychiatric practice or in out patient clinics, dosage is 5 or 10 mg 3 or 4 times daily.
In moderate to severe conditions, for hospitalized or adequately supervised patients, usual starting dosage is 10 mg 3 or 4 times daily. Increase dosage gradually until symptoms are controlled or side effects become bothersome. When dosage is increased by small increments every 2 or 3 days, side effects either do not occur or are easily controlled. Some patients respond satisfactorily on 50 to 75mg daily. In more severe disturbances, optimum dosage is usually 100 to 150mg daily.
DOSAGE AND ADMINISTRATION--CHILDREN
Do not use in pediatric surgery. Children seem more prone to develop extrapyramidal reactions, even on moderate doses. Therefore, use lowest effective dosage. Tell parents not to exceed prescribed dosage, since the possibility for adverse reactions increases as dosage rises. Occasionally the patient may react to the drug with signs of restlessness and excitement; if this occurs, do not administer additional doses. Take particular precaution in administering the drug to children with acute illnesses or dehydration (see under Dystonias).
1. Severe Nausea and Vomiting in Children: Prochlorperazine should not be used in pediatric patients under 20 pounds in weight or 2 years of age. It should not be used in conditions for which children’s dosages have not been established. Dosage and frequency of administration should be adjusted according to the severity of the symptoms and the response of the patient. The duration of activity following intramuscular administration may last up to 12 hours. Subsequent doses may be given by the same route if necessary.
Oral Dosage: More than 1 day’s therapy is seldom necessary.
Weight
Usual Dosage
Not to Exceed
under 20 lbs not recommended
20 to 29 lbs
2½ mg 1 or 2 times a day
7.5 mg per day
30 to 39 lbs
2½ mg 2 or 3 times a day
10 mg per day
40 to 85 lbs
2½ mg 3 times a day or 5 mg 2 times a day
15 mg per day
2. Children with schizophrenia: Oral Dosage: For children 2 to 12 years, starting dosage is 21/2 mg 2 or 3 times daily. Do not give more than 10 mg the first day. Then increase dosage according to patient’s response.FOR AGES 2 to 5, total daily dosage usually does not exceed 20mg.FOR AGES 6 to 12, total daily dosage usually does not exceed 25mg.
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![Acyclovir Suspension [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=bdee576a-24bf-41a0-b948-e4c8a33cc8d0&name=bdee576a-24bf-41a0-b948-e4c8a33cc8d0-02.jpg)
Acyclovir Suspension
Acute Treatment Of Herpes Zoster: 800 mg every 4 hours orally, 5 times daily for 7 to 10 days.
Genital Herpes:Treatment Of Initial Genital Herpes: 200 mg every 4 hours, 5 times daily for 10 days.
Chronic Suppressive Therapy For Recurrent Disease: 400 mg 2 times daily for up to 12 months, followed by re-evaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily.
The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient’s genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir.
Intermittent Therapy: 200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.
Treatment Of Chickenpox:Children (2 Years Of Age And Older): 20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.
Adults And Children Over 40 kg: 800 mg 4 times daily for 5 days.
Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients.
When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.
Patients With Acute Or Chronic Renal Impairment:In patients with renal impairment, the dose of Acyclovir Oral Suspension should be modified as shown in Table 3:
Table 3: Dosage Modification for Renal Impairment Normal Dosage Regimen Creatinine Clearance (mL/min/1.73m2) Adjusted Dosage Regimen Dose (mg) Dosage Interval200 mg every 4 hours
>100-10
200200
every 4 hours,5 x dailyevery 12 hours
400 mg every 12 hours
>100-10
400200
every 12 hoursevery 12 hours
800 mg every 4 hours
>2510-250-10
800800800
every 4 hours,5 x dailyevery 8 hoursevery 12 hours
Hemodialysis: For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6-hour dialysis period. Therefore, the patient’s dosing schedule should be adjusted so that an additional dose is administered after each dialysis.
Peritoneal Dialysis: No supplemental dose appears to be necessary after adjustment of the dosing interval.
Bioequivalence Of Dosage Forms: Acyclovir oral suspension was shown to be bioequivalent to acyclovir capsules (n = 20) and 1 acyclovir 800-mg tablet was shown to be bioequivalent to 4 acyclovir 200-mg capsules (n = 24).
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![Albuterol Sulfate Solution [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=53176c67-ebcd-4b07-a08a-f2df3c541af9&name=53176c67-ebcd-4b07-a08a-f2df3c541af9-06.jpg)
Albuterol Sulfate Solution
To avoid microbial contamination, proper aseptic techniques should be used each time the bottle is opened. Precautions should be taken to prevent contact of the dropper tip of the bottle with any surface, including the nebulizer reservoir and associated ventilatory equipment. In addition, if the solution changes color or becomes cloudy, it should not be used.
Children 2 to 12 Years of Age
For children 2 to 12 years of age, initial dosing should be based upon body weight (0.1 to 0.15 mg/kg per dose), with subsequent dosing titrated to achieve the desired clinical response. Dosing should not exceed 2.5 mg three to four times daily by nebulization. The following table outlines approximate dosing according to body weight.
Approximate Weight (kg)
Approximate Weight (lb)
Dose (mg)
Volume of Inhalation Solution
10-15
22-33
1.25
0.25 mL
>15
>33
2.5
0.5 mL
The appropriate volume of the 0.5% inhalation solution should be diluted in sterile normal saline solution to a total volume of 3 mL prior to administration via nebulization.
Adults and Children Over 12 Years of Age
The usual dosage for adults and children 12 years of age and older is 2.5 mg of albuterol administered three to four times daily by nebulization.
More frequent administration or higher doses are not recommended. To administer 2.5 mg of albuterol, dilute 0.5 mL of the 0.5% inhalation solution with 2.5 mL of sterile normal saline solution. The flow rate is regulated to suit the particular nebulizer so that albuterol sulfate inhalation solution will be delivered over approximately 5 to 15 minutes.
The use of albuterol sulfate inhalation solution can be continued as medically indicated to control recurring bouts of bronchospasm. During this time most patients gain optimal benefit from regular use of the inhalation solution.
If a previously effective dosage regimen fails to provide the usual relief, medical advice should be sought immediately as this is often a sign of seriously worsening asthma that would require reassessment of therapy.
Drug compatibility (physical and chemical), efficacy, and safety of albuterol sulfate inhalation solution when mixed with other drugs in a nebulizer have not been established.
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![Lidocaine And Prilocaine Cream [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=7a18a4f4-5487-4cf6-a46d-58369dc5833c&name=7a18a4f4-5487-4cf6-a46d-58369dc5833c-02.jpg)
Lidocaine And Prilocaine
Cutaneous candidiasis, tinea corporis, tinea cruris, tinea pedis, and tinea (pityriasis) versicolor: It is recommended that ketoconazole cream, 2% be applied once daily to cover the affected and immediate surrounding area. Clinical improvement may be seen fairly soon after treatment is begun; however, candidal infections and tinea cruris and corporis should be treated for two weeks in order to reduce the possibility of recurrence. Patients with tinea versicolor usually require two weeks of treatment. Patients with tinea pedis require six weeks of treatment.
If a patient shows no clinical improvement after the treatment period, the diagnosis should be redetermined.
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![Milk Of Magnesia Original (Magnesium Hydroxide) Liquid [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=7b81c589-85d9-4f31-b110-c3da4cf6ea86&name=7b81c589-85d9-4f31-b110-c3da4cf6ea86-01.jpg)
Milk Of Magnesia Original
• shake well before use• do not exceed the maximum recommended daily dose in a 24 hour period• dose may be taken once a day preferably at bedtime, in divided doses, or as directed by a doctor• drink a full glass (8 oz) of liquid with each doseadults and children 12 years and older: 2 to 4 tablespoonfulschildren 6 to 11 years: 1 to 2 tablespoonfulschildren under 6 years: ask a doctor
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![Geri-lanta Antacid Antigas (Aluminum Hydroxide, Magnesium Hydroxide, Dimethicone) Liquid [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=3f3be283-2331-441a-90b5-4bfe9699a3b1&name=3f3be283-2331-441a-90b5-4bfe9699a3b1-01.jpg)
Geri-lanta Antacid Antigas
• shake well before use• adults and children 12 years and older: take 2 to 4 teaspoonfuls between meals, at bedtime, or as directed by a doctor• do not take more than 24 teaspoonfuls in 24 hours or use the maximum dosage for more than 2 weeks• children under 12 years: ask a doctor
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![Bengay Ultra Strength Pain Relieving (Camphor (Synthetic), Menthol, And Methyl Salicylate) Cream [Johnson & Johnson Consumer Products Company, Division Of Johnson & Johnson Consumer Companies, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=5c489585-7839-4701-8b26-bb84f0e970c1&name=metaxalone-tablets-800-mg-4.jpg)
Bengay Ultra Strength Pain Relieving
The recommended dose for adults and children over 12 years of age is one 800 mg tablet three to four times a day.
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![Vp-pnv-dha (Folic Acid, Pyridoxine, Calcium Carbonate, Thiamine Mononitrate, Cholecalciferol, .alpha.-tocopherol, D-, Cyanocobalamin, Ferrous Fumarate, Magnesium Oxide, Riboflavin, Niacin, Ascorbic Acid, Cupric Sulfate, Vitamin A Palmitate, Zinc Oxide, Doconexent, And Ethyl Icosapentate) Capsule, Gelatin Coated [Virtus Pharmaceuticals]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=c0e1b335-4960-459e-9fc7-b31f7984cd92&name=levofloxacin-fig7.jpg)
Vp-pnv-dha
2.1 Dosage in Adult Patients with Normal Renal Function
The usual dose of levofloxacin tablets is 250 mg, 500 mg, or 750 mg administered orally every 24 hours, as indicated by infection and described in Table 1.
These recommendations apply to patients with creatinine clearance ≥ 50 mL/min. For patients with creatinine clearance <50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].
Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50 mL/min) * Due to the designated pathogens [see Indications and Usage (1)].† Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.‡ Due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [see Indications and Usage (1.2)]. § Due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see Indications and Usage (1.3)]. ¶ This regimen is indicated for cUTI due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and AP due to E. coli, including cases with concurrent bacteremia.# This regimen is indicated for cUTI due to Enterococcus faecalis, Enterococcus cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa; and for AP due to E. coli. Þ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)].ß The safety of levofloxacin tablets in adults for durations of therapy beyond 28 days or in pediatric patients for durations beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacintablets therapy should only be used when the benefit outweighs the risk.á Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Higher doses of levofloxacin tablets typically used for treatment of pneumonia can be used for treatment of plague, if clinically indicated.Type of Infection*
Dosed Every 24 hours
Duration (days)†
Nosocomial Pneumonia
750 mg
7 to 14
Community Acquired Pneumonia‡
500 mg
7 to 14
Community Acquired Pneumonia§
750 mg
5
Acute Bacterial Sinusitis
750 mg
5
500 mg
10 to 14
Acute Bacterial Exacerbation of Chronic Bronchitis
500 mg
7
Complicated Skin and Skin Structure Infections (SSSI)
750 mg
7 to 14
Uncomplicated SSSI
500 mg
7 to 10
Chronic Bacterial Prostatitis
500 mg
28
Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)¶
750 mg
5
Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)#
250 mg
10
Uncomplicated Urinary Tract Infection
250 mg
3
Inhalational Anthrax (Post-Exposure), adult and pediatric patients > 50 kg Þ,ß Pediatric patients < 50 kg and ≥ 6 months of age Þ,ß
500 mgsee Table 2 below (2.2)
60 ß 60 ß
Plague, adult and pediatric patients > 50 kgá Pediatric patients < 50 kg and ≥ 6 months of age
500 mg see Table 2 below (2.2)
10 to 14 10 to 14
2.2 Dosage in Pediatric Patients
The dosage in pediatric patients ≥ 6 months of age is described below in Table 2.
Table 2: Dosage in Pediatric Patients ≥ 6 months of age Type of Infection* Dose Freq. Once every Duration† * Due to Bacillus anthracis [see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage (1.14)].† Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.‡ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)]. § The safety of levofloxacin tablets in pediatric patients for durations of therapy beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin tablets therapy should only be used when the benefit outweighs the risk. ¶ Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis.Inhalational Anthrax (post-exposure)‡, §
Pediatric patients > 50 kg
500 mg
24 hr
60 days§
Pediatric patients < 50 kg and ≥ 6 months of age
8 mg/kg (not to exceed 250 mg per dose)
12 hr
60 days§
Plague¶
Pediatric patients > 50 kg
500 mg
24 hr
10 to 14 days
Pediatric patients < 50 kg and ≥ 6 months of age
8 mg/kg (not to exceed 250 mg per dose)
12 hr
10 to 14 days
2.3 Dosage Adjustment in Adults with Renal Impairment
Administer levofloxacin tablets with caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced.No adjustment is necessary for patients with a creatinine clearance ≥ 50 mL/min.In patients with impaired renal function (creatinine clearance <50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [see Use in Specific Populations (8.6)].Table 3 shows how to adjust dose based on creatinine clearance.
Table 3: Dosage Adjustment in Adult Patients with Renal Impairment (creatinine clearance <50 mL/min) Dosage in Normal Renal Function Every 24 hours Creatinine Clearance 20 to 49 mL/min Creatinine Clearance 10 to 19 mL/min Hemodialysis or Chronic Ambulatory Peritoneal Dialysis (CAPD)750 mg
750 mg every 48 hours
750 mg initial dose, then 500 mg every 48 hours
750 mg initial dose, then 500 mg every 48 hours
500 mg
500 mg initial dose, then 250 mg every 24 hours
500 mg initial dose, then 250 mg every 48 hours
500 mg initial dose, then 250 mg every 48 hours
250 mg
No dosage adjustment required
250 mg every 48 hours. If treating uncomplicated UTI, then no dosage adjustment is required
No information on dosing adjustment is available
2.4 Drug Interaction With Chelation Agents: Antacids, Sucralfate, Metal Cations, Multivitamins
Levofloxacin tablets should be administered at least two hours before or two hours after antacids containing magnesium, aluminum, as well as sucralfate, metal cations such as iron, and multivitamin preparations with zinc or didanosine chewable/buffered tablets or the pediatric powder for oral solution [see Drug Interactions (7.1) and Patient Counseling Information (17.2)].
2.5 Administration Instructions
Food and Levofloxacin Tablets Levofloxacin tablets can be administered without regard to food.Hydration for Patients Receiving Levofloxacin Tablets Adequate hydration of patients receiving oral levofloxacin tablets should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)].
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![Hgh Vitality (Agnus Castus, Ambra Grisea, Conium Maculatum, Apiolum, Estradiol, Estriol, Folliculinum, L-dopa, Melatonin, Testosterone, Alpha-lipocicum Acidum) Tablet [Deseret Biologicals]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=dec9c5f6-929e-493d-ac4f-c24cf1f9e6ef&name=image-01.jpg)
Hgh Vitality
• take dose one hour before travel starts • tablets can be chewed or swallowed whole with water • adults & children 12 years and over: 1-2 tablets once daily children under 12 years: ask a doctor
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![Pentoxifylline Tablet, Extended Release [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=ff347283-b9ce-4570-8501-43cab7e2ecc8&name=ff347283-b9ce-4570-8501-43cab7e2ecc8-02.jpg)
Pentoxifylline
The usual dosage of pentoxifylline in extended-release tablet form is one tablet (400 mg) three times a day with meals.
While the effect of pentoxifylline may be seen within 2 to 4 weeks, it is recommended that treatment be continued for at least 8 weeks. Efficacy has been demonstrated in double-blind clinical studies of 6 months duration.
Digestive and central nervous system side effects are dose related. If patients develop these effects it is recommended that the dosage be lowered to one tablet twice a day (800 mg/day). If side effects persist at this lower dosage, the administration of pentoxifylline should be discontinued.
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![Hydroxyzine Hydrochloride Tablet, Film Coated [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=10d5c641-e53c-40a3-b635-de4b612659a5&name=10d5c641-e53c-40a3-b635-de4b612659a5-03.jpg)
Hydroxyzine Hydrochloride
For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested: Adults, 50 to 100 mg q.i.d.; children under 6 years, 50 mg daily in divided doses; children over 6 years, 50 to 100 mg daily in divided doses.
For use in the management of pruritus due to allergic conditions such as chronic urticarial and atopic and contact dermatoses and in histamine-mediated pruritus: adults, 25 mg t.i.d. or q.i.d.; children under 6 years, 50 mg daily in divided doses; children over 6 years, 50 to 100 mg daily in divided doses.
As a sedative when used as a premedication and following general anesthesia: 50 to 100 mg for adults and 0.6 mg/kg of body weight in children.
When treatment is initiated by the intramuscular route of administration, subsequent doses may be administered orally.
As with all potent medication, the dosage should be adjusted according to the patient’s response to therapy.
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![Gentak (Gentamicin Sulfate) Ointment [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=d1f5095e-199a-4be8-a1fb-7c01c5054ff9&name=d1f5095e-199a-4be8-a1fb-7c01c5054ff9-02.jpg)
Gentak
Apply a small amount (approximately 1/2 inch ribbon) of ointment to the affected eye(s) two or three times a day.
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![Prednisolone Acetate Suspension/ Drops [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=4bf2d51d-2944-4450-a817-1baec6a909ef&name=4bf2d51d-2944-4450-a817-1baec6a909ef-03.jpg)
Prednisolone Acetate Suspension Drops
Shake well before using. Instill one to two drops into the conjunctival sac two to four times daily. During the initial 24 to 48 hours, the dosing frequency may be increased if necessary. Care should be taken not to discontinue therapy prematurely.
If signs and symptoms fail to improve after 2 days, the patient should be re-evaluated (see PRECAUTIONS).
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![Spironolactone Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=6878653f-d45f-4ac5-8ac4-35f40307fc06&name=6878653f-d45f-4ac5-8ac4-35f40307fc06-04.jpg)
Spironolactone
Primary hyperaldosteronism. Spironolactone may be employed as an initial diagnostic measure to provide presumptive evidence of primary hyperaldosteronism while patients are on normal diets.
Long test: Spironolactone is administered at a daily dosage of 400 mg for three to four weeks. Correction of hypokalemia and of hypertension provides presumptive evidence for the diagnosis of primary hyperaldosteronism.
Short test: Spironolactone is administered at a daily dosage of 400 mg for four days. If serum potassium increases during spironolactone administration but drops when spironolactone is discontinued, a presumptive diagnosis of primary hyperaldosteronism should be considered.
After the diagnosis of hyperaldosteronism has been established by more definitive testing procedures, spironolactone may be administered in doses of 100 to 400 mg daily in preparation for surgery. For patients who are considered unsuitable for surgery, spironolactone may be employed for long-term maintenance therapy at the lowest effective dosage determined for the individual patient.
Edema in adults (congestive heart failure, hepatic cirrhosis, or nephrotic syndrome). An initial daily dosage of 100 mg of spironolactone administered in either single or divided doses is recommended, but may range from 25 to 200 mg daily. When given as the sole agent for diuresis, spironolactone should be continued for at least five days at the initial dosage level, after which it may be adjusted to the optimal therapeutic or maintenance level administered in either single or divided daily doses. If, after five days, an adequate diuretic response to spironolactone has not occurred, a second diuretic that acts more proximally in the renal tubule may be added to the regimen. Because of the additive effect of spironolactone when administered concurrently with such diuretics, an enhanced diuresis usually begins on the first day of combined treatment; combined therapy is indicated when more rapid diuresis is desired. The dosage of spironolactone should remain unchanged when other diuretic therapy is added.
Essential hypertension. For adults, an initial daily dosage of 50 to 100 mg of spironolactone administered in either single or divided doses is recommended. Spironolactone may also be given with diuretics that act more proximally in the renal tubule or with other antihypertensive agents. Treatment with spironolactone should be continued for at least two weeks, since the maximum response may not occur before this time. Subsequently, dosage should be adjusted according to the response of the patient.
Hypokalemia. Spironolactone in a dosage ranging from 25 mg to 100 mg daily is useful in treating a diuretic-induced hypokalemia, when oral potassium supplements or other potassium-sparing regimens are considered inappropriate.
Severe heart failure (NYHA class III – IV). Treatment should be initiated with spironolactone 25 mg once daily if the patient’s serum potassium is ≤5.0 mEq/L and the patient’s serum creatinine is ≤ 2.5 mg/dL. Patients who tolerate 25 mg once daily may have their dosage increased to 50 mg once daily as clinically indicated. Patients who do not tolerate 25 mg once-daily dose may have their dosage reduced to 25 mg every other day. SEE WARNINGS: Hyperkalemia in patients with severe heart failure for advice on monitoring serum potassium and serum creatinine.
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![Albuterol Sulfate Solution [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=5a56892b-7485-4570-9a1d-53ef23f07cbe&name=f54e6b32-4a34-4cfe-8351-68e3eb8d9bb6-05.jpg)
Albuterol Sulfate Solution
Adults and Children 2 to 12 Years of Age: The usual dosage for adults and for children weighing at least 15 kg is 2.5 mg of albuterol (one vial) administered three to four times daily by nebulization. Children weighing < 15 kg who require < 2.5 mg/dose (i.e., less than a full vial) should use albuterol inhalation solution, 0.5% instead of albuterol inhalation solution, 0.083%. More frequent administration or higher doses are not recommended. To administer 2.5 mg of albuterol, administer the entire contents of one sterile unit-dose vial (3 mL of 0.083% inhalation solution) by nebulization. The flow rate is regulated to suit the particular nebulizer so that albuterol inhalation solution will be delivered over approximately 5 to 15 minutes.
The use of albuterol sulfate inhalation solution can be continued as medically indicated to control recurring bouts of bronchospasm. During this time most patients gain optimum benefit from regular use of the inhalation solution.
If a previously effective dosage regimen fails to provide the usual relief, medical advice should be sought immediately, as this is often a sign of seriously worsening asthma that would require reassessment of therapy.
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![Meclizine Hcl Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=f0f88667-2888-4176-98ba-cac06b75bf32&name=f0f88667-2888-4176-98ba-cac06b75bf32-01.jpg)
Meclizine Hcl
adults and children 12 years and over: 2-4 caplets once daily children under 12 years: ask a doctor
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![Hydroquinone With Sunscreens (Hydroquinone, Dioxybenzone, Oxybenzone, Padimate O) Cream [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=b3fd799d-3d27-4683-9d9b-3ed43722704c&name=ebcc0570-4a54-4f10-be90-da603ccf96d4-02.jpg)
Hydroquinone With Sunscreens
Hydroquinone USP, 4% Skin Bleaching Cream with Sunscreens should be applied to affected areas and rubbed in well twice daily, in the morning and before bedtime, or as directed by a physician. If no improvement is seen after 2 months of treatment, use of this product should be discontinued. There is no recommended dosage for pediatric patients under 12 years of age except under the advice and supervision of a physician.
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![Pravastatin Sodium Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=17d768ea-8b6f-4a0e-821c-20c187ba68a4&name=17d768ea-8b6f-4a0e-821c-20c187ba68a4-03.jpg)
Pravastatin Sodium
2.1 General Dosing Information
The patient should be placed on a standard cholesterol-lowering diet before receiving pravastatin sodium tablets and should continue on this diet during treatment with pravastatin sodium tablets [see NCEP Treatment Guidelines for details on dietary therapy].
2.2 Adult Patients
The recommended starting dose is 40 mg once daily. If a daily dose of 40 mg does not achieve desired cholesterol levels, 80 mg once daily is recommended. In patients with significant renal impairment, a starting dose of 10 mg daily is recommended. Pravastatin sodium tablets can be administered orally as a single dose at any time of the day, with or without food. Since the maximal effect of a given dose is seen within 4 weeks, periodic lipid determinations should be performed at this time and dosage adjusted according to the patient’s response to therapy and established treatment guidelines.
2.3 Pediatric Patients
Children (Ages 8 to 13 Years, Inclusive)
The recommended dose is 20 mg once daily in children 8 to 13 years of age. Doses greater than 20 mg have not been studied in this patient population.
Adolescents (Ages 14 to 18 Years)
The recommended starting dose is 40 mg once daily in adolescents 14 to 18 years of age. Doses greater than 40 mg have not been studied in this patient population.
Children and adolescents treated with pravastatin should be reevaluated in adulthood and appropriate changes made to their cholesterol-lowering regimen to achieve adult goals for LDL-C [see Indications and Usage (1.2)].
2.4 Concomitant Lipid-Altering Therapy
Pravastatin sodium tablets may be used with bile acid resins. When administering a bile-acid-binding resin (e.g., cholestyramine, colestipol) and pravastatin, pravastatin sodium tablets should be given either 1 hour or more before or at least 4 hours following the resin. [See Clinical Pharmacology (12.3).]
2.5 Dosage in Patients Taking Cyclosporine
In patients taking immunosuppressive drugs such as cyclosporine concomitantly with pravastatin, therapy should begin with 10 mg of pravastatin sodium once-a-day at bedtime and titration to higher doses should be done with caution. Most patients treated with this combination received a maximum pravastatin sodium dose of 20 mg/day. In patients taking cyclosporine, therapy should be limited to 20 mg of pravastatin sodium once daily [see Warnings and Precautions (5.1) and Drug Interactions (7.1)].
2.6 Dosage in Patients Taking Clarithromycin
In patients taking clarithromycin, therapy should be limited to 40 mg of pravastatin sodium once daily [see Drug Interactions (7.2)].
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![Topcare Headache Pm Formula (Acetaminophen, Diphenhydramine Hcl) Tablet, Film Coated [Topco Associates Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=8ca9438d-320f-4499-aee7-6b8ca7cccc65&name=4ed1b591-figure-02.jpg)
Topcare Headache Pm Formula
Adults
Two tablets per day; one in the morning and one in the evening.
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![Hydrocortisone Cream [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=e05143f7-6d76-4492-9d49-7e3947d93c90&name=e05143f7-6d76-4492-9d49-7e3947d93c90-02.jpg)
Hydrocortisone
Topical corticosteroids are generally applied to the affected area as a thin film from two to four times daily depending on the severity of the condition.
Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions.
If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.
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![Apizelen (Alfalfa, Avena Sativa, Chelidonium Majus, Aralia Quinquefolia, Beta Vulgaris, Calendula Officinalis, Cuprum Aceticum, Echinacea, Natrum Muriaticum, Oxalis Acetosella Paloondo,) Liquid [Bioactive Nutritional, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=f678594f-1e1a-4fed-8ff3-6c64a6fa5cf9&name=hydro-5.jpg)
Apizelen
Dosage should be adjusted according to the severity of the pain and the response of the patient. However, it should be kept in mind that tolerance to hydrocodone can develop with continued use and that the incidence of untoward effects is dose related.
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 5 mg/325 mg
The usual adult dosage is one or two tablets every four to six hours as needed for pain. The total daily dosage should not exceed 12 tablets.
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg/325 mg
The usual adult dosage is one tablet every four to six hours as needed for pain. The total daily dosage should not exceed 6 tablets.
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg
The usual adult dosage is one tablet every four to six hours as needed for pain. The total daily dosage should not exceed 6 tablets.
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 5 mg/325 mg
The usual adult dosage is one or two tablets every four to six hours as needed for pain. The total daily dosage should not exceed 12 tablets.
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg/325 mg
The usual adult dosage is one tablet every four to six hours as needed for pain. The total daily dosage should not exceed 6 tablets.
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg
The usual adult dosage is one tablet every four to six hours as needed for pain. The total daily dosage should not exceed 6 tablets.
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![Day Time Cold Multi-symptom Severe (Acetaminophen, Phenylephrine Hcl, Dextromethorphan Hbr And Guiafenesin) Tablet, Coated [Dolgencorp, Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=73f4a334-66d7-4e06-82f1-562bd7cb601a&name=db3cc1b1-ab22-44e6-846c-ce1231f4daf7-02.jpg)
Day Time Cold Multi-symptom Severe
Therapy with metoclopramide tablets should not exceed 12 weeks in duration.
For the Relief of Symptomatic Gastroesophageal Reflux
Administer from 10 mg to 15 mg metoclopramide tablets, USP orally up to q.i.d. 30 minutes before each meal and at bedtime, depending upon symptoms being treated and clinical response (see CLINICAL PHARMACOLOGY and INDICATIONS AND USAGE). If symptoms occur only intermittently or at specific times of the day, use of metoclopramide in single doses up to 20 mg prior to the provoking situation may be preferred rather than continuous treatment. Occasionally, patients (such as elderly patients) who are more sensitive to the therapeutic or adverse effects of metoclopramide will require only 5 mg per dose.
Experience with esophageal erosions and ulcerations is limited, but healing has thus far been documented in one controlled trial using q.i.d. therapy at 15 mg/dose, and this regimen should be used when lesions are present, so long as it is tolerated (see ADVERSE REACTIONS). Because of the poor correlation between symptoms and endoscopic appearance of the esophagus, therapy directed at esophageal lesions is best guided by endoscopic evaluation.
Therapy longer than 12 weeks has not been evaluated and cannot be recommended.
For the Relief of Symptoms Associated with Diabetic Gastroparesis (Diabetic Gastric Stasis)
Administer 10 mg of metoclopramide 30 minutes before each meal and at bedtime for two to eight weeks, depending upon response and the likelihood of continued well-being upon drug discontinuation.
The initial route of administration should be determined by the severity of the presenting symptoms. If only the earliest manifestations of diabetic gastric stasis are present, oral administration of metoclopramide tablets may be initiated. However, if severe symptoms are present, therapy should begin with metoclopramide injection (consult labeling of the injection prior to initiating parenteral administration).
Administration of metoclopramide injection up to 10 days may be required before symptoms subside, at which time oral administration may be instituted. Since diabetic gastric stasis is frequently recurrent, metoclopramide tablets therapy should be reinstituted at the earliest manifestation.
Use in Patients with Renal or Hepatic Impairment
Since metoclopramide is excreted principally through the kidneys, in those patients whose creatinine clearance is below 40 mL/min, therapy should be initiated at approximately one-half the recommended dosage. Depending upon clinical efficacy and safety considerations, the dosage may be increased or decreased as appropriate.
See OVERDOSAGEsection for information regarding dialysis.
Metoclopramide undergoes minimal hepatic metabolism, except for simple conjugation. Its safe use has been described in patients with advanced liver disease whose renal function was normal.
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![Metoclopramide Hydrochloride Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=5be0c7c9-2d88-46fc-8d7f-350969bb9d68&name=5be0c7c9-2d88-46fc-8d7f-350969bb9d68-02.jpg)
Metoclopramide Hydrochloride
Therapy with metoclopramide tablets should not exceed 12 weeks in duration.
For the Relief of Symptomatic Gastroesophageal Reflux:
Administer from 10 mg to 15 mg metoclopramide hydrochloride, USP orally up to q.i.d. 30 minutes before each meal and at bedtime, depending upon symptoms being treated and clinical response (seeCLINICAL PHARMACOLOGY and INDICATIONS AND USAGE). If symptoms occur only intermittently or at specific times of the day, use of metoclopramide in single doses up to 20 mg prior to the provoking situation may be preferred rather than continuous treatment. Occasionally, patients (such as elderly patients) who are more sensitive to the therapeutic or adverse effects of metoclopramide will require only 5 mg per dose.
Experience with esophageal erosions and ulcerations is limited, but healing has thus far been documented in one controlled trial using q.i.d. therapy at 15 mg per dose, and this regimen should be used when lesions are present, so long as it is tolerated (seeADVERSE REACTIONS). Because of the poor correlation between symptoms and endoscopic appearance of the esophagus, therapy directed at esophageal lesions is best guided by endoscopic evaluation.
Therapy longer than 12 weeks has not been evaluated and cannot be recommended.
For the Relief of Symptoms Associated with Diabetic Gastroparesis (Diabetic Gastric Stasis)
Administer 10 mg of metoclopramide 30 minutes before each meal and at bedtime for two to eight weeks, depending upon response and the likelihood of continued well-being upon drug discontinuation.
The initial route of administration should be determined by the severity of the presenting symptoms. If only the earliest manifestations of diabetic gastric stasis are present, oral administration of metoclopramide may be initiated. However, if severe symptoms are present, therapy should begin with metoclopramide injection (consult labeling of the injection prior to initiating parenteral administration).
Administration of the metoclopramide injection up to 10 days may be required before symptoms subside, at which time oral administration may be instituted. Since diabetic gastric stasis is frequently recurrent, metoclopramide therapy should be reinstituted at the earliest manifestation.
Use in Patients with Renal or Hepatic Impairment:
Since metoclopramide is excreted principally through the kidneys, in those patients whose creatinine clearance is below 40 mL/min, therapy should be initiated at approximately one-half the recommended dosage. Depending upon clinical efficacy and safety considerations, the dosage may be increased or decreased as appropriate.
SeeOVERDOSAGE section for information regarding dialysis.
Metoclopramide undergoes minimal hepatic metabolism, except for simple conjugation. Its safe use has been described in patients with advanced liver disease whose renal function was normal.
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![Paroxetine (Paroxetine Hydrochloride) Tablet, Film Coated [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=605c1d23-c97c-4ea4-92d0-fed351de9d2e&name=7d1b0cdd-4111-4859-99cc-1aab30bfb081-02.jpg)
Paroxetine
Major Depressive Disorder:
Usual Initial Dosage:
Paroxetine tablets should be administered as a single daily dose with or without food, usually in the morning. The recommended initial dose is 20 mg/day. Patients were dosed in a range of 20 to 50 mg/day in the clinical trials demonstrating the effectiveness of paroxetine tablets in the treatment of major depressive disorder. As with all drugs effective in the treatment of major depressive disorder, the full effect may be delayed. Some patients not responding to a 20-mg dose may benefit from dose increases, in 10-mg/day increments, up to a maximum of 50 mg/day. Dose changes should occur at intervals of at least 1 week.
Maintenance Therapy:
There is no body of evidence available to answer the question of how long the patient treated with paroxetine tablets should remain on it. It is generally agreed that acute episodes of major depressive disorder require several months or longer of sustained pharmacologic therapy. Whether the dose needed to induce remission is identical to the dose needed to maintain and/or sustain euthymia is unknown.
Systematic evaluation of the efficacy of paroxetine tablets has shown that efficacy is maintained for periods of up to 1 year with doses that averaged about 30 mg.
Obsessive Compulsive Disorder:
Usual Initial Dosage:
Paroxetine tablets should be administered as a single daily dose with or without food, usually in the morning. The recommended dose of paroxetine tablets in the treatment of OCD is 40 mg daily. Patients should be started on 20 mg/day and the dose can be increased in 10-mg/day increments. Dose changes should occur at intervals of at least 1 week. Patients were dosed in a range of 20 to 60 mg/day in the clinical trials demonstrating the effectiveness of paroxetine tablets in the treatment of OCD. The maximum dosage should not exceed 60 mg/day.
Maintenance Therapy:
Long-term maintenance of efficacy was demonstrated in a 6-month relapse prevention trial. In this trial, patients with OCD assigned to paroxetine demonstrated a lower relapse rate compared to patients on placebo (see CLINICAL PHARMACOLOGY — Clinical Trials). OCD is a chronic condition, and it is reasonable to consider continuation for a responding patient. Dosage adjustments should be made to maintain the patient on the lowest effective dosage, and patients should be periodically reassessed to determine the need for continued treatment.
Panic Disorder:
Usual Initial Dosage:
Paroxetine tablets should be administered as a single daily dose with or without food, usually in the morning. The target dose of paroxetine tablets in the treatment of panic disorder is 40 mg/day. Patients should be started on 10 mg/day. Dose changes should occur in 10-mg/day increments and at intervals of at least 1 week. Patients were dosed in a range of 10 to 60 mg/day in the clinical trials demonstrating the effectiveness of paroxetine tablets. The maximum dosage should not exceed 60 mg/day.
Maintenance Therapy:
Long-term maintenance of efficacy was demonstrated in a 3-month relapse prevention trial. In this trial, patients with panic disorder assigned to paroxetine demonstrated a lower relapse rate compared to patients on placebo (see CLINICAL PHARMACOLOGY — Clinical Trials). Panic disorder is a chronic condition, and it is reasonable to consider continuation for a responding patient. Dosage adjustments should be made to maintain the patient on the lowest effective dosage, and patients should be periodically reassessed to determine the need for continued treatment.
Social Anxiety Disorder:
Usual Initial Dosage:
Paroxetine tablets should be administered as a single daily dose with or without food, usually in the morning. The recommended and initial dosage is 20 mg/day. In clinical trials the effectiveness of paroxetine tablets was demonstrated in patients dosed in a range of 20 to 60 mg/day. While the safety of paroxetine tablets has been evaluated in patients with social anxiety disorder at doses up to 60 mg/day, available information does not suggest any additional benefit for doses above 20 mg/day (see CLINICAL PHARMACOLOGY — Clinical Trials).
Maintenance Therapy:
There is no body of evidence available to answer the question of how long the patient treated with paroxetine tablets should remain on it. Although the efficacy of paroxetine tablets beyond 12 weeks of dosing has not been demonstrated in controlled clinical trials, social anxiety disorder is recognized as a chronic condition, and it is reasonable to consider continuation of treatment for a responding patient. Dosage adjustments should be made to maintain the patient on the lowest effective dosage, and patients should be periodically reassessed to determine the need for continued treatment.
Generalized Anxiety Disorder:
Usual Initial Dosage:
Paroxetine tablets should be administered as a single daily dose with or without food, usually in the morning. In clinical trials the effectiveness of paroxetine tablets was demonstrated in patients dosed in a range of 20 to 50 mg/day. The recommended starting dosage and the established effective dosage is 20 mg/day. There is not sufficient evidence to suggest a greater benefit to doses higher than 20 mg/day. Dose changes should occur in 10 mg/day increments and at intervals of at least 1 week.
Maintenance Therapy:
Systematic evaluation of continuing paroxetine tablets for periods of up to 24 weeks in patients with Generalized Anxiety Disorder who had responded while taking paroxetine tablets during an 8-week acute treatment phase has demonstrated a benefit of such maintenance (see CLINICAL PHARMACOLOGY — Clinical Trials). Nevertheless, patients should be periodically reassessed to determine the need for maintenance treatment.
Special Populations:
Treatment of Pregnant Women During the Third Trimester:
Neonates exposed to paroxetine tablets and other SSRIs or SNRIs, late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding (see WARNINGS: Usage in Pregnancy). When treating pregnant women with paroxetine during the third trimester, the physician should carefully consider the potential risks and benefits of treatment. The physician may consider tapering paroxetine in the third trimester.
Dosage for Elderly or Debilitated Patients, and Patients with Severe Renal or Hepatic Impairment:
The recommended initial dose is 10 mg/day for elderly patients, debilitated patients, and/or patients with severe renal or hepatic impairment. Increases may be made if indicated. Dosage should not exceed 40 mg/day.
Switching Patients to or from a Monoamine Oxidase Inhibitor:
At least 14 days should elapse between discontinuation of an MAOI and initiation of therapy with paroxetine tablets. Similarly, at least 14 days should be allowed after stopping paroxetine tablets before starting an MAOI.
Discontinuation of Treatment with Paroxetine Tablets:
Symptoms associated with discontinuation of paroxetine tablets have been reported(see PRECAUTIONS: Discontinuation of Treatment With Paroxetine Tablets). Patients should be monitored for these symptoms when discontinuing treatment, regardless of the indication for which paroxetine tablets are being prescribed. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate.
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![Fluconazole Tablet [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=26d01204-4002-4f4e-9c50-49c5a74858db&name=98a1d736-1994-4f60-b6f3-82bb4ca0b756-07.jpg)
Fluconazole
Dosage and Administration in Adults:
Single Dose
Vaginal candidiasis: The recommended dosage of fluconazole for vaginal candidiasis is150 mg as a single oral dose.
Multiple Dose
SINCE ORAL ABSORPTION IS RAPID AND ALMOST COMPLETE, THE DAILY DOSE OF FLUCONAZOLE IS THE SAME FOR ORAL TABLETS AND INTRAVENOUS ADMINISTRATION. In general, a loading dose of twice the daily dose is recommended on the first day of therapy to result in plasma concentrations close to steady-state by the second day of therapy.
The daily dose of fluconazole for the treatment of infections other than vaginal candidiasis should be based on the infecting organism and the patient’s response to therapy. Treatment should be continued until clinical parameters or laboratory tests indicate that active fungal infection has subsided. An inadequate period of treatment may lead to recurrence of active infection. Patients with AIDS and cryptococcal meningitis or recurrent oropharyngeal candidiasis usually require maintenance therapy to prevent relapse.
Oropharyngeal candidiasis: The recommended dosage of fluconazole for oropharyngealcandidiasis is 200 mg on the first day, followed by 100 mg once daily. Clinical evidence of oropharyngeal candidiasis generally resolves within several days, but treatment should be continued for at least 2 weeks to decrease the likelihood of relapse.
Esophageal candidiasis: The recommended dosage of fluconazole for esophageal candidiasis is 200 mg on the first day, followed by 100 mg once daily. Doses up to 400 mg/day may be used, based on medical judgment of the patient’s response to therapy. Patients with esophageal candidiasis should be treated for a minimum of three weeks and for at least two weeks following resolution of symptoms.
Systemic Candida infections: For systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia, optimal therapeutic dosage and duration of therapy have not been established. In open, noncomparative studies of small numbers of patients, doses of up to 400 mg daily have been used.
Urinary tract infections and peritonitis: For the treatment of Candida urinary tract infections and peritonitis, daily doses of 50-200 mg have been used in open, noncomparative studies of small numbers of patients.
Cryptococcal meningitis: For the treatment of acute cryptococcal meningitis, the recommended dosage is 12 mg/kg on the first day, followed by 6 mg/kg once daily. A dosage of 12 mg/kg once daily may be used, based on medical judgment of the patient’s response to therapy. The recommended duration of treatment for initial therapy of cryptococcal meningitis is 10-12 weeks after the cerebrospinal fluid becomes culture negative. For suppression of relapse of cryptococcal meningitis in children with AIDS, the recommended dose of fluconazole is 6 mg/kg once daily.
Dosage In Patients With Impaired Renal Function:
Fluconazole is cleared primarily by renal excretion as unchanged drug. There is no need to adjust single dose therapy for vaginal candidiasis because of impaired renal function. In patients with impaired renal function who will receive multiple doses of fluconazole, an initial loading dose of 50 to 400 mg should be given. After the loading dose, the daily dose (according to indication) should be based on the following table:
Creatinine Clearance (mL/min)
Percent of Recommended Dose
>50
100%
≤50 (no dialysis)
50%
Regular dialysis
100% after each dialysis
These are suggested dose adjustments based on pharmacokinetics following administration of multiple doses. Further adjustment may be needed depending upon clinical condition.
When serum creatinine is the only measure of renal function available, the following formula (based on sex, weight, and age of the patient) should be used to estimate the creatinine clearance in adults:
Males:
Weight (kg) × (140 – age)
72 × serum creatinine (mg/100 mL)
Females:
0.85 × above value
Although the pharmacokinetics of fluconazole has not been studied in children with renal insufficiency, dosage reduction in children with renal insufficiency should parallel that recommended for adults. The following formula may be used to estimate creatinine clearance in children:
K × linear length or height (cm)
serum creatinine (mg/100 mL)
(Where K=0.55 for children older than 1 year and 0.45 for infants.)
Administration
Fluconazole may be administered orally. Fluconazole can be taken with or without food.
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![Ipratropium Bromide Solution [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=d41e43e6-cb50-443f-800f-5c80a51798c8&name=d41e43e6-cb50-443f-800f-5c80a51798c8-05.jpg)
Ipratropium Bromide Solution
The usual dosage of ipratropium bromide inhalation solution is 500 mcg (1 Unit-Dose Vial) administered three to four times a day by oral nebulization, with doses 6 to 8 hours apart. Ipratropium bromide inhalation solution Unit-Dose Vials contain 500 mcg ipratropium bromide anhydrous in 2.5 mL normal saline. Ipratropium bromide inhalation solution can be mixed in the nebulizer with albuterol or metaproterenol if used within one hour. Drug stability and safety of ipratropium bromide inhalation solution when mixed with other drugs in a nebulizer have not been established.
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![E-z-hd (Barium Sulfate) Powder, For Suspension [E-z-em Canada Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=a9ac3d4e-f502-41e3-95c0-0d334584566d&name=image-02.jpg)
E-z-hd
2.1 Dosage in Adults
Use the lowest effective dose for the patient. The recommended initial dose is 5 mg for women and either 5 or 10 mg for men, taken only once per night immediately before bedtime with at least 7-8 hours remaining before the planned time of awakening. If the 5 mg dose is not effective, the dose can be increased to 10 mg. In some patients, the higher morning blood levels following use of the 10 mg dose increase the risk of next day impairment of driving and other activities that require full alertness [see Warnings and Precautions (5.1)]. The total dose of zolpidem tartrate tablets should not exceed 10 mg once daily immediately before bedtime.
The recommended initial doses for women and men are different because zolpidem clearance is lower in women.
2.2 Special Populations
Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.1); Use in Specific Populations (8.5)].
2.3 Use with CNS Depressants
Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.1)].
2.4 Administration
The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.
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![Aspirin Tablet, Coated [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=2a0dac57-929a-43e2-8834-f65c9367293c&name=b7209391-86c9-4f9c-867e-24d559101b94-01.jpg)
Aspirin
DOSAGE AND ADMINISTRATION:
Drink a full glass of water with each dose. Adults and children 12 years and over; take 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor. Children under 12 years; consult a doctor.
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![Ofloxacin Solution/ Drops [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=14276805-4e99-4bbe-ad76-ffc06eddb38a&name=ondansetron-fig1.jpg)
Ofloxacin Solution Drops
Prevention of Nausea and Vomiting Associated With Highly Emetogenic Cancer Chemotherapy The recommended adult oral dosage of ondansetron tablets is 24 mg given as three 8 mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥50 mg/m2. Multiday, single-dose administration of a 24 mg dosage has not been studied.Pediatric UseThere is no experience with the use of a 24 mg dosage in pediatric patients.Geriatric UseThe dosage recommendation is the same as for the general population.Prevention of Nausea and Vomiting Associated With Moderately Emetogenic Cancer Chemotherapy The recommended adult oral dosage is one 8 mg ondansetron tablet given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8 mg ondansetron tablet should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.Pediatric UseFor pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4 mg ondansetron tablet given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4 mg ondansetron tablet should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.Geriatric UseThe dosage is the same as for the general population. Prevention of Nausea and Vomiting Associated With Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions to the Abdomen The recommended oral dosage is one 8 mg ondansetron tablet given 3 times a day.For total body irradiation, one 8 mg ondansetron tablet should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.For single high-dose fraction radiotherapy to the abdomen, one 8 mg ondansetron tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.For daily fractionated radiotherapy to the abdomen, one 8 mg ondansetron tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.Pediatric UseThere is no experience with the use of ondansetron tablets in the prevention of radiation-induced nausea and vomiting in pediatric patients.Geriatric UseThe dosage recommendation is the same as for the general population.Postoperative Nausea and Vomiting The recommended dosage is 16 mg given as two 8 mg ondansetron tablets 1 hour before induction of anesthesia.Pediatric UseThere is no experience with the use of ondansetron tablets in the prevention of postoperative nausea and vomiting in pediatric patients.Geriatric UseThe dosage is the same as for the general population.Dosage Adjustment for Patients With Impaired Renal Function The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron.Dosage Adjustment for Patients With Impaired Hepatic Function In patients with severe hepatic impairment (Child-Pugh2 score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.
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![Neomycin Polymyxin B Sulfates And Dexamethasone (Neomycin Sulfate, Polymyxin B Sulfate And Dexamethasone) Suspension/ Drops [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=449a6fd8-c2ac-40d0-b74a-e5c7fc6670f3&name=322c5da9-9ffc-4deb-9593-3437df10a662-04.jpg)
Neomycin Polymyxin B Sulfates And Dexamethasone
One or two drops topically in the conjunctival sac(s). In severe disease, drops may be used hourly, being tapered to discontinuation as the inflammation subsides. In mild disease, drops may be used up to four to six times daily.
Not more than 20 mL should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in PRECAUTIONS above.
SHAKE WELL BEFORE USING.
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![Lovastatin Tablet [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=50b7fc3e-de79-4b08-a2b7-b05110ec70fb&name=c9a957b3-1d7f-4f61-a7d7-38f2edbeb69b-04.jpg)
Lovastatin
The patient should be placed on a standard cholesterol-lowering diet before receiving lovastatin and should continue on this diet during treatment with lovastatin (see NCEP Treatment Guidelines for details on dietary therapy). Lovastatin should be given with meals.
Adult Patients: The usual recommended starting dose is 20 mg once a day given with the evening meal. The recommended dosing range is 10-80 mg/day in single or two divided doses; the maximum recommended dose is 80 mg/day. Doses should be individualized according to the recommended goal of therapy (see NCEP Guidelines and CLINICAL PHARMACOLOGY). Patients requiring reductions in LDL-C of 20% or more to achieve their goal (see INDICATIONS AND USAGE) should be started on 20 mg/day of lovastatin. A starting dose of 10 mg may be considered for patients requiring smaller reductions. Adjustments should be made at intervals of 4 weeks or more.
Cholesterol levels should be monitored periodically and consideration should be given to reducing the dosage of lovastatin if cholesterol levels fall significantly below the targeted range.
Dosage In Patients Taking Cyclosporine Or Danazol:
In patients taking cyclosporine or danazol concomitantly with lovastatin (see WARNINGS, Myopathy/Rhabdomyolysis), therapy should begin with 10 mg of lovastatin and should not exceed 20 mg/day.
Dosage In Patients Taking Amiodarone Or Verapamil:
In patients taking amiodarone or verapamil concomitantly with lovastatin, the dose should not exceed 40 mg/day (see WARNINGS, Myopathy/Rhabdomyolysis and PRECAUTIONS, Drug Interactions, Other Drug Interactions).
Adolescent Patients (10-17 Years Of Age) With Heterozygous Familial Hypercholesterolemia:
The recommended dosing range is 10-40 mg/day; the maximum recommended dose is 40 mg/day. Doses should be individualized according to the recommended goal of therapy (see NCEP Pediatric Panel Guidelines††, CLINICAL PHARMACOLOGY, and INDICATIONS AND USAGE ). Patients requiring reductions in LDL-C of 20% or more to achieve their goal should be started on 20 mg/day of lovastatin. A starting dose of 10 mg may be considered for patients requiring smaller reductions. Adjustments should be made at intervals of 4 weeks or more.
Concomitant Lipid-Lowering Therapy:
Lovastatin is effective alone or when used concomitantly with bile-acid sequestrants. If lovastatin is used in combination with gemfibrozil, other fibrates or lipid-lowering doses (≥ 1g/day) of niacin, the dose of lovastatin should not exceed 20 mg/day (see WARNINGS, Myopathy/Rhabdomyolysis and PRECAUTIONS, Drug Interactions).
Dosage In Patients With Renal Insufficiency:
In patients with severe renal insufficiency (creatinine clearance <30 mL/min), dosage increases above 20 mg/day should be carefully considered and, if deemed necessary, implemented cautiously (see CLINICAL PHARMACOLOGY and WARNINGS, Myopathy/Rhabdomyolysis).
_________________
†† National Cholesterol Education Program (NCEP): Highlights of the Report of the Expert Panel on Blood Cholesterol Levels in Children and Adolescents. Pediatrics. 89(3):495-501. 1992.
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![Lovastatin Tablet [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=f5766e3f-374d-47b5-b141-2767cb7a4693&name=ec92b6a0-7a4c-4a17-99a4-a867dcb621c0-04.jpg)
Lovastatin
The patient should be placed on a standard cholesterol-lowering diet before receiving lovastatin and should continue on this diet during treatment with lovastatin (see NCEP Treatment Guidelines for details on dietary therapy). Lovastatin should be given with meals.
Adult Patients: The usual recommended starting dose is 20 mg once a day given with the evening meal. The recommended dosing range is 10-80 mg/day in single or two divided doses; the maximum recommended dose is 80 mg/day. Doses should be individualized according to the recommended goal of therapy (see NCEP Guidelines and CLINICAL PHARMACOLOGY). Patients requiring reductions in LDL-C of 20% or more to achieve their goal (see INDICATIONS AND USAGE) should be started on 20 mg/day of lovastatin. A starting dose of 10 mg may be considered for patients requiring smaller reductions. Adjustments should be made at intervals of 4 weeks or more.
Cholesterol levels should be monitored periodically and consideration should be given to reducing the dosage of lovastatin if cholesterol levels fall significantly below the targeted range.
Dosage In Patients Taking Cyclosporine Or Danazol:
In patients taking cyclosporine or danazol concomitantly with lovastatin (see WARNINGS, Myopathy/Rhabdomyolysis), therapy should begin with 10 mg of lovastatin and should not exceed 20 mg/day.
Dosage In Patients Taking Amiodarone Or Verapamil:
In patients taking amiodarone or verapamil concomitantly with lovastatin, the dose should not exceed 40 mg/day (see WARNINGS, Myopathy/Rhabdomyolysis and PRECAUTIONS, Drug Interactions, Other Drug Interactions).
Adolescent Patients (10-17 Years Of Age) With Heterozygous Familial Hypercholesterolemia:
The recommended dosing range is 10-40 mg/day; the maximum recommended dose is 40 mg/day. Doses should be individualized according to the recommended goal of therapy (see NCEP Pediatric Panel Guidelines††, CLINICAL PHARMACOLOGY, and INDICATIONS AND USAGE ). Patients requiring reductions in LDL-C of 20% or more to achieve their goal should be started on 20 mg/day of lovastatin. A starting dose of 10 mg may be considered for patients requiring smaller reductions. Adjustments should be made at intervals of 4 weeks or more.
Concomitant Lipid-Lowering Therapy:
Lovastatin is effective alone or when used concomitantly with bile-acid sequestrants. If lovastatin is used in combination with gemfibrozil, other fibrates or lipid-lowering doses (≥ 1g/day) of niacin, the dose of lovastatin should not exceed 20 mg/day (see WARNINGS, Myopathy/Rhabdomyolysis and PRECAUTIONS, Drug Interactions).
Dosage In Patients With Renal Insufficiency:
In patients with severe renal insufficiency (creatinine clearance <30 mL/min), dosage increases above 20 mg/day should be carefully considered and, if deemed necessary, implemented cautiously (see CLINICAL PHARMACOLOGY and WARNINGS, Myopathy/Rhabdomyolysis).
_________________
†† National Cholesterol Education Program (NCEP): Highlights of the Report of the Expert Panel on Blood Cholesterol Levels in Children and Adolescents. Pediatrics. 89(3):495-501. 1992.
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![Lovastatin Tablet [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=b1f9a948-f807-4256-b221-e431167f9d54&name=535a477c-f742-4033-be18-05ec78414357-04.jpg)
Lovastatin
The patient should be placed on a standard cholesterol-lowering diet before receiving lovastatin and should continue on this diet during treatment with lovastatin (see NCEP Treatment Guidelines for details on dietary therapy). Lovastatin should be given with meals.
Adult Patients: The usual recommended starting dose is 20 mg once a day given with the evening meal. The recommended dosing range is 10-80 mg/day in single or two divided doses; the maximum recommended dose is 80 mg/day. Doses should be individualized according to the recommended goal of therapy (see NCEP Guidelines and CLINICAL PHARMACOLOGY). Patients requiring reductions in LDL-C of 20% or more to achieve their goal (see INDICATIONS AND USAGE) should be started on 20 mg/day of lovastatin. A starting dose of 10 mg may be considered for patients requiring smaller reductions. Adjustments should be made at intervals of 4 weeks or more.
Cholesterol levels should be monitored periodically and consideration should be given to reducing the dosage of lovastatin if cholesterol levels fall significantly below the targeted range.
Dosage In Patients Taking Cyclosporine Or Danazol:
In patients taking cyclosporine or danazol concomitantly with lovastatin (see WARNINGS, Myopathy/Rhabdomyolysis), therapy should begin with 10 mg of lovastatin and should not exceed 20 mg/day.
Dosage In Patients Taking Amiodarone Or Verapamil:
In patients taking amiodarone or verapamil concomitantly with lovastatin, the dose should not exceed 40 mg/day (see WARNINGS, Myopathy/Rhabdomyolysis and PRECAUTIONS, Drug Interactions, Other Drug Interactions).
Adolescent Patients (10-17 Years Of Age) With Heterozygous Familial Hypercholesterolemia:
The recommended dosing range is 10-40 mg/day; the maximum recommended dose is 40 mg/day. Doses should be individualized according to the recommended goal of therapy (see NCEP Pediatric Panel Guidelines††, CLINICAL PHARMACOLOGY, and INDICATIONS AND USAGE ). Patients requiring reductions in LDL-C of 20% or more to achieve their goal should be started on 20 mg/day of lovastatin. A starting dose of 10 mg may be considered for patients requiring smaller reductions. Adjustments should be made at intervals of 4 weeks or more.
Concomitant Lipid-Lowering Therapy:
Lovastatin is effective alone or when used concomitantly with bile-acid sequestrants. If lovastatin is used in combination with gemfibrozil, other fibrates or lipid-lowering doses (≥ 1g/day) of niacin, the dose of lovastatin should not exceed 20 mg/day (see WARNINGS, Myopathy/Rhabdomyolysis and PRECAUTIONS, Drug Interactions).
Dosage In Patients With Renal Insufficiency:
In patients with severe renal insufficiency (creatinine clearance <30 mL/min), dosage increases above 20 mg/day should be carefully considered and, if deemed necessary, implemented cautiously (see CLINICAL PHARMACOLOGY and WARNINGS, Myopathy/Rhabdomyolysis).
_________________
†† National Cholesterol Education Program (NCEP): Highlights of the Report of the Expert Panel on Blood Cholesterol Levels in Children and Adolescents. Pediatrics. 89(3):495-501. 1992.
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![Hydroquinone Cream [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=c7aeab93-756e-4370-9989-8dfe3e2ff627&name=HydroquinoneSkinBleachingCreamPerrigo.jpg)
Hydroquinone
Hydroquinone USP, 4% Skin Bleaching Cream should be applied to affected areas and rubbed in well twice daily, in the morning and before bedtime, or as directed by a physician. If no improvement is seen after 2 months of treatment, use of this product should be discontinued. There is no recommended dosage for pediatric patients under 12 years of age except under the advice and supervision of a physician.
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![Nifedipine Tablet, Film Coated, Extended Release [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=5bd6a89c-b140-4c78-ba36-46450ed5cfc1&name=nifedipine-extended-release-tablets-usp-3.jpg)
Nifedipine
Dosage must be adjusted according to each patient's needs. Therapy for either hypertension or angina should be initiated with 30 or 60 mg once daily. Nifedipine Extended-release Tablets should be swallowed whole and should not be bitten or divided. In general, titration should proceed over a 7-14 day period so that the physician can fully assess the response to each dose level and monitor blood pressure before proceeding to higher doses. Since steady-state plasma levels are achieved on the second day of dosing, titration may proceed more rapidly, if symptoms so warrant, provided the patient is assessed frequently. Titration to doses above 120 mg are not recommended.
Angina patients controlled on nifedipine capsules alone or in combination with other antianginal medications may be safely switched to Nifedipine Extended-release Tablets at the nearest equivalent total daily dose (e.g., 30 mg t.i.d. of nifedipine capsules may be changed to 90 mg once daily of Nifedipine Extended-release Tablets). Subsequent titration to higher or lower doses may be necessary and should be initiated as clinically warranted. Experience with doses greater than 90 mg in patients with angina is limited. Therefore, doses greater than 90 mg should be used with caution and only when clinically warranted.
Avoid co-administration of nifedipine with grapefruit juice (see CLINICAL PHARMACOLOGY and PRECAUTIONS: Other Interactions).
No "rebound effect" has been observed upon discontinuation of Nifedipine Extended-release Tablets. However, if discontinuation of nifedipine is necessary, sound clinical practice suggests that the dosage should be decreased gradually with close physician supervision.
Care should be taken when dispensing Nifedipine Extended-release Tablets to assure that the extended release dosage form has been prescribed.
Coadministration with Other Antianginal Drugs
Sublingual nitroglycerin may be taken as required for the control of acute manifestations of angina, particularly during nifedipine titration. See PRECAUTIONS, Drug Interactions, for information on coadministration of nifedipine with beta-blockers or long-acting nitrates.
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![Furosemide Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=c8b3eb4f-5306-4d58-981f-b41aaae1adac&name=c8b3eb4f-5306-4d58-981f-b41aaae1adac-02.jpg)
Furosemide
Edema
Therapy should be individualized according to patient response to gain maximal therapeutic response and to determine the minimal dose needed to maintain that response.
Adults
The usual initial dose of furosemide is 20 to 80 mg given as a single dose. Ordinarily a prompt diuresis ensues. If needed, the same dose can be administered 6 to 8 hours later or the dose may be increased. The dose may be raised by 20 or 40 mg and given not sooner than 6 to 8 hours after the previous dose until the desired diuretic effect has been obtained. The individually determined single dose should then be given once or twice daily (e.g., at 8 am and 2 pm). The dose of furosemide may be carefully titrated up to 600 mg/day in patients with clinically severe edematous states.
Edema may be most efficiently and safely mobilized by giving furosemide on 2 to 4 consecutive days each week.
When doses exceeding 80 mg/day are given for prolonged periods, careful clinical observation and laboratory monitoring are particularly advisable. (See PRECAUTIONS: Laboratory Tests.)
Geriatric Patients
In general, dose selection for the elderly patient should be cautious, usually starting at the low end of the dosing range. (See PRECAUTIONS: Geriatric Use.)
Pediatric Patients
The usual initial dose of oral furosemide in pediatric patients is 2 mg/kg body weight, given as a single dose. If the diuretic response is not satisfactory after the initial dose, dosage may be increased by 1 or 2 mg/kg no sooner than 6 to 8 hours after the previous dose. Doses greater than 6 mg/kg body weight are not recommended. For maintenance therapy in pediatric patients, the dose should be adjusted to the minimum effective level.
Hypertension
Therapy should be individualized according to the patient’s response to gain maximal therapeutic response and to determine the minimal dose needed to maintain the therapeutic response.
Adults
The usual initial dose of furosemide for hypertension is 80 mg, usually divided into 40 mg twice a day. Dosage should then be adjusted according to response. If response is not satisfactory, add other antihypertensive agents.
Changes in blood pressure must be carefully monitored when furosemide is used with other antihypertensive drugs, especially during initial therapy. To prevent excessive drop in blood pressure, the dosage of other agents should be reduced by at least 50 percent when furosemide is added to the regimen. As the blood pressure falls under the potentiating effect of furosemide, a further reduction in dosage or even discontinuation of other antihypertensive drugs may be necessary.
Geriatric Patients
In general, dose selection and dose adjustment for the elderly patient should be cautious, usually starting at the low end of the dosing range. (See PRECAUTIONS: Geriatric Use.)
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![Ofloxacin (Ofloxaxin) Solution/ Drops [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=f11b01ea-5be5-49af-afda-4a648edba228&name=f11b01ea-5be5-49af-afda-4a648edba228-08.jpg)
Ofloxacin
Otitis Externa
The recommended dosage regimen for the treatment of otitis externa is:
For pediatric patients (from 6 months to 13 years old): Five drops (0.25 mL, 0.75 mg ofloxacin) instilled into the affected ear once daily for seven days. For patients 13 years and older: Ten drops (0.5 mL, 1.5 mg ofloxacin) instilled into the affected ear once daily for seven days. The solution should be warmed by holding the bottle in the hand for one or two minutes to avoid dizziness which may result from the instillation of a cold solution. The patient should lie with the affected ear upward, and then the drops should be instilled. This position should be maintained for five minutes to facilitate penetration of the drops into the ear canal. Repeat, if necessary, for the opposite ear.Acute Otitis Media in pediatric patients with tympanostomy tubes
The recommended dosage regimen for the treatment of acute otitis media in pediatric patients (from 1 to 12 years old) with tympanostomy tubes is:
Five drops (0.25 mL, 0.75 mg ofloxacin) instilled into the affected ear twice daily for ten days. The solution should be warmed by holding the bottle in the hand for one or two minutes to avoid dizziness which may result from the instillation of a cold solution. The patient should lie with the affected ear upward, and then the drops should be instilled. The tragus should then be pumped 4 times by pushing inward to facilitate penetration of the drops into the middle ear. This position should be maintained for five minutes. Repeat, if necessary, for the opposite ear.Chronic Suppurative Otitis Media with perforated tympanic membranes
The recommended dosage regimen for the treatment of chronic suppurative otitis media with perforated tympanic membranes in patients 12 years and older is:
Ten drops (0.5 mL, 1.5 mg ofloxacin) instilled into the affected ear twice daily for fourteen days. The solution should be warmed by holding the bottle in the hand for one or two minutes to avoid dizziness which may result from the instillation of a cold solution. The patient should lie with the affected ear upward, before instilling the drops. The tragus should then be pumped 4 times by pushing inward to facilitate penetration into the middle ear. This position should be maintained for five minutes. Repeat, if necessary, for the opposite ear. -
![Sertraline Hydrochloride Tablet [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=5213ff08-ba1f-4f22-99e0-9604dd13a63f&name=c300ee1d-c1c5-442b-85d2-01a8a13e1935-01.jpg)
Sertraline Hydrochloride
Initial Treatment Dosage for Adults
Major Depressive Disorder–Sertraline hydrochloride treatment should be administered at a dose of 50 mg once daily.
While a relationship between dose and effect has not been established for major depressive disorder patients were dosed in a range of 50-200 mg/day in the clinical trials demonstrating the effectiveness of sertraline hydrochloride for the treatment of this indication. Consequently, a dose of 50 mg, administered once daily, is recommended as the initial therapeutic dose. Patients not responding to a 50 mg dose may benefit from dose increases up to a maximum of 200 mg/day. Given the 24 hour elimination half-life of sertraline hydrochloride, dose changes should not occur at intervals of less than 1 week.
Premenstrual Dysphoric Disorder– Sertraline hydrochloride treatment should be initiated with a dose of 50 mg/day, either daily throughout the menstrual cycle or limited to the luteal phase of the menstrual cycle, depending on physician assessment.
While a relationship between dose and effect has not been established for PMDD, patients were dosed in the range of 50-150 mg/day with dose increases at the onset of each new menstrual cycle (see Clinical Trials under CLINICAL PHARMACOLOGY). Patients not responding to a 50 mg/day dose may benefit from dose increases (at 50 mg increments/menstrual cycle) up to 150 mg/day when dosing daily throughout the menstrual cycle, or 100 mg/day when dosing during the luteal phase of the menstrual cycle. If a 100 mg/day dose has been established with luteal phase dosing, a 50 mg/day titration step for three days should be utilized at the beginning of each luteal phase dosing period.
Sertraline hydrochloride should be administered once daily, either in the morning or evening.
Maintenance/Continuation/Extended Treatment
Major Depressive Disorder–It is generally agreed that acute episodes of major depressive disorder require several months or longer of sustained pharmacologic therapy beyond response to the acute episode. Systematic evaluation of sertraline hydrochloride has demonstrated that its antidepressant efficacy is maintained for periods of up to 44 weeks following 8 weeks of initial treatment at a dose of 50-200 mg/day (mean dose of 70 mg/day) (see Clinical Trials under CLINICAL PHARMACOLOGY). It is not known whether the dose of sertraline hydrochloride needed for maintenance treatment is identical to the dose needed to achieve an initial response. Patients should be periodically reassessed to determine the need for maintenance treatment.
Premenstrual Dysphoric Disorder–The effectiveness of sertraline hydrochloride in long-term use, that is, for more than 3 menstrual cycles, has not been systematically evaluated in controlled trials. However, as women commonly report that symptoms worsen with age until relieved by the onset of menopause, it is reasonable to consider continuation of a responding patient. Dosage adjustments, which may include changes between dosage regimens (e.g., daily throughout the menstrual cycle versus during the luteal phase of the menstrual cycle), may be needed to maintain the patient on the lowest effective dosage and patients should be periodically reassessed to determine the need for continued treatment.
Switching Patients to or from a Monoamine Oxidase Inhibitor–At least 14 days should elapse between discontinuation of an MAOI and initiation of therapy with sertraline hydrochloride. In addition, at least 14 days should be allowed after stopping sertraline hydrochloride before starting an MAOI (see CONTRAINDICATIONS and WARNINGS).
Special Populations
Dosage for Hepatically Impaired Patients–The use of sertraline in patients with liver disease should be approached with caution. The effects of sertraline in patients with moderate and severe hepatic impairment have not been studied. If sertraline is administered to patients with liver impairment, a lower or less frequent dose should be used (see CLINICAL PHARMACOLOGY and PRECAUTIONS).
Treatment of Pregnant Women During the Third Trimester–Neonates exposed to sertraline hydrochloride and other SSRIs or SNRIs, late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding (see PRECAUTIONS). When treating pregnant women with sertraline hydrochloride during the third trimester, the physician should carefully consider the potential risks and benefits of treatment. The physician may consider tapering sertraline hydrochloride in the third trimester.
Discontinuation of Treatment with sertraline hydrochloride
Symptoms associated with discontinuation of sertraline hydrochloride and other SSRIs and SNRIs, have been reported (see PRECAUTIONS). Patients should be monitored for these symptoms when discontinuing treatment. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate.
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![Acyclovir Capsule [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=e7591486-afb6-495a-889e-e6c5a8581786&name=e7591486-afb6-495a-889e-e6c5a8581786-03.jpg)
Acyclovir
Acute Treatment of Herpes Zoster: 800 mg every 4 hours orally, 5 times daily for 7 to 10 days.
Genital Herpes: Treatment of Initial Genital Herpes: 200 mg every 4 hours, 5 times daily for 10 days.
Chronic Suppressive Therapy for Recurrent Disease:
400 mg 2 times daily for up to 12 months, followed by reevaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily.
The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient's genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir.
Intermittent Therapy: 200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.
Treatment of Chickenpox: Children (2 years of age and older): 20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.
Adults and Children over 40 kg: 800 mg 4 times daily for 5 days.
Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients.
When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.
Patients With Acute or Chronic Renal Impairment: In patients with renal impairment, the dose of acyclovir capsules should be modified as shown in Table 3:
Table 3. Dosage Modification for Renal Impairment Normal Dosage Creatinine Clearance Adjusted Dosage Regimen Regimen mL/min/1.73 m2) Dose (mg) Dosing Interval 200 mg every >10 200 every 4 hours, 4 hours 5x daily 0-10 200 every 12 hours 400 mg every >10 400 every 12 hours 12 hours 0-10 200 every 12 hours 800 mg every >25 800 every 4 hours, 4 hours 5x daily 10-25 800 every 8 hours 0-10 800 every 12 hoursHemodialysis: For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6-hour dialysis period. Therefore, the patient's dosing schedule should be adjusted so that an additional dose is administered after each dialysis.
Peritoneal Dialysis: No supplemental dose appears to be necessary after adjustment of the dosing interval.
Bioequivalence of Dosage Forms: acyclovir Suspension was shown to be bioequivalent to acyclovir Capsules (n = 20) and 1 acyclovir 800-mg capsule was shown to be bioequivalent to 4 acyclovir 200-mg capsules (n = 24).
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![Diphenhydramine Hcl Capsule [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=3ac0beba-303d-404e-bfec-0cf8c0e8624d&name=image-01.jpg)
Diphenhydramine Hcl
• Take every 4-6 hours • Do not take more than 6 doses in 24 hours.
Adults and children 12 years or over
1 to 2 capsule
Children 6 to under 12 years
1 capsule
Children under 6 years
ask a doctor
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![Senna-lax (Sennosides) Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=487de613-59a5-480d-9556-6b9790a4a56e&name=487de613-59a5-480d-9556-6b9790a4a56e-01.jpg)
Senna-lax
• Take preferably at bedtime or as directed by doctor • If you do not have a comfortable bowel movement by the second day, increase dose by 1 tablet (do not exceed maximum dosage) or decrease dose until you are comfortable
Age Starting dosage Maximum dosage Adults and children over 12 years 2 tablets once a day 4 tablets twice a day children 6 to under 12 years 1 tablet once a day 2 tablets twice a day children 2 to under 6 years 1/2 tablet once a day 1 tablet twice a day children under 2 years consult a doctor -
![Senna Time (Sennosides) Tablet, Coated [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=02119f5d-7294-4cf0-9c93-6bc5a53a4ac8&name=02119f5d-7294-4cf0-9c93-6bc5a53a4ac8-01.jpg)
Senna Time
Directions:
Take preferably at bedtime or as directed by a doctor; if you do not have a comfortable bowel movement by the second day, increase dose by one tablet (do not exceed maximum dosage) or decrease dose until you are comfortable.
Adults and children 12 years and over - starting dosage: 2 tablets once a day Maximum dosage: 4 tablets twice a day
Children 6 to under 12 years - starting dosage: 1 tablet once a day Maximum dosage: 2 tablets twice a day
Children 2 to under 6 years - starting dosage: 1/2 tablet once a day Maximum dosage: 1 tablet twice a day
Children under 2 years - ask a doctor
Bottle of 30 - 68788-9992-3
Bottle of 100 - 68788-9992-1
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![Apiol (Apiolum) Liquid [Deseret Biologicals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=30f408b6-5344-47c2-8084-d465bc094cdf&name=image-02.jpg)
Apiol
2.1 Recommended Dosing Schedule
Pantoprazole sodium is supplied as delayed-release tablets. The recommended dosages are outlined in Table 1.
Table 1: Recommended Dosing Schedule for Pantoprazole Sodium Delayed-Release Tablets * For adult patients who have not healed after 8 weeks of treatment, an additional 8 week course of pantoprazole sodium delayed-release tablets may be considered. † Controlled studies did not extend beyond 12 months ‡ Dosage regimens should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 240 mg daily have been administered.Indication
Dose
Frequency
Short-Term Treatment of Erosive Esophagitis Associated With GERD
Adults
40 mg
Once daily for up to 8 weeks*
Children (5 Years and Older)
≥ 15 kg to < 40 kg
20 mg
Once Daily for up to 8 wks
≥ 40 kg
40 mg
Maintenance of Healing of Erosive Esophagitis
Adults
40 mg
Once daily†
Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome
Adults
40 mg
Twice daily‡
2.2 Administration Instructions
Directions for method of administration are presented in Table 2.
Table 2: Administration Instructions * Patients should be cautioned that pantoprazole sodium delayed-release tablets should not be split, chewed, or crushed.Formulation
Route
Instructions*
Delayed-Release Tablets
Oral
Swallowed whole, with or without food
Pantoprazole Sodium Delayed-Release Tablets
Pantoprazole sodium delayed-release tablets should be swallowed whole, with or without food in the stomach. If patients are unable to swallow a 40 mg tablet, two 20 mg tablets may be taken. Concomitant administration of antacids does not affect the absorption of pantoprazole sodium delayed-release tablets.
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![Paroxetine (Paroxetine Hydrochloride) Tablet, Film Coated [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=4a765347-d687-4af1-a33f-fbff972c6252&name=paroxetine-fig1.jpg)
Paroxetine
Major Depressive Disorder Usual Initial DosageParoxetine tablets, USP should be administered as a single daily dose with or without food, usually in the morning. The recommended initial dose is 20 mg/day. Patients were dosed in a range of 20 to 50 mg/day in the clinical trials demonstrating the effectiveness of paroxetine tablets, USP in the treatment of major depressive disorder. As with all drugs effective in the treatment of major depressive disorder, the full effect may be delayed. Some patients not responding to a 20 mg dose may benefit from dose increases, in 10 mg/day increments, up to a maximum of 50 mg/day. Dose changes should occur at intervals of at least 1 week.Maintenance TherapyThere is no body of evidence available to answer the question of how long the patient treated with paroxetine tablets, USP should remain on it. It is generally agreed that acute episodes of major depressive disorder require several months or longer of sustained pharmacologic therapy. Whether the dose needed to induce remission is identical to the dose needed to maintain and/or sustain euthymia is unknown.Systematic evaluation of the efficacy of paroxetine tablets, USP has shown that efficacy is maintained for periods of up to 1 year with doses that averaged about 30 mg.Obsessive Compulsive Disorder Usual Initial DosageParoxetine tablets, USP should be administered as a single daily dose with or without food, usually in the morning. The recommended dose of paroxetine tablets, USP in the treatment of OCD is 40 mg daily. Patients should be started on 20 mg/day and the dose can be increased in 10 mg/day increments. Dose changes should occur at intervals of at least 1 week. Patients were dosed in a range of 20 to 60 mg/day in the clinical trials demonstrating the effectiveness of paroxetine tablets, USP in the treatment of OCD. The maximum dosage should not exceed 60 mg/day.Maintenance TherapyLong-term maintenance of efficacy was demonstrated in a 6-month relapse prevention trial. In this trial, patients with OCD assigned to paroxetine demonstrated a lower relapse rate compared to patients on placebo (see CLINICAL PHARMACOLOGY: Clinical Trials). OCD is a chronic condition, and it is reasonable to consider continuation for a responding patient. Dosage adjustments should be made to maintain the patient on the lowest effective dosage, and patients should be periodically reassessed to determine the need for continued treatment.Panic Disorder Usual Initial DosageParoxetine tablets, USP should be administered as a single daily dose with or without food, usually in the morning. The target dose of paroxetine tablets, USP in the treatment of panic disorder is 40 mg/day. Patients should be started on 10 mg/day. Dose changes should occur in 10 mg/day increments and at intervals of at least 1 week. Patients were dosed in a range of 10 to 60 mg/day in the clinical trials demonstrating the effectiveness of paroxetine tablets, USP. The maximum dosage should not exceed 60 mg/day.Maintenance TherapyLong-term maintenance of efficacy was demonstrated in a 3-month relapse prevention trial. In this trial, patients with panic disorder assigned to paroxetine demonstrated a lower relapse rate compared to patients on placebo (see CLINICAL PHARMACOLOGY: Clinical Trials). Panic disorder is a chronic condition, and it is reasonable to consider continuation for a responding patient. Dosage adjustments should be made to maintain the patient on the lowest effective dosage, and patients should be periodically reassessed to determine the need for continued treatment.Generalized Anxiety Disorder Usual Initial DosageParoxetine tablets, USP should be administered as a single daily dose with or without food, usually in the morning. In clinical trials the effectiveness of paroxetine tablets, USP was demonstrated in patients dosed in a range of 20 to 50 mg/day. The recommended starting dosage and the established effective dosage is 20 mg/day. There is not sufficient evidence to suggest a greater benefit to doses higher than 20 mg/day. Dose changes should occur in 10 mg/day increments and at intervals of at least 1 week.Maintenance TherapySystematic evaluation of continuing paroxetine tablets, USP for periods of up to 24 weeks in patients with Generalized Anxiety Disorder who had responded while taking paroxetine tablets, USP during an 8-week acute treatment phase has demonstrated a benefit of such maintenance (see CLINICAL PHARMACOLOGY: Clinical Trials). Nevertheless, patients should be periodically reassessed to determine the need for maintenance treatment.Special Populations Treatment of Pregnant Women During the Third TrimesterNeonates exposed to paroxetine tablets, USP and other SSRIs or SNRIs, late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding (see WARNINGS: Usage in Pregnancy). When treating pregnant women with paroxetine during the third trimester, the physician should carefully consider the potential risks and benefits of treatment.Dosage for Elderly or Debilitated Patients, and Patients With Severe Renal or Hepatic ImpairmentThe recommended initial dose is 10 mg/day for elderly patients, debilitated patients, and/or patients with severe renal or hepatic impairment. Increases may be made if indicated. Dosage should not exceed 40 mg/day.Switching a Patient to or From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with paroxetine tablets, USP. Conversely, at least 14 days should be allowed after stopping paroxetine tablets, USP before starting an MAOI intended to treat psychiatric disorders (see CONTRAINDICATIONS).Use of Paroxetine Tablets, USP With Other MAOIs, Such as Linezolid or Methylene Blue Do not start paroxetine tablets, USP in a patient who is being treated with linezolid or intravenous methylene blue because there is increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered (see CONTRAINDICATIONS).In some cases, a patient already receiving therapy with paroxetine tablets, USP may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, paroxetine tablets, USP should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for 2 weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with paroxetine tablets, USP may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue (see WARNINGS).The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with paroxetine tablets is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use (see WARNINGS).
Discontinuation of Treatment With Paroxetine Tablets, USP
Symptoms associated with discontinuation of paroxetine tablets, USP have been reported (see PRECAUTIONS: Discontinuation of Treatment With Paroxetine Tablets). Patients should be monitored for these symptoms when discontinuing treatment, regardless of the indication for which paroxetine tablets, USP is being prescribed. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate.
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![Carvedilol Tablet, Film Coated [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=adca4651-75f9-44bb-bfa9-4a4219948cfa&name=b6a1bb7f-d5c4-4859-8471-a3a1036f26ed-04.jpg)
Carvedilol
Carvedilol tablets should be taken with food to slow the rate of absorption and reduce the incidence of orthostatic effects.
2.2 Left Ventricular Dysfunction Following Myocardial Infarction
DOSAGE MUST BE INDIVIDUALIZED AND MONITORED DURING UP-TITRATION. Treatment with carvedilol tablets may be started as an inpatient or outpatient and should be started after the patient is hemodynamically stable and fluid retention has been minimized. It is recommended that carvedilol tablets be started at 6.25 mg twice daily and increased after 3 to 10 days, based on tolerability, to 12.5 mg twice daily, then again to the target dose of 25 mg twice daily. A lower starting dose may be used (3.125 mg twice daily) and/or the rate of up-titration may be slowed if clinically indicated (e.g., due to low blood pressure or heart rate, or fluid retention). Patients should be maintained on lower doses if higher doses are not tolerated. The recommended dosing regimen need not be altered in patients who received treatment with an IV or oral β-blocker during the acute phase of the myocardial infarction.
2.3 Hypertension
DOSAGE MUST BE INDIVIDUALIZED. The recommended starting dose of carvedilol tablets is 6.25 mg twice daily. If this dose is tolerated, using standing systolic pressure measured about 1 hour after dosing as a guide, the dose should be maintained for 7 to 14 days, and then increased to 12.5 mg twice daily if needed, based on trough blood pressure, again using standing systolic pressure one hour after dosing as a guide for tolerance. This dose should also be maintained for 7 to 14 days and can then be adjusted upward to 25 mg twice daily if tolerated and needed. The full antihypertensive effect of carvedilol tablets is seen within 7 to 14 days. Total daily dose should not exceed 50 mg.
Concomitant administration with a diuretic can be expected to produce additive effects and exaggerate the orthostatic component of carvedilol action.
2.4 Hepatic Impairment
Carvedilol tablets should not be given to patients with severe hepatic impairment
[see Contraindications (4)].
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![Metoclopramide Tablet [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=9d648594-d657-4d9a-855e-0ea91eb49c98&name=image-02.jpg)
Metoclopramide
2.1 General Instructions
Carefully consider the potential benefits and risks of meloxicam tablets and other treatment options before deciding to use meloxicam tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5.4)].
After observing the response to initial therapy with meloxicam tablets, adjust the dose to suit an individual patient's needs.
In adults, the maximum recommended daily oral dose of meloxicam tablets are 15 mg regardless of formulation. In patients with hemodialysis, a maximum daily dosage of 7.5 mg is recommended [see Warnings and Precautions (5.6), Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].
Meloxicam oral suspension 7.5 mg/5 mL or 15 mg/10 mL may be substituted for meloxicam tablets 7.5 mg or 15 mg, respectively.
Meloxicam tablets may be taken without regard to timing of meals.
2.2 Osteoarthritis
For the relief of the signs and symptoms of osteoarthritis the recommended starting and maintenance oral dose of meloxicam tablets is 7.5 mg once daily. Some patients may receive additional benefit by increasing the dose to 15 mg once daily.
2.3 Rheumatoid Arthritis
For the relief of the signs and symptoms of rheumatoid arthritis, the recommended starting and maintenance oral dose of meloxicam tablets is 7.5 mg once daily. Some patients may receive additional benefit by increasing the dose to 15 mg once daily.
2.4 Juvenile Rheumatoid Arthritis (JRA) Pauciarticular and Polyarticular Course
To improve dosing accuracy in smaller weight children, the use of the meloxicam oral suspension is recommended. For the treatment of juvenile rheumatoid arthritis, the recommended oral dose of meloxicam is 0.125 mg/kg once daily up to a maximum of 7.5 mg. There was no additional benefit demonstrated by increasing the dose above 0.125 mg/kg once daily in these clinical trials.
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![Fluticasone Propionate Spray, Metered [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=4916301d-bcc8-4cd1-86b4-7bf0aecfbf68&name=4916301d-bcc8-4cd1-86b4-7bf0aecfbf68-04.jpg)
Fluticasone Propionate Spray
Patients should use fluticasone propionate nasal spray at regular intervals for optimal effect.
Adults
The recommended starting dosage in adults is 2 sprays (50 mcg of fluticasone propionate each) in each nostril once daily (total daily dose, 200 mcg). The same dosage divided into 100 mcg given twice daily (e.g., 8 a.m. and 8 p.m.) is also effective. After the first few days, patients may be able to reduce their dosage to 100 mcg (1 spray in each nostril) once daily for maintenance therapy. Some patients (12 years of age and older) with seasonal allergic rhinitis may find as-needed use of 200 mcg once daily effective for symptom control (see Clinical Trials). Greater symptom control may be achieved with scheduled regular use.
Adolescents and Children (4 Years of Age and Older)
Patients should be started with 100 mcg (1 spray in each nostril once daily). Patients not adequately responding to 100 mcg may use 200 mcg (2 sprays in each nostril). Once adequate control is achieved, the dosage should be decreased to 100 mcg (1 spray in each nostril) daily.
The maximum total daily dosage should not exceed 2 sprays in each nostril (200 mcg/day). (See Individualization of DosageandClinical Trials sections.)
Fluticasone propionate nasal spray is not recommended for children under 4 years of age.
Directions for Use
An illustrated patient leaflet for proper use accompanies each package of fluticasone propionate nasal spray.
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![Naphazoline (Naphazoline Hydrochloride) Solution/ Drops [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=484749dc-5abc-4f55-9e46-ac6b71c81026&name=484749dc-5abc-4f55-9e46-ac6b71c81026-02.jpg)
Naphazoline
Instill one or two drops in the conjunctival sac(s) every three to four hours as needed.
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![Carbidopa And Levodopa Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=4cb3471c-c68f-48f6-a5d0-ebaa2531c0ef&name=4cb3471c-c68f-48f6-a5d0-ebaa2531c0ef-03.jpg)
Carbidopa And Levodopa
The optimum daily dosage of carbidopa and levodopa must be determined by careful titration in each patient. Carbidopa and levodopa tablets are available in a 1:4 ratio of carbidopa to levodopa (carbidopa and levodopa tablets 25 mg/100 mg) as well as 1:10 ratio (carbidopa and levodopa tablets 25 mg/250 mg and carbidopa and levodopa tablets 10 mg/100 mg). Tablets of the two ratios may be given separately or combined as needed to provide the optimum dosage.
Studies show that peripheral dopa decarboxylase is saturated by carbidopa at approximately 70 to 100 mg a day. Patients receiving less than this amount of carbidopa are more likely to experience nausea and vomiting.
Usual Initial Dosage Dosage is best initiated with one tablet of carbidopa and levodopa tablets 25 mg/100 mg three times a day. This dosage schedule provides 75 mg of carbidopa per day. Dosage may be increased by one tablet every day or every other day, as necessary, until a dosage of eight tablets of carbidopa and levodopa tablets 25 mg/100 mg a day is reached.
If carbidopa and levodopa tablets 10 mg/100 mg are used, dosage may be initiated with one tablet three or four times a day. However, this will not provide an adequate amount of carbidopa for many patients. Dosage may be increased by one tablet every day or every other day until a total of eight tablets (2 tablets q.i.d.) is reached.
How to Transfer Patients from Levodopa Levodopa must be discontinued at least twelve hours before starting carbidopa and levodopa tablets. A daily dosage of carbidopa and levodopa should be chosen that will provide approximately 25% of the previous levodopa dosage. Patients who are taking less than 1500 mg of levodopa a day should be started on one tablet of carbidopa and levodopa 25 mg/100 mg three or four times a day. The suggested starting dosage for most patients taking more than 1500 mg of levodopa is one tablet of carbidopa and levodopa 25 mg/250 mg three or four times a day.
Maintenance Therapy should be individualized and adjusted according to the desired therapeutic response. At least 70 to 100 mg of carbidopa per day should be provided. When a greater proportion of carbidopa is required, one tablet of carbidopa and levodopa 25 mg/100 mg may be substituted for each tablet of carbidopa and levodopa 10 mg/100 mg. When more levodopa is required, carbidopa and levodopa tablets 25 mg/250 mg should be substituted for carbidopa and levodopa tablets 25 mg/100 mg or carbidopa and levodopa tablets 10 mg/100 mg. If necessary, the dosage of carbidopa and levodopa tablets 25 mg/250 mg may be increased by one-half or one tablet every day or every other day to a maximum of eight tablets a day. Experience with total daily dosages of carbidopa greater than 200 mg is limited.
Because both therapeutic and adverse responses occur more rapidly with carbidopa and levodopa than with levodopa alone, patients should be monitored closely during the dose adjustment period. Specifically, involuntary movements will occur more rapidly with carbidopa and levodopa than with levodopa. The occurrence of involuntary movements may require dosage reduction. Blepharospasm may be a useful early sign of excess dosage in some patients.
Addition of Other Antiparkinsonian Medications Standard drugs for Parkinson's disease, other than levodopa without a decarboxylase inhibitor, may be used concomitantly while carbidopa and levodopa tablets are being administered, although dosage adjustments may be required.
Interruption of Therapy Sporadic cases of a symptom complex resembling Neuroleptic Malignant Syndrome (NMS) have been associated with dose reductions and withdrawal of carbidopa and levodopa tablets. Patients should be observed carefully if abrupt reduction or discontinuation of carbidopa and levodopa tablets is required, especially if the patient is receiving neuroleptics (See WARNINGS).
If general anesthesia is required, carbidopa and levodopa may be continued as long as the patient is permitted to take fluids and medication by mouth. If therapy is interrupted temporarily, the patient should be observed for symptoms resembling NMS, and the usual daily dosage may be administered as soon as the patient is able to take oral medication.
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![Carvedilol Tablet, Film Coated [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=8da1445a-1d21-4c4f-aa55-da9957bf8cb1&name=cadeb5b8-985a-452a-ad2e-bffaaea94ca9-04.jpg)
Carvedilol
Carvedilol should be taken with food to slow the rate of absorption and reduce the incidence of orthostatic effects.
2.1 Left Ventricular Dysfunction Following Myocardial Infarction:
DOSAGE MUST BE INDIVIDUALIZED AND MONITORED DURING UP-TITRATION. Treatment with carvedilol tablets may be started as an inpatient or outpatient and should be started after the patient is hemodynamically stable and fluid retention has been minimized. It is recommended that carvedilol tablets be started at 6.25 mg twice daily and increased after 3 to 10 days, based on tolerability, to 12.5 mg twice daily, then again to the target dose of 25 mg twice daily. A lower starting dose may be used (3.125 mg twice daily) and/or the rate of up-titration may be slowed if clinically indicated (e.g., due to low blood pressure or heart rate, or fluid retention). Patients should be maintained on lower doses if higher doses are not tolerated. The recommended dosing regimen need not be altered in patients who received treatment with an IV or oral β-blocker during the acute phase of the myocardial infarction.
2.2 Hypertension
DOSAGE MUST BE INDIVIDUALIZED. The recommended starting dose of carvedilol tablets is 6.25 mg twice daily. If this dose is tolerated, using standing systolic pressure measured about 1 hour after dosing as a guide, the dose should be maintained for 7 to 14 days, and then increased to 12.5 mg twice daily if needed, based on trough blood pressure, again using standing systolic pressure one hour after dosing as a guide for tolerance. This dose should also be maintained for 7 to 14 days and can then be adjusted upward to 25 mg twice daily if tolerated and needed. The full antihypertensive effect of carvedilol tablet is seen within 7 to 14 days. Total daily dose should not exceed 50 mg.
Concomitant administration with a diuretic can be expected to produce additive effects and exaggerate the orthostatic component of carvedilol action.
2.3 Hepatic Impairment
Carvedilol tablets should not be given to patients with severe hepatic impairment [see CONTRAINDICATIONS (4)].
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![Tretinoin Cream [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=e0e25674-a9a8-4ad8-98b7-fcadce79d6be&name=e0e25674-a9a8-4ad8-98b7-fcadce79d6be-03.jpg)
Tretinoin
Tretinoin Cream or Tretinoin Gel should be applied once a day, before retiring, to the skin where acne lesions appear, using enough to cover the entire affected area lightly. Gel: Excessive application results in “pilling” of the gel, which minimizes the likelihood of over application by the patient.
Application may cause a transitory feeling of warmth or slight stinging. In cases where it has been necessary to temporarily discontinue therapy or to reduce the frequency of application, therapy may be resumed or frequency of application increased when the patients become able to tolerate the treatment.
Alterations of vehicle, drug concentration, or dose frequency should be closely monitored by careful observation of the clinical therapeutic response and skin tolerance.
During the early weeks of therapy, an apparent exacerbation of inflammatory lesions may occur. This is due to the action of the medication on deep, previously unseen lesions and should not be considered a reason to discontinue therapy.
Therapeutic results should be noticed after two to three weeks but more than six weeks of therapy may be required before definite beneficial effects are seen.
Once the acne lesions have responded satisfactorily, it may be possible to maintain the improvement with less frequent applications, or other dosage forms.
Patients treated with tretinoin acne treatment may use cosmetics, but the area to be treated should be cleansed thoroughly before the medication is applied. (see Precautions:.)
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![Carvedilol Tablet, Film Coated [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=506005f3-d79d-4de1-8bd2-71ade18b8d47&name=cb8b6e75-6865-4f77-924c-147774e15e31-04.jpg)
Carvedilol
Carvedilol should be taken with food to slow the rate of absorption and reduce the incidence of orthostatic effects.
2.1 Left Ventricular Dysfunction Following Myocardial Infarction:
DOSAGE MUST BE INDIVIDUALIZED AND MONITORED DURING UP-TITRATION. Treatment with carvedilol tablets may be started as an inpatient or outpatient and should be started after the patient is hemodynamically stable and fluid retention has been minimized. It is recommended that carvedilol tablets be started at 6.25 mg twice daily and increased after 3 to 10 days, based on tolerability, to 12.5 mg twice daily, then again to the target dose of 25 mg twice daily. A lower starting dose may be used (3.125 mg twice daily) and/or the rate of up-titration may be slowed if clinically indicated (e.g., due to low blood pressure or heart rate, or fluid retention). Patients should be maintained on lower doses if higher doses are not tolerated. The recommended dosing regimen need not be altered in patients who received treatment with an IV or oral β-blocker during the acute phase of the myocardial infarction.
2.2 Hypertension
DOSAGE MUST BE INDIVIDUALIZED. The recommended starting dose of carvedilol tablets is 6.25 mg twice daily. If this dose is tolerated, using standing systolic pressure measured about 1 hour after dosing as a guide, the dose should be maintained for 7 to 14 days, and then increased to 12.5 mg twice daily if needed, based on trough blood pressure, again using standing systolic pressure one hour after dosing as a guide for tolerance. This dose should also be maintained for 7 to 14 days and can then be adjusted upward to 25 mg twice daily if tolerated and needed. The full antihypertensive effect of carvedilol tablet is seen within 7 to 14 days. Total daily dose should not exceed 50 mg.
Concomitant administration with a diuretic can be expected to produce additive effects and exaggerate the orthostatic component of carvedilol action.
2.3 Hepatic Impairment
Carvedilol tablets should not be given to patients with severe hepatic impairment [see CONTRAINDICATIONS (4)].
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![Albuterol Sulfate Syrup [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=cbcc9dbb-5758-4979-b84b-891f3d04f61e&name=1b664106-570f-447e-8a3d-106f4a161a45-02.jpg)
Albuterol Sulfate Syrup
The following dosages of Albuterol Sulfate Syrup are expressed in terms of albuterol base.
Usual Dosage
Adults and Children Over 14 Years of Age: The usual starting dosage for adults and children over 14 years of age is 2 mg (1 teaspoonful) or 4 mg (2 teaspoonfuls) three or four times a day.
Children Over 6 Years to 14 Years of Age: The usual starting dosage for children over 6 years to 14 years of age is 2 mg (1 teaspoonful) three or four times a day.
Children 2 to 5 Years of Age: Dosing in children from 2 to 5 years of age should be initiated at 0.1 mg/kg of body weight three times a day. This starting dosage should not exceed 2 mg (1 teaspoonful) three times a day.
Dosage Adjustment
Adults and Children Over 14 Years of Age: For adults and children over 14 years of age, a dosage above 4 mg four times a day should be used only when the patient fails to respond. If a favorable response does not occur with the 4-mg initial dosage, it should be cautiously increased stepwise up to a maximum of 8 mg four times a day as tolerated.
Children Over 6 Years to 14 Years of Age Who Fail to Respond to the Initial Starting Dosage of 2 mg Four Times a Day: For children from 6 to 14 years of age who fail to respond to the initial starting dosage of 2 mg four times a day, the dosage may be cautiously increased stepwise, but not to exceed 24 mg/day (given in divided doses).
Children 2 to 5 Years of Age Who Do Not Respond Satisfactorily to the Initial Dosage: For children 2 to 5 years of age who do not respond satisfactorily to the initial starting dosage, the dosage may be increased stepwise to 0.2 mg/kg of body weight three times a day, but not to exceed a maximum of 4 mg (2 teaspoonfuls) given three times a day.
Elderly Patients and Those Sensitive to Beta-adrenergic Stimulators: The initial dosage should be restricted to 2 mg three or four times a day and individually adjusted thereafter.
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![Carvedilol Tablet, Film Coated [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=9bab0a6b-8ed4-46e4-8326-2f9e3c87559b&name=ac3d3aa4-c029-468f-a49c-e6a93fc92111-04.jpg)
Carvedilol
Carvedilol should be taken with food to slow the rate of absorption and reduce the incidence of orthostatic effects.
2.1 Left Ventricular Dysfunction Following Myocardial Infarction:
DOSAGE MUST BE INDIVIDUALIZED AND MONITORED DURING UP-TITRATION. Treatment with carvedilol tablets may be started as an inpatient or outpatient and should be started after the patient is hemodynamically stable and fluid retention has been minimized. It is recommended that carvedilol tablets be started at 6.25 mg twice daily and increased after 3 to 10 days, based on tolerability, to 12.5 mg twice daily, then again to the target dose of 25 mg twice daily. A lower starting dose may be used (3.125 mg twice daily) and/or the rate of up-titration may be slowed if clinically indicated (e.g., due to low blood pressure or heart rate, or fluid retention). Patients should be maintained on lower doses if higher doses are not tolerated. The recommended dosing regimen need not be altered in patients who received treatment with an IV or oral β-blocker during the acute phase of the myocardial infarction.
2.2 Hypertension
DOSAGE MUST BE INDIVIDUALIZED. The recommended starting dose of carvedilol tablets is 6.25 mg twice daily. If this dose is tolerated, using standing systolic pressure measured about 1 hour after dosing as a guide, the dose should be maintained for 7 to 14 days, and then increased to 12.5 mg twice daily if needed, based on trough blood pressure, again using standing systolic pressure one hour after dosing as a guide for tolerance. This dose should also be maintained for 7 to 14 days and can then be adjusted upward to 25 mg twice daily if tolerated and needed. The full antihypertensive effect of carvedilol tablet is seen within 7 to 14 days. Total daily dose should not exceed 50 mg.
Concomitant administration with a diuretic can be expected to produce additive effects and exaggerate the orthostatic component of carvedilol action.
2.3 Hepatic Impairment
Carvedilol tablets should not be given to patients with severe hepatic impairment [see CONTRAINDICATIONS (4)].
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![Baclofen Tablet [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=b78e1bca-1976-44cc-939f-7532a3a79bc1&name=250c440d-9148-4fdf-81af-48544b20e3c0-02.jpg)
Baclofen
The determination of optimal dosage requires individual titration. Start therapy at a low dosage and increase gradually until optimum effect is achieved (usually between 40-80 mg daily).
The following dosage titration schedule is suggested:
5 mg t.i.d. for 3 days
10 mg t.i.d. for 3 days
15 mg t.i.d. for 3 days
20 mg t.i.d. for 3 days
Thereafter additional increases may be necessary but the total daily dose should not exceed a maximum of 80 mg daily (20 mg q.i.d.).
The lowest dose compatible with an optimal response is recommended. If benefits are not evident after a reasonable trial period, patients should be slowly withdrawn from the drug (see WARNINGSAbrupt Drug Withdrawal ).
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![Bacitracin Ointment [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=5b75944b-f0cb-4ba6-b1b2-bb8dd0114cd9&name=b84d8603-9f8d-47c9-bb3c-be0834e821fe-01.jpg)
Bacitracin Ointment
• clean the affected area • apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily • may be covered with a sterile bandage
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![Miconazole 7 (Miconazole Nitrate) Cream [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=f9f553cd-84b9-40ab-9756-e80670faf8c9&name=af34793c-3492-4b25-b33e-a27f7e20ebdb-01.jpg)
Miconazole 7
•before using this product read the enclosed brochure for complete instructions • adults and children 12 years of age and over: • applicator: insert one applicatorful into the vagina at bedtime for 7 days in a row. Wash applicator after each use. • external cream: squeeze a small amount of cream onto your fingertip. Gently apply the cream onto the itchy, irritated skin outside the vagina. Use 2 times daily for up to 7 days as needed. • children under 12 years: ask a doctor
Other Information
• do not use if seal over tube opening has been punctured or cannot be seen• store at room temperature 15°-30°C (59°-86°F). Avoid heat over 30°C or 86°F.
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![Junior Acetaminophen (Acetaminophen) Tablet, Chewable [Supervalu Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=4a728c5e-0de6-4f05-b293-5d7799b7edf1&name=2d1a76c4-5e84-4245-a6d5-cbf88951c9de-02.jpg)
Junior Acetaminophen
For Oral Administration:
The initial dose varies from 0.75 to 9 mg a day depending on the disease being treated.
IT SHOULD BE EMPHASIZED THAT DOSAGE REQUIREMENTS ARE VARIABLE AND MUST BE INDIVIDUALIZED ON THE BASIS OF THE DISEASE UNDER TREATMENT AND THE RESPONSE OF THE PATIENT.
After a favorable initial response is noted, the proper maintenance dosage should be determined by decreasing the initial dosage in small decrements at appropriate time intervals until the lowest dosage that maintains an adequate clinical response is reached.
Situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient's individual drug responsiveness, and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment. In this latter situation it may be necessary to increase the dosage of the corticosteroid for a period of time consistent with the patient's condition. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.
In the treatment of acute exacerbations of multiple sclerosis, daily doses of 30 mg of dexamethasone for a week followed by 4 to 12 mg every other day for one month have been shown to be effective (see PRECAUTIONS: Neuro-Psychiatric).
In pediatric patients, the initial dose of dexamethasone may vary depending on the specific disease entity being treated. The range of initial doses is 0.02 to 0.3 mg/kg/day in three or four divided doses (0.6 to 9 mg/m2bsa/day).
For the purpose of comparison, the following is the equivalent milligram dosage of the various corticosteroids:
Cortisone, 25
Triamcinolone, 4
Hydrocortisone, 20
Paramethasone, 2
Prednisolone, 5
Betamethasone, 0.75
Prednisone, 5
Dexamethasone, 0.75
Methylprednisolone, 4
These dose relationships apply only to oral or intravenous administration of these compounds. When these substances or their derivatives are injected intramuscularly or into joint spaces, their relative properties may be greatly altered.
In acute, self-limited allergic disorders or acute exacerbations of chronic allergic disorders, the following dosage schedule combining parenteral and oral therapy is suggested:
Dexamethasone Sodium Phosphate injection, 4 mg per mL:
First Day
1 or 2 mL, intramuscularly
Dexamethasone tablets, 0.75 mg:
Second Day
4 tablets in two divided doses
Third Day
4 tablets in two divided doses
Fourth Day
2 tablets in two divided doses
Fifth Day
1 tablet
Sixth Day
1 tablet
Seventh Day
No treatment
Eighth Day
Follow-up visit
This schedule is designed to ensure adequate therapy during acute episodes, while minimizing the risk of overdosage in chronic cases.
In cerebral edema, dexamethasone sodium phosphate injection is generally administered initially in a dosage of 10 mg intravenously followed by 4 mg every six hours intramuscularly until the symptoms of cerebral edema subside. Response is usually noted within 12 to 24 hours and dosage may be reduced after two to four days and gradually discontinued over a period of five to seven days. For palliative management of patients with recurrent or inoperable brain tumors, maintenance therapy with either dexamethasone sodium phosphate injection or dexamethasone tablets in a dosage of 2 mg two or three times daily may be effective.
Dexamethasone Suppression Tests
Tests for Cushing’s syndrome
1. Give 1.0 mg of dexamethasone orally at 11:00 p.m. Blood is drawn for plasma cortisol determination at 8:00 a.m. the following morning. For greater accuracy, give 0.5 mg of dexamethasone orally every 6 hours for 48 hours. Twenty-four hour urine collections are made for determination of 17-hydroxycorticosteroid excretion. 2. Test to distinguish Cushing’s syndrome due to pituitary ACTH excess from Cushing’s syndrome due to other causes. Give 2.0 mg of dexamethasone orally every 6 hours for 48 hours. Twenty-four hour urine collections are made for determination of 17-hydroxycorticosteroid excretion. -
![Atenolol And Chlorthalidone Tablet [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=e5929809-f517-4383-a754-ba8afc00e5c4&name=7b791688-d32a-429c-886e-ffbe57ac0733-03.jpg)
Atenolol And Chlorthalidone
DOSAGE MUST BE INDIVIDUALIZED (SEEINDICATIONS AND USAGE): Chlorthalidone is usually given at a dose of 25 mg daily; the usual initial dose of atenolol is 50 mg daily. Therefore, the initial dose should be one atenolol and chlorthalidone 50 mg-25 mg tablet given once a day. If an optimal response is not achieved, the dosage should be increased to one atenolol and chlorthalidone 100 mg-25 mg tablet given once a day.
When necessary, another antihypertensive agent may be added gradually beginning with 50% of the usual recommended starting dose to avoid an excessive fall in blood pressure.
Since atenolol is excreted via the kidneys, dosage should be adjusted in cases of severe impairment of renal function. No significant accumulation of atenolol occurs until creatinine clearance falls below 35 mL/min/1.73 m2 (normal range is 100-150 mL/min/1.73 m2); therefore, the following maximum dosages are recommended for patients with renal impairment.
Creatinine Clearance Atenolol Elimination (mL/min/1.73 m2) Half-life (hrs) Maximum Dosage 15-35 16-27 50 mg daily <15 >27 50 mg every other day -
![Nitrostat (Nitroglycerin) Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=8c5eb53a-841e-4ee8-acd1-fb4b33460613&name=nitrostat-05.jpg)
Nitrostat
One tablet should be dissolved under the tongue or in the buccal pouch at the first sign of an acute anginal attack. The dose may be repeated approximately every 5 minutes until relief is obtained. If the pain persists after a total of 3 tablets in a 15-minute period, or if the pain is different than is typically experienced, prompt medical attention is recommended. NITROSTAT may be used prophylactically 5 to 10 minutes prior to engaging in activities that might precipitate an acute attack.
During administration the patient should rest, preferably in the sitting position.
No dosage adjustment is required in patients with renal failure.
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![Penicillin V Potassium Powder, For Solution [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=8c342c78-47fb-4f6b-9451-68b1f752555c&name=0fadc788-fdd8-4bfe-b518-e5892a553615-02.jpg)
Penicillin V Potassium
The dosage of penicillin V potassium tablets and penicillin V potassium for oral solution should be determined according to the sensitivity of the causative microorganisms and the severity of infection, and adjusted to the clinical response of the patient.
The usual dosage recommendations for adults and children 12 years and over are as follows:
Streptococcal infections—mild to moderately severe—of the upper respiratory tract and including scarlet fever and erysipelas: 125 to 250 mg (200,000 to 400,000 units) every 6 to 8 hours for 10 days.
Pneumococcal infections—mild to moderately severe—of the respiratory tract, including otitis media: 250 to 500 mg (400,000 to 800,000 units) every 6 hours until the patient has been afebrile for at least 2 days.
Staphylococcal infections—mild infections of skin and soft tissue (culture and sensitivity tests should be performed): 250 to 500 mg (400,000 to 800,000 units) every 6 to 8 hours.
Fusospirochetosis (Vincent’s infection) of the oropharynx. Mild to moderately severe infections: 250 to 500 mg (400,000 to 800,000 units) every 6 to 8 hours.
For the prevention of recurrence following rheumatic fever and/or chorea: 125 to 250 mg (200,000 to 400,000 units) twice daily on a continuing basis.
For prophylaxis against bacterial endocarditis1 in patients with congenital heart disease or rheumatic or other acquired valvular heart disease when undergoing dental procedures or surgical procedures of the upper respiratory tract: 2 gram of penicillin V (1 gram for children under 60 lbs.) 1 hour before the procedure, and then, 1 gram (500 mg for children under 60 lbs) 6 hours later.
Directions for Mixing Oral Solution
Do not add water until you dispense. When dispensing, slowly add the total amount of water for reconstitution (see table below). After partially filling bottle, replace cap and shake vigorously. Add remaining water and repeat shaking. After reconstitution, solution must be stored in a refrigerator. Discard any unused portion after 14 days.
125 mg/5 mL Bottle size Total Amount of Water Required for Reconstitution 100 mL 75 mL 200 mL 150 mL The resulting solution (red in color) will contain penicillin V potassium equivalent to penicillin V 125 mg (200,000 units) in each 5 mL (teaspoonful). 250 mg/5 mL Bottle size Total Amount of Water Required for Reconstitution 100 mL 75 mL 200 mL 150 mL The resulting solution (red in color) will contain penicillin V potassium equivalent to penicillin V 250 mg (400,000 units) in each 5 mL (teaspoonful). -
![Azithromycin Tablet, Film Coated [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=57160dd7-1f61-42de-9e87-ded819bb6bdb&name=98c45385-6138-44d6-92ae-c744540369cd-01.jpg)
Azithromycin
(See INDICATIONS AND USAGE and CLINICAL PHARMACOLOGY.)
Adults:
Infection* Recommended Dose/Duration of Therapy Community-acquired pneumonia (mild severity) Pharyngitis/tonsillitis (second line therapy) Skin/skin structure (uncomplicated) 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial exacerbations of chronic obstructive pulmonary disease (mild to moderate) 500 mg QD x 3 days OR 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial sinusitis 500 mg QD x 3 days Genital ulcer disease (chancroid) One single 1 gram dose Non-gonoccocal urethritis and cervicitis One single 1 gram dose Gonococcal urethritis and cervicitis One single 2 gram dose* DUE TO THE INDICATED ORGANISMS (See INDICATIONS AND USAGE.)Azithromycin tablets can be taken with or without food.
Renal Insufficiency:
No dosage adjustment is recommended for subjects with renal impairment (GFR ≤80 mL/min). The mean AUC0-120 was similar in subjects with GFR 10-80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR <10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency.)
Hepatic Insufficiency:
The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (See CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency.)
No dosage adjustment is recommended based on age or gender. (See CLINICAL PHARMACOLOGY, Special Populations.)
Pediatric Patients:
Azithromycin for oral suspension can be taken with or without food.
Acute Otitis Media: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.)
Acute bacterial Sinusitis: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days.(See chart below.)
Community-Acquired Pneumonia: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA,ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS-Pediatric Use.) Based on Body Weight OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5-Day Regimen)*Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5. Weight 100 mg/5 mL 200 mg/5 mL Total mL per Treatment Course Total mg per Treatment Course Kg Lbs. Day 1 Days 2-5 Day 1 Days 2-5 5 11 2.5 mL (½ tsp) 1.25 mL (¼ tsp) 7.5 mL 150 mg 10 22 5 mL (1 tsp) 2.5 mL (½ tsp) 15 mL 300 mg 20 44 5 mL (1 tsp) 2.5 mL (½ tsp) 15 mL 600 mg 30 66 7.5 mL (1½ tsp) 3.75 mL (3/4tsp) 22.5 mL 900 mg 40 88 10 mL (2 tsp) 5 mL (1tsp) 30 mL 1200 mg 50 and above 12.5 mL (2 ½ tsp) 6.25 mL (1¼ tsp) 37.5 mL 1500 mg*Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established.
OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)*Dosing Calculated on 10 mg/kg/day Day 1. Weight 100 mg/5 mL 200 mg/5 mL Total mL per Treatment Course Total mg per Treatment Course Kg Lbs. Day 1-3 Day 1-3 5 11 2.5 mL (½ tsp) 7.5 mL 150 mg 10 22 5 mL (1 tsp) 15 mL 300 mg 20 44 5 mL (1 tsp) 15 mL 600 mg 30 66 7.5 mL (1½ tsp) 22.5 mL 900 mg 40 88 10 mL (2 tsp) 30 mL 1200 mg 50 and above 110 and above 12.5 mL (2 ½ tsp ) 37.5 mL 1500 mg*Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established.
OTITIS MEDIA : (1-Day Regimen)Dosing Calculated on 30 mg/kg as a single dose Weight 200 mg/5 mL Total mL per Treatment course Total mg per Treatment course Kg Lbs. Day1 5 11 3.75 mL (3/4 tsp) 3.75 mL 150 mg 10 22 7.5 mL (1½ tsp) 7.5 mL 300 mg 20 44 15 mL (3 tsp) 15 mL 600 mg 30 66 22.5 mL (4 ½ tsp) 22.5 mL 900 mg 40 88 30 mL (6tsp) 30 mL 1200 mg 50 and above 110 and above 37.5 mL (7½ tsp) 37.5 mL 1500 mgThe safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/Tonsillitis:
The recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS /TONSILLITIS(Age 2 years and above, see PRECAUTIONS-Pediatric Use.)Based on Body weight
PHARYNGITIS/TONSILITIS: (5-Day Regimen)Dosing Calculated on 12 mg/kg/day for 5 days Weight 200mg/5mL Total mL per Treatment course Total mg per Treatment course Kg Lbs. Day 1-5 8 18 2.5 mL (½ tsp) 12.5 mL 500 mg 17 37 5 mL (1 tsp) 25 mL 1000 mg 25 55 7.5 mL (1 ½ tsp) 37.5 mL 1500 mg 33 73 10 mL (2 tsp) 50 mL 2000 mg 40 88 12.5 mL (2 ½ tsp) 62.5 mL 2500 mgAdults:
Infection* Recommended Dose/Duration of Therapy Community-acquired pneumonia (mild severity) Pharyngitis/tonsillitis (second line therapy) Skin/skin structure (uncomplicated) 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial exacerbations of chronic obstructive pulmonary disease (mild to moderate) 500 mg QD x 3 days OR 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial sinusitis 500 mg QD x 3 days Genital ulcer disease (chancroid) One single 1 gram dose Non-gonoccocal urethritis and cervicitis One single 1 gram dose Gonococcal urethritis and cervicitis One single 2 gram dose* DUE TO THE INDICATED ORGANISMS (See INDICATIONS AND USAGE.)Azithromycin tablets can be taken with or without food.
Renal Insufficiency:
No dosage adjustment is recommended for subjects with renal impairment (GFR ≤80 mL/min). The mean AUC0-120 was similar in subjects with GFR 10-80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR <10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency.)
Hepatic Insufficiency:
The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (See CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency.)
No dosage adjustment is recommended based on age or gender. (See CLINICAL PHARMACOLOGY, Special Populations.)
Pediatric Patients:
Azithromycin for oral suspension can be taken with or without food.
Acute Otitis Media: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.)
Acute bacterial Sinusitis: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days.(See chart below.)
Community-Acquired Pneumonia: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA,ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS-Pediatric Use.) Based on Body Weight OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5-Day Regimen)*Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5. Weight 100 mg/5 mL 200 mg/5 mL Total mL per Treatment Course Total mg per Treatment Course Kg Lbs. Day 1 Days 2-5 Day 1 Days 2-5 5 11 2.5 mL (½ tsp) 1.25 mL (¼ tsp) 7.5 mL 150 mg 10 22 5 mL (1 tsp) 2.5 mL (½ tsp) 15 mL 300 mg 20 44 5 mL (1 tsp) 2.5 mL (½ tsp) 15 mL 600 mg 30 66 7.5 mL (1½ tsp) 3.75 mL (3/4tsp) 22.5 mL 900 mg 40 88 10 mL (2 tsp) 5 mL (1tsp) 30 mL 1200 mg 50 and above 12.5 mL (2 ½ tsp) 6.25 mL (1¼ tsp) 37.5 mL 1500 mg*Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established.
OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)*Dosing Calculated on 10 mg/kg/day Day 1. Weight 100 mg/5 mL 200 mg/5 mL Total mL per Treatment Course Total mg per Treatment Course Kg Lbs. Day 1-3 Day 1-3 5 11 2.5 mL (½ tsp) 7.5 mL 150 mg 10 22 5 mL (1 tsp) 15 mL 300 mg 20 44 5 mL (1 tsp) 15 mL 600 mg 30 66 7.5 mL (1½ tsp) 22.5 mL 900 mg 40 88 10 mL (2 tsp) 30 mL 1200 mg 50 and above 110 and above 12.5 mL (2 ½ tsp ) 37.5 mL 1500 mg*Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established.
OTITIS MEDIA : (1-Day Regimen)Dosing Calculated on 30 mg/kg as a single dose Weight 200 mg/5 mL Total mL per Treatment course Total mg per Treatment course Kg Lbs. Day1 5 11 3.75 mL (3/4 tsp) 3.75 mL 150 mg 10 22 7.5 mL (1½ tsp) 7.5 mL 300 mg 20 44 15 mL (3 tsp) 15 mL 600 mg 30 66 22.5 mL (4 ½ tsp) 22.5 mL 900 mg 40 88 30 mL (6tsp) 30 mL 1200 mg 50 and above 110 and above 37.5 mL (7½ tsp) 37.5 mL 1500 mgThe safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/Tonsillitis:
The recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS /TONSILLITIS(Age 2 years and above, see PRECAUTIONS-Pediatric Use.)Based on Body weight
PHARYNGITIS/TONSILITIS: (5-Day Regimen)Dosing Calculated on 12 mg/kg/day for 5 days Weight 200mg/5mL Total mL per Treatment course Total mg per Treatment course Kg Lbs. Day 1-5 8 18 2.5 mL (½ tsp) 12.5 mL 500 mg 17 37 5 mL (1 tsp) 25 mL 1000 mg 25 55 7.5 mL (1 ½ tsp) 37.5 mL 1500 mg 33 73 10 mL (2 tsp) 50 mL 2000 mg 40 88 12.5 mL (2 ½ tsp) 62.5 mL 2500 mg -
![Sodium Citrate And Citric Acid (Sodium Citrate And Citric Acid Monohydrate) Solution [Cardinal Health]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=ad232149-329c-4f3d-b1c9-b34975a428fb&name=image-01.jpg)
Sodium Citrate And Citric Acid
• use enclosed dosage cup to accurately measure dosage as noted below • drink plenty of clear fluids to help prevent dehydration, which may accompany diarrhea • find right dose on chart. If possible, use weight to dose; otherwise, use age.
adults and children 12 years and older
4 teaspoonfuls (1 dosage cup) after the first loose bowel movement; 2 teaspoonfuls (1/2 dosage cup) after each subsequent loose bowel movement; but no more than 8 teaspoonfuls a day
children 9-11 years (60-95 lbs)
2 teaspoonfuls (1/2 dosage cup) after the first loose bowel movement; 1 teaspoonful (1/4 dosage cup) after each subsequent loose bowel movement; but no more than 6 teaspoonfuls a day
children 6-8 years (48-59 lbs)
2 teaspoonfuls (1/2 dosage cup) after the first loose bowel movement; 1 teaspoonful (1/4 dosage cup) after each subsequent loose bowel movement; but no more than 4 teaspoonfuls a day
children under 6 years (up to 47 lbs)
ask a doctor (not intended for use in children under 6 years old)
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![Tetracaine Hydrochloride Solution [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=65c195b1-db3e-4e8f-9d97-fa88d615c6dd&name=65c195b1-db3e-4e8f-9d97-fa88d615c6dd-03.jpg)
Tetracaine Hydrochloride Solution
For tonometry and other procedures of short duration, instill one or two drops just prior to evaluation. For minor surgical procedures such as foreign body or suture removal, administer one to two drops every five to ten minutes for one to three instillations. For prolonged anesthesia as in cataract extraction, instill one or two drops in the eye(s) every five to ten minutes for three to five doses.
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![Minocycline Hydrochloride Capsule [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=745c4530-32f7-47a8-8e4b-56cb64211d89&name=label100mg50count.jpg)
Minocycline Hydrochloride
THE USUAL DOSAGE AND FREQUENCY OF ADMINISTRATION OF MINOCYCLINE DIFFERS FROM THAT OF THE OTHER TETRACYCLINES. EXCEEDING THE RECOMMENDED DOSAGE MAY RESULT IN AN INCREASED INCIDENCE OF SIDE EFFECTS.
Minocycline hydrochloride capsules may be taken with or without food (see CLINICAL PHARMACOLOGY).
Ingestion of adequate amounts of fluids along with capsule and tablet forms of drugs in the tetracycline-class is recommended to reduce the risk of esophageal irritation and ulceration. The capsules should be swallowed whole.
For Pediatric Patients Above 8 Years of Age
Usual pediatric dose: 4 mg/kg initially followed by 2 mg/kg every 12 hours, not to exceed the usual adult dose.
Adults
The usual dosage of minocycline hydrochloride capsules is 200 mg initially followed by 100 mg every 12 hours. Alternatively, if more frequent doses are preferred, two or four 50 mg capsules may be given initially followed by one 50 mg capsule 4 times daily.
Uncomplicated gonococcal infections other than urethritis and anorectal infections in men: 200 mg initially, followed by 100 mg every 12 hours for a minimum of 4 days, with post-therapy cultures within 2 to 3 days.
In the treatment of uncomplicated gonococcal urethritis in men, 100 mg every 12 hours for 5 days is recommended.
For the treatment of syphilis, the usual dosage of minocycline hydrochloride should be administered over a period of 10 to 15 days. Close follow-up, including laboratory tests, is recommended.
In the treatment of meningococcal carrier state, the recommended dosage is 100 mg every 12 hours for 5 days.
Mycobacterium marinum infections: Although optimal doses have not been established, 100 mg every 12 hours for 6 to 8 weeks have been used successfully in a limited number of cases.
Uncomplicated urethral, endocervical, or rectal infection in adults caused by Chlamydia trachomatis or Ureaplasma urealyticum: 100 mg orally, every 12 hours for at least 7 days.
Ingestion of adequate amounts of fluids along with capsule and tablet forms of drugs in the tetracycline-class is recommended to reduce the risk of esophageal irritation and ulceration.
The pharmacokinetics of minocycline in patients with renal impairment (CLCR < 80mL/min) have not been fully characterized. Current data are insufficient to determine if a dosage adjustment is warranted. The total daily dosage should not exceed 200 mg in 24 hours. However, due to the anti-anabolic effect of tetracyclines, BUN and creatinine should be monitored (see WARNINGS).
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![Atenolol And Chlorthalidone Tablet [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=1e528336-c1a6-4657-96a6-5eb5121e757b&name=08ec739b-77c2-492d-bce4-f5178455c657-03.jpg)
Atenolol And Chlorthalidone
DOSAGE MUST BE INDIVIDUALIZED (SEEINDICATIONS AND USAGE): Chlorthalidone is usually given at a dose of 25 mg daily; the usual initial dose of atenolol is 50 mg daily. Therefore, the initial dose should be one atenolol and chlorthalidone 50 mg-25 mg tablet given once a day. If an optimal response is not achieved, the dosage should be increased to one atenolol and chlorthalidone 100 mg-25 mg tablet given once a day.
When necessary, another antihypertensive agent may be added gradually beginning with 50% of the usual recommended starting dose to avoid an excessive fall in blood pressure.
Since atenolol is excreted via the kidneys, dosage should be adjusted in cases of severe impairment of renal function. No significant accumulation of atenolol occurs until creatinine clearance falls below 35 mL/min/1.73 m2 (normal range is 100-150 mL/min/1.73 m2); therefore, the following maximum dosages are recommended for patients with renal impairment.
Creatinine Clearance Atenolol Elimination (mL/min/1.73 m2) Half-life (hrs) Maximum Dosage 15-35 16-27 50 mg daily <15 >27 50 mg every other day -
![Captopril (Captorpil) Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=9f7dae34-0112-4c11-b032-4f951e139705&name=eb4f916b-e9ef-4230-ad94-050985d2fca5-02.jpg)
Captopril
Captopril tablets should be taken one hour before meals. Dosage must be individualized.
Hypertension : Initiation of therapy requires consideration of recent antihypertensive drug treatment, the extent of blood pressure elevation, salt restriction, and other clinical circumstances. If possible, discontinue the patient's previous antihypertensive drug regimen for one week before starting captopril.
The initial dose of captopril tablets, USP is 25 mg b.i.d. or t.i.d. If satisfactory reduction of blood pressure has not been achieved after one or two weeks, the dose may be increased to 50 mg b.i.d. or t.i.d. Concomitant sodium restriction may be beneficial when captopril is used alone.
The dose of captopril in hypertension usually does not exceed 50 mg t.i.d. Therefore, if the blood pressure has not been satisfactorily controlled after one to two weeks at this dose, (and the patient is not already receiving a diuretic), a modest dose of thiazide-type diuretic (e.g., hydrochlorothiazide, 25 mg daily), should be added. The diuretic dose may be increased at one- to two-week intervals until its highest usual antihypertensive dose is reached.
If captopril is being started in a patient already receiving a diuretic, captopril therapy should be initiated under close medical supervision (seeWARNINGS and PRECAUTIONS: Drug Interactions regarding hypotension), with dosage and titration of captopril as noted above.
If further blood pressure reduction is required, the dose of captopril may be increased to 100 mg b.i.d. or t.i.d. and then, if necessary, to 150 mg b.i.d. or t.i.d . (while continuing the diuretic). The usual dose range is 25 to 150 mg b.i.d. or t.i.d. A maximum daily dose of 450 mg captopril should not be exceeded.
For patients with severe hypertension (e.g., accelerated or malignant hypertension), when temporary discontinuation of current antihypertensive therapy is not practical or desirable, or when prompt titration to more normotensive blood pressure levels is indicated, diuretic should be continued but other current antihypertensive medication stopped and captopril dosage promptly initiated at 25 mg b.i.d. or t.i.d., under close medical supervision.
When necessitated by the patient's clinical condition, the daily dose of captopril may be increased every 24 hours or less under continuous medical supervision until a satisfactory blood pressure response is obtained or the maximum dose of captopril is reached. In this regimen, addition of a more potent diuretic, e.g., furosemide, may also be indicated.
Beta-blockers may also be used in conjunction with captopril therapy (seePRECAUTIONS: Drug Interactions), but the effects of the two drugs are less than additive.
Heart Failure : Initiation of therapy requires consideration of recent diuretic therapy and the possibility of severe salt/volume depletion. In patients with either normal or low blood pressure, who have been vigorously treated with diuretics and who may be hyponatremic and/or hypovolemic, a starting dose of 6.25 or 12.5 mg t.i.d. may minimize the magnitude or duration of the hypotensive effect (see WARNINGS: Hypotension); for these patients, titration to the usual daily dosage can then occur within the next several days.
For most patients the usual initial daily dosage is 25 mg t.i.d. After a dose of 50 mg t.i.d. is reached, further increases in dosage should be delayed, where possible, for at least two weeks to determine if a satisfactory response occurs. Most patients studied have had a satisfactory clinical improvement at 50 or 100 mg t.i.d. A maximum daily dose of 450 mg of captopril should not be exceeded.
Captopril should generally be used in conjunction with a diuretic and digitalis.
Captopril therapy must be initiated under very close medical supervision.
Left Ventricular Dysfunction After Myocardial Infarction : The recommended dose for long-term use in patients following a myocardial infarction is a target maintenance dose of 50 mg t.i.d.
Therapy may be initiated as early as three days following a myocardial infarction. After a single dose of 6.25 mg, captopril tablets therapy should be initiated at 12.5 mg t.i.d. Captopril tablets should then be increased to 25 mg t.i.d. during the next several days and to a target dose of 50 mg t.i.d. over the next several weeks as tolerated (seeCLINICAL PHARMACOLOGY).
Captopril tablets may be used in patients treated with other post-myocardial infarction therapies, e.g. thrombolytics, aspirin, beta blockers.
Diabetic Nephropathy: The recommended dose of captopril tablets for long term use to treat diabetic nephropathy is 25 mg t.i.d.
Other antihypertensives such as diuretics, beta blockers, centrally acting agents or vasodilators may be used in conjuction with captopril tablets if additional therapy is required to further lower blood pressure.
Dosage Adjustment in Renal Impairment : Because captopril is excreted primarily by the kidneys, excretion rates are reduced in patients with impaired renal function. These patients will take longer to reach steady-state captopril levels and will reach higher steady-state levels for a given daily dose than patients with normal renal function. Therefore, these patients may respond to smaller or less frequent doses.
Accordingly, for patients with significant renal impairment, initial daily dosage of captopril should be reduced, and smaller increments utilized for titration, which should be quite slow (one- to two-week intervals). After the desired therapeutic effect has been achieved, the dose should be slowly back titrated to determine the minimal effective dose. When concomitant diuretic therapy is required, a loop diuretic (e.g., furosemide), rather than a thiazide diuretic, is preferred in patients with severe renal impairment. (SeeWARNINGS: Anaphylactoid reactions during membrane exposure and PRECAUTIONS: Hemodialysis.)
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![Betamethasone Dipropionate Cream [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=e882d315-5a04-4132-b311-a7750354bb8a&name=7c48d641-23ee-456d-9eac-e093aa33ae04-03.jpg)
Betamethasone Dipropionate
Apply a thin film of betamethasone dipropionate cream, 0.05% (augmented) to the affected skin areas once or twice daily. Treatment with betamethasone dipropionate cream, 0.05% (augmented) should be limited to 45 g per week.
Betamethasone dipropionate cream, 0.05% (augmented) is not to be used with occlusive dressings.
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![Betamethasone Dipropionate Ointment [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=686fc300-7cc6-4901-9640-ae60abb7c4de&name=333f374f-e0f9-4ac7-8f03-ae1fcc86d79c-02.jpg)
Betamethasone Dipropionate Ointment
Apply a thin film of Betamethasone Dipropionate Ointment 0.05% to the affected skin areas once daily. In some cases, a twice-daily dosage may be necessary.
Betamethasone Dipropionate Ointment is not to be used with occlusive dressings.
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![Lansoprazole Capsule, Delayed Release [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=c7d02978-a24a-4322-ac5c-0bc9525fc40d&name=c7d02978-a24a-4322-ac5c-0bc9525fc40d-04.jpg)
Lansoprazole
Lansoprazole delayed-release capsules are available in 15 mg and 30 mg strengths. Directions for use specific to the route and available methods of administration for each of these dosage forms are presented below. Lansoprazole delayed-release capsules should be taken before eating. Lansoprazole delayed-release capsules SHOULD NOT BE CRUSHED OR CHEWED. In the clinical trials, antacids were used concomitantly with lansoprazole.
2.1 Recommended Dose
*Please refer to amoxicillin and clarithromycin full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally-impaired patients.
†Controlled studies did not extend beyond indicated duration.
‡For patients who do not heal with lansoprazole for 8 weeks (5 to 10%), it may be helpful to give an additional 8 weeks of treatment. If there is a recurrence of erosive esophagitis, an additional 8 week course of lansoprazole may be considered.
§The lansoprazole dose was increased (up to 30 mg twice daily) in some pediatric patients after 2 or more weeks of treatment if they remained symptomatic. For pediatric patients unable to swallow an intact capsule please see Administration Options.
¶Varies with individual patient. Recommended adult starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Dosages up to 90 mg twice daily have been administered. Daily dose of greater than 120 mg should be administered in divided doses. Some patients with Zollinger-Ellison Syndrome have been treated continuously with lansoprazole for more than 4 years.
Indication Recommended Dose Frequency Duodenal Ulcers Short-Term Treatment 15 mg Once daily for 4 weeks Maintenance of Healed 15 mg Once daily H. pylori Eradication toReduce the Risk of Duodenal Ulcer Recurrence* Triple Therapy: Lansoprazole 30 mg Twice daily (q12h) for 10 or 14 days Amoxicillin 1 gram Twice daily (q12h) for 10 or 14 days Clarithromycin 500 mg Twice daily (q12h) for 10 or 14 days Dual Therapy: Lansoprazole 30 mg Three times daily (q8h) for 14 days Amoxicillin 1 gram Three times daily (q8h) for 14 days Benign Gastric Ulcer Short-Term Treatment 30 mg Once daily for up to 8 weeks NSAID-associated Gastric Ulcer Healing 30 mg Once daily for 8 weeks† Risk Reduction 15 mg Once daily for up to 12 weeks† Gastroesophageal Reflux Disease (GERD) Short-Term Treatment of Symptomatic GERD 15 mg Once daily for up to 8 weeks Short-Term Treatment of Erosive Esophagitis 30 mg Once daily for up to 8 weeks‡ Pediatric (1 to 11 years of age) Short-Term Treatment of Symptomatic GERD and Short-Term Treatment of Erosive Esophagitis ≤ 30 kg 15 mg Once daily for up to 12 weeks§ > 30 kg 30 mg Once daily for up to 12 weeks§ (12 to 17 years of age) Short-Term Treatment of Symptomatic GERD Nonerosive GERD 15 mg Once daily for up to 8 weeks Erosive Esophagitis 30 mg Once daily for up to 8 weeks Maintenance of Healing of Erosive Esophagitis 15 mg Once daily Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome 60 mg Once daily¶Patients should be instructed that if a dose is missed, it should be taken as soon as possible. However, if the next scheduled dose is due, the patient should not take the missed dose, and should be instructed to take the next dose on time. Patients should be instructed not to take 2 doses at one time to make up for a missed dose.
2.2 Special Populations
Renal impairment patients and geriatric patients do not require dosage adjustment. However, consider dose adjustment in patients with severe liver impairment [see Use in Specific Populations (8.5, 8.6 and 8.7)].
2.3 Important Administration Information
Administration Options
Lansoprazole Delayed-Release Capsules – Oral Administration
Lansoprazole delayed-release capsules should be swallowed whole. Alternatively, for patients who have difficulty swallowing capsules, lansoprazole delayed-release capsules can be opened and administered as follows:o Open capsule.
o Sprinkle intact granules on one tablespoon of either applesauce, ENSURE pudding, cottage cheese, yogurt or strained pears.
o Swallow immediately.
Lansoprazole delayed-release capsules may also be emptied into a small volume of either apple juice, orange juice or tomato juice and administered as follows:o Open capsule.
o Sprinkle intact granules into a small volume of either apple juice, orange juice or tomato juice (60 mL – approximately 2 ounces).
o Mix briefly.
o Swallow immediately.
o To ensure complete delivery of the dose, the glass should be rinsed with two or more volumes of juice and the contents swallowed immediately.
Lansoprazole Delayed-Release Capsules – Nasogastric Tube (≥16 French) Administration
For patients who have a nasogastric tube in place, lansoprazole delayed-release capsules can be administered as follows:o Open capsule.
o Mix intact granules into 40 mL of apple juice. DO NOT USE OTHER LIQUIDS.
o Inject through the nasogastric tube into the stomach.
o Flush with additional apple juice to clear the tube.
USE IN OTHER FOODS AND LIQUIDS HAS NOT BEEN STUDIED CLINICALLY AND IS THEREFORE NOT RECOMMENDED.
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![Lidocaine Hydrochloride (Lidocaine Hydrochloride Anhydrous) Injection, Solution [Cardinal Health]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=3d77b538-5e7f-409b-8538-ee94ad10f512&name=image-01.jpg)
Lidocaine Hydrochloride
take every 4 hours, or as directed by a doctor, and not more than 6 doses in 24 hours. This adult product is not intended for use in children under 12 years of age.
Adult and children 12 years and over
2 teaspoonfuls (TSP)
Children under 12 years
DO NOT USE
Other information ■ store at room temperature 20°-25°C (68° - 77°F) ■ Phenylketonurics: contains phenylalanine 3 mg per teaspoonful (5 mL)
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![Direct Safety Aspirin Free (Acetaminophen) Tablet, Film Coated [Conney Safety Products, Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=1ed2a01c-6521-451e-819f-7464562314a3&name=1ed2a01c-6521-451e-819f-7464562314a3-03.jpg)
Direct Safety Aspirin Free
Promethazine hydrochloride and phenylephrine hydrochloride syrup is contraindicated for children under 2 years of age (see WARNING:
and Use In Pediatric Patients).
The recommended doses are given in the following table:
Adults And Children 12 Years And Over
1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 6 teaspoonsful (30 mL) in 24 hours.
Children 6 To Under 12 Years Of Age
½ to 1 teaspoonful (2.5 to 5 mL) every 4 to 6 hours, not to exceed 6 teaspoonsful (30 mL) in 24 hours.
Children 2 To Under 6 Years Of Age
¼ to ½ teaspoonful (1.25 to 2.5 mL) every 4 to 6 hours.
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![Losartan Potassium Tablet, Film Coated [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=61b1a335-fca5-4a57-b24f-ae7d081d06ed&name=image-07.jpg)
Losartan Potassium
Adult Hypertensive Patients
Losartan potassium tablets USP may be administered with other antihypertensive agents, and with or without food.
Dosing must be individualized. The usual starting dose of losartan potassium tablets USP is 50 mg once daily, with 25 mg used in patients with possible depletion of intravascular volume (e.g., patients treated with diuretics) (see WARNINGS, Hypotension – Volume-Depleted Patients) and patients with a history of hepatic impairment (see PRECAUTIONS, General). Losartan potassium tablets USP can be administered once or twice daily with total daily doses ranging from 25 mg to 100 mg.
If the antihypertensive effect measured at trough using once-a-day dosing is inadequate, a twice-a-day regimen at the same total daily dose or an increase in dose may give a more satisfactory response. The effect of losartan is substantially present within one week but in some studies the maximal effect occurred in 3 to 6 weeks (see CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects, Hypertension).
If blood pressure is not controlled by losartan potassium tablets USP alone, a low dose of a diuretic may be added. Hydrochlorothiazide has been shown to have an additive effect (see CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects, Hypertension).
No initial dosage adjustment is necessary for elderly patients or for patients with renal impairment, including patients on dialysis.
Pediatric Hypertensive Patients Greater Than or Equal to 6 Years of Age
The usual recommended starting dose is 0.7 mg/kg once daily (up to 50 mg total) administered as a tablet or a suspension (see Preparation of Suspension (for 200 mL of a 2.5 mg/mL Suspension)). Dosage should be adjusted according to blood pressure response. Doses above 1.4 mg/kg (or in excess of 100 mg) daily have not been studied in pediatric patients (see CLINICAL PHARMACOLOGY, Pharmacokinetics, Special Populations and Pharmacodynamics and Clinical Effects, and WARNINGS, Hypotension – Volume-Depleted Patients).
Losartan potassium tablets USP are not recommended in pediatric patients less than 6 years of age or in pediatric patients with glomerular filtration rate less than 30 mL/min/1.73 m2 (see CLINICAL PHARMACOLOGY, Pharmacokinetics, Special Populations, Pharmacodynamics and Clinical Effects, and PRECAUTIONS).
Preparation of Suspension (for 200 mL of a 2.5 mg/mL Suspension)
Add 10 mL of Purified Water USP to an 8 ounce (240 mL) amber polyethylene terephthalate (PET) bottle containing ten 50 mg losartan potassium tablets USP. Immediately shake for at least 2 minutes. Let the concentrate stand for 1 hour and then shake for 1 minute to disperse the tablet contents. Separately prepare a 50/50 volumetric mixture of Ora-Plus™ and Ora-Sweet SF™. Add 190 mL of the 50/50 Ora-Plus™/Ora-Sweet SF™ mixture to the tablet and water slurry in the PET bottle and shake for 1 minute to disperse the ingredients. The suspension should be refrigerated at 2 to 8°C (36 to 46°F) and can be stored for up to 4 weeks. Shake the suspension prior to each use and return promptly to the refrigerator.
Hypertensive Patients With Left Ventricular Hypertrophy
The usual starting dose is 50 mg of losartan potassium tablets USP once daily. Hydrochlorothiazide 12.5 mg daily should be added and/or the dose of losartan potassium tablets USP should be increased to 100 mg once daily followed by an increase in hydrochlorothiazide to 25 mg once daily based on blood pressure response (see CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects, Reduction in the Risk of Stroke).
Nephropathy in Type 2 Diabetic Patients
The usual starting dose is 50 mg once daily. The dose should be increased to 100 mg once daily based on blood pressure response (see CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects, Nephropathy in Type 2 Diabetic Patients). Losartan potassium tablets USP may be administered with insulin and other commonly used hypoglycemic agents (e.g.,sulfonylureas, glitazones and glucosidase inhibitors).
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![Lansoprazole Capsule, Delayed Release [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=db0df90b-3f42-4288-ae23-c83aea044a45&name=b944787d-4dc0-4086-a5aa-e5beafa6e37d-04.jpg)
Lansoprazole
Lansoprazole delayed-release capsules are available in 15 mg and 30 mg strengths. Directions for use specific to the route and available methods of administration for this dosage form is presented below. Lansoprazole delayed-release capsules should be taken before eating. Lansoprazole delayed-release capsules SHOULD NOT BE CRUSHED OR CHEWED. In the clinical trials, antacids were used concomitantly with lansoprazole.
2.1 Recommended Dose
* Please refer to amoxicillin and clarithromycin full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally-impaired patients. † Controlled studies did not extend beyond indicated duration. ‡ For patients who do not heal with lansoprazole delayed-release capsules for 8 weeks (5 to 10%), it may be helpful to give an additional 8 weeks of treatment. If there is a recurrence of erosive esophagitis, an additional 8 week course of lansoprazole delayed-release capsules may be considered. § The lansoprazole dose was increased (up to 30 mg twice daily) in some pediatric patients after 2 or more weeks of treatment if they remained symptomatic. For pediatric patients unable to swallow an intact capsule please see Administration Options. ¶ Varies with individual patient. Recommended adult starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Dosages up to 90 mg twice daily have been administered. Daily dose of greater than 120 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with lansoprazole for more than 4 years.Indication
Recommended Dose
Frequency
Duodenal Ulcers
Short-Term Treatment
15 mg
Once daily for 4 weeks
Maintenance of Healed
15 mg
Once daily
H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence*
Triple Therapy:
Lansoprazole Delayed-Release Capsules
30 mg
Twice daily (q12h) for 10 or 14 days
Amoxicillin
1 gram
Twice daily (q12h) for 10 or 14 days
Clarithromycin
500 mg
Twice daily (q12h) for 10 or 14 days
Dual Therapy:
Lansoprazole Delayed-Release Capsules
30 mg
Three times daily (q8h) for 14 days
Amoxicillin
1 gram
Three times daily (q8h) for 14 days
Benign Gastric Ulcer
Short-Term Treatment
30 mg
Once daily for up to 8 weeks
NSAID-associated Gastric Ulcer
Healing
30 mg
Once daily for 8 weeks†
Risk Reduction
15 mg
Once daily for up to 12 weeks†
Gastroesophageal Reflux Disease (GERD)
Short-Term Treatment of Symptomatic GERD
15 mg
Once daily for up to 8 weeks
Short-Term Treatment of Erosive Esophagitis
30 mg
Once daily for up to 8 weeks‡
Pediatric
(1 to 11 years of age)
Short-Term Treatment of Symptomatic GERD and Short-Term Treatment of Erosive Esophagitis
≤ 30 kg
15 mg
Once daily for up to 12 weeks§
> 30 kg
30 mg
Once daily for up to 12 weeks§
(12 to 17 years of age)
Short-Term Treatment of Symptomatic GERD
Nonerosive GERD
15 mg
Once daily for up to 8 weeks
Erosive Esophagitis
30 mg
Once daily for up to 8 weeks
Maintenance of Healing of Erosive Esophagitis
15 mg
Once daily
Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome
60 mg
Once daily¶
Patients should be instructed that if a dose is missed, it should be taken as soon as possible. However, if the next scheduled dose is due, the patient should not take the missed dose, and should be instructed to take the next dose on time. Patients should be instructed not to take 2 doses at one time to make up for a missed dose.
2.2 Special Populations
Renal impairment patients and geriatric patients do not require dosage adjustment. However, consider dose adjustment in patients with severe liver impairment [see Use in Specific Populations (8.5, 8.6 and 8.7)].
2.3 Important Administration Information
Administration Options
Lansoprazole Delayed-Release Capsules - Oral Administration
• Lansoprazole delayed-release capsules should be swallowed whole. • Alternatively, for patients who have difficulty swallowing capsules, lansoprazole delayed-release capsules can be opened and administered as follows: • Open capsule. • Sprinkle intact granules on one tablespoon of either applesauce, ENSURE ® pudding, cottage cheese, yogurt or strained pears. • Swallow immediately. • Lansoprazole delayed-release capsules may also be emptied into a small volume of either apple juice, orange juice or tomato juice and administered as follows: • Open capsule. • Sprinkle intact granules into a small volume of either apple juice, orange juice or tomato juice (60 mL — approximately 2 ounces). • Mix briefly. • Swallow immediately. • To ensure complete delivery of the dose, the glass should be rinsed with two or more volumes of juice and the contents swallowed immediately.Lansoprazole Delayed-Release Capsules - Nasogastric Tube (≥ 16 French) Administration
• For patients who have a nasogastric tube in place, lansoprazole delayed-release capsules can be administered as follows: • Open capsule. • Mix intact granules into 40 mL of apple juice. DO NOT USE OTHER LIQUIDS. • Inject through the nasogastric tube into the stomach. • Flush with additional apple juice to clear the tube.USE IN OTHER FOODS AND LIQUIDS HAS NOT BEEN STUDIED CLINICALLY AND IS THEREFORE NOT RECOMMENDED.
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![Nystatin Suspension [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=c808de10-d308-4687-8af3-9e428b7fad8c&name=fdc76ebd-959d-4185-8906-81755f089fbd-02.jpg)
Nystatin Suspension
INFANTS: 2 mL (200,000 units) four times daily (in infants and young children, use dropper to place one-half of dose in each side of mouth and avoid feeding for 5 to 10 minutes). NOTE: Limited clinical studies in premature and low birth weight infants indicate that 1 mL four times daily is effective.
CHILDREN AND ADULTS: 4–6 mL (400,000 to 600,000 units) four times daily (one-half of dose in each side of mouth). The preparation should be retained in the mouth as long as possible before swallowing.
Continue treatment for at least 48 hours after perioral symptoms have disappeared and cultures demonstrate eradication of Candida albicans.
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![Clonidine Hydrochloride Tablet [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=f83b414f-1127-4c9c-9233-505dddbbf99c&name=clonidine-02.jpg)
Clonidine Hydrochloride
Adults
The dose of clonidine hydrochloride tablets USP must be adjusted according to the patient's individual blood pressure response. The following is a general guide to its administration.
Initial Dose
0.1 mg tablet twice daily (morning and bedtime). Elderly patients may benefit from a lower initial dose.
Maintenance Dose
Further increments of 0.1 mg per day may be made at weekly intervals if necessary until the desired response is achieved. Taking the larger portion of the oral daily dose at bedtime may minimize transient adjustment effects of dry mouth and drowsiness. The therapeutic doses most commonly employed have ranged from 0.2 mg to 0.6 mg per day given in divided doses. Studies have indicated that 2.4 mg is the maximum effective daily dose, but doses as high as this have rarely been employed.
Renal Impairment
Patients with renal impairment may benefit from a lower initial dose. Patients should be carefully monitored. Since only a minimal amount of clonidine is removed during routine hemodialysis, there is no need to give supplemental clonidine following dialysis.
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![Trazodone Hydrochloride Tablet [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=42a9e649-9093-4519-b4a6-eb630f4d9368&name=b9df7953-db50-4c87-b60f-cc61c7be4bf5-02.jpg)
Trazodone Hydrochloride
The dosage should be initiated at a low level and increased gradually, noting the clinical response and any evidence of intolerance. Occurrence of drowsiness may require the administration of a major portion of the daily dose at bedtime or a reduction of dosage. Trazodone Hydrochloride Tablets USP should be taken shortly after a meal or light snack. Symptomatic relief may be seen during the first week, with optimal antidepressant effects typically evident within two weeks. Twenty-five percent of those who respond to Trazodone Hydrochloride Tablets USP require more than two weeks (up to four weeks) of drug administration.
Usual Adult Dosage
An initial dose of 150 mg/day in divided doses is suggested. The dose may be increased by 50 mg/day every three to four days. The maximum dose for outpatients usually should not exceed 400 mg/day in divided doses. Inpatients (i.e., more severely depressed patients) may be given up to but not in excess of 600 mg/day in divided doses.
Maintenance
Dosage during prolonged maintenance therapy should be kept at the lowest effective level. Once an adequate response has been achieved, dosage may be gradually reduced, with subsequent adjustment depending on therapeutic response.
Although there has been no systematic evaluation of the efficacy of Trazodone Hydrochloride Tablets USP beyond 6 weeks, it is generally recommended that a course of antidepressant drug treatment should be continued for several months.
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![Analgesic Balm (Menthol And Methyl Salicylate) Ointment [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=b117c4f0-2579-46a6-9433-c5b5dfcf2b84&name=774e51bc-53bc-448c-b6af-4a9a07356125-01.jpg)
Analgesic Balm
Apply generously to affected area not more than 3 to 4 times daily.Children under 2 years of age: Consult a doctor.
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![Phentermine Hydrochloride Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=5fa25497-0ef0-4a21-9688-5b52d17f8202&name=eb09a435-0600-494a-801f-3d9c32648a11-03.jpg)
Phentermine Hydrochloride
Exogenous Obesity
Dosage should be individualized to obtain an adequate response with the lowest effective dose.
The usual adult dose is one tablet (37.5 mg) daily, as prescribed by the physician, administered before breakfast or 1 to 2 hours after breakfast. The dosage may be adjusted to the patient’s need. For some patients, half tablet (18.75 mg) daily may be adequate, while in some cases it may be desirable to give half tablets (18.75 mg) two times a day.
Phentermine hydrochloride is not recommended for use in pediatric patients ≤ 16 years of age.
Late evening medication should be avoided because of the possibility of resulting insomnia.
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Cheratussin Ac
• take every 4 hours • do not take more than 6 doses in any 24-hour period
adults and children 12 years and over
take 10 mL (2 tsp)
children 6 years to under 12 years
take 5 mL (1 tsp)
children 2 years to under 6 years
consult a doctor
children under 2 years
do not use
Attention: A special measuring device should be used to give an accurate dose of this product to children under 6 years of age. Giving a higher dose than recommended by a doctor could result in serious side effects for your child.
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![Phentermine Hydrochloride Capsule [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=28954277-bbf8-4d04-b183-eb605ec24533&name=73506290-e863-4782-94d4-933b1fffccb9-03.jpg)
Phentermine Hydrochloride
There is currently no dosage information available for this product. We apologize for any inconvenience.
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![Phentermine Hydrochloride Capsule [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=d6efcdad-418d-4f1f-90e7-a769e4815a1e&name=e062f22c-b3e3-4f7e-8701-fbe9cbd47be8-04.jpg)
Phentermine Hydrochloride
Exogenous Obesity
Dosage should be individualized to obtain an adequate response with the lowest effective dose.
The usual adult dose is 15 mg to 30 mg as prescribed by the physician, at approximately 2 hours after breakfast for appetite control. Administration of one 30 mg capsule daily has been found to be adequate in depression of the appetite for 12 to 14 hours. Phentermine is not recommended for use in pediatric patients ≤ 16 years of age.
Late evening medication should be avoided because of the possibility of resulting insomnia.
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![Phendimetrazine Tartrate Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=63a6b1fb-5cdd-4442-96be-fb19950605a7&name=9a5b9ba2-fe9b-495a-80a2-b8a317ad4538-02.jpg)
Phendimetrazine Tartrate
Acute overdosage with phendimetrazine tartrate may manifest itself by the following signs and symptoms: unusual restlessness, confusion, belligerence, hallucinations and panic states. Fatigue and depression usually follow the central stimulation. Cardiovascular effects include arrhythmias, hypertension or hypotension and circulatory collapse. Gastrointestinal symptoms include nausea, vomiting, diarrhea and abdominal cramps. Poisoning may result in convulsions, coma and death.
The management of overdosage is largely symptomatic. It includes sedation with a barbiturate. If hypertension is marked, the use of a nitrate or rapid-acting alpha receptor-blocking agent should be considered. Experience with hemodialysis or peritoneal dialysis is inadequate to permit recommendations for its use.
Usual Adult Dose
1 tablet (35 mg) b.i.d. or t.i.d., one hour before meals.
Dosage should be individualized to obtain an adequate response with the lowest effective dosage. In some cases 1/2 tablet (17.5 mg) per dose may be adequate. Dosage should not exceed 2 tablets t.i.d.
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![Albuterol Sulfate Solution [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=e0d31515-28cf-4041-9007-a5a9b52dc78d&name=26db00ff-75e8-4113-9ac5-1eb48e1d2541-02.jpg)
Albuterol Sulfate Solution
The following dosages of albuterol sulfate syrup (oral solution) are expressed in terms of albuterol base.
Usual Dosage:
Adults and Children Over 14 Years of Age: The usual starting dosage for adults and children over 14 years of age is 2 mg (1 teaspoonful) or 4 mg (2 teaspoonfuls) three or four times a day.
Children Over 6 Years to 14 Years of Age: The usual starting dosage for children over 6 years to 14 years of age is 2 mg (1 teaspoonful) three or four times a day.
Children 2 to 5 Years of Age: Dosing in children 2 to 5 years of age should be initiated at 0.1 mg/kg of body weight three times a day. This starting dosage should not exceed 2 mg (1 teaspoonful) three times a day.
Dosage Adjustment:
Adult and Children Over 14 Years of Age: For adults and children over 14 years of age, a dosage above 4 mg four times a day should be used only when the patient fails to respond. If a favorable response does not occur with the 4-mg initial dosage, it should be cautiously increased stepwise up to a maximum of 8 mg four times a day as tolerated.
Children Over 6 Years to 14 Years of Age Who Fail to Respond to the Initial Starting Dosage of 2 mg Four Times a Day: For children over 6 years to 14 years of age who fail to respond to the initial starting dosage of 2 mg four times a day, the dosage may be cautiously increased stepwise, but not to exceed 24 mg/day (given in divided doses).
Children 2 to 5 Years of Age Who Do Not Respond Satisfactorily to the Initial Dosage: For children from 2 to 5 years of age who do not respond satisfactorily to the initial starting dosage the dosage may be increased stepwise to 0.2 mg/kg of body weight three times a day, but not to exceed a maximum of 4 mg (2 teaspoonfuls) given three times a day.
Elderly Patients and Those Sensitive to Beta-Adrenergic Stimulators: The initial dosage should be restricted to 2 mg three or four times a day and individually adjusted thereafter.
Usual Dosage:
Adults and Children Over 14 Years of Age: The usual starting dosage for adults and children over 14 years of age is 2 mg (1 teaspoonful) or 4 mg (2 teaspoonfuls) three or four times a day.
Children Over 6 Years to 14 Years of Age: The usual starting dosage for children over 6 years to 14 years of age is 2 mg (1 teaspoonful) three or four times a day.
Children 2 to 5 Years of Age: Dosing in children 2 to 5 years of age should be initiated at 0.1 mg/kg of body weight three times a day. This starting dosage should not exceed 2 mg (1 teaspoonful) three times a day.
Dosage Adjustment:
Adult and Children Over 14 Years of Age: For adults and children over 14 years of age, a dosage above 4 mg four times a day should be used only when the patient fails to respond. If a favorable response does not occur with the 4-mg initial dosage, it should be cautiously increased stepwise up to a maximum of 8 mg four times a day as tolerated.
Children Over 6 Years to 14 Years of Age Who Fail to Respond to the Initial Starting Dosage of 2 mg Four Times a Day: For children over 6 years to 14 years of age who fail to respond to the initial starting dosage of 2 mg four times a day, the dosage may be cautiously increased stepwise, but not to exceed 24 mg/day (given in divided doses).
Children 2 to 5 Years of Age Who Do Not Respond Satisfactorily to the Initial Dosage: For children from 2 to 5 years of age who do not respond satisfactorily to the initial starting dosage the dosage may be increased stepwise to 0.2 mg/kg of body weight three times a day, but not to exceed a maximum of 4 mg (2 teaspoonfuls) given three times a day.
Elderly Patients and Those Sensitive to Beta-Adrenergic Stimulators: The initial dosage should be restricted to 2 mg three or four times a day and individually adjusted thereafter.
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![Promethazine With Codeine (Promethazine Hydrochloride And Codeine Phosphate) Syrup [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=164046da-3953-437b-bc8e-a8cb0465f616&name=05ee5bda-6c95-4ee8-ba95-7485603eae93-03.jpg)
Promethazine With Codeine
The combination of promethazine hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age, because the combination may cause fatal respiratory depression in this age population.
It is important that promethazine with codeine syrup is measured with an accurate measuring device (see PRECAUTIONS-Information For Patients). A household teaspoon is not an accurate measuring device and could lead to overdosage, especially when half a teaspoon is to be measured. It is strongly recommended that an accurate measuring device be used. A pharmacist can provide an appropriate device and can provide instructions for measuring the correct dose.
The average effective dose for adults and children 12 years of age and over is: 1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 30 mL in 24 hours.
The average effective dose for children 6 years to under 12 years of age is 1/2 to 1 teaspoonful (2.5 mL to 5 mL) every 4 to 6 hours, not to exceed 30 mL in 24 hours.
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![Temazepam Capsule [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=68e2c1d8-9d6a-44a0-86f0-ba63a3263d22&name=73099108-cee2-4c3d-8b9a-f66cb9795b30-03.jpg)
Temazepam
While the recommended usual adult dose is 15 mg before retiring, 7.5 mg may be sufficient for some patients, and others may need 30 mg. In transient insomnia, a 7.5 mg dose may be sufficient to improve sleep latency. In elderly or debilitated patients, it is recommended that therapy be initiated with 7.5 mg until individual responses are determined.
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![Broad Spectrum Spf 50 Sunscreen Bioelements (Avobenzone, Homosalate, Ocinoxate, Octisalate, Octocrylene, Oxybenzone) Cream [Bioelements]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=52b87520-de0b-40fd-bf59-c5bcaccb27c2&name=lisinopril-tablets-3.jpg)
Broad Spectrum Spf 50 Sunscreen Bioelements
2.1 Hypertension
Initial Therapy in adults: The recommended initial dose is 10 mg once a day. Dosage should be adjusted according to blood pressure response. The usual dosage range is 20 to 40 mg per day administered in a single daily dose. Doses up to 80 mg have been used but do not appear to give greater effect.
Use with diuretics in adults If blood pressure is not controlled with lisinopril tablets alone, a low dose of a diuretic may be added (e.g., hydrochlorothiazide, 12.5 mg). After the addition of a diuretic, it may be possible to reduce the dose of lisinopril tablets.
The recommended starting dose in adult patients with hypertension taking diuretics is 5 mg once per day.
Pediatric Patients 6 years of age and older with hypertension For pediatric patients with glomerular filtration rate > 30 mL/min/1.73m2, the recommended starting dose is 0.07 mg per kg once daily (up to 5 mg total). Dosage should be adjusted according to blood pressure response up to a maximum of 0.61 mg per kg (up to 40 mg) once daily. Doses above 0.61 mg per kg (or in excess of 40 mg) have not been studied in pediatric patients [see Clinical Pharmacology (12.3)].
Lisinopril tablets are not recommended in pediatric patients < 6 years or in pediatric patients with glomerular filtration rate < 30 mL/min/1.73m2 [see Use in Specific Populations (8.4) and Clinical Studies (14.1)].
2.2 Heart Failure
The recommended starting dose for lisinopril tablets, when used with diuretics and (usually) digitalis as adjunctive therapy for systolic heart failure, is 5 mg once daily. The recommended starting dose in these patients with hyponatremia (serum sodium < 130 mEq/L) is 2.5 mg once daily. Increase as tolerated to a maximum of 40 mg once daily.
Diuretic dose may need to be adjusted to help minimize hypovolemia, which may contribute to hypotension [see Warnings and Precautions (5.4), and Drug Interactions (7.1)]. The appearance of hypotension after the initial dose of lisinopril tablets does not preclude subsequent careful dose titration with the drug, following effective management of the hypotension.
2.3 Reduction of Mortality in Acute Myocardial Infarction
In hemodynamically stable patients within 24 hours of the onset of symptoms of acute myocardial infarction, give lisinopril tablets 5 mg orally, followed by 5 mg after 24 hours, 10 mg after 48 hours and then 10 mg once daily. Dosing should continue for at least six weeks.
Initiate therapy with 2.5 mg in patients with a low systolic blood pressure (≤ 120 mmHg and > 100 mmHg) during the first 3 days after the infarct [see Warnings and Precautions (5.4)]. If hypotension occurs (systolic blood pressure ≤ 100 mmHg) a daily maintenance dose of 5 mg may be given with temporary reductions to 2.5 mg if needed. If prolonged hypotension occurs (systolic blood pressure < 90 mmHg for more than 1 hour) lisinopril tablets should be withdrawn.
2.4 Dose in Patients with Renal Impairment
No dose adjustment of lisinopril tablets is required in patients with creatinine clearance > 30 mL/min. In patients with creatinine clearance ≥ 10 mL/min and ≤ 30 mL/min, reduce the initial dose of lisinopril tablets to half of the usual recommended dose i.e., hypertension, 5 mg; systolic heart failure, 2.5 mg and acute MI, 2.5 mg. Up titrate as tolerated to a maximum of 40 mg daily. For patients on hemodialysis or creatinine clearance < 10 mL/min, the recommended initial dose is 2.5 mg once daily [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].
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![Amlodipine Besylate Tablet [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=37b4cfba-6673-402e-bb5a-82b4ab6ef49b&name=4d11a254-8128-4df0-95f4-fa9e79af60da-04.jpg)
Amlodipine Besylate
2.1 Adults
The usual initial antihypertensive oral dose of amlodipine is 5 mg once daily, and the maximum dose is 10 mg once daily.
Small, fragile, or elderly patients, or patients with hepatic insufficiency may be started on 2.5 mg once daily and this dose may be used when adding amlodipine to other antihypertensive therapy.
Adjust dosage according to blood pressure goals. In general, wait 7 to 14 days between titration steps. Titrate more rapidly, however, if clinically warranted, provided the patient is assessed frequently.
Angina:
The recommended dose for chronic stable or vasospastic angina is 5 to 10 mg, with the lower dose suggested in the elderly and in patients with hepatic insufficiency. Most patients will require 10 mg for adequate effect.
Coronary artery disease:
The recommended dose range for patients with coronary artery disease is 5 to 10 mg once daily. In clinical studies, the majority of patients required 10 mg [see Clinical Studies (14.4)].
2.2 Children
The effective antihypertensive oral dose in pediatric patients ages 6 to 17 years is 2.5 mg to 5 mg once daily. Doses in excess of 5 mg daily have not been studied in pediatric patients [see Clinical Pharmacology (12.4), Clinical Studies (14.1)].
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![Phentermine Hydrochloride Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=07f4673f-680d-4dd7-90af-9751253080bf&name=1f4f3819-b4d6-4e52-b50e-cfc315f2e831-03.jpg)
Phentermine Hydrochloride
Exogenous Obesity
Dosage should be individualized to obtain an adequate response with the lowest effective dose.
The usual adult dose is one tablet (37.5 mg) daily, as prescribed by the physician, administered before breakfast or 1 to 2 hours after breakfast. The dosage may be adjusted to the patient's need. For some patients, half tablet (18.75 mg) daily may be adequate, while in some cases it may be desirable to give half tablets (18.75 mg) two times a day.
Phentermine is not recommended for use in pediatric patients ≤ 16 years of age.
Late evening medication should be avoided because of the possibility of resulting insomnia.
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![Terazosin Capsule [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=333dfa43-3554-48e9-ab02-429ea4020c2b&name=333dfa43-3554-48e9-ab02-429ea4020c2b-01.jpg)
Terazosin
If Terazosin Capsules administration is discontinued for several days, therapy should be reinstituted using the initial dosing regimen.
Benign Prostatic Hyperplasia
Initial Dose: 1 mg at bedtime is the starting dose for all patients, and this dose should not be exceeded as an initial dose. Patients should be closely followed during initial administration in order to minimize the risk of severe hypotensive response.
Subsequent Doses: The dose should be increased in a stepwise fashion to 2 mg, 5 mg, or 10 mg once daily to achieve the desired improvement of symptoms and/or flow rates. Doses of 10 mg once daily are generally required for the clinical response. Therefore, treatment with 10 mg for a minimum of 4-6 weeks may be required to assess whether a beneficial response has been achieved. Some patients may not achieve a clinical response despite appropriate titration. Although some additional patients responded at a 20 mg daily dose, there was an insufficient number of patients studied to draw definitive conclusions about this dose. There are insufficient data to support the use of higher doses for those patients who show inadequate or no response to 20 mg daily. If terazosin administration is discontinued for several days or longer, therapy should be reinstituted using the initial dosing regimen.
Use with Other Drugs: Caution should be observed when Terazosin Capsules are administered concomitantly with other antihypertensive agents, especially the calcium channel blocker verapamil, to avoid the possibility of developing significant hypotension. When using Terazosin Capsules and other antihypertensive agents concomitantly, dosage reduction and retitration of either agent may be necessary (see Precautions). Hypotension has been reported when Terazosin Capsules have been used with phosphodiesterase-5 (PDE-5) inhibitors.
Hypertension
The dose of Terazosin Capsules and the dose interval (12 or 24 hours) should be adjusted according to the patient's individual blood pressure response. The following is a guide to its administration:
Initial Dose:1 mg at bedtime is the starting dose for all patients, and this dose should not be exceeded. This initial dosing regimen should be strictly observed to minimize the potential for severe hypotensive effects.
Subsequent Doses: The dose may be slowly increased to achieve the desired blood pressure response. The usual recommended dose range is 1 mg to 5 mg administered once a day; however, some patients may benefit from doses as high as 20 mg per day. Doses over 20 mg do not appear to provide further blood pressure effect and doses over 40 mg have not been studied. Blood pressure should be monitored at the end of the dosing interval to be sure control is maintained throughout the interval. It may also be helpful to measure blood pressure 2-3 hours after dosing to see if the maximum and minimum responses are similar, and to evaluate symptoms such as dizziness or palpitations which can result from excessive hypotensive response. If response is substantially diminished at 24 hours an increased dose or use of a twice daily regimen can be considered. If terazosin administration is discontinued for several days or longer, therapy should be reinstituted using the initial dosing regimen. In clinical trials, except for the initial dose, the dose was given in the morning.
Use With Other Drugs: (see above)
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![Lorazepam Tablet [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=85efece9-04fe-4b58-8340-6fd7208cfe85&name=aa13aa41-720c-46e3-bf95-34fff5048581-02.jpg)
Lorazepam
Lorazepam tablets, USP are administered orally. For optimal results, dose, frequency of administration, and duration of therapy should be individualized according to patient response. To facilitate this, 0.5 mg, 1 mg, and 2 mg tablets are available.
The usual range is 2 to 6 mg/day given in divided doses, the largest dose being taken before bedtime, but the daily dosage may vary from 1 to 10 mg/day.
For anxiety, most patients require an initial dose of 2 to 3 mg/day given b.i.d. or t.i.d.
For insomnia due to anxiety or transient situational stress, a single daily dose of 2 to 4 mg may be given, usually at bedtime.
For elderly or debilitated patients, an initial dosage of 1 to 2 mg/day in divided doses is recommended, to be adjusted as needed and tolerated.
The dosage of lorazepam should be increased gradually when needed to help avoid adverse effects. When higher dosage is indicated, the evening dose should be increased before the daytime doses.
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![Hydrocodone Bitartate And Acetaminophen (Hydrocodone Bitartrate, Acetaminophen) Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=6f367d9b-7141-46d8-a3a3-5a241e167259&name=be430d5e-0007-431c-922f-29a546432d86-03.jpg)
Hydrocodone Bitartate And Acetaminophen
Dosage should be adjusted according to the severity of the pain and the response of the patient. However, it should be kept in mind that tolerance to hydrocodone can develop with continued use and that the incidence of untoward effects is dose related.
The usual adult dosage is one or two tablets every four to six hours as needed for pain. The total daily dosage should not exceed 12 tablets.
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![Aspirin Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=ab008c38-bea4-4484-a2f8-627def008a5c&name=ab008c38-bea4-4484-a2f8-627def008a5c-01.jpg)
Aspirin
drink a full glass of water with each dose adults and children 12 years and over: take 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor children under 12 years: consult a doctor
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Diphenoxylate Hydrochloride And Atropine Sulfate
DO NOT EXCEED RECOMMENDED DOSAGE.
Adults
The recommended initial dosage is two tablets four times daily (20 mg per day). Most patients will require this dosage until initial control has been achieved, after which the dosage may be reduced to meet individual requirements. Control may often be maintained with as little as 5 mg (two tablets) daily.
Clinical improvement of acute diarrhea is usually observed within 48 hours. If clinical improvement of chronic diarrhea after treatment with a maximum daily dose of 20 mg of diphenoxylate hydrochloride is not observed within 10 days, symptoms are unlikely to be controlled by further administration.
Children
Diphenoxylate hydrochloride and atropine sulfate tablets are not recommended in children under 2 years of age and should be used with special caution in young children (see WARNINGS and PRECAUTIONS). The nutritional status and degree of dehydration must be considered. In children under 13 years of age, use oral solution. Do not use tablets for this age group.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
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![Amoxicillin Tablet, Coated [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=878f5bb7-1fda-4ac9-8190-c7e5571993e2&name=3d185629-4e6b-4276-8d6d-45a09578e89c-02.jpg)
Amoxicillin
The 875-mg tablet has been studied only when administered at the start of a light meal. However, food effect studies have not been performed with the 200-mg and 500-mg formulations.
Neonates and Infants Aged ≤12 weeks (≤3 months): Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of Amoxicillin is 30 mg/kg/day divided q12h.
Adults and Pediatric Patients > 3 Months:
* Dosing for infections caused by less susceptible organisms should follow the recommendations for severe infections. † The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations. Infection Severity* Usual Adult Dosage Usual Dose for Children > 3 Months† Ear/Nose/ Throat Mild/ Moderate 500 mg every 12 hours or 250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours Lower Respiratory Tract Mild/ Moderate or Severe 875 mg every 12 hours or 500 mg every 8 hours45 mg/kg/day in divided doses every 12 hours
or
40 mg/kg/day in divided doses every 8 hours Skin/Skin Structure Mild/ Moderate 500 mg every 12 hours or 250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours Genitourinary Tract Mild/ Moderate 500 mg every 12 hours or 250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours Gonorrhea Acute, Uncomplicated Ano-genital and urethral infections in males and females 3 grams as single oral dosePrepubertal children: 50 mg/kg Amoxicillin combined with 25 mg/kg probenecid as single dose.
NOTE: SINCE PROBENICID IS CONTRAINDICATED IN CHILDREN UNDER 2 YEARS, DO NOT USE THIS REGIMEN IN THESE CASES.All patients with gonorrhea should be evaluated for syphilis. (See PRECAUTIONS – Laboratory Tests).
Larger doses may be required for stubborn or severe infections.
General: It should be recognized that in the treatment of chronic urinary tract infections, frequent bacteriological and clinical appraisals are necessary. Smaller doses than those recommended above should not be used. Even higher doses may be needed at times. In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy. Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever.
H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence: Triple therapy: Amoxicillin/clarithromycin/ lansoprazole
The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (q12h) for 14 days. (See INDICATIONS AND USAGE).
Dual therapy: Amoxicillin/lansoprazole
The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (q8h) for 14 days. (See INDICATIONS AND USAGE).
Please refer to clarithromycin and lansoprazole full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally impaired patients.
Dosing Recommendations for Adults with Impaired Renal Function: Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of <30 mL/min. should not receive the 875 mg tablet. Patients with a glomerular filtration rate of 10 to 30 mL/min. should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/min. glomerular filtration rate should receive 500 mg or 250 mg every 24 hours, depending on the severity of the infection. Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on the severity of the infection. They should receive an additional dose both during and at the end of dialysis.
There are currently no dosing recommendations for pediatric patients with impaired renal function.
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![Medrox (Menthol, Capsaicin) Patch [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=5b171000-a3d7-4adf-817f-1eba14773e0a&name=b46a5734-ff83-49ab-86f6-ee86aefbbabc-01.jpg)
Medrox
•Adults and children 12 years and over apply to affected area: change patch 1 to 2 times daily •Children under 12 years, consult physician before use •How to apply: •Clean and dry affected area •Cut open pouch and remove patch •Remove protective film and apply directly to area of pain •Apply to affected area not more than 3 times daily •Wash hands with soap after applying patch •Reseal pouch containing unused patches
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![Baclofen Tablet [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=90b8b4ba-0346-49ae-b5ad-85668e5d7ef3&name=5a2e876c-1255-47e3-90f9-7e3c8bc97114-02.jpg)
Baclofen
The determination of optimal dosage requires individual titration. Start therapy at a low dosage and increase gradually until optimum effect is achieved (usually between 40–80 mg daily).
The following dosage titration schedule is suggested:
5 mg t.i.d. for 3 days10 mg t.i.d. for 3 days15 mg t.i.d. for 3 days20 mg t.i.d. for 3 days
Thereafter additional increases may be necessary but the total daily dose should not exceed a maximum of 80 mg daily (20 mg q.i.d.).
The lowest dose compatible with an optimal response is recommended. If benefits are not evident after a reasonable trial period, patients should be slowly withdrawn from the drug (see WARNINGS Abrupt Drug Withdrawal).
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![Benazepril Hydrochloride Tablet, Film Coated [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=420a70f6-7b8b-42d0-8511-5320c841ef85&name=989900de-360f-4a72-9a2a-35345dbebd54-02.jpg)
Benazepril Hydrochloride
Hypertension
Adults
The recommended initial dose for patients not receiving a diuretic is 10 mg once a day. The usual maintenance dosage range is 20-40 mg per day administered as a single dose or in two equally divided doses. A dose of 80 mg gives an increased response, but experience with this dose is limited. The divided regimen was more effective in controlling trough (pre-dosing) blood pressure than the same dose given as a once-daily regimen. Dosage adjustment should be based on measurement of peak (2-6 hours after dosing) and trough responses. If a once-daily regimen does not give adequate trough response, an increase in dosage or divided administration should be considered. If blood pressure is not controlled with benazepril hydrochloride tablets alone, a diuretic can be added.
Total daily doses above 80 mg have not been evaluated.
Concomitant administration of benazepril hydrochloride tablets with potassium supplements, potassium salt substitutes, or potassium-sparing diuretics can lead to increases of serum potassium (see PRECAUTIONS).
In patients who are currently being treated with a diuretic, symptomatic hypotension occasionally can occur following the initial dose of benazepril hydrochloride tablets. To reduce the likelihood of hypotension, the diuretic should, if possible, be discontinued two to three days prior to beginning therapy with benazepril hydrochloride tablets (see WARNINGS). Then, if blood pressure is not controlled with benazepril hydrochloride tablets alone, diuretic therapy should be resumed.
If the diuretic cannot be discontinued, an initial dose of 5 mg benazepril hydrochloride tablets should be used to avoid excessive hypotension.
Pediatrics
In children, doses of benazepril hydrochloride between 0.1 and 0.6 mg/kg once daily have been studied, and doses greater than 0.1 mg/kg were shown to reduce blood pressure (see Pharmacodynamics). Based on this, the recommended starting dose of benazepril hydrochloride is 0.2 mg/kg once per day as monotherapy. Doses above 0.6 mg/kg (or in excess of 40 mg daily) have not been studied in pediatric patients.
For pediatric patients who cannot swallow tablets, or for whom the calculated dosage (mg/kg) does not correspond to the available tablet strengths for benazepril hydrochloride tablets, follow the suspension preparation instructions below to administer benazepril hydrochloride tablets as a suspension.
Treatment with benazepril hydrochloride tablets is not advised for children below the age of 6 years (see PRECAUTIONS, Pediatric Use) and in pediatric patients with glomerular filtration rate <30 mL, as there are insufficient data available to support a dosing recommendation in these groups.
For Hypertensive Patients with Renal Impairment
For patients with a creatinine clearance <30 mL/min/1.73 m2 (serum creatinine >3 mg/dL), the recommended initial dose is 5 mg benazepril hydrochloride tablet once daily. Dosage may be titrated upward until blood pressure is controlled or to a maximum total daily dose of 40 mg (see WARNINGS).
Preparation of Suspension (for 150 mL of a 2 mg/mL suspension)
Add 75 mL of Ora-Plus®* oral suspending vehicle to an amber polyethylene terephthalate (PET) bottle containing fifteen benazepril hydrochloride 20 mg tablets, and shake for at least 2 minutes. Allow the suspension to stand for a minimum of 1 hour. After the standing time, shake the suspension for a minimum of 1 additional minute. Add 75 mL of Ora-Sweet®* oral syrup vehicle to the bottle and shake the suspension to disperse the ingredients. The suspension should be refrigerated at 2°-8°C (36°-46°F) and can be stored for up to 30 days in the PET bottle with a child-resistant screw-cap closure. Shake the suspension before each use.
*Ora-Plus® and Ora-Sweet® are registered trademarks of Paddock Laboratories, Inc. Ora-Plus® contains carrageenan, citric acid, methylparaben, microcrystalline cellulose, carboxymethylcellulose sodium, potassium sorbate, simethicone, sodium phosphate monobasic, xanthan gum, and water. Ora-Sweet® contains berry citrus flavorant, glycerin, methylparaben, potassium sorbate, sodium phosphate monobasic, sorbitol, sucrose, and water.
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![Benazepril Hydrochloride Tablet, Film Coated [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=756a3a26-7230-410b-bfb1-7f074688ff05&name=fe9e9710-e1c9-4d58-bee1-f48383ee8276-02.jpg)
Benazepril Hydrochloride
Hypertension
Adults
The recommended initial dose for patients not receiving a diuretic is 10 mg once a day. The usual maintenance dosage range is 20 mg to 40 mg per day administered as a single dose or in two equally divided doses. A dose of 80 mg gives an increased response, but experience with this dose is limited. The divided regimen was more effective in controlling trough (pre-dosing) blood pressure than the same dose given as a once-daily regimen. Dosage adjustment should be based on measurement of peak (2 to 6 hours after dosing) and trough responses. If a once-daily regimen does not give adequate trough response, an increase in dosage or divided administration should be considered. If blood pressure is not controlled with benazepril hydrochloride tablets alone, a diuretic can be added.
Total daily doses above 80 mg have not been evaluated.
Concomitant administration of benazepril hydrochloride tablets with potassium supplements, potassium salt substitutes or potassium-sparing diuretics can lead to increases of serum potassium (see PRECAUTIONS).
In patients who are currently being treated with a diuretic, symptomatic hypotension occasionally can occur following the initial dose of benazepril hydrochloride tablets. To reduce the likelihood of hypotension, the diuretic should, if possible, be discontinued two to three days prior to beginning therapy with benazepril hydrochloride tablets (see WARNINGS). Then, if blood pressure is not controlled with benazepril hydrochloride tablets alone, diuretic therapy should be resumed.
If the diuretic cannot be discontinued, an initial dose of 5 mg benazepril hydrochloride tablets should be used to avoid excessive hypotension.
Pediatrics
In children, doses of benazepril hydrochloride tablets between 0.1 mg/kg and 0.6 mg/kg once daily have been studied, and doses greater than 0.1 mg/kg were shown to reduce blood pressure (see CLINICAL PHARMACOLOGY, Pharmacodynamics). Based on this, the recommended starting dose of benazepril hydrochloride tablets is 0.2 mg/kg once per day as monotherapy. Doses above 0.6 mg/kg (or in excess of 40 mg daily) have not been studied in pediatric patients.
For pediatric patients who cannot swallow tablets, or for whom the calculated dosage (mg/kg) does not correspond to the available tablet strengths for benazepril hydrochloride tablets, follow the suspension preparation instructions below to administer benazepril hydrochloride tablets as a suspension.
Treatment with benazepril hydrochloride tablets is not advised for children below the age of 6 years (see PRECAUTIONS, Pediatric Use) and in pediatric patients with glomerular filtration rate <30 mL, as there are insufficient data available to support a dosing recommendation in these groups.
For Hypertensive Patients with Renal Impairment
For patients with a creatinine clearance <30 mL/min/1.73 m2 (serum creatinine >3 mg/dL), the recommended initial dose is 5 mg benazepril hydrochloride tablets once daily. Dosage may be titrated upward until blood pressure is controlled or to a maximum total daily dose of 40 mg (see WARNINGS).
Preparation of Suspension (for 150 mL of a 2 mg/mL suspension)
Add 75 mL of Ora-Plus®* oral suspending vehicle to an amber polyethylene terephthalate (PET) bottle containing fifteen benazepril hydrochloride 20 mg tablets, and shake for at least 2 minutes. Allow the suspension to stand for a minimum of 1 hour. After the standing time, shake the suspension for a minimum of 1 additional minute. Add 75 mL of Ora-Sweet®* oral syrup vehicle to the bottle and shake the suspension to disperse the ingredients. The suspension should be refrigerated at 2° to 8°C (36° to 46°F) and can be stored for up to 30 days in the PET bottle with a child-resistant screw-cap closure. Shake the suspension before each use.
*Ora-Plus® and Ora-Sweet® are registered trademarks of Paddock Laboratories, Inc. Ora-Plus® contains carrageenan, citric acid, methylparaben, microcrystalline cellulose, carboxymethylcellulose sodium, potassium sorbate, simethicone, sodium phosphate monobasic, xanthan gum, and water. Ora-Sweet® contains citric acid, berry citrus flavorant, glycerin, methylparaben, potassium sorbate, sodium phosphate monobasic, sorbitol, sucrose, and water.
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![Lovastatin Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=ea4df37b-21e9-4dc3-83af-1be1b50bfdc9&name=lov00-0005-05.jpg)
Lovastatin
The patient should be placed on a standard cholesterol-lowering diet before receiving lovastatin and should continue on this diet during treatment with lovastatin (see NCEP Treatment Guidelines for details on dietary therapy). Lovastatin should be given with meals.
Adult Patients
The usual recommended starting dose is 20 mg once a day given with the evening meal. The recommended dosing range is 10 to 80 mg/day in single or two divided doses; the maximum recommended dose is 80 mg/day. Doses should be individualized according to the recommended goal of therapy (see NCEP Guidelines and CLINICAL PHARMACOLOGY ). Patients requiring reductions in LDL-C of 20% or more to achieve their goal (see INDICATIONS AND USAGE) should be started on 20 mg/day of lovastatin. A starting dose of 10 mg may be considered for patients requiring smaller reductions. Adjustments should be made at intervals of 4 weeks or more.
Cholesterol levels should be monitored periodically and consideration should be given to reducing the dosage of lovastatin if cholesterol levels fall significantly below the targeted range.
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![Bupropion Hydrochloride Tablet, Film Coated, Extended Release [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=dbc0f86b-55e7-4667-a26e-47b948f608bd&name=dbc0f86b-55e7-4667-a26e-47b948f608bd-02.jpg)
Bupropion Hydrochloride
General Dosing Considerations:
It is particularly important to administer bupropion hydrochloride extended-release tablets (SR) in a manner most likely to minimize the risk of seizure (see WARNINGS). Gradual escalation in dosage is also important if agitation, motor restlessness, and insomnia, often seen during the initial days of treatment, are to be minimized. If necessary, these effects may be managed by temporary reduction of dose or the short-term administration of an intermediate to long-acting sedative hypnotic. A sedative hypnotic usually is not required beyond the first week of treatment. Insomnia may also be minimized by avoiding bedtime doses. If distressing, untoward effects supervene, dose escalation should be stopped.
Bupropion hydrochloride extended-release tablets (SR) should be swallowed whole and not crushed, divided, or chewed.
Initial Treatment:
The usual adult target dose for bupropion hydrochloride extended-release tablets (SR) is 300 mg/day, given as 150 mg twice daily. Dosing with bupropion hydrochloride extended-release tablets (SR) should begin at 150 mg/day given as a single daily dose in the morning. If the 150 mg initial dose is adequately tolerated, an increase to the 300 mg/day target dose, given as 150 mg twice daily, may be made as early as day 4 of dosing. There should be an interval of at least 8 hours between successive doses.
Increasing the Dosage Above 300 mg/day:
As with other antidepressants, the full antidepressant effect of bupropion hydrochloride extended-release tablets (SR) may not be evident until 4 weeks of treatment or longer. An increase in dosage to the maximum of 400 mg/day, given as 200 mg twice daily, may be considered for patients in whom no clinical improvement is noted after several weeks of treatment at 300 mg/day.
Maintenance Treatment:
It is generally agreed that acute episodes of depression require several months or longer of sustained pharmacological therapy beyond response to the acute episode. In a study in which patients with major depressive disorder, recurrent type, who had responded during 8 weeks of acute treatment with bupropion were assigned randomly to placebo or to the same dose of bupropion (150 mg twice daily) during 44 weeks of maintenance treatment as they had received during the acute stabilization phase, longer-term efficacy was demonstrated (see CLINICAL TRIALS under CLINICAL PHARMACOLOGY). Based on these limited data, it is unknown whether or not the dose of bupropion needed for maintenance treatment is identical to the dose needed to achieve an initial response. Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment.
Dosage Adjustment for Patients with Impaired Hepatic Function:
Bupropion should be used with extreme caution in patients with severe hepatic cirrhosis. The dose should not exceed 100 mg every day or 150 mg every other day in these patients. Bupropion should be used with caution in patients with hepatic impairment (including mild-to-moderate hepatic cirrhosis) and a reduced frequency and/or dose should be considered in patients with mild-to-moderate hepatic cirrhosis (see CLINICAL PHARMACOLOGY, WARNINGS, and PRECAUTIONS).
Dosage Adjustment for Patients with Impaired Renal Function:
Bupropion should be used with caution in patients with renal impairment and a reduced frequency and/or dose should be considered (see CLINICAL PHARMACOLOGY and PRECAUTIONS).
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![Bupropion Hydrochloride Tablet, Film Coated, Extended Release [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=e9cef726-267e-4e4f-ac12-d92a8664bf20&name=97487323-0c0d-4dd9-aa7b-39bfe201effa-02.jpg)
Bupropion Hydrochloride
General Dosing Considerations: It is particularly important to administer bupropion hydrochloride extended-release tablets (SR) in a manner most likely to minimize the risk of seizure (see WARNINGS). Gradual escalation in dosage is also important if agitation, motor restlessness, and insomnia, often seen during the initial days of treatment, are to be minimized. If necessary, these effects may be managed by temporary reduction of dose or the short-term administration of an intermediate to long-acting sedative hypnotic. A sedative hypnotic usually is not required beyond the first week of treatment. Insomnia may also be minimized by avoiding bedtime doses. If distressing, untoward effects supervene, dose escalation should be stopped. Bupropion hydrochloride extended-release tablets (SR) should be swallowed whole and not crushed, divided, or chewed, as this may lead to an increased risk of adverse effects including seizures.
Initial Treatment: The usual adult target dose for bupropion hydrochloride extended-release tablets (SR) is 300 mg/day, given as 150 mg twice daily. Dosing with bupropion hydrochloride extended-release tablets (SR) should begin at 150 mg/day given as a single daily dose in the morning. If the 150-mg initial dose is adequately tolerated, an increase to the 300-mg/day target dose, given as 150 mg twice daily, may be made as early as day 4 of dosing. There should be an interval of at least 8 hours between successive doses.
Increasing the Dosage Above 300 mg/day: As with other antidepressants, the full antidepressant effect of bupropion hydrochloride extended-release tablets (SR) may not be evident until 4 weeks of treatment or longer. An increase in dosage to the maximum of 400 mg/day, given as 200 mg twice daily, may be considered for patients in whom no clinical improvement is noted after several weeks of treatment at 300 mg/day.
Maintenance Treatment: It is generally agreed that acute episodes of depression require several months or longer of sustained pharmacological therapy beyond response to the acute episode. In a study in which patients with major depressive disorder, recurrent type, who had responded during 8 weeks of acute treatment with bupropion hydrochloride extended-release tablets (SR) were assigned randomly to placebo or to the same dose of bupropion hydrochloride extended-release tablets (SR) (150 mg twice daily) during 44 weeks of maintenance treatment as they had received during the acute stabilization phase, longer-term efficacy was demonstrated (see CLINICAL TRIALS under CLINICAL PHARMACOLOGY). Based on these limited data, it is unknown whether or not the dose of bupropion hydrochloride extended-release tablets (SR) needed for maintenance treatment is identical to the dose needed to achieve an initial response. Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment.
Dosage Adjustment for Patients with Impaired Hepatic Function: Bupropion hydrochloride extended-release tablets (SR) should be used with extreme caution in patients with severe hepatic cirrhosis. The dose should not exceed 100 mg every day or 150 mg every other day in these patients. Bupropion hydrochloride extended-release tablets (SR) should be used with caution in patients with hepatic impairment (including mild-to-moderate hepatic cirrhosis) and a reduced frequency and/or dose should be considered in patients with mild-to-moderate hepatic cirrhosis (see CLINICAL PHARMACOLOGY, WARNINGS, and PRECAUTIONS).
Dosage Adjustment for Patients with Impaired Renal Function: Bupropion hydrochloride extended-release tablets (SR) should be used with caution in patients with renal impairment and a reduced frequency and/or dose should be considered (see CLINICAL PHARMACOLOGY and PRECAUTIONS).
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![Amoxicillin Powder, For Suspension [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=b23637eb-16ff-4e92-96e5-d6efd5cc4ee8&name=bcb7d4f0-33a8-4583-a54c-bb371d985289-02.jpg)
Amoxicillin
2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age
Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by
Streptococcus pyogenes
to prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.
Table 1. Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age Infection Severitya Usual Adult Dose Usual Dose for Children > 3 Monthsb a Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections.b The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations. Ear/Nose/Throat Skin/Skin Structure Genitourinary Tract Mild/Moderate 500 mg every 12 hours or250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours Severe 875 mg every 12 hours or500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours Lower Respiratory Tract Mild/Moderate or Severe 875 mg every 12 hours or500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours Gonorrhea Acute, uncomplicated ano-genital and urethral infections in males and females 3 grams as single oral dose Prepubertal children: 50 mg/kg amoxicillin for oral suspension, combined with 25 mg/kg probenecid as a single dose. Note: Since probenecid is contraindicated in children under 2 years, do not use this regimen in children under 2 years of age.2.2 Dosing in Neonates and Infants Aged12 Weeks ( 3 Months)
Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by
Streptococcus pyogenes
to prevent the occurrence of acute rheumatic fever. Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin for oral suspension is
30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function.
2.3 Dosing for H. pylori Infection
Triple Therapy:
The recommended adult oral dose is 1 gram amoxicillin for oral suspension, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days.
Dual Therapy:
The recommended adult oral dose is 1 gram amoxicillin for oral suspension and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days.
Please refer to clarithromycin and lansoprazole full prescribing information.
2.4 Dosing in Renal Impairment
Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of < 30 mL/min. should not receive a 875 mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.2.5 Directions for Mixing Oral Suspension
Tap bottle until all powder flows freely. Add approximately 1/3 of the total amount of water for reconstitution (see Table 2) and shake vigorously to wet powder. Add remainder of the water and again shake vigorously.
Table 2. Amount of Water for Mixing Oral Suspension Strength Bottle Size Amount of Water Required for Reconstitution Oral Suspension 200 mg/5 mL 50 mL 35 mL 75 mL 52 mL 100 mL 69 mL Oral Suspension 400 mg/5 mL 50 mL 35 mL 75 mL 52 mL 100 mL 69 mLAfter reconstitution, the required amount of suspension should be placed directly on the child’s tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately.
NOTE:
SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration is preferable, but not required.
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![Clotrimazole Cream [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=624827d6-dbf8-4f3d-a8c0-c92474cad7de&name=624827d6-dbf8-4f3d-a8c0-c92474cad7de-01.jpg)
Clotrimazole
before using this product read the enclosed educational brochure for complete directions and information adults and children 12 years of age and over: vaginal cream: insert one applicatorful of cream into the vagina at bedtime for 7 days in a row. Wash applicator after each use. external cream: use the same tube of cream if you have itching and irritation on the skin outside the vagina. Squeeze a small amount of cream onto your fingertip. Apply to itchy, irritated skin outside the vagina. Use 2 times daily for up to 7 days as needed. children under 12 years of age: ask a doctor
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![Erythromycin Ointment [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=3c1a0020-f3aa-49c9-89ff-b5c548494619&name=3c1a0020-f3aa-49c9-89ff-b5c548494619-03.jpg)
Erythromycin Ointment
In the treatment of superficial ocular infections, a ribbon approximately 1 cm in length of Erythromycin Ophthalmic Ointment should be applied directly to the infected structure up to 6 times daily, depending on the severity of the infection.
For prophylaxis of neonatal gonococcal or chlamydial conjunctivitis, a ribbon of ointment approximately 1 cm in length should be instilled into each lower conjunctival sac. The ointment should not be flushed from the eye following instillation. A new tube should be used for each infant.
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![Cetirizine Hydrochloride Syrup [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=3a412d83-bc2c-45c6-bb1b-c1e02c2e3e18&name=9d529239-be05-4022-8864-43b07b2e02c2-02.jpg)
Cetirizine Hydrochloride Syrup
Cetirizine hydrochloride syrup (cetirizine hydrochloride oral solution) can be taken without regard to food consumption.
Children 2 to 5 Years for Chronic Urticaria:
The recommended initial dose of cetirizine hydrochloride syrup (cetirizine hydrochloride oral solution) in children aged 2 to 5 years is 2.5 mg (½ teaspoonful) syrup once daily. The dosage in this age group can be increased to a maximum dose of 5 mg per day given as 1 teaspoonful syrup once a day, or one ½ teaspoonful syrup given every 12 hours.
Children 6 months to <2 years for Perennial Allergic Rhinitis and Chronic Urticaria:
The recommended dose of cetirizine hydrochloride syrup (cetirizine hydrochloride oral solution) in children 6 months to 23 months of age is 2.5 mg (½ teaspoonful) once daily. The dose in children 12 to 23 months of age can be increased to a maximum dose of 5 mg per day, given as ½ teaspoonful (2.5 mg) every 12 hours.
Children 2 to 5 Years for Chronic Urticaria:
The recommended initial dose of cetirizine hydrochloride syrup (cetirizine hydrochloride oral solution) in children aged 2 to 5 years is 2.5 mg (½ teaspoonful) syrup once daily. The dosage in this age group can be increased to a maximum dose of 5 mg per day given as 1 teaspoonful syrup once a day, or one ½ teaspoonful syrup given every 12 hours.
Children 6 months to <2 years for Perennial Allergic Rhinitis and Chronic Urticaria:
The recommended dose of cetirizine hydrochloride syrup (cetirizine hydrochloride oral solution) in children 6 months to 23 months of age is 2.5 mg (½ teaspoonful) once daily. The dose in children 12 to 23 months of age can be increased to a maximum dose of 5 mg per day, given as ½ teaspoonful (2.5 mg) every 12 hours.
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![Quazepam Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=5521d2b6-c792-424c-b6cd-680c3d2e2c10&name=5521d2b6-c792-424c-b6cd-680c3d2e2c10-02.jpg)
Quazepam
Use the lowest dose effective for the patient, as important adverse effects of QUAZEPAM are dose related.
The recommended initial dose is 7.5 mg. The 7.5 mg dose can be increased to 15 mg if necessary for efficacy.
The 7.5 mg dose can be achieved by splitting the 15 mg tablet along the score line.
2.1 Special Populations
Elderly and debilitated patients may be more sensitive to benzodiazepines.
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![Hydrocortisone Acetate Suppository [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=39e14cf5-2463-41e1-95cc-5df97b2a3052&name=39e14cf5-2463-41e1-95cc-5df97b2a3052-02.jpg)
Hydrocortisone Acetate Suppository
Usual dosage:
One suppository in the rectum morning and night for two weeks, in nonspecific proctitis. In more severe cases, one suppository three times daily; or two suppositories twice daily. In factitial proctitis, recommended therapy is six to eight weeks or less, according to response.
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![Atenolol Tablet [Ncs Healthcare Of Ky, Inc Dba Vangard Labs]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=4220ded0-36b2-4e48-8280-aecfce89ebe2&name=levothyroxine-sodium-tablets-usp-5.jpg)
Atenolol
General Principles:
The goal of replacement therapy is to achieve and maintain a clinical and biochemical euthyroid state. The goal of suppressive therapy is to inhibit growth and/or function of abnormal thyroid tissue. The dose of Levothyroxine Sodium Tablets, USP that is adequate to achieve these goals depends on a variety of factors including the patient's age, body weight, cardiovascular status, concomitant medical conditions, including pregnancy, concomitant medications, and the specific nature of the condition being treated (see WARNINGS and PRECAUTIONS). Hence, the following recommendations serve only as dosing guidelines. Dosing must be individualized and adjustments made based on periodic assessment of the patient's clinical response and laboratory parameters (see PRECAUTIONS, Laboratory Tests).
Levothyroxine Sodium Tablets, USP should be taken in the morning on an empty stomach, at least one-half hour to one hour before any food is eaten. Levothyroxine Sodium Tablets, USP should be taken at least 4 hours apart from drugs that are known to interfere with its absorption (see PRECAUTIONS, Drug Interactions).
Due to the long half-life of levothyroxine, the peak therapeutic effect at a given dose of levothyroxine sodium may not be attained for 4-6 weeks.
Caution should be exercised when administering Levothyroxine Sodium Tablets, USP to patients with underlying cardiovascular disease, to the elderly, and to those with concomitant adrenal insufficiency (see PRECAUTIONS).
Specific Patient Populations:
Hypothyroidism in Adults and in Children in Whom Growth and Puberty are Complete (see WARNINGS and PRECAUTIONS, Laboratory Tests).
Therapy may begin at full replacement doses in otherwise healthy individuals less than 50 years old and in those older than 50 years who have been recently treated for hyperthyroidism or who have been hypothyroid for only a short time (such as a few months). The average full replacement dose of levothyroxine sodium is approximately 1.7 mcg/kg/day (e.g., 100-125 mcg/day for a 70 kg adult). Older patients may require less than 1 mcg/kg/day. Levothyroxine sodium doses greater than 200 mcg/day are seldom required. An inadequate response to daily doses ≥ 300 mcg/day is rare and may indicate poor compliance, malabsorption, and/or drug interactions.
For most patients older than 50 years or for patients under 50 years of age with underlying cardiac disease, an initial starting dose of 25-50 mcg/day of levothyroxine sodium is recommended, with gradual increments in dose at 6-8 week intervals, as needed. The recommended starting dose of levothyroxine sodium in elderly patients with cardiac disease is 12.5-25 mcg/day, with gradual dose increments at 4-6 week intervals. The levothyroxine sodium dose is generally adjusted in 12.5-25 mcg increments until the patient with primary hypothyroidism is clinically euthyroid and the serum TSH has normalized.
In patients with severe hypothyroidism, the recommended initial levothyroxine sodium dose is 12.5-25 mcg/day with increases of 25 mcg/day every 2-4 weeks, accompanied by clinical and laboratory assessment, until the TSH level is normalized.
In patients with secondary (pituitary) or tertiary (hypothalamic) hypothyroidism, the levothyroxine sodium dose should be titrated until the patient is clinically euthyroid and the serum free-T4 level is restored to the upper half of the normal range.
Pediatric Dosage - Congenital or Acquired Hypothyroidism (see PRECAUTIONS, Laboratory Tests)
General Principles
In general, levothyroxine therapy should be instituted at full replacement doses as soon as possible. Delays in diagnosis and institution of therapy may have deleterious effects on the child's intellectual and physical growth and development.
Undertreatment and overtreatment should be avoided (see PRECAUTIONS, Pediatric Use).
Levothyroxine Sodium Tablets, USP may be administered to infants and children who cannot swallow intact tablets by crushing the tablet and suspending the freshly crushed tablet in a small amount (5-10 mL or 1-2 teaspoons) of water. This suspension can be administered by spoon or dropper. DO NOT STORE THE SUSPENSION. Foods that decrease absorption of levothyroxine, such as soybean infant formula, should not be used for administering levothyroxine sodium tablets. (see PRECAUTIONS, Drug-Food Interactions).
Newborns
The recommended starting dose of levothyroxine sodium in newborn infants is 10-15 mcg/kg/day. A lower starting dose (e.g., 25 mcg/day) should be considered in infants at risk for cardiac failure, and the dose should be increased in 4-6 weeks as needed based on clinical and laboratory response to treatment. In infants with very low (< 5 mcg/dL) or undetectable serum T4 concentrations, the recommended initial starting dose is 50 mcg/day of levothyroxine sodium.
Infants and Children
Levothyroxine therapy is usually initiated at full replacement doses, with the recommended dose per body weight decreasing with age (see TABLE 3). However, in children with chronic or severe hypothyroidism, an initial dose of 25 mcg/day of levothyroxine sodium is recommended with increments of 25 mcg every 2-4 weeks until the desired effect is achieved.
Hyperactivity in an older child can be minimized if the starting dose is one-fourth of the recommended full replacement dose, and the dose is then increased on a weekly basis by an amount equal to one-fourth the full-recommended replacement dose until the full recommended replacement dose is reached.
Table 3: Levothyroxine Sodium Dosing Guidelines for Pediatric Hypothyroidism a. The dose should be adjusted based on clinical response and laboratory parameters (see PRECAUTlONS, Laboratory Tests and Pediatric Use).AGE
Daily Dose Per Kg Body Weighta
0-3 months
10-15 mcg/kg/day
3-6 months
8-10 mcg/kg/day
6-12 months
6-8 mcg/kg/day
1-5 years
5-6 mcg/kg/day
6-12 years
4-5 mcg/kg/day
>12 years but growth and puberty incomplete
2-3 mcg/kg/day
Growth and puberty complete
1.7 mcg/kg/day
Pregnancy- Pregnancy may increase levothyroxine requirements (see PREGNANCY).
Subclinical Hypothyroidism- If this condition is treated, a lower levothyroxine sodium dose (e.g., 1 mcg/kg/day) than that used for full replacement may be adequate to normalize the serum TSH level. Patients who are not treated should be monitored yearly for changes in clinical status and thyroid laboratory parameters.
TSH Suppression in Well-differentiated Thyroid Cancer and Thyroid Nodules- The target level for TSH suppression in these conditions has not been established with controlled studies. In addition, the efficacy of TSH suppression for benign nodular disease is controversial. Therefore, the dose of Levothyroxine Sodium Tablets, USP used for TSH suppression should be individualized based on the specific disease and the patient being treated.
In the treatment of well differentiated (papillary and follicular) thyroid cancer, levothyroxine is used as an adjunct to surgery and radioiodine therapy. Generally, TSH is suppressed to <0.1 mU/L, and this usually requires a levothyroxine sodium dose of greater than 2 mcg/kg/day. However, in patients with high-risk tumors, the target level for TSH suppression may be <0.01 mU/L.
In the treatment of benign nodules and nontoxic multinodular goiter, TSH is generally suppressed to a higher target (e.g., 0.1-0.5 mU/L for nodules and 0.5-1.0 mU/L for multinodular goiter) than that used for the treatment of thyroid cancer. Levothyroxine sodium is contraindicated if the serum TSH is already suppressed due to the risk of precipitating overt thyrotoxicosis (see CONTRAINDICATIONS, WARNINGS and PRECAUTIONS).
Myxedema Coma - Myxedema coma is a life-threatening emergency characterized by poor circulation and hypometabolism, and may result in unpredictable absorption of levothyroxine sodium from the gastrointestinal tract. Therefore, oral thyroid hormone drug products are not recommended to treat this condition. Thyroid hormone products formulated for intravenous administration should be administered.
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![Ibuprofen Suspension [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=29fa276b-86d4-4128-ae89-5e7d035a75b4&name=54c7dce2-7ec4-4b07-bf60-1bc910381c3d-03.jpg)
Ibuprofen Suspension
Carefully consider the potential benefits and risks of Ibuprofen Oral Suspension and other treatment options before deciding to use Ibuprofen Oral Suspension. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with Ibuprofen Oral Suspension, the dose and frequency should be adjusted to suit an individual patient's needs.
PEDIATRIC PATIENTS
Fever Reduction:
For reduction of fever in children, 6 months up to 2 years of age, the dosage should be adjusted on the basis of the initial temperature level (see CLINICAL PHARMACOLOGY). The recommended dose is 5 mg/kg if the baseline temperature is less than 102.5°F, or 10 mg/kg if the baseline temperature is 102.5°F or greater. The duration of fever reduction is generally 6 to 8 hours. The recommended maximum daily dose is 40 mg/kg.
Analgesia:
For relief of mild to moderate pain in children 6 months up to 2 years of age, the recommended dosage is 10 mg/kg, every 6 to 8 hours. The recommended maximum daily dose is 40 mg/kg. Doses should be given so as not to disturb the child's sleep pattern.
Juvenile Arthritis:
The recommended dose is 30 to 40 mg/kg/day divided into three to four doses (see Individualization of Dosage). Patients with milder disease may be adequately treated with 20 mg/kg/day.
In patients with juvenile arthritis, doses above 50 mg/kg/day are not recommended because they have not been studied and doses exceeding the upper recommended dose of 40 mg/kg/day may increase the
risk of causing serious adverse events. The therapeutic response may require from a few days to several weeks to be achieved. Once a clinical effect is obtained, the dosage should be lowered to the smallest dose of ibuprofen needed to maintain adequate control of symptoms.
Pediatric patients receiving doses above 30 mg/kg/day or if abnormal liver function tests have occurred with previous NSAID treatments should be carefully followed for signs and symptoms of early liver dysfunction.
ADULTS
Primary Dysmenorrhea:
For the treatment of primary dysmenorrhea, beginning with the earliest onset of such pain, Ibuprofen Oral Suspension should be given in a dose of 400 mg every 4 hours, as necessary, for the relief of pain.
Rheumatoid Arthritis and Osteoarthritis:
Suggested dosage: 1200-3200 mg daily (300 mg q.i.d. or 400 mg, 600 mg or 800 mg t.i.d. or q.i.d.). Individual patients may show a better response to 3200 mg daily, as compared with 2400 mg, although in well-controlled clinical trials patients on 3200 mg did not show a better mean response in terms of efficacy. Therefore, when treating patients with 3200 mg/day, the physician should observe sufficient increased clinical benefits to offset potential increased risk.
Individualization of Dosage:
The dose of Ibuprofen Oral Suspension should be tailored to each patient, and may be lowered or raised from the suggested doses depending on the severity of symptoms either at time of initiating drug therapy or as the patient responds or fails to respond.
One fever study showed that, after the initial dose of ibuprofen oral suspension, subsequent doses may be lowered and still provide adequate fever control.
In a situation when low fever would require the ibuprofen oral suspension 5 mg/kg dose in a child with pain, the dose that will effectively treat the predominant symptom should be chosen.
In chronic conditions, a therapeutic response to ibuprofen oral suspension therapy is sometimes seen in a few days to a week, but most often is observed by two weeks. After a satisfactory response has been achieved, the patient's dose should be reviewed and adjusted as required.
Patients with rheumatoid arthritis seem to require higher doses than do patients with osteoarthritis. The smallest dose of Ibuprofen Oral Suspension that yields acceptable control should be employed.
Ibuprofen Oral Suspension may be used in combination with gold salts and/or corticosteroids.
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![Cimetidine Tablet, Film Coated [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=89c78896-7b10-4612-90dd-60f952937685&name=351bdcf3-3491-4a55-a27e-50fad226b49b-02.jpg)
Cimetidine
Duodenal Ulcer
Active Duodenal Ulcer
Clinical studies have indicated that suppression of nocturnal acid is the most important factor in duodenal ulcer healing (see CLINICAL PHARMACOLOGY, Acid Secretion). This is supported by recent clinical trials (see Clinical Trials, Active duodenal ulcer). Therefore, there is no apparent rationale, except for familiarity with use, for treating with anything other than a once-daily at bedtime oral dosage regimen.
In a U.S. oral dose-ranging study of 400 mg at bedtime, 800 mg at bedtime and 1600 mg at bedtime, a continuous dose response relationship for ulcer healing was demonstrated.
However, 800 mg at bedtime is the dose of choice for most patients, as it provides a high healing rate (the difference between 800 mg at bedtime and 1600 mg at bedtime being small), maximal pain relief, a decreased potential for drug interactions (see PRECAUTIONS, Drug Interactions) and maximal patient convenience. Patients unhealed at four weeks, or those with persistent symptoms, have been shown to benefit from two to four weeks of continued therapy.
It has been shown that patients who both have an endoscopically demonstrated ulcer larger than 1 cm and are also heavy smokers (i.e., smoke one pack of cigarettes or more per day) are more difficult to heal. There is some evidence which suggests that more rapid healing can be achieved in this subpopulation with cimetidine 1600 mg at bedtime. While early pain relief with either 800 mg at bedtime or 1600 mg at bedtime is equivalent in all patients, 1600 mg at bedtime provides an appropriate alternative when it is important to ensure healing within four weeks for this subpopulation. Alternatively, approximately 94% of all patients will also heal in eight weeks with cimetidine 800 mg at bedtime.
Other cimetidine oral regimens in the U.S. which have been shown to be effective are: 300 mg four times daily, with meals and at bedtime, the original regimen with which U.S. physicians have the most experience, and 400 mg twice daily, in the morning and at bedtime (see Clinical Trials, Active duodenal ulcer).
Concomitant antacids should be given as needed for relief of pain. However, simultaneous administration of oral cimetidine and antacids is not recommended, since antacids have been reported to interfere with the absorption of cimetidine.
While healing with cimetidine often occurs during the first week or two, treatment should be continued for 4 to 6 weeks unless healing has been demonstrated by endoscopic examination.
Maintenance Therapy for Duodenal Ulcer
In those patients requiring maintenance therapy, the recommended adult oral dose is 400 mg at bedtime.
Active Benign Gastric Ulcer
The recommended adult oral dosage for short-term treatment of active benign gastric ulcer is 800 mg at bedtime, or 300 mg four times a day with meals and at bedtime. Controlled clinical studies were limited to six weeks of treatment (see Clinical Trials). 800 mg at bedtime is the preferred regimen for most patients based upon convenience and reduced potential for drug interactions. Symptomatic response to cimetidine dose not preclude the presence of a gastric malignancy. It is important to follow gastric ulcer patients to assure rapid progress to complete healing.
Erosive Gastroesophageal Reflux Disease (GERD)
The recommended adult oral dosage for the treatment of erosive esophagitis that has been diagnosed by endoscopy is 1600 mg daily in divided doses (800 mg twice daily or 400 mg four times daily) for 12 weeks. The use of cimetidine beyond 12 weeks has not been established.
Pathological Hypersecretory Conditions (such as Zollinger-Ellison Syndrome)
Recommended adult oral dosage: 300 mg four times a day with meals at bedtime. In some patients it may be necessary to administer higher doses more frequently. Doses should be adjusted to individual patient needs, but should not usually exceed 2400 mg per day and should continue as long as clinically needed.
Dosage Adjustments for Patients with Impaired Renal Function
Patients with severely impaired renal function have been treated with cimetidine. However, such dosage has been very limited. On the basis of this experience the recommended dosage is 300 mg every 12 hours orally. Should the patient’s condition require, the frequency of dosing may be increased to every 8 hours or even further with caution. In severe renal failure, accumulation may occur and the lower frequency of dosing comparable with an adequate patient response should be used. When liver impairment is also present, further reductions in dosage may be necessary. Hemodialysis reduces the level of circulating cimetidine. Ideally, the dosage schedule should be adjusted so that the timing of a scheduled dose coincides with the end of hemodialysis.
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![Methylprednisolone Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=ebe4f4a5-3fec-4f30-8289-25e594162c49&name=ebe4f4a5-3fec-4f30-8289-25e594162c49-02.jpg)
Methylprednisolone
The initial dosage of Methylprednisolone Tablets may vary from 4 mg to 48 mg of methylprednisolone per day depending on the specific disease entity being treated. In situations of less severity lower doses will generally suffice while in selected patients higher initial doses may be required. The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time there is a lack of satisfactory clinical response, Methylprednisolone should be discontinued and the patient transferred to other appropriate therapy.
IT SHOULD BE EMPHASIZED THAT DOSAGE REQUIREMENTS ARE VARIABLE AND MUST BE INDIVIDUALIZED ON THE BASIS OF THE DISEASE UNDER TREATMENT AND THE RESPONSE OF THE PATIENT. After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. It should be kept in mind that constant monitoring is needed in regard to drug dosage. Included in the situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient's individual drug responsiveness, and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment; in this latter situation it may be necessary to increase the dosage of Methylprednisolone for a period of time consistent with the patient's condition. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.
Multiple Sclerosis: In treatment of acute exacerbations of multiple sclerosis daily doses of 200 mg of prednisolone for a week followed by 80 mg every other day for 1 month have been shown to be effective (4 mg of methylprednisolone is equivalent to 5 mg of prednisolone).
ADT (Alternative Day Therapy): Alternative day therapy is a corticosteroid dosing regimen in which twice the usual daily dose of corticoid is administered every other morning. The purpose of this mode of therapy is to provide the patient requiring long-term pharmacologic dose treatment with the beneficial effects of corticoids while minimizing certain undesirable effects, including pituitary-adrenal suppression, the Cushingoid state, Corticoid withdrawal symptoms, and growth suppression in children.
The rationale for this treatment schedule is based on two major premises: (a) the anti-inflammatory or therapeutic effect of corticoids persists longer than their physical presence and metabolic effects and (b) administration of the corticosteroid every other morning allows for reestablishment of more nearly normal hypothalamic-pituitary-adrenal (HPA) activity on the off-steroid day.
A brief review of the HPA physiology may be helpful in understanding this rationale. Acting primarily through the hypothalamus a fall in free cortisol stimulates the pituitary gland to produce increasing amounts of corticotropin (ACTH) while a rise in free cortisol inhibits ACTH secretion. Normally the HPA system is characterized by diurnal (circadian) rhythm. Serum levels of ACTH rise from a low point about 10 pm to a peak level about 6 am. Increasing levels of ACTH stimulate adrenal cortical activity resulting in a rise in plasma cortisol with maximal levels occurring between 2 am and 8 am. This rise in cortisol dampens ACTH production and in turn adrenal cortical activity. There is a gradual fall in plasma corticoids during the day with lowest levels occurring about midnight.
The diurnal rhythm of the HPA axis is lost in Cushing's disease, a syndrome of adrenal cortical hyperfunction characterized by obesity with centripetal fat distribution, thinning of the skin with easy bruisability, muscle wasting with weakness, hypertension, latent diabetes, osteoporosis, electrolyte imbalance, etc. The same clinical findings of hyperadrenocorticism may be noted during long-term pharmacologic dose corticoid therapy administered in conventional daily divided doses. It would appear, then, that a disturbance in the diurnal cycle with maintenance of elevated corticoid values during the night may play a significant role in the development of undesirable corticoid effects. Escape from these constantly elevated plasma levels for even short periods of time may be instrumental in protecting against undesirable pharmacologic effects.
During conventional pharmacologic dose corticosteroid therapy, ACTH production is inhibited with subsequent suppression of cortisol production by the adrenal cortex. Recovery time for normal HPA activity is variable depending upon the dose and duration of treatment. During this time the patient is vulnerable to any stressful situation. Although it has been shown that there is considerably less adrenal suppression following a single morning dose of prednisolone (10 mg) as opposed to a quarter of that dose administered every six hours, there is evidence that some suppressive effect on adrenal activity may be carried over into the following day when pharmacologic doses are used. Further, it has been shown that a single dose of certain corticosteroids will produce adrenal cortical suppression for two or more days. Other corticoids, including methylprednisolone, hydrocortisone, prednisone, and prednisolone, are considered to be short acting (producing adrenal cortical suppression for 1 1/4 to 1 1/2 days following a single dose) and thus are recommended for alternate day therapy.
The following should be kept in mind when considering alternate day therapy:
Basic principles and indications for corticosteroid therapy should apply. The benefits of ADT should not encourage the indiscriminate use of steroids. ADT is a therapeutic technique primarily designed for patients in whom long-term pharmacologic corticoid therapy is anticipated. In less severe disease processes in which corticoid therapy is indicated, it may be possible to initiate treatment with ADT. More severe disease states usually will require daily divided high dose therapy for initial control of the disease process. The initial suppressive dose level should be continued until satisfactory clinical response is obtained, usually four to ten days in the case of many allergic and collagen diseases. It is important to keep the period of initial suppressive dose as brief as possible particularly when subsequent use of alternate day therapy is intended. Once control has been established, two courses are available: (a) change to ADT and then gradually reduce the amount of corticoid given every other day or (b) following control of the disease process reduce the daily dose of corticoid to the lowest effective level as rapidly as possible and then change over to an alternate day schedule. Theoretically, course (a) may be preferable. Because of the advantages of ADT, it may be desirable to try patients on this form of therapy who have been on daily corticoids for long periods of time (eg, patients with rheumatoid arthritis). Since these patients may already have a suppressed HPA axis, establishing them on ADT may be difficult and not always successful. However, it is recommended that regular attempts be made to change them over. It may be helpful to triple or even quadruple the daily maintenance dose and administer this every other day rather than just doubling the daily dose if difficulty is encountered. Once the patient is again controlled, an attempt should be made to reduce this dose to a minimum. As indicated above, certain corticosteroids, because of their prolonged suppressive effect on adrenal activity, are not recommended for alternate day therapy (eg, dexamethasone and betamethasone). The maximal activity of the adrenal cortex is between 2 am and 8 am, and it is minimal between 4 pm and midnight. Exogenous corticosteroids suppress adrenocortical activity the least, when given at the time of maximal activity (am). In using ADT it is important, as in all therapeutic situations to individualize and tailor the therapy to each patient. Complete control of symptoms will not be possible in all patients. An explanation of the benefits of ADT will help the patient to understand and tolerate the possible flare-up in symptoms which may occur in the latter part of the off-steroid day. Other symptomatic therapy may be added or increased at this time if needed. In the event of an acute flare-up of the disease process, it may be necessary to return to a full suppressive daily divided corticoid dose for control. Once control is again established alternate day therapy may be reinstituted. Although many of the undesirable features of corticosteroid therapy can be minimized by ADT, as in any therapeutic situation, the physician must carefully weigh the benefit-risk ratio for each patient in whom corticoid therapy is being considered. -
![Citalopram Tablet [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=3da2a185-28af-418f-bc86-fd1ed50e2de0&name=8f6f6c40-f8d7-4c3c-a570-86ec234c6f73-02.jpg)
Citalopram
Initial Treatment
Citalopram should be administered at an initial dose of 20 mg once daily, generally with an increase to a dose of 40 mg/day. Dose increases should usually occur in increments of 20 mg at intervals of no less than one week. Although certain patients may require a dose of 60 mg/day, the only study pertinent to dose response for effectiveness did not demonstrate an advantage for the 60 mg/day dose over the 40 mg/day dose; doses above 40 mg are therefore not ordinarily recommended.
Citalopram tablets should be administered once daily, in the morning or evening, with or without food.
Special Populations
20 mg/day is the recommended dose for most elderly patients and patients with hepatic impairment, with titration to 40 mg/day only for nonresponding patients.
No dosage adjustment is necessary for patients with mild or moderate renal impairment. Citalopram tablets should be used with caution in patients with severe renal impairment.
Treatment of Pregnant Women During the Third Trimester
Neonates exposed to Citalopram tablets and other SSRIs or SNRIs, late in the third trimester, have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding (see PRECAUTIONS). When treating pregnant women with Citalopram tablets during the third trimester, the physician should carefully consider the potential risks and benefits of treatment. The physician may consider tapering Citalopram tablets in the third trimester.
Maintenance Treatment
It is generally agreed that acute episodes of depression require several months or longer of sustained pharmacologic therapy. Systematic evaluation of Citalopram tablets in two studies has shown that its antidepressant efficacy is maintained for periods of up to 24 weeks following 6 or 8 weeks of initial treatment (32 weeks total). In one study, patients were assigned randomly to placebo or to the same dose of Citalopram tablets (20-60 mg/day) during maintenance treatment as they had received during the acute stabilization phase, while in the other study, patients were assigned randomly to continuation of Citalopram tablets 20 or 40 mg/day, or placebo, for maintenance treatment. In the latter study, the rates of relapse to depression were similar for the two dose groups (see Clinical Trials under CLINICAL PHARMACOLOGY). Based on these limited data, it is not known whether the dose of citalopram needed to maintain euthymia is identical to the dose needed to induce remission. If adverse reactions are bothersome, a decrease in dose to 20 mg/day can be considered.
Discontinuation of Treatment with Citalopram tablets
Symptoms associated with discontinuation of Citalopram tablets and other SSRIs and SNRIs have been reported (see PRECAUTIONS). Patients should be monitored for these symptoms when discontinuing treatment. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate.
Switching Patients To or From a Monoamine Oxidase Inhibitor
At least 14 days should elapse between discontinuation of an MAOI and initiation of Citalopram therapy. Similarly, at least 14 days should be allowed after stopping Citalopram before starting a MAOI (see Contraindications and Warnings).
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![Thermazene Silver Sulfadiazine (Silver Sulfadiazine) Cream [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=42c3ece4-0df0-4ed8-ac0f-a65fad19eed7&name=1e2350d2-4579-4c21-b219-f574a28ccd7e-01.jpg)
Thermazene Silver Sulfadiazine
Prompt institution of appropriate regimens for care of the burned patient is of prime importance and includes the control of shock and pain. The burn wounds are then cleansed and debrided; Thermazene Cream is then applied under sterile conditions. The burn areas should be covered with Thermazene Cream at all times. The cream should be applied once to twice daily to a thickness of approximately one sixteenth of an inch. Whenever necessary, the cream should be reapplied to any areas from which it has been removed due to patient activity. Administration may be accomplished in minimal time because dressings are not required. However, if individual patient requirements make dressings necessary, they may be used. Reapply immediately after hydrotherapy. Treatment with Thermazene Cream should be continued until satisfactory healing has occurred or until the burn site is ready for grafting. The drug should not be withdrawn from the therapeutic regimen while there remains the possibility of infection except if a significant adverse reaction occurs.
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![Clotrimazole Cream [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=35fcd59e-9d23-468f-9168-a5fc8513a3f9&name=35fcd59e-9d23-468f-9168-a5fc8513a3f9-01.jpg)
Clotrimazole
Clean the affected area and dry thoroughly. Apply a thin layer of this product over affected area twice daily (morning and night), or as directed by a doctor. Supervise children in the use of this product. For athlete's foot, pay special attention to the spaces between the toes; wear well-fitting ventilated shoes, and change shoes and socks at least once daily. For athlete's foot and ringworm, use daily for 4 weeks. For jock itch, use daily for 2 weeks. If conditions persists longer, consult a doctor. This product is not effective on the scalp or nails.
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![Clonidine Hydrochloride Tablet [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=bceab3bd-04d4-46b1-8ded-0e79b0a30740&name=14603059-8773-43b1-adb5-ff3fbed2e5d8-03.jpg)
Clonidine Hydrochloride
Adults: The dose of clonidine hydrochloride tablets, USP must be adjusted according to the patient’s individual blood pressure response. The following is a general guide to its administration.
Initial Dose: 0.1 mg tablet twice daily (morning and bedtime). Elderly patients may benefit from a lower initial dose.
Maintenance Dose: Further increments of 0.1 mg per day may be made at weekly intervals if necessary until the desired response is achieved. Taking the larger portion of the oral daily dose at bedtime may minimize transient adjustment effects of dry mouth and drowsiness. The therapeutic doses most commonly employed have ranged from 0.2 mg to 0.6 mg per day given in divided doses.
Studies have indicated that 2.4 mg is the maximum effective daily dose, but doses as high as this have rarely been employed.
Renal Impairment: Patients with renal impairment may benefit from a lower initial dose. Patients should be carefully monitored. Since only a minimal amount of clonidine is removed during routine hemodialysis, there is no need to give supplemental clonidine following dialysis.
For questions regarding this product call Actavis at 1-800-432-8534.
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![Clobetasol Propionate Ointment [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=81af9a4d-99c9-4c18-92e6-6eae29a013d8&name=a6263943-bd35-4964-9db0-992553c3fa8e-02.jpg)
Clobetasol Propionate Ointment
Apply a thin layer of clobetasol propionate cream or ointment to the affected skin areas twice daily and rub in gently and completely (see INDICATIONS AND USAGE).
Clobetasol propionate cream and ointment are super-high potency topical corticosteroids; therefore, treatment should be limited to 2 consecutive weeks and amounts greater than 50 g/week should not be used.
As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.
Clobetasol propionate cream and ointment should not be used with occlusive dressings.
Geriatric Use
In studies where geriatric patients (65 years of age or older, see PRECAUTIONS) have been treated with clobetasol propionate cream or ointment, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended.
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![Sunmark Z Sleep (Diphenhydramine Hcl) Liquid [Mckesson]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=71fd8809-bbbb-44c3-add8-67d5afcbb8a8&name=image-01.jpg)
Sunmark Z Sleep
• do not take more than 6 doses in any 24-hour period repeat dose every 4 hours
Adult and children 12 years and over
2 teaspoonfuls
Children under 12 years
DO NOT USE
Other information store at room temperature 20°-25°C (68°-77°F) Phenylketonurics: contains phenylalanine 3 mg per teaspoonful (5 mL)
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![Clonidine Hydrochloride Tablet [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=045ce36b-b8fc-4875-b2b8-9be9d5493bba&name=7ced4016-b788-4256-8dbe-94e1e6b392f6-03.jpg)
Clonidine Hydrochloride
Adults: The dose of clonidine hydrochloride tablets, USP must be adjusted according to the patient’s individual blood pressure response. The following is a general guide to its administration.
Initial Dose: 0.1 mg tablet twice daily (morning and bedtime). Elderly patients may benefit from a lower initial dose.
Maintenance Dose: Further increments of 0.1 mg per day may be made at weekly intervals if necessary until the desired response is achieved. Taking the larger portion of the oral daily dose at bedtime may minimize transient adjustment effects of dry mouth and drowsiness. The therapeutic doses most commonly employed have ranged from 0.2 mg to 0.6 mg per day given in divided doses.
Studies have indicated that 2.4 mg is the maximum effective daily dose, but doses as high as this have rarely been employed.
Renal Impairment: Patients with renal impairment may benefit from a lower initial dose. Patients should be carefully monitored. Since only a minimal amount of clonidine is removed during routine hemodialysis, there is no need to give supplemental clonidine following dialysis.
For questions regarding this product call Actavis at 1-800-432-8534.
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![Doxycycline Hyclate Capsule [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=fd185704-9d91-4999-8c87-bd3cb5085e15&name=79eb9a46-668b-4eaf-a3ea-8670724a4edd-02.jpg)
Doxycycline Hyclate
In the treatment of superficial ocular infections, a ribbon approximately 1 cm in length of Erythromycin Opthalmic Ointment should be applied directly to the infected structure up to 6 times daily, depending on the severity of the infection.
For prophylaxis of neonatal gonococcal or chlamydial conjunctivitis, a ribbon of ointment approximately 1 cm in length should be instilled into each lower conjunctival sac. The ointment should not be flushed from the eye following instillation. A new tube should be used for each infant.
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![Atorvastatin Calcium Tablet, Film Coated [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=7ba5c4ab-e385-4803-9a5c-ea7eafad550f&name=a61b1da3-cc66-41ef-8de1-494bcee448c6-05.jpg)
Atorvastatin Calcium
2.1 Hyperlipidemia (Heterozygous Familial and Nonfamilial) and Mixed Dyslipidemia (Fredrickson Types IIa and IIb)
The recommended starting dose of atorvastatin calcium tablets is 10 or 20 mg once daily. Patients who require a large reduction in LDL-C (more than 45%) may be started at 40 mg once daily. The dosage range of atorvastatin calcium tablets is 10 to 80 mg once daily. Atorvastatin calcium tablets can be administered as a single dose at any time of the day, with or without food. The starting dose and maintenance doses of atorvastatin calcium tablets should be individualized according to patient characteristics such as goal of therapy and response (see current NCEP Guidelines). After initiation and/or upon titration of atorvastatin calcium tablets, lipid levels should be analyzed within 2 to 4 weeks and dosage adjusted accordingly.
2.2 Heterozygous Familial Hypercholesterolemia in Pediatric Patients (10 to 17 years of age)
The recommended starting dose of atorvastatin calcium tablets is 10 mg/day; the maximum recommended dose is 20 mg/day (doses greater than 20 mg have not been studied in this patient population). Doses should be individualized according to the recommended goal of therapy [see current NCEP Pediatric Panel Guidelines, Clinical Pharmacology (12), and Indications and Usage (1.2)]. Adjustments should be made at intervals of 4 weeks or more.
2.3 Homozygous Familial Hypercholesterolemia
The dosage of atorvastatin calcium tablets in patients with homozygous FH is 10 to 80 mg daily. Atorvastatin calcium tablets should be used as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) in these patients or if such treatments are unavailable.
2.4 Concomitant Lipid-Lowering Therapy
Atorvastatin calcium tablets may be used with bile acid resins. The combination of HMG-CoA reductase inhibitors (statins) and fibrates should generally be used with caution [see Warnings and Precautions, Skeletal Muscle (5.1), Drug Interactions (7)].
2.5 Dosage in Patients With Renal Impairment
Renal disease does not affect the plasma concentrations nor LDL-C reduction of atorvastatin; thus, dosage adjustment in patients with renal dysfunction is not necessary [see Warnings and Precautions, Skeletal Muscle (5.1), Clinical Pharmacology, Pharmacokinetics (12.3)].
2.6 Dosage in Patients Taking Cyclosporine, Clarithromycin, Itraconazole, or Certain Protease Inhibitors
In patients taking cyclosporine or the HIV protease inhibitors (tipranavir plus ritonavir) or the hepatitis C protease inhibitor (telaprevir), therapy with atorvastatin should be avoided. In patients with HIV taking lopinavir plus ritonavir, caution should be used when prescribing atorvastatin and the lowest dose necessary employed. In patients taking clarithromycin, itraconazole, or in patients with HIV taking a combination of saquinavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, or fosamprenavir plus ritonavir, therapy with atorvastatin should be limited to 20 mg, and appropriate clinical assessment is recommended to ensure that the lowest dose necessary of atorvastatin is employed. In patients taking the HIV protease inhibitor nelfinavir or the hepatitis C protease inhibitor boceprevir, therapy with atorvastatin should be limited to 40 mg, and appropriate clinical assessment is recommended to ensure that the lowest dose necessary of atorvastatin is employed [see Warnings and Precautions, Skeletal Muscle (5.1), Drug Interactions (7)].
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![Promethazine Hydrochloride Solution [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=2b1a9b82-4637-4dc9-83c5-ac34cb14372f&name=2b1a9b82-4637-4dc9-83c5-ac34cb14372f-02.jpg)
Promethazine Hydrochloride Solution
It is important that Promethazine HCl Oral Solution is measured with an accurate measuring device (see PRECAUTIONS-Information for Patients). A household teaspoon is not an accurate measuring device and could lead to overdosage, especially when half a teaspoon is to be measured. It is strongly recommended that an accurate measuring device be used. A pharmacist can provide an appropriate device and can provide instructions for measuring the correct dose.
Promethazine HCl Oral Solution is contraindicated for children under 2 years of age (see WARNINGS – Boxed Warning and Use in Pediatric Patients).
Allergy
The average oral dose is 25 mg taken before retiring; however, 12.5 mg may be taken before meals and on retiring, if necessary. Single 25 mg doses at bedtime or 6.25 to 12.5 mg taken three times daily will usually suffice.
After initiation of treatment in children or adults, dosage should be adjusted to the smallest amount adequate to relieve symptoms.
The administration of promethazine HCl in 25 mg doses will control minor transfusion reactions of an allergic nature.
Motion Sickness
The average adult dose is 25 mg taken twice daily. The initial dose should be taken one-half to one hour before anticipated travel and be repeated 8 to 12 hours later, if necessary. On succeeding days of travel, it is recommended that 25 mg be taken on arising and again before the evening meal. For children, 12.5 to 25 mg, twice daily, may be administered.
Nausea and Vomiting
Antiemetics should not be used in vomiting of unknown etiology in children and adolescents (see WARNINGS- Use in Pediatric Patients).
The average effective dose of Promethazine HCl Oral Solution for the active therapy of nausea and vomiting in children or adults is 25 mg. When oral medication cannot be tolerated, the dose should be given parenterally (cf. Promethazine Hydrochloride Injection) or by rectal suppository. 12.5 to 25 mg doses may be repeated, as necessary, at 4 to 6 hour intervals.
For nausea and vomiting in children, the usual dose is 0.5 mg per pound of body weight, and the dose should be adjusted to the age and weight of the patient and the severity of the condition being treated.
For prophylaxis of nausea and vomiting, as during surgery and the postoperative period, the average dose is 25 mg repeated at 4 to 6 hour intervals, as necessary.
Sedation
This product relieves apprehension and induces a quiet sleep from which the patient can be easily aroused. Administration of 12.5 to 25 mg Promethazine HCl Oral Solution by the oral route at bedtime will provide sedation in children. Adults usually require 25 to 50 mg for nighttime, presurgical, or obstetrical sedation.
Pre- and Postoperative Use
Promethazine HCl Oral Solution in 12.5 to 25 mg doses for children and 50 mg doses for adults the night before surgery relieves apprehension and produces a quiet sleep. For preoperative medication children require doses of 0.5 mg per pound of body weight in combination with an appropriately reduced dose of narcotic or barbiturate and the appropriate dose of an atropine-like drug.
Usual adult dosage is 50 mg Promethazine HCl Oral Solution with an appropriately reduced dose of narcotic or barbiturate and the required amount of a belladonna alkaloid.
Postoperative sedation and adjunctive use with analgesics may be obtained by the administration of 12.5 to 25 mg in children and 25 to 50 mg doses in adults.
Promethazine HCl Oral Solution is contraindicated for children under 2 years of age.
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![Terocin (Lidocaine, Menthol) Patch [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=23843354-e242-4a8a-8818-897592d4d9a0&name=23843354-e242-4a8a-8818-897592d4d9a0-01.jpg)
Terocin
Adults and children 12 years and over: Apply patch to affected area 1 to 2 times daily or as directed.
Instructions for use:
Clean and dry the affected area Open pouch and remove one patch Remove any protective film and apply directly to affected area of pain Wash hands with soap and water after applying patch Reseal pouch containing unused patches after each use -
![Childrens Fever Reducer And Pain Reliever (Acetaminophen) Suspension [Rite Aid Corporation]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=afde60c2-55a2-45d8-b381-a6c8896ed896&name=image-01.jpg)
Childrens Fever Reducer And Pain Reliever
Nortriptyline hydrochloride is not recommended for children.
Nortriptyline hydrochloride is administered orally in the form of capsules. Lower than usual dosages are recommended for elderly patients and adolescents. Lower dosages are also recommended for outpatients than for hospitalized patients who will be under close supervision. The physician should initiate dosage at a low level and increase it gradually, noting carefully the clinical response and any evidence of intolerance. Following remission, maintenance medication may be required for a longer period of time at the lowest dose that will maintain remission.
If a patient develops minor side effects, the dosage should be reduced. The drug should be discontinued promptly if adverse effects of a serious nature or allergic manifestations occur.
Usual Adult Dose
25 mg three or four times daily; dosage should begin at a low level and be increased as required. As an alternate regimen, the total daily dosage may be given once a day. When doses above 100 mg daily are administered, plasma levels of nortriptyline should be monitored and maintained in the optimum range of 50 to 150 ng/mL. Doses above 150 mg/day are not recommended.
Elderly and Adolescent Patients
30 to 50 mg/day, in divided doses, or the total daily dosage may be given once a day.
Switching a Patient To or From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders
At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with nortriptyline hydrochloride. Conversely, at least 14 days should be allowed after stopping nortriptyline hydrochloride before starting an MAOI intended to treat psychiatric disorders (see CONTRAINDICATIONS).
Use of Nortriptyline Hydrochloride With Other MAOIs, Such as Linezolid or Methylene Blue
Do not start nortriptyline hydrochloride in a patient who is being treated with linezolid or intravenous methylene blue because there is increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered (see CONTRAINDICATIONS).
In some cases, a patient already receiving nortriptyline hydrochloride therapy may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, nortriptyline hydrochloride should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for two weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with nortriptyline hydrochloride may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue (see WARNINGS).
The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with nortriptyline hydrochloride is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use (see WARNINGS).
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![Rexall Nicotine (Nicotine Polacrilex) Lozenge [Dolgencorp, Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=996c5b2a-cea0-4d8c-8ddb-6f68697e6a08&name=image-01.jpg)
Rexall Nicotine
Each tablet contains: Calcium 20 mg (2% daily value) Store in a dry place at controlled room temperature at 15-30 °C (59°-86° F). Do not expose to excessive heat or moisture.
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![Doxazosin (Doxazosin Mesylate) Tablet [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=d7bb63a9-5ad7-449e-b1f2-7254370bada8&name=a8da6642-94c4-495a-86d6-8c073b73f33c-04.jpg)
Doxazosin
DOSAGE MUST BE INDIVIDUALIZED. The initial dosage of doxazosin tablets USP in patients with hypertension and/or BPH is 1 mg given once daily in the a.m. or p.m. This starting dose is intended to minimize the frequency of postural hypotension and first-dose syncope associated with doxazosin tablets USP. Postural effects are most likely to occur between 2 and 6 hours after a dose. Therefore, blood pressure measurements should be taken during this time period after the first dose and with each increase in dose. If doxazosin tablet USP administration is discontinued for several days, therapy should be restarted using the initial dosing regimen.
Concomitant administration of doxazosin tablets USP with a PDE-5 inhibitor can result in additive blood pressure lowering effects and symptomatic hypotension; therefore, PDE-5 inhibitor therapy should be initiated at the lowest dose in patients taking doxazosin tablets USP.
Benign Prostatic Hyperplasia 1 to 8 mg once daily
The initial dosage of doxazosin mesylate is 1 mg, given once daily in the a.m. or p.m. Depending on the individual patient’s urodynamics and BPH symptomatology, dosage may then be increased to 2 mg and thereafter to 4 mg and 8 mg once daily, the maximum recommended dose for BPH. The recommended titration interval is 1 to 2 weeks. Blood pressure should be evaluated routinely in these patients.
Hypertension 1 to 16 mg once daily
The initial dosage of doxazosin mesylate is 1 mg given once daily. Depending on the individual patient’s standing blood pressure response (based on measurements taken at 2 to 6 hours post-dose and 24 hours post-dose), dosage may then be increased to 2 mg and thereafter if necessary to 4 mg, 8 mg and 16 mg to achieve the desired reduction in blood pressure. Increases in dose beyond 4 mg increase the likelihood of excessive postural effects, including syncope, postural dizziness/vertigo and postural hypotension. At a titrated dose of 16 mg once daily, the frequency of postural effects is about 12% compared to 3% for placebo.
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![Natural Fiber Therapy Natural Laxative (Psyllium Husk) Powder, For Solution [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=9ea01674-ef5f-49ec-a9c2-300bb12d6254&name=9ea01674-ef5f-49ec-a9c2-300bb12d6254-01.jpg)
Natural Fiber Therapy Natural Laxative
Other information
each tablespoon contains: potassium 30 mg; sodium 5 mg store at room temperature, USP protect contents from humidity contains a 100% natural, therapeutic fiber -
![Desipramine Hydrochloride Tablet, Film Coated [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=c7cdd04c-6c34-4780-8b21-a6f9fc74cf46&name=70aa7ff2-5780-4ffb-890f-8c862f535541-02.jpg)
Desipramine Hydrochloride
Not recommended for use in children (see WARNINGS).
Lower dosages are recommended for elderly patients and adolescents. Lower dosages are also recommended for outpatients compared to hospitalized patients, who are closely supervised. Dosage should be initiated at a low level and increased according to clinical response and any evidence of intolerance. Following remission, maintenance medication may be required for a period of time and should be at the lowest dose that will maintain remission.
Usual Adult Dose
The usual adult dose is 100 to 200 mg per day. In more severely ill patients, dosage may be further increased gradually to 300 mg/day if necessary. Dosages above 300 mg/day are not recommended.
Dosage should be initiated at a lower level and increased according to tolerance and clinical response.
Treatment of patients requiring as much as 300 mg should generally be initiated in hospitals, where regular visits by the physician, skilled nursing care, and frequent electrocardiograms (ECGs) are available.
The best available evidence of impending toxicity from very high doses of desipramine is prolongation of the QRS or QT intervals on the ECG. Prolongation of the PR interval is also significant, but less closely correlated with plasma levels. Clinical symptoms of intolerance, especially drowsiness, dizziness, and postural hypotension, should also alert the physician to the need for reduction in dosage.
Initial therapy may be administered in divided doses or a single daily dose.
Maintenance therapy may be given on a once-daily schedule for patient convenience and compliance.
Adolescent and Geriatric Dose
The usual adolescent and geriatric dose is 25 to 100 mg daily.
Dosage should be initiated at a lower level and increased according to tolerance and clinical response to a usual maximum of 100 mg daily. In more severely ill patients, dosage may be further increased to 150 mg/day. Doses above 150 mg/day are not recommended in these age groups.
Initial therapy may be administered in divided doses or a single daily dose.
Maintenance therapy may be given on a once-daily schedule for patient convenience and compliance.
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![Donepezil Hydrochloride Tablet, Film Coated [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=b49afded-0215-4c61-a7aa-932302ade00d&name=797a7a46-f54a-4ef3-9a2e-c5bc31e063fe-12.jpg)
Donepezil Hydrochloride
Donepezil hydrochloride tablets should be taken in the evening, just prior to retiring.
Donepezil hydrochloride tablets can be taken with or without food.
2.1 Mild to Moderate Alzheimer’s Disease
The dosages of donepezil hydrochloride tablets shown to be effective in controlled clinical trials are 5 mg and 10 mg administered once per day.
The higher dose of 10 mg did not provide a statistically significantly greater clinical benefit than 5 mg. There is a suggestion, however, based upon order of group mean scores and dose trend analyses of data from these clinical trials, that a daily dose of 10 mg of donepezil hydrochloride tablets might provide additional benefit for some patients. Accordingly, whether or not to employ a dose of 10 mg is a matter of prescriber and patient preference.
2.2 Severe Alzheimer’s Disease
Donepezil hydrochloride tablets have been shown to be effective in controlled clinical trials at a dose of 10 mg administered once daily.
2.3 Titration
The recommended starting dose of donepezil hydrochloride tablets is 5 mg once daily. Evidence from the controlled trials in mild to moderate Alzheimer’s disease indicates that the 10 mg dose, with a one week titration, is likely to be associated with a higher incidence of cholinergic adverse events compared to the 5 mg dose. In open-label trials using a 6 week titration, the type and frequency of these same adverse events were similar between the 5 mg and 10 mg dose groups. Therefore, because donepezil hydrochloride tablets steady state is achieved about 15 days after it is started and because the incidence of untoward effects may be influenced by the rate of dose escalation, a dose of 10 mg should not be administered until patients have been on a daily dose of 5 mg for 4 to 6 weeks.
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![Docuprene (Docusate Sodium) Tablet [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=b53e64a7-1e8b-4e3a-9d45-89693a213569&name=bd2f5cb0-b1eb-4964-8a07-538088a7a889-01.jpg)
Docuprene
Adults and children 12 years of age and older: Take 1 or 2 tablets daily
Children Under 12 years of age: Do not use, Consult a doctor before use.
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![Dicyclomine (Dicyclomine Hydrochloride) Tablet [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=7454bfef-ee61-4226-839e-47bba65f9125&name=95daf8b8-77ee-40cd-9918-3f650317e669-02.jpg)
Dicyclomine
Dosage must be adjusted to individual patient needs.
2.1 Oral Dosage and Administration in Adults
The recommended initial dose is 20 mg four times a day. After one week treatment with the initial dose, the dose may be increased to 40 mg four times a day unless side effects limit dosage escalation.
If efficacy is not achieved within 2 weeks or side effects require doses below 80 mg per day, the drug should be discontinued. Documented safety data are not available for doses above 80 mg daily for periods longer than 2 weeks.
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![Triazolam Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=611724e3-af8a-4e1c-9d45-6855905c2f92&name=611724e3-af8a-4e1c-9d45-6855905c2f92-02.jpg)
Triazolam
It is important to individualize the dosage of triazolam tablets for maximum beneficial effect and to help avoid significant adverse effects.
The recommended dose for most adults is 0.25 mg before retiring. A dose of 0.125 mg may be found to be sufficient for some patients (e.g., low body weight). A dose of 0.5 mg should be used only for exceptional patients who do not respond adequately to a trial of a lower dose since the risk of several adverse reactions increases with the size of the dose administered. A dose of 0.5 mg should not be exceeded.
In geriatric and/or debilitated patients the recommended dosage range is 0.125 mg to 0.25 mg. Therapy should be initiated at 0.125 mg in these groups and the 0.25 mg dose should be used only for exceptional patients who do not respond to a trial of the lower dose. A dose of 0.25 mg should not be exceeded in these patients.
As with all medications, the lowest effective dose should be used.
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![Ventolin Hfa (Albuterol Sulfate) Aerosol, Metered [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=acc9a53e-304d-44e4-b4ab-5303d1361118&name=acc9a53e-304d-44e4-b4ab-5303d1361118-14.jpg)
Ventolin Hfa
Administer VENTOLIN HFA by oral inhalation only. Shake VENTOLIN HFA well before each spray.
2.1 Bronchospasm
For treatment of acute episodes of bronchospasm or prevention of symptoms associated with bronchospasm, the usual dosage for adults and children is 2 inhalations repeated every 4 to 6 hours; in some patients, 1 inhalation every 4 hours may be sufficient. More frequent administration or a larger number of inhalations is not recommended.
2.2 Exercise-Induced Bronchospasm
The usual dosage for adults and children 4 years of age and older is 2 inhalations 15 to 30 minutes before exercise.
2.3 Administration Information
Priming: Priming VENTOLIN HFA is essential to ensure appropriate albuterol content in each actuation. Prime VENTOLIN HFA before using for the first time, when the inhaler has not been used for more than 2 weeks, or when the inhaler has been dropped. To prime VENTOLIN HFA, release 4 sprays into the air away from the face, shaking well before each spray.
Cleaning: To ensure proper dosing and to prevent actuator orifice blockage, wash the actuator with warm water and let it air-dry completely at least once a week.
Dose Counter: VENTOLIN HFA has a dose counter attached to the canister that starts at 204 or 64 and counts down each time a spray is released [see Dosage Forms and Strengths (3)]. When the counter reads 020, the patient should contact the pharmacist for a refill of medication or consult the physician to determine whether a prescription refill is needed.
VENTOLIN HFA comes in a moisture-protective foil pouch, which should be removed prior to use. Discard VENTOLIN HFA when the counter reads 000 or 12 months after removal from the moisture-protective foil pouch, whichever comes first [see Dosage Forms and Strengths (3)].
See Patient Information tear-off leaflet for instructions on how to prime and clean the inhaler to ensure proper dosing and to prevent actuator orifice blockage.
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![Verapamil Hydrochloride Tablet, Extended Release [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=abb61929-9939-425c-96b4-13da1c76fddd&name=abb61929-9939-425c-96b4-13da1c76fddd-02.jpg)
Verapamil Hydrochloride
Essential Hypertension
The dose of verapamil hydrochloride extended-release tablets should be individualized by titration and the drug should be administered with food. Initiate therapy with 180 mg of extended-release verapamil hydrochloride, given in the morning. Lower, initial doses of 120 mg a day may be warranted in patients who may have an increased response to verapamil (e.g., the elderly or small people etc.). Upward titration should be based on therapeutic efficacy and safety evaluated weekly and approximately 24 hours after the previous dose. The anti-hypertensive effects of verapamil hydrochloride extended-release tablets are evident within the first week of therapy.
If adequate response is not obtained with 180 mg of verapamil hydrochloride extended-release tablets, the dose may be titrated upward in the following manner:
240 mg each morning, 180 mg each morning plus 180 mg each evening, or 240 mg each morning plus 120 mg each evening 240 mg every twelve hoursWhen switching from verapamil hydrochloride immediate-release tablets to verapamil hydrochloride extended-release tablets, the total daily dose in milligrams may remain the same.
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![Dicyclomine Hydrochloride Capsule [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=fcca6fd5-6a67-4bb9-b9f2-634c87b8cc31&name=e6ed8f98-559e-415a-9331-a6696c18a159-02.jpg)
Dicyclomine Hydrochloride
Dosage must be adjusted to individual patient needs.
2.1 Oral Dosage and Administration in Adults
The recommended initial dose is 20 mg four times a day. After one week treatment with the initial dose, the dose may be increased to 40 mg four times a day unless side effects limit dosage escalation.
If efficacy is not achieved within 2 weeks or side effects require doses below 80 mg per day, the drug should be discontinued. Documented safety data are not available for doses above 80 mg daily for periods longer than 2 weeks.
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![Sumatriptan (Sumatriptan Succinate) Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=f2e7d756-1e12-462a-a43f-a9d860b11ee8&name=f2e7d756-1e12-462a-a43f-a9d860b11ee8-04.jpg)
Sumatriptan
In controlled clinical trials, single doses of 25, 50, or 100 mg of sumatriptan tablets were effective for the acute treatment of migraine in adults. There is evidence that doses of 50 and 100 mg may provide a greater effect than 25 mg (see CLINICAL TRIALS). There is also evidence that doses of 100 mg do not provide a greater effect than 50 mg. Individuals may vary in response to doses of sumatriptan tablets. The choice of dose should therefore be made on an individual basis, weighing the possible benefit of a higher dose with the potential for a greater risk of adverse events. If the headache returns or the patient has a partial response to the initial dose, the dose may be repeated after 2 hours, not to exceed a total daily dose of 200 mg. If a headache returns following an initial treatment with sumatriptan succinate injection, additional single sumatriptan tablets (up to 100 mg/day) may be given with an interval of at least 2 hours between tablet doses. The safety of treating an average of more than 4 headaches in a 30-day period has not been established. Because of the potential of MAO-A inhibitors to cause unpredictable elevations in the bioavailability of oral sumatriptan, their combined use is contraindicated (see CONTRAINDICATIONS). Hepatic disease/functional impairment may also cause unpredictable elevations in the bioavailability of orally administered sumatriptan. Consequently, if treatment is deemed advisable in the presence of liver disease, the maximum single dose should in general not exceed 50 mg (see CLINICAL PHARMACOLOGY for the basis of this recommendation).
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![Promethazine Hydrochloride Solution [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=ad808072-3d50-4f8d-b590-7bdc3d7578da&name=1f0e63f9-ea9d-4aff-94a5-530c0709d127-02.jpg)
Promethazine Hydrochloride Solution
It is important that Promethazine HCl Oral Solution is measured with an accurate measuring device (see PRECAUTIONS-Information for Patients). A household teaspoon is not an accurate measuring device and could lead to overdosage, especially when half a teaspoon is to be measured. It is strongly recommended that an accurate measuring device be used. A pharmacist can provide an appropriate device and can provide instructions for measuring the correct dose.
Promethazine HCl Oral Solution is contraindicated for children under 2 years of age (see WARNINGS – Boxed Warning and Use in Pediatric Patients).
Allergy
The average oral dose is 25 mg taken before retiring; however, 12.5 mg may be taken before meals and on retiring, if necessary. Single 25 mg doses at bedtime or 6.25 to 12.5 mg taken three times daily will usually suffice.
After initiation of treatment in children or adults, dosage should be adjusted to the smallest amount adequate to relieve symptoms.
The administration of promethazine HCl in 25 mg doses will control minor transfusion reactions of an allergic nature.
Motion Sickness
The average adult dose is 25 mg taken twice daily. The initial dose should be taken one-half to one hour before anticipated travel and be repeated 8 to 12 hours later, if necessary. On succeeding days of travel, it is recommended that 25 mg be taken on arising and again before the evening meal. For children, 12.5 to 25 mg, twice daily, may be administered.
Nausea and Vomiting
Antiemetics should not be used in vomiting of unknown etiology in children and adolescents (see WARNINGS- Use in Pediatric Patients).
The average effective dose of Promethazine HCl Oral Solution for the active therapy of nausea and vomiting in children or adults is 25 mg. When oral medication cannot be tolerated, the dose should be given parenterally (cf. Promethazine Hydrochloride Injection) or by rectal suppository. 12.5 to 25 mg doses may be repeated, as necessary, at 4 to 6 hour intervals.
For nausea and vomiting in children, the usual dose is 0.5 mg per pound of body weight, and the dose should be adjusted to the age and weight of the patient and the severity of the condition being treated.
For prophylaxis of nausea and vomiting, as during surgery and the postoperative period, the average dose is 25 mg repeated at 4 to 6 hour intervals, as necessary.
Sedation
This product relieves apprehension and induces a quiet sleep from which the patient can be easily aroused. Administration of 12.5 to 25 mg Promethazine HCl Oral Solution by the oral route at bedtime will provide sedation in children. Adults usually require 25 to 50 mg for nighttime, presurgical, or obstetrical sedation.
Pre- and Postoperative Use
Promethazine HCl Oral Solution in 12.5 to 25 mg doses for children and 50 mg doses for adults the night before surgery relieves apprehension and produces a quiet sleep. For preoperative medication children require doses of 0.5 mg per pound of body weight in combination with an appropriately reduced dose of narcotic or barbiturate and the appropriate dose of an atropine-like drug.
Usual adult dosage is 50 mg Promethazine HCl Oral Solution with an appropriately reduced dose of narcotic or barbiturate and the required amount of a belladonna alkaloid.
Postoperative sedation and adjunctive use with analgesics may be obtained by the administration of 12.5 to 25 mg in children and 25 to 50 mg doses in adults.
Promethazine HCl Oral Solution is contraindicated for children under 2 years of age.
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![Berri-freez (Menthol) Gel [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=dead7515-8312-4c37-8cd8-e47b51e7ed60&name=dead7515-8312-4c37-8cd8-e47b51e7ed60-01.jpg)
Berri-freez
Apply to affected area not more than 3 to 4 times daily
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![Prednisolone Solution [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=26c4a7ad-934a-4b10-809e-82ac53306266&name=cbd19d91-68c9-42d9-bb17-60c7d85448a5-02.jpg)
Prednisolone Solution
Dosage of Prednisolone Oral Solution should be individualized according to the severity of the disease and the response of the patient. For infants and children, the recommended dosage should be governed by the same considerations rather than strict adherence to the ratio indicated by age or body weight.
Hormone therapy is an adjunct to and not a replacement for conventional therapy. Dosage should be decreased or discontinued gradually when the drug has been administered for more than a few days.
The severity, prognosis, expected duration of the disease, and the reaction of the patient to medication are primary factors in determining dosage.
If a period of spontaneous remission occurs in a chronic condition, treatment should be discontinued.
Blood pressure, body weight, routine laboratory studies, including two-hour postprandial blood glucose and serum potassium, and a chest X-ray should be obtained at regular intervals during prolonged therapy. Upper GI X-rays are desirable in patients with known or suspected peptic ulcer disease.
The initial dosage of Prednisolone Oral Solution may vary from 5 mg to 60 mg per day depending on the specific disease entity being treated. In situations of less severity lower doses will generally suffice while in selected patients higher initial doses may be required. The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time there is a lack of satisfactory clinical response, Prednisolone Oral Solution should be discontinued and the patient transferred to other appropriate therapy. IT SHOULD BE EMPHASIZED THAT DOSAGE REQUIREMENTS ARE VARIABLE AND MUST BE INDIVIDUALIZED ON THE BASIS OF THE DISEASE UNDER TREATMENT AND THE RESPONSE OF THE PATIENT.
After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. It should be kept in mind that constant monitoring is needed in regard to drug dosage. Included in the situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient’s individual drug responsiveness, and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment. In this latter situation it may be necessary to increase the dosage of Prednisolone Oral Solution for a period of time consistent with the patient’s condition. If after longterm therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.
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![Pantoprazole Sodium Tablet, Delayed Release [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=b84682bf-0693-4f22-8ebf-36870072d55b&name=b84682bf-0693-4f22-8ebf-36870072d55b-02.jpg)
Pantoprazole Sodium
2.1 Recommended Dosing Schedule
Pantoprazole sodium is supplied as delayed-release tablets. The recommended dosages are outlined in Table 1.
Table 1: Recommended Dosing Schedule for Pantoprazole Sodium Delayed-Release Tablets Indication Dose FrequencyShort-Term Treatment of Erosive Esophagitis Associated With GERD
Adults
40 mg
Once daily for up to 8 weeks*
Maintenance of Healing of Erosive Esophagitis
Adults
40 mg
Once daily
Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome
Adults
40 mg
Twice daily**
* For adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium delayed-release tablets may be considered.
Pediatric dosing information in pediatric patients ages five years and older with erosive esophagitis associated with GERD is approved for Wyeth Pharmaceuticals Inc.’s pantoprazole sodium delayed-release tablets. However, due to Wyeth Pharmaceuticals Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
2.2 Administration Instructions
Directions for method of administration for each dosage form are presented in Table 2.
Table 2: Administration Instructions Formulation Route Instructions* * Patients should be cautioned that pantoprazole sodium delayed-release tablets should not be split, chewed, or crushedDelayed-Release Tablets
Oral
Swallowed whole, with or without food
Pantoprazole Sodium Delayed-Release Tablets, USP Pantoprazole sodium delayed-release tablets should be swallowed whole, with or without food in the stomach. If patients are unable to swallow a 40 mg tablet, two 20 mg tablets may be taken. Concomitant administration of antacids does not affect the absorption of pantoprazole sodium delayed-release tablets.
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![Prednisolone Syrup [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=71d300eb-b3fc-46b2-a23b-295c1eefc425&name=71d300eb-b3fc-46b2-a23b-295c1eefc425-02.jpg)
Prednisolone Syrup
Dosage of Prednisolone Syrup (Prednisolone Oral Solution USP) should be individualized according to the severity of the disease and the response of the patient. For infants and children, the recommended dosage should be governed by the same considerations rather than strict adherence to the ratio indicated by age or body weight.
Hormone therapy is an adjunct to and not a replacement for conventional therapy. Dosage should be decreased or discontinued gradually when the drug has been administered for more than a few days.
The severity, prognosis, expected duration of the disease, and the reaction of the patient to medication are primary factors in determining dosage. If a period of spontaneous remission occurs in a chronic condition, treatment should be discontinued.
Blood pressure, body weight, routine laboratory studies, including two-hour postprandial blood glucose and serum potassium, and a chest X-ray should be obtained at regular intervals during prolonged therapy. Upper GI X-rays are desirable in patients with known or suspected peptic ulcer disease.
The initial dosage of Prednisolone Syrup (Prednisolone Oral Solution USP) may vary from 5 mg to 60 mg per day depending on the specific disease entity being treated. In situations of less severity lower doses will generally suffice while in selected patients higher initial doses may be required. The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time there is a lack of satisfactory clinical response, Prednisolone Syrup (Prednisolone Oral Solution USP) should be discontinued and the patient transferred to other appropriate therapy. IT SHOULD BE EMPHASIZED THAT DOSAGE REQUIREMENTS ARE VARIABLE AND MUST BE INDIVIDUALIZED ON THE BASIS OF THE DISEASE UNDER TREATMENT AND THE RESPONSE OF THE PATIENT.
After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. It should be kept in mind that constant monitoring is needed in regard to drug dosage. Included in the situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient's individual drug responsiveness, and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment. In this latter situation it may be necessary to increase the dosage of Prednisolone Syrup (Prednisolone Oral Solution USP) for a period of time consistent with the patient's condition. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.
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![Omeprazole Capsule, Delayed Release [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=f1e576fc-3bce-40e2-bfba-de48e341b722&name=20mg-lbl-30.jpg)
Omeprazole
Omeprazole delayed-release capsules should be taken before eating. In the clinical trials, antacids were used concomitantly with omeprazole.
Patients should be informed that the omeprazole delayed-release capsule should be swallowed whole.
For patients unable to swallow an intact capsule, alternative administration options are available [see Dosage and Administration (2.8)].
2.1 Short-Term Treatment of Active Duodenal Ulcer
The recommended adult oral dose of omeprazole delayed-release capsules is 20 mg once daily. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.
2.2 H. pylori Eradication for the Reduction of the Risk of Duodenal Ulcer Recurrence
Triple Therapy (omeprazole/clarithromycin/amoxicillin) The recommended adult oral regimen is omeprazole delayed-release capsules 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.
Dual Therapy (omeprazole/clarithromycin) The recommended adult oral regimen is omeprazole delayed-release capsules 40 mg once daily plus clarithromycin 500 mg three times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.
2.3 Gastric Ulcer
The recommended adult oral dose is 40 mg once daily for 4 to 8 weeks.
2.4 Gastroesophageal Reflux Disease (GERD)
The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.
2.5 Maintenance of Healing of Erosive Esophagitis
The recommended adult oral dose is 20 mg daily. Controlled studies do not extend beyond 12 months [see Clinical Studies (14.4)].
2.6 Pathological Hypersecretory Conditions
The dosage of omeprazole delayed-release capsules in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with omeprazole delayed-release capsules for more than 5 years.
2.7 Pediatric Patients
For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 2 to 16 years of age is as follows:
Patient Weight Omeprazole Daily Dose10 < 20 kg
10 mg
≥ 20 kg
20 mg
On a per kg basis, the doses of omeprazole required to heal erosive esophagitis in pediatric patients are greater than those for adults.
Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule [see Dosage and Administration (2.8)].
2.8 Alternative Administration Options
Omeprazole is available as a delayed-release capsule.
For patients who have difficulty swallowing capsules, the contents of an omeprazole delayed-release capsule can be added to applesauce.
One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the pellets inside the capsule should be carefully emptied on the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the pellets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellets/applesauce mixture should not be stored for future use.
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![Being Well Stomach Relief Original Strength (Bismuth Subsalicylate) Liquid [Save-a-lot Food Stores Ltd]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=0818c344-2fc5-4cee-ac06-c9cd7fd07680&name=image-05.jpg)
Being Well Stomach Relief Original Strength
2.1 Dosage in Adult Patients With Normal Renal Function
The usual dose of levofloxacin tablets is 250 mg, 500 mg, or 750 mg administered orally every 24 hours, as indicated by infection and described in Table 1.
These recommendations apply to patients with creatinine clearance ≥ 50 mL/min. For patients with creatinine clearance < 50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].
Table 1: Dosage in Adult Patients With Normal Renal Function (Creatinine Clearance ≥ 50 mL/min) * Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician. † Due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [ see Indications and Usage (1.2)]. ‡ Due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [ see Indications and Usage (1.3)]. § This regimen is indicated for cUTI due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and AP due to E. coli, including cases with concurrent bacteremia. ¶ This regimen is indicated for cUTI due to Enterococcus faecalis, Enterococcus cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa; and for AP due to E. coli. # Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [ see Clinical Studies (14.9)]. Þ The safety of levofloxacin tablets in adults for durations of therapy beyond 28 days or in pediatric patients for durations beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [ see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin tablet therapy should only be used when the benefit outweighs the risk. ß Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Higher doses of levofloxacin tablets typically used for treatment of pneumonia can be used for treatment of plague, if clinically indicated.Type of Infection
Dosed Every 24 Hours
Duration (Days)*
Nosocomial Pneumonia
750 mg
7 to 14
Community Acquired Pneumonia†
500 mg
7 to 14
Community Acquired Pneumonia‡
750 mg
5
Acute Bacterial Sinusitis
750 mg
5
500 mg
10 to 14
Acute Bacterial Exacerbation of Chronic Bronchitis
500 mg
7
Complicated Skin and Skin Structure Infections (SSSI)
750 mg
7 to 14
Uncomplicated SSSI
500 mg
7 to 10
Chronic Bacterial Prostatitis
500 mg
28
Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)§
750 mg
5
Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)¶
250 mg
10
Uncomplicated Urinary Tract Infection
250 mg
3
Inhalational Anthrax (Post-Exposure), adult and pediatric patients > 50 kg#,Þ
Pediatric patients < 50 kg and ≥ 6 months of age#,Þ
500 mg
see Table 2 below
(2.2)
60Þ
60Þ
Plague, adult and pediatric patients > 50 kgß
500 mg
10 to 14
Pediatric patients < 50 kg and ≥ 6 months of age
see Table 2 below (2.2)
10 to 14
2.2 Dosage in Pediatric Patients
The dosage in pediatric patients ≥ 6 months of age is described below in Table 2.
Table 2: Dosage in Pediatric Patients ≥ 6 Months of Age * Due to Bacillus anthracis [ see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage (1.14)]. † Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician. ‡ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [ see Clinical Studies (14.9)]. § The safety of levofloxacin tablets in pediatric patients for durations of therapy beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [ see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin tablet therapy should only be used when the benefit outweighs the risk. ¶ Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis.Type of Infection*
Dose
Freq. Once Every
Duration†
Inhalational Anthrax (post-exposure)‡,§
Pediatric patients > 50 kg
500 mg
24 hr
60 days§
Pediatric patients < 50 kg and ≥ 6 months of age
8 mg/kg (not to exceed 250 mg per dose)
12 hr
60 days§
Plague¶
Pediatric patients > 50 kg
500 mg
24 hr
10 to 14 days
Pediatric patients < 50 kg and ≥ 6 months of age
8 mg/kg(not to exceed 250 mg per dose)
12 hr
10 to 14 days
2.3 Dosage Adjustment in Adults With Renal Impairment
Administer levofloxacin tablets with caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced.
No adjustment is necessary for patients with a creatinine clearance ≥ 50 mL/min.
In patients with impaired renal function (creatinine clearance < 50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [see Use in Specific Populations (8.6)].
Table 3 shows how to adjust dose based on creatinine clearance.
Table 3: Dosage Adjustment in Adult Patients With Renal Impairment (Creatinine Clearance < 50 mL/min)Dosage in Normal Renal Function Every 24 Hours
Creatinine Clearance 20 to 49 mL/min
Creatinine Clearance 10 to 19 mL/min
Hemodialysis or Chronic Ambulatory Peritoneal Dialysis (CAPD)
750 mg
750 mg every 48 hours
750 mg initial dose, then 500 mg every 48 hours
750 mg initial dose, then 500 mg every 48 hours
500 mg
500 mg initial dose, then 250 mg every 24 hours
500 mg initial dose, then 250 mg every 48 hours
500 mg initial dose, then 250 mg every 48 hours
250 mg
No dosage adjustment required
250 mg every 48 hours. If treating uncomplicated UTI, then no dosage adjustment is required
No information on dosing adjustment is available
2.4 Drug Interaction With Chelation Agents: Antacids, Sucralfate, Metal Cations, Multivitamins
Levofloxacin Tablets
Levofloxacin tablets should be administered at least two hours before or two hours after antacids containing magnesium, aluminum, as well as sucralfate, metal cations such as iron, and multivitamin preparations with zinc or didanosine chewable/buffered tablets or the pediatric powder for oral solution [see Drug Interactions (7.1) and Patient Counseling Information (17.2)].
2.5 Administration Instructions
Food and Levofloxacin Tablets
Levofloxacin tablets can be administered without regard to food.
Hydration for Patients Receiving Levofloxacin Tablets
Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)].
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![Doxycycline Hyclate Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=0c91927f-91df-4fad-8fa1-d3b0b7a4ff9b&name=doxycycline-hyclate-tablets-usp-2.jpg)
Doxycycline Hyclate
Other dosage forms of doxycycline may be more appropriate to meet some of the dosing recommendations listed below.
THE USUAL DOSAGE AND FREQUENCY OF ADMINISTRATION OF DOXYCYCLINE DIFFERS FROM THAT OF THE OTHER TETRACYCLINES. EXCEEDING THE RECOMMENDED DOSAGE MAY RESULT IN AN INCREASED INCIDENCE OF SIDE EFFECTS.
Adults: The usual dose of oral doxycycline is 200 mg on the first day of treatment (administered 100 mg every 12 hours) followed by a maintenance dose of 100 mg/day.
In the management of more severe infections (particularly chronic infections of the urinary tract), 100 mg every 12 hours is recommended.
For children above eight years of age: The recommended dosage schedule for children weighing 100 pounds or less is 2 mg/lb of body weight divided into two doses on the first day of treatment, followed by 1 mg/lb of body weight given as a single daily dose or divided into two doses, on subsequent days. For more severe infections, up to 2 mg/lb of body weight may be used. For children over 100 lb the usual adult dose should be used.
The therapeutic antibacterial serum activity will usually persist for 24 hours following recommended dosage.
When used in streptococcal infections, therapy should be continued for 10 days.
Administration of adequate amounts of fluid along with capsule and tablet forms of drugs in the tetracycline class is recommended to wash down the drugs and reduce the risk of esophageal irritation and ulceration. (See ADVERSE REACTIONS.)
If gastric irritation occurs, it is recommended that doxycycline be given with food or milk. The absorption of doxycycline is not markedly influenced by simultaneous ingestion of food or milk.
Studies to date have indicated that administration of doxycycline at the usual recommended doses does not lead to excessive accumulation of doxycycline in patients with renal impairment.
Uncomplicated gonococcal infections in adults (except anorectal infections in men): 100 mg, by mouth, twice a day for 7 days. As an alternate single visit dose, administer 300 mg stat followed in one hour by a second 300 mg dose. The dose may be administered with food, including milk or carbonated beverage, as required.
Uncomplicated urethral, endocervical, or rectal infection in adults caused by Chlamydia trachomatis: 100 mg, by mouth twice a day for 7 days.
Nongonococcal urethritis (NGU) caused by C. trachomatis or U. urealyticum: 100 mg by mouth, twice a day for 7 days.
Syphilis – early: Patients who are allergic to penicillin should be treated with doxycycline 100 mg, by mouth, twice a day for 2 weeks.
Syphilis of more than one year’s duration: Patients who are allergic to penicillin should be treated with doxycycline 100 mg, by mouth, twice a day for 4 weeks.
Acute epididymo-orchitis caused by N. gonorrhoeae: 100 mg, by mouth, twice a day for at least 10 days.
Acute epididymo-orchitis caused by C. trachomatis: 100 mg, by mouth, twice a day for at least 10 days.
For prophylaxis of malaria: For adults, the recommended dose is 100 mg daily. For children over 8 years of age, the recommended dose is 2 mg/kg given once daily up to the adult dose. Prophylaxis should begin 1to 2 days before travel to the malarious area. Prophylaxis should be continued daily during travel in the malarious area and for 4 weeks after the traveler leaves the malarious area.
Inhalational anthrax (post-exposure):
ADULTS: 100 mg of doxycycline, by mouth, twice a day for 60 days.
CHILDREN: weighing less than 100 lb (45 kg); 1 mg/lb (2.2 mg/kg) of body weight by mouth, twice a day for 60 days. Children weighing 100 lb or more should receive the adult dose.
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![Acyclovir Suspension [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=0a1eb087-50a2-441a-a3fe-3d93e31fe39f&name=f1d500d6-fbe8-4454-b365-53d5ef591795-02.jpg)
Acyclovir Suspension
Acute Treatment of Herpes Zoster:
800 mg every 4 hours orally, 5 times daily for 7 to 10 days.
Genital Herpes:
Treatment of Initial Genital Herpes:
200 mg every 4 hours, 5 times daily for 10 days.
Chronic Suppressive Therapy for Recurrent Disease:
400 mg 2 times daily for up to 12 months, followed by re-evaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily.
The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient’s genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir oral suspension.
Intermittent Therapy:
200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.
Treatment of Chickenpox:
Children (2 years of age and older):
20 mg/kg per dose orally 4 times daily (80 mg/kg per day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.
Adults and Children over 40 kg:
800 mg 4 times daily for 5 days.
Intravenous acyclovir oral suspension is indicated for the treatment of varicellazoster infections in immunocompromised patients.
When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.
Patients With Acute or Chronic Renal Impairment:
In patients with renal impairment, the dose of acyclovir oral suspension should be modified as shown in Table 3:
Table 3: Dosage Modification for Renal ImpairmentNormal Dosage Regimen
Creatinine
Clearance (mL/min/1.73 m2)
Adjusted Dosage Regimen
Dose
(mg)
Dosing Interval
200 mg every 4 hours
> 10
0-10
200
200
every 4 hours, 5x daily
every 12 hours
400 mg every 12 hours
> 10
0-10
400
200
every 12 hours
every 12 hours
800 mg every 4 hours
> 25
10-25
0-10
800
800
800
every 4 hours, 5x daily
every 8 hours
every 12 hours
Hemodialysis:
For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6-hour dialysis period. Therefore, the patient’s dosing schedule should be adjusted so that an additional dose is administered after each dialysis.
Peritoneal Dialysis:
No supplemental dose appears to be necessary after adjustment of the dosing interval.
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![Ipratropium Bromide Solution [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=6786ddc2-75f0-4ffb-ae30-b0a69c52c8c2&name=c9009b9a-71b7-4956-a1d2-98adc2457c2b-05.jpg)
Ipratropium Bromide Solution
The usual dosage of ipratropium bromide inhalation solution is 500 mcg (1 Unit-Dose Vial) administered three to four times a day by oral nebulization, with doses 6 to 8 hours apart. Ipratropium bromide inhalation solution unit-dose vials contain 500 mcg ipratropium bromide, USP anhydrous in 2.5 mL normal saline. Ipratropium bromide inhalation solution can be mixed in the nebulizer with albuterol or metaproterenol if used within one hour. Drug stability and safety of Ipratropium Bromide Inhalation Solution when mixed with other drugs in a nebulizer have not been established.
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![Rugby Hemorrhoidal (Phenylephrine Hydrochloride And Fat, Hard) Suppository [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=7d957735-44cd-44af-bc12-edbb13cc2e3b&name=7d957735-44cd-44af-bc12-edbb13cc2e3b-01.jpg)
Rugby Hemorrhoidal
• when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe • gently dry by patting or blotting with a tissue or a soft cloth before insertion of suppository • detach one suppository from the strip • separate the two tabs of the white plastic wrap • with thumb and forefinger of each hand, grasp the tabs and peel downward, unwrapping the suppository • insert suppository into the rectum
adults and children 12 years and over
insert one suppository rectally up to 4 times daily
children under 12 years
ask a doctor
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![Amantadine Hcl (Amantadine Hydrochloride) Capsule, Liquid Filled [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=13602c1d-d1c9-496b-baa6-8dee92519d67&name=13602c1d-d1c9-496b-baa6-8dee92519d67-02.jpg)
Amantadine Hcl
The dosage of Amantadine Hydrochloride Capsules may need to be reduced in patients with congestive heart failure, peripheral edema, orthostatic hypotension, or impaired renal function (see Dosage for Impaired Renal Function).
Dosage for Prophylaxis and Treatment of Uncomplicated Influenza A Virus Illness
Adult: The adult daily dosage of Amantadine Hydrochloride Capsules is 200 mg; two 100 mg capsules as a single daily dose. The daily dosage may be split into one capsule of 100 mg twice a day. If central nervous system effects develop in once-a-day dosage, a split dosage schedule may reduce such complaints. In persons 65 years of age or older, the daily dosage of Amantadine Hydrochloride Capsules is 100 mg.
A 100 mg daily dose has also been shown in experimental challenge studies to be effective as prophylaxis in healthy adults who are not at high risk for influenza-related complications. However, it has not been demonstrated that a 100 mg daily dose is as effective as a 200 mg daily dose for prophylaxis, nor has the 100 mg daily dose been studied in the treatment of acute influenza illness. In recent clinical trials, the incidence of central nervous system (CNS) side effects associated with the 100 mg daily dose was at or near the level of placebo. The 100 mg dose is recommended for persons who have demonstrated intolerance to 200 mg of Amantadine Hydrochloride Capsules daily because of CNS or other toxicities.
Pediatric Patients: 1 yr. to 9 yrs. of age: The total daily dose should be calculated on the basis of 2 to 4 mg/lb/day (4.4 to 8.8 mg/kg/day), but not to exceed 150 mg per day.
9 yrs.to12 yrs. of age: The total daily dose is 200 mg given as one capsule of 100 mg twice a day. The 100 mg daily dose has not been studied in this pediatric population. Therefore, there are no data which demonstrate that this dose is as effective as or is safer than the 200 mg daily dose in this patient population.
Prophylactic dosing should be started in anticipation of an influenza A outbreak and before or after contact with individuals with influenza A virus respiratory tract illness.
Amantadine Hydrochloride Capsules should be continued daily for at least 10 days following a known exposure. If Amantadine Hydrochloride Capsules are used chemoprophylactically in conjunction with inactivated influenza A virus vaccine until protective antibody responses develop, then it should be administered for 2 to 4 weeks after the vaccine has been given. When inactivated influenza A virus vaccine is unavailable or contraindicated, Amantadine Hydrochloride Capsules should be administered for the duration of known influenza A in the community because of repeated and unknown exposure.
Treatment of influenza A virus illness should be started as soon as possible, preferably within 24 to 48 hours after onset of signs and symptoms, and should be continued for 24 to 48 hours after the disappearance of signs and symptoms.
Dosage for Parkinsonism
Adult: The usual dose of Amantadine Hydrochloride Capsules is 100 mg twice a day when used alone. Amantadine Hydrochloride Capsules have an onset of action usually within 48 hours.
The initial dose of Amantadine Hydrochloride Capsules is 100 mg daily for patients with serious associated medical illnesses or who are receiving high doses of other antiparkinson drugs. After one to several weeks at 100 mg once daily, the dose may be increased to 100 mg twice daily, if necessary.
Occasionally, patients whose responses are not optimal with Amantadine Hydrochloride Capsules at 200 mg daily may benefit from an increase up to 400 mg daily in divided doses. However, such patients should be supervised closely by their physicians.
Patients initially deriving benefit from Amantadine Hydrochloride Capsules not uncommonly experience a fall-off of effectiveness after a few months. Benefit may be regained by increasing the dose to 300 mg daily. Alternatively, temporary discontinuation of Amantadine Hydrochloride Capsules for several weeks, followed by reinitiation of the drug, may result in regaining benefit in some patients. A decision to use other antiparkinson drugs may be necessary.
Dosage for Concomitant Therapy
Some patients who do not respond to anticholinergic antiparkinson drugs may respond to Amantadine Hydrochloride Capsules. When Amantadine Hydrochloride Capsules or anticholinergic antiparkinson drugs are each used with marginal benefit, concomitant use may produce additional benefit.
When Amantadine Hydrochloride Capsules and levodopa are initiated concurrently, the patient can exhibit rapid therapeutic benefits. Amantadine Hydrochloride Capsules, should be held constant at 100 mg daily or twice daily while the daily dose of levodopa is gradually increased to optimal benefit.
When Amantadine Hydrochloride Capsules are added to optimal well-tolerated doses of levodopa, additional benefit may result, including smoothing out the fluctuations in improvement which sometimes occur in patients on levodopa alone. Patients who require a reduction in their usual dose of levodopa because of development of side effects may possibly regain lost benefit with the addition of Amantadine Hydrochloride Capsules.
Dosage for Drug-Induced Extrapyramidal Reactions
Adult: The usual dose of Amantadine Hydrochloride Capsules is 100 mg twice a day. Occasionally, patients whose responses are not optimal with Amantadine Hydrochloride Capsules at 200 mg daily may benefit from an increase up to 300 mg daily in divided doses.
Dosage for Impaired Renal Function
Depending upon creatinine clearance, the following dosage adjustments are recommended:
CREATININE CLEARANCE (mL/min/1.73 m2)
Amantadine Hydrochloride Capsules DOSAGE
30 to 50
200 mg 1st day and 100 mg each day thereafter
15 to 29
200 mg 1st day followed by 100 mg on alternate days
<15
200 mg every 7 days
The recommended dosage for patients on hemodialysis is 200 mg every 7 days.
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![Cephalexin Powder, For Suspension [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=07631a8b-eb84-46aa-844e-e93e548cb9b2&name=07631a8b-eb84-46aa-844e-e93e548cb9b2-02.jpg)
Cephalexin
Cephalexin is administered orally.
Adults
The adult dosage ranges from 1 to 4 g daily in divided doses. The 333 mg and 750 mg strengths should be administered such that the daily dose is within 1 to 4 grams per day. The usual adult dose is 250 mg every 6 hours. For the following infections, a dosage of 500 mg may be administered every 12 hours: streptococcal pharyngitis, skin and skin structure infections, and uncomplicated cystitis in patients over 15 years of age. Cystitis therapy should be continued for 7 to 14 days. For more severe infections or those caused by less susceptible organisms, larger doses may be needed. If daily doses of cephalexin greater than 4 g are required, parenteral cephalosporins, in appropriate doses, should be considered.
Pediatric Patients
The usual recommended daily dosage for pediatric patients is 25 to 50 mg/kg in divided doses. For streptococcal pharyngitis in patients over 1 year of age and for skin and skin structure infections, the total daily dose may be divided and administered every 12 hours.
Cephalexin Suspension
Weight
125 mg/5 mL
250 mg/5 mL
10 kg (22 lb)
1/2 to 1 tsp q.i.d.
1/4 to 1/2 tsp q.i.d.
20 kg (44 lb)
1 to 2 tsp q.i.d.
1/2 to 1 tsp q.i.d.
40 kg (88 lb)
2 to 4 tsp q.i.d.
1 to 2 tsp q.i.d.
or
Weight
125 mg/5 mL
250 mg/5 mL
10 kg (22 lb)
1 to 2 tsp b.i.d.
1/2 to 1 tsp b.i.d
20 kg (44 lb)
2 to 4 tsp b.i.d.
1 to 2 tsp b.i.d.
40 kg (88 lb)
4 to 8 tsp b.i.d.
2 to 4 tsp b.i.d.
In severe infections, the dosage may be doubled.
In the therapy of otitis media, clinical studies have shown that a dosage of 75 to 100 mg/kg/day in 4 divided doses is required.
In the treatment of β-hemolytic streptococcal infections, a therapeutic dosage of cephalexin should be administered for at least 10 days.
Directions for Mixing
125 mg per 5 mL (100 mL when mixed): Prepare suspension at time of dispensing. Add to the bottle a total of 71 mL of water. For ease in preparation, tap bottle to loosen powder, add the water in 2 portions, shaking well after each addition. The resulting suspension will contain cephalexin monohydrate equivalent to 125 mg cephalexin in each 5 mL (teaspoonful).
125 mg per 5 mL (200 mL when mixed): Prepare suspension at time of dispensing. Add to the bottle a total of 140 mL of water. For ease in preparation, tap bottle to loosen powder, add the water in 2 portions, shaking well after each addition. The resulting suspension will contain cephalexin monohydrate equivalent to 125 mg cephalexin in each 5 mL (teaspoonful).
250 mg per 5 mL (100 mL when mixed): Prepare suspension at time of dispensing. Add to the bottle a total of 71 mL of water. For ease in preparation, tap bottle to loosen powder, add the water in 2 portions, shaking well after each addition. The resulting suspension will contain cephalexin monohydrate equivalent to 250 mg cephalexin in each 5 mL (teaspoonful).
250 mg per 5 mL (200 mL when mixed): Prepare suspension at time of dispensing. Add to the bottle a total of 140 mL of water. For ease in preparation, tap bottle to loosen powder, add the water in 2 portions, shaking well after each addition. The resulting suspension will contain cephalexin monohydrate equivalent to 250 mg cephalexin in each 5 mL (teaspoonful).
* After mixing, store in refrigerator. May be kept for 14 days without significant loss of potency.
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![Eye Wash (Water) Solution [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=6119892d-ce34-4b3e-9a3e-3f8a94f3fbca&name=6119892d-ce34-4b3e-9a3e-3f8a94f3fbca-01.jpg)
Eye Wash
• flush the affected eye(s) as needed • control the rate of flow of solution by pressure on the bottle
When using an eye cup
• rinse the cup with clean water immediately before each use • avoid contamination of the rim and inside surfaces of the cup • fill the cup half full and apply the cup to the affected eye(s), pressing tightly to prevent the escape of the liquid • tilt the head backward. Open eyelids wide and rotate eyeball to ensure thorough bathing with the wash or lotion • rinse the cup with clean water after each useOther information
• store at 15º–30ºC (59º–86ºF) • keep tightly closed -
![Famotidine Tablet, Film Coated [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=a493eb6f-164e-4f1e-b27e-3b8331f474c7&name=75590fd0-5c64-462c-bc71-5818f75c570a-02.jpg)
Famotidine
Duodenal Ulcer
Acute Therapy:The recommended adult oral dosage for active duodenal ulcer is 40 mg once a day at bedtime. Most patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. A regimen of 20 mg b.i.d. is also effective.Maintenance Therapy: The recommended adult oral dose is 20 mg once a day at bedtime.
Benign Gastric Ulcer
Acute Therapy:The recommended adult oral dosage for active benign gastric ulcer is 40 mg once a day at bedtime.
Gastroesophageal Reflux Disease (GERD)The recommended oral dosage for treatment of adult patients with symptoms of GERD is 20 mg b.i.d. for up to 6 weeks. The recommended oral dosage for the treatment of adult patients with esophagitis including erosions and ulcerations and accompanying symptoms due to GERD is 20 or 40 mg b.i.d. for up to 12 weeks (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies).
Dosage for Pediatric Patients <1 year of ageGastroesophageal Reflux Disease (GERD)
See PRECAUTIONS, Pediatric Patients <1 year of age.
The studies described in PRECAUTIONS, PediatricPatients <1 year of age suggest the following startingdoses in pediatric patients <1 year of age:Gastroesophageal Reflux Disease (GERD) - 0.5mg/kg/dose of famotidine oral suspension for thetreatment of GERD for up to 8 weeks once daily inpatients <3 months of age and 0.5 mg/kg/dose twicedaily in patients 3 months to <1 year of age. Patientsshould also be receiving conservative measures (e.g.,thickened feedings). The use of intravenous famotidinein pediatric patients <1 year of age with GERD has notbeen adequately studied.
Dosage for Pediatric Patients 1-16 years of age
See PRECAUTIONS, Pediatric Patients 1-16 years of age.
The studies described in PRECAUTIONS, Pediatric Patients 1-16 years of age suggest the following starting doses in pediatric patients 1-16 years of age.
Peptic Ulcer - 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.
Gastroesophageal Reflux Disease with or without Esophagitis Including Erosions and Ulcerations – 1 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.
While published uncontrolled studies suggest effectiveness of famotidine in the treatment of gastroesophageal reflux disease and peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or pH determination (gastric or esophageal) and endoscopy. Published uncontrolled clinical studies in pediatric patients 1-16 years of age have employed doses up to 1 mg/kg/day for peptic ulcer and 2 mg/kg/day for GERD with or without esophagitis including erosions and ulcerations.
Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas)
The dosage of famotidine in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose for pathological hypersecretory conditions is 20 mg q 6 h. In some patients, a higher starting dose may be required. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. Doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison Syndrome.
Concomitant Use of Antacids
Antacids may be given concomitantly if needed.
Dosage Adjustment for Patients with Moderate or Severe Renal Insufficiency
In adult patients with moderate (creatinine clearance < 50 mL/min) or severe (creatinine clearance < 10 mL/min) renal insufficiency, the elimination half-life of famotidine is increased. For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients. Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of famotidine may be reduced to half the dose or the dosing interval may be prolonged to 36-48 hours as indicated by the patient’s clinical response.
Based on the comparison of pharmacokinetic parameters for famotidine in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.
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![Famotidine Tablet, Film Coated [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=497183a5-b889-4700-8f30-f7c6223fcf0a&name=image-01.jpg)
Famotidine
Duodenal Ulcer
Acute Therapy: The recommended adult oral dosage for active duodenal ulcer is 40 mg once a day at bedtime. Most patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. A regimen of 20 mg b.i.d. is also effective.
Maintenance Therapy: The recommended adult oral dose is 20 mg once a day at bedtime.
Benign Gastric Ulcer
Acute Therapy: The recommended adult oral dosage for active benign gastric ulcer is 40 mg once a day at bedtime.
Gastroesophageal Reflux Disease (GERD)
The recommended oral dosage for treatment of adult patients with symptoms of GERD is 20 mg b.i.d. for up to 6 weeks. The recommended oral dosage for the treatment of adult patients with esophagitis including erosions and ulcerations and accompanying symptoms due to GERD is 20 or 40 mg b.i.d. for up to 12 weeks (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies).
Dosage for Pediatric Patients <1 year of age Gastroesophageal Reflux Disease (GERD)
See PRECAUTIONS, Pediatric Patients <1 year of age.
The studies described in PRECAUTIONS, Pediatric Patients <1 year of age suggest the following starting doses in pediatric patients <1 year of age: Gastroesophageal Reflux Disease (GERD) -0.5 mg/kg/dose of famotidine oral suspension for the treatment of GERD for up to 8 weeks once daily in patients <3 months of age and 0.5 mg/kg/dose twice daily in patients 3 months to <1 year of age. Patients should also be receiving conservative measures (e.g., thickened feedings). The use of intravenous famotidine in pediatric patients <1 year of age with GERD has not been adequately studied.
Dosage for Pediatric Patients 1-16 years of age
See PRECAUTIONS, Pediatric Patients 1-16 years of age.
The studies described in PRECAUTIONS, Pediatric Patients 1-16 years of age suggest the following starting doses in pediatric patients 1-16 years of age:
Peptic ulcer - 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.
Gastroesophageal Reflux Disease with or without esophagitis including erosions and ulcerations - 1.0 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.
While published uncontrolled studies suggest effectiveness of famotidine in the treatment of gastroesophageal reflux disease and peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or pH determination (gastric or esophageal) and endoscopy. Published uncontrolled clinical studies in pediatric patients 1-16 years of age have employed doses up to 1 mg/kg/day for peptic ulcer and 2 mg/kg/day for GERD with or without esophagitis including erosions and ulcerations.
Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas)
The dosage of famotidine in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose for pathological hypersecretory conditions is 20 mg q 6 h. In some patients, a higher starting dose may be required. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. Doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison Syndrome.
Concomitant Use of Antacids
Antacids may be given concomitantly if needed.
Dosage Adjustment for Patients with Moderate or Severe Renal Insufficiency
In adult patients with moderate (creatinine clearance <50 mL/min) or severe (creatinine clearance <10 mL/min) renal insufficiency, the elimination half-life of famotidine is increased. For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients. Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of famotidine may be reduced to half the dose or the dosing interval may be prolonged to 36-48 hours as indicated by the patient's clinical response.
Based on the comparison of pharmacokinetic parameters for famotidine in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.
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![Ibuprofen Tablet, Film Coated [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=e911cb7c-1399-4e30-9d42-24125e6cf28f&name=image-01.jpg)
Ibuprofen
do not take more than directed the smallest effective dose should be used • adults and children 12 years and over: take 1 tablet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 tablet, 2 tablets may be used do not exceed 6 tablets in 24 hours, unless directed by a doctor children under 12 years: ask a doctor
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![Pain Relief Extra Strength (Acetaminophen) Tablet, Film Coated [Shopko Stores Operating Co., Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=0b8c9a9e-6c1e-463c-9982-b0ce15bee28b&name=nortriptyline-capsules-10-mg-25-mg-50-mg-75-mg-3.jpg)
Pain Relief Extra Strength
Nortriptyline hydrochloride is not recommended for children.
Nortriptyline hydrochloride is administered orally. Lower than usual dosages are recommended for elderly patients and adolescents. Lower dosages are also recommended for outpatients than for hospitalized patients who will be under close supervision. The physician should initiate dosage at a low level and increase it gradually, noting carefully the clinical response and any evidence of intolerance. Following remission, maintenance medication may be required for a longer period of time at the lowest dose that will maintain remission.
If a patient develops minor side effects, the dosage should be reduced. The drug should be discontinued promptly if adverse effects of a serious nature or allergic manifestations occur.
Usual Adult Dose - 25 mg three or four times daily; dosage should begin at a low level and be increased as required. As an alternate regimen, the total daily dosage may be given once a day. When doses above 100 mg daily are administered, plasma levels of nortriptyline should be monitored and maintained in the optimum range of 50 to 150 ng/mL. Doses above 150 mg/day are not recommended.
Elderly and Adolescent Patients - 30 to 50 mg/day, in divided doses, or the total daily dosage may be given once a day.
Switching a Patient To or From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders
At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with nortriptyline hydrochloride. Conversely, at least 14 days should be allowed after stopping nortriptyline hydrochloride before starting an MAOI intended to treat psychiatric disorders (see CONTRAINDICATIONS ).
Use of Nortriptyline Hydrochloride With Other MAOIs, Such as Linezolid or Methylene Blue Do not start nortriptyline hydrochloride in a patient who is being treated with linezolid or intravenous methylene blue because there is increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered (see CONTRAINDICATIONS).
In some cases, a patient already receiving nortriptyline hydrochloride therapy may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, nortriptyline hydrochloride should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for two weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with nortriptyline hydrochloride may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue (see WARNINGS).
The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with nortriptyline hydrochloride is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use (see WARNINGS).
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![Earwax Removal Aid (Carbamide Peroxide) Liquid [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=57f21b4e-a012-4c93-9468-dfb622f15d02&name=57f21b4e-a012-4c93-9468-dfb622f15d02-01.jpg)
Earwax Removal Aid
Directions FOR USE IN THE EAR ONLY Unscrew cap from bottle. Remove foil safety seal from bottle. Affix applicator cap to bottle.Adults and children over 12 years of age: - tilt head sideways and place 5 to 10 drops into ear- tip of applicator should not enter ear canal- keep drops in ear for several minutes by keeping head tilted or placing cotton in the ear- use twice daily for up to 4 days if needed, or as directed by a doctor- any wax remaining after treatment may be removed by gently flushing the ear with warm water, using a soft rubber ear syringe.Children under 12 years of age: consult a doctor.Other information - avoid exposing the bottle to excessive heat and direct sunlight- keep cap on bottle when not in use- Note: Drops foam on contact with ear wax due to release of oxygen. There may be an associated "cracking" sound- Note: Oversize packaging for ease in reading label information. Contains one bottle.- Store between 20 degrees to 25 degrees C (68 degrees to 77 degrees F)
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![Econazole Nitrate Cream [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=bda93c0e-e18a-4c6e-8dcc-6bd6c9d06634&name=econazole-02.jpg)
Econazole Nitrate
Sufficient econazole nitrate cream should be applied to cover affected areas once daily in patients with tinea pedis, tinea cruris, tinea corporis, and tinea versicolor, and twice daily (morning and evening) in patients with cutaneous candidiasis.
Early relief of symptoms is experienced by the majority of patients and clinical improvement may be seen fairly soon after treatment is begun; however, candidal infections and tinea cruris and corporis should be treated for two weeks and tinea pedis for one month in order to reduce the possibility of recurrence. If a patient shows no clinical improvement after the treatment period, the diagnosis should be redetermined. Patients with tinea versicolor usually exhibit clinical and mycological clearing after two weeks of treatment.
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![Telmisartan And Amlodipine Tablet [Lupin Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=bf492f66-080c-42ae-af1b-e14a26b3dde5&name=bf492f66-080c-42ae-af1b-e14a26b3dde5-02.jpg)
Telmisartan And Amlodipine
Therapy with metoclopramide tablets, USP should not exceed 12 weeks in duration.
For the Relief of Symptomatic Gastroesophageal Reflux
Administer from 10 mg to 15 mg of metoclopramide tablet, USP orally up to q.i.d. 30 minutes before each meal and at bedtime, depending upon symptoms being treated and clinical response (see CLINICAL PHARMACOLOGY and INDICATIONS AND USAGE). If symptoms occur only intermittently or at specific times of the day, use of metoclopramide in single doses up to 20 mg prior to the provoking situation may be preferred rather than continuous treatment. Occasionally, patients (such as elderly patients) who are more sensitive to the therapeutic or adverse effects of metoclopramide will require only 5 mg per dose.
Experience with esophageal erosions and ulcerations is limited, but healing has thus far been documented in one controlled trial using q.i.d. therapy at 15 mg/dose, and this regimen should be used when lesions are present, so long as it is tolerated (see ADVERSE REACTIONS). Because of the poor correlation between symptoms and endoscopic appearance of the esophagus, therapy directed at esophageal lesions is best guided by endoscopic evaluation.
Therapy longer than 12 weeks has not been evaluated and cannot be recommended.
For the Relief of Symptoms Associated With Diabetic Gastroparesis (Diabetic Gastric Stasis)
Administer 10 mg of metoclopramide 30 minutes before each meal and at bedtime for two to eight weeks, depending upon response and the likelihood of continued well-being upon drug discontinuation.
The initial route of administration should be determined by the severity of the presenting symptoms. If only the earliest manifestations of diabetic gastric stasis are present, oral administration of metoclopramide tablets, USP may be initiated. However, if severe symptoms are present, therapy should begin with metoclopramide injection (consult labeling of the injection prior to initiating parenteral administration).
Administration of metoclopramide injection up to 10 days may be required before symptoms subside, at which time oral administration may be instituted. Since diabetic gastric stasis is frequently recurrent, metoclopramide tablet, USP therapy should be reinstituted at the earliest manifestation.
Use in Patients With Renal or Hepatic Impairment
Since metoclopramide is excreted principally through the kidneys, in those patients whose creatinine clearance is below 40 mL/min, therapy should be initiated at approximately one-half the recommended dosage. Depending upon clinical efficacy and safety considerations, the dosage may be increased or decreased as appropriate.
See OVERDOSAGE section for information regarding dialysis.
Metoclopramide undergoes minimal hepatic metabolism, except for simple conjugation. Its safe use has been described in patients with advanced liver disease whose renal function was normal.
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![Neuralgo Rheum (Pseudognaphalium Obtusifolium, Causticum, Colchicum Autumnale Bulb, Citrullus Colocynthis Fruit Pulp, Iron, Lithium Benzoate, Toxicodendron Pubescens Leaf And Filipendula Ulmaria Root) Injection [Heel Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=0459b583-ef1c-4b82-8467-f4b80e9e2a46&name=image-02.jpg)
Neuralgo Rheum
For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested: in adults, 50 to 100 mg q.i.d.; children under 6 years, 50 mg daily in divided doses; and over 6 years, 50 to 100 mg daily in divided doses.
For use in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and in histamine-mediated pruritus: in adults, 25 mg t.i.d. or q.i.d.; children under 6 years, 50 mg daily in divided doses; and over 6 years, 50 to 100 mg daily in divided doses.
As a sedative when used as a premedication and following general anesthesia: 50 to 100 mg in adults, and 0.6 mg/kg in children.
When treatment is initiated by the intramuscular route of administration, subsequent doses may be administered orally.
As with all medications, the dosage should be adjusted according to the patient’s response to therapy.
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![Nystatin Cream [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=a6b33844-2be4-417e-90b9-e5e3914741a2&name=a6b33844-2be4-417e-90b9-e5e3914741a2-02.jpg)
Nystatin
Adults and Pediatric Patients (Neonates and Older): Apply liberally to affected areas twice daily or as indicated until healing is complete.
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![Lamotrigine Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=7f62f47d-4347-4a2b-a5c8-5495b57a7d97&name=0501592b-f7bf-4b0e-bae1-89ddc3ad8fc1-02.jpg)
Lamotrigine
2.1 General Dosing Considerations
Rash: There are suggestions, yet to be proven, that the risk of severe, potentially life-threatening rash may be increased by (1) coadministration of Lamotrigine with valproate, (2) exceeding the recommended initial dose of Lamotrigine, or (3) exceeding the recommended dose escalation for Lamotrigine. However, cases have occurred in the absence of these factors [see Boxed Warning]. Therefore, it is important that the dosing recommendations be followed closely.
The risk of nonserious rash may be increased when the recommended initial dose and/or the rate of dose escalation of Lamotrigine is exceeded and in patients with a history of allergy or rash to other AEDs.
It is recommended that Lamotrigine not be restarted in patients who discontinued due to rash associated with prior treatment with Lamotrigine, unless the potential benefits clearly outweigh the risks. If the decision is made to restart a patient who has discontinued Lamotrigine, the need to restart with the initial dosing recommendations should be assessed. The greater the interval of time since the previous dose, the greater consideration should be given to restarting with the initial dosing recommendations. If a patient has discontinued Lamotrigine for a period of more than 5 half-lives, it is recommended that initial dosing recommendations and guidelines be followed. The half-life of Lamotrigine is affected by other concomitant medications [see Clinical Pharmacology (12.3)].
Lamotrigine Added to Drugs Known to Induce or Inhibit Glucuronidation: Drugs other than those listed in the Clinical Pharmacology section [see Clinical Pharmacology (12.3)] have not been systematically evaluated in combination with Lamotrigine. Because Lamotrigine is metabolized predominantly by glucuronic acid conjugation, drugs that are known to induce or inhibit glucuronidation may affect the apparent clearance of Lamotrigine and doses of Lamotrigine may require adjustment based on clinical response.
Target Plasma Levels for Patients With Epilepsy or Bipolar Disorder: A therapeutic plasma concentration range has not been established for Lamotrigine. Dosing of Lamotrigine should be based on therapeutic response [see Clinical Pharmacology (12.3)].
Women Taking Estrogen-Containing Oral Contraceptives: Starting Lamotrigine in Women Taking Estrogen-Containing Oral Contraceptives: Although estrogen-containing oral contraceptives have been shown to increase the clearance of Lamotrigine [see Clinical Pharmacology (12.3)], no adjustments to the recommended dose-escalation guidelines for Lamotrigine should be necessary solely based on the use of estrogen-containing oral contraceptives. Therefore, dose escalation should follow the recommended guidelines for initiating adjunctive therapy with Lamotrigine based on the concomitant AED or other concomitant medications (see Table 1 or Table 5). See below for adjustments to maintenance doses of Lamotrigine in women taking estrogen-containing oral contraceptives.
Adjustments to the Maintenance Dose of Lamotrigine in Women Taking Estrogen-Containing Oral Contraceptives:
(1) Taking Estrogen-Containing Oral Contraceptives: For women not taking carbamazepine, phenytoin, phenobarbital, primidone, or other drugs such as rifampin that induce Lamotrigine glucuronidation [see Drug Interactions (7), Clinical Pharmacology (12.3)], the maintenance dose of Lamotrigine will in most cases need to be increased, by as much as 2-fold over the recommended target maintenance dose, in order to maintain a consistent Lamotrigine plasma level [see Clinical Pharmacology (12.3)].
(2) Starting Estrogen-Containing Oral Contraceptives: In women taking a stable dose of Lamotrigine and not taking carbamazepine, phenytoin, phenobarbital, primidone, or other drugs such as rifampin that induce Lamotrigine glucuronidation [see Drug Interactions (7), Clinical Pharmacology (12.3)], the maintenance dose will in most cases need to be increased by as much as 2-fold in order to maintain a consistent Lamotrigine plasma level. The dose increases should begin at the same time that the oral contraceptive is introduced and continue, based on clinical response, no more rapidly than 50 to 100 mg/day every week. Dose increases should not exceed the recommended rate (see Table 1 or Table 5) unless Lamotrigine plasma levels or clinical response support larger increases. Gradual transient increases in Lamotrigine plasma levels may occur during the week of inactive hormonal preparation (“pill-free” week), and these increases will be greater if dose increases are made in the days before or during the week of inactive hormonal preparation. Increased Lamotrigine plasma levels could result in additional adverse reactions, such as dizziness, ataxia, and diplopia. If adverse reactions attributable to Lamotrigine consistently occur during the “pill-free” week, dose adjustments to the overall maintenance dose may be necessary. Dose adjustments limited to the “pill-free” week are not recommended. For women taking Lamotrigine in addition to carbamazepine, phenytoin, phenobarbital, primidone, or other drugs such as rifampin that induce Lamotrigine glucuronidation [see Drug Interactions (7), Clinical Pharmacology (12.3)], no adjustment to the dose of Lamotrigine should be necessary.
(3) Stopping Estrogen-Containing Oral Contraceptives: For women not taking carbamazepine, phenytoin, phenobarbital, primidone, or other drugs such as rifampin that induce Lamotrigine glucuronidation [see Drug Interactions (7), Clinical Pharmacology (12.3)], the maintenance dose of Lamotrigine will in most cases need to be decreased by as much as 50% in order to maintain a consistent Lamotrigine plasma level. The decrease in dose of Lamotrigine should not exceed 25% of the total daily dose per week over a 2-week period, unless clinical response or Lamotrigine plasma levels indicate otherwise [see Clinical Pharmacology (12.3)]. For women taking Lamotrigine in addition to carbamazepine, phenytoin, phenobarbital, primidone, or other drugs such as rifampin that induce Lamotrigine glucuronidation [see Drug Interactions (7), Clinical Pharmacology (12.3)], no adjustment to the dose of Lamotrigine should be necessary.
Women and Other Hormonal Contraceptive Preparations or Hormone Replacement Therapy: The effect of other hormonal contraceptive preparations or hormone replacement therapy on the pharmacokinetics of Lamotrigine has not been systematically evaluated. It has been reported that ethinylestradiol, not progestogens, increased the clearance of Lamotrigine up to 2-fold, and the progestin-only pills had no effect on Lamotrigine plasma levels. Therefore, adjustments to the dosage of Lamotrigine in the presence of progestogens alone will likely not be needed.
Patients With Hepatic Impairment: Experience in patients with hepatic impairment is limited. Based on a clinical pharmacology study in 24 patients with mild, moderate, and severe liver impairment [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)], the following general recommendations can be made. No dosage adjustment is needed in patients with mild liver impairment. Initial, escalation, and maintenance doses should generally be reduced by approximately 25% in patients with moderate and severe liver impairment without ascites and 50% in patients with severe liver impairment with ascites. Escalation and maintenance doses may be adjusted according to clinical response.
Patients With Renal Impairment: Initial doses of Lamotrigine should be based on patients' concomitant medications (see Tables 1-3 or Table 5); reduced maintenance doses may be effective for patients with significant renal impairment [see Use in Specific Populations (8.7), Clinical Pharmacology (12.3)]. Few patients with severe renal impairment have been evaluated during chronic treatment with Lamotrigine. Because there is inadequate experience in this population, Lamotrigine should be used with caution in these patients.
Discontinuation Strategy: Epilepsy: For patients receiving Lamotrigine in combination with other AEDs, a re-evaluation of all AEDs in the regimen should be considered if a change in seizure control or an appearance or worsening of adverse reactions is observed.
If a decision is made to discontinue therapy with Lamotrigine, a step-wise reduction of dose over at least 2 weeks (approximately 50% per week) is recommended unless safety concerns require a more rapid withdrawal [see Warnings and Precautions (5.9)].
Discontinuing carbamazepine, phenytoin, phenobarbital, primidone, or other drugs such as rifampin that induce Lamotrigine glucuronidation should prolong the half-life of Lamotrigine; discontinuing valproate should shorten the half-life of Lamotrigine.
Bipolar Disorder: In the controlled clinical trials, there was no increase in the incidence, type, or severity of adverse reactions following abrupt termination of Lamotrigine. In clinical trials in patients with Bipolar Disorder, 2 patients experienced seizures shortly after abrupt withdrawal of Lamotrigine. However, there were confounding factors that may have contributed to the occurrence of seizures in these bipolar patients. Discontinuation of Lamotrigine should involve a step-wise reduction of dose over at least 2 weeks (approximately 50% per week) unless safety concerns require a more rapid withdrawal [see Warnings and Precautions (5.9)].
2.2 Epilepsy – Adjunctive Therapy
This section provides specific dosing recommendations for patients greater than 12 years of age and patients 2 to 12 years of age. Within each of these age-groups, specific dosing recommendations are provided depending upon concomitant AED or other concomitant medications (Table 1 for patients greater than 12 years of age and Table 2 for patients 2 to 12 years of age). A weight-based dosing guide for patients 2 to 12 years of age on concomitant valproate is provided in Table 3.
Patients Over 12 Years of Age: Recommended dosing guidelines are summarized in Table 1.
Table 1. Escalation Regimen for Lamotrigine in Patients Over 12 Years of Age With Epilepsy * Valproate has been shown to inhibit glucuronidation and decrease the apparent clearance of Lamotrigine [see Drug Interactions ( 7 ), Clinical Pharmacology ( 12.3 )]. † These drugs induce Lamotrigine glucuronidation and increase clearance [see Drug Interactions ( 7 ) Clinical Pharmacology ( 12.3 )]. Other drugs, that have similar effects include estrogen-containing oral contraceptives [see Drug Interactions ( 7 ), Clinical Pharmacology ( 12.3 )]. Dosing recommendations for oral contraceptives can be found in General Dosing Considerations [see Dosage and Administration ( 2.1 )]. Patients on rifampin, or other drugs that induce Lamotrigine glucuronidation and increase clearance, should follow the same dosing titration/maintenance regimen as that used with anticonvulsants that have this effect.For Patients TAKING Valproate*
For Patients NOT TAKING Carbamazepine, Phenytoin, Phenobarbital, Primidone†,or Valproate*
For Patients TAKING Carbamazepine, Phenytoin, Phenobarbital, or Primidone† and NOT TAKING Valproate*
Weeks 1 and 2
25 mg every other day
25 mg every day
50 mg/day
Weeks 3 and 4
25 mg every day
50 mg/day
100 mg/day (in 2 divided doses)
Weeks 5 onwards to maintenance
Increase by 25 to 50 mg/day every 1 to 2 weeks
Increase by 50 mg/day every 1 to 2 weeks
Increase by 100 mg/day every 1 to 2 weeks
Usual Maintenance Dose
100 to 200 mg/day with valproate alone 100 to 400 mg/day with valproate and other drugs that induce glucuronidation (in 1 or 2 divided doses)
225 to 375 mg/day (in 2 divided doses)
300 to 500 mg/day (in 2 divided doses)
Patients 2 to 12 Years of Age: Recommended dosing guidelines are summarized in Table 2.
Smaller starting doses and slower dose escalations than those used in clinical trials are recommended because of the suggestion that the risk of rash may be decreased by smaller starting doses and slower dose escalations. Therefore, maintenance doses will take longer to reach in clinical practice than in clinical trials. It may take several weeks to months to achieve an individualized maintenance dose. Maintenance doses in patients weighing less than 30 kg, regardless of age or concomitant AED, may need to be increased as much as 50%, based on clinical response.
Table 2. Escalation Regimen for Lamotrigine in Patients 2 to 12 Years of Age With Epilepsy * Valproate has been shown to inhibit glucuronidation and decrease the apparent clearance of Lamotrigine [see Drug Interactions (7 ), Clinical Pharmacology (12.3)]. † These drugs induce Lamotrigine glucuronidation and increase clearance [see Drug Interactions (7 ) Clinical Pharmacology (12.3)]. Other drugs, that have similar effects include estrogen-containing oral contraceptives [see Drug Interactions (7 ) Clinical Pharmacology (12.3)]. Dosing recommendations for oral contraceptives can be found in General Dosing Considerations [see Dosage and Administration ( 2.1 )]. Patients on rifampin, or other drugs that induce Lamotrigine glucuronidation and increase clearance, should follow the same dosing titration/maintenance regimen as that used with anticonvulsants that have this effect.For Patients TAKING Valproate*
For Patients NOT TAKING Carbamazepine, Phenytoin, Phenobarbital, Primidone† or Valproate*
For Patients TAKING Carbamazepine, Phenytoin, Phenobarbital, or Primidone† and NOT TAKING Valproate*
Weeks 1 and 2
0.15 mg/kg/day in 1 or 2 divided doses, rounded down to the nearest whole tablet (see Table 3 for weight based dosing guide)
0.3 mg/kg/day in 1 or 2 divided doses, rounded down to the nearest whole tablet
0.6 mg/kg/day in 2 divided doses, rounded down to the nearest whole tablet
Weeks 3 and 4
0.3 mg/kg/day in 1 or 2 divided doses, rounded down to the nearest whole tablet (see Table 3 for weight based dosing guide)
0.6 mg/kg/day in 2 divided doses, rounded down to the nearest whole tablet
1.2 mg/kg/day in 2 divided doses, rounded down to the nearest whole tablet
Weeks 5 onwards to maintenance
The dose should be increased every 1 to 2 weeks as follows: calculate 0.3 mg/kg/day, round this amount down to the nearest whole tablet, and add this amount to the previously administered daily dose
The dose should be increased every 1 to 2 weeks as follows: calculate 0.6 mg/kg/day, round this amount down to the nearest whole tablet, and add this amount to the previously administered daily dose
The dose should be increased every 1 to 2 weeks as follows: calculate 1.2 mg/kg/day, round this amount down to the nearest whole tablet, and add this amount to the previously administered daily dose
Usual Maintenance Dose
1 to 5 mg/kg/day (maximum 200 mg/day in 1 or 2 divided doses).1 to 3 mg/kg/day with valproate alone
4.5 to 7.5 mg/kg/day (maximum 300 mg/day in 2 divided doses)
5 to 15 mg/kg/day (maximum 400 mg/day in 2 divided doses)
Maintenance dose in patients less than 30 kg
May need to be increased by as much as 50%, based on clinical response
May need to be increased by as much as 50%, based on clinical response
May need to be increased by as much as 50%, based on clinical response
Note: Only whole tablets should be used for dosing.
Table 3. The Initial Weight-Based Dosing Guide for Patients 2 to 12 Years Taking Valproate (Weeks 1 to 4) With EpilepsyIf the patient’s weight is
Give this daily dose, using the most appropriate combination of Lamotrigine 2-mg and 5-mg tablets
Greater than
And less than
Weeks 1 and 2
Weeks 3 and 4
6.7 kg
14 kg
2 mg every other day
2 mg every day
14.1 kg
27 kg
2 mg every day
4 mg every day
27.1 kg
34 kg
4 mg every day
8 mg every day
34.1 kg
40 kg
5 mg every day
10 mg every day
Usual Adjunctive Maintenance Dose for Epilepsy: The usual maintenance doses identified in Tables 1 and 2 are derived from dosing regimens employed in the placebo-controlled adjunctive studies in which the efficacy of Lamotrigine was established. In patients receiving multidrug regimens employing carbamazepine, phenytoin, phenobarbital, or primidone without valproate, maintenance doses of adjunctive Lamotrigine as high as 700 mg/day have been used. In patients receiving valproate alone, maintenance doses of adjunctive Lamotrigine as high as 200 mg/day have been used. The advantage of using doses above those recommended in Tables 1 through 4 has not been established in controlled trials.
2.3 Epilepsy – Conversion From Adjunctive Therapy to Monotherapy
The goal of the transition regimen is to effect the conversion to monotherapy with Lamotrigine under conditions that ensure adequate seizure control while mitigating the risk of serious rash associated with the rapid titration of Lamotrigine.
The recommended maintenance dose of Lamotrigine as monotherapy is 500 mg/day given in 2 divided doses.
To avoid an increased risk of rash, the recommended initial dose and subsequent dose escalations of Lamotrigine should not be exceeded [see Boxed Warning].
Conversion From Adjunctive Therapy With Carbamazepine, Phenytoin, Phenobarbital, or Primidone to Monotherapy With Lamotrigine: After achieving a dose of 500 mg/day of Lamotrigine according to the guidelines in Table 1, the concomitant AED should be withdrawn by 20% decrements each week over a 4-week period. The regimen for the withdrawal of the concomitant AED is based on experience gained in the controlled monotherapy clinical trial.
Conversion from Adjunctive Therapy With Valproate to Monotherapy With Lamotrigine: The conversion regimen involves 4 steps outlined in Table 4.
Table 4. Conversion From Adjunctive Therapy With Valproate to Monotherapy With Lamotrigine in Patients ≥16 Years of Age with EpilepsyLamotrigine
Valproate
Step 1
Achieve a dose of 200 mg/day according to guidelines in Table 1 (if not already on 200 mg/day).
Maintain previous stable dose.
Step 2
Maintain at 200 mg/day.
Decrease to 500 mg/day by decrements no greater than 500 mg/day/week and then maintain the dose of 500 mg/day for 1 week.
Step 3
Increase to 300 mg/day and maintain for 1 week.
Simultaneously decrease to 250 mg/day and maintain for 1 week.
Step 4
Increase by 100 mg/day every week to achieve maintenance dose of 500 mg/day.
Discontinue.
Conversion from Adjunctive Therapy With Antiepileptic Drugs Other Than Carbamazepine, Phenytoin, Phenobarbital, Primidone, or Valproate to Monotherapy With Lamotrigine: No specific dosing guidelines can be provided for conversion to monotherapy with Lamotrigine with AEDs other than carbamazepine, phenobarbital, phenytoin, primidone, or valproate.
2.4 Bipolar Disorder
The goal of maintenance treatment with Lamotrigine is to delay the time to occurrence of mood episodes (depression, mania, hypomania, mixed episodes) in patients treated for acute mood episodes with standard therapy. The target dose of Lamotrigine is 200 mg/day (100 mg/day in patients taking valproate, which decreases the apparent clearance of Lamotrigine, and 400 mg/day in patients not taking valproate and taking either carbamazepine, phenytoin, phenobarbital, primidone, or other drugs such as rifampin, that increase the apparent clearance of Lamotrigine). In the clinical trials, doses up to 400 mg/day as monotherapy were evaluated; however, no additional benefit was seen at 400 mg/day compared with 200 mg/day [see Clinical Studies (14.2)]. Accordingly, doses above 200 mg/day are not recommended. Treatment with Lamotrigine is introduced, based on concurrent medications, according to the regimen outlined in Table 5. If other psychotropic medications are withdrawn following stabilization, the dose of Lamotrigine should be adjusted. For patients discontinuing valproate, the dose of Lamotrigine should be doubled over a 2-week period in equal weekly increments (see Table 6). For patients discontinuing carbamazepine, phenytoin, phenobarbital, primidone, or other drugs such as rifampin that induce Lamotrigine glucuronidation, the dose of Lamotrigine should remain constant for the first week and then should be decreased by half over a 2-week period in equal weekly decrements (see Table 6). The dose of Lamotrigine may then be further adjusted to the target dose (200 mg) as clinically indicated.
If other drugs are subsequently introduced, the dose of Lamotrigine may need to be adjusted. In particular, the introduction of valproate requires reduction in the dose of Lamotrigine [see Drug Interactions (7), Clinical Pharmacology (12.3)].
To avoid an increased risk of rash, the recommended initial dose and subsequent dose escalations of Lamotrigine should not be exceeded [see Boxed Warning].
Table 5. Escalation Regimen for Lamotrigine for Patients With Bipolar Disorder * Valproate has been shown to inhibit glucuronidation and decrease the apparent clearance of Lamotrigine [see Drug Interactions (7 ), Clinical Pharmacology (12.3)]. † These drugs induce Lamotrigine glucuronidation and increase clearance [see Drug Interactions (7 ), Clinical Pharmacology (12.3)]. Other drugs that have similar effects include estrogen- containing oral contraceptives [see Drug Interactions (7), Clinical Pharmacology (12.3)]. Dosing recommendations for oral contraceptives can be found in General Dosing Considerations [see Dosage and Administration (2.1)]. Patients on rifampin, or other drugs that induce Lamotrigine glucuronidation and increase clearance, should follow the same dosing titration/ maintenance regimen as that used with anticonvulsants that have this effect.For Patients TAKING Valproate*
For Patients NOT TAKING Carbamazepine, Phenytoin, Phenobarbital, Primidone†, or Valproate*
For Patients TAKING Carbamazepine, Phenytoin, Phenobarbital, or Primidone† and NOT TAKING Valproate*
Weeks 1 and 2
25 mg every other day
25 mg daily
50 mg daily
Weeks 3 and 4
25 mg daily
50 mg daily
100 mg daily, in divided doses
Week 5
50 mg daily
100 mg daily
200 mg daily, in divided doses
Week 6
100 mg daily
200 mg daily
300 mg daily, in divided doses
Week 7
100 mg daily
200 mg daily
up to 400 mg daily, in divided doses
Table 6. Dosage Adjustments to Lamotrigine for Patients With Bipolar Disorder Following Discontinuation of Psychotropic Medications * These drugs induce Lamotrigine glucuronidation and increase clearance [see Drug Interactions (7 ), Clinical Pharmacology (12.3)]. Other drugs that have similar effects include estrogen-containing oral contraceptives [see Drug Interactions (7), Clinical Pharmacology (12.3)]. Dosing recommendations for oral contraceptives can be found in General Dosing Considerations [see Dosage and Administration (2.1)]. Patients on rifampin, or other drugs that induce Lamotrigine glucuronidation and increase clearance, should follow the same dosing titration/ maintenance regimen as that used with anticonvulsants that have this effect. † Valproate has been shown to inhibit glucuronidation and decrease the apparent clearance of Lamotrigine [see Drug Interactions (7), Clinical Pharmacology (12.3)].Discontinuation of Psychotropic Drugs (excluding Carbamazepine, Phenytoin, Phenobarbital, Primidone*, or Valproate†)
After Discontinuation of Valproate†
After Discontinuation of Carbamazepine, Phenytoin, Phenobarbital, or Primidone*
Current dose of Lamotrigine (mg/day) 100
Current dose of Lamotrigine (mg/day) 400
Week 1
Maintain current dose of Lamotrigine
150
400
Week 2
Maintain current dose of Lamotrigine
200
300
Week 3 onward
Maintain current dose of Lamotrigine
200
200
The benefit of continuing treatment in patients who had been stabilized in an 8- to 16-week open-label phase with Lamotrigine was established in 2 randomized, placebo-controlled clinical maintenance trials [see Clinical Studies (14.2)]. However, the optimal duration of treatment with Lamotrigine has not been established. Thus, patients should be periodically reassessed to determine the need for maintenance treatment.
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![Hydrocortisone Ointment [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=f01242d2-ae87-46a5-816a-77feec744023&name=f01242d2-ae87-46a5-816a-77feec744023-01.jpg)
Hydrocortisone Ointment
• for itching of skin irritation, inflammation, and rashes: • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily • children under 2 years of age: do not use, ask a doctor • for external anal and genital itching, adults: • when practical, clean the affected area with mild soap and warm water and rinse thoroughly • gently dry by patting or blotting with toilet tissue or a soft cloth before applying • apply to affected area not more than 3 to 4 times daily • children under 12 years of age: ask a doctor
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Olanzapine
2.1 Dosage in Adults
Use the lowest effective dose for the patient. The recommended initial dose is 5 mg for women and either 5 or 10 mg for men, taken only once per night immediately before bedtime with at least 7-8 hours remaining before the planned time of awakening. If the 5 mg dose is not effective, the dose can be increased to 10 mg. In some patients, the higher morning blood levels following use of the 10 mg dose increase the risk of next day impairment of driving and other activities that require full alertness [see Warnings and Precautions (5.1)]. The total dose of zolpidem tartrate tablets should not exceed 10 mg once daily immediately before bedtime.
The recommended initial doses for women and men are different because zolpidem clearance is lower in women.
2.2 Special Populations
Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.1); Use in Specific Populations (8.5)].
2.3 Use with CNS Depressants
Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.1)].
2.4 Administration
The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.
2.1 Dosage in Adults
Use the lowest effective dose for the patient. The recommended initial dose is 5 mg for women and either 5 or 10 mg for men, taken only once per night immediately before bedtime with at least 7-8 hours remaining before the planned time of awakening. If the 5 mg dose is not effective, the dose can be increased to 10 mg. In some patients, the higher morning blood levels following use of the 10 mg dose increase the risk of next day impairment of driving and other activities that require full alertness [see Warnings and Precautions (5.1)]. The total dose of zolpidem tartrate tablets should not exceed 10 mg once daily immediately before bedtime.
The recommended initial doses for women and men are different because zolpidem clearance is lower in women.
2.2 Special Populations
Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.1); Use in Specific Populations (8.5)].
2.3 Use with CNS Depressants
Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.1)].
2.4 Administration
The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.
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![Bupropion Hydrochloride Tablet, Film Coated, Extended Release [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=58571c86-e748-43a8-aed3-30750047efac&name=58571c86-e748-43a8-aed3-30750047efac-02.jpg)
Bupropion Hydrochloride
General Dosing Considerations: It is particularly important to administer bupropion hydrochloride extended-release tablets (XL) in a manner most likely to minimize the risk of seizure (see WARNINGS). Gradual escalation in dosage is also important if agitation, motor restlessness, and insomnia, often seen during the initial days of treatment, are to be minimized. If necessary, these effects may be managed by temporary reduction of dose or the short-term administration of an intermediate to long-acting sedative hypnotic. A sedative hypnotic usually is not required beyond the first week of treatment. Insomnia may also be minimized by avoiding bedtime doses. If distressing, untoward effects supervene, dose escalation should be stopped. Bupropion hydrochloride extended-release tablets (XL) should be swallowed whole and not crushed, divided, or chewed, as this may lead to an increased risk of adverse effects including seizures. Bupropion hydrochloride extended-release tablets (XL) may be taken without regard to meals.
Major Depressive Disorder: Initial Treatment: The usual adult target dose for bupropion hydrochloride extended-release tablets (XL) is 300 mg/day, given once daily in the morning. Dosing with bupropion hydrochloride extended-release tablets (XL) should begin at 150 mg/day given as a single daily dose in the morning. If the 150-mg initial dose is adequately tolerated, an increase to the 300-mg/day target dose, given as once daily, may be made as early as day 4 of dosing. There should be an interval of at least 24 hours between successive doses.
Increasing the Dosage Above 300 mg/day: As with other antidepressants, the full antidepressant effect of bupropion hydrochloride extended-release tablets (XL) may not be evident until 4 weeks of treatment or longer. An increase in dosage to the maximum of 450 mg/day, given as a single dose, may be considered for patients in whom no clinical improvement is noted after several weeks of treatment at 300 mg/day.
Maintenance Treatment: It is generally agreed that acute episodes of depression require several months or longer of sustained pharmacological therapy beyond response to the acute episode. It is unknown whether or not the dose of bupropion hydrochloride extended-release tablets (XL) needed for maintenance treatment is identical to the dose needed to achieve an initial response. Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment.
Seasonal Affective Disorder: For the prevention of seasonal major depressive episodes associated with seasonal affective disorder, bupropion hydrochloride extended-release tablets (XL) should generally be initiated in the autumn prior to the onset of depressive symptoms. Treatment should continue through the winter season and should be tapered and discontinued in early spring. The timing of initiation and duration of treatment should be individualized based on the patient's historical pattern of seasonal major depressive episodes. Patients whose seasonal depressive episodes are infrequent or not associated with significant impairment should not generally be treated prophylactically.
Dosing with bupropion hydrochloride extended-release tablets (XL) should begin at 150 mg/day given as a single daily dose in the morning. If the 150-mg initial dose is adequately tolerated, the dose of bupropion hydrochloride extended-release tablets (XL) should be increased to the 300-mg/day dose after 1 week. If the 300-mg dose is not adequately tolerated, the dose can be reduced to 150 mg/day. The usual adult target dose for bupropion hydrochloride extended-release tablets (XL) is 300 mg/day, given once daily in the morning.
For patients taking 300 mg/day during the autumn-winter season, the dose should be tapered to 150 mg/day for 2 weeks prior to discontinuation.
Doses of bupropion hydrochloride extended-release tablets (XL) above 300 mg/day have not been studied for the prevention of seasonal major depressive episodes.
Switching Patients from WELLBUTRIN® Tablets (bupropion hydrochloride tablets) or from WELLBUTRIN SR® Sustained-Release Tablets (bupropion hydrochloride extended release tablets (SR)): When switching patients from WELLBUTRIN® Tablets (bupropion hydrochloride tablets) to bupropion hydrochloride extended-release tablets (XL), or from WELLBUTRIN SR® Sustained-Release Tablets (bupropion hydrochloride extended release tablets (SR)) to bupropion hydrochloride extended-release tablets (XL), give the same total daily dose when possible. Patients who are currently being treated with WELLBUTRIN® Tablets (bupropion hydrochloride tablets) at 300 mg/day (for example, 100 mg 3 times a day) may be switched to bupropion hydrochloride extended-release tablets (XL) 300 mg once daily. Patients who are currently treated with WELLBUTRIN SR® Sustained-Release Tablets (bupropion hydrochloride extended release tablets (SR)) at 300 mg/day (for example, 150 mg twice daily) may be switched to bupropion hydrochloride extended-release tablets (XL) 300 mg once daily.
Dosage Adjustment for Patients With Impaired Hepatic Function: Bupropion hydrochloride extended-release tablets (XL) should be used with extreme caution in patients with severe hepatic cirrhosis. The dose should not exceed 150 mg every other day in these patients. Bupropion hydrochloride extended-release tablets (XL) should be used with caution in patients with hepatic impairment (including mild to moderate hepatic cirrhosis) and a reduced frequency and/or dose should be considered in patients with mild to moderate hepatic cirrhosis (see CLINICAL PHARMACOLOGY, WARNINGS, and PRECAUTIONS).
Dosage Adjustment for Patients With Impaired Renal Function: Bupropion hydrochloride extended-release tablets (XL) should be used with caution in patients with renal impairment and a reduced frequency and/or dose should be considered (see CLINICAL PHARMACOLOGY and PRECAUTIONS).
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Hydrocortisone
Adults and children 2 years of age and older
• apply to affected area not more than 3 to 4 times dailyChildren under 2 years of age
• do not use. Consult a doctor.For external anal itching
• adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with toilet tissue or a soft cloth before application of this product • children under 12 years of age with external anal itching: consult a doctor -
![Diltiazem Hydrochloride Capsule, Extended Release [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=a02d87b9-bb28-45b7-8bf4-d17daca78c28&name=20030c53-ad1d-41bf-bf24-4c27959cc9fd-03.jpg)
Diltiazem Hydrochloride
Patients controlled on diltiazem alone or in combination with other medications may be switched to diltiazem hydrochloride extended-release capsules at the nearest equivalent total daily dose. Higher doses of diltiazem hydrochloride extended-release capsules may be needed in some patients. Patients should be closely monitored. Subsequent titration to higher or lower doses may be necessary and should be initiated as clinically warranted. There is limited general clinical experience with doses above 360 mg, but doses to 540 mg have been studied in clinical trials. The incidence of side effects increases as the dose increases with first-degree AV block, dizziness, and sinus bradycardia bearing the strongest relationship to dose.
Hypertension: Dosage needs to be adjusted by titration to individual patient needs. When used as monotherapy, reasonable starting doses are 180 to 240 mg once daily, although some patients may respond to lower doses. Maximum antihypertensive effect is usually observed by 14 days of chronic therapy; therefore, dosage adjustments should be scheduled accordingly. The usual dosage range studied in clinical trials was 240 to 360 mg once daily. Individual patients may respond to higher doses of up to 480 mg once daily.
Angina: Dosages for the treatment of angina should be adjusted to each patient’s needs, starting with a dose of 120 or 180 mg once daily. Individual patients may respond to higher doses of up to 480 mg once daily. When necessary, titration may be carried out over a 7- to 14-day period.
Concomitant Use With Other Cardiovascular Agents
1. Sublingual NTG - May be taken as required to abort acute anginal attacks during diltiazem hydrochloride extended-release capsules therapy. 2. Prophylactic Nitrate Therapy - Diltiazem hydrochloride extended-release capsules may be safely coadministered with short-and long-acting nitrates. 3. Beta-Blockers - (See WARNINGS and PRECAUTIONS). 4. Antihypertensives - Diltiazem hydrochloride extended-release capsules have an additive antihypertensive effect when used with other antihypertensive agents. Therefore, the dosage of diltiazem hydrochloride extended-release capsules or the concomitant antihypertensives may need to be adjusted when adding one to the other. -
![Childrens Ibuprofen (Ibuprofen) Suspension [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=89956ef5-83a7-4cd6-9db8-2fafdbfe0947&name=da685bb0-9b81-4df6-9e71-92f7dbfb4a42-01.jpg)
Childrens Ibuprofen
• this product does not contain directions or complete warnings for adult use • do not give more than directed • shake well before using • find right dose on chart. If possible, use weight to dose; otherwise use age. • use only enclosed measuring cup • if needed, repeat dose every 6-8 hours • do not use more than 4 times a day • replace original bottle cap to maintain child resistance Dosing Chart Weight (lb) Age (yr) Dose (tsp or mL)
under 2 years
ask a doctor
24 – 35 lbs
2 – 3 years
1 tsp or 5 mL
36 – 47 lbs
4 – 5 years
1½ tsp or 7.5 mL
48 – 59 lbs
6 – 8 years
2 tsp or 10 mL
60 – 71 lbs
9 – 10 years
2½ tsp or 12.5 mL
72 – 95 lbs
11 years
3 tsp or 15 mL
Other information
• each teaspoon contains: sodium 2 mg • do not use if printed neckband is broken or missing • store between 20 - 25°C (68 - 77°F) • see bottom panel for lot number and expiration date -
![Hydroxyzine Hydrochloride Solution [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=e3baaa92-8668-441c-a2cc-ca4f85e67d4a&name=e3baaa92-8668-441c-a2cc-ca4f85e67d4a-02.jpg)
Hydroxyzine Hydrochloride Solution
For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested: in adults, 50-100 mg q.i.d.: children under 6 years, 50 mg daily in divided doses: children over 6 years: 50-100 mg daily in divided doses.
For use in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and in histamine-mediated pruritus: in adults, 25 mg t.i.d. or q.i.d.; children under 6 years, 50 mg daily in divided doses and children over 6 years, 50-100 mg daily in divided doses.
As a sedative when used as a premedication and following general anesthesia: 50-100 mg in adults, and 0.6 mg/kg in children.
When treatment is initiated by the intramuscular route of administration, subsequent doses may be administered orally.
As with all medications, the dosage should be adjusted according to the patient's response to therapy.
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![Clopidogrel Bisulfate Tablet, Film Coated [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=3e08ca1d-35ef-4b65-9799-5c62c6444d26&name=2ddfb83f-73ef-4ccb-b537-2438f6a828d1-10.jpg)
Clopidogrel Bisulfate
2.1 Acute Coronary Syndrome
Clopidogrel tablets can be administered with or without food [see Clinical Pharmacology (12.3)]
1. For patients with non-ST-elevation ACS (UA/NSTEMI), initiate clopidogrel tablets with a single 300 mg oral loading dose and then continue at 75 mg once daily. Initiate aspirin (75-325 mg once daily) and continue in combination with clopidogrel tablets [see Clinical Studies (14.1)]. 2. For patients with STEMI, the recommended dose of clopidogrel tablets is 75 mg once daily orally, administered in combination with aspirin (75-325 mg once daily), with or without thrombolytics. Clopidogrel tablets may be initiated with or without a loading dose [see Clinical Studies (14.1)].2.2 Recent MI, Recent Stroke, or Established Peripheral Arterial Disease
The recommended daily dose of clopidogrel tablets is 75 mg once daily orally, with or without food [see Clinical Pharmacology (12.3)].
2.3 CYP2C19 Poor Metabolizers
CYP2C19 poor metabolizer status is associated with diminished antiplatelet response to clopidogrel. Although a higher dose regimen in poor metabolizers increases antiplatelet response [see Clinical Pharmacology (12.5)], an appropriate dose regimen for this patient population has not been established.
2.4 Use with Proton Pump Inhibitors (PPI)
Avoid using omeprazole or esomeprazole with clopidogrel tablets. Omeprazole and esomeprazole significantly reduce the antiplatelet activity of clopidogrel tablets. When concomitant administration of a PPI is required, consider using another acid-reducing agent with minimal or no CYP2C19 inhibitory effect on the formation of clopidogrel active metabolite [see Warnings and Precautions (5.1), Drug Interactions (7.1) and Clinical Pharmacology (12.3)].
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![Finasteride Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=db499a51-42f2-40bd-afe6-b2a715e723be&name=db499a51-42f2-40bd-afe6-b2a715e723be-06.jpg)
Finasteride
Finasteride tablets USP may be administered with or without meals.
2.1 Monotherapy
The recommended dose of finasteride tablet USP are one tablet (5 mg) taken once a day [see Clinical Studies (14.1)].
2.2 Combination with Alpha-Blocker
The recommended dose of Finasteride tablets USP is one tablet (5 mg) taken once a day in combination with the alpha-blocker doxazosin [see Clinical Studies (14.2)].
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![Finasteride Tablet, Film Coated [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=1a11f437-a2aa-4f2b-b368-d1075cf857a9&name=1a11f437-a2aa-4f2b-b368-d1075cf857a9-03.jpg)
Finasteride
Finastedride tablets may be administered with or without meals.
The recommended dose of finasteride tablets is one tablet (1 mg) taken once daily.
In general, daily use for three months or more is necessary before benefit is observed. Continued use is recommended to sustain benefit, which should be re-evaluated periodically. Withdrawal of treatment leads to reversal of effect within 12 months.
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![Valacyclovir Hydrochloride Tablet, Film Coated [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=c5d2d5e0-4a7c-4d54-b155-c34076302854&name=8ef17b69-b81a-4df4-b738-0c602d99184b-02.jpg)
Valacyclovir Hydrochloride
• Valacyclovir hydrochloride tablets may be given without regard to meals. • Valacyclovir oral suspension (25 mg/mL or 50 mg/mL) may be prepared extemporaneously from valacyclovir hydrochloride tablets, 500 mg for use in pediatric patients for whom a solid dosage form is not appropriate [ see Dosage and Administration (2.3)].
2.1 Adult Dosing Recommendations
Cold Sores (Herpes Labialis): The recommended dosage of valacyclovir hydrochloride tablets for treatment of cold sores is 2 grams twice daily for 1 day taken 12 hours apart. Therapy should be initiated at the earliest symptom of a cold sore (e.g., tingling, itching, or burning).
Genital Herpes: Initial Episode: The recommended dosage of valacyclovir hydrochloride tablets for treatment of initial genital herpes is 1 gram twice daily for 10 days. Therapy was most effective when administered within 48 hours of the onset of signs and symptoms.
Recurrent Episodes: The recommended dosage of valacyclovir hydrochloride tablets for treatment of recurrent genital herpes is 500 mg twice daily for 3 days. Initiate treatment at the first sign or symptom of an episode.
Suppressive Therapy: The recommended dosage of valacyclovir hydrochloride tablets for chronic suppressive therapy of recurrent genital herpes is 1 gram once daily in patients with normal immune function. In patients with a history of 9 or fewer recurrences per year, an alternative dose is 500 mg once daily.
In HIV-infected patients with a CD4+ cell count ≥100 cells/mm3, the recommended dosage of valacyclovir hydrochloride tablets for chronic suppressive therapy of recurrent genital herpes is 500 mg twice daily.
Reduction of Transmission: The recommended dosage of valacyclovir hydrochloride tablets for reduction of transmission of genital herpes in patients with a history of 9 or fewer recurrences per year is 500 mg once daily for the source partner.
Herpes Zoster: The recommended dosage of valacyclovir hydrochloride tablets for treatment of herpes zoster is 1 gram 3 times daily for 7 days. Therapy should be initiated at the earliest sign or symptom of herpes zoster and is most effective when started within 48 hours of the onset of rash.
2.2 Pediatric Dosing Recommendations
Cold Sores (Herpes Labialis): The recommended dosage of valacyclovir hydrochloride tablets for the treatment of cold sores in pediatric patients≥12 years of age is 2 grams twice daily for 1 day taken 12 hours apart. Therapy should be initiated at the earliest symptom of a cold sore (e.g., tingling, itching, or burning).
Chickenpox: The recommended dosage of valacyclovir hydrochloride tablets for treatment of chickenpox in immunocompetent pediatric patients 2 to < 18 years of age is 20 mg/kg administered 3 times daily for 5 days. The total dose should not exceed 1 gram 3 times daily. Therapy should be initiated at the earliest sign or symptom [see Use in Specific Populations (8.4), Clinical Pharmacology (12.3), Clinical Studies (14.4)].
2.3 Extemporaneous Preparation of Oral Suspension
Ingredients and Preparation per USP-NF: Valacyclovir hydrochloride tablets, 500 mg, cherry flavor, and Suspension Structured Vehicle USP-NF (SSV). Valacyclovir oral suspension (25 mg/mL or 50 mg/mL) should be prepared in lots of 100 mL.
Prepare Suspension at Time of Dispensing as Follows:
• Prepare SSV according to the USP-NF. • Using a pestle and mortar, grind the required number of valacyclovir hydrochloride tablets, 500 mg until a fine powder is produced (5 valacyclovir hydrochloride tablets for 25 mg/mL suspension; 10 valacyclovir hydrochloride tablets for 50 mg/mL suspension). • Gradually add approximately 5 mL aliquots of SSV to the mortar and triturate the powder until a paste has been produced. Ensure that the powder has been adequately wetted. • Continue to add approximately 5 mL aliquots of SSV to the mortar, mixing thoroughly between additions, until a concentrated suspension is produced, to a minimum total quantity of 20 mL SSV and a maximum total quantity of 40 mL SSV for both the 25 mg/mL and 50 mg/mL suspensions. • Transfer the mixture to a suitable 100 mL measuring flask. • Transfer the cherry flavor* to the mortar and dissolve in approximately 5 mL of SSV. Once dissolved, add to the measuring flask. • Rinse the mortar at least 3 times with approximately 5 mL aliquots of SSV, transferring the rinsing to the measuring flask between additions. • Make the suspension to volume (100 mL) with SSV and shake thoroughly to mix. • Transfer the suspension to an amber glass medicine bottle with a child-resistant closure. • The prepared suspension should be labeled with the following information "Shake well before using. Store suspension between 2° to 8°C (36° to 46°F) in a refrigerator. Discard after 28 days."*The amount of cherry flavor added is as instructed by the suppliers of the cherry flavor.
2.4 Patients With Renal Impairment
Dosage recommendations for adult patients with reduced renal function are provided in Table 1 [see Use in Specific Populations (8.5, 8.6), Clinical Pharmacology (12.3)]. Data are not available for the use of valacyclovir hydrochloride tablets in pediatric patients with a creatinine clearance <50 mL/min/1.73 m2.
Table 1. Valacyclovir Hydrochloride Tablets Dosage Recommendations for Adults With Renal ImpairmentNormal Dosage Regimen
Creatinine Clearance (mL/min)
Indications
(Creatinine Clearance ≥50 mL/min)
30-49
10-29
<10
Cold sores (Herpes labialis) Do not exceed 1 day of treatment.
Two 2 gram doses taken 12 hours apart
Two 1 gram doses taken 12 hours apart
Two 500 mg doses taken 12 hours apart
500 mg single dose
Genital herpes: Initial episode
1 gram every12 hours
no reduction
1 gram every24 hours
500 mg every24 hours
Genital herpes: Recurrent episode
500 mg every12 hours
no reduction
500 mg every24 hours
500 mg every24 hours
Genital herpes: Suppressive therapy
Immunocompetent patients
1 gram every24 hours
no reduction
500 mg every24 hours
500 mg every24 hours
Alternate dose for immunocompetent patients with ≤9 recurrences/year
500 mg every24 hours
no reduction
500 mg every48 hours
500 mg every48 hours
HIV-infected patients
500 mg every12 hours
no reduction
500 mg every24 hours
500 mg every24 hours
Herpes zoster
1 gram every8 hours
1 gram every12 hours
1 gram every24 hours
500 mg every24 hours
Hemodialysis: Patients requiring hemodialysis should receive the recommended dose of valacyclovir hydrochloride tablets after hemodialysis. During hemodialysis, the half-life of acyclovir after administration of valacyclovir hydrochloride tablets are approximately 4 hours. About one third of acyclovir in the body is removed by dialysis during a 4-hour hemodialysis session.
Peritoneal Dialysis: There is no information specific to administration of valacyclovir hydrochloride tablets in patients receiving peritoneal dialysis. The effect of chronic ambulatory peritoneal dialysis (CAPD) and continuous arteriovenous hemofiltration/dialysis (CAVHD) on acyclovir pharmacokinetics has been studied. The removal of acyclovir after CAPD and CAVHD is less pronounced than with hemodialysis, and the pharmacokinetic parameters closely resemble those observed in patients with end-stage renal disease (ESRD) not receiving hemodialysis. Therefore, supplemental doses of valacyclovir hydrochloride tablets should not be required following CAPD or CAVHD.
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Sulfamethoxazole And Trimethoprim Suspension
Sulfamethoxazole and trimethoprim is contraindicated in pediatric patients less than 2 months of age.
Urinary Tract Infections and Shigellosis in Adults and Pediatric Patients, and Acute Otitis Media in Children
Adults
The usual adult dosage in the treatment of urinary tract infections is four teaspoonfuls (20mL) Sulfamethoxazole and trimethoprim oral suspension every 12 hours for 10 to 14 days. An identical daily dosage is used for 5 days in the treatment of shigellosis.
Children
The recommended dose for children with urinary tract infections or acute otitis media is 40 mg/kg sulfamethoxazole and 8 mg/kg trimethoprim per 24 hours, given in two divided doses every 12 hours for 10 days. An identical daily dosage is used for 5 days in the treatment of shigellosis. The following table is a guideline for the attainment of this dosage:
Children 2 months of age or older:
Weight
Dose - every 12 hours
lb
kg
Teaspoonfuls
22
10
1 (5 mL)
44
20
2 (10 mL)
66
30
3 (15 mL)
88
40
4 (20 mL)
For Patients with Impaired Renal Function: When renal function is impaired, a reduced dosage should be employed using the following table:
Creatinine Clearance (mL/min)
Recommended Dosage Regimen
Above 30
Use standard regimen
15 to 30
½ the usual regimen
Below 15
Use not recommended
Acute Exacerbations of Chronic Bronchitis in Adults
The usual adult dosage in the treatment of acute exacerbations of chronic bronchitis is four teaspoonfuls (20 mL) sulfamethoxazole and trimethoprim oral suspension every 12 hours for 14 days.
Pneumocystis Jiroveci Pneumonia
Treatment
Adults and Children: The recommended dosage for treatment of patients with documented Pneumocystis jiroveci pneumonia is 75 to 100 mg/kg sulfamethoxazole and 15 to 20 mg/kg trimethoprim per 24 hours given in equally divided doses every 6 hours for 14 to 21 days.11 The following table is a guideline for the upper limit of this dosage:
Weight
Dose - every 6 hours
lb
kg
Teaspoonfuls
18
8
1 (5 mL)
35
16
2 (10 mL)
53
24
3 (15 mL)
70
32
4 (20 mL)
88
40
5 (25 mL)
106
48
6 (30 mL)
141
64
8 (40 mL)
176
80
10 (50 mL)
For the lower limit dose (75 mg/kg sulfamethoxazole and 15 mg/kg trimethoprim per 24 hours) administer 75% of the dose in the above table.
Prophylaxis
Adults
The recommended dosage for prophylaxis in adults is four teaspoonfuls (20 mL) of the oral suspension daily.12
Children
For children, the recommended dose is 750 mg/m2/day sulfamethoxazole with 150 mg/m2/day trimethoprim given orally in equally divided doses twice a day, on 3 consecutive days per week. The total daily dose should not exceed 1600 mg sulfamethoxazole and 320 mg trimethoprim.13 The following table is a guideline for the attainment of this dosage in children:
Body Surface Area
Dose - every 12 hours
(m2)
Teaspoonfuls
0.26
½ (2.5 mL)
0.53
1 (5 mL)
1.06
2 (10 mL)
Travelers’ Diarrhea in Adults
For the treatment of travelers' diarrhea, the usual adult dosage is four teaspoonfuls (20 mL) of sulfamethoxazole and trimethoprim oral suspension every 12 hours for 5 days.
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![Enalapril Maleate Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=8abc2534-c20f-4344-8d29-c52b0bfd76b8&name=fb88c505-580e-4e91-86a2-24b3bb8c6a24-02.jpg)
Enalapril Maleate
Hypertension
In patients who are currently being treated with a diuretic, symptomatic hypotension occasionally may occur following the initial dose of enalapril maleate tablets. The diuretic should, if possible, be discontinued for two to three days before beginning therapy with enalapril maleate tablets to reduce the likelihood of hypotension (see WARNINGS). If the patient's blood pressure is not controlled with enalapril maleate tablets alone, diuretic therapy may be resumed.
If the diuretic cannot be discontinued an initial dose of 2.5 mg should be used under medical supervision for at least two hours and until blood pressure has stabilized for at least an additional hour (see WARNINGS and PRECAUTIONS, Drug Interactions).
The recommended initial dose in patients not on diuretics is 5 mg once a day. Dosage should be adjusted according to blood pressure response. The usual dosage range is 10 to 40 mg per day administered in a single dose or two divided doses. In some patients treated once daily, the antihypertensive effect may diminish toward the end of the dosing interval. In such patients, an increase in dosage or twice daily administration should be considered. If blood pressure is not controlled with enalapril maleate tablets alone, a diuretic may be added.
Concomitant administration of enalapril maleate tablets with potassium supplements, potassium salt substitutes, or potassium-sparing diuretics may lead to increases of serum potassium (see PRECAUTIONS).
Dosage Adjustment in Hypertensive Patients with Renal Impairment
The usual dose of enalapril is recommended for patients with a creatinine clearance >30 mL/min (serum creatinine of up to approximately 3 mg/dL). For patients with creatinine clearance ≤30 mL/min (serum creatinine ≥3 mg/dL), the first dose is 2.5 mg once daily. The dosage may be titrated upward until blood pressure is controlled or to a maximum of 40 mg daily.
* See WARNINGS, Anaphylactoid reactions during membrane exposure † Dosage on nondialysis days should be adjusted depending on the blood pressure response.Renal Status
Creatinine- Clearance mL/min
Initial Dose mg/day
Normal Renal Function
>80 mL/min
5 mg
Mild Impairment
≤80 >30 mL/min
5 mg
Moderate to Severe Impairment
≤30 mL/min
2.5 mg
Dialysis Patients*
-
2.5 mg on dialysis days†
Heart Failure
Enalapril maleate tablets are indicated for the treatment of symptomatic heart failure, usually in combination with diuretics and digitalis. In the placebo-controlled studies that demonstrated improved survival, patients were titrated as tolerated up to 40 mg, administered in two divided doses.
The recommended initial dose is 2.5 mg. The recommended dosing range is 2.5 to 20 mg given twice a day. Doses should be titrated upward, as tolerated, over a period of a few days or weeks. The maximum daily dose administered in clinical trials was 40 mg in divided doses.
After the initial dose of enalapril maleate tablets, the patient should be observed under medical supervision for at least two hours and until blood pressure has stabilized for at least an additional hour (see WARNINGS and PRECAUTIONS, Drug Interactions). If possible, the dose of any concomitant diuretic should be reduced which may diminish the likelihood of hypotension. The appearance of hypotension after the initial dose of enalapril maleate tablets does not preclude subsequent careful dose titration with the drug, following effective management of the hypotension.
Asymptomatic Left Ventricular Dysfunction
In the trial that demonstrated efficacy, patients were started on 2.5 mg twice daily and were titrated as tolerated to the targeted daily dose of 20 mg (in divided doses).
After the initial dose of enalapril maleate tablets, the patient should be observed under medical supervision for at least two hours and until blood pressure has stabilized for at least an additional hour (see WARNINGS and PRECAUTIONS, Drug Interactions). If possible, the dose of any concomitant diuretic should be reduced which may diminish the likelihood of hypotension. The appearance of hypotension after the initial dose of enalapril maleate tablets does not preclude subsequent careful dose titration with the drug, following effective management of the hypotension.
Dosage Adjustment in Patients with Heart Failure and Renal Impairment or Hyponatremia
In patients with heart failure who have hyponatremia (serum sodium less than 130 mEq/L) or with serum creatinine greater than 1.6 mg/dL, therapy should be initiated at 2.5 mg daily under close medical supervision (see DOSAGE AND ADMINISTRATION, Heart Failure, WARNINGS and PRECAUTIONS, Drug Interactions). The dose may be increased to 2.5 mg b.i.d., then 5 mg b.i.d. and higher as needed, usually at intervals of four days or more if at the time of dosage adjustment there is not excessive hypotension or significant deterioration of renal function. The maximum daily dose is 40 mg.
Pediatric Hypertensive Patients
The usual recommended starting dose is 0.08 mg/kg (up to 5 mg) once daily. Dosage should be adjusted according to blood pressure response. Doses above 0.58 mg/kg (or in excess of 40 mg) have not been studied in pediatric patients (see CLINICAL PHARMACOLOGY, Clinical Pharmacology in Pediatric Patients).
Enalapril maleate is not recommended in neonates and in pediatric patients with glomerular filtration rate <30 mL/ min/1.73 m2, as no data are available.
Preparation of Suspension (for 200 mL of a 1.0 mg/mL suspension)
Add 50 mL of Bicitra®** to a polyethylene terephthalate (PET) bottle containing ten 20 mg tablets of enalapril maleate and shake for at least 2 minutes. Let concentrate stand for 60-minutes. Following the 60-minute hold time, shake the concentrate for an additional minute. Add 150 mL of Ora-Sweet SFTM*** to the concentrate in the PET bottle and shake the suspension to disperse the ingredients.
The suspension should be refrigerated at 2-8°C (36-46°F) and can be stored for up to 30 days. Shake the suspension before each use.
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Nitrofurantoin Monohydrate Macrocrystalline
Nitrofurantoin monohydrate/macrocrystals capsules should be taken with food.
Adults and Pediatric Patients Over 12 Years: One 100 mg capsule every 12 hours for seven days.
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![Sulfamethoxazole And Trimethoprim Suspension [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=bbad2036-e2a8-4c56-bb92-dea833598ebc&name=bbad2036-e2a8-4c56-bb92-dea833598ebc-03.jpg)
Sulfamethoxazole And Trimethoprim Suspension
Sulfamethoxazole and trimethoprim oral suspension is contraindicated in pediatric patients less than 2 months of age. Urinary Tract Infections and Shigellosis in Adults and Pediatric Patients, and Acute Otitis Media in Children AdultsThe usual adult dosage in the treatment of urinary tract infections is four teaspoonfuls (20 mL) sulfamethoxazole and trimethoprim oral suspension every 12 hours for 10 to 14 days. An identical daily dosage is used for 5 days in the treatment of shigellosis.ChildrenThe recommended dose for children with urinary tract infections or acute otitis media is 40 mg/kg sulfamethoxazole and 8 mg/kg trimethoprim per 24 hours, given in two divided doses every 12 hours for 10 days. An identical daily dosage is used for 5 days in the treatment of shigellosis. The following table is a guideline for the attainment of this dosage:Children 2 months of age or older:
Weight
Dose–every 12 hours
lb
kg
Teaspoonfuls
22
10
1 (5 mL)
44
20
2 (10 mL)
66
30
3 (15 mL)
88
40
4 (20 mL)
For Patients with Impaired Renal Function When renal function is impaired, a reduced dosage should be employed using the following table:
Creatinine Clearance (mL/min)
Recommended Dosage Regimen
Above 30
Usual standard regimen
15 to 30
½ the usual regimen
Below 15
Use not recommended
Acute Exacerbations of Chronic Bronchitis in Adults The usual adult dosage in the treatment of acute exacerbations of chronic bronchitis is four teaspoonfuls (20 mL) sulfamethoxazole and trimethoprim oral suspension every 12 hours for 14 days.Pneumocystis Jiroveci PneumoniaTreatmentAdults and Children The recommended dosage for treatment of patients with documented Pneumocystis jiroveci pneumonia is 75 to 100 mg/kg sulfamethoxazole and 15 to 20 mg/kg trimethoprim per 24 hours given in equally divided doses every 6 hours for 14 to 21 days.11 The following table is a guideline for the upper limit of this dosage:
Weight
Dose–every 6 hours
lb
kg
Teaspoonfuls
18
8
1 (5 mL)
35
16
2 (10 mL)
53
24
3 (15 mL)
70
32
4 (20 mL)
88
40
5 (25 mL)
106
48
6 (30 mL)
141
64
8 (40 mL)
176
80
10 (50 mL)
For the lower limit dose (75 mg/kg sulfamethoxazole and 15 mg/kg trimethoprim per 24 hours) administer 75% of the dose in the above table.ProphylaxisAdults The recommended dosage for prophylaxis in adults is four teaspoonfuls (20 mL) of the suspension daily.12 Children For children, the recommended dose is 750 mg/m2/day sulfamethoxazole with 150 mg/m2/day trimethoprim given orally in equally divided doses twice a day, on 3 consecutive days per week. The total daily dose should not exceed 1600 mg sulfamethoxazole and 320 mg trimethoprim.13 The following table is a guideline for the attainment of this dosage in children:
Body Surface Area
Dose–every 12 hours
(m2)
Teaspoonfuls
0.26
½ (2.5 mL)
0.53
1 (5 mL)
1.06
2 (10 mL)
Traveler’s Diarrhea in Adults For the treatment of traveler’s diarrhea, the usual adult dosage is four teaspoonfuls (20 mL) of the suspension every 12 hours for 5 days.
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![Estradiol Tablet [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=e6c0ee96-5d2a-4725-a460-5ca62f2b6c36&name=c77cbd62-c0a0-446b-b6f3-3c8827c7d5fb-02.jpg)
Estradiol
Dosage and Administration
When estrogen is prescribed for a postmenopausal woman with a uterus, a progestin should also be initiated to reduce the risk of endometrial cancer. A woman without a uterus does not need progestin. Use of estrogen, alone or in combination with a progestin, should be with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Patients should be reevaluated periodically as clinically appropriate (e.g., 3-month to 6-month intervals) to determine if treatment is still necessary (see BOXED WARNINGS and WARNINGS). For women who have a uterus, adequate diagnostic measures, such as endometrial sampling, when indicated, should be undertaken to rule out malignancy in cases of undiagnosed persistent or recurring abnormal vaginal bleeding.
Patients should be started at the lowest dose for the indication.
1. For treatment of moderate to severe vasomotor symptoms, vulval and vaginal atrophy associated with the menopause, the lowest dose and regimen that will control symptoms should be chosen and medication should be discontinued as promptly as possible.
Attempts to discontinue or taper medication should be made at 3-month to 6-month intervals. The usual initial dosage range is 1 to 2 mg daily of estradiol adjusted as necessary to control presenting symptoms. The minimal effective dose for maintenance therapy should be determined by titration. Administration should be cyclic (e.g., 3 weeks on and 1 week off).
2. For treatment of female hypoestrogenism due to hypogonadism, castration, or primary ovarian failure.
Treatment is usually initiated with a dose of 1 to 2 mg daily of estradiol, adjusted as necessary to control presenting symptoms; the minimal effective dose for maintenance therapy should be determined by titration.
3. For treatment of breast cancer, for palliation only, in appropriately selected women and men with metastatic disease.
Suggested dosage is 10 mg three times daily for a period of at least three months.
4. For treatment of advanced androgen-dependent carcinoma of the prostate, for palliation only.
Suggested dosage is 1 to 2 mg three times daily. The effectiveness of therapy can be judged by phosphatase determinations as well as by symptomatic improvement of the patient.
5. For prevention of osteoporosis.
When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should be considered only for women at significant risk of osteoporosis and for whom non-estrogen medications are not considered to be appropriate.
The lowest effective dose of estradiol has not been determined.
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![Dicyclomine Hydrochloride Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=f3a3e5ad-9178-4855-b537-abd125836a07&name=f3a3e5ad-9178-4855-b537-abd125836a07-02.jpg)
Dicyclomine Hydrochloride
Dosage must be adjusted to individual patient needs.
2.1 Oral Dosage and Administration in Adults
The recommended initial dose is 20 mg four times a day.
After one week treatment with the initial dose, the dose may be increased to 40 mg four times a day unless side effects limit dosage escalation.
If efficacy is not achieved within 2 weeks or side effects require doses below 80 mg per day, the drug should be discontinued. Documented safety data are not available for doses above 80 mg daily for periods longer than 2 weeks.
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![Erythromycin Base Base (Erythromycin) Tablet, Film Coated [Pd-rx Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=16490d70-8737-4a45-bc45-c9f22b22767a&name=acetaminophen-and-codeine-phosphate-8.jpg)
Erythromycin Base Base
Dosage should be adjusted according to severity of pain and response of the patient.
The usual adult dosage is:
Single Doses (Range)
Maximum 24-Hour Dose
Codeine Phosphate
15 mg to 60 mg
360 mg
Acetaminophen
300 mg to 1000 mg
4000 mg
Doses may be repeated up to every 4 hours.
The prescriber must determine the number of tablets per dose, and the maximum number of tablets per 24 hours based upon the above dosage guidance. This information should be conveyed in the prescription.
It should be kept in mind, however, that tolerance to codeine can develop with continued use and that the incidence of untoward effects is dose related. Adult doses of codeine higher than 60 mg fail to give commensurate relief of pain but merely prolong analgesia and are associated with an appreciably increased incidence of undesirable side effects. Equivalently high doses in children would have similar effects.
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Fluconazole
Dosage and Administration in Adults:
Single Dose
Vaginal candidiasis: The recommended dosage of fluconazole for vaginal candidiasis is150 mg as a single oral dose.
Multiple Dose
SINCE ORAL ABSORPTION IS RAPID AND ALMOST COMPLETE, THE DAILY DOSE OF FLUCONAZOLE IS THE SAME FOR ORAL TABLETS AND INTRAVENOUS ADMINISTRATION. In general, a loading dose of twice the daily dose is recommended on the first day of therapy to result in plasma concentrations close to steady-state by the second day of therapy.
The daily dose of fluconazole for the treatment of infections other than vaginal candidiasis should be based on the infecting organism and the patient’s response to therapy. Treatment should be continued until clinical parameters or laboratory tests indicate that active fungal infection has subsided. An inadequate period of treatment may lead to recurrence of active infection. Patients with AIDS and cryptococcal meningitis or recurrent oropharyngeal candidiasis usually require maintenance therapy to prevent relapse.
Oropharyngeal candidiasis: The recommended dosage of fluconazole for oropharyngealcandidiasis is 200 mg on the first day, followed by 100 mg once daily. Clinical evidence of oropharyngeal candidiasis generally resolves within several days, but treatment should be continued for at least 2 weeks to decrease the likelihood of relapse.
Esophageal candidiasis: The recommended dosage of fluconazole for esophageal candidiasis is 200 mg on the first day, followed by 100 mg once daily. Doses up to 400 mg/day may be used, based on medical judgment of the patient’s response to therapy. Patients with esophageal candidiasis should be treated for a minimum of three weeks and for at least two weeks following resolution of symptoms.
Systemic Candida infections: For systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia, optimal therapeutic dosage and duration of therapy have not been established. In open, noncomparative studies of small numbers of patients, doses of up to 400 mg daily have been used.
Urinary tract infections and peritonitis: For the treatment of Candida urinary tract infections and peritonitis, daily doses of 50-200 mg have been used in open, noncomparative studies of small numbers of patients.
Cryptococcal meningitis: For the treatment of acute cryptococcal meningitis, the recommended dosage is 12 mg/kg on the first day, followed by 6 mg/kg once daily. A dosage of 12 mg/kg once daily may be used, based on medical judgment of the patient’s response to therapy. The recommended duration of treatment for initial therapy of cryptococcal meningitis is 10-12 weeks after the cerebrospinal fluid becomes culture negative. For suppression of relapse of cryptococcal meningitis in children with AIDS, the recommended dose of fluconazole is 6 mg/kg once daily.
Dosage In Patients With Impaired Renal Function:
Fluconazole is cleared primarily by renal excretion as unchanged drug. There is no need to adjust single dose therapy for vaginal candidiasis because of impaired renal function. In patients with impaired renal function who will receive multiple doses of fluconazole, an initial loading dose of 50 to 400 mg should be given. After the loading dose, the daily dose (according to indication) should be based on the following table:
Creatinine Clearance (mL/min)
Percent of Recommended Dose
>50
100%
≤50 (no dialysis)
50%
Regular dialysis
100% after each dialysis
These are suggested dose adjustments based on pharmacokinetics following administration of multiple doses. Further adjustment may be needed depending upon clinical condition.
When serum creatinine is the only measure of renal function available, the following formula (based on sex, weight, and age of the patient) should be used to estimate the creatinine clearance in adults:
Males:
Weight (kg) × (140 – age)
72 × serum creatinine (mg/100 mL)
Females:
0.85 × above value
Although the pharmacokinetics of fluconazole has not been studied in children with renal insufficiency, dosage reduction in children with renal insufficiency should parallel that recommended for adults. The following formula may be used to estimate creatinine clearance in children:
K × linear length or height (cm)
serum creatinine (mg/100 mL)
(Where K=0.55 for children older than 1 year and 0.45 for infants.)
Administration
Fluconazole may be administered orally. Fluconazole can be taken with or without food.
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![Lorazepam Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=5c6bb800-ad50-4e9f-a996-02405f7ea60a&name=8e44d4f5-eb44-49ba-9570-298c14359694-02.jpg)
Lorazepam
Lorazepam Tablets, USP are administered orally. For optimal results, dose, frequency of administration, and duration of therapy should be individualized according to patient response. To facilitate this, 0.5 mg, 1 mg, and 2 mg tablets are available.
The usual range is 2 to 6 mg/day given in divided doses, the largest dose being taken before bedtime, but the daily dose may vary from 1 to 10 mg/day.
For anxiety, most patients require an initial dose of 2 to 3 mg/day given b.i.d. or t.i.d.
For insomnia due to anxiety or transient situational stress, a single daily dose of 2 to 4 mg may be given, usually at bedtime.
For elderly or debilitated patients, an initial dosage of 1 to 2 mg/day in divided doses is recommended, to be adjusted as needed and tolerated.
The dosage of lorazepam tablets should be increased gradually when needed to help avoid adverse effects. When higher dosage is indicated, the evening dose should be increased before the daytime doses.
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![Tizanidine Tablet [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=fce6f784-cfc5-49ef-af1f-fa6dc389ed3e&name=119bd962-30d2-49a6-8aee-238f82527cb0-04.jpg)
Tizanidine
A single dose of 8 mg of tizanidine reduces muscle tone in patients with spasticity for a period of several hours. The effect peaks at approximately 1 to 2 hours and dissipates between 3 to 6 hours. Effects are dose-related.
Although single doses of less than 8 mg have not been demonstrated to be effective in controlled clinical studies, the dose-related nature of tizanidine’s common adverse events make it prudent to begin treatment with single oral doses of 4 mg. Increase the dose gradually (2 to 4 mg steps) to optimum effect (satisfactory reduction of muscle tone at a tolerated dose).
The dose can be repeated at 6 to 8 hour intervals, as needed, to a maximum of three doses in 24 hours. The total daily dose should not exceed 36 mg.
Experience with single doses exceeding 8 mg and daily doses exceeding 24 mg is limited. There is essentially no experience with repeated, single, daytime doses greater than 12 mg or total daily doses greater than 36 mg (see WARNINGS).
Food has complex effects on tizanidine pharmacokinetics, which differ with the different formulations. These pharmacokinetic differences may result in clinically significant differences when switching administration of the tablet between the fed or fasted state. These changes may result in increased adverse events or delayed/more rapid onset of activity, depending upon the nature of the switch. For this reason, the prescriber should be thoroughly familiar with the changes in kinetics associated with these different conditions (see CLINICAL PHARMACOLOGY: Pharmacokinetics).
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![Levofloxacin Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=d00c32db-b320-4574-a941-440f22d8b368&name=3bb4d8c3-d8b0-4f54-9267-13f2bf09176e-04.jpg)
Levofloxacin
2.1 Dosage in Adult Patients with Normal Renal Function
The usual dose of levofloxacin tablets are 250 mg, 500 mg, or 750 mg administered orally every 24 hours, as indicated by infection and described in Table 1.
These recommendations apply to patients with creatinine clearance ≥ 50 mL/min. For patients with creatinine clearance <50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].
Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50 mL/min) * Due to the designated pathogens [see Indications and Usage (1)]. † Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician. ‡Due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [see Indications and Usage (1.2)]. § Due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see Indications and Usage (1.3)]. ¶ This regimen is indicated for cUTI due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and AP due to E. coli, including cases with concurrent bacteremia. # This regimen is indicated for cUTI due to Enterococcus faecalis, Enterococcus cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa; and for AP due to E. coli. Þ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)]. ß The safety of levofloxacin in adults for durations of therapy beyond 28 days or in pediatric patients for durations beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk. à Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersiniapestis. Higher doses of levofloxacin typically used for treatment of pneumonia can be used for treatment of plague, if clinically indicated.Type of Infection*
Dosed Every 24 hours
Duration (days)†
Nosocomial Pneumonia
750 mg
7-14
Community Acquired Pneumonia‡
500 mg
7-14
Community Acquired Pneumonia§
750 mg
5
Acute Bacterial Sinusitis
750 mg
5
500 mg
10-14
Acute Bacterial Exacerbation of Chronic Bronchitis
500 mg
7
Complicated Skin and Skin Structure Infections (SSSI)
750 mg
7-14
Uncomplicated SSSI
500 mg
7-10
Chronic Bacterial Prostatitis
500 mg
28
Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)¶
750 mg
5
Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)#
250 mg
10
Uncomplicated Urinary Tract Infection
250 mg
3
Inhalational Anthrax (Post-Exposure), adult and pediatric patients > 50 kg Þ, ß Pediatric patients < 50 kg and ≥ 6 months of age Þ, ß
500 mgSee Table 2 below (2.2)
60 ß 60 ß
Plague, adult and pediatric patients > 50 kg à Pediatric patients < 50 kg and ≥ 6 months of age
500 mgSee Table 2 below (2.2)
10 to 1410 to 14
2.2 Dosage in Pediatric Patients
The dosage in pediatric patients ≥ 6 months of age is described below in Table 2.
Table 2: Dosage in Pediatric Patients ≥ 6 months of age * Due to Bacillus anthracis [see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage (1.14)]. † Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician. ‡ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)] § The safety of levofloxacin in pediatric patients for durations of therapy beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk. ¶ Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis.Type of Infection*
Dose
Freq. Once every
Duration†
Inhalational Anthrax (post-exposure)‡,§
Pediatric patients > 50 kg
500 mg
24 hr
60 days§
Pediatric patients < 50 kg and ≥ 6 months of age
8 mg/kg (not to exceed 250 mg per dose)
12 hr
60 days§
Plague ¶
Pediatric patients > 50 kg
500 mg
24 hr
10 to 14 days
Pediatric patients < 50 kg and ≥ 6 months of age
8 mg/kg (not to exceed 250 mg per dose)
12 hr
10 to 14 days
2.3 Dosage Adjustment in Adults with Renal Impairment
Administer levofloxacin with caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced.
No adjustment is necessary for patients with a creatinine clearance ≥ 50 mL/min.
In patients with impaired renal function (creatinine clearance <50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [see Use in Specific Populations (8.6)].
Table 3 shows how to adjust dose based on creatinine clearance.
Table 3: Dosage Adjustment in Adult Patients with Renal Impairment (creatinine clearance <50 mL/min)Dosage in Normal Renal Function Every 24 hours
Creatinine Clearance 20 to 49 mL/min
Creatinine Clearance 10 to 19 mL/min
Hemodialysis or Chronic Ambulatory Peritoneal Dialysis (CAPD)
750 mg
750 mg every 48 hours
750 mg initial dose, then 500 mg every 48 hours
750 mg initial dose, then 500 mg every 48 hours
500 mg
500 mg initial dose, then 250 mg every 24 hours
500 mg initial dose, then 250 mg every 48 hours
500 mg initial dose, then 250 mg every 48 hours
250 mg
No dosage adjustment required
250 mg every 48 hours. If treating uncomplicated UTI, then no dosage adjustment is required
No information on dosing adjustment is available
2.4 Drug Interaction With Chelation Agents: Antacids, Sucralfate, Metal Cations, Multivitamins
Levofloxacin Tablets
Levofloxacin Tablets should be administered at least two hours before or two hours after antacids containing magnesium, aluminum, as well as sucralfate, metal cations such as iron, and multivitamin preparations with zinc or didanosine chewable/buffered tablets or the pediatric powder for oral solution [see Drug Interactions (7.1) and Patient Counseling Information (17.2)].
2.5 Administration Instructions
Food and Levofloxacin Tablets
Levofloxacin Tablets can be administered without regard to food.
Hydration for Patients Receiving Levofloxacin Tablets
Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)].
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![Sulfamethoxazole And Trimethoprim Tablet [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=1d3e46c4-6652-44c9-8aa6-2bae30d4b246&name=62e18e8f-676c-4ae7-82c4-20e534f35694-03.jpg)
Sulfamethoxazole And Trimethoprim
Sulfamethoxazole and trimethoprim is contraindicated in pediatric patients less than 2 months of age.
Urinary Tract Infections and Shigellosis in Adults and Pediatric Patients, and Acute Otitis Media in Children:
Adults:
The usual adult dosage in the treatment of urinary tract infections is 1 sulfamethoxazole and trimethoprim DS (double strength) tablet or 2 sulfamethoxazole and trimethoprim tablets every 12 hours for 10 to 14 days. An identical daily dosage is used for 5 days in the treatment of shigellosis.
Children:
The recommended dose for children with urinary tract infections or acute otitis media is 40 mg/kg sulfamethoxazole and 8 mg/kg trimethoprim per 24 hours, given in two divided doses every 12 hours for 10 days. An identical daily dosage is used for 5 days in the treatment of shigellosis. The following table is a guideline for the attainment of this dosage:
Children 2 months of age or older:
Weight Dose-every 12 hours lb kg Tablets22
10
-
44
20
1
66
30
1½
88
40
2 or 1 DS tablet
For Patients with Impaired Renal Function:
When renal function is impaired, a reduced dosage should be employed using the following table:
CreatinineClearance (mL/min)
Recommended Dosage Regimen
Above 30
Usual standard regimen
15–30
½ the usual regimen
Below 15
Use not recommended
Acute Exacerbations of Chronic Bronchitis in Adults:
The usual adult dosage in the treatment of acute exacerbations of chronic bronchitis is 1 sulfamethoxazole and trimethoprim DS (double strength) tablet or 2 sulfamethoxazole and trimethoprim tablets every 12 hours for 14 days.
Pneumocystis Jiroveci Pneumonia:
Treatment: Adults and Children:
The recommended dosage for treatment of patients with documented Pneumocystis jiroveci pneumonia is 75 to 100 mg/kg sulfamethoxazole and 15 to 20 mg/kg trimethoprim per 24 hours given in equally divided doses every 6 hours for 14 to 21 days.11 The following table is a guideline for the upper limit of this dosage:
Weight Dose-every 6 hours lb kg Tablets18
8
-
35
16
1
53
24
1½
70
32
2 or 1 DS tablet
88
40
2½
106
48
3 or 1½ DS tablets
141
64
4 or 2 DS tablets
176
80
5 or 2½ DS tablets
For the lower limit dose (75 mg/kg sulfamethoxazole and 15 mg/kg trimethoprim per 24 hours) administer 75% of the dose in the above table.
Prophylaxis:
Adults:
The recommended dosage for prophylaxis in adults is 1 sulfamethoxazole and trimethoprim DS (double strength) tablet daily.12
Children:
For children, the recommended dose is 750 mg/m2/day sulfamethoxazole with 150 mg/m2/day trimethoprim given orally in equally divided doses twice a day, on 3 consecutive days per week. The total daily dose should not exceed 1600 mg sulfamethoxazole and 320 mg trimethoprim.13 The following table is a guideline for the attainment of this dosage in children:
Body Surface Area Dose-every 12 hours (m2) Tablets0.26
-
0.53
½
1.06
1
Traveler's Diarrhea in Adults:
For the treatment of traveler's diarrhea, the usual adult dosage is 1 sulfamethoxazole and trimethoprim DS (double strength) tablet or 2 sulfamethoxazole and trimethoprim tablets every 12 hours for 5 days.
Urinary Tract Infections and Shigellosis in Adults and Pediatric Patients, and Acute Otitis Media in Children:
Adults:
The usual adult dosage in the treatment of urinary tract infections is 1 sulfamethoxazole and trimethoprim DS (double strength) tablet or 2 sulfamethoxazole and trimethoprim tablets every 12 hours for 10 to 14 days. An identical daily dosage is used for 5 days in the treatment of shigellosis.
Children:
The recommended dose for children with urinary tract infections or acute otitis media is 40 mg/kg sulfamethoxazole and 8 mg/kg trimethoprim per 24 hours, given in two divided doses every 12 hours for 10 days. An identical daily dosage is used for 5 days in the treatment of shigellosis. The following table is a guideline for the attainment of this dosage:
Children 2 months of age or older:
Weight Dose-every 12 hours lb kg Tablets22
10
-
44
20
1
66
30
1½
88
40
2 or 1 DS tablet
Adults:
The usual adult dosage in the treatment of urinary tract infections is 1 sulfamethoxazole and trimethoprim DS (double strength) tablet or 2 sulfamethoxazole and trimethoprim tablets every 12 hours for 10 to 14 days. An identical daily dosage is used for 5 days in the treatment of shigellosis.
Children:
The recommended dose for children with urinary tract infections or acute otitis media is 40 mg/kg sulfamethoxazole and 8 mg/kg trimethoprim per 24 hours, given in two divided doses every 12 hours for 10 days. An identical daily dosage is used for 5 days in the treatment of shigellosis. The following table is a guideline for the attainment of this dosage:
Children 2 months of age or older:
Weight Dose-every 12 hours lb kg Tablets22
10
-
44
20
1
66
30
1½
88
40
2 or 1 DS tablet
For Patients with Impaired Renal Function:
When renal function is impaired, a reduced dosage should be employed using the following table:
CreatinineClearance (mL/min)
Recommended Dosage Regimen
Above 30
Usual standard regimen
15–30
½ the usual regimen
Below 15
Use not recommended
Acute Exacerbations of Chronic Bronchitis in Adults:
The usual adult dosage in the treatment of acute exacerbations of chronic bronchitis is 1 sulfamethoxazole and trimethoprim DS (double strength) tablet or 2 sulfamethoxazole and trimethoprim tablets every 12 hours for 14 days.
Pneumocystis Jiroveci Pneumonia:
Treatment: Adults and Children:
The recommended dosage for treatment of patients with documented Pneumocystis jiroveci pneumonia is 75 to 100 mg/kg sulfamethoxazole and 15 to 20 mg/kg trimethoprim per 24 hours given in equally divided doses every 6 hours for 14 to 21 days.11 The following table is a guideline for the upper limit of this dosage:
Weight Dose-every 6 hours lb kg Tablets18
8
-
35
16
1
53
24
1½
70
32
2 or 1 DS tablet
88
40
2½
106
48
3 or 1½ DS tablets
141
64
4 or 2 DS tablets
176
80
5 or 2½ DS tablets
For the lower limit dose (75 mg/kg sulfamethoxazole and 15 mg/kg trimethoprim per 24 hours) administer 75% of the dose in the above table.
Treatment: Adults and Children:
The recommended dosage for treatment of patients with documented Pneumocystis jiroveci pneumonia is 75 to 100 mg/kg sulfamethoxazole and 15 to 20 mg/kg trimethoprim per 24 hours given in equally divided doses every 6 hours for 14 to 21 days.11 The following table is a guideline for the upper limit of this dosage:
Weight Dose-every 6 hours lb kg Tablets18
8
-
35
16
1
53
24
1½
70
32
2 or 1 DS tablet
88
40
2½
106
48
3 or 1½ DS tablets
141
64
4 or 2 DS tablets
176
80
5 or 2½ DS tablets
For the lower limit dose (75 mg/kg sulfamethoxazole and 15 mg/kg trimethoprim per 24 hours) administer 75% of the dose in the above table.
Prophylaxis:
Adults:
The recommended dosage for prophylaxis in adults is 1 sulfamethoxazole and trimethoprim DS (double strength) tablet daily.12
Children:
For children, the recommended dose is 750 mg/m2/day sulfamethoxazole with 150 mg/m2/day trimethoprim given orally in equally divided doses twice a day, on 3 consecutive days per week. The total daily dose should not exceed 1600 mg sulfamethoxazole and 320 mg trimethoprim.13 The following table is a guideline for the attainment of this dosage in children:
Body Surface Area Dose-every 12 hours (m2) Tablets0.26
-
0.53
½
1.06
1
Adults:
The recommended dosage for prophylaxis in adults is 1 sulfamethoxazole and trimethoprim DS (double strength) tablet daily.12
Children:
For children, the recommended dose is 750 mg/m2/day sulfamethoxazole with 150 mg/m2/day trimethoprim given orally in equally divided doses twice a day, on 3 consecutive days per week. The total daily dose should not exceed 1600 mg sulfamethoxazole and 320 mg trimethoprim.13 The following table is a guideline for the attainment of this dosage in children:
Body Surface Area Dose-every 12 hours (m2) Tablets0.26
-
0.53
½
1.06
1
Traveler's Diarrhea in Adults:
For the treatment of traveler's diarrhea, the usual adult dosage is 1 sulfamethoxazole and trimethoprim DS (double strength) tablet or 2 sulfamethoxazole and trimethoprim tablets every 12 hours for 5 days.
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![Ofloxacin Otic (Ofloxacin) Solution [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=7397f901-7ce5-4751-a996-22d51d95a888&name=7397f901-7ce5-4751-a996-22d51d95a888-11.jpg)
Ofloxacin Otic
Otitis Externa
The recommended dosage regimen for the treatment of otitis externa is:
For pediatric patients (from 6 months to 13 years old): Five drops (0.25 mL, 0.75 mg ofloxacin) instilled into the affected ear once daily for seven days.
For patients 13 years and older: Ten drops (0.5 mL, 1.5 mg ofloxacin) instilled into the affected ear once daily for seven days.
The solution should be warmed by holding the bottle in the hand for one or two minutes to avoid dizziness which may result from the instillation of a cold solution. The patient should lie with the affected ear upward, and then the drops should be instilled. This position should be maintained for five minutes to facilitate penetration of the drops into the ear canal. Repeat, if necessary, for the opposite ear.
Acute Otitis Media in Pediatric Patients with Tympanostomy Tubes
The recommended dosage regimen for the treatment of acute otitis media in pediatric patients (from one to 12 years old) with tympanostomy tubes is:
• Five drops (0.25 mL, 0.75 mg ofloxacin) instilled into the affected ear twice daily for ten days. The solution should be warmed by holding the bottle in the hand for one or two minutes to avoid dizziness that may result from the instillation of a cold solution. The patient should lie with the affected ear upward, and then the drops should be instilled. The tragus should then be pumped 4 times by pushing inward to facilitate penetration of the drops into the middle ear. This position should be maintained for five minutes. Repeat, if necessary, for the opposite ear.Chronic Suppurative Otitis Media with Perforated Tympanic Membranes
The recommended dosage regimen for the treatment of chronic suppurative otitis media with perforated tympanic membranes in patients 12 years and older is:
• Ten drops (0.5 mL, 1.5 mg ofloxacin) instilled into the affected ear twice daily for fourteen days. The solution should be warmed by holding the bottle in the hand for one or two minutes to avoid dizziness that may result from the instillation of a cold solution. The patient should lie with the affected ear upward, before instilling the drops. The tragus should then be pumped 4 times by pushing inward to facilitate penetration into the middle ear. This position should be maintained for five minutes. Repeat, if necessary, for the opposite ear.Otitis Externa
The recommended dosage regimen for the treatment of otitis externa is:
For pediatric patients (from 6 months to 13 years old): Five drops (0.25 mL, 0.75 mg ofloxacin) instilled into the affected ear once daily for seven days.
For patients 13 years and older: Ten drops (0.5 mL, 1.5 mg ofloxacin) instilled into the affected ear once daily for seven days.
The solution should be warmed by holding the bottle in the hand for one or two minutes to avoid dizziness which may result from the instillation of a cold solution. The patient should lie with the affected ear upward, and then the drops should be instilled. This position should be maintained for five minutes to facilitate penetration of the drops into the ear canal. Repeat, if necessary, for the opposite ear.
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![Levofloxacin Tablet, Film Coated [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=34704c52-b71c-4a6d-9335-00cce4ec7302&name=image-06.jpg)
Levofloxacin
2.1 Dosage in Adult Patients With Normal Renal Function
The usual dose of levofloxacin tablets is 250 mg, 500 mg, or 750 mg administered orally every 24 hours, as indicated by infection and described in Table 1.
These recommendations apply to patients with creatinine clearance ≥ 50 mL/min. For patients with creatinine clearance < 50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].
Table 1: Dosage in Adult Patients With Normal Renal Function (Creatinine Clearance ≥ 50 mL/min) * Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician. † Due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [ see Indications and Usage (1.2)]. ‡ Due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [ see Indications and Usage (1.3)]. § This regimen is indicated for cUTI due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and AP due to E. coli, including cases with concurrent bacteremia. ¶ This regimen is indicated for cUTI due to Enterococcus faecalis, Enterococcus cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa; and for AP due to E. coli. # Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [ see Clinical Studies (14.9)]. Þ The safety of levofloxacin tablets in adults for durations of therapy beyond 28 days or in pediatric patients for durations beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [ see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin tablet therapy should only be used when the benefit outweighs the risk. ß Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Higher doses of levofloxacin tablets typically used for treatment of pneumonia can be used for treatment of plague, if clinically indicated.Type of Infection
Dosed Every 24 Hours
Duration (Days)*
Nosocomial Pneumonia
750 mg
7 to 14
Community Acquired Pneumonia†
500 mg
7 to 14
Community Acquired Pneumonia‡
750 mg
5
Acute Bacterial Sinusitis
750 mg
5
500 mg
10 to 14
Acute Bacterial Exacerbation of Chronic Bronchitis
500 mg
7
Complicated Skin and Skin Structure Infections (SSSI)
750 mg
7 to 14
Uncomplicated SSSI
500 mg
7 to 10
Chronic Bacterial Prostatitis
500 mg
28
Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)§
750 mg
5
Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)¶
250 mg
10
Uncomplicated Urinary Tract Infection
250 mg
3
Inhalational Anthrax (Post-Exposure), adult and pediatric patients > 50 kg#,Þ
Pediatric patients < 50 kg and ≥ 6 months of age#,Þ
500 mg
see Table 2 below
(2.2)
60Þ
60Þ
Plague, adult and pediatric patients > 50 kgß
500 mg
10 to 14
Pediatric patients < 50 kg and ≥ 6 months of age
see Table 2 below (2.2)
10 to 14
2.2 Dosage in Pediatric Patients
The dosage in pediatric patients ≥ 6 months of age is described below in Table 2.
Table 2: Dosage in Pediatric Patients ≥ 6 Months of Age * Due to Bacillus anthracis [ see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage (1.14)]. † Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician. ‡ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [ see Clinical Studies (14.9)]. § The safety of levofloxacin tablets in pediatric patients for durations of therapy beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [ see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin tablet therapy should only be used when the benefit outweighs the risk. ¶ Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis.Type of Infection*
Dose
Freq. Once Every
Duration†
Inhalational Anthrax (post-exposure)‡,§
Pediatric patients > 50 kg
500 mg
24 hr
60 days§
Pediatric patients < 50 kg and ≥ 6 months of age
8 mg/kg (not to exceed 250 mg per dose)
12 hr
60 days§
Plague¶
Pediatric patients > 50 kg
500 mg
24 hr
10 to 14 days
Pediatric patients < 50 kg and ≥ 6 months of age
8 mg/kg(not to exceed 250 mg per dose)
12 hr
10 to 14 days
2.3 Dosage Adjustment in Adults With Renal Impairment
Administer levofloxacin tablets with caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced.
No adjustment is necessary for patients with a creatinine clearance ≥ 50 mL/min.
In patients with impaired renal function (creatinine clearance < 50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [see Use in Specific Populations (8.6)].
Table 3 shows how to adjust dose based on creatinine clearance.
Table 3: Dosage Adjustment in Adult Patients With Renal Impairment (Creatinine Clearance < 50 mL/min)Dosage in Normal Renal Function Every 24 Hours
Creatinine Clearance 20 to 49 mL/min
Creatinine Clearance 10 to 19 mL/min
Hemodialysis or Chronic Ambulatory Peritoneal Dialysis (CAPD)
750 mg
750 mg every 48 hours
750 mg initial dose, then 500 mg every 48 hours
750 mg initial dose, then 500 mg every 48 hours
500 mg
500 mg initial dose, then 250 mg every 24 hours
500 mg initial dose, then 250 mg every 48 hours
500 mg initial dose, then 250 mg every 48 hours
250 mg
No dosage adjustment required
250 mg every 48 hours. If treating uncomplicated UTI, then no dosage adjustment is required
No information on dosing adjustment is available
2.4 Drug Interaction With Chelation Agents: Antacids, Sucralfate, Metal Cations, Multivitamins
Levofloxacin Tablets
Levofloxacin tablets should be administered at least two hours before or two hours after antacids containing magnesium, aluminum, as well as sucralfate, metal cations such as iron, and multivitamin preparations with zinc or didanosine chewable/buffered tablets or the pediatric powder for oral solution [see Drug Interactions (7.1) and Patient Counseling Information (17.2)].
2.5 Administration Instructions
Food and Levofloxacin Tablets
Levofloxacin tablets can be administered without regard to food.
Hydration for Patients Receiving Levofloxacin Tablets
Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)].
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![Levofloxacin Tablet, Film Coated [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=82adba8d-b31d-4164-96bf-b452eb2206d8&name=levofloxacin-fig5.jpg)
Levofloxacin
2.1 Dosage in Adult Patients with Normal Renal Function
The usual dose of levofloxacin tablets is 250 mg, 500 mg, or 750 mg administered orally every 24 hours, as indicated by infection and described in Table 1.
These recommendations apply to patients with creatinine clearance ≥ 50 mL/min. For patients with creatinine clearance <50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].
Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50 mL/min) * Due to the designated pathogens [see Indications and Usage (1)].† Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.‡ Due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [see Indications and Usage (1.2)]. § Due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see Indications and Usage (1.3)]. ¶ This regimen is indicated for cUTI due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and AP due to E. coli, including cases with concurrent bacteremia.# This regimen is indicated for cUTI due to Enterococcus faecalis, Enterococcus cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa; and for AP due to E. coli. Þ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)].ß The safety of levofloxacin tablets in adults for durations of therapy beyond 28 days or in pediatric patients for durations beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacintablets therapy should only be used when the benefit outweighs the risk.á Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Higher doses of levofloxacin tablets typically used for treatment of pneumonia can be used for treatment of plague, if clinically indicated.Type of Infection*
Dosed Every 24 hours
Duration (days)†
Nosocomial Pneumonia
750 mg
7 to 14
Community Acquired Pneumonia‡
500 mg
7 to 14
Community Acquired Pneumonia§
750 mg
5
Acute Bacterial Sinusitis
750 mg
5
500 mg
10 to 14
Acute Bacterial Exacerbation of Chronic Bronchitis
500 mg
7
Complicated Skin and Skin Structure Infections (SSSI)
750 mg
7 to 14
Uncomplicated SSSI
500 mg
7 to 10
Chronic Bacterial Prostatitis
500 mg
28
Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)¶
750 mg
5
Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)#
250 mg
10
Uncomplicated Urinary Tract Infection
250 mg
3
Inhalational Anthrax (Post-Exposure), adult and pediatric patients > 50 kg Þ,ß Pediatric patients < 50 kg and ≥ 6 months of age Þ,ß
500 mgsee Table 2 below (2.2)
60 ß 60 ß
Plague, adult and pediatric patients > 50 kgá Pediatric patients < 50 kg and ≥ 6 months of age
500 mg see Table 2 below (2.2)
10 to 14 10 to 14
2.2 Dosage in Pediatric Patients
The dosage in pediatric patients ≥ 6 months of age is described below in Table 2.
Table 2: Dosage in Pediatric Patients ≥ 6 months of age Type of Infection* Dose Freq. Once every Duration† * Due to Bacillus anthracis [see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage (1.14)].† Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.‡ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)]. § The safety of levofloxacin tablets in pediatric patients for durations of therapy beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin tablets therapy should only be used when the benefit outweighs the risk. ¶ Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis.Inhalational Anthrax (post-exposure)‡, §
Pediatric patients > 50 kg
500 mg
24 hr
60 days§
Pediatric patients < 50 kg and ≥ 6 months of age
8 mg/kg (not to exceed 250 mg per dose)
12 hr
60 days§
Plague¶
Pediatric patients > 50 kg
500 mg
24 hr
10 to 14 days
Pediatric patients < 50 kg and ≥ 6 months of age
8 mg/kg (not to exceed 250 mg per dose)
12 hr
10 to 14 days
2.3 Dosage Adjustment in Adults with Renal Impairment
Administer levofloxacin tablets with caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced.No adjustment is necessary for patients with a creatinine clearance ≥ 50 mL/min.In patients with impaired renal function (creatinine clearance <50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [see Use in Specific Populations (8.6)].Table 3 shows how to adjust dose based on creatinine clearance.
Table 3: Dosage Adjustment in Adult Patients with Renal Impairment (creatinine clearance <50 mL/min) Dosage in Normal Renal Function Every 24 hours Creatinine Clearance 20 to 49 mL/min Creatinine Clearance 10 to 19 mL/min Hemodialysis or Chronic Ambulatory Peritoneal Dialysis (CAPD)750 mg
750 mg every 48 hours
750 mg initial dose, then 500 mg every 48 hours
750 mg initial dose, then 500 mg every 48 hours
500 mg
500 mg initial dose, then 250 mg every 24 hours
500 mg initial dose, then 250 mg every 48 hours
500 mg initial dose, then 250 mg every 48 hours
250 mg
No dosage adjustment required
250 mg every 48 hours. If treating uncomplicated UTI, then no dosage adjustment is required
No information on dosing adjustment is available
2.4 Drug Interaction With Chelation Agents: Antacids, Sucralfate, Metal Cations, Multivitamins
Levofloxacin tablets should be administered at least two hours before or two hours after antacids containing magnesium, aluminum, as well as sucralfate, metal cations such as iron, and multivitamin preparations with zinc or didanosine chewable/buffered tablets or the pediatric powder for oral solution [see Drug Interactions (7.1) and Patient Counseling Information (17.2)].
2.5 Administration Instructions
Food and Levofloxacin Tablets Levofloxacin tablets can be administered without regard to food.Hydration for Patients Receiving Levofloxacin Tablets Adequate hydration of patients receiving oral levofloxacin tablets should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)].
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![Levofloxacin Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=94eb5927-4194-4dd0-8037-cb7d8d1fbeab&name=levofloxacin-figure-08.jpg)
Levofloxacin
2.1 Dosage in Adult Patients with Normal Renal Function
The usual dose of levofloxacin tablets is 250 mg, 500 mg, or 750 mg administered orally every 24 hours, as indicated by infection and described in Table 1.
These recommendations apply to patients with creatinine clearance ≥50 mL/min. For patients with creatinine clearance < 50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].
Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance≥ 50 mL/min) * Due to the designated pathogens [see Indications and Usage (1)]. †Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician. ‡ Due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [see Indications and Usage (1.2)]. § Due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see Indications and Usage (1.3)]. ¶This regimen is indicated for cUTI due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and AP due to E. coli, including cases with concurrent bacteremia. #This regimen is indicated for cUTI due to Enterococcus faecalis, Enterococcus cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa; and for AP due to E. coli. Þ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)]. ß The safety of levofloxacin tablets in adults for durations of therapy beyond 28 days or in pediatric patients for durations beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk. à Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Higher doses of levofloxacin tablets typically used for treatment of pneumonia can be used for treatment of plague, if clinically indicated.Type of Infection*
Dosed Every 24 hours
Duration (days)†
Nosocomial Pneumonia
750 mg
7-14
Community Acquired Pneumonia‡
500 mg
7-14
Community Acquired Pneumonia§
750 mg
5
Acute Bacterial Sinusitis
750 mg
5
500 mg
10-14
Acute Bacterial Exacerbation of Chronic Bronchitis
500 mg
7
Complicated Skin and Skin Structure Infections (SSSI)
750 mg
7-14
Uncomplicated SSSI
500 mg
7-10
Chronic Bacterial Prostatitis
500 mg
28
Complicated Urinary Tract Infection (cUTI)or Acute Pyelonephritis (AP)¶
750 mg
5
Complicated Urinary Tract Infection (cUTI)or Acute Pyelonephritis (AP)#
250 mg
10
Uncomplicated Urinary Tract Infection
250 mg
3
Inhalational Anthrax (Post-Exposure),adultand pediatric patients > 50 kg Þ,ß Pediatric patients < 50 kg and ≥ 6 months of ageÞ,ß
500 mgsee Table 2 below (2.2)
60ß 60ß
Plague, adult and pediatric patients > 50 kg à Pediatric patients < 50 kg and ≥ 6 months of age
500 mgsee Table 2 below (2.2)
10 to 1410 to 14
2.2 Dosage in Pediatric Patients
The dosage in pediatric patients ≥ 6 months of age is described below in Table 2.
Table 2: Dosage in Pediatric Patients ≥ 6 months of age * Due to Bacillus anthracis [see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage(1.14)]. †Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician. ‡Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)] § The safety of levofloxacin tablets in pediatric patients for durations of therapy beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk. ¶ Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis.Type of Infection*
Dose
Freq. Once every
Duration†
Inhalational Anthrax (post-exposure)‡,§
Pediatric patients > 50 kg
500 mg
24 hr
60 days§
Pediatric patients < 50 kg and ≥ 6 months of age
8 mg/kg(not to exceed 250 mg per dose)
12 hr
60days§
Plague¶
Pediatric patients > 50 kg
500 mg
24 hr
10 to 14 days
Pediatric patients < 50 kg and ≥ 6 months of age
8 mg/kg(not to exceed 250 mg per dose)
12 hr
10 to 14 days
2.3 Dosage Adjustment in Adults with Renal Impairment
Administer levofloxacin tablets with caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced.
No adjustment is necessary for patients with a creatinine clearance ≥ 50 mL/min.
In patients with impaired renal function (creatinine clearance < 50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [see Use in Specific Populations (8.6)].
Table 3 shows how to adjust dose based on creatinine clearance.
Table 3: Dosage Adjustment in Adult Patients with Renal Impairment (creatinine clearance < 50 mL/min)Dosage in Normal Renal Function Every 24 hours
Creatinine Clearance 20 to 49 mL/min
Creatinine Clearance 10 to 19 mL/min
Hemodialysis or Chronic Ambulatory Peritoneal Dialysis (CAPD)
750 mg
750 mgevery 48 hours
750 mg initial dose,then 500 mgevery 48 hours
750 mg initial dose,then 500 mgevery 48 hours
500 mg
500 mg initial dose,then 250 mgevery 24 hours
500 mg initial dose,then 250 mgevery 48 hours
500 mg initial dose,then 250 mgevery 48 hours
250 mg
No dosageadjustmentrequired
250 mgevery 48 hours.If treatinguncomplicated UTI, then no dosageadjustment isrequired
No informationon dosingadjustment isavailable
2.4 Drug Interaction With Chelation Agents: Antacids, Sucralfate, Metal Cations, Multivitamins
Levofloxacin Tablets
Levofloxacin tablets should be administered at least two hours before or two hours after antacids containing magnesium, aluminum, as well as sucralfate, metal cations such as iron, and multivitamin preparations with zinc or didanosine chewable/buffered tablets or the pediatric powder for oral solution [see Drug Interactions (7.1) and Patient Counseling Information (17.2)].
2.5 Administration Instructions
Food and Levofloxacin Tablets
Levofloxacin tablets can be administered without regard to food.
Hydration for Patients Receiving Levofloxacin Tablets
Adequate hydration of patients receiving oral levofloxacin tablets should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)].
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![Gabapentin Capsule [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=b452453b-add6-48a0-9ae8-9db6c48eec17&name=b452453b-add6-48a0-9ae8-9db6c48eec17-06.jpg)
Gabapentin
Gabapentinis given orally with or without food.
If gabapentindose is reduced, discontinued, or substituted with an alternative medication, this should be done gradually over a minimum of 1 week (a longer period may be needed at the discretion of the prescriber).
Postherpetic Neuralgia
In adults with postherpetic neuralgia, gabapentin therapy may be initiated as a single 300-mg dose on Day 1, 600 mg/day on Day 2 (divided BID), and 900 mg/day on Day 3 (divided TID). The dose can subsequently be titrated up as needed for pain relief to a daily dose of 1800 mg (divided TID). In clinical studies, efficacy was demonstrated over a range of doses from 1800 mg/day to 3600 mg/day with comparable effects across the dose range. Additional benefit of using doses greater than 1800 mg/day was not demonstrated.
Epilepsy
Gabapentin is recommended for add-on therapy in patients 3 years of age and older. Effectiveness in pediatric patients below the age of 3 years has not been established.
Patients >12 years of age: The effective dose of gabapentin is 900 to 1800 mg/day and given in divided doses (three times a day) using 300 or 400 mg capsules. The starting dose is 300 mg three times a day. If necessary, the dose may be increased using 300 or 400 mg capsules, three times a day up to 1800 mg/day. Dosages up to 2400 mg/day have been well tolerated in long-term clinical studies. Doses of 3600 mg/day have also been administered to a small number of patients for a relatively short duration, and have been well tolerated. The maximum time between doses in the TID schedule should not exceed 12 hours.
Pediatric Patients Age 3 to 12 years: The starting dose should range from 10 to15 mg/kg/day in 3 divided doses, and the effective dose reached by upward titration over a period of approximately 3 days. The effective dose of gabapentin in patients 5 years of age and older is 25 to 35 mg/kg/day and given in divided doses (three times a day). The effective dose in pediatric patients ages 3 and 4 years is 40 mg/kg/day and given in divided doses (three times a day) (see CLINICAL PHARMACOLOGY, Pediatric). Gabapentin may be administered as the oral solution, capsule, or tablet, or using combinations of these formulations. Dosages up to 50 mg/kg/day have been well tolerated in a long-term clinical study. The maximum time interval between doses should not exceed 12 hours.
It is not necessary to monitor gabapentin plasma concentrations to optimize gabapentintherapy. Further, because there are no significant pharmacokinetic interactions among gabapentinand other commonly used antiepileptic drugs, the addition of gabapentin does not alter the plasma levels of these drugs appreciably.
If gabapentin is discontinued and/or an alternate anticonvulsant medication is added to the therapy, this should be done gradually over a minimum of 1 week.
Dosage in Renal Impairment
Creatinine clearance is difficult to measure in outpatients. In patients with stable renal function, creatinine clearance (CCr) can be reasonably well estimated using the equation of Cockcroft and Gault:
for females CCr=(0.85)(140-age)(weight)/[(72)(SCr)]
for males CCr=(140-age)(weight)/[(72)(SCr)]
in which age is in years, weight is in kilograms, and SCr is serum creatinine in mg/dL.
Dosage adjustment in patients ≥12 years of age with compromised renal function or undergoing hemodialysis is recommended as follows (see dosing recommendations above for effective doses in each indication).
TABLE 6. Gabapentin Dosage Based on Renal Function
Renal Function Creatinine Clearance (mL/min)
Total Daily Dose Range(mg/day)
Dose Regimen(mg)
≥60
900 to 3600
300 TID
400 TID
600 TID
800 TID
1200 TID
>30 to 59
400 to 1400
200 BID
300 BID
400 BID
500 BID
700 BID
>15 to 29
200 to 700
200 QD
300 QD
400 QD
500 QD
700 QD
15a
100 to 300
100 QD
125 QD
150 QD
200 QD
300 QD
Post-Hemodialysis Supplemental Dose (mg)b
Hemodialysis
125b
150b
200b
250b
350b
a For patients with creatinine clearance <15 mL/min, reduce daily dose in proportion to creatinine clearance (e.g., patients with a creatinine clearance of 7.5 mL/min should receive one-half the daily dose that patients with a creatinine clearance of 15 mL/min receive).b Patients on hemodialysis should receive maintenance doses based on estimates of creatinine clearance as indicated in the upper portion of the table and a supplemental post-hemodialysis dose administered after each 4 hours of hemodialysis as indicated in the lower portion of the table.
The use of gabapentin in patients <12 years of age with compromised renal function has not been studied.
Dosage in Elderly
Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and dose should be adjusted based on creatinine clearance values in these patients.
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![Desmopressin Acetate Tablet [Bluepoint Laboratories]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=3848bfdc-21e6-4eef-a731-eec14ad39793&name=prednisonetab-4.jpg)
Desmopressin Acetate
Gastric irritation may be reduced if taken before, during, or immediately after meals or with food or milk.
The maximal activity of the adrenal cortex is between 2 am and 8 am, and it is minimal between 4 pm and midnight. Exogenous corticosteroids suppress adrenocorticoid activity the least when given at the time of maximal activity (am) for single dose administration. Therefore, it is recommended that prednisone be administered in the morning prior to 9 am and when large doses are given, administration of antacids between meals to help prevent peptic ulcers. Multiple dose therapy should be evenly distributed in evenly spaced intervals throughout the day.
Dietary salt restriction may be advisable in patients.
Do not stop taking this medicine without first talking to your doctor. Avoid abrupt withdraw of therapy.
The initial dosage of PredniSONE Tablets may vary from 5 mg to 60 mg per day, depending on the specific disease entity being treated. In situations of less severity lower doses will generally suffice, while in selected patients higher initial doses may be required. The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time there is a lack of satisfactory clinical response, PredniSONE should be discontinued and the patient transferred to other appropriate therapy. IT SHOULD BE EMPHASIZED THAT DOSAGE REQUIREMENTS ARE VARIABLE AND MUST BE INDIVIDUALIZED ON THE BASIS OF THE DISEASE UNDER TREATMENT AND THE RESPONSE OF THE PATIENT. After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small increments at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. It should be kept in mind that constant monitoring is needed in regard to drug dosage. Included in the situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient's individual drug responsiveness, and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment; in this latter situation, it may be necessary to increase the dosage of PredniSONE for a period of time consistent with the patient's condition. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.
Multiple Sclerosis
In the treatment of acute exacerbations of multiple sclerosis daily doses of 200 mg of prednisolone for a week followed by 80 mg every other day for 1 month have been shown to be effective. (Dosage range is the same for prednisone and prednisolone.)
Alternate Day Therapy
Alternate day therapy is a corticosteroid dosing regimen in which twice the usual daily dose of corticoid is administered every other morning. The purpose of this mode of therapy is to provide the patient requiring long-term pharmacologic dose treatment with the beneficial effects of corticoids while minimizing certain undesirable effects, including pituitary-adrenal suppression, the Cushingoid state, corticoid withdrawal symptoms, and growth suppression in children.
The rationale for this treatment schedule is based on two major premises: (a) the anti-inflammatory or therapeutic effect of corticoids persists longer than their physical presence and metabolic effects and (b) administration of the corticosteroid every other morning allows for re-establishment of more nearly normal hypothalamic-pituitary-adrenal (HPA) activity on the off-steroid day.
A brief review of the HPA physiology may be helpful in understanding this rationale. Acting primarily through the hypothalamus a fall in free cortisol stimulates the pituitary gland to produce increasing amounts of corticotropin (ACTH) while a rise in free cortisol inhibits ACTH secretion. Normally the HPA system is characterized by diurnal (circadian) rhythm. Serum levels of ACTH rise from a low point about 10 pm to a peak level about 6 am. Increasing levels of ACTH stimulate adrenocortical activity resulting in a rise in plasma cortisol with maximal levels occurring between 2 am and 8 am. This rise in cortisol dampens ACTH production and in turn adrenocortical activity. There is a gradual fall in plasma corticoids during the day with lowest levels occurring about midnight.
The diurnal rhythm of the HPA axis is lost in Cushing's disease, a syndrome of adrenocortical hyperfunction characterized by obesity with centripetal fat distribution, thinning of the skin with easy bruisability, muscle wasting with weakness, hypertension, latent diabetes, osteoporosis, electrolyte imbalance, etc. The same clinical findings of hyperadrenocorticism may be noted during long-term pharmacologic dose corticoid therapy administered in conventional daily divided doses. It would appear, then, that a disturbance in the diurnal cycle with maintenance of elevated corticoid values during the night may play a significant role in the development of undesirable corticoid effects. Escape from these constantly elevated plasma levels for even short periods of time may be instrumental in protecting against undesirable pharmacologic effects.
During conventional pharmacologic dose corticosteroid therapy, ACTH production is inhibited with subsequent suppression of cortisol production by the adrenal cortex. Recovery time for normal HPA activity is variable depending upon the dose and duration of treatment. During this time the patient is vulnerable to any stressful situation. Although it has been shown that there is considerably less adrenal suppression following a single morning dose of prednisolone (10 mg) as opposed to a quarter of that dose administered every 6 hours, there is evidence that some suppressive effect on adrenal activity may be carried over into the following day when pharmacologic doses are used. Further, it has been shown that a single dose of certain corticosteroids will produce adrenocortical suppression for two or more days. Other corticoids, including methylprednisolone, hydrocortisone, prednisone, and prednisolone, are considered to be short acting (producing adrenocortical suppression for 1¼ to 1½ days following a single dose) and thus are recommended for alternate day therapy.
The following should be kept in mind when considering alternate day therapy:
Basic principles and indications for corticosteroid therapy should apply. The benefits of alternate day therapy should not encourage the indiscriminate use of steroids. Alternate day therapy is a therapeutic technique primarily designed for patients in whom long-term pharmacologic corticoid therapy is anticipated. In less severe disease processes in which corticoid therapy is indicated, it may be possible to initiate treatment with alternate day therapy. More severe disease states usually will require daily divided high dose therapy for initial control of the disease process. The initial suppressive dose level should be continued until satisfactory clinical response is obtained, usually four to ten days in the case of many allergic and collagen diseases. It is important to keep the period of initial suppressive dose as brief as possible particularly when subsequent use of alternate day therapy is intended. Once control has been established, two courses are available: (a) change to alternate day therapy and then gradually reduce the amount of corticoid given every other day or (b) following control of the disease process reduce the daily dose of corticoid to the lowest effective level as rapidly as possible and then change over to an alternate day schedule. Theoretically, course (a) may be preferable. Because of the advantages of alternate day therapy, it may be desirable to try patients on this form of therapy who have been on daily corticoids for long periods of time (e.g., patients with rheumatoid arthritis). Since these patients may already have a suppressed HPA axis, establishing them on alternate day therapy may be difficult and not always successful. However, it is recommended that regular attempts be made to change them over. It may be helpful to triple or even quadruple the daily maintenance dose and administer this every other day rather than just doubling the daily dose if difficulty is encountered. Once the patient is again controlled, an attempt should be made to reduce this dose to a minimum. As indicated above, certain corticosteroids, because of their prolonged suppressive effect on adrenal activity, are not recommended for alternate day therapy (e.g., dexamethasone and betamethasone). The maximal activity of the adrenal cortex is between 2 am and 8 am, and it is minimal between 4 pm and midnight. Exogenous corticosteroids suppress adrenocortical activity the least, when given at the time of maximal activity (am). In using alternate day therapy it is important, as in all therapeutic situations to individualize and tailor the therapy to each patient. Complete control of symptoms will not be possible in all patients. An explanation of the benefits of alternate day therapy will help the patient to understand and tolerate the possible flare-up in symptoms which may occur in the latter part of the off-steroid day. Other symptomatic therapy may be added or increased at this time if needed. In the event of an acute flare-up of the disease process, it may be necessary to return to a full suppressive daily divided corticoid dose for control. Once control is again established alternate day therapy may be re-instituted. Although many of the undesirable features of corticosteroid therapy can be minimized by alternate day therapy, as in any therapeutic situation, the physician must carefully weigh the benefit-risk ratio for each patient in whom corticoid therapy is being considered.Multiple Sclerosis
In the treatment of acute exacerbations of multiple sclerosis daily doses of 200 mg of prednisolone for a week followed by 80 mg every other day for 1 month have been shown to be effective. (Dosage range is the same for prednisone and prednisolone.)
Alternate Day Therapy
Alternate day therapy is a corticosteroid dosing regimen in which twice the usual daily dose of corticoid is administered every other morning. The purpose of this mode of therapy is to provide the patient requiring long-term pharmacologic dose treatment with the beneficial effects of corticoids while minimizing certain undesirable effects, including pituitary-adrenal suppression, the Cushingoid state, corticoid withdrawal symptoms, and growth suppression in children.
The rationale for this treatment schedule is based on two major premises: (a) the anti-inflammatory or therapeutic effect of corticoids persists longer than their physical presence and metabolic effects and (b) administration of the corticosteroid every other morning allows for re-establishment of more nearly normal hypothalamic-pituitary-adrenal (HPA) activity on the off-steroid day.
A brief review of the HPA physiology may be helpful in understanding this rationale. Acting primarily through the hypothalamus a fall in free cortisol stimulates the pituitary gland to produce increasing amounts of corticotropin (ACTH) while a rise in free cortisol inhibits ACTH secretion. Normally the HPA system is characterized by diurnal (circadian) rhythm. Serum levels of ACTH rise from a low point about 10 pm to a peak level about 6 am. Increasing levels of ACTH stimulate adrenocortical activity resulting in a rise in plasma cortisol with maximal levels occurring between 2 am and 8 am. This rise in cortisol dampens ACTH production and in turn adrenocortical activity. There is a gradual fall in plasma corticoids during the day with lowest levels occurring about midnight.
The diurnal rhythm of the HPA axis is lost in Cushing's disease, a syndrome of adrenocortical hyperfunction characterized by obesity with centripetal fat distribution, thinning of the skin with easy bruisability, muscle wasting with weakness, hypertension, latent diabetes, osteoporosis, electrolyte imbalance, etc. The same clinical findings of hyperadrenocorticism may be noted during long-term pharmacologic dose corticoid therapy administered in conventional daily divided doses. It would appear, then, that a disturbance in the diurnal cycle with maintenance of elevated corticoid values during the night may play a significant role in the development of undesirable corticoid effects. Escape from these constantly elevated plasma levels for even short periods of time may be instrumental in protecting against undesirable pharmacologic effects.
During conventional pharmacologic dose corticosteroid therapy, ACTH production is inhibited with subsequent suppression of cortisol production by the adrenal cortex. Recovery time for normal HPA activity is variable depending upon the dose and duration of treatment. During this time the patient is vulnerable to any stressful situation. Although it has been shown that there is considerably less adrenal suppression following a single morning dose of prednisolone (10 mg) as opposed to a quarter of that dose administered every 6 hours, there is evidence that some suppressive effect on adrenal activity may be carried over into the following day when pharmacologic doses are used. Further, it has been shown that a single dose of certain corticosteroids will produce adrenocortical suppression for two or more days. Other corticoids, including methylprednisolone, hydrocortisone, prednisone, and prednisolone, are considered to be short acting (producing adrenocortical suppression for 1¼ to 1½ days following a single dose) and thus are recommended for alternate day therapy.
The following should be kept in mind when considering alternate day therapy:
Basic principles and indications for corticosteroid therapy should apply. The benefits of alternate day therapy should not encourage the indiscriminate use of steroids. Alternate day therapy is a therapeutic technique primarily designed for patients in whom long-term pharmacologic corticoid therapy is anticipated. In less severe disease processes in which corticoid therapy is indicated, it may be possible to initiate treatment with alternate day therapy. More severe disease states usually will require daily divided high dose therapy for initial control of the disease process. The initial suppressive dose level should be continued until satisfactory clinical response is obtained, usually four to ten days in the case of many allergic and collagen diseases. It is important to keep the period of initial suppressive dose as brief as possible particularly when subsequent use of alternate day therapy is intended. Once control has been established, two courses are available: (a) change to alternate day therapy and then gradually reduce the amount of corticoid given every other day or (b) following control of the disease process reduce the daily dose of corticoid to the lowest effective level as rapidly as possible and then change over to an alternate day schedule. Theoretically, course (a) may be preferable. Because of the advantages of alternate day therapy, it may be desirable to try patients on this form of therapy who have been on daily corticoids for long periods of time (e.g., patients with rheumatoid arthritis). Since these patients may already have a suppressed HPA axis, establishing them on alternate day therapy may be difficult and not always successful. However, it is recommended that regular attempts be made to change them over. It may be helpful to triple or even quadruple the daily maintenance dose and administer this every other day rather than just doubling the daily dose if difficulty is encountered. Once the patient is again controlled, an attempt should be made to reduce this dose to a minimum. As indicated above, certain corticosteroids, because of their prolonged suppressive effect on adrenal activity, are not recommended for alternate day therapy (e.g., dexamethasone and betamethasone). The maximal activity of the adrenal cortex is between 2 am and 8 am, and it is minimal between 4 pm and midnight. Exogenous corticosteroids suppress adrenocortical activity the least, when given at the time of maximal activity (am). In using alternate day therapy it is important, as in all therapeutic situations to individualize and tailor the therapy to each patient. Complete control of symptoms will not be possible in all patients. An explanation of the benefits of alternate day therapy will help the patient to understand and tolerate the possible flare-up in symptoms which may occur in the latter part of the off-steroid day. Other symptomatic therapy may be added or increased at this time if needed. In the event of an acute flare-up of the disease process, it may be necessary to return to a full suppressive daily divided corticoid dose for control. Once control is again established alternate day therapy may be re-instituted. Although many of the undesirable features of corticosteroid therapy can be minimized by alternate day therapy, as in any therapeutic situation, the physician must carefully weigh the benefit-risk ratio for each patient in whom corticoid therapy is being considered. -
![Etodolac Tablet, Film Coated [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=77eb8a63-bcbb-489c-9420-93dd8cc1d833&name=escitalopram-fig3.jpg)
Etodolac
Escitalopram tablets should be administered once daily, in the morning or evening, with or without food.
2.1 Major Depressive Disorder
Initial Treatment Adolescents The recommended dose of escitalopram tablets is 10 mg once daily. A flexible-dose trial of escitalopram tablets (10 to 20 mg/day) demonstrated the effectiveness of escitalopram tablets [see Clinical Studies (14.1)]. If the dose is increased to 20 mg, this should occur after a minimum of three weeks.Adults The recommended dose of escitalopram tablets is 10 mg once daily. A fixed-dose trial of escitalopram tablets demonstrated the effectiveness of both 10 mg and 20 mg of escitalopram tablets, but failed to demonstrate a greater benefit of 20 mg over 10 mg [see Clinical Studies (14.1)]. If the dose is increased to 20 mg, this should occur after a minimum of one week.Maintenance Treatment It is generally agreed that acute episodes of major depressive disorder require several months or longer of sustained pharmacological therapy beyond response to the acute episode. Systematic evaluation of continuing escitalopram tablets 10 or 20 mg/day in adults patients with major depressive disorder who responded while taking escitalopram tablets during an 8-week, acute-treatment phase demonstrated a benefit of such maintenance treatment [see Clinical Studies (14.1)]. Nevertheless, the physician who elects to use escitalopram tablets for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient. Patients should be periodically reassessed to determine the need for maintenance treatment.
2.2 Generalized Anxiety Disorder
Initial Treatment Adults The recommended starting dose of escitalopram tablets is 10 mg once daily. If the dose is increased to 20 mg, this should occur after a minimum of one week.Maintenance Treatment Generalized anxiety disorder is recognized as a chronic condition. The efficacy of escitalopram tablets in the treatment of GAD beyond 8 weeks has not been systematically studied. The physician who elects to use escitalopram tablets for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
2.3 Special Populations
10 mg/day is the recommended dose for most elderly patients and patients with hepatic impairment.No dosage adjustment is necessary for patients with mild or moderate renal impairment. Escitalopram tablets should be used with caution in patients with severe renal impairment.
2.4 Discontinuation of Treatment with Escitalopram Tablets
Symptoms associated with discontinuation of escitalopram tablets and other SSRIs and SNRIs have been reported [see Warnings and Precautions (5.3)]. Patients should be monitored for these symptoms when discontinuing treatment. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate.
2.5 Switching a Patient To or From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders
At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with escitalopram tablets. Conversely, at least 14 days should be allowed after stopping escitalopram tablets before starting an MAOI intended to treat psychiatric disorders [see Contraindications (4.1)].
2.6 Use of Escitalopram Tablets with Other MAOIs such as Linezolid or Methylene Blue
Do not start escitalopram tablets in a patient who is being treated with linezolid or intravenous methylene blue because there is an increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered [see Contraindications (4.1)]. In some cases, a patient already receiving escitalopram tablets therapy may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, escitalopram tablets should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for 2 weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with escitalopram tablets may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue [see Warnings and Precautions (5.2)].The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with escitalopram tablets is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use [see Warnings and Precautions (5.2)].
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Etodolac Capsule Etodolac
Carefully consider the potential benefits and risks of etodolac capsules and tablets, USP and other treatment options before deciding to use etodolac capsules and tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with etodolac capsules and tablets, USP, the dose and frequency should be adjusted to suit an individual patient's needs.
Dosage adjustment of etodolac capsules and tablets, USP is generally not required in patients with mild to moderate renal impairment. Etodolac should be used with caution in such patients, because, as with other NSAIDs, it may further decrease renal function in some patients with impaired renal function (see WARNINGS, Renal Effects).
Analgesia
The recommended total daily dose of etodolac for acute pain is up to 1000 mg, given as 200-400 mg every 6 to 8 hours. Doses of etodolac greater than 1000 mg/day have not been adequately evaluated in wellcontrolled trials.
Osteoarthritis and Rheumatoid Arthritis
The recommended starting dose of etodolac for the management of the signs and symptoms of osteoarthritis or rheumatoid arthritis is: 300 mg b.i.d., t.i.d., or 400 mg b.i.d., or 500 mg b.i.d. A lower dose of 600 mg/day may suffice for long-term administration. Physicians should be aware that doses above 1000 mg/day have not been adequately evaluated in well-controlled clinical trials.
In chronic conditions, a therapeutic response to therapy with etodolac is sometimes seen within one week of therapy, but most often is observed by two weeks. After a satisfactory response has been achieved, the patient's dose should be reviewed and adjusted as required.
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![Ondansetron Hydrochloride Tablet, Film Coated [Taro Pharmaceuticals U.s.a., Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=49421564-d2d3-4f69-93b2-bd9eec7feb8f&name=image-02.jpg)
Ondansetron Hydrochloride
Dosage and Administration in Adults
Single Dose
Vaginal Candidiasis
The recommended dosage of fluconazole for vaginal candidiasis is 150 mg as a single oral dose.
Multiple Dose
SINCE ORAL ABSORPTION IS RAPID AND ALMOST COMPLETE, THE DAILY DOSE OF FLUCONAZOLE IS THE SAME FOR ORAL (TABLETS AND SUSPENSION) AND INTRAVENOUS ADMINISTRATION. In general, a loading dose of twice the daily dose is recommended on the first day of therapy to result in plasma concentrations close to steady-state by the second day of therapy.
The daily dose of fluconazole for the treatment of infections other than vaginal candidiasis should be based on the infecting organism and the patient’s response to therapy. Treatment should be continued until clinical parameters or laboratory tests indicate that active fungal infection has subsided. An inadequate period of treatment may lead to recurrence of active infection. Patients with AIDS and cryptococcal meningitis or recurrent oropharyngeal candidiasis usually require maintenance therapy to prevent relapse.
Oropharyngeal Candidiasis
The recommended dosage of fluconazole for oropharyngeal candidiasis is 200 mg on the first day, followed by 100 mg once daily. Clinical evidence of oropharyngeal candidiasis generally resolves within several days, but treatment should be continued for at least 2 weeks to decrease the likelihood of relapse.
Esophageal Candidiasis
The recommended dosage of fluconazole for esophageal candidiasis is 200 mg on the first day, followed by 100 mg once daily. Doses up to 400 mg/day may be used, based on medical judgment of the patient’s response to therapy. Patients with esophageal candidiasis should be treated for a minimum of three weeks and for at least two weeks following resolution of symptoms.
Systemic Candida Infections
For systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia, optimal therapeutic dosage and duration of therapy have not been established. In open, noncomparative studies of small numbers of patients, doses of up to 400 mg daily have been used.
Urinary Tract Infections and Peritonitis
For the treatment of Candida urinary tract infections and peritonitis, daily doses of 50 to 200 mg have been used in open, noncomparative studies of small numbers of patients.
Cryptococcal Meningitis
The recommended dosage for treatment of acute cryptococcal meningitis is 400 mg on the first day, followed by 200 mg once daily. A dosage of 400 mg once daily may be used, based on medical judgment of the patient’s response to therapy. The recommended duration of treatment for initial therapy of cryptococcal meningitis is 10 to 12 weeks after the cerebrospinal fluid becomes culture negative. The recommended dosage of fluconazole for suppression of relapse of cryptococcal meningitis in patients with AIDS is 200 mg once daily.
Prophylaxis in Patients Undergoing Bone Marrow Transplantation
The recommended fluconazole daily dosage for the prevention of candidiasis in patients undergoing bone marrow transplantation is 400 mg, once daily. Patients who are anticipated to have severe granulocytopenia (less than 500 neutrophils per cu mm) should start fluconazole prophylaxis several days before the anticipated onset of neutropenia, and continue for 7 days after the neutrophil count rises above 1000 cells per cu mm.
Dosage and Administration in Children
The following dose equivalency scheme should generally provide equivalent exposure in pediatric and adult patients:
Pediatric Patients Adults * Some older children may have clearances similar to that of adults. Absolute doses exceeding 600 mg/day are not recommended.3 mg/kg
100 mg
6 mg/kg
200 mg
12* mg/kg
400 mg
Experience with fluconazole in neonates is limited to pharmacokinetic studies in premature newborns (see CLINICAL PHARMACOLOGY). Based on the prolonged half-life seen in premature newborns (gestational age 26 to 29 weeks), these children, in the first two weeks of life, should receive the same dosage (mg/kg) as in older children, but administered every 72 hours. After the first two weeks, these children should be dosed once daily. No information regarding fluconazole pharmacokinetics in full-term newborns is available.
Oropharyngeal Candidiasis
The recommended dosage of fluconazole for oropharyngeal candidiasis in children is 6 mg/kg on the first day, followed by 3 mg/kg once daily. Treatment should be administered for at least 2 weeks to decrease the likelihood of relapse.
Esophageal Candidiasis
For the treatment of esophageal candidiasis, the recommended dosage of fluconazole in children is 6 mg/kg on the first day, followed by 3 mg/kg once daily. Doses up to 12 mg/kg/day may be used based on medical judgment of the patient’s response to therapy. Patients with esophageal candidiasis should be treated for a minimum of three weeks and for at least 2 weeks following the resolution of symptoms.
Systemic Candida Infections
For the treatment of candidemia and disseminated Candida infections, daily doses of 6 to 12 mg/kg/day have been used in an open, noncomparative study of a small number of children.
Cryptococcal Meningitis
For the treatment of acute cryptococcal meningitis, the recommended dosage is 12 mg/kg on the first day, followed by 6 mg/kg once daily. A dosage of 12 mg/kg once daily may be used, based on medical judgment of the patient’s response to therapy. The recommended duration of treatment for initial therapy of cryptococcal meningitis is 10 to 12 weeks after the cerebrospinal fluid becomes culture negative. For suppression of relapse of cryptococcal meningitis in children with AIDS, the recommended dose of fluconazole is 6 mg/kg once daily.
Dosage in Patients With Impaired Renal Function
Fluconazole is cleared primarily by renal excretion as unchanged drug. There is no need to adjust single dose therapy for vaginal candidiasis because of impaired renal function. In patients with impaired renal function who will receive multiple doses of fluconazole, an initial loading dose of 50 to 400 mg should be given. After the loading dose, the daily dose (according to indication) should be based on the following table:
Creatinine Clearance (mL/min)
Percent of Recommended Dose
> 50
100%
≤ 50 (no dialysis)
50%
Regular dialysis
100% after each dialysis
These are suggested dose adjustments based on pharmacokinetics following administration of multiple doses. Further adjustment may be needed depending upon clinical condition.
When serum creatinine is the only measure of renal function available, the following formula (based on sex, weight, and age of the patient) should be used to estimate the creatinine clearance in adults:
Males:
Weight (kg) × (140 - age)
72 × serum creatinine (mg/100 mL)
Females: 0.85 × above value
Although the pharmacokinetics of fluconazole has not been studied in children with renal insufficiency, dosage reduction in children with renal insufficiency should parallel that recommended for adults. The following formula may be used to estimate creatinine clearance in children:
K ×
linear length or height (cm)
serum creatinine (mg/100 mL)
(Where K = 0.55 for children older than 1 year and 0.45 for infants.)
Administration
Fluconazole can be taken with or without food.
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Sulfamethoxazole And Trimethoprim
DOSAGE AND ADMINISTRATION
Not recommended for use in pediatric patients less than 2 months of age.
Urinary Tract Infections and Shigellosis in Adults and Pediatric Patients, and Acute Otitis Media in Children
Adults: The usual adult dosage in the treatment of urinary tract infections is 1 sulfamethoxazole and trimethoprim DS (double strength) tablet every 12 hours for 10 to 14 days. An identical daily dosage is used for 5 days in the treatment of shigellosis.Children: The recommended dose for children with urinary tract infections or acute otitis media is 40 mg/kg sulfamethoxazole and 8 mg/kg trimethoprim per 24 hours, given in two divided doses every 12 hours for 10 days. An identical daily dosage is used for 5 days in the treatment of shigellosis. The following table is a guideline for the attainment of this dosage:
Children 2 months of age and older:
Weight
Dose – every 12 hours
lb
kg
Tablets
22
10
-
44
20
1
66
30
1 ½
88
40
2 or 1 DS tablet
For Patients with Impaired Renal Function
When renal function is impaired, a reduced dosage should be employed using the following table:
Creatinine Clearance (mL/min)
Recommended Dosage Regimen
Above 30
Usual standard regimen
15-30
1/2 the usual regimen
Below 15
Use not recommended
Acute Exacerbations of Chronic Bronchitis in Adults
The usual adult dosage in the treatment of acute exacerbations of chronic bronchitis is 1 sulfamethoxazole and trimethoprim double strength tablet or 2 sulfamethoxazole and trimethoprim tablets every 12 hours for 14 days.
Pneumocystis Carinii Pneumonia
Treatment: Adults and Children:The recommended dosage for patients with documented Pneumocystis carinii pneumonia is 75 to 100 mg/kg sulfamethoxazole and 15 to 20 mg/kg trimethoprim per 24 hours given in equally divided doses every 6 hours for 14 to 21 days11. The following table is a guideline for the upper limit of this dosage.
Weight
Dose – every 6 hours
lb
kg
Tablets
18
8
-
35
16
1
53
24
1 ½
70
32
2 or 1 DS tablet
88
40
2 ½
106
48
3 or 1 ½ DS tablets
141
64
4 or 2 DS tablets
176
80
5 or 2 ½ DS tablets
For the lower limit dose (75 mg/kg sulfamethoxazole and 15 mg/kg trimethoprim per 24 hours) administer 75% of the dose in the above table.Prophylaxis AdultsThe recommended dosage for prophylaxis in adults is 1 sulfamethoxazole and trimethoprim DS (double strength) tablet daily12 ChildrenFor children, the recommended dose is 750 mg/m2/day sulfamethoxazole with 150 mg/m2/day trimethoprim given orally in equally divided doses twice a day, on 3 consecutive days per week.The total daily dose should not exceed 1600 mg sulfamethoxazole and 320 mg trimethoprim13 The following table is a guideline for the attainment of this dosage in children:
Body Surface Area
Dose – every 12 hours
(m2)
Tablets
0.26
-
0.53
½
1.06
1
Traveler’s Diarrhea in Adults For the treatment of traveler’s diarrhea, the usual adult dosage is 1 sulfamethoxazole and trimethoprim DS (double strength) tablet or 2 sulfamethoxazole and trimethoprim tablets every 12 hours for 5 days.
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Phenazopyridine Hcl
Adults: 200 mg 3 times daily after meals. When used concomitantly with an antibacterial agent for the treatment of a urinary tract infection, the administration of phenazopyridine should not exceed 2 days. If symptoms persist, the patient should be re-evaluated.
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Phenazopyridine Hydrochloride
100 mg Tablets: Average adult dosage is two tablets 3 times a day after meals.
200 mg Tablets: Average adult dosage is one tablet 3 times a day after meals.
When used concomitantly with an antibacterial agent for the treatment of a urinary tract infection, the administration of Phenazopyridine HCl should not exceed 2 days.
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Topiramate
2.1 Epilepsy
It is not necessary to monitor topiramate plasma concentrations to optimize topiramate tablets therapy.
On occasion, the addition of topiramate tablets to phenytoin may require an adjustment of the dose of phenytoin to achieve optimal clinical outcome. Addition or withdrawal of phenytoin and/or carbamazepine during adjunctive therapy with topiramate tablets may require adjustment of the dose of topiramate tablets.
Because of the bitter taste, tablets should not be broken.
Topiramate tablets can be taken without regard to meals.
Monotherapy Use
Adults and Pediatric Patients 10 Years and Older
The recommended dose for topiramate monotherapy in adults and pediatric patients 10 years of age and older is 400 mg/day in two divided doses. Approximately 58% of patients randomized to 400 mg/day achieved this maximal dose in the monotherapy controlled trial; the mean dose achieved in the trial was 275 mg/day. The dose should be achieved by titration according to the following schedule:
Table 1: Monotherapy Titration Schedule for Adults and Pediatric Patients 10 years and olderMorning Dose
Evening Dose
Week 1
25 mg
25 mg
Week 2
50 mg
50 mg
Week 3
75 mg
75 mg
Week 4
100 mg
100 mg
Week 5
150 mg
150 mg
Week 6
200 mg
200 mg
Children Ages 2 to <10 Years
Dosing of topiramate as initial monotherapy in children 2 to < 10 years of age with partial onset or primary generalized tonic-clonic seizures was based on a pharmacometric bridging approach [see Clinical Studies (14.1)].
Dosing in patients 2 to <10 years is based on weight. During the titration period, the initial dose of topiramate tablets should be 25 mg/day administered nightly for the first week. Based upon tolerability, the dosage can be increased to 50 mg/day (25 mg twice daily) in the second week.Dosage can be increased by 25-50 mg/day each subsequent week as tolerated. Titration to the minimum maintenance dose should be attempted over 5-7 weeks of the total titration period.Based upon tolerability and seizure control, additional titration to a higher dose (up to the maximum maintenance dose) can be attempted at 25-50 mg/day weekly increments. The total daily dose should not exceed the maximum maintenance dose for each range of body weight (Table 2).
Table 2: Monotherapy Target Total Daily Maintenance Dosing for Patients 2 to <10 Years * Administered in two equally divided dosesWeight (kg)
Total Daily Dose (mg/day)* Minimum Maintenance Dose
Total Daily Dose (mg/day)* Maximum Maintenance Dose
Up to 11
150
250
12 – 22
200
300
23 – 31
200
350
32-38
250
350
Greater than 38
250
400
Adjunctive Therapy Use
Adults (17 Years of Age and Over) - Partial Onset Seizures, Primary Generalized Tonic-Clonic Seizures, or Lennox-Gastaut Syndrome
The recommended total daily dose of topiramate tablets as adjunctive therapy in adults with partial onset seizures is 200 to 400 mg/day in two divided doses, and 400 mg/day in two divided doses as adjunctive treatment in adults with primary generalized tonic-clonic seizures. It is recommended that therapy be initiated at 25 to 50 mg/day followed by titration to an effective dose in increments of 25 to 50 mg/day every week. Titrating in increments of 25 mg/day every week may delay the time to reach an effective dose. Doses above 400 mg/day (600, 800 or 1,000 mg/day) have not been shown to improve responses in dose-response studies in adults with partial onset seizures. Daily doses above 1,600 mg have not been studied.
In the study of primary generalized tonic-clonic seizures the initial titration rate was slower than in previous studies; the assigned dose was reached at the end of 8 weeks [see Clinical Studies (14.1)].
Pediatric Patients (Ages 2 - 16 Years) – Partial Onset Seizures, Primary Generalized Tonic-Clonic Seizures, or Lennox-Gastaut Syndrome
The recommended total daily dose of topiramate tablets as adjunctive therapy for pediatric patients with partial onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome is approximately 5 to 9 mg/kg/day in two divided doses. Titration should begin at 25 mg/day (or less, based on a range of 1 to 3 mg/kg/day) nightly for the first week. The dosage should then be increased at 1- or 2-week intervals by increments of 1 to 3 mg/kg/day (administered in two divided doses), to achieve optimal clinical response. Dose titration should be guided by clinical outcome.
In the study of primary generalized tonic-clonic seizures the initial titration rate was slower than in previous studies; the assigned dose of 6 mg/kg/day was reached at the end of 8 weeks [see Clinical Studies (14.1)].
2.4 Patients with Renal Impairment
In renally impaired subjects (creatinine clearance less than 70 mL/min/1.73 m2), one-half of the usual adult dose is recommended. Such patients will require a longer time to reach steady-state at each dose.
2.5 Geriatric Patients (Ages 65 Years and Over)
Dosage adjustment may be indicated in the elderly patient when impaired renal function (creatinine clearance rate <70 mL/min/1.73 m2) is evident [see Clinical Pharmacology (12.3)].
2.6 Patients Undergoing Hemodialysis
Topiramate is cleared by hemodialysis at a rate that is 4 to 6 times greater than a normal individual. Accordingly, a prolonged period of dialysis may cause topiramate concentration to fall below that required to maintain an anti-seizure effect. To avoid rapid drops in topiramate plasma concentration during hemodialysis, a supplemental dose of topiramate may be required. The actual adjustment should take into account 1) the duration of dialysis period, 2) the clearance rate of the dialysis system being used, and 3) the effective renal clearance of topiramate in the patient being dialyzed.
2.7 Patients with Hepatic Disease
In hepatically impaired patients, topiramate plasma concentrations may be increased. The mechanism is not well understood.
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![Topiramate Tablet, Film Coated [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=5d4301d0-c224-4962-9bf3-118d754311f0&name=5d4301d0-c224-4962-9bf3-118d754311f0-03.jpg)
Topiramate
Epilepsy
In the controlled add-on trials, no correlation has been demonstrated between trough plasma concentrations of topiramate and clinical efficacy. No evidence of tolerance has been demonstrated in humans. Doses above 400 mg/day (600, 800, or 1000 mg/day) have not been shown to improve responses in dose-response studies in adults with partial onset seizures.
It is not necessary to monitor topiramate plasma concentrations to optimize topiramate therapy. On occasion, the addition of topiramate to phenytoin may require an adjustment of the dose of phenytoin to achieve optimal clinical outcome. Addition or withdrawal of phenytoin and/or carbamazepine during adjunctive therapy with topiramate may require adjustment of the dose of topiramate. Because of the bitter taste, tablets should not be broken.
Topiramate tablets can be taken without regard to meals.
Monotherapy Use
The recommended dose for topiramate monotherapy in adults and children 10 years of age and older is 400 mg/day in two divided doses. Approximately 58% of patients randomized to 400 mg/day achieved this maximal dose in the monotherapy controlled trial; the mean dose achieved in the trial was 275 mg/day. The dose should be achieved by titrating according to the following schedule:
Morning Dose Evening DoseWeek 1
25 mg
25 mg
Week 2
50 mg
50 mg
Week 3
75 mg
75 mg
Week 4
100 mg
100 mg
Week 5
150 mg
150 mg
Week 6
200 mg
200 mg
Adjunctive Therapy Use
Adults (17 Years of Age and Over) - Partial Seizures, Primary Generalized Tonic-Clonic Seizures, or Lennox-Gastaut Syndrome
The recommended total daily dose of topiramate as adjunctive therapy in adults with partial seizures is 200 to 400 mg/day in two divided doses, and 400 mg/day in two divided doses as adjunctive treatment in adults with primary generalized tonic-clonic seizures. It is recommended that therapy be initiated at 25 to 50 mg/day followed by titration to an effective dose in increments of 25 to 50 mg/week. Titrating in increments of 25 mg/week may delay the time to reach an effective dose. Daily doses above 1,600 mg have not been studied.
In the study of primary generalized tonic-clonic seizures the initial titration rate was slower than in previous studies; the assigned dose was reached at the end of 8 weeks (see CLINICAL STUDIES, Adjunctive Therapy Controlled Trials in Patients With Primary Generalized Tonic-Clonic Seizures).
Pediatric Patients (Ages 2 to 16 Years)– Partial Seizures, Primary Generalized Tonic-Clonic Seizures, or Lennox-Gastaut Syndrome
The recommended total daily dose of topiramate as adjunctive therapy for patients with partial seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome is approximately 5 to 9 mg/kg/day in two divided doses. Titration should begin at 25 mg (or less, based on a range of 1 to 3 mg/kg/day) nightly for the first week. The dosage should then be increased at 1- or 2-week intervals by increments of 1 to 3 mg/kg/day (administered in two divided doses), to achieve optimal clinical response. Dose titration should be guided by clinical outcome.
In the study of primary generalized tonic-clonic seizures the initial titration rate was slower than in previous studies; the assigned dose of 6 mg/kg/day was reached at the end of 8 weeks (see CLINICAL STUDIES, Adjunctive Therapy Controlled Trials in Patients With Primary Generalized Tonic-Clonic Seizures).
Patients with Renal Impairment:
In renally impaired subjects (creatinine clearance less than 70 mL/min/1.73 m2), one half of the usual adult dose is recommended. Such patients will require a longer time to reach steady-state at each dose.
Geriatric Patients (Ages 65 Years and Over):
Dosage adjustment may be indicated in the elderly patient when impaired renal function (creatinine clearance rate ≤70 mL/min/1.73 m2) is evident (see DOSAGE AND ADMINISTRATION: Patients with Renal Impairment and CLINICAL PHARMACOLOGY: Special Populations: Age, Gender, and Race).
Patients Undergoing Hemodialysis:
Topiramate is cleared by hemodialysis at a rate that is 4 to 6 times greater than a normal individual. Accordingly, a prolonged period of dialysis may cause topiramate concentration to fall below that required to maintain an anti-seizure effect. To avoid rapid drops in topiramate plasma concentration during hemodialysis, a supplemental dose of topiramate may be required. The actual adjustment should take into account 1) the duration of dialysis period, 2) the clearance rate of the dialysis system being used, and 3) the effective renal clearance of topiramate in the patient being dialyzed.
Patients with Hepatic Disease:
In hepatically impaired patients topiramate plasma concentrations may be increased. The mechanism is not well understood.
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![Gabapentin Tablet [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=ce99bebb-8b73-4d45-b922-9c22e18f32ce&name=Gaba-600mg.jpg)
Gabapentin
Gabapentin tablets USP are given orally with or without food. Patients should be informed that, should they break the scored 600 or 800 mg tablet in order to administer a half-tablet, they should take the unused half-tablet as the next dose. Half-tablets not used within several days of breaking the scored tablet should be discarded.
If gabapentin tablets USP dose is reduced, discontinued or substituted with an alternative medication, this should be done gradually over a minimum of 1 week (a longer period may be needed at the discretion of the prescriber).
Postherpetic Neuralgia
In adults with postherpetic neuralgia, gabapentin tablets USP therapy may be initiated as a single 300 mg dose on Day 1, 600 mg/day on Day 2 (divided BID), and 900 mg/day on Day 3 (divided TID). The dose can subsequently be titrated up as needed for pain relief to a daily dose of 1800 mg (divided TID). In clinical studies, efficacy was demonstrated over a range of doses from 1800 mg/day to 3600 mg/day with comparable effects across the dose range. Additional benefit of using doses greater than 1800 mg/day was not demonstrated.
Epilepsy
Gabapentin tablets USP are recommended for add-on therapy in patients 3 years of age and older. Effectiveness in pediatric patients below the age of 3 years has not been established.
Patients >12 years of age:
The effective dose of gabapentin tablets USP is 900 to 1800 mg/day and given in divided doses (three times a day) using 600 or 800 mg tablets. The starting dose is 300 mg three times a day. If necessary, the dose may be increased using 600 or 800 mg tablets three times a day up to 1800 mg/day. Dosages up to 2400 mg/day have been well tolerated in long-term clinical studies. Doses of 3600 mg/day have also been administered to a small number of patients for a relatively short duration, and have been well tolerated. The maximum time between doses in the TID schedule should not exceed 12 hours.
Pediatric Patients Age 3–12 years:
The starting dose should range from 10-15 mg/kg/day in 3 divided doses, and the effective dose reached by upward titration over a period of approximately 3 days. The effective dose of gabapentin tablets USP in patients 5 years of age and older is 25–35 mg/kg/day and given in divided doses (three times a day). The effective dose in pediatric patients ages 3 and 4 years is 40 mg/kg/day and given in divided doses (three times a day) (see CLINICAL PHARMACOLOGY, Pediatric). Dosages up to 50 mg/kg/day have been well-tolerated in a long-term clinical study. The maximum time interval between doses should not exceed 12 hours.
It is not necessary to monitor gabapentin plasma concentrations to optimize gabapentin tablets USP therapy. Further, because there are no significant pharmacokinetic interactions among gabapentin tablets USP and other commonly used antiepileptic drugs, the addition of gabapentin tablets USP does not alter the plasma levels of these drugs appreciably.
If gabapentin tablets USP are discontinued and/or an alternate anticonvulsant medication is added to the therapy, this should be done gradually over a minimum of 1 week.
Dosage in Renal Impairment
Creatinine clearance is difficult to measure in outpatients. In patients with stable renal function, creatinine clearance (CCr) can be reasonably well estimated using the equation of Cockcroft and Gault:
for females CCr=(0.85)(140-age)(weight)/[(72)(SCr)]
for males CCr=(140-age)(weight)/[(72)(SCr)]
in which age is in years, weight is in kilograms and SCr is serum creatinine in mg/dL.
Dosage adjustment in patients ≥12 years of age with compromised renal function or undergoing hemodialysis is recommended as follows (see dosing recommendations above for effective doses in each indication).
TABLE 6. Gabapentin Tablets USP Dosage Based on Renal FunctionRenal Function Creatinine Clearance
(mL/min)
Total Daily Dose Range
(mg/day)
Dose Regimen
(mg)
≥60
900-3600
300 TID
400 TID
600 TID
800 TID
1200 TID
>30-59
400-1400
200 BID
300 BID
400 BID
500 BID
700 BID
>15-29
200-700
200 QD
300 QD
400 QD
500 QD
700 QD
15a
100-300
100 QD
125 QD
150 QD
200 QD
300 QD
Post-Hemodialysis Supplemental Dose (mg)b
Hemodialysis
125b
150b
200b
250b
350b
a For patients with creatinine clearance <15 mL/min, reduce daily dose in proportion to creatinine clearance (e.g., patients with a creatinine clearance of 7.5 mL/min should receive one-half the daily dose that patients with a creatinine clearance of 15 mL/min receive).
b Patients on hemodialysis should receive maintenance doses based on estimates of creatinine clearance as indicated in the upper portion of the table and a supplemental post-hemodialysis dose administered after each 4 hours of hemodialysis as indicated in the lower portion of the table.
The use of gabapentin tablets USP in patients <12 years of age with compromised renal function has not been studied.
Dosage in Elderly
Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and dose should be adjusted based on creatinine clearance values in these patients.
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![Penicillin V Potassium Tablet, Film Coated [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=71ea3dc2-6dfc-477a-aaa2-155c1cf76d80&name=e6204fc5-f198-4afe-bbcd-45ae2ab5297d-02.jpg)
Penicillin V Potassium
The dosage of Penicillin V should be determined according to the sensitivity of the causative microorganism and the severity of infection, and adjusted to the clinical response of the patient.
The usual dosage recommendations for adults and children 12 years and over are as follows:
Streptococcal Infections - mild to moderately severe - of the upper respiratory tract and including scarlet fever and erysipelas: 125 to 250 mg (200,000 to 400,000 units) every 6 to 8 hours for 10 days.
Pneumococcal Infections - mild to moderately severe - of the respiratory tract, including otitis media: 250 to 500 mg (400,000 to 800,000 units) every 6 hours until the patient has been afebrile for at least 2 days.
Staphylococcal Infections - mild infections of skin and soft tissue (culture and sensitive tests should be performed): 250 to 500 mg (400,000 to 800,000 units) every 6 to 8 hours.
Fusospirochetosis (Vincent’s infection) of the oropharynx. Mild to moderately severe infections: 250 to 500 mg (400,000 to 800,000 units) every 6 to 8 hours.
For the prevention of recurrence following rheumatic fever and/or chorea: 125 mg to 250 mg (200,000 to 400,000 units) twice daily on a continuing basis.
For prophylaxis against bacterial endocarditis1 in patients with congenital heart disease or rheumatic or other acquired valvular heart disease when undergoing dental procedures or surgical procedures of the upper respiratory tract: 2 gram of penicillin V (1 gram for children under 60 lbs.) 1 hour before the procedure, and then, 1 gram (500 mg for children under 60 lbs.) 6 hours later.
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![Gentamicin Sulfate Solution/ Drops [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=c5fac820-18a1-452f-bc2c-58ed73babb0c&name=f6e5d260-d7c3-48d4-96fc-8998690f5f85-02.jpg)
Gentamicin Sulfate Solution Drops
Instill one or two drops into the affected eye(s) every four hours. In severe infections dosage may be increased to as much as two drops every hour.
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![Gentamicin Sulfate Solution/ Drops [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=6a8e95ad-0a33-4d97-b44c-57555ccdf83a&name=df6fcd1e-8bb8-4004-b941-4c8d973907bf-03.jpg)
Gentamicin Sulfate Solution Drops
Instill one or two drops into the affected eye(s) every four hours. In severe infections, dosage may be increased to as much as two drops every hour.
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![Gemfibrozil Tablet [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=16a775ec-47e7-491f-8c48-319ce43dcd3b&name=483428f4-7df8-43f9-9567-1fdcc4f85bf7-02.jpg)
Gemfibrozil
The recommended dose for adults is 1200 mg administered in two divided doses 30 minutes before the morning and evening meal (see CLINICAL PHARMACOLOGY).
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![Terocin (Methyl Salicylate, Capsaicin, Menthol And Lidocaine Hydrochloride) Lotion [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=1402d6fc-73e9-4702-a2e3-71485d37122f&name=1402d6fc-73e9-4702-a2e3-71485d37122f-01.jpg)
Terocin
Wash and dry affected area. Shake bottle well before each use and gently rub
over area of pain. Use is not recommended more than four times a day. Wash
hands immediately afterwards to avoid contact with eyes.
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![Ciprofloxacin Tablet [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=702fffd7-b826-4081-83f7-4b6db6770c2c&name=image-01.jpg)
Ciprofloxacin
DOSAGE AND ADMINISTRATION - ADULTS
Ciprofloxacin Tablets USP 250 mg, 500 mg and 750 mg should be administered orally to adults as described in the Dosage Guidelines table.
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient’s host-defense mechanisms, and the status of renal function and hepatic function.
The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, or sucralfate, Videx® (didanosine) chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.
ADULT DOSAGE GUIDELINES Infection Severity Dose Frequency Usual Durations† * used in conjunction with metronidazole † Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection have disappeared, except for inhalational anthrax (post-exposure). ** Drug administration should begin as soon as possible after suspected or confirmed exposure. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.4 For a discussion of ciprofloxacin serum concentrations in various human populations, seeINHALATIONAL ANTHRAX – ADDITIONAL INFORMATION.Urinary Tract
Acute Uncomplicated
250 mg
q 12 h
3 Days
Mild/Moderate
250 mg
q 12 h
7 to 14 Days
Severe/Complicated
500 mg
q 12 h
7 to 14 Days
Chronic Bacterial Prostatits
Mild/Moderate
500 mg
q 12 h
28 Days
Lower Respiratory Tract
Mild/Moderate
500 mg
q 12 h
7 to 14 days
Severe/Complicated
750 mg
q 12 h
7 to 14 days
Acute Sinusitis
Mild/Moderate
500 mg
q 12 h
10 days
Skin and Skin Structure
Mild/Moderate
500 mg
q 12 h
7 to 14 Days
Severe/Complicated
750 mg
q 12 h
7 to 14 Days
Bone and Joint
Mild/Moderate
500 mg
q 12 h
≥4 to 6 weeks
Severe/Complicated
750 mg
q 12 h
≥4 to 6 weeks
Intra-Abdominal*
Complicated
500 mg
q 12 h
7 to 14 Days
Infectious Diarrhea
Mild/Moderate/Severe
500 mg
q 12 h
5 to 7 Days
Typhoid Fever
Mild/Moderate
500 mg
q 12 h
10 Days
Urethral and Cervical Gonococcal Infections
Uncomplicated
250 mg
single dose
single dose
Inhalational anthrax (post-exposure)**
500 mg
q 12 h
60 Days
Conversion of I.V. to Oral Dosing in Adults:
Patients whose therapy is started with CIPRO I.V. may be switched to Ciprofloxacin Tablets USP 250 mg, 500 mg and 750 mg when clinically indicated at the discretion of the physician (See CLINICAL PHARMACOLOGY and table below for the equivalent dosing regimens).
Equivalent AUC Dosing Regimens Cipro Oral Dosage Equivalent Cipro I.V. Dosage250 mg Tablet q 12 h
200 mg I.V. q 12 h
500 mg Tablet q 12 h
400 mg I.V. q 12 h
750 mg Tablet q 12 h
400 mg I.V. q 8 h
Adults with Impaired Renal Function:
Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:
RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine Clearance (mL/min) Dose> 50
See Usual Dosage.
30-50
250-500 mg q 12 h
5-29
250-500 mg q 18 h
Patients on hemodialysis or Peritoneal dialysis
250-500 mg q 24 h (after dialysis)
When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
Weight (kg) x (140 - age)
Men: Creatinine clearance (mL/min) = 72 x serum creatinine (mg/dL)
Women: 0.85 x the value calculated for men.
The serum creatinine should represent a steady state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored.
DOSAGE AND ADMINISTRATION - PEDIATRICS
Ciprofloxacin Tablets USP 250 mg, 500 mg and 750 mg should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS and CLINICAL STUDIES.)
Dosing and initial route of therapy (i.e., I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
PEDIATRIC DOSAGE GUIDELINES Infection Route of Administration Dose (mg/kg) Frequency Total Duration * The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days). ** Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.5 For a discussion of ciprofloxacin serum concentrations in various human populations, seeINHALATIONAL ANTHRAX – ADDITIONAL INFORMATION.Complicated Urinary Tract or Pyelonephritis
Intravenous
6 to 10 mg/kg(maximum 400 mgper dose; not to be exceeded even in patients weighing > 51 kg)
Every 8 hours
10-21 days*
(patients from 1 to 17 years of age)
Oral
10 mg/kg to 20 mg/kg (maximum 750 mg per dose; not to be exceeded even in patients weighing > 51 kg)
Every 12 hours
Inhalational Anthrax (Post-Exposure)**
Intravenous
10 mg/kg(maximum 400 mg per dose)
Every 12 hours
60 days
Oral
15 mg/kg(maximum 500 mg per dose)
Every 12 hours
Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of < 50 mL/min/1.73m2).
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![Tizanidine Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=e4723fbe-ad87-4d72-9c20-b0621f349dfc&name=e47f2934-f961-4588-a218-b7f8b10d1163-05.jpg)
Tizanidine
2.1 Dosing Information
Tizanidine tablets may be prescribed with or without food. Once the formulation has been selected and the decision to take with or without food has been made, this regimen should not be altered.
Food has complex effects on tizanidine pharmacokinetics, which differ with the different formulations. Tizanidine capsules and tizanidine tablets are bioequivalent to each other under fasting conditions (more than 3 hours after a meal), but not under fed conditions (within 30 minutes of a meal). These pharmacokinetic differences may result in clinically significant differences when switching administration of tablet and capsules and when switching administration between the fed or fasted state. These changes may result in increased adverse events, or delayed or more rapid onset of activity, depending upon the nature of the switch. For this reason, the prescriber should be thoroughly familiar with the changes in kinetics associated with these different conditions [see Clinical Pharmacology (12.3)].
The recommended starting dose is 2 mg. Because the effect of tizanidine peaks at approximately 1 to 2 hours post-dose and dissipates between 3 to 6 hours post-dose, treatment can be repeated at 6 to 8 hour intervals, as needed, to a maximum of three doses in 24 hours.
Dosage can be gradually increased by 2 mg to 4 mg at each dose, with 1 to 4 days between dosage increases, until a satisfactory reduction of muscle tone is achieved. The total daily dose should not exceed 36 mg. Single doses greater than 16 mg have not been studied.
2.2 Dosing in Patients with Renal Impairment
Tizanidine should be used with caution in patients with renal insufficiency (creatinine clearance < 25 mL/min), as clearance is reduced by more than 50%. In these patients, during titration, the individual doses should be reduced. If higher doses are required, individual doses rather than dosing frequency should be increased [see Warnings and Precautions (5.7)].
2.3 Dosing in Patients with Hepatic Impairment
Tizanidine should be used with caution in patients with any hepatic impairment. In these patients, during titration, the individual doses should be reduced. If higher doses are required, individual doses rather than dosing frequency should be increased. Monitoring of aminotransferase levels is recommended for baseline and 1 month after maximum dose is achieved, or if hepatic injury is suspected [see Use in Specific Populations (8.7)].
2.4 Drug Discontinuation
If therapy needs to be discontinued, particularly in patients who have been receiving high doses (20 mg to 36 mg daily) for long periods (9 weeks or more) or who may be on concomitant treatment with narcotics, the dose should be decreased slowly (2 mg to 4 mg per day) to minimize the risk of withdrawal and rebound hypertension, tachycardia, and hypertonia [see Drug Abuse and Dependence (9.3)].
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![Ibuprofen Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=bc962c56-db28-434b-bdf3-1cb3475287df&name=e72386cf-722b-4beb-ac18-b7ff89ad87ae-02.jpg)
Ibuprofen
Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).After observing the response to initial therapy with ibuprofen tablets, the dose and frequency should be adjusted to suit an individual patient’s needs.Do not exceed 3200 mg total daily dose. If gastrointestinal complaints occur, administer ibuprofen tablets with meals or milk.Rheumatoid arthritis and osteoarthritis, including flare-ups of chronic disease Suggested Dosage: 1200 mg-3200 mg daily (300 mg qid; 400 mg, 600 mg or 800 mg tid or qid). Individual patients may show a better response to 3200 mg daily, as compared with 2400 mg, although in well-controlled clinical trials patients on 3200 mg did not show a better mean response in terms of efficacy. Therefore, when treating patients with 3200 mg/day, the physician should observe sufficient increased clinical benefits to offset potential increased risk.The dose should be tailored to each patient, and may be lowered or raised depending on the severity of symptoms either at time of initiating drug therapy or as the patient responds or fails to respond.In general, patients with rheumatoid arthritis seem to require higher doses of ibuprofen tablets than do patients with osteoarthritis.The smallest dose of ibuprofen tablets that yields acceptable control should be employed. A linear blood level dose-response relationship exists with single doses up to 800 mg (See CLINICAL PHARMACOLOGY for effects of food on rate of absorption).The availability of four tablet strengths facilitates dosage adjustment.In chronic conditions, a therapeutic response to therapy with ibuprofen tablets is sometimes seen in a few days to a week but most often is observed by two weeks. After a satisfactory response has been achieved, the patient’s dose should be reviewed and adjusted as required.Mild to moderate pain: 400 mg every 4 to 6 hours as necessary for relief of pain.In controlled analgesic clinical trials, doses of ibuprofen tablets greater than 400 mg were no more effective than the 400 mg dose.Dysmenorrhea For the treatment of dysmenorrhea, beginning with the earliest onset of such pain, ibuprofen tablets should be given in a dose of 400 mg every 4 hours as necessary for the relief of pain.
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![Indomethacin Capsule [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=d3f12dab-1802-4d6a-9f90-6359e6b24565&name=image-01.jpg)
Indomethacin
Carefully consider the potential benefits and risks of indomethacin and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with indomethacin, the dose and frequency should be adjusted to suit an individual patient’s needs.
Indomethacin is available as 25 and 50 mg capsules.
Adverse reactions appear to correlate with the size of the dose of indomethacin in most patients but not all. Therefore, every effort should be made to determine the smallest effective dosage for the individual patient.
Pediatric Use
Indomethacin ordinarily should not be prescribed for pediatric patients 14 years of age and under (see PRECAUTIONS, Pediatric Use).
Adult Use
Dosage Recommendations for Active Stages of the Following:
1. Moderate to severe rheumatoid arthritis including acute flares of chronic disease; moderate to severe ankylosing spondylitis; and moderate to severe osteoarthritis. Suggested Dosage: Indomethacin capsules 25 mg b.i.d. or t.i.d. If this is well tolerated, increase the daily dosage by 25 or by 50 mg, if required by continuing symptoms, at weekly intervals until a satisfactory response is obtained or until a total daily dose of 150 - 200 mg is reached. DOSES ABOVE THIS AMOUNT GENERALLY DO NOT INCREASE THE EFFECTIVENESS OF THE DRUG. In patients who have persistent night pain and/or morning stiffness, the giving of a large portion, up to a maximum of 100 mg, of the total daily dose at bedtime, either orally or by rectal suppositories, may be helpful in affording relief. The total daily dose should not exceed 200 mg. In acute flares of chronic rheumatoid arthritis, it may be necessary to increase the dosage by 25 mg or, if required, by 50 mg daily. If minor adverse effects develop as the dosage is increased, reduce the dosage rapidly to a tolerated dose and OBSERVE THE PATIENT CLOSELY. If severe adverse reactions occur, STOP THE DRUG. After the acute phase of the disease is under control, an attempt to reduce the daily dose should be made repeatedly until the patient is receiving the smallest effective dose or the drug is discontinued. Careful instructions to, and observations of, the individual patient are essential to the prevention of serious, irreversible, including fatal, adverse reactions. As advancing years appear to increase the possibility of adverse reactions, indomethacin should be used with greater care in the elderly (see PRECAUTIONS, Geriatric Use). 2. Acute painful shoulder (bursitis and/or tendinitis). Initial Dose: 75 mg to 150 mg daily in 3 or 4 divided doses. The drug should be discontinued after the signs and symptoms of inflammation have been controlled for several days. The usual course of therapy is 7 to 14 days. 3. Acute gouty arthritis. Suggested Dose: Indomethacin capsules 50 mg t.i.d. until pain is tolerable. The dose should then be rapidly reduced to complete cessation of the drug. Definite relief of pain has been reported within 2 to 4 hours. Tenderness and heat usually subside in 24 to 36 hours, and swelling gradually disappears in 3 to 5 days. -
![Ibuprofen Tablet [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=72ec2491-924d-460f-9510-62d624d54b59&name=400mg100.jpg)
Ibuprofen
Carefully consider the potential benefits and risks of IBU tabletsand other treatment options before deciding to use IBU tablets. Usethe lowest effective dose for the shortest duration consistent withindividual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with IBU tablets, thedose and frequency should be adjusted to suit an individual patient’sneeds.Do not exceed 3200 mg total daily dose. If gastrointestinal complaintsoccur, administer IBU tablets with meals or milk.
Rheumatoid arthritis and osteoarthritis, including flare-ups ofchronic disease:
Suggested Dosage: 1200 mg-3200 mg daily (400 mg, 600 mg or800 mg tid or qid). Individual patients may show a better responseto 3200 mg daily, as compared with 2400 mg, although in well-controlledclinical trials patients on 3200 mg did not show a better meanresponse in terms of efficacy. Therefore, when treating patients with3200 mg/day, the physician should observe sufficient increased clinicalbenefits to offset potential increased risk.The dose should be tailored to each patient, and may be loweredor raised depending on the severity of symptoms either at time of initiatingdrug therapy or as the patient responds or fails to respond.In general, patients with rheumatoid arthritis seem to require higherdoses of IBU tablets than do patients with osteoarthritis.
The smallest dose of IBU tablets that yields acceptable controlshould be employed. A linear blood level dose-response relationshipexists with single doses up to 800 mg (See CLINICAL PHARMACOLOGYfor effects of food on rate of absorption).
The availability of three tablet strengths facilitates dosage adjustment.In chronic conditions, a therapeutic response to therapy with IBU tablets is sometimes seen in a few days to a week but most often isobserved by two weeks. After a satisfactory response has beenachieved, the patient’s dose should be reviewed and adjusted asrequired.
Mild to moderate pain:
400 mg every 4 to 6 hours as necessaryfor relief of pain.In controlled analgesic clinical trials, doses of Ibuprofen tabletsgreater than 400 mg were no more effective than the 400 mg dose.
Dysmenorrhea:
For the treatment of dysmenorrhea, beginningwith the earliest onset of such pain, IBU tablets should be given in adose of 400 mg every 4 hours as necessary for the relief of pain.
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![Ibuprofen Tablet [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=e31d4be3-e542-43a1-a6e3-4f6937a003ae&name=30343076-a968-45ae-b341-84c621e628f4-02.jpg)
Ibuprofen
Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with ibuprofen tablets the dose and frequency should be adjusted to suit an individual patient's needs.
Do not exceed 3200 mg total daily dose. If gastrointestinal complaints occur, administer Ibuprofen Tablets, USP with meals or milk.
Rheumatoid arthritis and osteoarthritis, including flare-ups of chronic disease:
Suggested Dosage: 1200 mg-3200 mg daily (300 mg qid; 400 mg, 600 mg or 800 mg tid or qid).
Individual patients may show a better response to 3200 mg daily, as compared with 2400 mg, although in well-controlled clinical trials patients on 3200 mg did not show a better mean response in terms of efficacy. Therefore, when treating patients with 3200 mg/day, the physician should observe sufficient increased clinical benefits to offset potential increased risk.
The dose should be tailored to each patient, and may be lowered or raised depending on the severity of symptoms either at time of initiating drug therapy or as the patient responds or fails to respond.
In general, patients with rheumatoid arthritis seem to require higher doses of ibuprofen tablets than do patients with osteoarthritis.
The smallest dose of ibuprofen tablets that yields acceptable control should be employed. A linear blood level dose-response relationship exists with single doses up to 800 mg (See CLINICAL PHARMACOLOGY for effects of food on rate of absorption). The availability of four tablet strengths facilitates dosage adjustment.
In chronic conditions, a therapeutic response to therapy with ibuprofen tablets is sometimes seen in a few days to a week but most often is observed by two weeks. After a satisfactory response has been achieved, the patient's dose should be reviewed and adjusted as required.
Mild to moderate pain: 400 mg every 4 to 6 hours as necessary for relief of pain.
In controlled analgesic clinical trials, doses of ibuprofen tablets greater than 400 mg were no more effective than the 400 mg dose.
Dysmenorrhea: For the treatment of dysmenorrhea, beginning with the earliest onset of such pain, ibuprofen tablets should be given in a dose of 400 mg every 4 hours as necessary for the relief of pain.
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Potassium Chloride
The recommended dose of carisoprodol is 350 mg three times a day and at bedtime. The recommended maximum duration of carisoprodol tablets use is up to two or three weeks.
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![Topcare Zzz Sleep (Diphenhydramine Hcl) Liquid [Topco Associates Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=27a36034-e265-445e-8ec1-9277c6ed3b35&name=da843179-713c-418a-839a-5650009f74e2-02.jpg)
Topcare Zzz Sleep
There is no fixed dosage regimen for the management of diabetes mellitus with glipizide or any other hypoglycemic agent. In addition to the usual monitoring of urinary glucose, the patient’s blood glucose must also be monitored periodically to determine the minimum effective dose for the patient; to detect primary failure, i.e., inadequate lowering of blood glucose at the maximum recommended dose of medication; and to detect secondary failure, i.e., loss of an adequate blood-glucose-lowering response after an initial period of effectiveness. Glycosylated hemoglobin levels may also be of value in monitoring the patient’s response to therapy.
Short-term administration of glipizide may be sufficient during periods of transient loss of control in patients usually controlled well on diet.
In general, glipizide should be given approximately 30 minutes before a meal to achieve the greatest reduction in postprandial hyperglycemia.
Initial Dose
The recommended starting dose is 5 mg, given before breakfast. Geriatric patients or those with liver disease may be started on 2.5 mg.
Titration
Dosage adjustments should ordinarily be in increments of 2.5 to 5 mg, as determined by blood glucose response. At least several days should elapse between titration steps. If response to a single dose is not satisfactory, dividing that dose may prove effective. The maximum recommended once daily dose is 15 mg. Doses above 15 mg should ordinarily be divided and given before meals of adequate caloric content. The maximum recommended total daily dose is 40 mg.
Maintenance
Some patients may be effectively controlled on a once-a-day regimen, while others show better response with divided dosing. Total daily doses above 15 mg should ordinarily be divided. Total daily doses above 30 mg have been safely given on a b.i.d. basis to long-term patients.
In elderly patients, debilitated or malnourished patients, and patients with impaired renal or hepatic function, the initial and maintenance dosing should be conservative to avoid hypoglycemic reactions (see PRECAUTIONS section).
Patients Receiving Insulin
As with other sulfonylurea-class hypoglycemics, many stable non-insulin-dependent diabetic patients receiving insulin may be safely placed on glipizide. When transferring patients from insulin to glipizide, the following general guidelines should be considered:
For patients whose daily insulin requirement is 20 units or less, insulin may be discontinued and glipizide therapy may begin at usual dosages. Several days should elapse between glipizide titration steps. For patients whose daily insulin requirement is greater than 20 units, the insulin dose should be reduced by 50% and glipizide therapy may begin at usual dosages. Subsequent reductions in insulin dosage should depend on individual patient response. Several days should elapse between glipizide titration steps.During the insulin withdrawal period, the patient should test urine samples for sugar and ketone bodies at least three times daily. Patients should be instructed to contact the prescriber immediately if these tests are abnormal. In some cases, especially when patient has been receiving greater than 40 units of insulin daily, it may be advisable to consider hospitalization during the transition period.
Patients Receiving Other Oral Hypoglycemic Agents
As with other sulfonylurea-class hypoglycemics, no transition period is necessary when transferring patients to glipizide. Patients should be observed carefully (1 to 2 weeks) for hypoglycemia when being transferred from longer half-life sulfonylureas (e.g., chlorpropamide) to glipizide due to potential overlapping of drug effect.
When colesevelam is coadministered with glipizide ER, maximum plasma concentration and total exposure to glipizide is reduced. Therefore, glipizide tablets should be administered at least 4 hours prior to colesevelam.
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![Carbamazepine Tablet, Chewable [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=157f67bd-74f0-4d68-9058-8fa707c564be&name=b387be7e-e619-46b5-a7cc-2fcc0484e30a-02.jpg)
Carbamazepine
(SEE TABLE BELOW)
Carbamazepine suspension in combination with liquid chlorpromazine or thioridazine results in precipitate formation, and, in the case of chlorpromazine, there has been a report of a patient passing an orange rubbery precipitate in the stool following coadministration of the two drugs. (see PRECAUTIONS, Drug Interactions). Because the extent to which this occurs with other liquid medications is not known, carbamazepine suspension should not be administered simultaneously with other liquid medications or diluents.
Monitoring of blood levels has increased the efficacy and safety of anticonvulsants (see PRECAUTIONS, Laboratory Tests). Dosage should be adjusted to the needs of the individual patient. A low initial daily dosage with a gradual increase is advised. As soon as adequate control is achieved, the dosage may be reduced very gradually to the minimum effective level. Medication should be taken with meals.
Since a given dose of carbamazepine suspension will produce higher peak levels than the same dose given as the tablet, it is recommended to start with low doses (children 6 to 12 years: ½ teaspoon q.i.d.) and to increase slowly to avoid unwanted side effects.
Conversion of patients from oral carbamazepine tablets to carbamazepine suspension: Patients should be converted by administering the same number of mg per day in smaller, more frequent doses (i.e., b.i.d. tablets to t.i.d. suspension).
Carbamazepine extended-release tablets is an extended-release formulation for twice-a-day administration. When converting patients from carbamazepine conventional tablets to carbamazepine extended-release tablets, the same total daily mg dose of carbamazepine extended-release tablets should be administered. Carbamazepine extended-release tablets must be swallowed whole and never crushed or chewed. Carbamazepine extended-release tablets should be inspected for chips or cracks. Damaged tablets should not be consumed.
Epilepsy
(SEE INDICATIONS AND USAGE)
Adults and children over 12 years of age-Initial: Either 200 mg b.i.d. for tablets and extended-release tablets, or 1 teaspoon q.i.d. for suspension (400 mg/day). Increase at weekly intervals by adding up to 200 mg/day using a b.i.d. regimen of carbamazepine extended-release tablets or a t.i.d. or q.i.d. regimen of the other formulations until the optimal response is obtained. Dosage generally should not exceed 1000 mg daily in children 12 to 15 years of age, and 1200 mg daily in patients above 15 years of age. Doses up to 1600 mg daily have been used in adults in rare instances.
Maintenance: Adjust dosage to the minimum effective level, usually 800 to 1200 mg daily.
Children 6 to 12 years of age-Initial: Either 100 mg b.i.d. for tablets or extended-release tablets, or ½ teaspoon q.i.d. for suspension (200 mg/day). Increase at weekly intervals by adding up to 100 mg/day using a b.i.d. regimen of carbamazepine extended-release tablets or a t.i.d. or q.i.d. regimen of the other formulations until the optimal response is obtained. Dosage generally should not exceed 1000 mg daily. Maintenance: Adjust dosage to the minimum effective level, usually 400 to 800 mg daily.
Children under 6 years of age-Initial: 10 to 20 mg/kg/day b.i.d. or t.i.d. as tablets, or q.i.d. as suspension. Increase weekly to achieve optimal clinical response administered t.i.d. or q.i.d. Maintenance: Ordinarily, optimal clinical response is achieved at daily doses below 35 mg/kg. If satisfactory clinical response has not been achieved, plasma levels should be measured to determine whether or not they are in the therapeutic range. No recommendation regarding the safety of carbamazepine for use at doses above 35 mg/kg/24 hours can be made.
Combination Therapy: Carbamazepine may be used alone or with other anticonvulsants. When added to existing anticonvulsant therapy, the drug should be added gradually while the other anticonvulsants are maintained or gradually decreased, except phenytoin, which may have to be increased (see PRECAUTIONS, Drug Interactions, and Pregnancy Category D).
Trigeminal Neuralgia
(SEE INDICATIONS AND USAGE)
Initial: On the first day, either 100 mg b.i.d. for tablets or extended-release tablets, or ½ teaspoon q.i.d. for suspension, for a total daily dose of 200 mg. This daily dose may be increased by up to 200 mg/day using increments of 100 mg every 12 hours for tablets or extended-release tablets, or 50 mg (½ teaspoon) q.i.d. for suspension, only as needed to achieve freedom from pain. Do not exceed 1200 mg daily. Maintenance: Control of pain can be maintained in most patients with 400 to 800 mg daily. However, some patients may be maintained on as little as 200 mg daily, while others may require as much as 1200 mg daily. At least once every 3 months throughout the treatment period, attempts should be made to reduce the dose to the minimum effective level or even discontinue the drug.
Dosage Information Initial Dose Subsequent Dose Maximum Daily Dose Indication Tablet* XR† Suspension Tablet* XR† Suspension Tablet* XR† Suspension * Tablet = Chewable or conventional tablets. † XR = Carbamazepine extended-release tabletsEpilepsy Under 6 yr
10 to 20 mg/kg/day b.i.d. or t.i.d.
10 to 20 mg/kg/day q.i.d.
Increase weekly to achieve optimal clinical response, t.i.d. or q.i.d.
Increase weekly to achieve optimal clinical response, t.i.d. or q.i.d.
35 mg/kg/24 hr (see Dosage and Administration section above)
35 mg/kg/24 hr (see Dosage and Administration section above)
6 to 12 yr
100 mg b.i.d. (200 mg/day)
100 mg b.i.d. (200 mg/day)
½ tsp q.i.d. (200 mg/day)
Add up to 100 mg/day at weekly intervals, t.i.d. or q.i.d.
Add 100 mg/day at weekly intervals, b.i.d.
Add up to 1 tsp (100 mg)/day at weekly intervals, t.i.d. or q.i.d.
1000 mg/24 hr
Over 12 yr
200 mg b.i.d. (400 mg/day)
200 mg b.i.d. (400 mg/day)
1 tsp q.i.d. (400 mg/day)
Add up to 200 mg/day at weekly intervals, t.i.d. or q.i.d.
Add up to 200 mg/day at weekly intervals, b.i.d.
Add up to 2 tsp (200 mg)/day at weekly intervals, t.i.d. or q.i.d.
1000 mg/24 hr (12 to 15 yr)1200 mg/24 hr (> 15 yr)1600 mg/24 hr (adults, in rare instances)
Trigeminal Neuralgia
100 mg b.i.d. (200 mg/day)
100 mg b.i.d. (200 mg/day)
½ tsp q.i.d. (200 mg/day)
Add up to 200 mg/day in increments of 100 mg every 12 hr
Add up to 200 mg/day in increments of 100 mg every 12 hr
Add up to 2 tsp (200 mg)/day in increments of 50 mg (½ tsp) q.i.d.
1200 mg/24 hr
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![Cetirizine Hydrochloride Solution [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=50b105e6-4505-4f85-8b77-50095fc36d8f&name=0349b228-0f87-41d3-9fce-4e1142005db2-01.jpg)
Cetirizine Hydrochloride Solution
• use only with enclosed dosing cup
adults and children 6 years and over
1 teaspoonful (5 mL) or 2 teaspoonfuls (10 mL) once daily depending upon severity of symptoms; do not take more than 2 teaspoonfuls (10 mL) in 24 hours.
adults 65 years and older
1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours.
children 2 to under 6 years of age
1/2 teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or 1/2 teaspoonful (2.5 mL) every 12 hours. Do not give more than 1 teaspoonful (5 mL) in 24 hours.
children under 2 years of age
ask a doctor
consumers with liver or kidney disease
ask a doctor
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![Triamterene And Hydrochlorothiazide Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=871a6920-da41-4869-ade2-ddc0fbb4b979&name=871a6920-da41-4869-ade2-ddc0fbb4b979-03.jpg)
Triamterene And Hydrochlorothiazide
Note: 37.5 mg/25 mg = 37.5 mg triamterene and 25 mg hydrochlorothiazide
75 mg/50 mg = 75 mg triamterene and 50 mg hydrochlorothiazide
The usual dose of Triamterene and Hydrochlorothiazide 37.5 mg/25 mg is one or two tablets daily, given as a single dose, with appropriate monitoring of serum potassium (see WARNINGS). The usual dose of Triamterene and Hydrochlorothiazide 75 mg/50 mg is one tablet daily, with appropriate monitoring of serum potassium (see WARNINGS). There is no experience with the use of more than one 75 mg/50 mg tablet daily or more than two 37.5 mg/25 mg tablets daily. Clinical experience with the administration of two 37.5 mg/25 mg tablets daily in divided doses (rather than as a single dose) suggests an increased risk of electrolyte imbalance and renal dysfunction.
Patients receiving 50 mg of hydrochlorothiazide who become hypokalemic may be transferred to 75 mg/50 mg product directly. Patients receiving 25 mg hydrochlorothiazide who become hypokalemic may be transferred to a 37.5 mg triamterene/25 mg hydrochlorothiazide directly.
In patients requiring hydrochlorothiazide therapy and in whom hypokalemia cannot be risked, therapy may be initiated with 37.5 mg/25 mg of triamterene and hydrochlorothiazide. If an optimal blood pressure response is not obtained with 37.5 mg/25 mg of triamterene and hydrochlorothiazide, the dose should be increased to two 37.5 mg/25 mg tablets daily as a single dose, or one 75 mg/50 mg tablet daily. If blood pressure still is not controlled, another antihypertensive agent may be added (see PRECAUTIONS, Drug Interactions).
Clinical studies have shown that patients taking less bioavailable formulations of triamterene and hydrochlorothiazide in daily doses of 25 mg to 50 mg hydrochlorothiazide and 50 mg to 100 mg triamterene may be safely changed to one 37.5 mg/25 mg of triamterene and hydrochlorothiazide daily. All patients changed from less bioavailable formulations to triamterene and hydrochlorothiazide should be monitored clinically and for serum potassium after the transfer.
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![Cetirizine Hydrochloride Solution [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=7fa54999-fc16-49e4-ab62-ac3a5532cf37&name=7fa54999-fc16-49e4-ab62-ac3a5532cf37-02.jpg)
Cetirizine Hydrochloride Solution
Cetirizine hydrochloride Syrup can be taken without regard to food consumption.
Children 2 to 5 years for Chronic Urticaria
The recommended initial dose of cetirizine hydrochloride syrup in children aged 2 to 5 years is 2.5 mg (½ teaspoon) syrup once daily. The dosage in this age group can be increased to a maximum dose of 5 mg per day given as 1 teaspoonful syrup once a day, or one ½ teaspoonful syrup given every 12 hours.
Children 6 months to <2 years for Perennial Allergic Rhinitis and Chronic Urticaria
The recommended dose of cetirizine hydrochloride syrup in children 6 months to 23 months of age is 2.5 mg (½ teaspoonful) once daily. The dose in children 12 to 23 months of age can be increased to a maximum dose of 5 mg per day, given as ½ teaspoonful (2.5 mg) every 12 hours.
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![Up And Up First Aid Antibiotic Pain Relieving (Neomycin, Polymyxin B, Pramoxine Hcl) Cream [Target Corporation]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=30b44840-3357-4eea-a165-385f8c7939c5&name=image-01.jpg)
Up And Up First Aid Antibiotic Pain Relieving
• adults and children 12 years and over: take 1 to 2 capsules every 4-6 hours; not more than 6 doses in 24 hours • children under 12 years: ask a doctor
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![Fluoxetine (Fluoxetine Hydrochloride) Capsule [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=9e1353d7-83d1-4522-9352-5545db044a50&name=fluoxetine-fig1.jpg)
Fluoxetine
2.1 Major Depressive Disorder
Initial Treatment Adult — In controlled trials used to support the efficacy of fluoxetine, patients were administered morning doses ranging from 20 to 80 mg/day. Studies comparing fluoxetine 20, 40, and 60 mg/day to placebo indicate that 20 mg/day is sufficient to obtain a satisfactory response in Major Depressive Disorder in most cases. Consequently, a dose of 20 mg/day, administered in the morning, is recommended as the initial dose.A dose increase may be considered after several weeks if insufficient clinical improvement is observed. Doses above 20 mg/day may be administered on a once-a-day (morning) or BID schedule (i.e., morning and noon) and should not exceed a maximum dose of 80 mg/day.Pediatric (children and adolescents) — In the short-term (8 to 9 week) controlled clinical trials of fluoxetine supporting its effectiveness in the treatment of Major Depressive Disorder, patients were administered fluoxetine doses of 10 to 20 mg/day [see Clinical Studies (14.1)]. Treatment should be initiated with a dose of 10 or 20 mg/day. After 1 week at 10 mg/day, the dose should be increased to 20 mg/day. However, due to higher plasma levels in lower weight children, the starting and target dose in this group may be 10 mg/day. A dose increase to 20 mg/day may be considered after several weeks if insufficient clinical improvement is observed.All patients — As with other drugs effective in the treatment of Major Depressive Disorder, the full effect may be delayed until 4 weeks of treatment or longer.Maintenance/Continuation/Extended Treatment — It is generally agreed that acute episodes of Major Depressive Disorder require several months or longer of sustained pharmacologic therapy. Whether the dose needed to induce remission is identical to the dose needed to maintain and/or sustain euthymia is unknown.Daily Dosing — Systematic evaluation of fluoxetine capsules in adult patients has shown that its efficacy in Major Depressive Disorder is maintained for periods of up to 38 weeks following 12 weeks of open-label acute treatment (50 weeks total) at a dose of 20 mg/day [see Clinical Studies (14.1)].Switching Patients to a Tricyclic Antidepressant (TCA) — Dosage of a TCA may need to be reduced, and plasma TCA concentrations may need to be monitored temporarily when fluoxetine is coadministered or has been recently discontinued [see Warnings and Precautions (5.2) and Drug Interactions (7.7)].
2.2 Obsessive Compulsive Disorder
Initial Treatment Adult — In the controlled clinical trials of fluoxetine supporting its effectiveness in the treatment of OCD, patients were administered fixed daily doses of 20, 40, or 60 mg of fluoxetine or placebo [see Clinical Studies (14.2)]. In one of these studies, no dose-response relationship for effectiveness was demonstrated. Consequently, a dose of 20 mg/day, administered in the morning, is recommended as the initial dose. Since there was a suggestion of a possible dose-response relationship for effectiveness in the second study, a dose increase may be considered after several weeks if insufficient clinical improvement is observed. The full therapeutic effect may be delayed until 5 weeks of treatment or longer.Doses above 20 mg/day may be administered on a once daily (i.e., morning) or BID schedule (i.e., morning and noon). A dose range of 20 to 60 mg/day is recommended; however, doses of up to 80 mg/day have been well tolerated in open studies of OCD. The maximum fluoxetine dose should not exceed 80 mg/day.Pediatric (children and adolescents) — In the controlled clinical trial of fluoxetine supporting its effectiveness in the treatment of OCD, patients were administered fluoxetine doses in the range of 10 to 60 mg/day [see Clinical Studies (14.2)]. In adolescents and higher weight children, treatment should be initiated with a dose of 10 mg/day. After 2 weeks, the dose should be increased to 20 mg/day. Additional dose increases may be considered after several more weeks if insufficient clinical improvement is observed. A dose range of 20 to 60 mg/day is recommended.In lower weight children, treatment should be initiated with a dose of 10 mg/day. Additional dose increases may be considered after several more weeks if insufficient clinical improvement is observed. A dose range of 20 to 30 mg/day is recommended. Experience with daily doses greater than 20 mg is very minimal, and there is no experience with doses greater than 60 mg.Maintenance/Continuation Treatment — While there are no systematic studies that answer the question of how long to continue fluoxetine capsules, OCD is a chronic condition and it is reasonable to consider continuation for a responding patient. Although the efficacy of fluoxetine capsules after 13 weeks has not been documented in controlled trials, adult patients have been continued in therapy under double-blind conditions for up to an additional 6 months without loss of benefit. However, dosage adjustments should be made to maintain the patient on the lowest effective dosage, and patients should be periodically reassessed to determine the need for treatment.
2.3 Bulimia Nervosa
Initial Treatment — In the controlled clinical trials of fluoxetine supporting its effectiveness in the treatment of Bulimia Nervosa, patients were administered fixed daily fluoxetine doses of 20 or 60 mg, or placebo [see Clinical Studies (14.3)]. Only the 60 mg dose was statistically significantly superior to placebo in reducing the frequency of binge-eating and vomiting. Consequently, the recommended dose is 60 mg/day, administered in the morning. For some patients it may be advisable to titrate up to this target dose over several days. Fluoxetine doses above 60 mg/day have not been systematically studied in patients with bulimia.Maintenance/Continuation Treatment — Systematic evaluation of continuing fluoxetine capsules 60 mg/day for periods of up to 52 weeks in patients with bulimia who have responded while taking fluoxetine capsules 60 mg/day during an 8-week acute treatment phase has demonstrated a benefit of such maintenance treatment [see Clinical Studies (14.3)]. Nevertheless, patients should be periodically reassessed to determine the need for maintenance treatment.
2.4 Panic Disorder
Initial Treatment — In the controlled clinical trials of fluoxetine supporting its effectiveness in the treatment of Panic Disorder, patients were administered fluoxetine doses in the range of 10 to 60 mg/day [see Clinical Studies (14.4)]. Treatment should be initiated with a dose of 10 mg/day. After one week, the dose should be increased to 20 mg/day. The most frequently administered dose in the 2 flexible-dose clinical trials was 20 mg/day.A dose increase may be considered after several weeks if no clinical improvement is observed. Fluoxetine doses above 60 mg/day have not been systematically evaluated in patients with Panic Disorder.Maintenance/Continuation Treatment — While there are no systematic studies that answer the question of how long to continue fluoxetine capsules, panic disorder is a chronic condition and it is reasonable to consider continuation for a responding patient. Nevertheless, patients should be periodically reassessed to determine the need for continued treatment.
2.5 Fluoxetine Capsules and Olanzapine in Combination: Depressive Episodes Associated with Bipolar I Disorder
When using fluoxetine capsules and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax.
Adult —Fluoxetine should be administered in combination with oral olanzapine once daily in the evening, without regard to meals, generally beginning with 5 mg of oral olanzapine and 20 mg of fluoxetine. Dosage adjustments, if indicated, can be made according to efficacy and tolerability within dose ranges of fluoxetine 20 to 50 mg and oral olanzapine 5 to 12.5 mg. Antidepressant efficacy was demonstrated with olanzapine and fluoxetine in combination with a dose range of olanzapine 6 to 12 mg and fluoxetine 25 to 50 mg. Safety of co-administration of doses above 18 mg olanzapine with 75 mg fluoxetine has not been evaluated in clinical studies.Information for pediatric patients (10 to 17 years) is approved for Eli Lilly and Company’s Fluoxetine Capsules. However due to Eli Lilly and Company’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
Safety and efficacy of fluoxetine in combination with olanzapine was determined in clinical trials supporting approval of Symbyax (fixed-dose combination of olanzapine and fluoxetine). Symbyax is dosed between 3 mg/25 mg (olanzapine/fluoxetine) per day and 12 mg/50 mg (olanzapine/fluoxetine) per day. The following table demonstrates the appropriate individual component doses of fluoxetine capsules and olanzapine versus Symbyax. Dosage adjustments, if indicated, should be made with the individual components according to efficacy and tolerability.
Table 1: Approximate Dose Correspondence Between Symbyax1 and the Combination of Fluoxetine and Olanzapine For Symbyax (mg/day) Use in Combination Olanzapine (mg/day) Fluoxetine (mg/day) 1 Symbyax (olanzapine/fluoxetine hydrochloride) is a fixed-dose combination of fluoxetine and olanzapine.3 mg olanzapine/25 mg fluoxetine
2.5
20
6 mg olanzapine/25 mg fluoxetine
5
20
12 mg olanzapine/25 mg fluoxetine
10+2.5
20
6 mg olanzapine/50 mg fluoxetine
5
40+10
12 mg olanzapine/50 mg fluoxetine
10+2.5
40+10
While there is no body of evidence to answer the question of how long a patient treated with fluoxetine capsules and olanzapine in combination should remain on it, it is generally accepted that Bipolar I Disorder, including the depressive episodes associated with Bipolar I Disorder, is a chronic illness requiring chronic treatment. The physician should periodically re-examine the need for continued pharmacotherapy.Fluoxetine capsules monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder.
2.7 Dosing in Specific Populations
Treatment of Pregnant Women— When treating pregnant women with fluoxetine capsules, the physician should carefully consider the potential risks and potential benefits of treatment. Neonates exposed to SSRIs or SNRIs late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding [see Use in Specific Populations (8.1)]. Geriatric— A lower or less frequent dosage should be considered for the elderly [see Use in Specific Populations (8.5)]. Hepatic Impairment— As with many other medications, a lower or less frequent dosage should be used in patients with hepatic impairment [see Clinical Pharmacology (12.4) and Use in Specific Populations (8.6)]. Concomitant Illness— Patients with concurrent disease or on multiple concomitant medications may require dosage adjustments [see Clinical Pharmacology (12.4) and Warnings and Precautions (5.12)]. Fluoxetine Capsules and Olanzapine in Combination — The starting dose of oral olanzapine 2.5 to 5 mg with fluoxetine 20 mg should be used for patients with a predisposition to hypotensive reactions, patients with hepatic impairment, or patients who exhibit a combination of factors that may slow the metabolism of olanzapine or fluoxetine in combination (female gender, geriatric age, non-smoking status), or those patients who may be pharmacodynamically sensitive to olanzapine. Dosing modifications may be necessary in patients who exhibit a combination of factors that may slow metabolism. When indicated, dose escalation should be performed with caution in these patients. Fluoxetine capsules and olanzapine in combination have not been systematically studied in patients over 65 years of age or in patients less than 10 years of age [see Warnings and Precautions (5.16)and Drug Interactions (7.7)].
2.8 Discontinuation of Treatment
Symptoms associated with discontinuation of fluoxetine, SNRIs, and SSRIs, have been reported [see Warnings and Precautions (5.15)].
2.9 Switching a Patient To or From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders
At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with fluoxetine capsules. Conversely, at least 5 weeks should be allowed after stopping fluoxetine capsules before starting an MAOI intended to treat psychiatric disorders [see Contraindications (4.1)].
2.10 Use of Fluoxetine Capsules with Other MAOIs such as Linezolid or Methylene Blue
Do not start fluoxetine capsules in a patient who is being treated with linezolid or intravenous methylene blue because there is an increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered [see Contraindications (4.1)]. In some cases, a patient already receiving fluoxetine capsules therapy may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, fluoxetine capsules should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for five weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with fluoxetine capsules may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue [see Warnings and Precautions (5.2)]. The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with fluoxetine capsules is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use [see Warnings and Precautions (5.2)].
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![Ed A-hist (Chlorpheniramine Maleate And Phenylephrine Hydrochloride) Tablet, Coated [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=a1e2d82a-ff0d-46ae-a818-7ee540dcca47&name=a1e2d82a-ff0d-46ae-a818-7ee540dcca47-01.jpg)
Ed A-hist
Do not exceed recommended dosage.
Adults and children 12 years of age and over:
1 tablet every 4 hours, not to exceed 6 tablets in 24 hours, or as directed by a doctor
Children 6 to under 12 years of age:
1/2 tablet every 4 hours, not to exceed 3 tablets is 24 hours, or as directed by a doctor
Children under 6 years of age:
Consult a doctor.
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![Fluoxetine (Fluoxetine Hydrochloride) Capsule [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=e07fa54e-f4ee-496d-a7e9-533c85564be1&name=fluoxetine-fig2.jpg)
Fluoxetine
2.1 Major Depressive Disorder
Initial Treatment Adult — In controlled trials used to support the efficacy of fluoxetine, patients were administered morning doses ranging from 20 to 80 mg/day. Studies comparing fluoxetine 20, 40, and 60 mg/day to placebo indicate that 20 mg/day is sufficient to obtain a satisfactory response in Major Depressive Disorder in most cases. Consequently, a dose of 20 mg/day, administered in the morning, is recommended as the initial dose.A dose increase may be considered after several weeks if insufficient clinical improvement is observed. Doses above 20 mg/day may be administered on a once-a-day (morning) or BID schedule (i.e., morning and noon) and should not exceed a maximum dose of 80 mg/day.Pediatric (children and adolescents) — In the short-term (8 to 9 week) controlled clinical trials of fluoxetine supporting its effectiveness in the treatment of Major Depressive Disorder, patients were administered fluoxetine doses of 10 to 20 mg/day [see Clinical Studies (14.1)]. Treatment should be initiated with a dose of 10 or 20 mg/day. After 1 week at 10 mg/day, the dose should be increased to 20 mg/day. However, due to higher plasma levels in lower weight children, the starting and target dose in this group may be 10 mg/day. A dose increase to 20 mg/day may be considered after several weeks if insufficient clinical improvement is observed.All patients — As with other drugs effective in the treatment of Major Depressive Disorder, the full effect may be delayed until 4 weeks of treatment or longer.Maintenance/Continuation/Extended Treatment — It is generally agreed that acute episodes of Major Depressive Disorder require several months or longer of sustained pharmacologic therapy. Whether the dose needed to induce remission is identical to the dose needed to maintain and/or sustain euthymia is unknown.Daily Dosing — Systematic evaluation of fluoxetine capsules in adult patients has shown that its efficacy in Major Depressive Disorder is maintained for periods of up to 38 weeks following 12 weeks of open-label acute treatment (50 weeks total) at a dose of 20 mg/day [see Clinical Studies (14.1)].Switching Patients to a Tricyclic Antidepressant (TCA) — Dosage of a TCA may need to be reduced, and plasma TCA concentrations may need to be monitored temporarily when fluoxetine is coadministered or has been recently discontinued [see Warnings and Precautions (5.2) and Drug Interactions (7.7)].
2.2 Obsessive Compulsive Disorder
Initial Treatment Adult — In the controlled clinical trials of fluoxetine supporting its effectiveness in the treatment of OCD, patients were administered fixed daily doses of 20, 40, or 60 mg of fluoxetine or placebo [see Clinical Studies (14.2)]. In one of these studies, no dose-response relationship for effectiveness was demonstrated. Consequently, a dose of 20 mg/day, administered in the morning, is recommended as the initial dose. Since there was a suggestion of a possible dose-response relationship for effectiveness in the second study, a dose increase may be considered after several weeks if insufficient clinical improvement is observed. The full therapeutic effect may be delayed until 5 weeks of treatment or longer.Doses above 20 mg/day may be administered on a once daily (i.e., morning) or BID schedule (i.e., morning and noon). A dose range of 20 to 60 mg/day is recommended; however, doses of up to 80 mg/day have been well tolerated in open studies of OCD. The maximum fluoxetine dose should not exceed 80 mg/day.Pediatric (children and adolescents) — In the controlled clinical trial of fluoxetine supporting its effectiveness in the treatment of OCD, patients were administered fluoxetine doses in the range of 10 to 60 mg/day [see Clinical Studies (14.2)]. In adolescents and higher weight children, treatment should be initiated with a dose of 10 mg/day. After 2 weeks, the dose should be increased to 20 mg/day. Additional dose increases may be considered after several more weeks if insufficient clinical improvement is observed. A dose range of 20 to 60 mg/day is recommended.In lower weight children, treatment should be initiated with a dose of 10 mg/day. Additional dose increases may be considered after several more weeks if insufficient clinical improvement is observed. A dose range of 20 to 30 mg/day is recommended. Experience with daily doses greater than 20 mg is very minimal, and there is no experience with doses greater than 60 mg.Maintenance/Continuation Treatment — While there are no systematic studies that answer the question of how long to continue fluoxetine capsules, OCD is a chronic condition and it is reasonable to consider continuation for a responding patient. Although the efficacy of fluoxetine capsules after 13 weeks has not been documented in controlled trials, adult patients have been continued in therapy under double-blind conditions for up to an additional 6 months without loss of benefit. However, dosage adjustments should be made to maintain the patient on the lowest effective dosage, and patients should be periodically reassessed to determine the need for treatment.
2.3 Bulimia Nervosa
Initial Treatment — In the controlled clinical trials of fluoxetine supporting its effectiveness in the treatment of Bulimia Nervosa, patients were administered fixed daily fluoxetine doses of 20 or 60 mg, or placebo [see Clinical Studies (14.3)]. Only the 60 mg dose was statistically significantly superior to placebo in reducing the frequency of binge-eating and vomiting. Consequently, the recommended dose is 60 mg/day, administered in the morning. For some patients it may be advisable to titrate up to this target dose over several days. Fluoxetine doses above 60 mg/day have not been systematically studied in patients with bulimia.Maintenance/Continuation Treatment — Systematic evaluation of continuing fluoxetine capsules 60 mg/day for periods of up to 52 weeks in patients with bulimia who have responded while taking fluoxetine capsules 60 mg/day during an 8-week acute treatment phase has demonstrated a benefit of such maintenance treatment [see Clinical Studies (14.3)]. Nevertheless, patients should be periodically reassessed to determine the need for maintenance treatment.
2.4 Panic Disorder
Initial Treatment — In the controlled clinical trials of fluoxetine supporting its effectiveness in the treatment of Panic Disorder, patients were administered fluoxetine doses in the range of 10 to 60 mg/day [see Clinical Studies (14.4)]. Treatment should be initiated with a dose of 10 mg/day. After one week, the dose should be increased to 20 mg/day. The most frequently administered dose in the 2 flexible-dose clinical trials was 20 mg/day.A dose increase may be considered after several weeks if no clinical improvement is observed. Fluoxetine doses above 60 mg/day have not been systematically evaluated in patients with Panic Disorder.Maintenance/Continuation Treatment — While there are no systematic studies that answer the question of how long to continue fluoxetine capsules, panic disorder is a chronic condition and it is reasonable to consider continuation for a responding patient. Nevertheless, patients should be periodically reassessed to determine the need for continued treatment.
2.5 Fluoxetine Capsules and Olanzapine in Combination: Depressive Episodes Associated with Bipolar I Disorder
When using fluoxetine capsules and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax.
Adult —Fluoxetine should be administered in combination with oral olanzapine once daily in the evening, without regard to meals, generally beginning with 5 mg of oral olanzapine and 20 mg of fluoxetine. Dosage adjustments, if indicated, can be made according to efficacy and tolerability within dose ranges of fluoxetine 20 to 50 mg and oral olanzapine 5 to 12.5 mg. Antidepressant efficacy was demonstrated with olanzapine and fluoxetine in combination with a dose range of olanzapine 6 to 12 mg and fluoxetine 25 to 50 mg. Safety of co-administration of doses above 18 mg olanzapine with 75 mg fluoxetine has not been evaluated in clinical studies.Information for pediatric patients (10 to 17 years) is approved for Eli Lilly and Company’s Fluoxetine Capsules. However due to Eli Lilly and Company’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
Safety and efficacy of fluoxetine in combination with olanzapine was determined in clinical trials supporting approval of Symbyax (fixed-dose combination of olanzapine and fluoxetine). Symbyax is dosed between 3 mg/25 mg (olanzapine/fluoxetine) per day and 12 mg/50 mg (olanzapine/fluoxetine) per day. The following table demonstrates the appropriate individual component doses of fluoxetine capsules and olanzapine versus Symbyax. Dosage adjustments, if indicated, should be made with the individual components according to efficacy and tolerability.
Table 1: Approximate Dose Correspondence Between Symbyax1 and the Combination of Fluoxetine and Olanzapine For Symbyax (mg/day) Use in Combination Olanzapine (mg/day) Fluoxetine (mg/day) 1 Symbyax (olanzapine/fluoxetine hydrochloride) is a fixed-dose combination of fluoxetine and olanzapine.3 mg olanzapine/25 mg fluoxetine
2.5
20
6 mg olanzapine/25 mg fluoxetine
5
20
12 mg olanzapine/25 mg fluoxetine
10+2.5
20
6 mg olanzapine/50 mg fluoxetine
5
40+10
12 mg olanzapine/50 mg fluoxetine
10+2.5
40+10
While there is no body of evidence to answer the question of how long a patient treated with fluoxetine capsules and olanzapine in combination should remain on it, it is generally accepted that Bipolar I Disorder, including the depressive episodes associated with Bipolar I Disorder, is a chronic illness requiring chronic treatment. The physician should periodically re-examine the need for continued pharmacotherapy.Fluoxetine capsules monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder.
2.7 Dosing in Specific Populations
Treatment of Pregnant Women— When treating pregnant women with fluoxetine capsules, the physician should carefully consider the potential risks and potential benefits of treatment. Neonates exposed to SSRIs or SNRIs late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding [see Use in Specific Populations (8.1)]. Geriatric— A lower or less frequent dosage should be considered for the elderly [see Use in Specific Populations (8.5)]. Hepatic Impairment— As with many other medications, a lower or less frequent dosage should be used in patients with hepatic impairment [see Clinical Pharmacology (12.4) and Use in Specific Populations (8.6)]. Concomitant Illness— Patients with concurrent disease or on multiple concomitant medications may require dosage adjustments [see Clinical Pharmacology (12.4) and Warnings and Precautions (5.12)]. Fluoxetine Capsules and Olanzapine in Combination — The starting dose of oral olanzapine 2.5 to 5 mg with fluoxetine 20 mg should be used for patients with a predisposition to hypotensive reactions, patients with hepatic impairment, or patients who exhibit a combination of factors that may slow the metabolism of olanzapine or fluoxetine in combination (female gender, geriatric age, non-smoking status), or those patients who may be pharmacodynamically sensitive to olanzapine. Dosing modifications may be necessary in patients who exhibit a combination of factors that may slow metabolism. When indicated, dose escalation should be performed with caution in these patients. Fluoxetine capsules and olanzapine in combination have not been systematically studied in patients over 65 years of age or in patients less than 10 years of age [see Warnings and Precautions (5.16)and Drug Interactions (7.7)].
2.8 Discontinuation of Treatment
Symptoms associated with discontinuation of fluoxetine, SNRIs, and SSRIs, have been reported [see Warnings and Precautions (5.15)].
2.9 Switching a Patient To or From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders
At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with fluoxetine capsules. Conversely, at least 5 weeks should be allowed after stopping fluoxetine capsules before starting an MAOI intended to treat psychiatric disorders [see Contraindications (4.1)].
2.10 Use of Fluoxetine Capsules with Other MAOIs such as Linezolid or Methylene Blue
Do not start fluoxetine capsules in a patient who is being treated with linezolid or intravenous methylene blue because there is an increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered [see Contraindications (4.1)]. In some cases, a patient already receiving fluoxetine capsules therapy may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, fluoxetine capsules should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for five weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with fluoxetine capsules may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue [see Warnings and Precautions (5.2)]. The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with fluoxetine capsules is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use [see Warnings and Precautions (5.2)].
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![Alprazolam Tablet [Direct Rx]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=18921375-a801-4614-95f1-54cb22c32028&name=ondan4mglabel.jpg)
Alprazolam
Prevention of Nausea and Vomiting Associated With Highly Emetogenic Cancer Chemotherapy
The recommended adult oral dosage of ondansetron tablets is 24 mg given as three 8 mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥ 50 mg/m2. Multiday, single-dose administration of a 24 mg dosage has not been studied.
Pediatric Use
There is no experience with the use of a 24 mg dosage in pediatric patients.
Geriatric Use
The dosage recommendation is the same as for the general population
Prevention of Nausea and Vomiting Associated With Moderately Emetogenic Cancer Chemotherapy
The recommended adult oral dosage is one 8 mg ondansetron tablet given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8 mg ondansetron tablet should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.Pediatric Use
For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4 mg ondansetron tablet or one 4 mg given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4 mg ondansetron tablet should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.
Geriatric Use
The dosage is the same as for the general population.
Prevention of Nausea and Vomiting Associated With Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions to the Abdomen
The recommended oral dosage is one 8 mg ondansetron tablet given 3 times a day.
For total body irradiation, one 8 mg ondansetron tablet should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.
For single high-dose fraction radiotherapy to the abdomen, one 8 mg ondansetron tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.
For daily fractionated radiotherapy to the abdomen, one 8 mg ondansetron tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.
Pediatric Use
There is no experience with the use of ondansetron tablet in the prevention of radiation-induced nausea and vomiting in pediatric patients.
Geriatric Use The dosage recommendation is the same as for the general population.
Postoperative Nausea and Vomiting
The recommended dosage is 16 mg given as two 8 mg ondansetron tablets 1 hour before induction of anesthesia.Pediatric Use There is no experience with the use of ondansetron tablets in the prevention of postoperative nausea and vomiting in pediatric patients.
Geriatric Use The dosage is the same as for the general population.
Dosage Adjustment for Patients With Impaired Renal Function
The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron.
Dosage Adjustment for Patients With Impaired Hepatic Function
In patients with severe hepatic impairment (Child-Pugh2 score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.
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![Quetiapine Fumarate Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=8626710e-571b-449a-8235-74f49b611732&name=8626710e-571b-449a-8235-74f49b611732-04.jpg)
Quetiapine Fumarate
Quetiapine tablets can be taken with or without food.
2.1 Recommended Dosing
The recommended initial dose, titration, dose range and maximum quetiapine dose for each approved indication is displayed in Table 1. After initial dosing, adjustments can be made upwards or downwards, if necessary, depending upon the clinical response and tolerability of the patient [see Clinical Studies (14.1 and 14.2)].
Table 1: Recommended Dosing for quetiapine
Indication
Initial Dose and Titration
RecommendedDose
Maximum Dose
Schizophrenia-Adults(2.1)
Day 1: 25 mg twice daily.Increase in increments of 25 mg to 50 mg divided two or three times on Days 2 and 3 to range of 300 to 400 mg by Day 4. Further adjustments can be made in increments of 25 to 50 mg twice a day, in intervals of not less than 2 days.
150 to 750mg/day
750 mg/day
Schizophrenia-Adolescents (13 to 17 years) (2.1)
Day 1: 25 mg twice daily.Day 2: Twice daily dosing totaling 100 mg.Day 3: Twice daily dosing totaling 200 mg.Day 4: Twice daily dosing totaling 300 mg.Day 5: Twice daily dosing totaling 400 mg.Further adjustments should be in increments no greater than 100 mg/day within the recommended dose range of 400 to 800 mg/day. Based on response and tolerability, may be administered three times daily.
400 to 800 mg/day
800 mg/day
Schizophrenia-Maintenance
N/A
400 to 800mg/day
800 mg/day
Bipolar Mania- Adults Monotherapy or as an adjunct to lithium or divalproex (2.2)
Day 1: Twice daily dosing totaling 100 mg.Day 2: Twice daily dosing totaling 200 mg.Day 3: Twice daily dosing totaling 300 mg. Day 4: Twice daily dosing totaling 400 mg.Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of no greater than 200 mg/day.
400 to 800mg/day
800 mg/day
Bipolar Mania-Children and Adolescents (10 to 17 years),Monotherapy
Day 1: 25 mg twice daily.Day 2: Twice daily dosing totaling 100 mg. Day 3: Twice daily dosing totaling 200 mg. Day 4: Twice daily dosing totaling 300 mg.Day 5: Twice daily dosing totaling 400 mg.Further adjustments should be in increments no greater than 100 mg/day within the recommended dose range of 400 to 600 mg/day. Based on response and tolerability, may be administered three times daily.
400 to 600 mg/day
600 mg/day
Bipolar Depression-Adults
Administer once daily at bedtime.Day 1: 50 mgDay 2: 100 mgDay 3: 200 mgDay 4: 300 mg
300 mg/day
300 mg/day
Bipolar I DisorderMaintenance Therapy- Adults
Administer twice daily totaling 400 to 800 mg/day as adjunct to lithium or divalproex. Generally, in the maintenance phase, patients continued on the same dose on which they were stabilized.
400 to 800mg/day
800 mg/day
N/A Not applicable
Maintenance Treatment for Schizophrenia and Bipolar I Disorder
Maintenance Treatment—Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment [see Clinical Studies (14.2)].
2.2 Dose Modifications in Elderly Patients
Consideration should be given to a slower rate of dose titration and a lower target dose in the elderly and in patients who are debilitated or who have a predisposition to hypotensive reactions [see Clinical Pharmacology (12.3)]. When indicated, dose escalation should be performed with caution in these patients.
Elderly patients should be started on quetiapine 50 mg/day and the dose can be increased in increments of 50 mg/day depending on the clinical response and tolerability of the individual patient.
2.3 Dose Modifications in Hepatically Impaired Patients
Patients with hepatic impairment should be started on 25 mg/day. The dose should be increased daily in increments of 25 mg/day - 50 mg/day to an effective dose, depending on the clinical response and tolerability of the patient.
2.4 Dose Modifications when used with CYP3A4 Inhibitors
Quetiapine dose should be reduced to one sixth of original dose when co-medicated with a potent CYP3A4 inhibitor (e.g. ketoconazole, itraconazole, indinavir, ritonavir, nefazodone, etc.). When the CYP3A4 inhibitor is discontinued, the dose of quetiapine should be increased by 6 fold [see Clinical Pharmacology (12.3) and Drug Interactions 7.1)].
2.5 Dose Modifications when used with CYP3A4 Inducers
Quetiapine dose should be increased up to 5 fold of the original dose when used in combination with a chronic treatment (e.g., greater than 7-14 days) of a potent CYP3A4 inducer (e.g. phenytoin, carbamazepine, rifampin, avasimibe, St. John’s wort etc.). The dose should be titrated based on the clinical response and tolerability of the individual patient. When the CYP3A4 inducer is discontinued, the dose of quetiapine should be reduced to the original level within 7-14 days [see Clinical Pharmacology (12.3) and Drug Interactions (7.1)].
2.6 Reinitiation of Treatment in Patients Previously Discontinued
Although there are no data to specifically address re-initiation of treatment, it is recommended that when restarting therapy of patients who have been off quetiapine for more than one week, the initial dosing schedule should be followed. When restarting patients who have been off quetiapine for less than one week, gradual dose escalation may not be required and the maintenance dose may be reinitiated.
2.7 Switching from Antipsychotics
There are no systematically collected data to specifically address switching patients with schizophrenia from antipsychotics to quetiapine, or concerning concomitant administration with antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients with schizophrenia from depot antipsychotics, if medically appropriate, initiate quetiapine therapy in place of the next scheduled injection. The need for continuing existing EPS medication should be re-evaluated periodically.
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![Milk Of Magnesia (Magnesium Hydroxide) Liquid [Hyvee Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=ad18a9e9-2fa0-40b0-a438-9146a150ab39&name=MeloxicamTablets15mg.jpg)
Milk Of Magnesia
2.1 General Instructions
Carefully consider the potential benefits and risks of meloxicam tablets USP and other treatment options before deciding to use meloxicam tablets USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5.4)].
After observing the response to initial therapy with meloxicam tablets USP, adjust the dose to suit an individual patient's needs.
In adults, the maximum recommended daily oral dose of meloxicam tablets USP is 15 mg regardless of formulation. In patients with hemodialysis, a maximum daily dosage of 7.5 mg is recommended [see Warnings and Precautions (5.6), Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].
Meloxicam tablets USP may be taken without regard to timing of meals.
2.2 Osteoarthritis
For the relief of the signs and symptoms of osteoarthritis the recommended starting and maintenance oral dose of meloxicam tablets USP is 7.5 mg once daily. Some patients may receive additional benefit by increasing the dose to 15 mg once daily.
2.3 Rheumatoid Arthritis
For the relief of the signs and symptoms of rheumatoid arthritis, the recommended starting and maintenance oral dose of meloxicam tablets USP is 7.5 mg once daily. Some patients may receive additional benefit by increasing the dose to 15 mg once daily.
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![Quetiapine Fumarate Tablet, Film Coated [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=6de40b0a-870e-4322-9b5b-66ce876be96d&name=6de40b0a-870e-4322-9b5b-66ce876be96d-02.jpg)
Quetiapine Fumarate
Quetiapine fumarate tablets can be taken with or without food.
2.1 Schizophrenia
Adults
Dose Selection— Quetiapine fumarate tablets should generally be administered with an initial dose of 25 mg twice daily, with increases in total daily dose of 25 mg to 50 mg divided in two or three doses on the second and third day, as tolerated, to a total dose range of 300 mg to 400 mg daily by the fourth day. Further dosage adjustments, if indicated, should generally occur at intervals of not less than 2 days, as steady-state for quetiapine fumarate tablets would not be achieved for approximately 1 to 2 days in the typical patient. When dosage adjustments are necessary, dose increments/decrements of 25 mg to 50 mg divided twice daily are recommended. Most efficacy data with quetiapine fumarate tablets were obtained using three times daily dosing regimens, but in one controlled trial 225 mg given twice per day was also effective.
Efficacy in schizophrenia was demonstrated in a dose range of 150 mg/day to 750 mg/day in the clinical trials supporting the effectiveness of quetiapine fumarate tablets. In a dose response study, doses above 300 mg/day were not demonstrated to be more efficacious than the 300 mg/day dose. In other studies, however, doses in the range of 400 mg/day to 500 mg/day appeared to be needed. The safety of doses above 800 mg/day has not been evaluated in clinical trials.
Maintenance Treatment— The effectiveness of quetiapine fumarate tablets for longer than 6 weeks has not been evaluated in controlled clinical trials. While there is no body of evidence available to answer the question of how long the patient treated with quetiapine fumarate tablets should be maintained, it is generally recommended that responding patients be continued beyond the acute response, but at the lowest dose needed to maintain remission. Patients should be periodically reassessed to determine the need for maintenance treatment.
Adolescents (13 to 17 years)
Pediatric dosing information in patients (13 to 17 years of age) with schizophrenia is approved for AstraZeneca Pharmaceuticals LP’s quetiapine fumarate drug product labeling. However, due to AstraZeneca Pharmaceuticals LP’s marketing exclusivity rights; this drug product is not labeled for such use in those adolescent patients.
2.2 Bipolar Disorder
Adults
Acute Treatment of Manic Episodes in Bipolar I Disorder
Dose Selection—When used as monotherapy or adjunct therapy (with lithium or divalproex), quetiapine fumarate tablets should be initiated in twice daily doses totaling 100 mg/day on Day 1, increased to 400 mg/day on Day 4 in increments of up to 100 mg/day in twice daily divided doses. Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of no greater than 200 mg/day. Data indicate that the majority of patients responded between 400 mg/day to 800 mg/day. The safety of doses above 800 mg/day has not been evaluated in clinical trials.
Acute Treatment of Depressive Episodes in Bipolar Disorder
Dose Selection— Quetiapine fumarate tablets should be administered once daily at bedtime to reach 300 mg/day by Day 4.
Recommended Dosing Schedule Day Day 1 Day 2 Day 3 Day 4Quetiapine fumarate tablets
50 mg
100 mg
200 mg
300 mg
In the clinical trials supporting effectiveness, the dosing schedule was 50 mg, 100 mg, 200 mg and 300 mg/day for Days 1 to 4 respectively. Patients receiving 600 mg increased to 400 mg on Day 5 and 600 mg on Day 8 (Week 1). Antidepressant efficacy was demonstrated with quetiapine fumarate tablets at both 300 mg and 600 mg; however, no additional benefit was seen in the 600 mg group.
Maintenance Treatment of Bipolar I Disorder
Maintenance of efficacy in bipolar I disorder was demonstrated with quetiapine fumarate tablets (administered twice daily totaling 400 to 800 mg per day) as adjunct therapy to lithium or divalproex. Generally, in the maintenance phase, patients continued on the same dose on which they were stabilized during the stabilization phase [see Clinical Studies (14.2)].
Children and Adolescents (10 to 17 years)
Pediatric dosing information in patients (10 to 17 years of age) with bipolar mania is approved for AstraZeneca Pharmaceuticals LP’s quetiapine fumarate drug product labeling. However, due to AstraZeneca Pharmaceuticals LP’s marketing exclusivity rights; this drug product is not labeled for such use in those pediatric patients.
2.3 Dosing in Special Populations
Consideration should be given to a slower rate of dose titration and a lower target dose in the elderly and in patients who are debilitated or who have a predisposition to hypotensive reactions [see Clinical Pharmacology (12)]. When indicated, dose escalation should be performed with caution in these patients.
Patients with hepatic impairment should be started on 25 mg/day. The dose should be increased daily in increments of 25 mg/day to 50 mg/day to an effective dose, depending on the clinical response and tolerability of the patient.
2.4 Reinitiation of Treatment in Patients Previously Discontinued
Although there are no data to specifically address reinitiation of treatment, it is recommended that when restarting patients who have had an interval of less than one week off quetiapine fumarate tablets, titration of quetiapine fumarate tablet is not required and the maintenance dose may be reinitiated. When restarting therapy of patients who have been off quetiapine fumarate tablets for more than one week, the initial titration schedule should be followed.
2.5 Switching from Antipsychotics
There are no systematically collected data to specifically address switching patients with schizophrenia from antipsychotics to quetiapine fumarate tablets, or concerning concomitant administration with antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients with schizophrenia from depot antipsychotics, if medically appropriate, initiate quetiapine fumarate tablets therapy in place of the next scheduled injection. The need for continuing existing EPS medication should be re-evaluated periodically.
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![Fludeoxyglucose F-18 Injection, Solution [Precision Nuclear Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=37971502-e292-463e-ad02-b8bd277dcf7c&name=cep-500mg-100cap.jpg)
Fludeoxyglucose F-18
Cephalexin is administered orally.
Adults — The adult dosage ranges from 1 to 4 g daily in divided doses. The 333 mg and 750 mg strengths should be administered such that the daily dose is within 1 to 4 grams per day. The usual adult dose is 250 mg every 6 hours. For the following infections, a dosage of 500 mg may be administered every 12 hours: streptococcal pharyngitis, skin and skin structure infections, and uncomplicated cystitis in patients over 15 years of age. Cystitis therapy should be continued for 7 to 14 days. For more severe infections or those caused by less susceptible organisms, larger doses may be needed. If daily doses of cephalexin greater than 4 g are required, parenteral cephalosporins, in appropriate doses, should be considered.
Pediatric Patients — The usual recommended daily dosage for pediatric patients is 25 to 50 mg/kg in divided doses. For streptococcal pharyngitis in patients over 1 year of age and for skin and skin structure infections, the total daily dose may be divided and administered every 12 hours.
In severe infections, the dosage may be doubled.
In the therapy of otitis media, clinical studies have shown that a dosage of 75 to 100 mg/kg/day in 4 divided doses is required.
In the treatment of β-hemolytic streptococcal infections, a therapeutic dosage of Cephalexin should be administered for at least 10 days.
-
Flu And Severe Cold And Cough Nighttime
Dosage should be adjusted according to severity of pain and response of the patient.The usual adult dosage is:
Single Doses Maximum Range 24-Hour Dose Codeine Phosphate 15mg to 60mg 360 mg Acetaminophen 300 mg to 1000 mg 4000 mgThe usual dose of codeine phosphate in children is 0.5 mg/kg.
Doses may be repeated up to every 4 hours.
The prescriber must determine the number of tablets per dose, and the maximum number of tablets per 24 hours, based upon the above dosage guidance. This information should be conveyed in the prescription.
It should be kept in mind, however, that tolerance to codeine can develop with continued use and that the incidence of untoward effects is dose related. Adult doses of codeine higher than 60 mg fail to give commensurate relief of pain but merely prolong analgesia and are associated with an appreciably increased incidence of undesirable side effects. Equivalently high doses in children would have similar effects.
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![Chlorhexidine Gluconate Rinse [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=f2d2677e-8bd1-4c1c-8991-ea07009490d5&name=f2d2677e-8bd1-4c1c-8991-ea07009490d5-02.jpg)
Chlorhexidine Gluconate Rinse
Chlorhexidine Gluconate Oral Rinse, 0.12% therapy should be initiated directly following a dental prophylaxis. Patients using Chlorhexidine Gluconate Oral Rinse, 0.12% should be reevaluated and given a thorough prophylaxis at intervals no longer than six months.
Recommended use is twice daily oral rinsing for 30 seconds, morning and evening after toothbrushing. Usual dosage is 1/2 fl oz (marked in cup) of undiluted Chlorhexidine Gluconate Oral Rinse, 0.12%. Patients should be instructed to not rinse with water or other mouthwashes, brush teeth or eat immediately after using Chlorhexidine Gluconate Oral Rinse, 0.12%. Chlorhexidine Gluconate Oral Rinse, 0.12% is not intended for ingestion and should be expectorated after rinsing.
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![Folic Acid Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=bb310224-d5b6-4151-87e8-803bdce459c1&name=bb310224-d5b6-4151-87e8-803bdce459c1-02.jpg)
Folic Acid
Oral administration is preferred. Although most patients with malabsorption cannot absorb food folates, they are able to absorb folic acid, USP given orally. Parenteral administration is not advocated but may be necessary in some individuals (e.g., patients receiving parenteral or enteral alimentation). Doses greater than 0.1 mg should not be used unless anemia due to vitamin B12 deficiency has been ruled out or is being adequately treated with a cobalamin. Daily doses greater than 1 mg do not enhance the hematologic effect, and most of the excess is excreted unchanged in the urine.
The usual therapeutic dosage in adults and children (regard less of age) is up to 1 mg daily. Resistant cases may require larger doses.
When clinical symptoms have subsided and the blood picture has become normal, a daily maintenance level should be used, i.e., 0.1 mg for infants and up to 0.3 mg for children under 4 years of age, 0.4 mg for adults and children 4 or more years of age, and 0.8 mg for pregnant and lactating women, but never less than 0.1 mg/day. Patients should be kept under close supervision and adjustment of the maintenance level made if relapse appears imminent.
In the presence of alcoholism, hemolytic anemia, anticonvulsant therapy, or chronic infection, the maintenance level may need to be increased.
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![Proparacaine Hydrochloride Solution/ Drops [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=99db9629-5678-4471-8555-332064f4d3d4&name=99db9629-5678-4471-8555-332064f4d3d4-02.jpg)
Proparacaine Hydrochloride Solution Drops
Deep anesthesia as in cataract extraction:
Instill 1 drop every 5 to 10 minutes for 5 to 7 doses.
Removal of sutures:
Instill 1 or 2 drops 2 or 3 minutes before removal of stitches.
Removal of foreign bodies:
Instill 1 or 2 drops prior to operating.
Tonometry:
Instill 1 or 2 drops immediately before measurement
FOR OPHTHALMIC USE ONLY
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![Venlafaxine Hydrochloride Capsule, Extended Release [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=1a666faf-d9fa-4ed7-8d78-8372c024368f&name=1a666faf-d9fa-4ed7-8d78-8372c024368f-02.jpg)
Venlafaxine Hydrochloride
Venlafaxine hydrochloride extended-release capsules should be administered in a single dose with food either in the morning or in the evening at approximately the same time each day. Each capsule should be swallowed whole with fluid and not divided, crushed, chewed, or placed in water, or it may be administered by carefully opening the capsule and sprinkling the entire contents on a spoonful of applesauce. This drug/food mixture should be swallowed immediately without chewing and followed with a glass of water to ensure complete swallowing of the pellets.
Initial Treatment
Major Depressive Disorder
For most patients, the recommended starting dose for venlafaxine hydrochloride extended-release capsules is 75 mg/day, administered in a single dose. In the clinical trials establishing the efficacy of venlafaxine hydrochloride extended-release capsules in moderately depressed outpatients, the initial dose of venlafaxine was 75 mg/day. For some patients, it may be desirable to start at 37.5 mg/day for 4 to 7 days, to allow new patients to adjust to the medication before increasing to 75 mg/day. While the relationship between dose and antidepressant response for venlafaxine hydrochloride extended-release capsules has not been adequately explored, patients not responding to the initial 75 mg/day dose may benefit from dose increases to a maximum of approximately 225 mg/day. Dose increases should be in increments of up to 75 mg/day, as needed, and should be made at intervals of not less than 4 days, since steady state plasma levels of venlafaxine and its major metabolites are achieved in most patients by day 4. In the clinical trials establishing efficacy, upward titration was permitted at intervals of 2 weeks or more; the average doses were about 140 to 180 mg/day (see Clinical Trials under CLINICAL PHARMACOLOGY).
It should be noted that, while the maximum recommended dose for moderately depressed outpatients is also 225 mg/day for venlafaxine hydrochloride tablets (immediate release), more severely depressed inpatients in one study of the development program for that product responded to a mean dose of 350 mg/day (range of 150 to 375 mg/day). Whether or not higher doses of venlafaxine hydrochloride extended-release capsules are needed for more severely depressed patients is unknown; however, the experience with venlafaxine hydrochloride extended-release capsule doses higher than 225 mg/day is very limited. (See PRECAUTIONS-General-Use in Patients with Concomitant Illness.)
Generalized Anxiety Disorder
For most patients, the recommended starting dose for venlafaxine hydrochloride extended-release capsules are 75 mg/day, administered in a single dose. In clinical trials establishing the efficacy of venlafaxine hydrochloride extended-release capsules in outpatients with Generalized Anxiety Disorder (GAD), the initial dose of venlafaxine was 75 mg/day. For some patients, it may be desirable to start at 37.5 mg/day for 4 to 7 days, to allow new patients to adjust to the medication before increasing to 75 mg/day. Although a dose-response relationship for effectiveness in GAD was not clearly established in fixed-dose studies, certain patients not responding to the initial 75 mg/day dose may benefit from dose increases to a maximum of approximately 225 mg/day. Dose increases should be in increments of up to 75 mg/day, as needed, and should be made at intervals of not less than 4 days. (See the Use in Patients with Concomitant Illness section of PRECAUTIONS.)
Social Anxiety Disorder (Social Phobia)
The recommended dose is 75 mg/day, administered in a single dose. There was no evidence that higher doses confer any additional benefit. (See the Use in Patients with Concomitant Illness section of PRECAUTIONS.)
Panic Disorder
It is recommended that initial single doses of 37.5 mg/day of venlafaxine hydrochloride extended-release capsules be used for 7 days. In clinical trials establishing the efficacy of venlafaxine hydrochloride extended-release capsules in outpatients with panic disorder, initial doses of 37.5 mg/day for 7 days were followed by doses of 75 mg/day and subsequent weekly dose increases of 75 mg/day to a maximum dose of 225 mg/day. Although a dose-response relationship for effectiveness in patients with panic disorder was not clearly established in fixed-dose studies, certain patients not responding to 75 mg/day may benefit from dose increases to a maximum of approximately 225 mg/day. Dose increases should be in increments of up to 75 mg/day, as needed, and should be made at intervals of not less than 7 days. (See the Use in Patients with Concomitant Illness section of PRECAUTIONS.)
Switching Patients from Venlafaxine Hydrochloride Tablets
Depressed patients who are currently being treated at a therapeutic dose with venlafaxine hydrochloride tablets (immediate release) may be switched to venlafaxine hydrochloride extended-release capsules at the nearest equivalent dose (mg/day), eg, 37.5 mg venlafaxine two-times-a-day to 75 mg venlafaxine hydrochloride extended-release capsules once daily. However, individual dosage adjustments may be necessary.
Switching a Patient To or From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders
At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with venlafaxine hydrochloride extended-release capsules. Conversely, at least 7 days should be allowed after stopping venlafaxine hydrochloride extended-release capsules before starting an MAOI intended to treat psychiatric disorders (see CONTRAINDICATIONS).
Use of Venlafaxine Hydrochloride Extended-Release Capsules With Other MAOls, Such as Linezolid or Methylene Blue
Do not start venlafaxine hydrochloride extended-release capsules in a patient who is being treated with linezolid or intravenous methylene blue because there is increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered (see CONTRAINDICATIONS).
In some cases, a patient already receiving therapy with venlafaxine hydrochloride extended-release capsules may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, venlafaxine hydrochloride extended-release capsules should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for 7 days or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with venlafaxine hydrochloride extended-release capsules may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue (see WARNINGS).
The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with venlafaxine hydrochloride extended-release capsules is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use (see WARNINGS).
Special Populations
Treatment of Pregnant Women During the Third Trimester
Neonates exposed to venlafaxine hydrochloride extended-release capsules, other SNRIs, or SSRIs, late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding (see PRECAUTIONS). When treating pregnant women with venlafaxine hydrochloride extended-release capsules during the third trimester, the physician should carefully consider the potential risks and benefits of treatment.
Patients with Hepatic Impairment
Given the decrease in clearance and increase in elimination half-life for both venlafaxine and ODV that is observed in patients with hepatic cirrhosis and mild and moderate hepatic impairment compared with normal subjects (see CLINICAL PHARMACOLOGY), it is recommended that the total daily dose be reduced by 50% in patients with mild to moderate hepatic impairment. Since there was much individual variability in clearance between subjects with cirrhosis, it may be necessary to reduce the dose even more than 50%, and individualization of dosing may be desirable in some patients.
Patients with Renal Impairment
Given the decrease in clearance for venlafaxine and the increase in elimination half-life for both venlafaxine and ODV that is observed in patients with renal impairment (GFR = 10 to 70 mL/min) compared with normal subjects (see CLINICAL PHARMACOLOGY), it is recommended that the total daily dose be reduced by 25% to 50%. In patients undergoing hemodialysis, it is recommended that the total daily dose be reduced by 50%. Because there was much individual variability in clearance between patients with renal impairment, individualization of dosage may be desirable in some patients.
Elderly Patients
No dose adjustment is recommended for elderly patients solely on the basis of age. As with any drug for the treatment of major depressive disorder, Generalized Anxiety Disorder, Social Anxiety Disorder, or panic disorder, however, caution should be exercised in treating the elderly. When individualizing the dosage, extra care should be taken when increasing the dose.
Maintenance Treatment
There is no body of evidence available from controlled trials to indicate how long patients with major depressive disorder, Generalized Anxiety Disorder, Social Anxiety Disorder, or panic disorder, should be treated with venlafaxine hydrochloride extended-release capsules.
It is generally agreed that acute episodes of major depressive disorder require several months or longer of sustained pharmacological therapy beyond response to the acute episode. In one study, in which patients responding during 8 weeks of acute treatment with venlafaxine hydrochloride extended-release capsules were assigned randomly to placebo or to the same dose of venlafaxine hydrochloride extended-release capsules (75, 150, or 225 mg/day, qAM) during 26 weeks of maintenance treatment as they had received during the acute stabilization phase, longer-term efficacy was demonstrated. A second longer-term study has demonstrated the efficacy of venlafaxine hydrochloride tablets in maintaining a response in patients with recurrent major depressive disorder who had responded and continued to be improved during an initial 26 weeks of treatment and were then randomly assigned to placebo or venlafaxine hydrochloride tablets for periods of up to 52 weeks on the same dose (100 to 200 mg/day, on a b.i.d. schedule) (see Clinical Trials under CLINICAL PHARMACOLOGY). Based on these limited data, it is not known whether or not the dose of venlafaxine hydrochloride extended-release capsules needed for maintenance treatment is identical to the dose needed to achieve an initial response. Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment.
In patients with Generalized Anxiety Disorder, venlafaxine hydrochloride extended-release capsules have been shown to be effective in 6-month clinical trials. The need for continuing medication in patients with GAD who improve with venlafaxine hydrochloride extended-release capsule treatment should be periodically reassessed.
In patients with Social Anxiety Disorder, venlafaxine hydrochloride extended-release capsules have been shown to be effective in a 6-month clinical trial. The need for continuing medication in patients with Social Anxiety Disorder who improve with venlafaxine hydrochloride extended-release capsule treatment should be periodically reassessed.
In a study of panic disorder in which patients responding during 12 weeks of acute treatment with venlafaxine hydrochloride extended-release capsules were assigned randomly to placebo or to the same dose of venlafaxine hydrochloride extended-release capsules (75, 150, or 225 mg/day), patients continuing venlafaxine hydrochloride extended-release capsules experienced a significantly longer time to relapse than patients randomized to placebo. The need for continuing medication in patients with panic disorder who improve with venlafaxine hydrochloride extended-release capsules treatment should be periodically reassessed.
Discontinuing Venlafaxine Hydrochloride Extended-Release Capsules
Symptoms associated with discontinuation of venlafaxine hydrochloride extended-release capsules, other SNRIs, and SSRIs, have been reported (see PRECAUTIONS). Patients should be monitored for these symptoms when discontinuing treatment. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate. In clinical trials with venlafaxine hydrochloride extended-release capsules, tapering was achieved by reducing the daily dose by 75 mg at 1 week intervals. Individualization of tapering may be necessary.
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![Gavilax (Polyethylene Glycol 3350) Powder, For Solution [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=10593ae1-02ac-4ae9-b9e1-9ad37409b82c&name=e733babc-7065-4cbf-ab6a-df19c3d8af63-01.jpg)
Gavilax
• you have rectal bleeding or your nausea, bloating, cramping or abdominal pain gets worse. These may be signs of a serious condition. • you get diarrhea • you need to use a laxative for longer than 1 week
If pregnant or breast-feeding, ask a health professional before use.
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![Olay Total Effects Pore Minimizing Cc Broadspectrum Spf 15 Medium To Deep (Homosalate, Octisalate, And Octocrylene) Lotion [Procter & Gamble Manufacturing Company]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=50f7b453-d064-4308-a3f4-e035be2046f9&name=pantoprazole-03.jpg)
Olay Total Effects Pore Minimizing Cc Broadspectrum Spf 15 Medium To Deep
2.1 Recommended Dosing Schedule
Pantoprazole sodium is supplied as delayed-release tablets. The recommended dosages are outlined in Table 1.
Table 1: Recommended Dosing Schedule for Pantoprazole Sodium Delayed-Release Tablets Indication Dose Frequency * For adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium may be considered. † Dosage regimens should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 240 mg daily have been administered.Short-Term Treatment of Erosive Esophagitis Associated With GERD
Adults
40 mg
Once daily for up to 8 weeks*
Children (5 years and older)
≥ 15 kg to < 40 kg
20 mg
Once daily for up to 8 weeks
≥ 40 kg
40 mg
Maintenance of Healing of Erosive Esophagitis
Adults
40 mg
Once daily
Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome
Adults
40 mg
Twice daily†
2.2 Administration Instructions
Directions for method of administration for each dosage form are presented in Table 2.
Table 2: Administration Instructions Formulation Route Instructions* * Patients should be cautioned that Pantoprazole Sodium Delayed-Release Tablets should not be split, chewed, or crushed.Delayed-Release Tablets
Oral
Swallowed whole, with or without food
Pantoprazole Sodium Delayed-Release Tablets
Pantoprazole Sodium Delayed-Release Tablets should be swallowed whole, with or without food in the stomach. If patients are unable to swallow a 40 mg tablet, two 20 mg tablets may be taken. Concomitant administration of antacids does not affect the absorption of Pantoprazole Sodium Delayed-Release Tablets.
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![Pantoprazole Sodium Tablet, Delayed Release [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=03a78883-ef93-4968-95dd-f241ede73696&name=f9bdd283-ac31-47a8-9ed0-c2e7d524ff0d-02.jpg)
Pantoprazole Sodium
2.1 Recommended Dosing Schedule
Pantoprazole is supplied as delayed-release tablets. The recommended dosages are outlined in Table 1.
Table 1: Recommended Dosing Schedule for Pantoprazole
Indication
Dose
Frequency
Short-Term Treatment of Erosive Esophagitis Associated With GERD
Adults
40 mg
Once daily for up to 8 weeks*
Children (5 years and older) ≥ 15 kg to < 40 kg ≥ 40 kg
20 mg40 mg
Once daily for up to 8 weeks
Maintenance of Healing of Erosive Esophagitis
Adults
40 mg
Once daily
Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome
Adults
40 mg
Twice daily**
* For adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole may be considered. ** Dosage regimens should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 240 mg daily have been administered.
2.2 Administration Instructions
Directions for method of administration for pantoprazole sodium delayed-release tablets are presented in Table 2.
Table 2: Administration Instructions
Formulation
Route
Instructions*
Delayed-Release Tablets
Oral
Swallowed whole, with or without food
* Patients should be cautioned that Pantoprazole Sodium Delayed-Release Tablets should not be split, chewed, or crushed.
Pantoprazole Sodium Delayed-Release Tablets USP Pantoprazole sodium delayed-release tablets USP should be swallowed whole, with or without food in the stomach. If patients are unable to swallow a 40 mg tablet, two 20 mg tablets may be taken. Concomitant administration of antacids does not affect the absorption of pantoprazole sodium delayed‑release tablets USP.
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![Pantoprazole Sodium Tablet, Delayed Release [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=8ff2fb38-c13d-4863-98e2-1fcbdadb1d15&name=0696e79f-4411-41ca-9d5a-6b3e47501a94-05.jpg)
Pantoprazole Sodium
2.1 Recommended Dosing Schedule
Pantoprazole sodium delayed-release is supplied as delayed-release tablets. The recommended dosages are outlined in Table 1.
Table 1: Recommended Dosing Schedule for Pantoprazole Sodium Delayed-Release Tablets Indication Dose Frequency * For adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium delayed-release may be considered. ** Dosage regimens should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 240 mg daily have been administered.Short-Term Treatment of Erosive Esophagitis Associated With GERD
Adults
40 mg
Once daily for up to 8 weeks*
Children (5 years and older)
≥ 15 kg to < 40 kg
20 mg
Once daily for up to 8 weeks
≥ 40 kg
40 mg
Maintenance of Healing of Erosive Esophagitis
Adults
40 mg
Once daily
Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome
Adults
40 mg
Twice daily**
2.2 Administration Instructions
Directions for method of administration for each dosage form are presented in Table 2.
Table 2: Administration Instructions Formulation Route Instructions* * Patients should be cautioned that pantoprazole sodium delayed-release tablets MUST NOT BE SPLIT, CHEWED, OR CRUSHED before administration.Delayed-Release Tablets
Oral
Swallowed whole, with or without food
Pantoprazole sodium delayed-release tablets should be swallowed whole, with or without food in the stomach. If patients are unable to swallow a 40 mg tablet, two 20 mg tablets may be taken. Concomitant administration of antacids does not affect the absorption of pantoprazole sodium delayed-release tablets.
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![Tamsulosin Hydrochloride Capsule [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=6fb8a408-8e63-41f0-adc3-ddac62b64503&name=6fb8a408-8e63-41f0-adc3-ddac62b64503-07.jpg)
Tamsulosin Hydrochloride
Tamsulosin hydrochloride capsules 0.4 mg once daily is recommended as the dose for the treatment of the signs and symptoms of BPH. It should be administered approximately one-half hour following the same meal each day. For those patients who fail to respond to the 0.4 mg dose after 2 to 4 weeks of dosing, the dose of tamsulosin hydrochloride capsules can be increased to 0.8 mg once daily. Tamsulosin hydrochloride capsules 0.4 mg should not be used in combination with strong inhibitors of CYP3A4 (e.g., ketoconazole) [see Warnings and Precautions (5.2)]. If tamsulosin hydrochloride capsules administration is discontinued or interrupted for several days at either the 0.4 mg or 0.8 mg dose, therapy should be started again with the 0.4 mg once-daily dose.
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![Pantoprazole Sodium Tablet, Delayed Release [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=0cc892c0-d32d-4622-96c9-8948e61d7c39&name=8a3f2fd8-d8a0-4307-85b6-ff9217b54324-02.jpg)
Pantoprazole Sodium
2.1 Recommended Dosing Schedule
Pantoprazole sodium is supplied as delayed-release tablets. The recommended dosages are outlined in Table 1.
Table 1: Recommended Dosing Schedule for Pantoprazole Sodium Delayed-Release Tablets * For adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium delayed-release tablets may be considered.** Dosage regimens should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 240 mg daily have been administered.Indication
Dose
Frequency
Short-Term Treatment of Erosive Esophagitis Associated With GERD
Adults
40 mg
Once daily for up to 8 weeks*
Children (5 years and older)
≥ 15 kg to < 40 kg
20 mg
Once daily for up to 8 weeks
≥ 40 kg
40 mg
Maintenance of Healing of Erosive Esophagitis
Adults
40 mg
Once daily
Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome
Adults
40 mg
Twice daily**
2.2 Administration Instructions
Directions for method of administration of pantoprazole sodium delayed-release tablets are presented in Table 2.
Table 2: Administration Instructions * Patients should be cautioned that pantoprazole sodium delayed-release tablets should not be split, chewed, or crushed.Formulation
Route
Instructions*
Delayed-Release Tablets
Oral
Swallowed whole, with or without food
Pantoprazole sodium delayed-release tablets should be swallowed whole, with or without food in the stomach. If patients are unable to swallow a 40 mg tablet, two 20 mg tablets may be taken. Concomitant administration of antacids does not affect the absorption of pantoprazole sodium delayed-release tablets.
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![Diethylpropion Hydrochloride Er (Diethylpropion Hydrochloride) Tablet, Extended Release [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=4bf6ac3d-78e9-4110-809b-791a36c11622&name=4bf6ac3d-78e9-4110-809b-791a36c11622-02.jpg)
Diethylpropion Hydrochloride Er
Diethylpropion Hydrochloride Extended Release Tablets, 75 mg:
One extended-release 75 mg tablet daily, swallowed whole, in midmorning.
Geriatric use
This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. (See PRECAUTIONS, Geriatric Use.)
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![Pantoprazole Sodium Tablet, Delayed Release [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=74c806da-aee3-46ed-a75a-713f363a2bc4&name=pantoprazolesodium-figure-04.jpg)
Pantoprazole Sodium
2.1 Recommended Dosing Schedule
Pantoprazole sodium is supplied as delayed-release tablets. The recommended dosages are outlined in Table 1.
Table 1: Recommended Dosing Schedule for Pantoprazole Sodium Delayed-Release Tablets * For adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium delayed-release tablets may be considered. ** Dosage regimens should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 240 mg daily have been administered.Indication
Dose
Frequency
Short-Term Treatment of Erosive Esophagitis Associated With GERD
Adults
40 mg
Once daily for up to 8 weeks*
Children (5 years and older) ≥ 15 kg to < 40 kg ≥ 40 kg
20 mg 40 mg
Once daily for up to 8 weeks
Maintenance of Healing of Erosive Esophagitis
Adults
40 mg
Once daily
Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome
Adults
40 mg
Twice daily**
2.2 Administration Instructions
Directions for method of administration are presented in Table 2.
Table 2: Administration Instructions * Patients should be cautioned that pantoprazole sodium delayed-release tablets should not be split, chewed, or crushed.Formulation
Route
Instructions*
Delayed-Release Tablets
Oral
Swallowed whole, with or without food
Pantoprazole sodium delayed-release tablets
Pantoprazole sodium delayed-release tablets should be swallowed whole, with or without food in the stomach. If patients are unable to swallow a 40 mg tablet, two 20 mg tablets may be taken. Concomitant administration of antacids does not affect the absorption of pantoprazole sodium delayed-release tablets.
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![Montelukast Sodium Tablet, Chewable [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=030edd89-4d48-4741-bebc-e22ec053613a&name=030edd89-4d48-4741-bebc-e22ec053613a-04.jpg)
Montelukast Sodium
2.1 Asthma
Montelukast sodium should be taken once daily in the evening. The following doses are recommended:
For adults and adolescents 15 years of age and older: one 10‑mg tablet.
For pediatric patients 6 to 14 years of age: one 5‑mg chewable tablet.
For pediatric patients 2 to 5 years of age: one 4‑mg chewable tablet.
Safety and effectiveness in pediatric patients less than 12 months of age with asthma have not been established.
There have been no clinical trials in patients with asthma to evaluate the relative efficacy of morning versus evening dosing. The pharmacokinetics of montelukast are similar whether dosed in the morning or evening. Efficacy has been demonstrated for asthma when montelukast was administered in the evening without regard to time of food ingestion.
2.2 Exercise-Induced Bronchoconstriction (EIB) in Patients 15 Years of Age and Older
For prevention of EIB, a single 10 mg dose of montelukast should be taken at least 2 hours before exercise. An additional dose of montelukast should not be taken within 24 hours of a previous dose. Patients already taking montelukast sodium daily for another indication (including chronic asthma) should not take an additional dose to prevent EIB. All patients should have available for rescue a short-acting β‑agonist. Safety and effectiveness in patients younger than 15 years of age have not been established. Daily administration of montelukast sodium for the chronic treatment of asthma has not been established to prevent acute episodes of EIB.
Pediatric use information for patients ages 6 to 14 years of age for acute prevention of exercise-induced bronchoconstriction (EIB) is approved for Merck Sharp & Dohme Corp’s montelukast tablet products. However, due to Merck Sharp & Dohme Corp’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
2.3 Allergic Rhinitis
For allergic rhinitis, montelukast sodium should be taken once daily. Efficacy was demonstrated for seasonal allergic rhinitis when montelukast was administered in the morning or the evening without regard to time of food ingestion. The time of administration may be individualized to suit patient needs.
The following doses for the treatment of symptoms of seasonal allergic rhinitis are recommended:
For adults and adolescents 15 years of age and older: one 10‑mg tablet.
For pediatric patients 6 to 14 years of age: one 5‑mg chewable tablet.
For pediatric patients 2 to 5 years of age: one 4‑mg chewable tablet.
Safety and effectiveness in pediatric patients younger than 2 years of age with seasonal allergic rhinitis have not been established.
The following doses for the treatment of symptoms of perennial allergic rhinitis are recommended:
For adults and adolescents 15 years of age and older: one 10‑mg tablet.
For pediatric patients 6 to 14 years of age: one 5‑mg chewable tablet.
For pediatric patients 2 to 5 years of age: one 4‑mg chewable tablet.
Safety and effectiveness in pediatric patients younger than 6 months of age with perennial allergic rhinitis have not been established.
2.4 Asthma and Allergic Rhinitis
Patients with both asthma and allergic rhinitis should take only one montelukast sodium dose daily in the evening.
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![Tamsulosin Hydrochloride Capsule [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=feebbae8-f226-45b2-b284-edf43b178fbb&name=label-30crc.jpg)
Tamsulosin Hydrochloride
Tamsulosin hydrochloride capsules 0.4 mg once daily is recommended as the dose for the treatment of the signs and symptoms of BPH. It should be administered approximately one-half hour following the same meal each day. For those patients who fail to respond to the 0.4 mg dose after 2 to 4 weeks of dosing, the dose of tamsulosin hydrochloride capsules can be increased to 0.8 mg once daily. Tamsulosin hydrochloride capsules 0.4 mg should not be used in combination with strong inhibitors of CYP3A4 (e.g., ketoconazole) [see Warnings and Precautions (5.2)].If tamsulosin hydrochloride capsules administration is discontinued or interrupted for several days at either the 0.4 mg or 0.8 mg dose, therapy should be started again with the 0.4 mg once-daily dose.
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![Cefuroxime Axetil Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=0bfa8845-9664-450d-b268-5dbaa0301c40&name=cefuroximeaxitel-figure-02.jpg)
Cefuroxime Axetil
NOTE: CEFUROXIME AXETIL TABLETS AND CEFUROXIME AXETIL FOR ORAL SUSPENSION ARE NOT BIOEQUIVALENT AND ARE NOT SUBSTITUTABLE ON A MILLIGRAM PER MILLIGRAM BASIS (see CLINICAL PHARMACOLOGY ).
Table 4: Cefuroxime Axetil Tablets(May be administered without regard to meals.) Population/Infection Dosage Duration (days) * The safety and effectiveness of cefuroxime axetil tablets administered for less than 10 days in patients with acute exacerbations of chronic bronchitis have not been established.Adolescents and Adults (13 years and older)
Pharyngitis/tonsillitis
250 mg b.i.d.
10
Acute bacterial maxillary sinusitis
250 mg b.i.d.
10
Acute bacterial exacerbations of chronic bronchitis
250 or 500 mg b.i.d.
10*
Secondary bacterial infections of acute bronchitis
250 or 500 mg b.i.d.
5 - 10
Uncomplicated skin and skin-structure infections
250 or 500 mg b.i.d.
10
Uncomplicated urinary tract infections
250 mg b.i.d.
7 – 10
Uncomplicated gonorrhea
1000 mg once
single dose
Early Lyme disease
500 mg b.i.d.
20
Pediatric Patients (who can swallow tablets whole)
Acute otitis media
250 mg b.i.d.
10
Acute bacterial maxillary sinusitis
250 mg b.i.d.
10
Patients With Renal Failure:
The safety and efficacy of cefuroxime axetil in patients with renal failure have not been established. Since cefuroxime is renally eliminated, its half-life will be prolonged in patients with renal failure.
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![Cefuroxime Axetil Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=2722942a-7225-43bd-8814-52147fe6f7f2&name=cefuroxime-fig3.jpg)
Cefuroxime Axetil
NOTE: CEFUROXIME AXETIL TABLETS AND CEFUROXIME AXETIL FOR ORAL SUSPENSION ARE NOT BIOEQUIVALENT AND ARE NOT SUBSTITUTABLE ON A MILLIGRAM-PER-MILLIGRAM BASIS (SEE CLINICAL PHARMACOLOGY).
Table 4. Cefuroxime Axetil Tablets (May be administered without regard to meals.) *The safety and effectiveness of cefuroxime axetil administered for less than 10 days in patients with acute exacerbations of chronic bronchitis have not been established.Population/Infection
Dosage
Duration(days)
Adolescents and Adults (13 years and older)
Pharyngitis/tonsillitis
250 mg b.i.d.
10
Acute bacterial maxillary sinusitis
250 mg b.i.d.
10
Acute bacterial exacerbations of chronic bronchitis
250 or 500 mg b.i.d.
10*
Secondary bacterial infections of acute bronchitis
250 or 500 mg b.i.d.
5-10
Uncomplicated skin and skin‑-structure infections
250 or 500 mg b.i.d.
10
Uncomplicated urinary tract infections
250 mg b.i.d.
7-10
Uncomplicated gonorrhea
1,000 mg once
single dose
Early Lyme disease
500 mg b.i.d.
20
Pediatric Patients (who can swallow tablets whole)
Acute otitis media
250 mg b.i.d.
10
Acute bacterial maxillary sinusitis
250 mg b.i.d.
10
Patients With Renal Failure
The safety and efficacy of cefuroxime axetil in patients with renal failure have not been established. Since cefuroxime is renally eliminated, its half-life will be prolonged in patients with renal failure.
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![Neomycin And Polymyxin B Sulfates And Hydrocortisone (Neomycin Sulfate, Polymyxin B Sulfate And Hydrocortisone) Suspension/ Drops [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=f8dc2b6f-daf3-4a3a-b31f-b97e2f152eae&name=a5f50a91-45db-4de0-8cfb-dfd33da7475f-04.jpg)
Neomycin And Polymyxin B Sulfates And Hydrocortisone
Therapy with this product should be limited to 10 consecutive days.
The external auditory canal should be thoroughly cleansed and dried with a sterile cotton applicator.
For adults, 4 drops of the suspension should be instilled into the affected ear 3 to 4 times daily. For infants and children, 3 drops are suggested because of the smaller capacity of the ear canal.
The patient should lie with the affected ear upward and then the drops should be instilled. This position should be maintained for 5 minutes to facilitate penetration of the drops into the ear canal. Repeat, if necessary, for the opposite ear.
If preferred, a cotton wick may be inserted into the canal and then the cotton may be saturated with the suspension. This wick should be kept moist by adding further suspension every 4 hours. The wick should be replaced at least once every 24 hours.
SHAKE WELL BEFORE USING.
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![Prochlorperazine Maleate Tablet, Film Coated [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=516481e0-cff2-401c-82cb-637cd54b6593&name=516481e0-cff2-401c-82cb-637cd54b6593-02.jpg)
Prochlorperazine Maleate
Adults
(For children’s dosage and administration, see below.) Dosage should be increased more gradually in debilitated or emaciated patients.
Elderly Patients
In general, dosages in the lower range are sufficient for most elderly patients. Since they appear to be more susceptible to hypotension and neuromuscular reactions, such patients should be observed closely. Dosage should be tailored to the individual, response carefully monitored, and dosage adjusted accordingly. Dosage should be increased more gradually in elderly patients.
1. To Control Severe Nausea and Vomiting
Adjust dosage to the response of the individual. Begin with the lowest recommended dosage.
Oral Dosage – Tablets
Usually one 5 mg or 10 mg tablet 3 or 4 times daily. Daily dosages above 40 mg should be used only in resistant cases.
2. In Adult Psychiatric Disorders
Adjust dosage to the response of the individual and according to the severity of the condition. Begin with the lowest recommended dose. Although response ordinarily is seen within a day or two, longer treatment is usually required before maximal improvement is seen.
Oral Dosage
Non-Psychotic Anxiety – Usual dosage is 5 mg 3 or 4 times daily. Do not administer in doses of more than 20 mg per day or for longer than 12 weeks.
Psychotic Disorders including Schizophrenia – In relatively mild conditions, as seen in private psychiatric practice or in outpatient clinics, dosage is 5 or 10 mg 3 or 4 times daily.
In moderate to severe conditions, for hospitalized or adequately supervised patients, usual starting dosage is 10 mg 3 or 4 times daily. Increase dosage gradually until symptoms are controlled or side effects become bothersome. When dosage is increased by small increments every 2 or 3 days, side effects either do not occur or are easily controlled. Some patients respond satisfactorily on 50 to 75 mg daily.
In more severe disturbances, optimum dosage is usually 100 to 150 mg daily.
Children
Do not use in pediatric surgery.
Children seem more prone to develop extrapyramidal reactions, even on moderate doses. Therefore, use lowest effective dosage. Tell parents not to exceed prescribed dosage, since the possibility of adverse reactions increases as dosage rises.
Occasionally the patient may react to the drug with signs of restlessness and excitement; if this occurs, do not administer additional doses. Take particular precaution in administering the drug to children with acute illnesses or dehydration (see under Dystonia).
1. Severe Nausea and Vomiting In Children
Prochlorperazine should not be used in pediatric patients under 20 pounds in weight or 2 years of age. It should not be used in conditions for which children’s dosages have not been established. Dosage and frequency of administration should be adjusted according to the severity of the symptoms and the response of the patient. The duration of activity following intramuscular administration may last up to 12 hours. Subsequent doses may be given by the same route if necessary.
Oral Dosage
More than 1 day’s therapy is seldom necessary.
Weight
Usual Dosage
Not to Exceed
under 20 lbs not recommended
20 to 29 lbs
2½ mg 1 or 2 times a day
7.5 mg per day
30 to 39 lbs
2½ mg 2 or 3 times a day
10 mg per day
40 to 85 lbs
2½ mg 3 times a day or
5 mg 2 times a day
15 mg per day
2. In Children with Schizophrenia
Oral Dosage
For children 2 to 12 years, starting dosage is 2-1/2 mg 2 or 3 times daily. Do not give more than 10 mg the first day. Then increase dosage according to patient’s response.
FOR AGES 2 to 5, total daily dosage usually does not exceed 20 mg.
FOR AGES 6 to 12, total daily dosage usually does not exceed 25 mg.
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![Prochlorperazine Maleate Tablet, Film Coated [Preferred Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=5cfd84b0-46a3-4379-9454-62f183370a76&name=6a98a1ea-d344-4655-9291-13cebf1b537b-03.jpg)
Prochlorperazine Maleate
Adults
(For children’s dosage and administration, see below.) Dosage should be increased more gradually in debilitated or emaciated patients.
Elderly Patients
In general, dosages in the lower range are sufficient for most elderly patients. Since they appear to be more susceptible to hypotension and neuromuscular reactions, such patients should be observed closely. Dosage should be tailored to the individual, response carefully monitored and dosage adjusted accordingly. Dosage should be increased more gradually in elderly patients.
1. To Control Severe Nausea and Vomiting
Adjust dosage to the response of the individual. Begin with the lowest recommended dosage.
Oral Dosage - Tablets
Usually one 5 mg or 10 mg tablet 3 or 4 times daily. Daily dosages above 40 mg should be used only in resistant cases.
2. In Adult Psychiatric Disorders
Adjust dosage to the response of the individual and according to the severity of the condition. Begin with the lowest recommended dose. Although response ordinarily is seen within a day or 2, longer treatment is usually required before maximal improvement is seen.
Oral Dosage
Non-Psychotic Anxiety – Usual dosage is 5 mg 3 or 4 times daily. Do not administer in doses of more than 20 mg per day or for longer than 12 weeks.
Psychotic Disorders including Schizophrenia – In relatively mild conditions, as seen in private psychiatric practice or in outpatient clinics, dosage is 5 or 10 mg 3 or 4 times daily.
In moderate to severe conditions, for hospitalized or adequately supervised patients, usual starting dosage is 10 mg 3 or 4 times daily. Increase dosage gradually until symptoms are controlled or side effects become bothersome. When dosage is increased by small increments every 2 or 3 days, side effects either do not occur or are easily controlled. Some patients respond satisfactorily on 50 to 75 mg daily.
In more severe disturbances, optimum dosage is usually 100 to 150 mg daily.
Children
Do not use in pediatric surgery.
Children seem more prone to develop extrapyramidal reactions, even on moderate doses. Therefore, use lowest effective dosage. Tell parents not to exceed prescribed dosage, since the possibility of adverse reactions increases as dosage rises.
Occasionally the patient may react to the drug with signs of restlessness and excitement; if this occurs, do not administer additional doses. Take particular precaution in administering the drug to children with acute illnesses or dehydration (see under Dystonia).
1. Severe Nausea and Vomiting in Children
Prochlorperazine should not be used in pediatric patients under 20 pounds in weight or 2 years of age. It should not be used in conditions for which children’s dosages have not been established. Dosage and frequency of administration should be adjusted according to the severity of the symptoms and the response of the patient. The duration of activity following intramuscular administration may last up to 12 hours. Subsequent doses may be given by the same route if necessary.
Oral Dosage
More than 1 day’s therapy is seldom necessary.
Weight
Usual Dosage
Not to Exceed
under 20 lbs not recommended
20 to 29 lbs
2.5 mg 1 or 2 times a day
7.5 mg per day
30 to 39 lbs
2.5 mg 2 or 3 times a day
10 mg per day
40 to 85 lbs
2.5 mg 3 times a day or 5 mg 2 times a day
15 mg per day
2. In Children With Schizophrenia
Oral Dosage
For children 2 to 12 years, starting dosage is 2.5 mg 2 or 3 times daily. Do not give more than 10 mg the first day. Then increase dosage according to patient’s response.
FOR AGES 2 to 5, total daily dosage usually does not exceed 20 mg.
FOR AGES 6 to 12, total daily dosage usually does not exceed 25 mg.
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![Neomycin And Polymyxin B Sulfates And Hydrocortisone (Neomycin Sulfate, Polymyxin B Sulfate And Hydrocortisone) Suspension [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=85f47a6f-bd76-4369-bcb4-e70281a0ec28&name=carton.jpg)
Neomycin And Polymyxin B Sulfates And Hydrocortisone
Therapy with this product should be limited to 10 consecutive days.
The external auditory canal should be thoroughly cleansed and dried with a sterile cotton applicator.
For adults, 4 drops of the suspension should be instilled into the affected ear 3 or 4 times daily. For infants and children, 3 drops are suggested because of the smaller capacity of the ear canal.
The patient should lie with the affected ear upward and then the drops should be instilled. This position should be maintained for 5 minutes to facilitate penetration of the drops into the ear canal. Repeat, if necessary, for the opposite ear. If preferred, a cotton wick may be inserted into the canal and then the cotton may be saturated with the suspension. This wick should be kept moist by adding further suspension every 4 hours. The wick should be replaced at least once every 24 hours.
SHAKE WELL BEFORE USING.
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![Prochlorperazine Maleate Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=572f5428-5978-4e3a-8877-ba514f382cc9&name=115_label.jpg)
Prochlorperazine Maleate
(For children’s dosage and administration, see below.) Dosage should be increased more gradually in debilitated or emaciated patients.
Elderly Patients: In general, dosages in the lower range are sufficient for most elderly patients. Since they appear to be more susceptible to hypotension and neuromuscular reac‑tions, such patients should be observed closely. Dosage should be tailored to the individual, response carefully moni‑tored and dosage adjusted accordingly. Dosage should be increased more gradually in elderly patients.
1.To Control Severe Nausea and Vomiting: Adjust dosage to the response of the individual. Begin with the lowest recommended dosage.Oral Dosage-Tablets: Usually one 5mg or 10mg tablet 3 or 4 times daily. Daily dosages above 40 mgs should be used only in resistant cases.
2.In Adult Psychiatric Disorders: Adjust dosage to the response of the individual and according to the severity of the condition. Begin with the lowest recom‑mended dose. Although response ordinarily is seen within a day or 2, longer treatment is usually required before maximal improvement is seen.Oral Dosage: Non-Psychotic Anxiety--Usual dosage is 5 mg 3 or4 times daily. Do not administer in doses of more than 20mg per day or for longer than 12 weeks.
Psychotic Disorders including Schizophrenia--Inrelatively mild conditions, as seen in private psychiatric practice or in out patient clinics, dosage is 5 or 10 mg 3 or 4 times daily.
In moderate to severe conditions, for hospitalized or adequate‑ly supervised patients, usual starting dosage is 10 mg 3 or 4 times daily. Increase dosage gradually until symptoms are con‑trolled or side effects become bothersome. When dosage is increased by small increments every 2 or 3 days, side effects either do not occur or are easily controlled. Some patients respond satisfactorily on 50 to 75mg daily. In more severe dis‑turbances, optimum dosage is usually 100 to 150mg daily.
DOSAGE AND ADMINISTRATION--CHILDREN
Do not use in pediatric surgery. Children seem more prone to develop extrapyramidal reac‑tions, even on moderate doses. Therefore, use lowest effec‑tive dosage. Tell parents not to exceed prescribed dosage, since the possibility for adverse reactions increases as dosage rises. Occasionally the patient may react to the drug with signs of restlessness and excitement; if this occurs, do not administer additional doses. Take particular precaution in administering the drug to children with acute illnesses or dehydration (see under Dystonias).
1. Severe Nausea and Vomiting in Children: Prochlorperazine should not be used in pediatric patients under 20 pounds in weight or 2 years of age. It should not be used in conditions for which children’s dosages have not been established. Dosage and frequency of administration should be adjusted according to the severity of the symptoms and the response of the patient. The duration of activity following intra‑muscular administration may last up to 12 hours. Subsequent doses may be given by the same route if necessary.
Oral Dosage: More than 1 day’s therapy is seldom necessary.
Weight
Usual Dosage
Not to Exceed
under 20 lbs not recommended
20 to 29 lbs
2½ mg 1 or 2 times a day
7.5 mg per day
30 to 39 lbs
2½ mg 2 or 3 times a day
10 mg per day
40 to 85 lbs
2½ mg 3 times a day or 5 mg 2 times a day
15 mg per day
2. Children with schizophrenia: Oral Dosage: For children 2 to 12 years, starting dosage is 21/2 mg 2 or 3 times daily. Do not give more than 10 mg the first day. Then increase dosage according to patient’s response.FOR AGES 2 to 5, total daily dosage usually does not exceed 20mg.FOR AGES 6 to 12, total daily dosage usually does not exceed 25mg.
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![Triamterene And Hydrochlorothiazide Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=b2d1fc09-f8f9-42d7-ae95-b447509062d9&name=triamterene-and-hctz-tabs-3.jpg)
Triamterene And Hydrochlorothiazide
Note: 37.5 mg/25 mg= 37.5 mg triamterene and 25 mg hydrochlorothiazide 75 mg/50 mg= 75 mg triamterene and 50 mg hydrochlorothiazide
The usual dosage of triamterene and hydrochlorothiazide as a tablet is 37.5 mg/25 mg or 75 mg/50 mg daily, given as a single dose, with appropriate monitoring of serum potassium (see WARNINGS). There is no experience with the use of more than 75 mg/50 mg daily of triamterene and hydrochlorothiazide. Clinical experience with the administration of 37.5 mg/25 mg of triamterene and hydrochlorothiazide twice daily in divided doses (rather than as a single dose) suggests an increased risk of electrolyte imbalance and renal dysfunction.
Patients receiving 50 mg of hydrochlorothiazide who become hypokalemic may be transferred to this 75 mg/50 mg product directly. Patients receiving 25 mg hydrochlorothiazide who become hypokalemic may be transferred to a 37.5 mg/25 mg product directly.
In patients requiring hydrochlorothiazide therapy and in whom hypokalemia cannot be risked, therapy may be initiated with 37.5 mg/25 mg of triamterene and hydrochlorothiazide. If an optimal blood pressure response is not obtained with 37.5 mg/25 mg triamterene and hydrochlorothiazide, the dose should be increased to 75 mg/50 mg daily as a single dose. If blood pressure still is not controlled, another antihypertensive agent may be added (see PRECAUTIONS: Drug Interactions).
Clinical studies have shown that patients taking less bioavailable formulations of triamterene and hydrochlorothiazide in daily doses of 25 mg to 50 mg hydrochlorothiazide and 50 mg to 100 mg of triamterene may be safely changed to 37.5 mg/25 mg of triamterene and hydrochlorothiazide daily. All patients changed from less bioavailable formulations to triamterene and hydrochlorothiazide tablets should be monitored clinically and for serum potassium after the transfer.
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![Hydrocodone Bitartrate And Acetaminophen Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=6ccf6d8d-b301-433d-aec0-396b5d3e14ad&name=hydrocodone-fig2.jpg)
Hydrocodone Bitartrate And Acetaminophen
Dosage should be adjusted according to the severity of the pain and the response of the patient. However, it should be kept in mind that tolerance to hydrocodone can develop with continued use and that the incidence of untoward effects is dose related.
5 mg/325 mg
The usual adult dosage is one or two tablets every four to six hours as needed for pain.
7.5 mg/325 mg
The usual adult dosage is one tablet every four to six hours as needed for pain. The total daily dosage should not exceed 6 tablets.
10 mg/325 mg
The usual adult dosage is one tablet every four to six hours as needed for pain. The total daily dosage should not exceed 6 tablets.
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![Glipizide Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=097424ef-612f-4bc2-809a-e5bb8eeae244&name=10mg-500btl.jpg)
Glipizide
There is no fixed dosage regimen for the management of diabetes mellitus with glipizide or any other hypoglycemic agent. In addition to the usual monitoring of urinary glucose, the patient's blood glucose must also be monitored periodically to determine the minimum effective dose for the patient; to detect primary failure, i.e., inadequate lowering of blood glucose at the maximum recommended dose of medication; and to detect secondary failure, i.e., loss of an adequate blood-glucose-lowering response after an initial period of effectiveness. Glycosylated hemoglobin levels may also be of value in monitoring the patient's response to therapy.
Short-term administration of glipizide may be sufficient during periods of transient loss of control in patients usually controlled well on diet.
In general, glipizide tablets should be given approximately 30 minutes before a meal to achieve the greatest reduction in postprandial hyperglycemia.
Initial Dose
The recommended starting dose is 5 mg, given before breakfast. Geriatric patients or those with liver disease may be started on 2.5 mg.
Titration
Dosage adjustments should ordinarily be in increments of 2.5 to 5 mg, as determined by blood glucose response. At least several days should elapse between titration steps. If response to a single dose is not satisfactory, dividing that dose may prove effective. The maximum recommended once daily dose is 15 mg. Doses above 15 mg should ordinarily be divided and given before meals of adequate caloric content. The maximum recommended total daily dose is 40 mg.
Maintenance
Some patients may be effectively controlled on a once-a-day regimen, while others show better response with divided dosing. Total daily doses above 15 mg should ordinarily be divided. Total daily doses above 30 mg have been safely given on a b.i.d. basis to long-term patients.
In elderly patients, debilitated or malnourished patients, and patients with impaired renal or hepatic function, the initial and maintenance dosing should be conservative to avoid hypoglycemic reactions (see PRECAUTIONS section).
Patients Receiving Insulin
As with other sulfonylurea-class hypoglycemics, many stable non-insulin-dependent diabetic patients receiving insulin may be safely placed on glipizide. When transferring patients from insulin to glipizide, the following general guidelines should be considered:
For patients whose daily insulin requirement is 20 units or less, insulin may be discontinued and glipizide therapy may begin at usual dosages. Several days should elapse between glipizide titration steps.
For patients whose daily insulin requirement is greater than 20 units, the insulin dose should be reduced by 50% and glipizide therapy may begin at usual dosages. Subsequent reductions in insulin dosage should depend on individual patient response. Several days should elapse between glipizide titration steps.
During the insulin withdrawal period, the patient should test urine samples for sugar and ketone bodies at least three times daily. Patients should be instructed to contact the prescriber immediately if these tests are abnormal. In some cases, especially when patient has been receiving greater than 40 units of insulin daily, it may be advisable to consider hospitalization during the transition period.
Patients Receiving Other Oral Hypoglycemic Agents
As with other sulfonylurea-class hypoglycemics, no transition period is necessary when transferring patients to glipizide. Patients should be observed carefully (1 to 2 weeks) for hypoglycemia when being transferred from longer half-life sulfonylureas (e.g., chlorpropamide) to glipizide due to potential overlapping of drug effect.
When colesevelam is coadministered with glipizide ER, maximum plasma concentration and total exposure to glipizide is reduced. Therefore, glipizide should be administered at least 4 hours prior to colesevelam.
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![Kirkland Signature Acetaminophen Adult Extra Strength (Acetaminophen) Tablet [Costco Wholesale Company]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=dc21a4f9-d8f3-4804-ba3e-a26cae143f26&name=d026018a-1f31-457a-994d-883653762087-04.jpg)
Kirkland Signature Acetaminophen Adult Extra Strength
Carefully consider the potential benefits and risks of ketoprofen capsules and other treatment options before deciding to use ketoprofen capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with ketoprofen capsules, the dose and frequency should be adjusted to suit an individual patient's needs.
Concomitant use of ketoprofen capsules and ketoprofen extended-release capsules is not recommended.
If minor side effects appear, they may disappear at a lower dose which may still have an adequate therapeutic effect. If well tolerated but not optimally effective, the dosage may be increased. Individual patients may show a better response to 300 mg of ketoprofen capsules daily as compared to 200 mg, although in well-controlled clinical trials patients on 300 mg did not show greater mean effectiveness. They did, however, show an increased frequency of upper- and lower-GI distress and headaches. It is of interest that women also had an increased frequency of these adverse effects compared to men. When treating patients with 300 mg/day, the physician should observe sufficient increased clinical benefit to offset potential increased risk.
In patients with mildly impaired renal function, the maximum recommended total daily dose of ketoprofen capsules is 150 mg. In patients with a more severe renal impairment (GFR less than 25 mL/min/1.73 m2 or end-stage renal impairment), the maximum total daily dose of ketoprofen capsules should not exceed 100 mg.
In elderly patients, renal function may be reduced with apparently normal serum creatinine and/or BUN levels. Therefore, it is recommended that the initial dosage of ketoprofen capsules should be reduced for patients over 75 years of age (see Geriatric Use).
It is recommended that for patients with impaired liver function and serum albumin concentration less than 3.5 g/dL, the maximum initial total daily dose of ketoprofen capsules should be 100 mg. All patients with metabolic impairment, particularly those with both hypoalbuminemia and reduced renal function, may have increased levels of free (biologically active) ketoprofen and should be closely monitored. The dosage may be increased to the range recommended for the general population, if necessary, only after good individual tolerance has been ascertained.
Because hypoalbuminemia and reduced renal function both increase the fraction of free drug (biologically active form), patients who have both conditions may be at greater risk of adverse effects. Therefore, it is recommended that such patients also be started on lower doses of ketoprofen capsules and closely monitored.
Rheumatoid Arthritis and Osteoarthritis
The recommended starting dose of ketoprofen capsules in otherwise healthy patients is 75 mg three times or 50 mg four times a day. Smaller doses of ketoprofen capsules should be utilized initially in small individuals or in debilitated or elderly patients. The recommended maximum daily dose of ketoprofen capsules is 300 mg/day.
Dosages higher than 300 mg/day of ketoprofen capsules are not recommended because they have not been studied. Concomitant use of ketoprofen capsules and ketoprofen extended-release capsules is not recommended. Relatively smaller people may need smaller doses.
As with other non-steroidal anti-inflammatory drugs, the predominant adverse effects of ketoprofen are gastrointestinal. To attempt to minimize these effects, physicians may wish to prescribe that ketoprofen capsules be taken with antacids, food, or milk. Although food delays the absorption of ketoprofen capsules (see CLINICAL PHARMACOLOGY), in most of the clinical trials ketoprofen was taken with food or milk.
Physicians may want to make specific recommendations to patients about when they should take ketoprofen capsules in relation to food and/or what patients should do if they experience minor GI symptoms associated with ketoprofen capsules.
Management of Pain and Dysmenorrhea
The usual dose of ketoprofen capsules recommended for mild-to-moderate pain and dysmenorrhea is 25 to 50 mg every 6 to 8 hours as necessary. A smaller dose should be utilized initially in small individuals, in debilitated or elderly patients, or in patients with renal or liver disease (see PRECAUTIONS). A larger dose may be tried if the patient’s response to a previous dose was less than satisfactory, but doses above 75 mg have not been shown to give added analgesia. Daily doses above 300 mg are not recommended because they have not been adequately studied. Because of its typical non-steroidal anti-inflammatory drug-side-effect profile, including as its principal adverse effect GI side effects (see WARNINGS and ADVERSE REACTIONS), higher doses of ketoprofen capsules should be used with caution and patients receiving them observed carefully.
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![Fluocinonide Cream [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=cb4cf79b-3521-4727-ae32-e61bc3786300&name=fluocinonide-03.jpg)
Fluocinonide
Fluocinonide Cream USP, 0.05%, Fluocinonide Cream USP, 0.05% (Emulsified Base), Fluocinonide Gel USP, 0.05% and Fluocinonide Ointment USP, 0.05% are generally applied to the affected area as a thin film from two to four times daily depending on the severity of the condition.
Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions.
If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.
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![Alendronate Sodium Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=de178171-a3a5-42c6-ad19-74e4668ab633&name=70mg-30btl.jpg)
Alendronate Sodium
2.1 Treatment of Osteoporosis in Postmenopausal Women
The recommended dosage is:
1. one 70 mg tablet once weekly or 2. one 10 mg tablet once daily2.2 Prevention of Osteoporosis in Postmenopausal Women
The recommended dosage is:
1. one 35 mg tablet once weekly or 2. one 5 mg tablet once daily2.3 Treatment to Increase Bone Mass in Men with Osteoporosis
The recommended dosage is:
1. one 70 mg tablet once weekly or 2. one 10 mg tablet once daily2.4 Treatment of Glucocorticoid-Induced Osteoporosis
The recommended dosage is one 5 mg (alendronate) tablet once daily, except for postmenopausal women not receiving estrogen, for whom the recommended dosage is one 10 mg (alendronate) tablet once daily.
2.5 Treatment of Paget's Disease of Bone
The recommended treatment regimen is 40 mg once a day for six months.
Re-treatment of Paget’s Disease Re-treatment with alendronate sodium tablets may be considered, following a six-month post-treatment evaluation period in patients who have relapsed, based on increases in serum alkaline phosphatase, which should be measured periodically. Re-treatment may also be considered in those who failed to normalize their serum alkaline phosphatase.
2.6 Important Administration Instructions
Instruct patients to do the following:
1. Take alendronate sodium tablets at least one-half hour before the first food, beverage, or medication of the day with plain water only [ see Patient Counseling Information (17.2)]. Other beverages (including mineral water), food, and some medications are likely to reduce the absorption of alendronate sodium tablets [ see Drug Interactions (7.1)]. Waiting less than 30 minutes, or taking alendronate sodium tablets with food, beverages (other than plain water) or other medications will lessen the effect of alendronate sodium by decreasing its absorption into the body. 2. Take alendronate sodium tablets upon arising for the day. To facilitate delivery to the stomach and thus reduce the potential for esophageal irritation, an alendronate sodium tablet should be swallowed with a full glass of water (6 to 8 ounces). Patients should not lie down for at least 30 minutes and until after their first food of the day. Alendronate sodium tablets should not be taken at bedtime or before arising for the day. Failure to follow these instructions may increase the risk of esophageal adverse experiences [ see Warnings and Precautions (5.1) and Patient Counseling Information (17.2)].2.7 Recommendations for Calcium and Vitamin D Supplementation
Instruct patients to take supplemental calcium if dietary intake is inadequate [see Warnings and Precautions (5.2)]. Patients at increased risk for vitamin D insufficiency (e.g., over the age of 70 years, nursing home-bound, or chronically ill) may need vitamin D supplementation. Patients with gastrointestinal malabsorption syndromes may require higher doses of vitamin D supplementation and measurement of 25-hydroxyvitamin D should be considered.
Patients treated with glucocorticoids should receive adequate amounts of calcium and vitamin D.
2.8 Administration Instructions for Missed Doses
If a once-weekly dose of alendronate sodium tablets is missed, instruct patients to take one dose on the morning after they remember. They should not take two doses on the same day but should return to taking one dose once a week, as originally scheduled on their chosen day.
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![A4100-17 Continuous Epidural 17g Tuohy () Kit [Smiths Medical Asd, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=899a9cb9-09b2-4e16-baa3-058eaab04739&name=899a9cb9-09b2-4e16-baa3-058eaab04739-02.jpg)
A4100-17 Continuous Epidural 17g Tuohy
Cutaneous candidiasis, tinea corporis, tinea cruris, tinea pedis, and tinea (pityriasis) versicolor
It is recommended that ketoconazole cream, 2% be applied once daily to cover the affected and immediate surrounding area. Clinical improvement may be seen fairly soon after treatment is begun; however, candidal infections and tinea cruris and corporis should be treated for two weeks in order to reduce the possibility of recurrence.
Patients with tinea versicolor usually require two weeks of treatment. Patients with tinea pedis require six weeks of treatment.
Seborrheic dermatitis
Ketoconazole cream, 2% should be applied to the affected area twice daily for four weeks or until clinical clearing.
If a patient shows no clinical improvement after the treatment period, the diagnosis should be redetermined.
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![Lisinopril Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=92921e88-c9b8-4f12-8961-d544d0647f35&name=10mg-100btl.jpg)
Lisinopril
Hypertension
Initial Therapy
In patients with uncomplicated essential hypertension not on diuretic therapy, the recommended initial dose is 10 mg once a day. Dosage should be adjusted according to blood pressure response. The usual dosage range is 20 to 40 mg per day administered in a single daily dose. The antihypertensive effect may diminish toward the end of the dosing interval regardless of the administered dose, but most commonly with a dose of 10 mg daily. This can be evaluated by measuring blood pressure just prior to dosing to determine whether satisfactory control is being maintained for 24 hours. If it is not, an increase in dose should be considered. Doses up to 80 mg have been used but do not appear to give greater effect. If blood pressure is not controlled with lisinopril tablets alone, a low dose of a diuretic may be added. Hydrochlorothiazide, 12.5 mg has been shown to provide an additive effect. After the addition of a diuretic, it may be possible to reduce the dose of lisinopril tablets.
Diuretic Treated Patients
In hypertensive patients who are currently being treated with a diuretic, symptomatic hypotension may occur occasionally following the initial dose of lisinopril tablets. The diuretic should be discontinued, if possible, for two to three days before beginning therapy with lisinopril tablets to reduce the likelihood of hypotension (see WARNINGS). The dosage of lisinopril tablets should be adjusted according to blood pressure response. If the patient’s blood pressure is not controlled with lisinopril tablets alone, diuretic therapy may be resumed as described above.
If the diuretic cannot be discontinued, an initial dose of 5 mg should be used under medical supervision for at least two hours and until blood pressure has stabilized for at least an additional hour (see WARNINGS and PRECAUTIONS, Drug Interactions).
Concomitant administration of lisinopril tablets with potassium supplements, potassium salt substitutes, or potassium-sparing diuretics may lead to increases of serum potassium (see PRECAUTIONS).
Dosage Adjustment in Renal Impairment
The usual dose of lisinopril tablets (10 mg) is recommended for patients with creatinine clearance >30 mL/min (serum creatinine of up to approximately 3 mg/dL). For patients with creatinine clearance ≥ 10 mL/min ≤ 30 mL/min (serum creatinine ≥ 3 mg/dL), the first dose is 5 mg once daily. For patients with creatinine clearance <10 mL/min (usually on hemodialysis) the recommended initial dose is 2.5 mg. The dosage may be titrated upward until blood pressure is controlled or to a maximum of 40 mg daily.
Renal Status
Creatinine Clearance
mL/min
Initial Dose mg/day
Normal Renal Function to Mild Impairment
>30
10
Moderate to Severe Impairment
≥10 ≤30
5
Dialysis Patients*
<10
2.5**
* See WARNINGS, Anaphylactoid Reactions During Membrane Exposure.
**Dosage or dosing interval should be adjusted depending on the blood pressure response.
Heart Failure
Lisinopril tablets are indicated as adjunctive therapy with diuretics and (usually) digitalis. The recommended starting dose is 5 mg once a day. When initiating treatment with lisinopril in patients with heart failure, the initial dose should be administered under medical observation, especially in those patients with low blood pressure (systolic blood pressure below 100 mmHg). The mean peak blood pressure lowering occurs six to eight hours after dosing. Observation should continue until blood pressure is stable. The concomitant diuretic dose should be reduced, if possible, to help minimize hypovolemia which may contribute to hypotension (see WARNINGS and PRECAUTIONS, Drug Interactions). The appearance of hypotension after the initial dose of lisinopril tablets does not preclude subsequent careful dose titration with the drug, following effective management of the hypotension.
The usual effective dosage range is 5 to 40 mg per day administered as a single daily dose. The dose of lisinopril tablets can be increased by increments of no greater than 10 mg, at intervals of no less than 2 weeks to the highest tolerated dose, up to a maximum of 40 mg daily. Dose adjustment should be based on the clinical response of individual patients.
Dosage Adjustment in Patients with Heart Failure and Renal Impairment or Hyponatremia
In patients with heart failure who havehyponatremia (serum sodium < 130 mEq/L) or moderate to severe renalimpairment (creatinine clearance ≤ 30 mL/min or serum creatinine > 3mg/dL), therapy with lisinopril tablets should be initiated at a dose of 2.5 mg once a day under close medical supervision (see WARNINGS and PRECAUTIONS, Drug Interactions).
Acute Myocardial Infarction
In hemodynamically stable patients within 24 hours of the onset of symptoms of acute myocardial infarction, the first dose of lisinopril tablets is 5 mg given orally, followed by 5 mg after 24 hours, 10 mg after 48 hours and then 10 mg of lisinopril tablets once daily. Dosing should continue for six weeks. Patients should receive, as appropriate, the standard recommended treatments such as thrombolytics, aspirin, and beta-blockers.
Patients with a low systolic blood pressure (≤ 120 mmHg) when treatment is started or during the first 3 days after the infarct should be given a lower 2.5 mg oral dose of lisinopril tablets (see WARNINGS). If hypotension occurs (systolic blood pressure ≤ 100 mmHg) a daily maintenance dose of 5 mg may be given with temporary reductions to 2.5 mg if needed. If prolonged hypotension occurs (systolic blood pressure < 90 mmHg for more than 1 hour) lisinopril tablets should be withdrawn. For patients who develop symptoms of heart failure (see DOSAGE AND ADMINISTRATION, Heart Failure).
Dosage Adjustment in Patients With Myocardial Infarction with Renal Impairment
In acute myocardial infarction, treatment withlisinopril tablets should be initiated with caution in patients with evidence of renal dysfunction, defined as serum creatinine concentrationexceeding 2 mg/dL. No evaluation of dosing adjustments in myocardial infarction patients with severe renal impairment has been performed.
Use in Elderly
In general, the clinical response was similar in younger and older patients given similar doses of lisinopril tablets. Pharmacokineticstudies, however indicate that maximum blood levels and area under the plasma concentration time curve (AUC) are doubled in older patients, so that dosage adjustments should be made with particular caution.
Pediatric Hypertensive Patients ≥ 6 years of age
The usual recommended starting dose is 0.07 mg/kg once daily (up to 5 mg total). Dosage should be adjusted according to blood pressure response. Doses above 0.61 mg/kg (or in excess of 40 mg) have not been studied in pediatric patients (see CLINICAL PHARMACOLOGY, Pharmacokinetics and Metabolism and Pharmacodynamics and Clinical Effects).
Lisinopril is not recommended in pediatric patients < 6 years or in pediatric patients with glomerular filtration rate < 30 mL/min/1.73 m2 (see CLINICAL PHARMACOLOGY, Pharmacokinetics and Metabolism and Pharmacodynamics and Clinical Effects and PRECAUTIONS).
Preparation of Suspension (for 200 mL of a 1.0 mg/mL suspension)
Add 10 mL of purified water USP to a polyethylene terephthalate (PET) bottle containing ten 20-mg tablets of lisinopril and shake for at least one minute. Add 30 mL of Bicitra®† diluent and 160 mL of Ora-Sweet SF™†† to the concentrate in the PET bottle and gently shake for several seconds to disperse the ingredients. The suspension should be stored at or below 25ºC (77ºF) and can be stored for up to four weeks. Shake the suspension before each use.
†Registered trademark of Alza Corporation
††Trademark of Paddock Laboratories, Inc.
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![Double Antibiotic (Bacitracin Zinc And Polymyxin B Sulfate) Ointment [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=6b5d9180-ea2f-4bb7-9e88-b596b638cb1d&name=image-01.jpg)
Double Antibiotic
Directions
• clean the affected area • apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily • may be covered with a sterile bandage -
![Senexon-s (Docusate Sodium -sennosides) Tablet, Coated [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=53048b99-bb1a-4821-94e2-b7999d5617b8&name=image-01.jpg)
Senexon-s
Dosage and Administration
Adults and children 12 years and over - 2 tablets once a day - maximum dosage - 4 tablets twice a day
children 6 to under 12 years - 1 tablet once a day maximum dosage - 2 tablets twice a day
children 2 to under 6 years - 1/2 tablet once a day - maximum dosage- 1 tablet twice a day
children uner 2 years - ask a doctor
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![Glyburide And Metformin Hydrochloride Tablet, Film Coated [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=1701ff4e-6c26-495f-8dbc-df68b0be6c82&name=glymet-fig2.jpg)
Glyburide And Metformin Hydrochloride
General Considerations
Dosage of glyburide and metformin hydrochloride tablets must be individualized on the basis of both effectiveness and tolerance while not exceeding the maximum recommended daily dose of 20 mg glyburide/2000 mg metformin. Glyburide and metformin hydrochloride tablets should be given with meals and should be initiated at a low dose, with gradual dose escalation as described below, in order to avoid hypoglycemia (largely due to glyburide), reduce GI side effects (largely due to metformin), and permit determination of the minimum effective dose for adequate control of blood glucose for the individual patient.With initial treatment and during dose titration, appropriate blood glucose monitoring should be used to determine the therapeutic response to glyburide and metformin hydrochloride tablets and to identify the minimum effective dose for the patient. Thereafter, HbA1c should be measured at intervals of approximately 3 months to assess the effectiveness of therapy. The therapeutic goal in all patients with type 2 diabetes is to decrease FPG, PPG, and HbA1c to normal or as near normal as possible. Ideally, the response to therapy should be evaluated using HbA1c (glycosylated hemoglobin), which is a better indicator of long-term glycemic control than FPG alone.No studies have been performed specifically examining the safety and efficacy of switching to glyburide and metformin hydrochloride tablets therapy in patients taking concomitant glyburide (or other sulfonylurea) plus metformin. Changes in glycemic control may occur in such patients, with either hyperglycemia or hypoglycemia possible. Any change in therapy of type 2 diabetes should be undertaken with care and appropriate monitoring.
Glyburide and Metformin Hydrochloride Tablets in Patients with Inadequate Glycemic Control on Diet and Exercise
Recommended starting dose: 1.25 mg/250 mg once or twice daily with meals. For patients with type 2 diabetes whose hyperglycemia cannot be satisfactorily managed with diet and exercise alone, the recommended starting dose of glyburide and metformin hydrochloride tablets is 1.25 mg/250 mg once a day with a meal. As initial therapy in patients with baseline HbA1c >9% or an FPG >200 mg/dL, a starting dose of glyburide and metformin hydrochloride tablets 1.25 mg/250 mg twice daily with the morning and evening meals may be used. Dosage increases should be made in increments of 1.25 mg/250 mg per day every 2 weeks up to the minimum effective dose necessary to achieve adequate control of blood glucose. In clinical trials of glyburide and metformin hydrochloride tablets as initial therapy, there was no experience with total daily doses >10 mg/2000 mg per day. Glyburide and metformin hydrochloride tablet 5 mg/500 mg should not be used as initial therapy due to an increased risk of hypoglycemia.
Glyburide and Metformin Hydrochloride Tablets Use in Patients with Inadequate Glycemic Control on a Sulfonylurea and/or Metformin
Recommended starting dose: 2.5 mg/500 mg or 5 mg/500 mg twice daily with meals. For patients not adequately controlled on either glyburide (or another sulfonylurea) or metformin alone, the recommended starting dose of glyburide and metformin hydrochloride tablets is 2.5 mg/500 mg or 5 mg/500 mg twice daily with the morning and evening meals. In order to avoid hypoglycemia, the starting dose of glyburide and metformin hydrochloride tablets should not exceed the daily doses of glyburide or metformin already being taken. The daily dose should be titrated in increments of no more than 5 mg/500 mg up to the minimum effective dose to achieve adequate control of blood glucose or to a maximum dose of 20 mg/2000 mg per day.For patients previously treated with combination therapy of glyburide (or another sulfonylurea) plus metformin, if switched to glyburide and metformin hydrochloride tablets, the starting dose should not exceed the daily dose of glyburide (or equivalent dose of another sulfonylurea) and metformin already being taken. Patients should be monitored closely for signs and symptoms of hypoglycemia following such a switch and the dose of glyburide and metformin hydrochloride tablets should be titrated as described above to achieve adequate control of blood glucose.
Addition of Thiazolidinediones to Glyburide and Metformin Hydrochloride Tablets Therapy
For patients not adequately controlled on glyburide and metformin hydrochloride tablets, a thiazolidinedione can be added to glyburide and metformin hydrochloride tablets therapy. When a thiazolidinedione is added to glyburide and metformin hydrochloride tablets therapy, the current dose of glyburide and metformin hydrochloride tablets can be continued and the thiazolidinedione initiated at its recommended starting dose. For patients needing additional glycemic control, the dose of the thiazolidinedione can be increased based on its recommended titration schedule. The increased glycemic control attainable with glyburide and metformin hydrochloride tablets plus a thiazolidinedione may increase the potential for hypoglycemia at any time of day. In patients who develop hypoglycemia when receiving glyburide and metformin hydrochloride tablets and a thiazolidinedione, consideration should be given to reducing the dose of the glyburide component of glyburide and metformin hydrochloride tablets. As clinically warranted, adjustment of the dosages of the other components of the antidiabetic regimen should also be considered.
Patients Receiving Colesevelam
When colesevelam is coadministered with glyburide, maximum plasma concentration and total exposure to glyburide is reduced. Therefore, glyburide and metformin hydrochloride tablets should be administered at least 4 hours prior to colesevelam.
Specific Patient Populations
Glyburide and metformin hydrochloride tablets are not recommended for use during pregnancy. The initial and maintenance dosing of glyburide and metformin hydrochloride tablets should be conservative in patients with advanced age, due to the potential for decreased renal function in this population. Any dosage adjustment requires a careful assessment of renal function. Generally, elderly, debilitated, and malnourished patients should not be titrated to the maximum dose of glyburide and metformin hydrochloride tablets to avoid the risk of hypoglycemia. Monitoring of renal function is necessary to aid in prevention of metformin-associated lactic acidosis, particularly in the elderly. (See WARNINGS.)
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![Hydrochlorothiazide Capsule [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=f14f4d97-ce6b-4e1e-8d94-0a778c4efc6c&name=hctzcapsnewheritage-figure-03.jpg)
Hydrochlorothiazide
For Control of Hypertension: The adult initial dose of hydrochlorothiazide capsules is one capsule given once daily whether given alone or in combination with other antihypertensives. Total daily doses greater than 50 mg are not recommended.
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![Hydrochlorothiazide Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=6a191733-410e-4e02-910f-c400829a846a&name=hydrotabs-2.jpg)
Hydrochlorothiazide
Therapy should be individualized according to patient response. Use the smallest dosage necessary to achieve the required response.
Adults
For Edema
The usual adult dosage is 25 mg to 100 mg daily as a single or divided dose. Many patients with edema respond to intermittent therapy, i.e., administration on alternate days or on 3 to 5 days each week. With an intermittent schedule, excessive response and the resulting undesirable electrolyte imbalance are less likely to occur.
For Control of Hypertension
The usual initial dose in adults is 25 mg daily given as a single dose. The dose may be increased to 50 mg daily, given as a single or two divided doses. Doses above 50 mg are often associated with marked reductions in serum potassium (see also PRECAUTIONS).
Patients usually do not require doses in excess of 50 mg of hydrochlorothiazide daily when used concomitantly with other antihypertensive agents.
Infants and Children
For Diuresis and For Control of Hypertension
The usual pediatric dosage is 0.5 mg to 1 mg per pound (1 to 2 mg/kg) per day in single or two divided doses, not to exceed 37.5 mg per day in infants up to 2 years of age or 100 mg per day in children 2 to 12 years of age. In infants less than 6 months of age, doses up to 1.5 mg per pound (3 mg/kg) per day in two divided doses may be required (see PRECAUTIONS, Pediatric Use).
Adults
For Edema
The usual adult dosage is 25 mg to 100 mg daily as a single or divided dose. Many patients with edema respond to intermittent therapy, i.e., administration on alternate days or on 3 to 5 days each week. With an intermittent schedule, excessive response and the resulting undesirable electrolyte imbalance are less likely to occur.
For Control of Hypertension
The usual initial dose in adults is 25 mg daily given as a single dose. The dose may be increased to 50 mg daily, given as a single or two divided doses. Doses above 50 mg are often associated with marked reductions in serum potassium (see also PRECAUTIONS).
Patients usually do not require doses in excess of 50 mg of hydrochlorothiazide daily when used concomitantly with other antihypertensive agents.
For Edema
The usual adult dosage is 25 mg to 100 mg daily as a single or divided dose. Many patients with edema respond to intermittent therapy, i.e., administration on alternate days or on 3 to 5 days each week. With an intermittent schedule, excessive response and the resulting undesirable electrolyte imbalance are less likely to occur.
For Control of Hypertension
The usual initial dose in adults is 25 mg daily given as a single dose. The dose may be increased to 50 mg daily, given as a single or two divided doses. Doses above 50 mg are often associated with marked reductions in serum potassium (see also PRECAUTIONS).
Patients usually do not require doses in excess of 50 mg of hydrochlorothiazide daily when used concomitantly with other antihypertensive agents.
Infants and Children
For Diuresis and For Control of Hypertension
The usual pediatric dosage is 0.5 mg to 1 mg per pound (1 to 2 mg/kg) per day in single or two divided doses, not to exceed 37.5 mg per day in infants up to 2 years of age or 100 mg per day in children 2 to 12 years of age. In infants less than 6 months of age, doses up to 1.5 mg per pound (3 mg/kg) per day in two divided doses may be required (see PRECAUTIONS, Pediatric Use).
For Diuresis and For Control of Hypertension
The usual pediatric dosage is 0.5 mg to 1 mg per pound (1 to 2 mg/kg) per day in single or two divided doses, not to exceed 37.5 mg per day in infants up to 2 years of age or 100 mg per day in children 2 to 12 years of age. In infants less than 6 months of age, doses up to 1.5 mg per pound (3 mg/kg) per day in two divided doses may be required (see PRECAUTIONS, Pediatric Use).
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![Glyburide Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=6af5f069-e9dd-4faa-b4ed-af6941d25033&name=glyburide-fig3.jpg)
Glyburide
Patients should be retitrated when transferred from micronized glyburide tablets or other oral hypoglycemic agents. (See PRECAUTIONS). There is no fixed dosage regimen for the management of diabetes mellitus with glyburide tablets or any other hypoglycemic agent. In addition to the usual monitoring of urinary glucose, the patient’s blood glucose must also be monitored periodically to determine the minimum effective dose for the patient; to detect primary failure, i.e., inadequate lowering of blood glucose at the maximum recommended dose of medication; and to detect secondary failure, i.e., loss of adequate blood glucose lowering response after an initial period of effectiveness. Glycosylated hemoglobin levels may also be of value in monitoring the patient’s response to therapy.Short-term administration of glyburide may be sufficient during periods of transient loss of control in patients usually controlled well on diet.
Usual Starting Dose
The usual starting dose of glyburide tablets is 2.5 to 5 mg daily, administered with breakfast or the first main meal. Those patients who may be more sensitive to hypoglycemic drugs should be started at 1.25 mg daily. (See PRECAUTIONS section for patients at increased risk.) Failure to follow an appropriate dosage regimen may precipitate hypoglycemia. Patients who do not adhere to their prescribed dietary and drug regimen are more prone to exhibit unsatisfactory response to therapy.Transfer From Other Hypoglycemic Therapy Patients Receiving Other Oral Antidiabetic TherapyTransfer of patients from other oral antidiabetic regimens to glyburide should be done conservatively and the initial daily dose should be 2.5 to 5 mg. When transferring patients from oral hypoglycemic agents other than chlorpropamide to glyburide, no transition period and no initial or priming dose are necessary. When transferring patients from chlorpropamide, particular care should be exercised during the first two weeks because the prolonged retention of chlorpropamide in the body and subsequent overlapping drug effects may provoke hypoglycemia.Patients Receiving Insulin Some Type II diabetic patients being treated with insulin may respond satisfactorily to glyburide. If the insulin dose is less than 20 units daily, substitution of glyburide tablets 2.5 to 5 mg as a single daily dose may be tried. If the insulin dose is between 20 and 40 units daily, the patient may be placed directly on glyburide tablets 5 mg daily as a single dose. If the insulin dose is more than 40 units daily, a transition period is required for conversion to glyburide. In these patients, insulin dosage is decreased by 50% and glyburide tablets 5 mg daily is started. Please refer to Titration to Maintenance Dose for further explanation.Patients Receiving Colesevelam When colesevelam is coadministered with glyburide, maximum plasma concentration and total exposure to glyburide is reduced. Therefore, glyburide should be administered at least 4 hours prior to colesevelam.
Titration to Maintenance Dose
The usual maintenance dose is in the range of 1.25 to 20 mg daily, which may be given as a single dose or in divided doses (See Dosage Interval section). Dosage increases should be made in increments of no more than 2.5 mg at weekly intervals based upon the patient’s blood glucose response.No exact dosage relationship exists between glyburide and the other oral hypoglycemic agents. Although patients may be transferred from the maximum dose of other sulfonylureas, the maximum starting dose of 5 mg of glyburide tablets should be observed. A maintenance dose of 5 mg of glyburide tablets provides approximately the same degree of blood glucose control as 250 to 375 mg chlorpropamide, 250 to 375 mg tolazamide, 500 to 750 mg acetohexamide, or 1000 to 1500 mg tolbutamide.When transferring patients receiving more than 40 units of insulin daily, they may be started on a daily dose of glyburide tablets 5 mg concomitantly with a 50% reduction in insulin dose. Progressive withdrawal of insulin and increase of glyburide in increments of 1.25 to 2.5 mg every 2 to 10 days is then carried out. During this conversion period when both insulin and glyburide are being used, hypoglycemia may rarely occur. During insulin withdrawal, patients should test their urine for glucose and acetone at least three times daily and report results to their physician. The appearance of persistent acetonuria with glycosuria indicates that the patient is a Type I diabetic who requires insulin therapy.Concomitant Glyburide and Metformin Therapy Glyburide tablets should be added gradually to the dosing regimen of patients who have not responded to the maximum dose of metformin monotherapy after four weeks (see Usual Starting Dose and Titration to Maintenance Dose). Refer to metformin package insert.With concomitant glyburide and metformin therapy, the desired control of blood glucose may be obtained by adjusting the dose of each drug. However, attempts should be made to identify the optimal dose of each drug needed to achieve this goal. With concomitant glyburide and metformin therapy, the risk of hypoglycemia associated with sulfonylurea therapy continues and may be increased. Appropriate precautions should be taken (see PRECAUTIONS section).Maximum Dose Daily doses of more than 20 mg are not recommended.
Dosage Interval
Once-a-day therapy is usually satisfactory. Some patients, particularly those receiving more than 10 mg daily, may have a more satisfactory response with twice-a-day dosage.Specific Patient Populations Glyburide is not recommended for use in pregnancy or for use in pediatric patients.In elderly patients, debilitated or malnourished patients, and patients with impaired renal or hepatic function, the initial and maintenance dosing should be conservative to avoid hypoglycemic reactions. (See PRECAUTIONS section.)
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![Diclofenac Sodium Tablet, Film Coated, Extended Release [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=69d6802e-86b1-43f7-86ef-982ffd24511d&name=diclofenac-02.jpg)
Diclofenac Sodium
Carefully consider the potential benefits and risks of Diclofenac Sodium Extended-release Tablets and other treatment options before deciding to use Diclofenac Sodium Extended-release Tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with Diclofenac Sodium Extended-release Tablets, the dose and frequency should be adjusted to suit an individual patient's needs.
For the relief of osteoarthritis, the recommended dosage is 100 mg q.d.
For the relief of rheumatoid arthritis, the recommended dosage is 100 mg q.d. In the rare patient where Diclofenac Sodium Extended-release Tablets 100 mg/day is unsatisfactory, the dose may be increased to 100 mg b.i.d. if the benefits outweigh the clinical risks of increased side effects.
Different formulations of diclofenac [diclofenac sodium enteric-coated tablets; diclofenac sodium extended-release tablets; diclofenac potassium immediate-release tablets] are not necessarily bioequivalent even if the milligram strength is the same.
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![Hydrocortisone Maximum Strength (Hydrocortisone) Cream [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=67b8fab6-0e22-4ed1-a7c1-0c4191ee9341&name=image-01.jpg)
Hydrocortisone Maximum Strength
Adults and children 2 years of age and older
• apply to affected area not more than 3 to 4 times daily Children under 2 years of age • do not use, consult a doctor For external anal itching Adults: when practical, clean the affected area with mild soap and warm water, rinse thoroughly, gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product Children under 12 years of age: consult a doctor -
![Avapro (Irbesartan) Tablet [Sanofi-aventis U.s. Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=b2df0e0e-43ba-47ab-b8f9-22c8010772ba&name=5b5a189d-c172-4dc2-b2fa-8fd28f8da1a1-06.jpg)
Avapro
Gabapentin Capsules, USP are given orally with or without food.
If gabapentin dose is reduced, discontinued or substituted with an alternative medication, this should be done gradually over a minimum of 1 week (a longer period may be needed at the discretion of the prescriber).
Postherpetic Neuralgia
In adults with postherpetic neuralgia, gabapentin therapy may be initiated as a single 300-mg dose on Day 1, 600 mg/day on Day 2 (divided BID), and 900 mg/day on Day 3 (divided TID). The dose can subsequently be titrated up as needed for pain relief to a daily dose of 1800 mg (divided TID). In clinical studies, efficacy was demonstrated over a range of doses from 1800 mg/day to 3600 mg/day with comparable effects across the dose range. Additional benefit of using doses greater than 1800 mg/day was not demonstrated.
Epilepsy
Gabapentin is recommended for add-on therapy in patients 3 years of age and older. Effectiveness in pediatric patients below the age of 3 years has not been established.
Patients >12 years of age: The effective dose of gabapentin is 900 to 1800 mg/day and given in divided doses (three times a day) using 300 or 400 mg capsules, or 600 or 800 mg tablets. The starting dose is 300 mg three times a day. If necessary, the dose may be increased using 300 or 400 mg capsules, or 600 or 800 mg tablets three times a day up to 1800 mg/day. Dosages up to 2400 mg/day have been well tolerated in long-term clinical studies. Doses of 3600 mg/day have also been administered to a small number of patients for a relatively short duration, and have been well tolerated. The maximum time between doses in the TID schedule should not exceed 12 hours.
Pediatric Patients Age 3–12 years: The starting dose should range from 10-15 mg/kg/day in 3 divided doses, and the effective dose reached by upward titration over a period of approximately 3 days. The effective dose of gabapentin in patients 5 years of age and older is 25–35 mg/kg/day and given in divided doses (three times a day). The effective dose in pediatric patients ages 3 and 4 years is 40 mg/kg/day and given in divided doses (three times a day) (see CLINICAL PHARMACOLOGY, Pediatrics.) Gabapentin may be administered as the oral solution, capsule, or tablet, or using combinations of these formulations. Dosages up to 50 mg/kg/day have been well-tolerated in a long-term clinical study. The maximum time interval between doses should not exceed 12 hours.
It is not necessary to monitor gabapentin plasma concentrations to optimize gabapentin therapy. Further, because there are no significant pharmacokinetic interactions among gabapentin and other commonly used antiepileptic drugs, the addition of gabapentin does not alter the plasma levels of these drugs appreciably.
If gabapentin is discontinued and/or an alternate anticonvulsant medication is added to the therapy, this should be done gradually over a minimum of 1 week.
Dosage in Renal Impairment
Creatinine clearance is difficult to measure in outpatients. In patients with stable renal function, creatinine clearance (CCr) can be reasonably well estimated using the equation of Cockcroft and Gault: for females CCr=(0. 85)( 140-age)(weight)/[(72)(SCr)] for males CCr=(140-age)(weight)/[(72)(SCr)]
where age is in years, weight is in kilograms and SCr is serum creatinine in mg/dL.
Dosage adjustment in patients ≥ 12 years of age with compromised renal function or undergoing hemodialysis is recommended as follows (see dosing recommendations above for effective doses in each indication).
TABLE 6. Gabapentin Dosage Based on Renal Function Renal Function Creatinine Clearance (mL/min) Total Daily Dose Range (mg/day) Dose Regimen (mg) a For patients with creatinine clearance <15 mL/min, reduce daily dose in proportion to creatinine clearance (e.g., patients with a creatinine clearance of 7.5 mL/min should receive one-half the daily dose that patients with a creatinine clearance of 15 mL/min receive). b Patients on hemodialysis should receive maintenance doses based on estimates of creatinine clearance as indicated in the upper portion of the table and a supplemental post-hemodialysis dose administered after each 4 hours of hemodialysis as indicated in the lower portion of the table.≥60
900-3600
300 TID
400 TID
600 TID
800 TID
1200 TID
>30-59
400-1400
200 BID
300 BID
400 BID
500 BID
700 BID
>15-29
200-700
200 QD
300 QD
400 QD
500 QD
700 QD
15a
100-300
100 QD
125 QD
150 QD
200 QD
300 QD
Post-Hemodialysis Supplemental Dose (mg)b
Hemodialysis
125b
150b
200b
250b
350b
The use of gabapentin in patients <12 years of age with compromised renal function has not been studied.
Dosage in Elderly
Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and dose should be adjusted based on creatinine clearance values in these patients.
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![Ketoconazole Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=be3eb758-2659-4f8b-abb7-cc57740e7331&name=1e0cf120-8a49-4d12-9d3d-e04fcc6ad147-02.jpg)
Ketoconazole
There should be laboratory as well as clinical documentation of infection prior to starting ketoconazole therapy. The usual duration of therapy for systemic infection is 6 months. Treatment should be continued until active fungal infection has subsided.
Adults
The recommended starting dose of ketoconazole tablets is a single daily administration of 200 mg (one tablet). If clinical responsiveness is insufficient within the expected time, the dose of ketoconazole tablets may be increased to 400 mg (two tablets) once daily.
Children
In small numbers of children over 2 years of age, a single daily dose of 3.3 to 6.6 mg/kg has been used. Ketoconazole tablets have not been studied in children under 2 years of age.
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![Ketoconazole Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=760ddedd-9ae6-452c-8e10-e91c5baffd09&name=ketoconazole-02.jpg)
Ketoconazole
There should be laboratory as well as clinical documentation of infection prior to starting ketoconazole therapy. The usual duration of therapy for systemic infection is 6 months. Treatment should be continued until active fungal infection has subsided.
Adults
The recommended starting dose of ketoconazole tablets is a single daily administration of 200 mg (one tablet). If clinical responsiveness is insufficient within the expected time, the dose of ketoconazole tablets may be increased to 400 mg (two tablets) once daily.
Children
In small numbers of children over 2 years of age, a single daily dose of 3.3 to 6.6 mg/kg has been used. Ketoconazole tablets have not been studied in children under 2 years of age.
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![Glyburide And Metformin Hydrochloride Tablet, Film Coated [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=55fec4f1-0429-4913-8e9e-be1cb537bb68&name=glyburide-and-metformin-hcl-tablets-usp-8.jpg)
Glyburide And Metformin Hydrochloride
General Considerations
Dosage of Glyburide and Metformin Hydrochloride must be individualized on the basis of both effectiveness and tolerance while not exceeding the maximum recommended daily dose of 20 mg glyburide/2000 mg metformin. Glyburide and Metformin Hydrochloride should be given with meals and should be initiated at a low dose, with gradual dose escalation as described below, in order to avoid hypoglycemia (largely due to glyburide), to reduce GI side effects (largely due to metformin), and to permit determination of the minimum effective dose for adequate control of blood glucose for the individual patient.
With initial treatment and during dose titration, appropriate blood glucose monitoring should be used to determine the therapeutic response to Glyburide and Metformin Hydrochloride and to identify the minimum effective dose for the patient. Thereafter, HbA1c should be measured at intervals of approximately 3 months to assess the effectiveness of therapy. The therapeutic goal in all patients with type 2 diabetes is to decrease FPG, PPG, and HbA1c to normal or as near normal as possible. Ideally, the response to therapy should be evaluated using HbA1c (glycosylated hemoglobin), which is a better indicator of long-term glycemic control than FPG alone.
No studies have been performed specifically examining the safety and efficacy of switching to Glyburide and Metformin Hydrochloride therapy in patients taking concomitant glyburide (or other sulfonylurea) plus metformin. Changes in glycemic control may occur in such patients, with either hyperglycemia or hypoglycemia possible. Any change in therapy of type 2 diabetes should be undertaken with care and appropriate monitoring.
Glyburide and Metformin Hydrochloride in Patients with Inadequate Glycemic Control on Diet and Exercise
Recommended starting dose: 1.25 mg/250 mg once or twice daily with meals.
For patients with type 2 diabetes whose hyperglycemia cannot be satisfactorily managed with diet and exercise alone, the recommended starting dose of Glyburide and Metformin Hydrochloride is 1.25 mg/250 mg once a day with a meal. As initial therapy in patients with baseline HbA1c >9% or an FPG >200 mg/dL, a starting dose of Glyburide and Metformin Hydrochloride 1.25 mg/250 mg twice daily with the morning and evening meals may be used. Dosage increases should be made in increments of 1.25 mg/250 mg per day every two weeks up to the minimum effective dose necessary to achieve adequate control of blood glucose. In clinical trials of Glyburide and Metformin Hydrochloride as initial therapy, there was no experience with total daily doses greater than 10 mg/2000 mg per day. Glyburide and Metformin Hydrochloride 5 mg/500 mg should not be used as initial therapy due to an increased risk of hypoglycemia.
Glyburide and Metformin Hydrochloride Use in Patients with Inadequate Glycemic Control on a Sulfonylurea and/or Metformin
Recommended starting dose: 2.5 mg/500 mg or 5 mg/500 mg twice daily with meals.
For patients not adequately controlled on either glyburide (or another sulfonylurea) or metformin alone, the recommended starting dose of Glyburide and Metformin Hydrochloride is 2.5 mg/500 mg or 5 mg/500 mg twice daily with the morning and evening meals. In order to avoid hypoglycemia, the starting dose of Glyburide and Metformin Hydrochloride should not exceed the daily doses of glyburide or metformin already being taken. The daily dose should be titrated in increments of no more than 5 mg/500 mg up to the minimum effective dose to achieve adequate control of blood glucose or to a maximum dose of 20 mg/2000 mg per day.
For patients previously treated with combination therapy of glyburide (or another sulfonylurea) plus metformin, if switched to Glyburide and Metformin Hydrochloride, the starting dose should not exceed the daily dose of glyburide (or equivalent dose of another sulfonylurea) and metformin already being taken. Patients should be monitored closely for signs and symptoms of hypoglycemia following such a switch and the dose of Glyburide and Metformin Hydrochloride should be titrated as described above to achieve adequate control of blood glucose.
Addition of Thiazolidinediones to Glyburide and Metformin Hydrochloride Therapy
For patients not adequately controlled on Glyburide and Metformin Hydrochloride, a thiazolidinedione can be added to Glyburide and Metformin Hydrochloride therapy. When a thiazolidinedione is added to Glyburide and Metformin Hydrochloride therapy, the current dose of Glyburide and Metformin Hydrochloride can be continued and the thiazolidinedione initiated at its recommended starting dose. For patients needing additional glycemic control, the dose of the thiazolidinedione can be increased based on its recommended titration schedule. The increased glycemic control attainable with Glyburide and Metformin Hydrochloride plus a thiazolidinedione may increase the potential for hypoglycemia at any time of day.
In patients who develop hypoglycemia when receiving Glyburide and Metformin Hydrochloride and a thiazolidinedione, consideration should be given to reducing the dose of the glyburide component of Glyburide and Metformin Hydrochloride. As clinically warranted, adjustment of the dosages of the other components of the antidiabetic regimen should also be considered.
Specific Patient Populations
Glyburide and Metformin Hydrochloride is not recommended for use during pregnancy. The initial and maintenance dosing of Glyburide and Metformin Hydrochloride should be conservative in patients with advanced age, due to the potential for decreased renal function in this population. Any dosage adjustment requires a careful assessment of renal function. Generally, elderly, debilitated, and malnourished patients should not be titrated to the maximum dose of Glyburide and Metformin Hydrochloride to avoid the risk of hypoglycemia. Monitoring of renal function is necessary to aid in prevention of metformin-associated lactic acidosis, particularly in the elderly. (See WARNINGS.)
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![Isoniazid Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=45df9851-27b4-4cce-aed1-c15314876fc1&name=isoniazid-tablets-3.jpg)
Isoniazid
(See also INDICATIONS AND USAGE): NOTE: For preventive therapy of tuberculous infection and treatment of tuberculosis, it is recommended that physicians be familiar with the following publications: (1) the recommendations of the Advisory Council for the Elimination of Tuberculosis, published in the MMWR: vol 42; RR-4, 1993 and (2) Treatment of Tuberculosis and Tuberculosis Infection in Adults and Children, American Journal of Respiratory and Critical Care Medicine: vol 149; 1359-1374, 1994.
For Treatment of Tuberculosis:
Isoniazid is used in conjunction with other effective anti-tuberculosis agents. Drug susceptibility testing should be performed on the organisms initially isolated from all patients with newly diagnosed tuberculosis. If the bacilli becomes resistant, therapy must be changed to agents to which the bacilli are susceptible.
Usual Oral Dosage (depending on the regimen used):
Adults:
5 mg/kg up to 300 mg daily in a single dose; or15 mg/kg up to 900 mg/day, two or three times/week
Chidren:
10 to 15 mg/kg up to 300 mg daily in a single dose; or20 to 40 mg/kg up to 900 mg/day, two or three time/week
Patients with Pulmonary Tuberculosis Without HIV Infection:
There are 3 regimen options for the initial treatment of tuberculosis in children and adults:
Option 1: Daily isoniazid, rifampin, and pyrazinamide for 8 weeks followed by 16 weeks of isoniazid and rifampin daily or 2 to 3 times weekly. Ethambutol or streptomycin should be added to the initial regimen until sensitivity to isoniazid and rifampin is demonstrated. The addition of a fourth drug is optional if the relative prevalence of isoniazid-resistant Mycobacterium tuberculosis isolates in the community is less than or equal to four percent.
Option 2: Daily isoniazid, rifampin, pyrazinamide, and streptomycin or ethambutol for 2 weeks followed by twice weekly administration of the same drugs for 6 weeks, subsequently twice weekly isoniazid and rifampin for 16 weeks.
Option 3: Three times weekly with isoniazid, rifampin, pyrazinamide, and ethambutol or streptomycin for 6 months.
*All regimens given twice weekly or 3 times weekly should be administered by directly observed therapy (see also Directly Observed Therapy (DOT)).
The above treatment guidelines apply only when the disease is caused by organisms that are susceptible to the standard antituberculous agents. Because of the impact of resistance to isoniazid and rifampin on the response to therapy, it is essential that physicians initiating therapy for tuberculosis be familiar with the prevalence of drug resistance in their communities. It is suggested that ethambutol not be used in children whose visual acuity cannot be monitored.
Patients with Pulmonary Tuberculosis and HIV Infection:
The response of the immunologically impaired host to treatment may not be as satisfactory as that of a person with normal host responsiveness. For this reason, therapeutic decisions for the impaired host must be individualized. Since patients co-infected with HIV may have problems with malabsorption, screening of antimycobacterial drug levels, especially in patients with advanced HIV disease, may be necessary to prevent the emergence of MDRTB.
Patients with Extra Pulmonary Tuberculosis:
The basic principles that underlie the treatment of pulmonary tuberculosis also apply to Extra pulmonary forms of the disease. Although there have not been the same kinds of carefully conducted controlled trials of treatment of Extra pulmonary tuberculosis as for pulmonary disease, increasing clinical experience indicates that a 6 to 9 month short-course regimen is effective. Because of the insufficient data, miliary tuberculosis, bone/joint tuberculosis, and tuberculous meningitis in infants and children should receive 12 months therapy.
Bacteriologic evaluation of Extra pulmonary tuberculosis may be limited by the relative inaccessibility of the sites of disease. Thus, response to treatment often must be judged on the basis of clinical and radiographic findings.
The use of adjunctive therapies such as surgery and corticosteroids is more commonly required in Extra pulmonary tuberculosis than in pulmonary disease. Surgery may be necessary to obtain specimens for diagnosis and to treat such processes as constrictive pericarditis and spinal cord compression from Pott’s Disease. Corticosteriods have been shown to be of benefit in preventing cardiac constriction from tuberculous pericarditis and in decreasing the neurologic sequelae of all stages of tuberculosis meningitis, especially when administered early in the course of the disease.
Pregnant Women with Tuberculosis:
The options listed above must be adjusted for the pregnant patient. Streptomycin interferes with in utero development of the ear and may cause congenital deafness. Routine use of pyrazinamide is also not recommended in pregnancy because of inadequate teratogenicity data. The initial treatment regimen should consist of isoniazid and rifampin. Ethambutol should be included unless primary isoniazid resistance is unlikely (isoniazid resistance rate documented to be less than 4%).
Treatment of Patients with Multi-Drug Resistant Tuberculosis (MDRTB):
Multiple-drug resistant tuberculosis (i.e., resistance to at least isoniazid and rifampin) presents difficult treatment problems. Treatment must be individualized and based on susceptibility studies. In such cases, consultation with an expert in tuberculosis is recommended.
Directly Observed Therapy (DOT):
A major cause of drug-resistant tuberculosis is patient noncompliance with treatment. The use of DOT can help assure patient compliance with drug therapy. DOT is the observation of the patient by a health care provider or other responsible person as the patient ingests anti-tuberculosis medications. DOT can be achieved with daily, twice weekly or thrice weekly regimens, and is recommended for all patients.
For Preventative Therapy of Tuberculosis:
Before isoniazid preventive therapy is initiated, bacteriologically positive or radiographically progressive tuberculosis must be excluded. Appropriate evaluations should be performed if Extra pulmonary tuberculosis is suspected.
Adults over 30 Kg: 300 mg per day in a single dose.
Infants and Children: 10 mg/kg (up to 300 mg daily) in a single dose. In situations where adherence with daily preventative therapy cannot be assured, 20 to 30 mg/kg (not to exceed 900 mg) twice weekly under the direct observation of a health care worker at the time of administration8.
Continuous administration of isoniazid for a sufficient period is an essential part of the regimen because relapse rates are higher if chemotherapy is stopped prematurely. In the treatment of tuberculosis, resistant organisms may multiply and the emergence of resistant organisms during the treatment may necessitate a change in the regimen.
For following patient compliance: the Potts-Cozart test9, a simple colorimetric6 method of checking for isoniazid in the urine, is a useful tool for assuring patient compliance, which is essential for effective tuberculosis control. Additionally, isoniazid test strips are also available to check patient compliance.
Concomitant administration of pyridoxine (B6) is recommended in the malnourished and in those predisposed to neuropathy (e.g., alcoholics and diabetics).
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![Acetaminophen And Codeine Phosphate Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=5e21778e-81a1-4f56-95c0-957bd639a6d1&name=image-04.jpg)
Acetaminophen And Codeine Phosphate
Dosage should be adjusted according to severity of pain and response of the patient.
The usual adult dosage is:
Single Doses (range)
Maximum 24 Hour Dose
Codeine Phosphate
15 mg to 60 mg
360 mg
Acetaminophen
300 mg to 1000 mg
4000 mg
The usual dose of codeine phosphate in children is 0.5 mg/kg.
Doses may be repeated up to every 4 hours.
The prescriber must determine the number of tablets per dose, and the maximum number of tablets per 24 hours based upon the above dosage guidance. This information should be conveyed in the prescription.
It should be kept in mind, however, that tolerance to codeine can develop with continued use and that the incidence of untoward effects is dose related. Adult doses of codeine higher than 60 mg fail to give commensurate relief of pain but merely prolong analgesia and are associated with an appreciably increased incidence of undesirable side effects. Equivalently high doses in children would have similar effects.
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![Ketoconazole Shampoo, Suspension [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=51cc682c-6b56-4fe9-bd95-09bdbe35e252&name=d2cac47a-figure-02.jpg)
Ketoconazole Shampoo
Apply the shampoo to the damp skin of the affected area and a wide margin surrounding this area. Lather, leave in place for 5 minutes, and then rinse off with water.
One application of the shampoo should be sufficient.
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![Hydrochlorothiazide Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=0bcce31c-35cb-44f9-94fc-692a3fc74d9e&name=hctztabsnewheritage-figure-05.jpg)
Hydrochlorothiazide
Therapy should be individualized according to patient response. Use the smallest dosage necessary to achieve the required response.
Adults
For Edema
The usual adult dosage is 25 to 100 mg daily as a single or divided dose. Many patients with edema respond to intermittent therapy, i.e., administration on alternate days or on three to five days each week. With an intermittent schedule, excessive response and the resulting undesirable electrolyte imbalance are less likely to occur.
For Control of Hypertension
The usual initial dose in adults is 25 mg daily given as a single dose. The dose may be increased to 50 mg daily, given as a single or two divided doses. Doses above 50 mg are often associated with marked reductions in serum potassium (see also PRECAUTIONS). Patients usually do not require doses in excess of 50 mg of hydrochlorothiazide daily when used concomitantly with other antihypertensive agents.
Infants and Children
For Diuresis and For Control of Hypertension
The usual pediatric dosage is 0.5 to 1 mg per pound (1 to 2 mg/kg) per day in single or two divided doses, not to exceed 37.5 mg per day in infants up to 2 years of age or 100 mg per day in children 2 to 12 years of age. In infants less than 6 months of age, doses up to 1.5 mg per pound (3 mg/kg) per day in two divided doses may be required. (See PRECAUTIONS, Pediatric Use)
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![Lansoprazole Capsule, Delayed Release [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=09a7dc01-4657-48a8-884d-8444ff323b2f&name=lansofig8.jpg)
Lansoprazole
Lansoprazole is available as a capsule, in 15 mg and 30 mg strengths. Directions for use specific to the route and available methods of administration for each of these dosage forms is presented below. Lansoprazole delayed-release capsules should be taken before eating. Lansoprazole products SHOULD NOT BE CRUSHED OR CHEWED. In the clinical trials, antacids were used concomitantly with lansoprazole delayed-release capsules.
2.1 Recommended Dose
*Please refer to amoxicillin and clarithromycin full prescribing information forCONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally-impaired patients. †Controlled studies did not extend beyond indicated duration. ‡For patients who do not heal with lansoprazole delayed-release capsules for 8 weeks (5–10%), it may be helpful to give an additional 8 weeks of treatment. If there is a recurrence of erosive esophagitis, an additional 8 week course of lansoprazole delayed-release capsules may be considered.§The lansoprazole delayed-release capsules dose was increased (up to 30 mg twice daily) in some pediatric patients after 2 or more weeks of treatment if they remained symptomatic. For pediatric patients unable to swallow an intact capsule please see Administration Options. ¶Varies with individual patient. Recommended adult starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Dosages up to 90 mg twice daily have been administered. Daily dose of greater than 120 mg should be administered in divided doses. Some patients with Zollinger-Ellison Syndrome have been treated continuously with lansoprazole delayed-release capsules for more than 4 years.Indication
Recommended Dose
Frequency
Duodenal Ulcers Short-Term Treatment Maintenance of Healed
15 mg15 mg
Once daily for 4 weeksOnce daily
H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence*
Triple Therapy:
Lansoprazole delayed-release capsules
30 mg
Twice daily (q12h) for 10 or 14 days
Amoxicillin
1 gram
Twice daily (q12h) for 10 or 14 days
Clarithromycin
500 mg
Twice daily (q12h) for 10 or 14 days
Dual Therapy:
Lansoprazole delayed-release capsules
30 mg
Three times daily (q8h) for 14 days
Amoxicillin
1 gram
Three times daily (q8h) for 14 days
Benign Gastric Ulcer
Short-Term Treatment
30 mg
Once daily for up to 8 weeks
NSAID-associated Gastric Ulcer
Healing
30 mg
Once daily for 8 weeks†
Risk Reduction
15 mg
Once daily for up to 12 weeks†
Gastroesophageal Reflux Disease (GERD)
Short-Term Treatment of Symptomatic GERD
15 mg
Once daily for up to 8 weeks
Short-Term Treatment of Erosive Esophagitis
30 mg
Once daily for up to 8 weeks‡
Pediatric
(1 to 11 years of age)Short-Term Treatment of Symptomatic GERD and Short-Term Treatment of Erosive Esophagitis
≤ 30 kg
15 mg
Once daily for up to 12 weeks§
> 30 kg
30 mg
Once daily for up to 12 weeks§
(12 to 17 years of age)Short-Term Treatment of Symptomatic GERD
Nonerosive GERD
15 mg
Once daily for up to 8 weeks
Erosive Esophagitis
30 mg
Once daily for up to 8 weeks
Maintenance of Healing of Erosive Esophagitis
15 mg
Once daily
Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome
60 mg
Once daily¶
Patients should be instructed that if a dose is missed, it should be taken as soon as possible. However, if the next scheduled dose is due, the patient should not take the missed dose, and should be instructed to take the next dose on time. Patients should be instructed not to take 2 doses at one time to make up for a missed dose.
2.2 Special Populations
Renal impairment patients and geriatric patients do not require dosage adjustment. However, consider dose adjustment in patients with severe liver impairment [see Use in Specific Populations (8.5, 8.6 and 8.7)].
2.3 Important Administration Information
Administration Options
Lansoprazole delayed-release capsules - Oral Administration
• Lansoprazole delayed-release capsules should be swallowed whole. • Alternatively, for patients who have difficulty swallowing capsules, lansoprazole delayed-release capsules can be opened and administered as follows:o Open capsule.
o Sprinkle intact granules on one tablespoon of either applesauce, ENSURE pudding, cottage cheese, yogurt or strained pears.
o Swallow immediately.
• Lansoprazole delayed-release capsules may also be emptied into a small volume of either apple juice, orange juice or tomato juice and administered as follows:o Open capsule.
o Sprinkle intact granules into a small volume of either apple juice, orange juice or tomato juice (60 mL – approximately 2 ounces).
o Mix briefly.
o Swallow immediately.
o To ensure complete delivery of the dose, the glass should be rinsed with two or more volumes of juice and the contents swallowed immediately.
Lanlansoprazole delayed-release capsules – Nasogastric Tube (≥16 French) Administration
• For patients who have a nasogastric tube in place, lansoprazole delayed-release capsules can be administered as follows: o Open capsule. o Mix intact granules into 40 mL of apple juice. DO NOT USE OTHER LIQUIDS. o Inject through the nasogastric tube into the stomach. o Flush with additional apple juice to clear the tube.USE IN OTHER FOODS AND LIQUIDS HAS NOT BEEN STUDIED CLINICALLY AND IS THEREFORE NOT RECOMMENDED.
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![Alprazolam Tablet, Extended Release [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=bdd5c1be-df05-4423-9e27-2b96a1a35c9a&name=alprazolam-extended-release-tablets-3.jpg)
Alprazolam
Alprazolam extended-release tablets may be administered once daily, preferably in the morning. The tablets should be taken intact; they should not be chewed, crushed, or broken.
The suggested total daily dose ranges between 3 to 6 mg/day. Dosage should be individualized for maximum beneficial effect. While the suggested total daily dosages given will meet the needs of most patients, there will be some patients who require doses greater than 6 mg/day. In such cases, dosage should be increased cautiously to avoid adverse effects.
Dosing in Special Populations
In elderly patients, in patients with advanced liver disease, or in patients with debilitating disease, the usual starting dose of alprazolam extended-release tablets is 0.5 mg once daily. This may be gradually increased if needed and tolerated (see Dose Titration).The elderly may be especially sensitive to the effects of benzodiazepines.
Dose Titration
Treatment with alprazolam extended-release tablets may be initiated with a dose of 0.5 mg to 1 mg once daily. Depending on the response, the dose may be increased at intervals of 3 to 4 days in increments of no more than 1 mg/day. Slower titration to the dose levels may be advisable to allow full expression of the pharmacodynamic effect of alprazolam extended-release tablets.
Generally, therapy should be initiated at a low dose to minimize the risk of adverse responses in patients especially sensitive to the drug. Dose should be advanced until an acceptable therapeutic response (i.e., a substantial reduction in or total elimination of panic attacks) is achieved, intolerance occurs, or the maximum recommended dose is attained.
Dose Maintenance
In controlled trials conducted to establish the efficacy of alprazolam extended-release tablets in panic disorder, doses in the range of 1 to 10 mg/day were used. Most patients showed efficacy in the dose range of 3 to 6 mg/day. Occasional patients required as much as 10 mg/day to achieve a successful response.
The necessary duration of treatment for panic disorder patients responding to alprazolam extended-release tablets is unknown. However, periodic reassessment is advised. After a period of extended freedom from attacks, a carefully supervised tapered discontinuation may be attempted, but there is evidence that this may often be difficult to accomplish without recurrence of symptoms and/or the manifestation of withdrawal phenomena.
Dose Reduction
Because of the danger of withdrawal, abrupt discontinuation of treatment should be avoided (see WARNINGS, PRECAUTIONS, DRUG ABUSE AND DEPENDENCE).
In all patients, dosage should be reduced gradually when discontinuing therapy or when decreasing the daily dosage. Although there are no systematically collected data to support a specific discontinuation schedule, it is suggested that the daily dosage be decreased by no more than 0.5 mg every three days. Some patients may require an even slower dosage reduction.
In any case, reduction of dose must be undertaken under close supervision and must be gradual. If significant withdrawal symptoms develop, the previous dosing schedule should be reinstituted and, only after stabilization, should a less rapid schedule of discontinuation be attempted. In a controlled postmarketing discontinuation study of panic disorder patients which compared this recommended taper schedule with a slower taper schedule, no difference was observed between the groups in the proportion of patients who tapered to zero dose; however, the slower schedule was associated with a reduction in symptoms associated with a withdrawal syndrome. It is suggested that the dose be reduced by no more than 0.5 mg every three days, with the understanding that some patients may benefit from an even more gradual discontinuation. Some patients may prove resistant to all discontinuation regimens.
Switch from Alprazolam Immediate-Release Tablets to Alprazolam Extended-Release Tablets
Patients who are currently being treated with divided doses of alprazolam (immediate-release) tablets, for example 3 to 4 times a day, may be switched to alprazolam extended-release tablets at the same total daily dose taken once daily. If the therapeutic response after switching is inadequate, the dosage may be titrated as outlined above.
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Alprazolam
Alprazolam extended-release tablets may be administered once daily, preferably in the morning. The tablets should be taken intact; they should not be chewed, crushed, or broken.The suggested total daily dose ranges between 3 to 6 mg/day. Dosage should be individualized for maximum beneficial effect. While the suggested total daily dosages given will meet the needs of most patients, there will be some patients who require doses greater than 6 mg/day. In such cases, dosage should be increased cautiously to avoid adverse effects.Dosing in Special Populations In elderly patients, in patients with advanced liver disease, or in patients with debilitating disease, the usual starting dose of alprazolam extended-release tablets is 0.5 mg once daily. This may be gradually increased if needed and tolerated (see Dose Titration). The elderly may be especially sensitive to the effects of benzodiazepines.
Dose Titration
Treatment with alprazolam extended-release tablets may be initiated with a dose of 0.5 mg to 1 mg once daily. Depending on the response, the dose may be increased at intervals of 3 to 4 days in increments of no more than 1 mg/day. Slower titration to the dose levels may be advisable to allow full expression of the pharmacodynamic effect of alprazolam extended-release tablets.Generally, therapy should be initiated at a low dose to minimize the risk of adverse responses in patients especially sensitive to the drug. Dose should be advanced until an acceptable therapeutic response (i.e., a substantial reduction in or total elimination of panic attacks) is achieved, intolerance occurs, or the maximum recommended dose is attained.Dose Maintenance In controlled trials conducted to establish the efficacy of alprazolam extended-release tablets in panic disorder, doses in the range of 1 to 10 mg/day were used. Most patients showed efficacy in the dose range of 3 to 6 mg/day. Occasional patients required as much as 10 mg/day to achieve a successful response.The necessary duration of treatment for panic disorder patients responding to alprazolam extended-release tablets is unknown. However, periodic reassessment is advised. After a period of extended freedom from attacks, a carefully supervised tapered discontinuation may be attempted, but there is evidence that this may often be difficult to accomplish without recurrence of symptoms and/or the manifestation of withdrawal phenomena.Dose Reduction Because of the danger of withdrawal, abrupt discontinuation of treatment should be avoided (see WARNINGS, PRECAUTIONS, and DRUG ABUSE AND DEPENDENCE).In all patients, dosage should be reduced gradually when discontinuing therapy or when decreasing the daily dosage. Although there are no systematically collected data to support a specific discontinuation schedule, it is suggested that the daily dosage be decreased by no more than 0.5 mg every three days. Some patients may require an even slower dosage reduction.In any case, reduction of dose must be undertaken under close supervision and must be gradual. If significant withdrawal symptoms develop, the previous dosing schedule should be reinstituted and, only after stabilization, should a less rapid schedule of discontinuation be attempted. In a controlled postmarketing discontinuation study of panic disorder patients which compared this recommended taper schedule with a slower taper schedule, no difference was observed between the groups in the proportion of patients who tapered to zero dose; however, the slower schedule was associated with a reduction in symptoms associated with a withdrawal syndrome. It is suggested that the dose be reduced by no more than 0.5 mg every three days, with the understanding that some patients may benefit from an even more gradual discontinuation. Some patients may prove resistant to all discontinuation regimens.Switch from Alprazolam (Immediate-Release) Tablets to Alprazolam Extended-Release Tablets Patients who are currently being treated with divided doses of alprazolam (immediate-release) tablets, for example 3 to 4 times a day, may be switched to alprazolam extended-release tablets at the same total daily dose taken once daily. If the therapeutic response after switching is inadequate, the dosage may be titrated as outlined above.
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![Amoxicillin And Clavulanate Potassium Powder, For Suspension [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=83e8b659-e32d-45ed-84d4-70670e0c1d27&name=amoxicillin-and-clavulanate-potassium-200-and-400-03.jpg)
Amoxicillin And Clavulanate Potassium
Amoxicillin and clavulanate potassium suspension may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when amoxicillin and clavulanate potassium suspension is administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium suspension should be taken at the start of a meal.
2.1 Adults
The usual adult dose is one 500-mg tablet of amoxicillin and clavulanate potassium every 12 hours or one 250-mg tablet of amoxicillin and clavulanate potassium every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one 875-mg tablet of amoxicillin and clavulanate potassium every 12 hours or one 500-mg tablet of amoxicillin and clavulanate potassium every 8 hours. Adults who have difficulty swallowing may be given the 125 mg/5 mL or 250 mg/5 mL suspension in place of the 500-mg tablet. The 200 mg/5 mL suspension or the 400 mg/5 mL suspension may be used in place of the 875-mg tablet.
Two 250-mg tablets of amoxicillin and clavulanate potassium should not be substituted for one 500-mg tablet of amoxicillin and clavulanate potassium. Since both the 250-mg and 500-mg tablets of amoxicillin and clavulanate potassium contain the same amount of clavulanic acid (125 mg, as the potassium salt), two 250-mg tablets are not equivalent to one 500-mg tablet of amoxicillin and clavulanate potassium.
The 250-mg tablet of amoxicillin and clavulanate potassium and the 250-mg chewable tablet should not be substituted for each other, as they are not interchangeable. The 250-mg tablet of amoxicillin and clavulanate potassium and the 250-mg chewable tablet do not contain the same amount of clavulanic acid (as the potassium salt). The 250-mg tablet of amoxicillin and clavulanate potassium contains 125 mg of clavulanic acid, whereas the 250-mg chewable tablet contains 62.5 mg of clavulanic acid.
2.2 Pediatric Patients
Based on the amoxicillin component, amoxicillin and clavulanate potassium suspension should be dosed as follows:
Neonates and Infants Aged <12 weeks (<3 months) : The recommended dose of amoxicillin and clavulanate potassium suspension 30 mg/kg/day divided every 12 hours, based on the amoxicillin component. Experience with the 200 mg/5 mL formulation in this age group is limited, and thus, use of the 125 mg/5 mL oral suspension is recommended.
Patients Aged 12 weeks (3 months) and Older : See dosing regimens provided in Table 1. The every 12 hours regimen is recommended as it is associated with significantly less diarrhea [ see Clinical Studies (14.2) ]. However, the every 12 hours suspension (200 mg/5 mL and 400 mg/5 mL) and chewable tablets (200 mg and 400 mg) contain aspartame and should not be used by phenylketonurics. [ see Warnings and Precautions (5.6) ]
Table 1: Dosing in Patients Aged 12 weeks (3 months) and OlderINFECTION
DOSING REGIMEN
Every 12 hours
Every 8 hours
200 mg/5 mL or 400 mg/5 mL oral suspensiona
125 mg/5 mL or 250 mg/5 mL oral suspensiona
Otitis mediab, sinusitis, lower respiratory tract infections, and more severe infections
45 mg/kg/day every 12 hours
40 mg/kg/day every 8 hours
Less severe infections
25 mg/kg/day every 12 hours
20 mg/kg/day every 8 hours
a Each strength of suspension of amoxicillin and clavulanate potassium is available as a chewable tablet for use by older children. b Duration of therapy studied and recommended for acute otitis media is 10 days.
Patients Weighing 40 kg or More : Pediatric patients weighing 40 kg or more should be dosed according to adult recommendations.
The 250-mg tablet of amoxicillin and clavulanate potassium should not be used until the child weighs at least 40 kg, due to the different amoxicillin to clavulanic acid ratios in the 250-mg tablet of amoxicillin and clavulanate potassium (250/125) versus the 250-mg chewable tablet of amoxicillin and clavulanate potassium (250/62.5).
2.3 Patients with Renal Impairment
Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Renal impairment patients with a glomerular filtration rate of <30 mL/min should not receive the 875-mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.
Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.
2.4 Directions for Mixing Oral Suspension
Prepare a suspension at time of dispensing as follows: Tap bottle until all the powder flows freely. Add approximately 2/3 of the total amount of water for reconstitution (see Table 2 below) and shake vigorously to suspend powder. Add remainder of the water and again shake vigorously.
Table 2: Amount of Water for Mixing Oral SuspensionStrength
Bottle Size
Amount of Water for Reconstitution
Contents of Each Teaspoonful (5 mL)
200 mg/5 mL
50 mL75 mL100 mL
48 mL71 mL95 mL
200 mg amoxicillin and 28.5 mg of clavulanic acid as the potassium salt
400 mg/5 mL
50 mL 75 mL 100 mL
45 mL 68 mL 90 mL
400 mg amoxicillin and 57.0 mg of clavulanic acid as the potassium salt
Note: Shake oral suspension well before using. Reconstituted suspension must be stored under refrigeration and discarded after 10 days.
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![Folic Acid Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=dbb9324c-8d42-474c-aea7-b2ba5490ec29&name=folic-acid-tablets-2.jpg)
Folic Acid
Oral administration is preferred. Although most patients with malabsorption cannot absorb food folates, they are able to absorb folic acid given orally. Parenteral administration is not advocated but may be necessary in some individuals (e.g., patients receiving parenteral or enteral alimentation). Doses greater than 0.1 mg should not be used unless anemia due to vitamin B12 deficiency has been ruled out or is being adequately treated with cobalamin. Daily doses greater than 1 mg do not enhance the hematologic effect, and most of the excess is excreted unchanged in the urine.
The usual therapeutic dosage in adults and children (regardless of age) is up to 1 mg daily. Resistant cases may require larger doses.
When clinical symptoms have subsided and the blood picture has become normal, a daily maintenance level should be used, i.e., 0.1 mg for infants and up to 0.3 mg for children under 4 years of age, 0.4 mg for adults and children 4 or more years of age, and 0.8 mg for pregnant and lactating women, but never less than 0.1 mg/day. Patients should be kept under close supervision and adjustment of the maintenance level made if relapse appears imminent.
In the presence of alcoholism, hemolytic anemia, anticonvulsant therapy, or chronic infection, the maintenance level may need to be increased.
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Metronidazole
Trichomoniasis In the Female One-day treatment — two grams of metronidazole tablets, given either as a single dose or in two divided doses of one gram each, given in the same day.
Seven-day course of treatment — 250 mg three times daily for seven consecutive days. There is some indication from controlled comparative studies that cure rates as determined by vaginal smears and signs and symptoms, may be higher after a seven-day course of treatment than after a one-day treatment regimen.
The dosage regimen should be individualized. Single-dose treatment can assure compliance, especially if administered under supervision, in those patients who cannot be relied on to continue the seven-day regimen. A seven-day course of treatment may minimize reinfection by protecting the patient long enough for the sexual contacts to obtain appropriate treatment. Further, some patients may tolerate one treatment regimen better than the other.
Pregnant patients should not be treated during the first trimester (see CONTRAINDICATIONS). In pregnant patients for whom alternative treatment has been inadequate, the one-day course of therapy should not be used, as it results in higher serum levels which can reach the fetal circulation (see PRECAUTIONS, Pregnancy .
When repeat courses of the drug are required, it is recommended that an interval of four to six weeks elapse between courses and that the presence of the trichomonad be reconfirmed by appropriate laboratory measures. Total and differential leukocyte counts should be made before and after re-treatment.
In the Male
Treatment should be individualized as it is for the female.
Amebiasis
Adults
For acute intestinal amebiasis (acute amebic dysentery): 750 mg orally three times daily for 5 to 10 days.
For amebic liver abscess: 500 mg or 750 mg orally three times daily for 5 to 10 days.
Pediatric patients
35 to 50 mg/kg/24 hours, divided into three doses, orally for 10 days.
Anaerobic Bacterial Infections
In the treatment of most serious anaerobic infections, intravenous metronidazole is usually administered initially.
The usual adult oraldosage is 7.5 mg/kg every six hours (approx. 500 mg for a 70 kg adult). A maximum of 4 g should not be exceeded during a 24-hour period.
The usual duration of therapy is 7 to 10 days; however, infections of the bone and joint, lower respiratory tract, and endocardium may require longer treatment.
Dosage Adjustments
Patients with Severe Hepatic Impairment
For patients with severe hepatic
impairment (Child-Pugh C), the dose of metronidazole should be reduced by 50% (see CLINICAL PHARMACOLOGY and PRECAUTIONS).
Patients Undergoing Hemodialysis:
Hemodialysis removes significant amounts of metronidazole and its metabolites from systemic circulation. The clearance of metronidazole will depend on the type of dialysis membrane used, the duration of the dialysis session, and other factors. If the administration of metronidazole cannot be separated from the hemodialysis session, supplementation of metronidazole dosage following the hemodialysis session should be considered, depending on the patient’s clinical situation (see CLINICAL PHARMACOLOGY).
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Metronidazole
There is currently no dosage information available for this product. We apologize for any inconvenience.
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![Amoxicillin Capsule [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=c7563d60-e2bf-4384-b9ee-c9e8c45b509b&name=amoxicillin-fig1.jpg)
Amoxicillin
2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age
Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.
Table 1. Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age Infection Severitya Usual Adult Dose Usual Dose for Children > 3 Monthsb a Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections. b The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.Ear/Nose/Throat Skin/Skin Structure Genitourinary Tract
Mild/Moderate
500 mg every 12 hours or 250 mg every 8 hours
25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours
Severe
875 mg every 12 hours or 500 mg every 8 hours
45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours
Lower Respiratory Tract
Mild/Moderate or Severe
875 mg every 12 hours or 500 mg every 8 hours
45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours
Gonorrhea Acute, uncomplicated ano -genital and urethral infections in males and females
3 grams as single oral dose
Prepubertal children: 50 mg/kg amoxicillin, combined with 25 mg/kg probenecid as a single dose. Note: Since probenecid is contraindicated in children under 2 years, do not use this regimen in children under 2 years of age.
2.2 Dosing in Neonates and Infants Aged ≤ 12 Weeks ( ≤ 3 Months)
Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin capsules is 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function.
2.3 Dosing for H. pylori Infection
Triple Therapy: The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days. Dual Therapy: The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days. Please refer to clarithromycin and lansoprazole full prescribing information.
2.4 Dosing in Renal Impairment
• Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. • Severely impaired patients with a glomerular filtration rate of < 30 mL/min should not receive a 875 mg dose. • Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. • Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. • Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis. -
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Amoxicillin
2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age
Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.
Table 1. Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age Infection Severitya Usual Adult Dose Usual Dose for Children > 3 Monthsb a Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections. b The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.Ear/Nose/Throat Skin/Skin Structure Genitourinary Tract
Mild/Moderate
500 mg every 12 hours or 250 mg every 8 hours
25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours
Severe
875 mg every 12 hours or 500 mg every 8 hours
45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours
Lower Respiratory Tract
Mild/Moderate or Severe
875 mg every 12 hours or 500 mg every 8 hours
45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours
Gonorrhea Acute, uncomplicated ano -genital and urethral infections in males and females
3 grams as single oral dose
Prepubertal children: 50 mg/kg amoxicillin, combined with 25 mg/kg probenecid as a single dose. Note: Since probenecid is contraindicated in children under 2 years, do not use this regimen in children under 2 years of age.
2.2 Dosing in Neonates and Infants Aged ≤ 12 Weeks ( ≤ 3 Months)
Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin capsules is 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function.
2.3 Dosing for H. pylori Infection
Triple Therapy: The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days. Dual Therapy: The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days. Please refer to clarithromycin and lansoprazole full prescribing information.
2.4 Dosing in Renal Impairment
• Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. • Severely impaired patients with a glomerular filtration rate of < 30 mL/min should not receive a 875 mg dose. • Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. • Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. • Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis. -
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Amoxicillin
2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age
Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.
Table 1. Dosing Recommendations for Adult and Pediatric Patients > 3 Months of AgeInfection
Severity a
Usual Adult Dose
Usual Dose for Children > 3 Monthsb
Ear/Nose/ThroatSkin/ Skin StructureGenitourinary Tract
Mild/Moderate
500 mg every 12 hours or 250 mg every 8 hours
25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours
Severe
875 mg every 12 hours or 500 mg every 8 hours
45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours
Lower Respiratory Tract
Mild/Moderate or Severe
875 mg every 12 hours or 500 mg every 8 hours
45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours
GonorrheaAcute, uncomplicated ano-genital and urethral infections in males and females
3 grams as single oral dose
Prepubertal children:50 mg/kg amoxicillin, combined with 25 mg/kg probenecid as a single dose.Note: since probenecid is contraindicated in children under 2 years. Do not use this regimen in children under 2 years of age.
a Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections.b The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.
2.2 Dosing in Neonates and Infants Aged ≤ 12 Weeks (≤ 3 Months)
Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function.
2.3 Dosing for H. pylori Infection
Triple therapy: The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days.
Dual therapy: The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days.
Please refer to clarithromycin and lansoprazole full prescribing information.
2.4 Dosing in Renal Impairment
• Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. • Severely impaired patients with a glomerular filtration rate of < 30 mL/min. should not receive a 875-mg dose. • Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. • Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. • Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.2.5 Directions for Mixing Oral Suspension
Tap bottle until all powder flows freely. Add approximately 1/3 of the total amount of water for reconstitution (see Table 2) and shake vigorously to wet powder. Add remainder of the water and again shake vigorously.
Table 2. Amount of Water for Mixing Oral SuspensionStrength
Bottle Size
Amount of Water Required for Reconstitution
Oral Suspension 125 mg /5 mL
80 mL
66 mL
100 mL
83 mL
150 mL
125 mL
Oral Suspension 200 mg /5 mL
50 mL
39 mL
75 mL
59 mL
100 mL
78 mL
Oral Suspension 250 mg /5 mL
80 mL
59 mL
100 mL
73 ml
150 mL
110 mL
Oral Suspension 400 mg /5 mL
50 mL
34 mL
75 mL
51 mL
100 mL
68 mL
After reconstitution, the required amount of suspension should be placed directly on the child’s tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately.
NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration is preferable, but not required.
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![Tonymoly Floria Whitening Essence (Dimethicone) Cream [Tonymoly Co., Ltd.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=918f50d4-5468-400e-b51f-72ac883af46e&name=918f50d4-5468-400e-b51f-72ac883af46e-08.jpg)
Tonymoly Floria Whitening Essence
The recommended dose is one applicator full of Metronidazole Vaginal Gel (approximately 5 grams containing approximately 37.5 mg of metronidazole) intravaginally once or twice a day for 5 days. For once a day dosing, Metronidazole Vaginal Gel should be administered at bedtime.
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![Ak-con (Naphazoline Hydrochloride) Solution/ Drops [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=8d353143-cd29-4a5f-9d67-293a6322e088&name=nap02-0000-02.jpg)
Ak-con
Instill one or two drops in the conjunctival sac(s) every three to four hours as needed.
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![Amoxicillin Capsule [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=b44a012a-d4d3-4383-8770-ce37367704ee&name=amoxicillin-2.jpg)
Amoxicillin
Amoxicillin capsules may be given without regard to meals. However, food effect studies have not been performed with the 500 mg formulation.
Neonates and infants aged ≤ 12 weeks (≤ 3 months):
Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided q12h.
Adults and pediatric patients >3 months: * Dosing for infections caused by less susceptible organisms should follow the recommendations for severe infections. † The children's dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.Infection
Severity*
Usual
Usual Dose
Adult Dose
for Children
>3 months†
Ear/nose/throat
Mild/Moderate
500 mg
25 mg/kg/day
every 12 hours
in divided doses
or
every 12 hours
250 mg
or
every 8 hours
20 mg/kg/day
in divided doses
every 8 hours
Severe
875 mg
45 mg/kg/day
every 12 hours
in divided doses
or
every 12 hours
500 mg
or
every 8 hours
40 mg/kg/day
in divided doses
every 8 hours
Lower respiratory
Mild/Moderate
875 mg
45 mg/kg/day
Tract
or Severe
every 12 hours
in divided doses
or
every 12 hours
500 mg every
or
8 hours
40 mg/kg/day
in divided doses
every 8 hours
Skin/Skin
Mild/Moderate
500 mg
25 mg/kg/day
Structure
every 12 hours
in divided doses
or
every 12 hours
250 mg every
or
8 hours
20 mg/kg/day
in divided doses
every 8 hours
Severe
875 mg
45 mg/kg/day
every 12 hours
in divided doses
or
every 12 hours
500 mg every
or
8 hours
40 mg/kg/day
in divided doses
every 8 hours
Genitourinary
Mild/Moderate
500 mg
25 mg/kg/day
Tract
every 12 hours
in divided doses
or
every 12 hours
250 mg every
or
8 hours
20 mg/kg/day
in divided doses
every 8 hours
Severe
875 mg
45 mg/kg/day
every 12 hours
in divided doses
or
every 12 hours
500 mg
or
every 8 hours
40 mg/kg/day
in divided doses
every 8 hours
Gonorrhea
3 grams
Prepubertal children:
Acute,
as
50 mg/kg amoxicillin combined with
uncomplicated
single oral dose
25 mg/kg probenecid as a single dose.
ano-genital and
NOTE: SINCE PROBENECID IS CONTRA-
urethral infections in males and females
INDICATED IN CHILDREN UNDER 2 YEARS. DO NOT USE THIS REGIMEN IN THESE CASES.
All patients with gonorrhea should be evaluated for syphilis. (See PRECAUTIONS - Laboratory Tests.)
Larger doses may be required for stubborn or severe infections.
General:
It should be recognized that in the treatment of chronic urinary tract infections, frequent bacteriological and clinical appraisals are necessary. Smaller doses than those recommended above should not be used. Even higher doses may be needed at times. In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy. Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days' treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever.
H. pylori eradication to reduce the risk of duodenal ulcer recurrence:
Triple therapy:
Amoxicillin/clarithromycin/lansoprazole
The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (q12h) for 14 days. (See INDICATIONS AND USAGE.)
Dual therapy:
Amoxicillin/lansoprazole
The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (q8h) for 14 days. (See INDICATIONS AND USAGE.)
Please refer to clarithromycin and lansoprazole full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally impaired patients.
Dosing recommendations for adults with impaired renal function:
Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of <30 mL/min. should not receive the 875-mg tablet. Patients with a glomerular filtration rate of 10 to 30 mL/min. should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/minute glomerular filtration rate should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.
Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.
There are currently no dosing recommendations for pediatric patients with impaired renal function.
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![Amoxicillin Powder, For Suspension [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=88e76bdd-39f2-48c4-91ca-609511afd382&name=fa7c7427-a6b2-4b4b-b9b0-3dcafacd375e-06.jpg)
Amoxicillin
2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age
Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenesto prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.
Table 1. Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age Infection Severity* Usual Adult Dose Usual Dose for Children > 3 Months† * Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections. † The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations. Ear/Nose/Throat Skin/Skin Structure Genitourinary TractMild/Moderate
500 mg every 12 hours or 250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hoursSevere
875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours Lower Respiratory Tract Mild/Moderate or Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hoursor
40 mg/kg/day in divided doses
every 8 hours
Gonorrhea
Acute, uncomplicated
ano-genital and urethral infections in males and females
3 grams as single oral dose
Prepubertal children:
50 mg/kg amoxicillin, combined with 25 mg/kg probenecid as a single dose.
Note: since probenecid is contraindicated in children under 2 years, do not use this regimen in children under 2 years of age.
2.2 Dosing in Neonates and Infants Aged ≤ 12 Weeks (≤ 3 Months)
Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenesto prevent the occurrence of acute rheumatic fever. Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function.
2.3 Dosing for H. pylori Infection
Triple therapy: The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days.
Dual therapy: The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days.
Please refer to clarithromycin and lansoprazole full prescribing information.
2.4 Dosing in Renal Impairment
• Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. • Severely impaired patients with a glomerular filtration rate of < 30 mL/min. should not receive a 875-mg dose. • Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. • Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. • Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.2.5 Directions for Mixing Oral Suspension
Tap bottle until all powder flows freely. Add approximately 1/3 of the total amount of water for reconstitution (see Table 2) and shake vigorously to wet powder. Add remainder of the water and again shake vigorously.
Table 2. Amount of Water for Mixing Oral Suspension Strength Bottle Size Amount of Water Required for ReconstitutionOral Suspension 125 mg/5 mL
80 mL
55 mL
100 mL
68 mL
150 mL
102 mL
Oral Suspension 200 mg/5 mL
50 mL
34 mL
75 mL
51 mL
100 mL
68 mL
Oral Suspension 250 mg/5 mL
80 mL
55 mL
100 mL
68 mL
150 mL
102 mL
Oral Suspension 400 mg/5 mL
50 mL
34 mL
75 mL
51 mL
100 mL
68 mL
After reconstitution, the required amount of suspension should be placed directly on the child’s tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately.
NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration is preferable, but not required.
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![Burberry Fresh Glow B.b. Luminous Skin Perfecting Beauty Balm Sunscreen Broad Spectrum Spf 20 Fair 01 (Octinoxate, Titanium Dioxide) Cream [Burberry Limited]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=d719366b-8316-4d16-91e3-e1be52337f5b&name=023264db-0a45-4ca0-8d09-ed51cc15a5cb-02.jpg)
Burberry Fresh Glow B.b. Luminous Skin Perfecting Beauty Balm Sunscreen Broad Spectrum Spf 20 Fair 01
Dosage must be adjusted to individual patient needs.
2.1 Oral Dosage and Administration in Adults
The recommended initial dose is 20 mg four times a day.
After one week treatment with the initial dose, the dose may be increased to 40 mg four times a day unless side effects limit dosage escalation.
If efficacy is not achieved within 2 weeks or side effects require doses below 80 mg per day, the drug should be discontinued. Documented safety data are not available for doses above 80 mg daily for periods longer than 2 weeks.
-
Severe Cold And Flu Relief
Dosage should be adjusted according to the severity of the pain and the response of the patient. However, it should be kept in mind that tolerance to hydrocodone can develop with continued use and that the incidence of untoward effects is dose related.
The usual adult dosage is one tablet every four to six hours as needed for pain. The total daily dose should not exceed 6 tablets.
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![Antipyrine And Benzocaine Solution [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=9cf27708-0c6f-4586-a4cd-0e8fde7a61b1&name=eebb3171-figure-03.jpg)
Antipyrine And Benzocaine Solution
Acute otitis media: Instill Antipyrine and Benzocaine Otic Solution, permitting the solution to run along the wall of the ear canal until it is filled. Avoid touching the ear with dropper. Then moisten a cotton pledget with Antipyrine and Benzocaine Otic Solution and insert into meatus. Repeat every one to two hours until pain and congestion are relieved.
Removal of Cerumen:
Before: Instill Antipyrine and Benzocaine Otic Solution three times daily for two or three days to help detach cerumen from wall of ear canal and facilitate removal.
After: Antipyrine and Benzocaine Otic Solution is useful for drying out the ear canal or relieving discomfort.
Before and after removal of cerumen, a cotton pledget moistened with Antipyrine and Benzocaine Otic Solution should be inserted into the meatus following instillation.
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![Ciprofloxacin (Ciprofloxacin Hydrochloride) Solution/ Drops [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=b9eae7c0-4a58-44c4-9e10-aef2dd379c5d&name=ciprofloxacin_7229_7588-figure-2-Ciprofloxacin_Ophthalmic_2.5_mL_-_PDP.jpg.jpg)
Ciprofloxacin
Corneal Ulcers: The recommended dosage regimen for the treatment of corneal ulcers is two drops into the affected eye every 15 minutes for the first six hours and then two drops into the affected eye every 30 minutes for the remainder of the first day. On the second day, instill two drops in the affected eye hourly. On the third through the fourteenth day, place two drops in the affected eye every four hours. Treatment may be continued after 14 days if corneal re-epithelialization has not occurred.
Bacterial Conjunctivitis: The recommended dosage regimen for the treatment of bacterial conjunctivitis is one or two drops instilled into the conjunctival sac(s) every two hours while awake for two days and one or two drops every four hours while awake for the next five days.
How Supplied: As a sterile ophthalmic solution, in a plastic dispenser:
5 mL - 68788-9391-5
STORAGE: Store at 25°C (77°F); excursions permitted to15 - 30°C (59 - 86°F) [See USP controlled room temperature]. Protect from light. Retain in carton until contents are used.
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![Erythromycin Ointment [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=d8952bd4-927b-4bdf-8e13-95a08fca2784&name=87b45f99-a4d1-47e0-bbb6-50ca19c10010-02.jpg)
Erythromycin Ointment
In the treatment of superficial ocular infections, a ribbon approximately 1 cm in length of Erythromycin Ophthalmic Ointment should be applied directly to the infected structure up to 6 times daily, depending on the severity of the infection. For prophylaxis of neonatal gonococcal or chlamydial conjunctivitis, a ribbon of ointment approximately 1 cm in length should be instilled into each lower conjunctival sac. The ointment should not be flushed from the eye following instillation. A new tube should be used for each infant.
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![Atenolol Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=aa39a909-3ce1-4350-8dfb-6b2a32c41729&name=atenololtabs-figure-02.jpg)
Atenolol
Hypertension
The initial dose of atenolol is 50 mg given as one tablet a day either alone or added to diuretic therapy. The full effect of this dose will usually be seen within one to two weeks. If an optimal response is not achieved, the dosage should be increased to atenolol 100 mg given as one tablet a day. Increasing the dosage beyond 100 mg a day is unlikely to produce any further benefit.
Atenolol may be used alone or concomitantly with other antihypertensive agents including thiazide-type diuretics, hydralazine, prazosin, and alpha-methyldopa.
Angina Pectoris
The initial dose of atenolol is 50 mg given as one tablet a day. If an optimal response is not achieved within one week, the dosage should be increased to atenolol 100 mg given as one tablet a day. Some patients may require a dosage of 200 mg once a day for optimal effect.
Twenty-four hour control with once daily dosing is achieved by giving doses larger than necessary to achieve an immediate maximum effect. The maximum early effect on exercise tolerance occurs with doses of 50 to 100 mg, but at these doses the effect at 24 hours is attenuated, averaging about 50% to 75% of that observed with once a day oral doses of 200 mg.
Acute Myocardial Infarction
In patients with definite or suspected acute myocardial infarction, treatment with atenolol I.V. injection should be initiated as soon as possible after the patient’s arrival in the hospital and after eligibility is established. Such treatment should be initiated in a coronary care or similar unit immediately after the patient’s hemodynamic condition has stabilized. Treatment should begin with the intravenous administration of 5 mg atenolol over 5 minutes followed by another 5 mg intravenous injection 10 minutes later. Atenolol I.V. injection should be administered under carefully controlled conditions including monitoring of blood pressure, heart rate, and electrocardiogram. Dilutions of atenolol I.V. injection in Dextrose Injection USP, Sodium Chloride Injection USP, or Sodium Chloride and Dextrose Injection may be used. These admixtures are stable for 48 hours if they are not used immediately.
In patients who tolerate the full intravenous dose (10 mg), atenolol tablets 50 mg should be initiated 10 minutes after the last intravenous dose followed by another 50 mg oral dose 12 hours later. Thereafter, atenolol can be given orally either 100 mg once daily or 50 mg twice a day for a further 6 to 9 days or until discharge from the hospital. If bradycardia or hypotension requiring treatment or any other untoward effects occur, atenolol should be discontinued. (See full prescribing information prior to initiating therapy with atenolol tablets.)
Data from other beta-blocker trials suggest that if there is any question concerning the use of IV beta-blocker or clinical estimate that there is a contraindication, the IV beta-blocker may be eliminated and patients fulfilling the safety criteria may be given atenolol tablets 50 mg twice daily or 100 mg once a day for at least seven days (if the IV dosing is excluded).
Although the demonstration of efficacy of atenolol is based entirely on data from the first seven postinfarction days, data from other beta-blocker trials suggest that treatment with beta-blockers that are effective in the postinfarction setting may be continued for one to three years if there are no contraindications.
Atenolol is an additional treatment to standard coronary care unit therapy.
Elderly Patients or Patients with Renal Impairment
Atenolol is excreted by the kidneys; consequently dosage should be adjusted in cases of severe impairment of renal function. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Evaluation of patients with hypertension or myocardial infarction should always include assessment of renal function. Atenolol excretion would be expected to decrease with advancing age.
No significant accumulation of atenolol occurs until creatinine clearance falls below 35 mL/min/1.73 m2.Accumulation of atenolol and prolongation of its half-life were studied in subjects with creatinine clearance between 5 and 105 mL/min. Peak plasma levels were significantly increased in subjects with creatinine clearances below 30 mL/min.
The following maximum oral dosages are recommended for elderly, renally-impaired patients and for patients with renal impairment due to other causes:
Creatinine Clearance(mL/min/1.73 m2)
AtenololElimination Half-Life(h)
Maximum Dosage
15 to 35
16 to 27
50 mg daily
< 15
> 27
25 mg daily
Some renally-impaired or elderly patients being treated for hypertension may require a lower starting dose of atenolol: 25 mg given as one tablet a day. If this 25 mg dose is used, assessment of efficacy must be made carefully. This should include measurement of blood pressure just prior to the next dose ("trough" blood pressure) to ensure that the treatment effect is present for a full 24 hours.
Although a similar dosage reduction may be considered for elderly and/or renally-impaired patients being treated for indications other than hypertension, data are not available for these patient populations.
Patients on hemodialysis should be given 25 mg or 50 mg after each dialysis; this should be done under hospital supervision as marked falls in blood pressure can occur.
Cessation of Therapy in Patients with Angina Pectoris
If withdrawal of atenolol therapy is planned, it should be achieved gradually and patients should be carefully observed and advised to limit physical activity to a minimum.
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![Simvastatin Tablet, Film Coated [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=7d12557a-a156-4ca4-9926-a3da5addd65e&name=simvastatin-fig5.jpg)
Simvastatin
2.1 Recommended Dosing
The usual dosage range is 5 to 40 mg/day. In patients with CHD or at high risk of CHD, simvastatin tablets can be started simultaneously with diet. The recommended usual starting dose is 10 or 20 mg once a day in the evening. For patients at high risk for a CHD event due to existing CHD, diabetes, peripheral vessel disease, history of stroke or other cerebrovascular disease, the recommended starting dose is 40 mg/day. Lipid determinations should be performed after 4 weeks of therapy and periodically thereafter.
2.2 Restricted Dosing for 80 mg
Due to the increased risk of myopathy, including rhabdomyolysis, particularly during the first year of treatment, use of the 80 mg dose of simvastatin tablets should be restricted to patients who have been taking simvastatin 80 mg chronically (e.g., for 12 months or more) without evidence of muscle toxicity [see Warnings and Precautions (5.1)].Patients who are currently tolerating the 80 mg dose of simvastatin tablets who need to be initiated on an interacting drug that is contraindicated or is associated with a dose cap for simvastatin should be switched to an alternative statin with less potential for the drug-drug interaction.Due to the increased risk of myopathy, including rhabdomyolysis, associated with the 80 mg dose of simvastatin tablets, patients unable to achieve their LDL-C goal utilizing the 40 mg dose of simvastatin tablets should not be titrated to the 80 mg dose, but should be placed on alternative LDL-C-lowering treatment(s) that provides greater LDL-C lowering.
2.3 Coadministration with Other Drugs
Patients taking Verapamil, Diltiazem, or Dronedarone
• The dose of simvastatin tablets should not exceed 10 mg/day [see Warnings and Precautions (5.1), Drug Interactions (7.3), and Clinical Pharmacology (12.3)].Patients taking Amiodarone, Amlodipine or Ranolazine
• The dose of simvastatin tablets should not exceed 20 mg/day [see Warnings and Precautions (5.1), Drug Interactions (7.3), and Clinical Pharmacology (12.3)].2.4 Patients with Homozygous Familial Hypercholesterolemia
The recommended dosage is 40 mg/day in the evening [see Dosage and Administration, Restricted Dosing for 80 mg (2.2)]. Simvastatin tablets should be used as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) in these patients or if such treatments are unavailable.
Simvastatin exposure is approximately doubled with concomitant use of lomitapide; therefore, the dose of simvastatin tablets should be reduced by 50% if initiating lomitapide. Simvastatin tablets dosage should not exceed 20 mg/day (or 40 mg/day for patients who have previously taken simvastatin tablets 80 mg/day chronically, e.g., for 12 months or more, without evidence of muscle toxicity) while taking lomitapide.
2.5 Adolescents (10 to 17 years of age) with Heterozygous Familial Hypercholesterolemia
The recommended usual starting dose is 10 mg once a day in the evening. The recommended dosing range is 10 to 40 mg/day; the maximum recommended dose is 40 mg/day. Doses should be individualized according to the recommended goal of therapy [see NCEP Pediatric Panel Guidelines1 and Clinical Studies (14.2)]. Adjustments should be made at intervals of 4 weeks or more.————————————1National Cholesterol Education Program (NCEP): Highlights of the Report of the Expert Panel on Blood Cholesterol Levels in Children and Adolescents. Pediatrics. 89(3):495-501. 1992.
2.6 Patients with Renal Impairment
Because simvastatin tablets do not undergo significant renal excretion, modification of dosage should not be necessary in patients with mild to moderate renal impairment. However, caution should be exercised when simvastatin tablets are administered to patients with severe renal impairment; such patients should be started at 5 mg/day and be closely monitored [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.3)].
2.7 Chinese Patients Taking Lipid-Modifying Doses (greater than or equal to 1 g/day Niacin) of Niacin-Containing Products
Because of an increased risk for myopathy in Chinese patients taking simvastatin 40 mg coadministered with lipid-modifying doses (greater than or equal to 1 g/day niacin) of niacin-containing products, caution should be used when treating Chinese patients with simvastatin doses exceeding 20 mg/day coadministered with lipid-modifying doses of niacin-containing products. Because the risk for myopathy is dose-related, Chinese patients should not receive simvastatin 80 mg coadministered with lipid-modifying doses of niacin-containing products. The cause of the increased risk of myopathy is not known. It is also unknown if the risk for myopathy with coadministration of simvastatin with lipid-modifying doses of niacin-containing products observed in Chinese patients applies to other Asian patients. [See Warnings and Precautions (5.1).]
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![Furosemide Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=77bee32b-743c-424a-ad50-926e19e1cf95&name=furosemidetabs-figure-02.jpg)
Furosemide
Edema
Therapy should be individualized according to patient response to gain maximal therapeutic response and to determine the minimal dose needed to maintain that response.
Adults -- The usual initial dose of furosemide tablets, USP is 20 to 80 mg given as a single dose. Ordinarily a prompt diuresis ensues. If needed, the same dose can be administered 6 to 8 hours later or the dose may be increased. The dose may be raised by 20 or 40 mg and given not sooner than 6 to 8 hours after the previous dose until the desired diuretic effect has been obtained. The individually determined single dose should then be given once or twice daily (e.g., at 8 am and 2 pm). The dose of furosemide tablets, USP may be carefully titrated up to 600 mg/day in patients with clinically severe edematous states.
Edema may be most efficiently and safely mobilized by giving furosemide tablets, USP on 2 to 4 consecutive days each week.
When doses exceeding 80 mg/day are given for prolonged periods, careful clinical observation and laboratory monitoring are particularly advisable. (See PRECAUTIONS: Laboratory Tests)
Geriatric patients -- In general, dose selection for the elderly patient should be cautious, usually starting at the low end of the dosing range (see PRECAUTIONS: Geriatric Use).
Pediatric patients -- The usual initial dose of furosemide tablets, USP in pediatric patients is 2 mg/kg body weight, given as a single dose. If the diuretic response is not satisfactory after the initial dose, dosage may be increased by 1 or 2 mg/kg no sooner than 6 to 8 hours after the previous dose. Doses greater than 6 mg/kg body weight are not recommended. For maintenance therapy in pediatric patients, the dose should be adjusted to the minimum effective level.
Hypertension
Therapy should be individualized according to the patient’s response to gain maximal therapeutic response and to determine the minimal dose needed to maintain the therapeutic response.
Adults -- The usual initial dose of furosemide tablets, USP for hypertension is 80 mg, usually divided into 40 mg twice a day. Dosage should then be adjusted according to response. If response is not satisfactory, add other antihypertensive agents.
Changes in blood pressure must be carefully monitored when furosemide tablets, USP are used with other antihypertensive drugs, especially during initial therapy. To prevent excessive drop in blood pressure, the dosage of other agents should be reduced by at least 50 percent when furosemide tablets, USP are added to the regimen. As the blood pressure falls under the potentiating effect of furosemide tablets, USP a further reduction in dosage or even discontinuation of other antihypertensive drugs may be necessary.
Geriatric patients -- In general, dose selection and dose adjustment for the elderly patient should be cautious, usually starting at the low end of the dosing range (see PRECAUTIONS: Geriatric Use).
-
![Furosemide Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=e75f371f-a4fe-44ed-a510-c6f9825f236e&name=furosemidetabs-figure-03.jpg)
Furosemide
Edema
Therapy should be individualized according to patient response to gain maximal therapeutic response and to determine the minimal dose needed to maintain that response.
Adults -- The usual initial dose of furosemide tablets, USP is 20 to 80 mg given as a single dose. Ordinarily a prompt diuresis ensues. If needed, the same dose can be administered 6 to 8 hours later or the dose may be increased. The dose may be raised by 20 or 40 mg and given not sooner than 6 to 8 hours after the previous dose until the desired diuretic effect has been obtained. The individually determined single dose should then be given once or twice daily (e.g., at 8 am and 2 pm). The dose of furosemide tablets, USP may be carefully titrated up to 600 mg/day in patients with clinically severe edematous states.
Edema may be most efficiently and safely mobilized by giving furosemide tablets, USP on 2 to 4 consecutive days each week.
When doses exceeding 80 mg/day are given for prolonged periods, careful clinical observation and laboratory monitoring are particularly advisable. (See PRECAUTIONS: Laboratory Tests)
Geriatric patients -- In general, dose selection for the elderly patient should be cautious, usually starting at the low end of the dosing range (see PRECAUTIONS: Geriatric Use).
Pediatric patients -- The usual initial dose of furosemide tablets, USP in pediatric patients is 2 mg/kg body weight, given as a single dose. If the diuretic response is not satisfactory after the initial dose, dosage may be increased by 1 or 2 mg/kg no sooner than 6 to 8 hours after the previous dose. Doses greater than 6 mg/kg body weight are not recommended. For maintenance therapy in pediatric patients, the dose should be adjusted to the minimum effective level.
Hypertension
Therapy should be individualized according to the patient’s response to gain maximal therapeutic response and to determine the minimal dose needed to maintain the therapeutic response.
Adults -- The usual initial dose of furosemide tablets, USP for hypertension is 80 mg, usually divided into 40 mg twice a day. Dosage should then be adjusted according to response. If response is not satisfactory, add other antihypertensive agents.
Changes in blood pressure must be carefully monitored when furosemide tablets, USP are used with other antihypertensive drugs, especially during initial therapy. To prevent excessive drop in blood pressure, the dosage of other agents should be reduced by at least 50 percent when furosemide tablets, USP are added to the regimen. As the blood pressure falls under the potentiating effect of furosemide tablets, USP a further reduction in dosage or even discontinuation of other antihypertensive drugs may be necessary.
Geriatric patients -- In general, dose selection and dose adjustment for the elderly patient should be cautious, usually starting at the low end of the dosing range (see PRECAUTIONS: Geriatric Use).
-
![Azithromycin Powder, For Suspension [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=86071c7f-9f11-4783-9492-22beb55682e6&name=azithromycin-04.jpg)
Azithromycin
(See INDICATIONS AND USAGE.)
Azithromycin for oral suspension (single dose 1 g packet) can be taken with or without food after constitution. Not for pediatric use. For pediatric suspension, please refer to the INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION sections of the prescribing information for azithromycin for oral suspension 100 mg/5 mL and 200 mg/5 mL bottles.
Azithromycin tablets may be taken without regard to food. However, increased tolerability has been observed when tablets are taken with food.
The recommended dose of azithromycin for the treatment of non-gonococcal urethritis and cervicitis due to C. trachomatis is: a single 1 gram (1000 mg) dose of azithromycin. This dose can be administered as one single dose packet (1 g).
Prevention of Disseminated MAC Infections
The recommended dose of azithromycin for the prevention of disseminated Mycobacterium avium complex (MAC) disease is: 1200 mg taken once weekly. This dose of azithromycin may be combined with the approved dosage regimen of rifabutin.
Treatment of Disseminated MAC Infections
Azithromycin should be taken at a daily dose of 600 mg, in combination with ethambutol at the recommended daily dose of 15 mg/kg. Other antimycobacterial drugs that have shown in vitro activity against MAC may be added to the regimen of azithromycin plus ethambutol at the discretion of the physician or health care provider.
DIRECTIONS FOR ADMINISTRATION OF Azithromycin for oral suspension in the single dose packet (1 g)
The entire contents of the packet should be mixed thoroughly with two ounces (approximately 60 mL) of water. Drink the entire contents immediately; add an additional two ounces of water, mix, and drink to assure complete consumption of dosage. The single dose packet should not be used to administer doses other than 1000 mg of azithromycin. This packet not for pediatric use.
Renal Insufficiency
No dosage adjustment is recommended for subjects with renal impairment (GFR≤80mL/min). The mean AUC 0–120 was similar in subjects with GFR 10–80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR<10mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY-Renal Insufficiency.)
Hepatic Insufficiency
The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dosage adjustment recommendations can be made in patients with impaired hepatic function. (See CLINICAL PHARMACOLOGY-Hepatic Impairment.)
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![Azithromycin (Azithromycin Monohydrate) Powder, For Suspension [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=51835dc6-68c7-44b0-980c-f9b38b8d7203&name=c6aa18fa-b954-42f2-905f-09546792aed8-02.jpg)
Azithromycin
(See INDICATIONS AND USAGE and CLINICAL PHARMACOLOGY.)
Adults
* DUE TO THE INDICATED ORGANISMS (see INDICATIONS AND USAGE).Infection*
Recommended Dose/Duration of Therapy
Community-Acquired Pneumonia (Mild Severity) Pharyngitis/Tonsillitis (Second Line Therapy) Skin/Skin Structure (Uncomplicated)
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5.
Acute Bacterial Exacerbations of Chronic Obstructive Pulmonary Disease (Mild to Moderate)
500 mg QD × 3 days OR 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5.
Acute Bacterial Sinusitis
500 mg QD × 3 days
Genital Ulcer Disease (Chancroid)
One single 1 gram dose
Non-Gonococcal Urethritis and Cervicitis
One single 1 gram dose
Gonococcal Urethritis and Cervicitis
One single 2 gram dose
Azithromycin tablets can be taken with or without food.
Renal Insufficiency
No dosage adjustment is recommended for subjects with renal impairment (GFR ≤ 80 mL/min). The mean AUC0 to 120 was similar in subjects with GFR 10 to 80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR < 10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment (see CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency).
Hepatic Insufficiency
The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (see CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency).
No dosage adjustment is recommended based on age or gender (see CLINICAL PHARMACOLOGY, Special Populations).
Pediatric Patients
Azithromycin for Oral Suspension can be taken with or without food.
Acute Otitis Media
The recommended dose of Azithromycin for Oral Suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5 (see chart below).
Acute Bacterial Sinusitis
The recommended dose of Azithromycin for Oral Suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days (see chart below).
Community-Acquired Pneumonia
The recommended dose of Azithromycin for Oral Suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5 (see chart below).
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA, ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 Months and Above, see PRECAUTIONS, Pediatric Use.) Based on Body Weight * Effectiveness of the 3 day or 1 day regimen in pediatric patients with community-acquired pneumonia has not been established.OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5 Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1and 5 mg/kg/day Days 2 to 5.
Weight
100 mg/5 mL
200 mg/5 mL
Total mL per Treatment Course
Total mg per Treatment Course
Kg
Lbs.
Day 1
Days 2 to 5
Day 1
Days 2 to 5
5
11
2.5 mL (½ tsp)
1.25 mL (¼ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
2.5 mL (½ tsp)
15 mL
300 mg
20
44
5 mL (1 tsp)
2.5 mL (½ tsp)
15 mL
600 mg
30
66
7.5 mL (1½ tsp)
3.75 mL (¾ tsp)
22.5 mL
900 mg
40
88
10 mL (2 tsp)
5 mL (1 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL (2½ tsp)
6.25 mL (1¼ tsp)
37.5 mL
1500 mg
* Effectiveness of the 5 day or 1 day regimen in pediatric patients with acute bacterial sinusitis has not been established.OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3 Day Regimen)*
Dosing Calculated on 10 mg/kg/day
Weight
100 mg/5 mL
200 mg/5 mL
Total mL perTreatmentCourse
Total mg perTreatmentCourse
Kg
Lbs.
Day 1 to 3
Day 1 to 3
5
11
2.5 mL (½ tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
15 mL
300 mg
20
44
5 mL (1 tsp)
15 mL
600 mg
30
66
7.5 mL (1½ tsp)
22.5 mL
900 mg
40
88
10 mL (2 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL (2½ tsp)
37.5 mL
1500 mg
OTITIS MEDIA: (1 Day Regimen)
Dosing Calculated on 30 mg/kg as a Single Dose
Weight
200 mg/5 mL
Total mL perTreatment Course
Total mg perTreatment Course
Kg
Lbs.
Day 1
5
11
3.75 mL (¾ tsp)
3.75 mL
150 mg
10
22
7.5 mL (1½ tsp)
7.5 mL
300 mg
20
44
15 mL (3 tsp)
15 mL
600 mg
30
66
22.5 mL (4½ tsp)
22.5 mL
900 mg
40
88
30 mL (6 tsp)
30 mL
1200 mg
50 and above
110 and above
37.5 mL (7½ tsp)
37.5 mL
1500 mg
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/Tonsillitis
The recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days (see chart below).
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS/TONSILLITIS (Age 2 Years and Above, see PRECAUTIONS, Pediatric Use.) Based on Body WeightPHARYNGITIS/TONSILLITIS: (5 Day Regimen)
Dosing Calculated on 12 mg/kg/day for 5 days.
Weight
200 mg/5 mL
Total mL perTreatment Course
Total mg perTreatment Course
Kg
Lbs.
Day 1 to 5
8
18
2.5 mL (½ tsp)
12.5 mL
500 mg
17
37
5 mL (1 tsp)
25 mL
1000 mg
25
55
7.5 mL (1½ tsp)
37.5 mL
1500 mg
33
73
10 mL (2 tsp)
50 mL
2000 mg
40
88
12.5 mL (2½ tsp)
62.5 mL
2500 mg
Constituting instructions for Azithromycin for Oral Suspension USP, 300, 600, 900, and 1200 mg bottles. The table below indicates the volume of water to be used for constitution:
Amount of Water to be Added
Total Volume After Constitution (Azithromycin Content)
Azithromycin Concentration After Constitution
9 mL (300 mg)
15 mL (300 mg)
100 mg/5 mL
9 mL (600 mg)
15 mL (600 mg)
200 mg/5 mL
12 mL (900 mg)
22.5 mL (900 mg)
200 mg/5 mL
15 mL (1200 mg)
30 mL (1200 mg)
200 mg/5 mL
Shake well before each use. Oversized bottle provides shake space. Keep tightly closed.
After mixing, store suspension at 5° to 30°C (41° to 86°F) and use within 10 days. Discard after full dosing is completed.
-
![Azithromycin Powder, For Suspension [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=035ce971-cf46-40c0-9b2f-ae52ab4e3468&name=4c093ab3-1599-4dec-8f7b-6d6b7fa233b2-02.jpg)
Azithromycin
See INDICATIONS AND USAGE and CLINICAL PHARMACOLOGY.
Adults
*DUE TO THE INDICATED ORGANISMS (see INDICATIONS AND USAGE).Infection*
Recommended Dose/Duration of Therapy
Community-acquired pneumonia (mild severity)
Pharyngitis/tonsillitis (second line therapy)
Skin/skin structure (uncomplicated)
500 mg as a single dose on Day 1, followed
by 250 mg once daily on Days 2 through 5.
Acute bacterial exacerbations of chronic obstructive pulmonary disease (mild to moderate)
500 mg QD x 3 days
OR
500 mg as a single dose on Day 1, followed
by 250 mg once daily on Days 2 through 5.
Acute bacterial sinusitis
500 mg QD x 3 days
Genital ulcer disease (chancroid)
One single 1 gram dose
Non-gonococcal urethritis and cervicitis
One single 1 gram dose
Gonococcal urethritis and cervicitis
One single 2 gram dose
Renal Insufficiency
No dosage adjustment is recommended for subjects with renal impairment (GFR ≤ 80 mL/min). The mean AUC0-120 was similar in subjects with GFR 10 to 80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR < 10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment (see CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency).
Hepatic Insufficiency
The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (see CLINICALPHARMACOLOGY, Special Populations, Hepatic Insufficiency).
No dosage adjustment is recommended based on age or gender (see CLINICAL PHARMACOLOGY,Special Populations).
Pediatric Patients
Azithromycin for oral suspension can be taken with or without food.
Acute Otitis Media: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.)
Acute Bacterial Sinusitis: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days. (See chart below.)
Community-Acquired Pneumonia: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA, ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS, Pediatric Use.) Based on Body Weight * Effectiveness of the 3 day or 1 day regimen in pediatric patients with community-acquired pneumonia has not been established.OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5 Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5.
Weight
100 mg/5 mL
200 mg/5 mL
Total mL per Treatment Course
Total mg per Treatment Course
Kg
Lbs.
Day 1
Days 2 to 5
Day 1
Days 2 to 5
5
11
2.5 mL
(1/2 tsp)
1.25 mL (1/4 tsp)
7.5 mL
150 mg
10
22
5 mL
(1 tsp)
2.5 mL (1/2 tsp)
15 mL
300 mg
20
44
5 mL
(1 tsp)
2.5 mL
(½ tsp)
15 mL
600 mg
30
66
7.5 mL
(1½ tsp)
3.75 mL (¾ tsp)
22.5 mL
900 mg
40
88
10 mL (2 tsp)
5 mL
(1 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL (2½ tsp)
6.25 mL (1¼ tsp)
37.5 mL
1500 mg
* Effectiveness of the 5 day or 1 day regimen in pediatric patients with acute bacterial sinusitis has not been established.OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3 Day Regimen)*
Dosing Calculated on 10 mg/kg/day.
Weight
100 mg/5 mL
200 mg/5 mL
Total mL per Treatment Course
Total mg per Treatment Course
Kg
Lbs.
Day 1 to 3
Day 1 to 3
5
11
2.5 mL
(½ tsp)
7.5 mL
150 mg
10
22
5 mL
(1 tsp)
15 mL
300 mg
20
44
5 mL
(1 tsp)
15 mL
600 mg
30
66
7.5 mL
(1½ tsp)
22.5 mL
900 mg
40
88
10 mL
(2 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL
(2½ tsp)
37.5 mL
1500 mg
OTITIS MEDIA: (1 Day Regimen)
Dosing Calculated on 30 mg/kg as a single dose.
Weight
200 mg/5 mL
Total mL per Treatment Course
Total mg per Treatment Course
Kg
Lbs.
Day 1
5
11
3.75 mL
(¾ tsp)
3.75 mL
150 mg
10
22
7.5 mL
(1½ tsp)
7.5 mL
300 mg
20
44
15 mL
(3 tsp)
15 mL
600 mg
30
66
22.5 mL
(4½ tsp)
22.5 mL
900 mg
40
88
30 mL
(6 tsp)
30 mL
1200 mg
50 and above
110 and above
37.5 mL
(7½ tsp)
37.5 mL
1500 mg
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/Tonsillitis: The recommended dose of azithromycin for oral suspension for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS/TONSILLITIS (Age 2 years and above, see PRECAUTIONS, Pediatric Use.) Based on Body WeightPHARYNGITIS/TONSILLITIS: (5 Day Regimen)
Dosing Calculated on 12 mg/kg/day for 5 days.
Weight
200 mg/5 mL
Total mL per Treatment Course
Total mg per
Treatment Course
Kg
Lbs.
Day 1 to 5
8
18
2.5 mL
(½ tsp)
12.5 mL
500 mg
17
37
5 mL
(1 tsp)
25 mL
1000 mg
25
55
7.5 mL
(1½ tsp)
37.5 mL
1500 mg
33
73
10 mL
(2 tsp)
50 mL
2000 mg
40
88
12.5 mL
(2½ tsp)
62.5 mL
2500 mg
Constituting instructions for azithromycin for oral suspension, 300, 600, 900, 1200 mg bottles. The table below indicates the volume of water to be used for constitution:
Amount of
water to be added
Total volume after constitution (azithromycin content)
Azithromycin concentration after constitution
9 mL (300 mg)
15 mL (300 mg)
100 mg/5 mL
9 mL (600 mg)
15 mL (600 mg)
200 mg/5 mL
12 mL (900 mg)
22.5 mL (900 mg)
200 mg/5 mL
15 mL (1200 mg)
30 mL (1200 mg)
200 mg/5 mL
Shake well before each use. Oversized bottle provides shake space. Keep tightly closed.
After mixing, store suspension at 5° to 25°C (41° to 77°F) and use within 10 days. Discard after full dosing is completed.
-
![Azithromycin Tablet, Film Coated [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=035002de-abec-4da4-8010-c42d186c04a2&name=azithromycin-05.jpg)
Azithromycin
(SeeINDICATIONS AND USAGE and CLINICAL PHARMACOLOGY.)
Adults
Infection* Recommended Dose/Duration of Therapy * DUE TO THE INDICATED ORGANISMS (See INDICATIONS AND USAGE.)Community-aquired pneumonia (mild severity) Pharyngitis/tonsillitis (second line therapy) Skin/skin structure (uncomplicated)
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5.
Acute bacterial exacerbations of chronic obstructive pulmonary disease (mild to moderate)
500 mg QD × 3 days OR 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5.
Acute bacterial sinusitis
500 mg QD × 3 days
Genital ulcer disease (chancroid)
One single 1 gram dose
Non-gonoccocal urethritis and cervicitis
One single 1 gram dose
Gonococcal urethritis and cervicitis
One single 2 gram dose
Azithromycin tablets can be taken with or without food.
Renal Insufficiency
No dosage adjustment is recommended for subjects with renal impairment (GFR ≤80 mL/min). The mean AUC0–120 was similar in subjects with GFR 10–80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR <10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency.)
Hepatic Insufficiency
The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (See CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency.)
No dosage adjustment is recommended based on age or gender. (See CLINICAL PHARMACOLOGY, Special Populations.)
Pediatric Patients
Azithromycin for oral suspension can be taken with or without food.
Acute Otitis Media
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.)
Acute Bacterial Sinusitis
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days. (See chart below.)
Community-Acquired Pneumonia
The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA, ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS—Pediatric Use.) Based on Body Weight
OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5-Day Regimen)* Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5. Weight 100 mg/5 mL 200 mg/5 mL Total mL per Treatment Course Total mg per Treatment Course Kg Lbs. Day 1 Days 2–5 Day 1 Days 2–5 * Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established.5
11
2.5 mL (½ tsp)
1.25 mL (¼ tsp)
7.5 mL
150 mg
10
22
5 mL(1 tsp)
2.5 mL(½ tsp)
15 mL
300 mg
20
44
5 mL(1 tsp)
2.5 mL(½ tsp)
15 mL
600 mg
30
66
7.5 mL(1½ tsp)
3.75 mL(¾ tsp)
22.5 mL
900 mg
40
88
10 mL(2 tsp)
5 mL(1 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL (2½ tsp)
6.25 mL (1¼ tsp)
37.5 mL
1500 mg
OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)* Dosing Calculated on 10 mg/kg/day Weight 100 mg/5 mL 200 mg/5 mL Total mL per Treatment Course Total mg per Treatment Course Kg Lbs. Day 1–3 Day 1–3 * Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established.5
11
2.5 mL (1/2 tsp)
7.5 mL
150 mg
10
22
5 mL (1 tsp)
15 mL
300 mg
20
44
5 mL (1 tsp)
15 mL
600 mg
30
66
7.5 mL (1 ½ tsp)
22.5 mL
900 mg
40
88
10 mL (2 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL (2 ½ tsp)
37.5 mL
1500 mg
OTITIS MEDIA: (1-Day Regimen) Dosing Calculated on 30 mg/kg as a single dose Weight 200 mg/5 mL Total mL per Treatment Course Total mg per Treatment Course Kg Lbs. Day 15
11
3.75 mL (3/4 tsp)
3.75 mL
150 mg
10
22
7.5 mL (1 ½ tsp)
7.5 mL
300 mg
20
44
15 mL (3 tsp)
15 mL
600 mg
30
66
22.5 mL (4 ½ tsp)
22.5 mL
900 mg
40
88
30 mL (6 tsp)
30 mL
1200 mg
50 and above
110 and above
37.5 mL (7 ½ tsp)
37.5 mL
1500 mg
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/Tonsillitis
The recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS/TONSILLITIS (Age 2 years and above, see PRECAUTIONS—Pediatric Use.) Based on Body Weight
PHARYNGITIS/TONSILLITIS: (5-Day Regimen) Dosing Calculated on 12 mg/kg/day for 5 days. Weight 200 mg/5 mL Total mL per Treatment Course Total mg per Treatment Course Kg Lbs. Day 1–58
18
2.5 mL(½ tsp)
12.5 mL
500 mg
17
37
5 mL(1 tsp)
25 mL
1000 mg
25
55
7.5 mL(1½ tsp)
37.5 mL
1500 mg
33
73
10 mL(2 tsp)
50 mL
2000 mg
40
88
12.5 mL(2½ tsp)
62.5 mL
2500 mg
Constituting instructions for azithromycin Oral Suspension, 300, 600, 900, 1200 mg bottles. The table below indicates the volume of water to be used for constitution:
Amount of water to be added Total volume after constitution (azithromycin content) Azithromycin concentration after constitution9 mL (300 mg)
15 mL (300 mg)
100 mg/5 mL
9 mL (600 mg)
15 mL (600 mg)
200 mg/5 mL
12 mL (900 mg)
22.5 mL (900 mg)
200 mg/5 mL
15 mL (1200 mg)
30 mL (1200 mg)
200 mg/5 mL
Shake well before each use. Oversized bottle provides shake space. Keep tightly closed.
After mixing, store suspension at 5° to 30°C (41° to 86°F) and use within 10 days. Discard after full dosing is completed.
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Simvastatin
2.1 Recommended Dosing
The usual dosage range is 5 to 40 mg/day. In patients with CHD or at high risk of CHD, simvastatin can be started simultaneously with diet. The recommended usual starting dose is 10 or 20 mg once a day in the evening. For patients at high risk for a CHD event due to existing CHD, diabetes, peripheral vessel disease, history of stroke or other cerebrovascular disease, the recommended starting dose is 40 mg/day. Lipid determinations should be performed after 4 weeks of therapy and periodically thereafter.
2.2 Restricted Dosing for 80 mg
Due to the increased risk of myopathy, including rhabdomyolysis, particularly during the first year of treatment, use of the 80-mg dose of simvastatin should be restricted to patients who have been taking simvastatin 80 mg chronically (e.g., for 12 months or more) without evidence of muscle toxicity [see Warnings and Precautions (5.1)].
Patients who are currently tolerating the 80-mg dose of simvastatin who need to be initiated on an interacting drug that is contraindicated or is associated with a dose cap for simvastatin should be switched to an alternative statin with less potential for the drug-drug interaction.
Due to the increased risk of myopathy, including rhabdomyolysis, associated with the 80-mg dose of simvastatin, patients unable to achieve their LDL-C goal utilizing the 40-mg dose of simvastatin should not be titrated to the 80-mg dose, but should be placed on alternative LDL-C-lowering treatment(s) that provides greater LDL-C lowering.
2.3 Coadministration with Other Drugs
Patients taking Verapamil, Diltiazem, or Dronedarone
• The dose of simvastatin should not exceed 10 mg/day [see Warnings and Precautions (5.1), Drug Interactions (7.3), and Clinical Pharmacology (12.3)].
Patients taking Amiodarone, amlodipine or Ranolazine
• The dose of simvastatin should not exceed 20 mg/day [see Warnings and Precautions (5.1), Drug Interactions (7.3), and Clinical Pharmacology (12.3)].
2.4 Patients with Homozygous Familial Hypercholesterolemia
The recommended dosage is 40 mg/day in the evening [see Dosage and Administration, Restricted Dosing for 80 mg (2.2)]. Simvastatin should be used as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) in these patients or if such treatments are unavailable.
2.5 Adolescents (10-17 years of age) with Heterozygous Familial Hypercholesterolemia
The recommended usual starting dose is 10 mg once a day in the evening. The recommended dosing range is 10 to 40 mg/day; the maximum recommended dose is 40 mg/day. Doses should be individualized according to the recommended goal of therapy [see NCEP Pediatric Panel Guidelines1 and Clinical Studies (14.2)]. Adjustments should be made at intervals of 4 weeks or more.
1 National Cholesterol Education Program (NCEP): Highlights of the Report of the Expert Panel on Blood Cholesterol Levels in Children and Adolescents. Pediatrics. 89(3):495-501. 1992.2.6 Patients with Renal Impairment
Because simvastatin does not undergo significant renal excretion, modification of dosage should not be necessary in patients with mild to moderate renal impairment. However, caution should be exercised when simvastatin is administered to patients with severe renal impairment; such patients should be started at 5 mg/day and be closely monitored [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.3)].
2.7 Chinese Patients Taking Lipid-Modifying Doses (≥1 g/day Niacin) of Niacin-Containing Products
Because of an increased risk for myopathy, in Chinese patients taking simvastatin 40 mg coadministered with lipid-modifying doses (≥1 g/day niacin) of niacin-containing products, caution should be used when treating Chinese patients with simvastatin doses exceeding 20 mg/day coadministered with lipid-modifying doses of niacin-containing products. Because the risk for myopathy is dose-related, Chinese patients should not receive simvastatin 80 mg coadministered with lipid-modifying doses of niacin-containing products. The cause of the increased risk of myopathy is not known. It is also unknown if the risk for myopathy with coadministration of simvastatin with lipid-modifying doses of niacin-containing products observed in Chinese patients applies to other Asian patients. [See Warnings and Precautions (5.1).]
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![Baclofen Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=17a4f424-ebe2-4971-b353-38a4713152e9&name=70aa3223-0501-4615-9856-8891702b8829-02.jpg)
Baclofen
The determination of optimal dosage requires individual titration. Start therapy at a low dosage and increase gradually until optimum effect is achieved (usually between 40-80 mg daily).
The following dosage titration schedule is suggested:
5 mg t.i.d. for 3 days
10 mg t.i.d. for 3 days
15 mg t.i.d. for 3 days
20 mg t.i.d. for 3 days
Thereafter additional increases may be necessary but the total daily dose should not exceed a maximum of 80 mg daily (20 mg q.i.d.).
The lowest dose compatible with an optimal response is recommended. If benefits are not evident after a reasonable trial period, patients should be slowly withdrawn from the drug (see WARNINGS, Abrupt Drug Withdrawal).
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Buspirone Hcl
The recommended initial dose is 15 mg daily (7.5 mg b.i.d.). To achieve an optimal therapeutic response, at intervals of 2 to 3 days the dosage may be increased 5 mg per day, as needed. The maximum daily dosage should not exceed 60 mg per day. In clinical trials allowing dose titration, divided doses of 20 mg to 30 mg per day were commonly employed.
The bioavailability of buspirone is increased when given with food as compared to the fasted state (see CLINICAL PHARMACOLOGY). Consequently, patients should take buspirone in a consistent manner with regard to the timing of dosing; either always with or always without food.
When buspirone is to be given with a potent inhibitor of CYP3A4 the dosage recommendations described in the PRECAUTIONS: Drug Interactions section should be followed.
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Buspirone Hydrochloride
The recommended initial dose is 15 mg daily (7.5 mg b.i.d.). To achieve an optimal therapeutic response, at intervals of 2 to 3 days the dosage may be increased 5 mg per day, as needed. The maximum daily dosage should not exceed 60 mg per day. In clinical trials allowing dose titration, divided doses of 20 to 30 mg per day were commonly employed.
The bioavailability of buspirone is increased when given with food as compared to the fasted state (see CLINICAL PHARMACOLOGY). Consequently, patients should take buspirone in a consistent manner with regard to the timing of dosing; either always with or always without food.
When buspirone is to be given with a potent inhibitor of CYP3A4, the dosage recommendations described in the PRECAUTIONS, Drug Interactions section should be followed.
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Simvastatin
2.1 Recommended Dosing
The usual dosage range is 5 to 40 mg/day. In patients with CHD or at high risk of CHD, simvastatin tablets can be started simultaneously with diet. The recommended usual starting dose is 10 or 20 mg once a day in the evening. For patients at high risk for a CHD event due to existing CHD, diabetes, peripheral vessel disease, history of stroke or other cerebrovascular disease, the recommended starting dose is 40 mg/day. Lipid determinations should be performed after 4 weeks of therapy and periodically thereafter.
2.2 Restricted Dosing for 80 mg
Due to the increased risk of myopathy, including rhabdomyolysis, particularly during the first year of treatment, use of the 80-mg dose of simvastatin tablets should be restricted to patients who have been taking simvastatin 80 mg chronically (e.g., for 12 months or more) without evidence of muscle toxicity. [see Warnings and Precautions (5.1)]
Patients who are currently tolerating the 80-mg dose of simvastatin tablets who need to be initiated on an interacting drug that is contraindicated or is associated with a dose cap for simvastatin should be switched to an alternative statin with less potential for the drug-drug interaction.
Due to the increased risk of myopathy, including rhabdomyolysis, associated with the 80-mg dose of simvastatin tablets, patients unable to achieve their LDL-C goal utilizing the 40-mg dose of simvastatin tablets should not be titrated to the 80-mg dose, but should be placed on alternative LDL-C-lowering treatment(s) that provides greater LDL-C lowering.
2.3 Coadministration with Other Drugs
Patients taking Verapamil, Diltiazem, or Dronedarone
• The dose of simvastatin tablets should not exceed 10 mg/day [see Warnings and Precautions (5.1), Drug Interactions (7.3), and Clinical Pharmacology (12.3)]. .Patients taking Amiodarone, Amlodipine or Ranolazine
• The dose of simvastatin tablets should not exceed 20 mg/day [see Warnings and Precautions (5.1), Drug Interactions (7.3), and Clinical Pharmacology (12.3)].2.4 Patients with Homozygous Familial Hypercholesterolemia
The recommended dosage is 40 mg/day in the evening [see Dosage and Administration, Restricted Dosing for 80 mg (2.2)] . Simvastatin tablets should be used as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) in these patients or if such treatments are unavailable.
Simvastatin exposure is approximately doubled with concomitant use of lomitapide; therefore, the dose of simvastatin tablets should be reduced by 50% if initiating lomitapide. Simvastatin tablets dosage should not exceed 20 mg/day (or 40 mg/day for patients who have previously taken simvastatin tablets 80 mg/day chronically, e.g., for 12 months or more, without evidence of muscle toxicity) while taking lomitapide.
2.5 Adolescents (10 to 17 years of age) with Heterozygous Familial Hypercholesterolemia
The recommended usual starting dose is 10 mg once a day in the evening. The recommended dosing range is 10 to 40 mg/day; the maximum recommended dose is 40 mg/day. Doses should be individualized according to the recommended goal of therapy [see NCEP Pediatric Panel Guidelines 1 and Clinical Studies (14.2)]. Adjustments should be made at intervals of 4 weeks or more.
1 National Cholesterol Education Program (NCEP): Highlights of the Report of the Expert Panel on Blood Cholesterol Levels in Children and Adolescents. Pediatrics 89(3):495-501. 1992.2.6 Patients with Renal Impairment
Because simvastatin tablets do not undergo significant renal excretion, modification of dosage should not be necessary in patients with mild to moderate renal impairment. However, caution should be exercised when simvastatin tablets are administered to patients with severe renal impairment; such patients should be started at 5 mg/day and be closely monitored [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.3) ].
2.7 Chinese Patients Taking Lipid-Modifying Doses (greater than or equal to 1 g/day Niacin) of Niacin-Containing Products
Because of an increased risk for myopathy, in Chinese patients taking simvastatin 40 mg coadministered with lipid-modifying doses (greater than or equal to 1 g/day niacin) of niacin-containing products, caution should be used when treating Chinese patients with simvastatin doses exceeding 20 mg/day coadministered with lipid-modifying doses of niacin-containing products. Because the risk for myopathy is dose-related, Chinese patients should not receive simvastatin 80 mg coadministered with lipid-modifying doses of niacin-containing products. The cause of the increased risk of myopathy is not known. It is also unknown if the risk for myopathy with coadministration of simvastatin with lipid-modifying doses of niacin-containing products observed in Chinese patients applies to other Asian patients. [see Warnings and Precautions (5.1)]
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![Metformin Hydrochloride Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=33347f3b-c347-4a52-b788-4e67894edc51&name=79cc3a62-figure-02.jpg)
Metformin Hydrochloride
There is no fixed dosage regimen for the management of hyperglycemia in patients with type 2 diabetes with metformin hydrochloride or any other pharmacologic agent. Dosage of metformin hydrochloride must be individualized on the basis of both effectiveness and tolerance, while not exceeding the maximum recommended daily doses. The maximum recommended daily dose of metformin hydrochloride is 2550 mg in adults and 2000 mg in pediatric patients (10 to 16 years of age).
Metformin hydrochloride should be given in divided doses with meals. Metformin hydrochloride should be started at a low dose, with gradual dose escalation, both to reduce gastrointestinal side effects and to permit identification of the minimum dose required for adequate glycemic control of the patient.
During treatment initiation and dose titration (see Recommended Dosing Schedule), fasting plasma glucose should be used to determine the therapeutic response to metformin hydrochloride and identify the minimum effective dose for the patient. Thereafter, glycosylated hemoglobin should be measured at intervals of approximately three months. The therapeutic goal should be to decrease both fasting plasma glucose and glycosylated hemoglobin levels to normal or near normal by using the lowest effective dose of metformin hydrochloride, either when used as monotherapy or in combination with sulfonylurea or insulin.
Monitoring of blood glucose and glycosylated hemoglobin will also permit detection of primary failure, i.e., inadequate lowering of blood glucose at the maximum recommended dose of medication, and secondary failure, i.e., loss of an adequate blood glucose lowering response after an initial period of effectiveness.
Short-term administration of metformin hydrochloride may be sufficient during periods of transient loss of control in patients usually well-controlled on diet alone.
Recommended Dosing Schedule
Adults – In general, clinically significant responses are not seen at doses below 1500 mg per day. However, a lower recommended starting dose and gradually increased dosage is advised to minimize gastrointestinal symptoms.
The usual starting dose of metformin hydrochloride is 500 mg twice a day or 850 mg once a day, given with meals. Dosage increases should be made in increments of 500 mg weekly or 850 mg every 2 weeks, up to a total of 2000 mg per day, given in divided doses. Patients can also be titrated from 500 mg twice a day to 850 mg twice a day after 2 weeks. For those patients requiring additional glycemic control, metformin hydrochloride may be given to a maximum daily dose of 2550 mg per day. Doses above 2000 mg may be better tolerated given three times a day with meals.
If higher doses of metformin are required, metformin hydrochloride should be used at total daily doses up to 2550 mg administered in divided daily doses, as described above. (See CLINICAL PHARMACOLOGY: Clinical Studies.)
Pediatrics – The usual starting dose of metformin hydrochloride is 500 mg twice a day, given with meals. Dosage increases should be made in increments of 500 mg weekly up to a maximum of 2000 mg per day, given in divided doses.
Transfer From Other Antidiabetic Therapy
When transferring patients from standard oral hypoglycemic agents other than chlorpropamide to metformin hydrochloride, no transition period generally is necessary. When transferring patients from chlorpropamide, care should be exercised during the first two weeks because of the prolonged retention of chlorpropamide in the body, leading to overlapping drug effects and possible hypoglycemia.
Concomitant Metformin Hydrochloride and Oral Sulfonylurea Therapy in Adult Patients
If patients have not responded to four weeks of the maximum dose of metformin hydrochloride monotherapy, consideration should be given to gradual addition of an oral sulfonylurea while continuing metformin hydrochloride at the maximum dose, even if prior primary or secondary failure to a sulfonylurea has occurred. Clinical and pharmacokinetic drug-drug interaction data are currently available only for metformin plus glyburide (glibenclamide).
With concomitant metformin hydrochloride and sulfonylurea therapy, the desired control of blood glucose may be obtained by adjusting the dose of each drug. In a clinical trial of patients with type 2 diabetes and prior failure on glyburide, patients started on metformin hydrochloride 500 mg and glyburide 20 mg were titrated to 1000/20 mg, 1500/20 mg, 2000/20 mg or 2500/20 mg of metformin hydrochloride and glyburide, respectively, to reach the goal of glycemic control as measured by FPG, HbA1c and plasma glucose response (see CLINICAL PHARMACOLOGY: Clinical Studies). However, attempts should be made to identify the minimum effective dose of each drug to achieve this goal. With concomitant metformin hydrochloride and sulfonylurea therapy, the risk of hypoglycemia associated with sulfonylurea therapy continues and may be increased. Appropriate precautions should be taken. (See Package Insert of the respective sulfonylurea.)
If patients have not satisfactorily responded to one to three months of concomitant therapy with the maximum dose of metformin hydrochloride and the maximum dose of an oral sulfonylurea, consider therapeutic alternatives including switching to insulin with or without metformin hydrochloride.
Concomitant Metformin Hydrochloride and Insulin Therapy in Adult Patients
The current insulin dose should be continued upon initiation of metformin hydrochloride therapy. Metformin hydrochloride therapy should be initiated at 500 mg once daily in patients on insulin therapy. For patients not responding adequately, the dose of metformin hydrochloride should be increased by 500 mg after approximately 1 week and by 500 mg every week thereafter until adequate glycemic control is achieved. The maximum recommended daily dose is 2500 mg for metformin hydrochloride. It is recommended that the insulin dose be decreased by 10% to 25% when fasting plasma glucose concentrations decrease to less than 120 mg/dL in patients receiving concomitant insulin and metformin hydrochloride. Further adjustment should be individualized based on glucose-lowering response.
Specific Patient Populations
Metformin hydrochloride is not recommended for use in pregnancy. Metformin hydrochloride is not recommended in patients below the age of 10 years.
The initial and maintenance dosing of metformin hydrochloride should be conservative in patients with advanced age, due to the potential for decreased renal function in this population. Any dosage adjustment should be based on a careful assessment of renal function. Generally, elderly, debilitated, and malnourished patients should not be titrated to the maximum dose of metformin hydrochloride.
Monitoring of renal function is necessary to aid in prevention of lactic acidosis, particularly in the elderly. (See WARNINGS.)
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![Diclofenac Sodium Tablet, Delayed Release [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=546c9817-e41b-4b1d-a1dd-1e9304c97557&name=8d6f0c39-920d-4453-aebd-8b6aa4e73043-02.jpg)
Diclofenac Sodium
Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with diclofenac sodium delayed-release tablets, the dose and frequency should be adjusted to suit an individual patient’s needs.
For the relief of osteoarthritis, the recommended dosage is 100-150 mg/day in divided doses (50 mg b.i.d. or t.i.d., or 75 mg b.i.d.).
For the relief of rheumatoid arthritis, the recommended dosage is 150-200 mg/day in divided doses (50 mg t.i.d. or q.i.d., or 75 mg b.i.d.).
For the relief of ankylosing spondylitis, the recommended dosage is 100-125 mg/day, administered as 25 mg q.i.d., with an extra 25-mg dose at bedtime if necessary.
Different formulations of diclofenac (diclofenac sodium enteric-coated tablets; diclofenac sodium extended-release tablets, diclofenac potassium immediate-release tablets) are not necessarily bioequivalent even if the milligram strength is the same.
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![Diclofenac Sodium Tablet, Film Coated, Extended Release [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=c1888b7a-0a14-4e24-9ba7-1458154d07d9&name=961fce3a-65d9-4559-a204-00f6463bea30-01.jpg)
Diclofenac Sodium
Carefully consider the potential benefits and risks of diclofenac sodium extended-release tablets, USP and other treatment options before deciding to use diclofenac sodium extended-release. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with diclofenac sodium extended-release, the dose and frequency should be adjusted to suit an individual patient’s needs.
For the relief of osteoarthritis, the recommended dosage is 100 mg q.d.
For the relief of rheumatoid arthritis, the recommended dosage is 100 mg q.d. In the rare patient where diclofenac sodium extended-release 100 mg/day is unsatisfactory, the dose may be increased to 100 mg b.i.d. if the benefits outweigh the clinical risks of increased side effects.
Different formulations of diclofenac (diclofenac sodium delayed-release tablets; diclofenac sodium extended-release tablets, USP; diclofenac potassium immediate-release tablets) are not necessarily bioequivalent even if the milligram strength is the same.
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![Diclofenac Sodium Tablet, Delayed Release [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=f32c0225-fd21-468a-90f5-6083071e80fb&name=00c44bc0-d8cb-4e59-97b0-89cf89519f8a-02.jpg)
Diclofenac Sodium
Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with diclofenac sodium delayed-release tablets, the dose and frequency should be adjusted to suit an individual patient’s needs.
For the relief of osteoarthritis, the recommended dosage is 100 to 150 mg/day in divided doses (50 mg b.i.d. or t.i.d., or 75 mg b.i.d.).
For the relief of rheumatoid arthritis, the recommended dosage is 150 to 200 mg/day in divided doses (50 mg t.i.d. or q.i.d., or 75 mg b.i.d.).
For the relief of ankylosing spondylitis, the recommended dosage is 100 to 125 mg/day, administered as 25 mg q.i.d., with an extra 25 mg dose at bedtime if necessary.
Different formulations of diclofenac are not necessarily bioequivalent even if the milligram strength is the same.
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![Diclofenac Sodium Tablet, Film Coated, Extended Release [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=d81dc6f5-7e4e-4fff-81e7-ee83c850c5f7&name=d81dc6f5-7e4e-4fff-81e7-ee83c850c5f7-03.jpg)
Diclofenac Sodium
Carefully consider the potential benefits and risks of diclofenac sodium extended-release tablets, USP and other treatment options before deciding to use diclofenac sodium extended-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with diclofenac sodium extended-release tablets, the dose and frequency should be adjusted to suit an individual patient’s needs.
For the relief of osteoarthritis, the recommended dosage is 100 mg q.d.
For the relief of rheumatoid arthritis, the recommended dosage is 100 mg q.d. In the rare patient where diclofenac sodium extended-release tablets 100 mg/day are unsatisfactory, the dose may be increased to 100 mg b.i.d. if the benefits outweigh the clinical risks of increased side effects.
Different formulations of diclofenac (diclofenac sodium enteric-coated tablets; diclofenac sodium extended-release tablets, USP, diclofenac potassium immediate-release tablets) are not necessarily bioequivalent even if the milligram strength is the same.
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Metformin Hydrochloride
There is no fixed dosage regimen for the management of hyperglycemia in patients with type 2 diabetes with metformin or any other pharmacologic agent. Dosage of metformin must be individualized on the basis of both effectiveness and tolerance, while not exceeding the maximum recommended daily dose. The maximum recommended daily dose of metformin hydrochloride tablets, USP is 2550 mg in adults and 2000 mg in pediatric patients (10-16 years of age).
Metformin should be given in divided doses with meals and should be started at a low dose, with gradual dose escalation, both to reduce gastrointestinal side effects and to permit identification of the minimum dose required for adequate glycemic control of the patient.
During treatment initiation and dose titration (see Recommended Dosing Schedule), fasting plasma glucose should be used to determine the therapeutic response to metformin and identify the minimum effective dose for the patient. Thereafter, glycosylated hemoglobin should be measured at intervals of approximately three months. The therapeutic goal should be to decrease both fasting plasma glucose and glycosylated hemoglobin levels to normal or near normal by using the lowest effective dose of metformin hydrochloride tablets, USP either when used as monotherapy or in combination with sulfonylureas or insulin.
Monitoring of blood glucose and glycosylated hemoglobin will also permit detection of primary failure, i.e., inadequate lowering of blood glucose at the maximum recommended dose of medication, and secondary failure, i.e., loss of an adequate blood glucose lowering response after an initial period of effectiveness.
Short-term administration of metformin may be sufficient during periods of transient loss of control in patients usually well-controlled on diet alone.
Recommended Dosing Schedule
Adults
In general, clinically significant responses are not seen at doses below 1500 mg per day. However, a lower recommended starting dose and gradually increased dosage is advised to minimize gastrointestinal symptoms.
The usual starting dose of metformin hydrochloride tablets, USP is 500 mg twice a day or 850 mg once a day, given with meals. Dosage increases should be made in increments of 500 mg weekly or 850 mg every 2 weeks, up to a total of 2000 mg per day, given in divided doses. Patients can also be titrated from 500 mg twice a day to 850 mg twice a day after 2 weeks. For those patients requiring additional glycemic control, metformin may be given to a maximum daily dose of 2550 mg per day. Doses above 2000 mg may be better tolerated given three times a day with meals.
Pediatrics
The usual starting dose of metformin hydrochloride tablets, USP is 500 mg twice a day, given with meals. Dosage increases should be made in increments of 500 mg weekly up to a maximum of 2000 mg per day, given in divided doses.
Transfer from Other Antidiabetic Therapy
When transferring patients from standard oral hypoglycemic agents other than chlorpropamide to metformin, no transition period generally is necessary. When transferring patients from chlorpropamide, care should be exercised during the first two weeks because of the prolonged retention of chlorpropamide in the body, leading to overlapping drug effects and possible hypoglycemia.
Concomitant Metformin Hydrochloride Tablets, USP and Oral Sulfonylurea Therapy in Adult Patients
If patients have not responded to four weeks of the maximum dose of metformin hydrochloride tablets, USP monotherapy, consideration should be given to gradual addition of an oral sulfonylurea while continuing metformin hydrochloride tablets, USP at the maximum dose, even if prior primary or secondary failure to a sulfonylurea has occurred. Clinical and pharmacokinetic drug-drug interaction data are currently available only for metformin plus glyburide (glibenclamide). With concomitant metformin hydrochloride tablets, USP and sulfonylurea therapy, the desired control of blood glucose may be obtained by adjusting the dose of each drug. In a clinical trial of patients with type 2 diabetes and prior failure on glyburide, patients started on metformin 500 mg and glyburide 20 mg were titrated to 1000/20 mg, 1500/20 mg, 2000/20 mg or 2500/20 mg of metformin and glyburide, respectively, to reach the goal of glycemic control as measured by FPG, HbA1c and plasma glucose response (see CLINICAL PHARMACOLOGY: Clinical Studies). However, attempts should be made to identify the minimum effective dose of each drug to achieve this goal. With concomitant metformin hydrochloride tablets, USP and sulfonylurea therapy, the risk of hypoglycemia associated with sulfonylurea therapy continues and may be increased. Appropriate precautions should be taken. (See Package Insert of the respective sulfonylurea.)
If patients have not satisfactorily responded to one to three months of concomitant therapy with the maximum dose of metformin and the maximum dose of an oral sulfonylurea, consider therapeutic alternatives including switching to insulin with or without metformin hydrochloride tablets, USP.
Concomitant Metformin Hydrochloride Tablets, USP and Insulin Therapy in Adult Patients
The current insulin dose should be continued upon initiation of metformin hydrochloride tablets, USP therapy. Metformin hydrochloride tablets, USP therapy should be initiated at 500 mg once daily in patients on insulin therapy. For patients not responding adequately, the dose of metformin hydrochloride tablets, USP should be increased by 500 mg after approximately 1 week and by 500 mg every week thereafter until adequate glycemic control is achieved. The maximum recommended daily dose is 2500 mg for metformin hydrochloride tablets, USP. It is recommended that the insulin dose be decreased by 10% to 25% when fasting plasma glucose concentrations decrease to less than 120 mg/dL in patients receiving concomitant insulin and metformin hydrochloride tablets, USP. Further adjustment should be individualized based on glucose-lowering response.
Specific Patient Populations
Metformin is not recommended for use in pregnancy.
Metformin hydrochloride tablets, USP are not recommended in patients below the age of 10 years.
The initial and maintenance dosing of metformin hydrochloride tablets, USP should be conservative in patients with advanced age, due to the potential for decreased renal function in this population. Any dosage adjustment should be based on a careful assessment of renal function. Generally, elderly, debilitated, and malnourished patients should not be titrated to the maximum dose of metformin hydrochloride tablets, USP.
Monitoring of renal function is necessary to aid in prevention of lactic acidosis, particularly in the elderly. (See WARNINGS.)
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![Diclofenac Sodium Tablet, Film Coated, Extended Release [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=1f5a4b8e-458d-43f1-a1e9-fac0df45954e&name=diclofenac-03.jpg)
Diclofenac Sodium
Carefully consider the potential benefits and risks of diclofenac sodium extended-release tablets, USP and other treatment options before deciding to use diclofenac sodium extended-release tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with diclofenac sodium extended-release tablets, USP, the dose and frequency should be adjusted to suit an individual patient’s needs.
For the relief of osteoarthritis, the recommended dosage is 100 mg q.d.
For the relief of rheumatoid arthritis, the recommended dosage is 100 mg q.d. In the rare patient where diclofenac sodium extended-release tablets, USP 100 mg/day is unsatisfactory, the dose may be increased to 100 mg b.i.d. if the benefits outweigh the clinical risks of increased side effects.
Different formulations of diclofenac (diclofenac sodium enteric-coated tablets; diclofenac sodium extended-release tablets, USP; diclofenac potassium immediate-release tablets) are not necessarily bioequivalent even if the milligram strength is the same.
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![Hydroxyzine Pamoate Capsule [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=ec7783c9-302f-4904-8046-b5ed43bb94b8&name=hydroxyzine-1b.jpg)
Hydroxyzine Pamoate
For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested: in adults, 50–100 mg q.i.d.; children under 6 years, 50 mg daily in divided doses; and over 6 years, 50–100 mg daily in divided doses.For use in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and in histamine-mediated pruritus: in adults, 25 mg t.i.d. or q.i.d.; children under 6 years, 50 mg daily in divided doses; and over 6 years, 50–100 mg daily in divided doses.As a sedative when used as a premedication and following general anesthesia: 50–100 mg in adults, and 0.6 mg/kg in children.When treatment is initiated by the intramuscular route of administration, subsequent doses may be administered orally.As with all medications, the dosage should be adjusted according to the patient's response to therapy.
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![Butalbital, Acetaminophen And Caffeine Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=71ab0446-3772-4680-93c5-8020d21dc15f&name=5caee91f-cf1c-41e9-ade5-5b7d65e46f41-04.jpg)
Butalbital
One or two tablets every four hours as needed. Total daily dosage should not exceed 6 tablets.
Extended and repeated use of this product is not recommended because of the potential for physical dependence.
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![Fluocinonide Cream [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=9a002ccd-8547-4d69-8955-b54f578fa465&name=15gcarton.jpg)
Fluocinonide
Fluocinonide cream 0.05% is generally applied to the affected area as a thin film from two to four times daily depending on the severity of the condition.Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions.If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.
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![Cilostazol Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=6a8b9b84-9942-4edd-8df9-319880d2feab&name=cilo-imtb-100mg-lbl-30.jpg)
Cilostazol
The recommended dosage of cilostazol is 100 mg b.i.d. taken at least half an hour before or two hours after breakfast and dinner. A dose of 50 mg b.i.d. should be considered during coadministration of such inhibitors of CYP3A4 as ketoconazole, itraconazole, erythromycin and diltiazem, and during coadministration of such inhibitors of CYP2C19 as omeprazole.
Patients may respond as early as 2 to 4 weeks after the initiation of therapy, but treatment for up to 12 weeks may be needed before a beneficial effect is experienced.
Discontinuation of Therapy
The available data suggest that the dosage of cilostazol can be reduced or discontinued without rebound (i.e., platelet hyperaggregability).
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![Promethazine Hydrochloride And Codeine Phosphate Syrup [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=09442938-34d5-495f-8833-73cf1e7131c9&name=pnc.jpg)
Promethazine Hydrochloride And Codeine Phosphate Syrup
The combination of promethazine hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age, because the combination may cause fatal respiratory depression in this age population.
It is important that promethazine hydrochloride and codeine phosphate syrup is measured with an accurate measuring device (see PRECAUTIONS-Information for Patients). A household teaspoon is not an accurate measuring device and could lead to overdosage, especially when half a teaspoon is to be measured. It is strongly recommended that an accurate measuring device be use. A pharmacist can provide an appropriate device and can provide instruction for measuring the correct dose.
The average effective dose for adults and children 12 years of age and over is: 1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 30 mL in 24 hours.
The average effective dose for children 6 years and under 12 years of age is ½ to 1 teaspoonful (2.5 mL to 5 mL) every 4 to 6 hours, not to exceed 30 mL in 24 hours.
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![Hydroxyzine Pamoate Capsule [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=fe8d07a0-979f-4859-8f43-1be2a54dcc1a&name=49fdcd63-2db7-42cf-ad51-fbe2af84f712-02.jpg)
Hydroxyzine Pamoate
For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested: in adults, 50 mg to 100 mg q.i.d.; children under 6 years, 50 mg daily in divided doses; and over 6 years, 50 mg to 100 mg daily in divided doses.
For use in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and in histamine-mediated pruritus: in adults, 25 mg t.i.d. or q.i.d.; children under 6 years, 50 mg daily in divided doses; and over 6 years, 50 mg to 100 mg daily in divided doses.
As a sedative when used as a premedication and following general anesthesia: 50 mg to 100 mg in adults, and 0.6 mg/kg in children. When treatment is initiated by the intramuscular route of administration, subsequent doses may be administered orally.
As with all medications, the dosage should be adjusted according to the patient’s response to therapy.
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![Clonazepam Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=f76370f6-bdf1-4514-ac0c-11e7aceeeb7a&name=d6db2ac2-93f8-4d95-915a-ed5fa80a023a-02.jpg)
Clonazepam
Clonazepam tablets USP should be administered with water by swallowing the tablet whole.
Seizure Disorders
Adults
The initial dose for adults with seizure disorders should not exceed 1.5 mg/day divided into three doses. Dosage may be increased in increments of 0.5 to 1 mg every 3 days until seizures are adequately controlled or until side effects preclude any further increase. Maintenance dosage must be individualized for each patient depending upon response. Maximum recommended daily dose is 20 mg.
The use of multiple anticonvulsants may result in an increase of depressant adverse effects. This should be considered before adding clonazepam to an existing anticonvulsant regimen.
Pediatric Patients
Clonazepam is administered orally. In order to minimize drowsiness, the initial dose for infants and children (up to 10 years of age or 30 kg of body weight) should be between 0.01 and 0.03 mg/kg/day but not to exceed 0.05 mg/kg/day given in two or three divided doses. Dosage should be increased by no more than 0.25 to 0.5 mg every third day until a daily maintenance dose of 0.1 to 0.2 mg/kg of body weight has been reached, unless seizures are controlled or side effects preclude further increase. Whenever possible, the daily dose should be divided into three equal doses. If doses are not equally divided, the largest dose should be given before retiring.
Geriatric Patients
There is no clinical trial experience with clonazepam in seizure disorder patients 65 years of age and older. In general, elderly patients should be started on low doses of clonazepam and observed closely (see PRECAUTIONS, Geriatric Use).
Panic Disorder
Adults
The initial dose for adults with panic disorder is 0.25 mg bid. An increase to the target dose for most patients of 1 mg/day may be made after 3 days. The recommended dose of 1 mg/day is based on the results from a fixed dose study in which the optimal effect was seen at 1 mg/day. Higher doses of 2, 3 and 4 mg/day in that study were less effective than the 1 mg/day dose and were associated with more adverse effects. Nevertheless, it is possible that some individual patients may benefit from doses of up to a maximum dose of 4 mg/day, and in those instances, the dose may be increased in increments of 0.125 to 0.25 mg bid every 3 days until panic disorder is controlled or until side effects make further increases undesired. To reduce the inconvenience of somnolence, administration of one dose at bedtime may be desirable.
Treatment should be discontinued gradually, with a decrease of 0.125 mg bid every 3 days, until the drug is completely withdrawn.
There is no body of evidence available to answer the question of how long the patient treated with clonazepam should remain on it. Therefore, the physician who elects to use clonazepam for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.
Pediatric Patients
There is no clinical trial experience with clonazepam in panic disorder patients under 18 years of age.
Geriatric Patients
There is no clinical trial experience with clonazepam in panic disorder patients 65 years of age and older. In general, elderly patients should be started on low doses of clonazepam and observed closely (see PRECAUTIONS, Geriatric Use).
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![Abacavir Sulfate Tablet, Film Coated [Apotex Corp]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=7510a9ec-6ef0-4610-8dce-8286a043d09c&name=hydro-3.jpg)
Abacavir Sulfate
Dosage should be adjusted according to the severity of the pain and the response of the patient. However, it should be kept in mind that tolerance to hydrocodone can develop with continued use and that the incidence of untoward effects is dose related.
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 5 mg/325 mg
The usual adult dosage is one or two tablets every four to six hours as needed for pain. The total daily dosage should not exceed 12 tablets.
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg/325 mg
The usual adult dosage is one tablet every four to six hours as needed for pain. The total daily dosage should not exceed 6 tablets.
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg
The usual adult dosage is one tablet every four to six hours as needed for pain. The total daily dosage should not exceed 6 tablets.
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 5 mg/325 mg
The usual adult dosage is one or two tablets every four to six hours as needed for pain. The total daily dosage should not exceed 12 tablets.
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg/325 mg
The usual adult dosage is one tablet every four to six hours as needed for pain. The total daily dosage should not exceed 6 tablets.
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg
The usual adult dosage is one tablet every four to six hours as needed for pain. The total daily dosage should not exceed 6 tablets.
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![Captopril Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=4a2d74a2-48c1-4833-a3aa-410edcceabf3&name=captopril-tablets-3.jpg)
Captopril
Captopril should be taken one hour before meals. Dosage must be individualized.
Hypertension:
Initiation of therapy requires consideration of recent antihypertensive drug treatment, the extent of blood pressure elevation, salt restriction, and other clinical circumstances. If possible, discontinue the patient’s previous antihypertensive drug regimen for one week before starting captopril.
The initial dose of captopril is 25 mg b.i.d. or t.i.d. If satisfactory reduction of blood pressure has not been achieved after one or two weeks, the dose may be increased to 50 mg b.i.d. or t.i.d. Concomitant sodium restriction may be beneficial when captopril is used alone.
The dose of captopril in hypertension usually does not exceed 50 mg t.i.d. Therefore, if the blood pressure has not been satisfactorily controlled after one to two weeks at this dose, (and the patient is not already receiving a diuretic), a modest dose of a thiazide-type diuretic (e.g., hydrochlorothiazide, 25 mg daily), should be added. The diuretic dose may be increased at one- to two-week intervals until its highest usual antihypertensive dose is reached.
If captopril is being started in a patient already receiving a diuretic, captopril therapy should be initiated under close medical supervision (see WARNINGS and PRECAUTIONS: Drug Interactions regarding hypotension), with dosage and titration of captopril as noted above.
If further blood pressure reduction is required, the dose of captopril may be increased to 100 mg b.i.d. or t.i.d. and then, if necessary, to 150 mg b.i.d. or t.i.d. (while continuing the diuretic). The usual dose range is 25 to 150 mg b.i.d. or t.i.d. A maximum daily dose of 450 mg captopril should not be exceeded.
For patients with severe hypertension (e.g., accelerated or malignant hypertension), when temporary discontinuation of current antihypertensive therapy is not practical or desirable, or when prompt titration to more normotensive blood pressure levels is indicated, diuretic should be continued but other current antihypertensive medication stopped and captopril dosage promptly initiated at 25 mg b.i.d. or t.i.d., under close medical supervision.
When necessitated by the patient’s clinical condition, the daily dose of captopril may be increased every 24 hours or less under continuous medical supervision until a satisfactory blood pressure response is obtained or the maximum dose of captopril is reached. In this regimen, addition of a more potent diuretic, e.g., furosemide, may also be indicated.
Beta-blockers may also be used in conjunction with captopril therapy (see PRECAUTIONS: Drug Interactions), but the effects of the two drugs are less than additive.
Heart Failure:
Initiation of therapy requires consideration of recent diuretic therapy and the possibility of severe salt/volume depletion. In patients with either normal or low blood pressure, who have been vigorously treated with diuretics and who may be hyponatremic and/or hypovolemic, a starting dose of 6.25 or 12.5 mg t.i.d. may minimize the magnitude or duration of the hypotensive effect (See WARNINGS: Hypotension); for these patients, titration to the usual daily dosage can then occur within the next several days.
For most patients the usual initial daily dosage is 25 mg t.i.d. After a dose of 50 mg t.i.d. is reached, further increases in dosage should be delayed, where possible, for at least two weeks to determine if a satisfactory response occurs. Most patients studied have had a satisfactory clinical improvement at 50 or 100 mg t.i.d. A maximum daily dose of 450 mg of captopril should not be exceeded.
Captopril should generally be used in conjunction with a diuretic and digitalis. Captopril therapy must be initiated under very close medical supervision.
Left Ventricular Dysfunction After Myocardial Infarction:
The recommended dose for long-term use in patients following a myocardial infarction is a target maintenance dose of 50 mg t.i.d.
Therapy may be initiated as early as three days following a myocardial infarction. After a single dose of 6.25 mg, captopril therapy should be initiated at 12.5 mg t.i.d. Captopril should then be increased to 25 mg t.i.d. during the next several days and to a target dose of 50 mg t.i.d. over the next several weeks as tolerated (see CLINICAL PHARMACOLOGY).
Captopril may be used in patients treated with other post-myocardial infarction therapies, e.g., thrombolytics, aspirin, beta blockers.
Diabetic Nephropathy:
The recommended dose of captopril for long term use to treat diabetic nephropathy is 25 mg t.i.d.
Other antihypertensives such as diuretics, beta blockers, centrally acting agents or vasodilators may be used in conjunction with captopril if additional therapy is required to further lower blood pressure.
Dosage Adjustment in Renal Impairment:
Because captopril is excreted primarily by the kidneys, excretion rates are reduced in patients with impaired renal function. These patients will take longer to reach steady-state captopril levels and will reach higher steady-state levels for a given daily dose than patients with normal renal function. Therefore, these patients may respond to smaller or less frequent doses.
Accordingly, for patients with significant renal impairment, initial daily dosage of captopril should be reduced, and smaller increments utilized for titration, which should be quite slow (one- to two-week intervals). After the desired therapeutic effect has been achieved, the dose should be slowly back-titrated to determine the minimal effective dose. When concomitant diuretic therapy is required, a loop diuretic (e.g., furosemide), rather than a thiazide diuretic, is preferred in patients with severe renal impairment. (See also WARNINGS: Anaphylactoid reactions during membrane exposure and PRECAUTIONS: Hemodialysis)
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![Carbamazepine Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=715555e5-49d2-4367-bcb7-78e7a23c6346&name=carbamazepinetablet-figure-04.jpg)
Carbamazepine
There is currently no dosage information available for this product. We apologize for any inconvenience.
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![Cephalexin For Suspension [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=5dfec608-4a61-45d6-b535-42c4cb8a170c&name=96a6ddb4-acfe-4a1f-9316-285217ee5942-02.jpg)
Cephalexin For Suspension
Cephalexin is administered orally.
Adults – The adult dosage ranges from 1 to 4 g daily in divided doses. The usual adult dose is 250 mg every 6 hours. For the following infections, a dosage of 500 mg may be administered every 12 hours: streptococcal pharyngitis, skin and skin structure infections, and uncomplicated cystitis in patients over 15 years of age. Cystitis therapy should be continued for 7 to 14 days. For more severe infections or those caused by less susceptible organisms, larger doses may be needed. If daily doses of cephalexin greater than 4 g are required, parenteral cephalosporins, in appropriate doses, should be considered.
Pediatric Patients – The usual recommended daily dosage for pediatric patients is 25 to 50 mg/kg in divided doses. For streptococcal pharyngitis in patients over 1 year of age and for skin and skin structure infections, the total daily dose may be divided and administered every 12 hours.
Cephalexin SuspensionWeight
125 mg/ 5 mL
10 kg (22 lb)
½to 1 tsp q.i.d.
20 kg (44 lb)
1 to 2 tsp q.i.d.
40 kg (88 lb)
2 to 4 tsp q.i.d.
Weight
250 mg/ 5 mL
10 kg (22 lb)
¼ to ½ tsp q.i.d.
20 kg (44 lb)
½ to 1 tsp q.i.d.
40 kg (88 lb)
1 to 2 tsp q.i.d.
or
Weight
125 mg/ 5 mL
10 kg (22 lb)
1 to 2 tsp b.i.d.
20 kg (44 lb)
2 to 4 tsp b.i.d.
40 kg (88 lb)
4 to 8 tsp b.i.d.
Weight
250 mg/ 5 mL
10 kg (22 lb)
½ to 1 tsp b.i.d.
20 kg (44 lb)
1 to 2 tsp b.i.d.
40 kg (88 lb)
2 to 4 tsp b.i.d.
In severe infections, the dosage may be doubled.
In the therapy of otitis media, clinical studies have shown that a dosage of 75 to 100 mg/kg/day in 4 divided doses is required.
In the treatment of β-hemolytic streptococcal infections, a therapeutic dosage of cephalexin should be administered for at least 10 days.
Directions for Mixing
For Cephalexin for Oral Suspension, USP 125 mg/5 mL:
Bottle size Reconstitution directions100 mL
Add 66 mL of water in two portions to the dry mixture in the bottle. Shake well after each addition
200 mL
Add 132 mL of water in two portions to the dry mixture in the bottle. Shake well after each addition.
For Cephalexin for Oral Suspension, USP 250 mg/5 mL:
Bottle size Reconstitution directions100 mL
Add 66 mL of water in two portions to the dry mixture in the bottle. Shake well after each addition.
200 mL
Add 132 mL of water in two portions to the dry mixture in the bottle. Shake well after each addition.
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![Childrens Qpap (Acetaminophen) Solution [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=b12e6a77-968f-4e06-8a96-936a39b974e3&name=image-01.jpg)
Childrens Qpap
this product does not contain directions or complete warnings for adult use
• find right dose on chart below. If possible, use weight to dose; otherwise, use age. • use only enclosed dosing cup designed for use with this product. Do not use any other dosing device. • if needed, repeat dose every 4 hours while symptoms last • do not give more than 5 times in 24 hours • do not give for more than 5 days unless directed by a doctorWeight (lb)
Age (yr)
Dose (tsp or mL)
under 24 lbs
under 2 years
ask a doctor
24-35 lbs
2-3 years
1 tsp or 5 mL
36-47 lbs
4-5 years
1 ½ tsp or 7.5 mL
48-59 lbs
6-8 years
2 tsp or 10 mL
60-71 lbs
9-10 years
2 ½ tsp or 12.5 mL
72-95 lbs
11 years
3 tsp or 15 mL
Attention: Specifically designed for use with enclosed measuring cup. Use only enclosed measuring cup to dose this product. Do not use any other dosing device.
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![Chlorhexidine Gluconate Rinse [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=1c3401ef-6a7a-485e-ab7e-52420a36f4e2&name=1c3401ef-6a7a-485e-ab7e-52420a36f4e2-02.jpg)
Chlorhexidine Gluconate Rinse
Chlorhexidine gluconate oral rinse therapy should be initiated directly following a dental prophylaxis. Patients using chlorhexidine gluconate oral rinse should be reevaluated and given a thorough prophylaxis at intervals no longer than six months.
Recommended use is twice daily oral rinsing for 30 seconds, morning and evening after tooth brushing. Usual dosage is 15 ml (marked in cap) of undiluted chlorhexidine gluconate oral rinse. Patients should be instructed to not rinse with water, or other mouthwashes, brush teeth, or eat immediately after using chlorhexidine gluconate oral rinse. Chlorhexidine gluconate oral rinse is not intended for ingestion and should be expectorated after rinsing.
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Metabopath
Dosage should be individualized for maximum beneficial effect. While the usual daily dosages given below will meet the needs of most patients, there will be some who require doses greater than 4 mg/day. In such cases, dosage should be increased cautiously to avoid adverse effects.Anxiety Disorders and Transient Symptoms of Anxiety: Treatment for patients with anxiety should be initiated with a dose of 0.25 to 0.5 mg given three times daily. The dose may be increased to achieve a maximum therapeutic effect, at intervals of 3 to 4 days, to a maximum daily dose of 4 mg, given in divided doses. The lowest possible effective dose should be employed and the need for continued treatment reassessed frequently. The risk of dependence may increase with dose and duration of treatment. In all patients, dosage should be reduced gradually when discontinuing therapy or when decreasing the daily dosage. Although there are no systematically collected data to support a specific discontinuation schedule, it is suggested that the daily dosage be decreased by no more than 0.5 mg every 3 days. Some patients may require an even slower dosage reduction. Panic Disorder: The successful treatment of many panic disorder patients has required the use of alprazolam tablets at doses greater than 4 mg daily. In controlled trials conducted to establish the efficacy of alprazolam tablets in panic disorder, doses in the range of 1 to 10 mg daily were used. The mean dosage employed was approximately 5 to 6 mg daily. Among the approximately 1700 patients participating in the panic disorder development program, about 300 received alprazolam tablets in dosages of greater than 7 mg/day, including approximately 100 patients who received maximum dosages of greater than 9 mg/day. Occasional patients required as much as 10 mg a day to achieve a successful response. Dose Titration: Treatment may be initiated with a dose of 0.5 mg three times daily. Depending on the response, the dose may be increased at intervals of 3 to 4 days in increments of no more than 1 mg per day. Slower titration to the dose levels greater than 4 mg/day may be advisable to allow full expression of the pharmacodynamic effect of alprazolam tablets. To lessen the possibility of interdose symptoms, the times of administration should be distributed as evenly as possible throughout the waking hours, that is, on a three or four times per day schedule. Generally, therapy should be initiated at a low dose to minimize the risk of adverse responses in patients especially sensitive to the drug. Dose should be advanced until an acceptable therapeutic response (ie, a substantial reduction in or total elimination of panic attacks) is achieved, intolerance occurs, or the maximum recommended dose is attained. Dose Maintenance: For patients receiving doses greater than 4 mg/day, periodic reassessment and consideration of dosage reduction is advised. In a controlled postmarketing dose-response study, patients treated with doses of alprazolam tablets greater than 4 mg/day for 3 months were able to taper to 50% of their total maintenance dose without apparent loss of clinical benefit. Because of the danger of withdrawal, abrupt discontinuation of treatment should be avoided. (See WARNINGS, PRECAUTIONS, DRUG ABUSE AND DEPENDENCE.) The necessary duration of treatment for panic disorder patients responding to alprazolam tablets is unknown. After a period of extended freedom from attacks, a carefully supervised tapered discontinuation may be attempted, but there is evidence that this may often be difficult to accomplish without recurrence of symptoms and/or the manifestation of withdrawal phenomena.Dose Reduction: Because of the danger of withdrawal, abrupt discontinuation of treatment should be avoided (see WARNINGS, PRECAUTIONS, DRUG ABUSE AND DEPENDENCE).In all patients, dosage should be reduced gradually when discontinuing therapy or when decreasing the daily dosage. Although there are no systematically collected data to support a specific discontinuation schedule, it is suggested that the daily dosage be decreased by no more than 0.5 mg every three days. Some patients may require an even slower dosage reduction.In any case, reduction of dose must be undertaken under close supervision and must be gradual. If significant withdrawal symptoms develop, the previous dosing schedule should be reinstituted and, only after stabilization, should a less rapid schedule of discontinuation be attempted. In a controlled postmarketing discontinuation study of panic disorder patients which compared this recommended taper schedule with a slower taper schedule, no difference was observed between the groups in the proportion of patients who tapered to zero dose; however, the slower schedule was associated with a reduction in symptoms associated with a withdrawal syndrome. It is suggested that the dose be reduced by no more than 0.5 mg every 3 days, with the understanding that some patients may benefit from an even more gradual discontinuation. Some patients may prove resistant to all discontinuation regimens.Dosing in Special Populations: In elderly patients, in patients with advanced liver disease or in patients with debilitating disease, the usual starting dose is 0.25 mg, given two or three times daily. This may be gradually increased if needed and tolerated. The elderly may be especially sensitive to the effects of benzodiazepines. If side effects occur at the recommended starting dose, the dose may be lowered.
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![Duloxetine Hydrochloride Capsule, Delayed Release [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=cd26d57b-a229-4990-bfcc-8e7cbad16dda&name=dulo-20mg.jpg)
Duloxetine Hydrochloride
Duloxetine delayed-release capsules, USP should be swallowed whole and should not be chewed or crushed, nor should the capsule be opened and its contents sprinkled on food or mixed with liquids. All of these might affect the enteric coating. Duloxetine delayed-release capsules, USP can be given without regard to meals.
2.1 Initial Treatment
Major Depressive Disorder Duloxetine delayed-release capsules, USP should be administered at a total dose of 40 mg/day (given as 20 mg twice daily) to 60 mg/day (given either once daily or as 30 mg twice daily). For some patients, it may be desirable to start at 30 mg once daily for 1 week, to allow patients to adjust to the medication before increasing to 60 mg once daily. While a 120 mg/day dose was shown to be effective, there is no evidence that doses greater than 60 mg/day confer any additional benefits. The safety of doses above 120 mg/day has not been adequately evaluated [see Clinical Studies (14.1)].
Generalized Anxiety Disorder For most patients, the recommended starting dose for duloxetine delayed-release capsules, USP is 60 mg administered once daily. For some patients, it may be desirable to start at 30 mg once daily for 1 week, to allow patients to adjust to the medication before increasing to 60 mg once daily. While a 120 mg once daily dose was shown to be effective, there is no evidence that doses greater than 60 mg/day confer additional benefit. Nevertheless, if a decision is made to increase the dose beyond 60 mg once daily, dose increases should be in increments of 30 mg once daily. The safety of doses above 120 mg once daily has not been adequately evaluated [see Clinical Studies (14.2)].
Diabetic Peripheral Neuropathic Pain The recommended dose for duloxetine delayed-release capsules, USP is 60 mg administered once daily. There is no evidence that doses higher than 60 mg confer additional significant benefit and the higher dose is clearly less well tolerated [see Clinical Studies (14.3)]. For patients for whom tolerability is a concern, a lower starting dose may be considered.
Since diabetes is frequently complicated by renal disease, a lower starting dose and gradual increase in dose should be considered for patients with renal impairment [see Dosage and Administration (2.3), Use in Specific Populations (8.10), and Clinical Pharmacology (12.3)].
Chronic Musculoskeletal Pain The recommended dose for duloxetine delayed-release capsules, USP is 60 mg once daily. Dosing may be started at 30 mg for one week, to allow patients to adjust to the medication before increasing to 60 mg once daily. There is no evidence that higher doses confer additional benefit, even in patients who do not respond to a 60 mg dose, and higher doses are associated with a higher rate of adverse reactions [see Clinical Studies (14.5)].
2.2 Maintenance/Continuation/Extended Treatment
Major Depressive Disorder It is generally agreed that acute episodes of major depression require several months or longer of sustained pharmacologic therapy. Maintenance of efficacy in MDD was demonstrated with duloxetine delayed-release capsules, USP as monotherapy. Duloxetine delayed-release capsules, USP should be administered at a total dose of 60 mg once daily. Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment [see Clinical Studies (14.1)].
Generalized Anxiety Disorder It is generally agreed that episodes of generalized anxiety disorder require several months or longer of sustained pharmacological therapy. Maintenance of efficacy in GAD was demonstrated with duloxetine delayed-release capsules, USP as monotherapy. Duloxetine delayed-release capsules, USP should be administered in a dose range of 60 to 120 mg once daily. Patients should be periodically reassessed to determine the continued need for maintenance treatment and the appropriate dose for such treatment [see Clinical Studies (14.2)].
Diabetic Peripheral Neuropathic Pain As the progression of diabetic peripheral neuropathy is highly variable and management of pain is empirical, the effectiveness of duloxetine delayed-release capsules, USP must be assessed individually. Efficacy beyond 12 weeks has not been systematically studied in placebo-controlled trials.
Chronic Musculoskeletal Pain The efficacy of duloxetine delayed-release capsules, USP have not been established in placebo-controlled studies beyond 13 weeks.
2.3 Dosing in Special Populations
Hepatic Insufficiency It is recommended that duloxetine delayed-release capsules, USP should ordinarily not be administered to patients with any hepatic insufficiency [see Warnings and Precautions (5.14) and Use in Specific Populations (8.9)].
Severe Renal Impairment Duloxetine delayed-release capsules, USP are not recommended for patients with end-stage renal disease or severe renal impairment (estimated creatinine clearance <30 mL/min) [see Warnings and Precautions (5.14) and Use in Specific Populations (8.10)].
Elderly Patients No dose adjustment is recommended for elderly patients on the basis of age. As with any drug, caution should be exercised in treating the elderly. When individualizing the dosage in elderly patients, extra care should be taken when increasing the dose [see Use in Specific Populations (8.5)].
Pregnant Women There are no adequate and well-controlled studies in pregnant women; therefore, duloxetine delayed-release capsules, USP should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus [see Use in Specific Populations (8.1)].
Nursing Mothers Because the safety of duloxetine in infants is not known, nursing while on duloxetine delayed-release capsules, USP is not recommended [see Use in Specific Populations (8.3)].
2.4 Discontinuing Duloxetine Delayed Release Capsules, USP
Symptoms associated with discontinuation of duloxetine delayed-release capsules, USP and other SSRIs and SNRIs have been reported. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible [see Warnings and Precautions (5.7)].
2.5 Switching a Patient To or From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders
At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with duloxetine delayed-release capsules, USP. Conversely, at least 5 days should be allowed after stopping duloxetine delayed-release capsules, USP before starting an MAOI intended to treat psychiatric disorders [see Contraindications (4.1)].
2.6 Use of Duloxetine Delayed-Release Capsules, USP with Other MAOIs such as Linezolid or Methylene Blue
Do not start duloxetine delayed-release capsules, USP in a patient who is being treated with linezolid or intravenous methylene blue because there is an increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered [see Contraindications (4.1)].
In some cases, a patient already receiving duloxetine delayed-release capsules, USP therapy may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, duloxetine delayed-release capsules, USP should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for 5 days or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with duloxetine delayed-release capsules, USP may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue [see Warnings and Precautions (5.4)].
The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with duloxetine delayed-release capsules, USP is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use [see Warnings and Precautions (5.4)].
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![Celebrex (Celecoxib) Capsule [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=e082d783-793f-4c17-b124-04fe377fb272&name=celebrex-07.jpg)
Celebrex
Use lowest effective dose for the shortest duration consistent with treatment goals for the individual patient.
These doses can be given without regard to timing of meals.
2.1Osteoarthritis
For relief of the signs and symptoms of OA the recommended oral dose is 200 mg per day administered as a single dose or as 100 mg twice daily.
2.2Rheumatoid Arthritis
For relief of the signs and symptoms of RA the recommended oral dose is 100 to 200 mg twice daily.
2.3Juvenile Rheumatoid Arthritis
For the relief of the signs and symptoms of JRA the recommended oral dose for pediatric patients (age 2 years and older) is based on weight. For patients ≥10 kg to ≤25 kg the recommended dose is 50 mg twice daily. For patients >25 kg the recommended dose is 100 mg twice daily.
For patients who have difficulty swallowing capsules, the contents of a CELEBREX capsule can be added to applesauce. The entire capsule contents are carefully emptied onto a level teaspoon of cool or room temperature applesauce and ingested immediately with water. The sprinkled capsule contents on applesauce are stable for up to 6 hours under refrigerated conditions (2–8° C/ 35–45° F).
2.4Ankylosing Spondylitis
For the management of the signs and symptoms of AS, the recommended dose of CELEBREX is 200 mg daily in single (once per day) or divided (twice per day) doses. If no effect is observed after 6 weeks, a trial of 400 mg daily may be worthwhile. If no effect is observed after 6 weeks on 400 mg daily, a response is not likely and consideration should be given to alternate treatment options.
2.5Management of Acute Pain and Treatment of Primary Dysmenorrhea
The recommended dose of CELEBREX is 400 mg initially, followed by an additional 200 mg dose if needed on the first day. On subsequent days, the recommended dose is 200 mg twice daily as needed.
2.6Special Populations
Hepatic insufficiency: The daily recommended dose of CELEBREX capsules in patients with moderate hepatic impairment (Child-Pugh Class B) should be reduced by 50%. The use of CELEBREX in patients with severe hepatic impairment is not recommended [see Warnings and Precautions (5.5), Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
Poor Metabolizers of CYP2C9 Substrates: Patients who are known or suspected to be poor CYP2C9 metabolizers based on genotype or previous history/experience with other CYP2C9 substrates (such as warfarin, phenytoin) should be administered celecoxib with caution. Consider starting treatment at half the lowest recommended dose in poor metabolizers (i.e. CYP2C9*3/*3). Consider using alternative management in JRA patients who are poor metabolizers. [see Use in Specific populations (8.8), and Clinical Pharmacology (12.5)].
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![Fenoprofen Capsule [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=490c0e17-0df1-46e1-9666-436a7613e499&name=7fe1991a-0b9c-4ff5-8dc0-568e235a4ad8-02.jpg)
Fenoprofen
Carefully consider the potential benefits and risks of Fenoprofen Calcium and other treatment options before deciding to use Fenoprofen Calcium. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with Fenoprofen Calcium, the dose and frequency should be adjusted to suit an individual patient's needs.
Analgesia
For the treatment of mild to moderate pain, the recommended dosage is 200 mg given orally every 4 to 6 hours, as needed.
Rheumatoid Arthritis and Osteoarthritis
For the relief of signs and symptoms of rheumatoid arthritis or osteoarthritis the recommended dose is 400 to 600 mg given orally, 3 or 4 times a day. The dose should be tailored to the needs of the patient and may be increased or decreased depending on the severity of the symptoms. Dosage adjustments may be made after initiation of drug therapy or during exacerbations of the disease. Total daily dosage should not exceed 3,200 mg.
Fenoprofen Calcium may be administered with meals or with milk. Although the total amount absorbed is not affected, peak blood levels are delayed and diminished.
Patients with rheumatoid arthritis generally seem to require larger doses of Fenoprofen Calcium than do those with osteoarthritis. The smallest dose that yields acceptable control should be employed.
Although improvement may be seen in a few days in many patients, an additional 2 to 3 weeks may be required to gauge the full benefits of therapy.
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![Triamcinolone Acetonide Cream [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=b5d1b944-83e7-4968-a2df-e6c6cf22904e&name=58848cfd-fa68-43ee-815b-4376894bf50d-06.jpg)
Triamcinolone Acetonide
Topical corticosteroids are generally applied to the affected area as a thin film from two to four times daily depending on the severity of the condition. Occlusive dressing may be used for the management of psoriasis or recalcitrant conditions.
If an infection develops, the use of occlusive dressing should be discontinued and appropriate antimicrobial therapy instituted.
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![Theophylline Tablet, Extended Release [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=8e2de7dc-72bc-44cc-97bf-efe776331a2d&name=a66a97c2-4d2b-4e4b-967e-1c8b67e364d9-03.jpg)
Theophylline
Taking theophylline extended-release tablets immediately after a high-fat content meal may result in a somewhat higher Cmax and delayed Tmax, and somewhat greater extent of absorption. However, the differences are usually not great and this product may normally be administered without regard to meals (see CLINICAL PHARMACOLOGY, Drug Interactions, Drug-Food Interactions).
Theophylline extended-release tablets are recommended for chronic or long-term management and prevention of symptoms, and not for use in treating acute symptoms of asthma and reversible bronchospasm.
General Considerations
The steady-state peak serum theophylline concentration is a function of the dose, the dosing interval, and the rate of theophylline absorption and clearance in the individual patient. Because of marked individual differences in the rate of theophylline clearance, the dose required to achieve a peak serum theophylline concentration in the 10 to 20 mcg/mL range varies fourfold among otherwise similar patients in the absence of factors known to alter theophylline clearance (e.g., 400 to 1600 mg/day in adults <60 years old and 10 to 36 mg/kg/day in children 1 to 9 years old). For a given population there is no single theophylline dose that will provide both safe and effective serum concentrations for all patients. Administration of the median theophylline dose required to achieve a therapeutic serum theophylline concentration in a given population may result in either subtherapeutic or potentially toxic serum theophylline concentrations in individual patients. For example, at a dose of 900 mg/d in adults <60 years or 22 mg/kg/d in children 1 to 9 years, the steady-state peak serum theophylline concentration will be <10 mcg/mL in about 30% of patients, 10 to 20 mcg/mL in about 50% and 20 to 30 mcg/mL in about 20% of patients. The dose of theophylline must be individualized on the basis of peak serum theophylline concentration measurements in order to achieve a dose that will provide maximum potential benefit with minimal risk of adverse effects.
Transient caffeine-like adverse effects and excessive serum concentrations in slow metabolizers can be avoided in most patients by starting with a sufficiently low dose and slowly increasing the dose, if judged to be clinically indicated, in small increments (see Table V). Dose increases should only be made if the previous dosage is well tolerated and at intervals of no less than 3 days to allow serum theophylline concentrations to reach the new steady state. Dosage adjustment should be guided by serum theophylline concentration measurement (see PRECAUTIONS, Laboratory Tests and DOSAGE AND ADMINISTRATION, Table VI). Health care providers should instruct patients and care givers to discontinue any dosage that causes adverse effects, to withhold the medication until these symptoms are gone and to then resume therapy at a lower, previously tolerated dosage (see WARNINGS).
If the patient’s symptoms are well controlled, there are no apparent adverse effects, and no intervening factors that might alter dosage requirements (see WARNINGS and PRECAUTIONS), serum theophylline concentrations should be monitored at 6 month intervals for rapidly growing children and at yearly intervals for all others. In acutely ill patients, serum theophylline concentrations should be monitored at frequent intervals, e.g. every 24 hours.
Theophylline distributes poorly into body fat, therefore, mg/kg dose should be calculated on the basis of ideal body weight.
Table V contains theophylline dosing titration schema recommended for patients in various age groups and clinical circumstances. Table VI contains recommendations for theophylline dosage adjustment based upon serum theophylline concentrations. Application of these general dosing recommendations to individual patients must take into account the unique clinical characteristics of each patient. In general, these recommendations should serve as the upper limit for dosage adjustments in order to decrease the risk of potentially serious adverse events associated with unexpected large increases in serum theophylline concentration.
Table V. Dosing initiation and titration (as anhydrous theophylline).* * Patients with more rapid metabolism, clinically identified by higher than average dose requirements, should receive a smaller dose more frequently (every 8 hours) to prevent breakthrough symptoms resulting from low trough concentrations before the next dose.A.
Children (6 to 15 years) and adults (16 to 60 years) without risk factors for impaired clearance.
Titration Step
Children <45 kg
Children >45 kg and adults
1.
Starting Dosage
12 to 14 mg/kg/day up
to a maximum of
300 mg/day divided
Q12 hrs*
300 mg/day divided Q12 hrs*
2.
After 3 days,
if tolerated,
increase dose to:
16 mg/kg/day up
to a maximum of
400 mg/day divided
Q12 hrs*
400 mg/day divided
Q12 hrs*
3.
After 3 more days,
if tolerated,
increase dose to:
20 mg/kg/day up to
a maximum of
600 mg/day
divided Q12 hrs*
600 mg/day divided
Q12 hrs*
B.
Patients With Risk Factors For Impaired Clearance, The Elderly (>60 Years), And Those In Whom It Is Not Feasible To Monitor Serum Theophylline Concentrations:
In children 6 to 15 years of age, the final theophylline dose should not exceed 16 mg/kg/day up to a maximum of 400 mg/day in the presence of risk factors for reduced theophylline clearance (see WARNINGS) or if it is not feasible to monitor serum theophylline concentrations.
In adolescents ≥16 years and adults, including the elderly, the final theophylline dose should not exceed 400 mg/day in the presence of risk factors for reduced theophylline clearance (see WARNINGS) or if it is not feasible to monitor serum theophylline concentrations.
Table VI. Dosage adjustment guided by serum theophylline concentration. * Dose reduction and/or serum theophylline concentration measurement is indicated whenever adverse effects are present, physiologic abnormalities that can reduce theophylline clearance occur (e.g., sustained fever), or a drug that interacts with theophylline is added or discontinued (see WARNINGS).Peak Serum
Concentration
Dosage Adjustment
<9.9 mcg/mL
If symptoms are not controlled and current dosage is tolerated, increase dose about 25%. Recheck serum concentration after three days for further dosage adjustment.
10 to 14.9 mcg/mL
If symptoms are controlled and current dosage is tolerated, maintain dose and recheck serum concentration at 6 to 12 month intervals.*
If symptoms are not controlled and current dosage is tolerated consider adding additional medication(s) to treatment regimen.
15 to 19.9 mcg/mL
Consider 10% decrease in dose to provide greater margin of safety even if current dosage is tolerated.*
20 to 24.9 mcg/mL
Decrease dose by 25% even if no adverse effects are present. Recheck serum concentration after 3 days to guide further dosage adjustment.
25 to 30 mcg/mL
Skip next dose and decrease subsequent doses at least 25% even if no adverse effects are present. Recheck serum concentration after 3 days to guide further dosage adjustment. If symptomatic, consider whether overdose treatment is indicated (see recommendations for chronic overdosage).
>30 mcg/mL
Treat overdose as indicated (see recommendations for chronic overdosage). If theophylline is subsequently resumed, decrease dose by at least 50% and recheck serum concentration after 3 days to guide further dosage adjustment.
Once-Daily Dosing
The slow absorption rate of this preparation may allow once-daily administration in adult non-smokers with appropriate total body clearance and other patients with low dosage requirements. Once-daily dosing should be considered only after the patient has been gradually and satisfactorily titrated to therapeutic levels with q12h dosing. Once-daily dosing should be based on twice the q12h dose and should be initiated at the end of the last q12h dosing interval. The trough concentration (Cmin) obtained following conversion to once-daily dosing may be lower (especially in high clearance patients) and the peak concentration (Cmax) may be higher (especially in low clearance patients) than that obtained with q12h dosing. If symptoms recur, or signs of toxicity appear during the once-daily dosing interval, dosing on the q12h basis should be reinstituted.
It is essential that serum theophylline concentrations be monitored before and after transfer to once-daily dosing.
Food and posture, along with changes associated with circadian rhythm, may influence the rate of absorption and/or clearance rates of theophylline from extended-release dosage forms administered at night. The exact relationship of these and other factors to nighttime serum concentrations and the clinical significance of such findings require additional study. Therefore, it is not recommended that theophylline extended-release once-daily dosing be administered at night.
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![Ciprofloxacin Solution/ Drops [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=201df228-e84a-4e78-965f-bf83f3db42e6&name=fd3c2dfe-43ff-46e0-8510-b61b985f275c-02.jpg)
Ciprofloxacin Solution Drops
Corneal Ulcers
The recommended dosage regimen for the treatment of corneal ulcers is two drops into the affected eye every 15 minutes for the first six hours and then two drops into the affected eye every 30 minutes for the remainder of the first day. On the second day, instill two drops in the affected eye hourly. On the third through the fourteenth day, place two drops in the affected eye every four hours. Treatment may be continued after 14 days if corneal re-epithelialization has not occurred.
Bacterial Conjunctivitis
The recommended dosage regimen for the treatment of bacterial conjunctivitis is one or two drops instilled into the conjunctival sac(s) every two hours while awake for two days and one or two drops every four hours while awake for the next five days.
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![Methocarbamol Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=8a6ab350-2e0a-4809-b943-8bd1e7b0f779&name=methocarbamol-2.jpg)
Methocarbamol
Methocarbamol, 500 mg — Adults: Initial dosage: 3 tablets q.i.d. Maintenance dosage: 2 tablets q.i.d.
Methocarbamol, 750 mg — Adults: Initial dosage: 2 tablets q.i.d. Maintenance dosage: 1 tablet q.4h. or 2 tablets t.i.d.
Six grams a day are recommended for the first 48 to 72 hours of treatment. (For severe conditions 8 grams a day may be administered). Thereafter, the dosage can usually be reduced to approximately 4 grams a day.
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![Ciprofloxacin (Ciprofloxacin Hydrochloride) Tablet, Film Coated [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=ea5155fb-cb1c-482d-8bdd-69ac994c56d1&name=ciprofloxacin-fig1.jpg)
Ciprofloxacin
Adults Ciprofloxacin tablets should be administered orally to adults as described in the Dosage Guidelines table.The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient’s host-defense mechanisms, and the status of renal function and hepatic function.The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, polymeric phosphate binders (for example, sevelamer, lanthanum carbonate) or sucralfate, Videx® (didanosine) chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.
ADULT DOSAGE GUIDELINES Infection Severity Dose Frequency Usual Durations† * Used in conjunction with metronidazole † Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection have disappeared, except for inhalational anthrax (post-exposure). ** Drug administration should begin as soon as possible after suspected or confirmed exposure.Urinary Tract
Acute Uncomplicated
250 mg
q 12 h
3 days
Mild/Moderate
250 mg
q 12 h
7 to 14 days
Severe/Complicated
500 mg
q 12 h
7 to 14 days
Chronic Bacterial Prostatitis
Mild/Moderate
500 mg
q 12 h
28 days
Lower Respiratory Tract
Mild/Moderate
500 mg
q 12 h
7 to 14 days
Severe/Complicated
750 mg
q 12 h
7 to 14 days
Acute Sinusitis
Mild/Moderate
500 mg
q 12 h
10 days
Skin and Skin Structure
Mild/Moderate
500 mg
q 12 h
7 to 14 days
Severe/Complicated
750 mg
q 12 h
7 to 14 days
Bone and Joint
Mild/Moderate
500 mg
q 12 h
≥ 4 to 6 weeks
Severe/Complicated
750 mg
q 12 h
≥ 4 to 6 weeks
Intra-Abdominal*
Complicated
500 mg
q 12 h
7 to 14 days
Infectious Diarrhea
Mild/Moderate/Severe
500 mg
q 12 h
5 to 7 days
Typhoid Fever
Mild/Moderate
500 mg
q 12 h
10 days
Urethral and Cervical Gonococcal Infections
Uncomplicated
250 mg
single dose
single dose
Inhalational anthrax (post-exposure)**
500 mg
q 12 h
60 days
This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.6 For a discussion of ciprofloxacin serum concentrations in various human populations, see Inhalational Anthrax, Additional Information.Conversion of IV to Oral Dosing in Adults Patients whose therapy is started with ciprofloxacin IV may be switched to ciprofloxacin tablets when clinically indicated at the discretion of the physician (See CLINICAL PHARMACOLOGY and table below for the equivalent dosing regimens).
Equivalent AUC Dosing Regimens Ciprofloxacin Oral Dosage Equivalent Ciprofloxacin IV Dosage250 mg Tablet q 12 h
200 mg IV q 12 h
500 mg Tablet q 12 h
400 mg IV q 12 h
750 mg Tablet q 12 h
400 mg IV q 8 h
Adults with Impaired Renal Function Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:
RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine Clearance (mL/min) Dose> 50
See Usual Dosage.
30 – 50
250 – 500 mg q 12 h
5 – 29
250 – 500 mg q 18 h
Patients on hemodialysis or Peritoneal dialysis
250 – 500 mg q 24 h (after dialysis)
When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
Weight (kg) x (140 - age)
Men: Creatinine clearance (mL/min) = ---------------------------------------
72 x serum creatinine (mg/dL)
Women: 0.85 x the value calculated for men.The serum creatinine should represent a steady state of renal function.In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored.Pediatrics Ciprofloxacin tablets should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS and CLINICAL STUDIES.) Dosing and initial route of therapy (that is, IV or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg IV every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
PEDIATRIC DOSAGE GUIDELINES Infection Route of Administration Dose (mg/kg) Frequency Total Duration * The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days). ** Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.6 For a discussion of ciprofloxacin serum concentrations in various human populations, see Inhalational Anthrax in Adults and Pediatrics, Additional Information.Complicated Urinary Tract or Pyelonephritis
Intravenous
6 to 10 mg/kg (maximum 400 mg per dose; not to be exceeded even in patients weighing > 51 kg)
Every 8 hours
10-21 days*
(patients from 1 to 17 years of age)
Oral
10 mg/kg to 20 mg/kg (maximum 750 mg per dose; not to be exceeded even in patients weighing > 51 kg)
Every 12 hours
Inhalational Anthrax (Post-Exposure)**
Intravenous
10 mg/kg (maximum 400 mg per dose)
Every 12 hours
60 days
Oral
15 mg/kg(maximum 500 mg per dose)
Every 12 hours
Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (that is, creatinine clearance of < 50 mL/min/1.73m2).
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![Tussin Cough Long Acting (Dextromethorphan Hydrobromide) Liquid [Hyvee Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=5cdbddda-2e5b-4e9a-b14f-2e732e814a55&name=phentermine-hydrochloride-capsules-usp---15-mg-30--3.jpg)
Tussin Cough Long Acting
Exogenous Obesity Dosage should be individualized to obtain an adequate response with the lowest effective dose.
The usual adult dose is 15 mg to 30 mg as prescribed by the physician, at approximately 2 hours after breakfast for appetite control. Administration of one 30 mg capsule daily has been found to be adequate in depression of the appetite for 12 to 14 hours. Phentermine is not recommended for use in pediatric patients ≤ 16 years of age.
Late evening medication should be avoided because of the possibility of resulting insomnia.
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![Clindamycin Hydrochloride Capsule [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=dc42379d-f649-4956-9f19-fb9b3be82731&name=clindamycin-fig1.jpg)
Clindamycin Hydrochloride
If significant diarrhea occurs during therapy, this antibiotic should be discontinued (see WARNING box).Adults Serious infections—150 to 300 mg every 6 hours. More severe infections—300 to 450 mg every 6 hours.Pediatric Patients Serious infections—8 to 16 mg/kg/day (4 to 8 mg/lb/day) divided into three or four equal doses. More severe infections—16 to 20 mg/kg/day (8 to 10 mg/lb/day) divided into three or four equal doses.To avoid the possibility of esophageal irritation, clindamycin hydrochloride capsules should be taken with a full glass of water.Serious infections due to anaerobic bacteria are usu‑ally treated with clindamycin injection. However, in clinically appropriate circum‑stances, the physician may elect to initiate treatment or continue treatment with clindamycin hydrochloride capsules.In cases of β-hemolytic streptococcal infections, treat‑ment should continue for at least 10 days.
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![Ciprofloxacin Tablet, Film Coated [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=a34ae37c-f8a3-4817-b7f3-babe474255f4&name=container2.jpg)
Ciprofloxacin
There is currently no dosage information available for this product. We apologize for any inconvenience.
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![Temozolomide Capsule [Sandoz Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=62e9b4a2-868d-45ea-af45-f193e7ad52bc&name=0418f6ee-bc12-4645-91e5-310f531c8fe4-02.jpg)
Temozolomide
Carefully consider the potential benefits and risks of etodolac tablets and other treatment options before deciding to use etodolac tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with etodolac tablets, the dose and frequency should be adjusted to suit an individual patient's needs.
Dosage adjustment of etodolac tablets is generally not required in patients with mild to moderate renal impairment. Etodolac tablets should be used with caution in such patients, because, as with other NSAIDs, they may further decrease renal function in some patients with impaired renal function (see WARNINGS, Renal Effects).
Analgesia
The recommended total daily dose of etodolac tablets for acute pain is up to 1,000 mg, given as 200 to 400 mg every 6 to 8 hours. Doses of etodolac greater than 1,000 mg/day have not been adequately evaluated in well-controlled clinical trials.
Osteoarthritis and Rheumatoid Arthritis
The recommended starting dose of etodolac tablets for the management of the signs and symptoms of osteoarthritis or rheumatoid arthritis is: 300 mg b.i.d., t.i.d., or 400 mg b.i.d., or 500 mg b.i.d. A lower dose of 600 mg/day may suffice for long-term administration. Physicians should be aware that doses above 1,000 mg/day have not been adequately evaluated in well-controlled clinical trials.
In chronic conditions, a therapeutic response to therapy with etodolac tablets is sometimes seen within one week of therapy, but most often is observed by two weeks. After a satisfactory response has been achieved, the patient’s dose should be reviewed and adjusted as required.
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![Miconazole Nitrate Cream [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=3d834359-b870-45ff-8d64-006e1cbc2c92&name=image-01.jpg)
Miconazole Nitrate
• clean the affected area and dry thoroughly • apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor • supervise children in the use of this product
For athlete's foot:
• use daily for 4 weeks. If condition persists longer, consult a doctor. • pay special attention to the spaces between the toes • wear well-fitting, ventilated shoes • change shoes and socks at least once dailyFor ringworm, use daily for 4 weeks. If condition persists longer, consult a doctor.
For jock itch, use daily for 2 weeks. If condition persists longer, consult a doctor.
This product is not effective on the scalp or nails.
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![Neomycin And Polymyxin B Sulfates And Dexamethasone (Neomycin, Polymyxin B Sulfates, Dexamethasone) Ointment [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=b12866e9-92ce-4c17-8b5d-fa755dd717ef&name=c8ae4afe-4f06-4441-9c5b-52f485f8f2f5-05.jpg)
Neomycin And Polymyxin B Sulfates And Dexamethasone
Apply a small amount into the conjunctival sac(s) up to three or four times daily.
How to Apply neomycin and polymyxin B sulfates and dexamethasone ophthalmic ointment:
1. Tilt your head back. 2. Place a finger on your cheek just under your eye and gently pull down until a "V" pocket is formed between your eyeball and your lower lid. 3. Place a small amount (about 1/2 inch) of neomycin and polymyxin B sulfates and dexamethasone ophthalmic ointment in the "V" pocket. Do not let the tip of the tube touch your eye. 4. Look downward before closing your eye.Not more than 8 g should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in PRECAUTIONS above.
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![Hydrogen Peroxide Spray [Safetec Of America, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=340f1a87-0bc6-46bf-8f16-80a5348ad15f&name=image-04.jpg)
Hydrogen Peroxide Spray
Instructions for Use/Handling Ondansetron Orally Disintegrating Tablets USP:
Do not attempt to push ondansetron orally disintegrating tablets USP through the foil backing. With dry hands, PEEL BACK the foil backing of 1 blister and GENTLY remove the tablet. IMMEDIATELY place the ondansetron orally disintegrating tablet USP on top of the tongue where it will dissolve in seconds, then swallow with saliva. Administration with liquid is not necessary.
Prevention of Nausea and Vomiting Associated With Highly Emetogenic Cancer Chemotherapy:
The recommended adult oral dosage of ondansetron is 24 mg given as three 8-mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥50 mg/m2. Multiday, single-dose administration of a 24 mg dosage has not been studied.
Pediatric Use:
There is no experience with the use of a 24 mg dosage in pediatric patients.
Geriatric Use:
The dosage recommendation is the same as for the general population.
Prevention of Nausea and Vomiting Associated With Moderately Emetogenic Cancer Chemotherapy:
The recommended adult oral dosage is one 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.
Pediatric Use:
For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4-mg ondansetron tablet USP or one 4-mg ondansetron orally disintegrating tablet USP given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4-mg ondansetron tablet USP or one 4-mg ondansetron orally disintegrating tablet USP should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.
Geriatric Use:
The dosage is the same as for the general population.
Prevention of Nausea and Vomiting Associated With Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions to the Abdomen:
The recommended oral dosage is one 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP given 3 times a day.
For total body irradiation, one 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.
For single high-dose fraction radiotherapy to the abdomen, one 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.
For daily fractionated radiotherapy to the abdomen, one 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.
Pediatric Use:
There is no experience with the use of ondansetron tablets USP or ondansetron orally disintegrating tablets USP in the prevention of postoperative nausea and vomiting in pediatric patients.
Geriatric Use:
The dosage recommendation is the same as for the general population.
Postoperative Nausea and Vomiting:
The recommended dosage is 16 mg given as two 8-mg ondansetron tablets USP or two 8-mg ondansetron orally disintegrating tablets USP 1 hour before induction of anesthesia.
Pediatric Use:
There is no experience with the use of ondansetron tablets USP or ondansetron orally disintegrating tablets USP in the prevention of postoperative nausea and vomiting in pediatric patients.
Geriatric Use:
The dosage is the same as for the general population.
Dosage Adjustment for Patients With Impaired Renal Function:
The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron.
Dosage Adjustment for Patients With Impaired Hepatic Function:
In patients with severe hepatic impairment (Child-Pugh2 score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.
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![Phentermine Hydrochloride Capsule [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=b78a92bc-6cd6-4808-84a3-861e95797409&name=phentermine-03.jpg)
Phentermine Hydrochloride
Exogenous Obesity
Dosage should be individualized to obtain an adequate response with the lowest effective dose.
The usual adult dose is 15 mg to 30 mg as prescribed by the physician, at approximately 2 hours after breakfast for appetite control. Administration of one 30 mg capsule daily has been found to be adequate in depression of the appetite for 12 to 14 hours. Phentermine is not recommended for use in pediatric patients ≤16 years of age.
Late evening medication should be avoided because of the possibility of resulting insomnia.
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![Eye Allergy Relief (Pheniramine Maleate And Naphazoline Hydrochloride) Solution/ Drops [Walgreen Company]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=098afc02-ac71-4214-9fe1-8b519b173bdf&name=b2ce0106-b2c3-4c4d-8dac-40050f6ea4ae-03.jpg)
Eye Allergy Relief
Apply the shampoo to the damp skin of the affected area and a wide margin surrounding this area. Lather, leave in place for 5 minutes, and then rinse off with water.
One application of the shampoo should be sufficient.
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![Nabumetone Tablet, Film Coated [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=2f7eb033-3912-4c1c-aa11-ac34c36ffe8a&name=2f7eb033-3912-4c1c-aa11-ac34c36ffe8a-12.jpg)
Nabumetone
Carefully consider the potential benefits and risks of nabumetone tablets and other treatment options before deciding to use nabumetone. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with nabumetone tablets, the dose and frequency should be adjusted to suit an individual patient's needs.
Osteoarthritis and Rheumatoid Arthritis:
The recommended starting dose is 1,000 mg taken as a single dose with or without food. Some patients may obtain more symptomatic relief from 1,500 mg to 2,000 mg per day. Nabumetone tablets can be given in either asingl or twice-daily dose. Dosages greater than 2,000 mg per day have not been studied. The lowest effective dose should be used for chronic treatment (see WARNINGS: Renal Effects: ). Patients weighing under 50 kg may be less likely to require dosages beyond 1,000 mg; therefore, after observing the response to initial therapy, the dose should be adjusted to meet individual patients' requirements.
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![Lenzagel (Lidocaine Hydrochloride, Menthol) Gel [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=324acb82-06c4-4c53-9113-e0a297568fa9&name=image-01.jpg)
Lenzagel
• Apply directly to effected area. Do not use more than four times per day.
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![Prednisone Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=95f510ad-a23a-4619-8a23-c84b3d677b66&name=prednisone-tablets-usp-4.jpg)
Prednisone
Gastric irritation may be reduced if taken before, during, or immediately after meals or with food or milk.
The maximal activity of the adrenal cortex is between 2 am and 8 am, and it is minimal between 4 pm and midnight. Exogenous corticosteroids suppress adrenocorticoid activity the least when given at the time of maximal activity (am) for single dose administration. Therefore, it is recommended that prednisone be administered in the morning prior to 9 am and when large doses are given, administration of antacids between meals to help prevent peptic ulcers. Multiple dose therapy should be evenly distributed in evenly spaced intervals throughout the day.
Dietary salt restriction may be advisable in patients.
Do not stop taking this medicine without first talking to your doctor. Avoid abrupt withdraw of therapy.
The initial dosage of prednisone may vary from 5 mg to 60 mg per day, depending on the specific disease entity being treated. In situations of less severity lower doses will generally suffice, while in selected patients higher initial doses may be required. The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time there is a lack of satisfactory clinical response, prednisone should be discontinued and the patient transferred to other appropriate therapy. IT SHOULD BE EMPHASIZED THAT DOSAGE REQUIREMENTS ARE VARIABLE AND MUST BE INDIVIDUALIZED ON THE BASIS OF THE DISEASE UNDER TREATMENT AND THE RESPONSE OF THE PATIENT. After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small increments at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. It should be kept in mind that constant monitoring is needed in regard to drug dosage. Included in the situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient’s individual drug responsiveness, and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment; in this latter situation, it may be necessary to increase the dosage of prednisone for a period of time consistent with the patient’s condition. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.
Multiple Sclerosis
In the treatment of acute exacerbations of multiple sclerosis daily doses of 200 mg of prednisolone for a week followed by 80 mg every other day for 1 month have been shown to be effective. (Dosage range is the same for prednisone and prednisolone.)
Alternate Day Therapy
Alternate day therapy is a corticosteroid dosing regimen in which twice the usual daily dose of corticoid is administered every other morning. The purpose of this mode of therapy is to provide the patient requiring long-term pharmacologic dose treatment with the beneficial effects of corticoids while minimizing certain undesirable effects, including pituitary-adrenal suppression, the cushingoid state, corticoid withdrawal symptoms, and growth suppression in children.
The rationale for this treatment schedule is based on two major premises: (a) the anti-inflammatory or therapeutic effect of corticoids persists longer than their physical presence and metabolic effects and (b) administration of the corticosteroid every other morning allows for re-establishment of more nearly normal hypothalamic-pituitary-adrenal (HPA) activity on the off-steroid day.
A brief review of the HPA physiology may be helpful in understanding this rationale. Acting primarily through the hypothalamus a fall in free cortisol stimulates the pituitary gland to produce increasing amounts of corticotropin (ACTH) while a rise in free cortisol inhibits ACTH secretion. Normally the HPA system is characterized by diurnal (circadian) rhythm. Serum levels of ACTH rise from a low point about 10 pm to a peak level about 6 am. Increasing levels of ACTH stimulate adrenocortical activity resulting in a rise in plasma cortisol with maximal levels occurring between 2 am and 8 am. This rise in cortisol dampens ACTH production and in turn adrenocortical activity. There is a gradual fall in plasma corticoids during the day with lowest levels occurring about midnight.
The diurnal rhythm of the HPA axis is lost in Cushing’s disease, a syndrome of adrenocortical hyperfunction characterized by obesity with centripetal fat distribution, thinning of the skin with easy bruisability, muscle wasting with weakness, hypertension, latent diabetes, osteoporosis, electrolyte imbalance, etc. The same clinical findings of hyperadrenocorticism may be noted during long-term pharmacologic dose corticoid therapy administered in conventional daily divided doses. It would appear, then, that a disturbance in the diurnal cycle with maintenance of elevated corticoid values during the night may play a significant role in the development of undesirable corticoid effects. Escape from these constantly elevated plasma levels for even short periods of time may be instrumental in protecting against undesirable pharmacologic effects.
During conventional pharmacologic dose corticosteroid therapy, ACTH production is inhibited with subsequent suppression of cortisol production by the adrenal cortex. Recovery time for normal HPA activity is variable depending upon the dose and duration of treatment. During this time the patient is vulnerable to any stressful situation. Although it has been shown that there is considerably less adrenal suppression following a single morning dose of prednisolone (10 mg) as opposed to a quarter of that dose administered every 6 hours, there is evidence that some suppressive effect on adrenal activity may be carried over into the following day when pharmacologic doses are used. Further, it has been shown that a single dose of certain corticosteroids will produce adrenocortical suppression for two or more days. Other corticoids, including methylprednisolone, hydrocortisone, prednisone, and prednisolone, are considered to be short acting (producing adrenocortical suppression for 1 1/4 to 1 1/2 days following a single dose) and thus are recommended for alternate day therapy.
The following should be kept in mind when considering alternate day therapy:
1. Basic principles and indications for corticosteroid therapy should apply. The benefits of alternate day therapy should not encourage the indiscriminate use of steroids.
2. Alternate day therapy is a therapeutic technique primarily designed for patients in whom long-term pharmacologic corticoid therapy is anticipated.
3. In less severe disease processes in which corticoid therapy is indicated, it may be possible to initiate treatment with alternate day therapy. More severe disease states usually will require daily divided high dose therapy for initial control of the disease process. The initial suppressive dose level should be continued until satisfactory clinical response is obtained, usually four to ten days in the case of many allergic and collagen diseases. It is important to keep the period of initial suppressive dose as brief as possible particularly when subsequent use of alternate day therapy is intended. Once control has been established, two courses are available: (a) change to alternate day therapy and then gradually reduce the amount of corticoid given every other day or (b) following control of the disease process reduce the daily dose of corticoid to the lowest effective level as rapidly as possible and then change over to an alternate day schedule. Theoretically, course (a) may be preferable.
4. Because of the advantages of alternate day therapy, it may be desirable to try patients on this form of therapy who have been on daily corticoids for long periods of time (e.g., patients with rheumatoid arthritis). Since these patients may already have a suppressed HPA axis, establishing them on alternate day therapy may be difficult and not always successful. However, it is recommended that regular attempts be made to change them over. It may be helpful to triple or even quadruple the daily maintenance dose and administer this every other day rather than just doubling the daily dose if difficulty is encountered. Once the patient is again controlled, an attempt should be made to reduce this dose to a minimum.
5. As indicated above, certain corticosteroids, because of their prolonged suppressive effect on adrenal activity, are not recommended for alternate day therapy (e.g., dexamethasone and betamethasone).
6. The maximal activity of the adrenal cortex is between 2 am and 8 am, and it is minimal between 4 pm and midnight. Exogenous corticosteroids suppress adrenocortical activity the least, when given at the time of maximal activity (am).
7. In using alternate day therapy it is important, as in all therapeutic situations to individualize and tailor the therapy to each patient. Complete control of symptoms will not be possible in all patients. An explanation of the benefits of alternate day therapy will help the patient to understand and tolerate the possible flare-up in symptoms which may occur in the latter part of the off-steroid day. Other symptomatic therapy may be added or increased at this time if needed.
8. In the event of an acute flare-up of the disease process, it may be necessary to return to a full suppressive daily divided corticoid dose for control. Once control is again established alternate day therapy may be re-instituted.
9. Although many of the undesirable features of corticosteroid therapy can be minimized by alternate day therapy, as in any therapeutic situation, the physician must carefully weigh the benefit-risk ratio for each patient in whom corticoid therapy is being considered.
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![Clobetasol Propionate Ointment [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=b22a7bb3-108b-4485-a721-1ea89adac36e&name=clobetasol-04.jpg)
Clobetasol Propionate Ointment
Apply a thin layer of clobetasol propionate gel, cream or ointment to the affected skin areas twice daily and rub in gently and completely. (See INDICATIONS AND USAGE.)
Clobetasol propionate gel, cream and ointment are super-high potency topical corticosteroids; therefore, treatment should be limited to 2 consecutive weeks, and amounts greater than 50 g per week should not be used.
As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.
Clobetasol propionate gel, cream or ointment should not be used with occlusive dressings.
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![Prednisone Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=c31d0539-4ee5-4a5f-b131-9a784e046989&name=prednisone-tablets-5mg-10-mg-20-mg-3.jpg)
Prednisone
The initial dosage of prednisone tablets may vary from 5 mg to 60 mg per day, depending on the specific disease entity being treated. In situations of less severity lower doses will generally suffice while in selected patients higher initial doses may be required. The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time there is a lack of satisfactory clinical response, prednisone should be discontinued and the patient transferred to other appropriate therapy. IT SHOULD BE EMPHASIZED THAT DOSAGE REQUIREMENTS ARE VARIABLE AND MUST BE INDIVIDUALIZED ON THE BASIS OF THE DISEASE UNDER TREATMENT AND THE RESPONSE OF THE PATIENT. After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. It should be kept in mind that constant monitoring is needed in regard to drug dosage. Included in the situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient’s individual drug responsiveness, and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment; in this latter situation it may be necessary to increase the dosage of prednisone for a period of time consistent with the patient’s condition. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.
Multiple Sclerosis
In the treatment of acute exacerbations of multiple sclerosis daily doses of 200 mg of prednisolone for a week followed by 80 mg every other day for 1 month have been shown to be effective. (Dosage range is the same for prednisone and prednisolone.)
Alternate Day Therapy
Alternate day therapy is a corticosteroid dosing regimen in which twice the usual daily dose of corticoid is administered every other morning. The purpose of this mode of therapy is to provide the patient requiring long-term pharmacologic dose treatment with the beneficial effects of corticoids while minimizing certain undesirable effects, including pituitary-adrenal suppression, the cushingoid state, corticoid withdrawal symptoms, and growth suppression in children.
The rationale for this treatment schedule is based on two major premises: (a) the antiinflammatory or therapeutic effect of corticoids persists longer than their physical presence and metabolic effects and (b) administration of the corticosteroid every other morning allows for re-establishment of more nearly normal hypothalamic-pituitary-adrenal (HPA) activity on the off-steroid day.
A brief review of the HPA physiology may be helpful in understanding this rationale. Acting primarily through the hypothalamus a fall in free cortisol stimulates the pituitary gland to produce increasing amounts of corticotropin (ACTH) while a rise in free cortisol inhibits ACTH secretion. Normally the HPA system is characterized by diurnal (circadian) rhythm. Serum levels of ACTH rise from a low point about 10 pm to a peak level about 6 am. Increasing levels of ACTH stimulate adrenocortical activity resulting in a rise in plasma cortisol with maximal levels occurring between 2 am and 8 am. This rise in cortisol dampens ACTH production and in turn adrenocortical activity. There is a gradual fall in plasma corticoids during the day with lowest levels occurring about midnight.
The diurnal rhythm of the HPA axis is lost in Cushing’s disease, a syndrome of adrenocortical hyperfunction characterized by obesity with centripetal fat distribution, thinning of the skin with easy bruisability, muscle wasting with weakness, hypertension, latent diabetes, osteoporosis, electrolyte imbalance, etc. The same clinical findings of hyperadrenocorticism may be noted during long-term pharmacologic dose corticoid therapy administered in conventional daily divided doses. It would appear, then, that a disturbance in the diurnal cycle with maintenance of elevated corticoid values during the night may play a significant role in the development of undesirable corticoid effects. Escape from these constantly elevated plasma levels for even short periods of time may be instrumental in protecting against undesirable pharmacologic effects.
During conventional pharmacologic dose corticosteroid therapy, ACTH production is inhibited with subsequent suppression of cortisol production by the adrenal cortex. Recovery time for normal HPA activity is variable depending upon the dose and duration of treatment. During this time the patient is vulnerable to any stressful situation. Although it has been shown that there is considerably less adrenal suppression following a single morning dose of prednisolone (10 mg) as opposed to a quarter of that dose administered every 6 hours, there is evidence that some suppressive effect on adrenal activity may be carried over into the following day when pharmacologic doses are used. Further, it has been shown that a single dose of certain corticosteroids will produce adrenocortical suppression for two or more days. Other corticoids, including methylprednisolone, hydrocortisone, prednisone and prednisolone, are considered to be short acting (producing adrenocortical suppression for 1¼ to 1½ days following a single dose) and thus are recommended for alternate day therapy.
The following should be kept in mind when considering alternate day therapy:
Basic principles and indications for corticosteroid therapy should apply. The benefits of alternate day therapy should not encourage the indiscriminate use of steroids. Alternate day therapy is a therapeutic technique primarily designed for patients in whom long-term pharmacologic corticoid therapy is anticipated. In less severe disease processes in which corticoid therapy is indicated, it may be possible to initiate treatment with alternate day therapy. More severe disease states usually will require daily divided high dose therapy for initial control of the disease process. The initial suppressive dose level should be continued until satisfactory clinical response is obtained, usually four to ten days in the case of many allergic and collagen diseases. It is important to keep the period of initial suppressive dose as brief as possible particularly when subsequent use of alternate day therapy is intended. Once control has been established, two courses are available: (a) change to alternate day therapy and then gradually reduce the amount of corticoid given every other day or (b) following control of the disease process reduce the daily dose of corticoid to the lowest effective level as rapidly as possible and then change over to an alternate-day schedule. Theoretically, course (a) may be preferable. Because of the advantages of alternate day therapy, it may be desirable to try patients on this form of therapy who have been on daily corticoids for long periods of time (e.g., patients with rheumatoid arthritis). Since these patients may already have a suppressed HPA axis, establishing them on alternate day therapy may be difficult and not always successful. However, it is recommended that regular attempts be made to change them over. It may be helpful to triple or even quadruple the daily maintenance dose and administer this every other day rather than just doubling the daily dose if difficulty is encountered. Once the patient is again controlled, an attempt should be made to reduce this dose to a minimum. As indicated above, certain corticosteroids, because of their prolonged suppressive effect on adrenal activity, are not recommended for alternate day therapy (e.g., dexamethasone and betamethasone). The maximal activity of the adrenal cortex is between 2 am and 8 am, and it is minimal between 4 pm and midnight. Exogenous corticosteroids suppress adrenocortical activity the least when given at the time of maximal activity (am). In using alternate day therapy it is important, as in all therapeutic situations, to individualize and tailor the therapy to each patient. Complete control of symptoms will not be possible in all patients. An explanation of the benefits of alternate day therapy will help the patient to understand and tolerate the possible flare-up in symptoms which may occur in the latter part of the offsteroid day. Other symptomatic therapy may be added or increased at this time if needed. In the event of an acute flare-up of the disease process, it may be necessary to return to a full suppressive daily divided corticoid dose for control. Once control is again established alternate day therapy may be reinstituted. Although many of the undesirable features of corticosteroid therapy can be minimized by alternate day therapy, as in any therapeutic situation, the physician must carefully weigh the benefit-risk ratio for each patient in whom corticoid therapy is being considered. -
![Clindamycin Phosphate Gel [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=8e76c7c7-04fd-47c9-8db9-6f74ceffe144&name=e0752517-f24c-4706-a832-10cdc9c4fc83-07.jpg)
Clindamycin Phosphate Gel
Apply a thin film of Clindamycin Phosphate Topical Solution, Clindamycin Phosphate Lotion, or Clindamycin Phosphate Gel twice daily to affected area.
Lotion: Shake well immediately before using.
Keep all liquid dosage forms in containers tightly closed.
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Isopropyl Alcohol 70 Percent Readyincase
Dosage should be individualized for maximum beneficial effect. While the usual daily dosages given below will meet the needs of most patients, there will be some who may require higher doses. In such cases dosage should be increased cautiously to avoid adverse effects.
ADULTS:
USUAL DAILY DOSE
Management of Anxiety Disorders and Relief of Symptoms of Anxiety
Depending upon severity of symptoms – 2 mg to 10 mg, 2 to 4 times daily
Symptomatic Relief in Acute Alcohol Withdrawal
10 mg, 3 or 4 times during the first 24 hours, reducing to 5 mg, 3 or 4 times daily as needed
Adjunctively for Relief of Skeletal Muscle Spasm
2 mg to 10 mg, 3 or 4 times daily
Adjunctively in Convulsive Disorders
2 mg to 10 mg, 2 to 4 times daily
Geriatric Patients, or in the presence of debilitating disease
2 mg to 2.5 mg, 1 or 2 times daily initially; increase gradually as needed and tolerated
PEDIATRIC PATIENTS:
Because of varied responses to CNS-acting drugs, initiate therapy with lowest dose and increase as required. Not for use in pediatric patients under 6 months.
1 mg to 2.5 mg, 3 or 4 times daily initially; increase gradually as needed and tolerated
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![Valacyclovir Hydrochloride Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=67d48963-f7bb-438c-9ad6-45f753e3422f&name=06ce1f4b-35ee-450f-bca3-b62f3bb66f04-02.jpg)
Valacyclovir Hydrochloride
• Valacyclovir tablets, USP may be given without regard to meals. • Valacyclovir oral suspension (25 mg/mL or 50 mg/mL) may be prepared extemporaneously from 500 mg valacyclovir tablets, USP for use in pediatric patients for whom a solid dosage form is not appropriate [see DOSAGE AND ADMINISTRATION (2.3) ].
2.1 Adult Dosing Recommendations
Cold Sores (Herpes Labialis)
The recommended dosage of valacyclovir tablets, USP for treatment of cold sores is 2 grams twice daily for 1 day taken 12 hours apart. Therapy should be initiated at the earliest symptom of a cold sore (e.g., tingling, itching, or burning).
Genital Herpes
Initial Episode
The recommended dosage of valacyclovir tablets, USP for treatment of initial genital herpes is 1 gram twice daily for 10 days. Therapy was most effective when administered within 48 hours of the onset of signs and symptoms.
Recurrent Episodes
The recommended dosage of valacyclovir tablets, USP for treatment of recurrent genital herpes is 500 mg twice daily for 3 days. Initiate treatment at the first sign or symptom of an episode.
Suppressive Therapy
The recommended dosage of valacyclovir tablets, USP for chronic suppressive therapy of recurrent genital herpes is 1 gram once daily in patients with normal immune function. In patients with a history of 9 or fewer recurrences per year, an alternative dose is 500 mg once daily.
In HIV-infected patients with a CD4+ cell count ≥100 cells/mm3, the recommended dosage of valacyclovir tablets, USP for chronic suppressive therapy of recurrent genital herpes is 500 mg twice daily.
Reduction of Transmission
The recommended dosage of valacyclovir tablets, USP for reduction of transmission of genital herpes in patients with a history of 9 or fewer recurrences per year is 500 mg once daily for the source partner.
Herpes Zoster
The recommended dosage of valacyclovir tablets, USP for treatment of herpes zoster is 1 gram 3 times daily for 7 days. Therapy should be initiated at the earliest sign or symptom of herpes zoster and is most effective when started within 48 hours of the onset of rash.
2.2 Pediatric Dosing Recommendations
Cold Sores (Herpes Labialis)
The recommended dosage of valacyclovir tablets,USP for the treatment of cold sores in pediatric patients ≥12 years of age is 2 grams twice daily for 1 day taken 12 hours apart. Therapy should be initiated at the earliest symptom of a cold sore (e.g., tingling, itching, or burning).
Chickenpox
The recommended dosage of valacyclovir tablets, USP for treatment of chickenpox in immunocompetent pediatric patients 2 to <18 years of age is 20 mg/kg administered 3 times daily for 5 days. The total dose should not exceed 1 gram 3 times daily. Therapy should be initiated at the earliest sign or symptom [seeUSE IN SPECIFIC POPULATIONS (8.4), CLINICAL PHARMACOLOGY (12.3), CLINICAL STUDIES (14.4)].
2.3 Extemporaneous Preparation of Oral Suspension
Ingredients and Preparation per USP-NF
Valacyclovir tablets, USP 500 mg, cherry flavor, and Suspension Structured Vehicle USP-NF (SSV). Valacyclovir oral suspension (25 mg/mL or 50 mg/mL) should be prepared in lots of 100 mL.
Prepare Suspension at Time of Dispensing as Follows
• Prepare SSV according to the USP-NF. • Using a pestle and mortar, grind the required number of valacyclovir 500 mg tablets until a fine powder is produced (5 valacyclovir tablets, USP for 25 mg/mL suspension; 10 valacyclovir tablets, USP for 50 mg/mL suspension. • Gradually add approximately 5 mL aliquots of SSV to the mortar and triturate the powder until a paste has been produced. Ensure that the powder has been adequately wetted. • Continue to add approximately 5 mL aliquots of SSV to the mortar, mixing thoroughly between additions, until a concentrated suspension is produced, to a minimum total quantity of 20 mL SSV and a maximum total quantity of 40 mL SSV for both the 25 mg/mL and 50 mg/mL suspensions. • Transfer the mixture to a suitable 100 mL measuring flask. • Transfer the cherry flavor* to the mortar and dissolve in approximately 5 mL of SSV. Once dissolved, add to the measuring flask. • Rinse the mortar at least 3 times with approximately 5 mL aliquots of SSV, transferring the rinsing to the measuring flask between additions. • Make the suspension to volume (100 mL) with SSV and shake thoroughly to mix. • Transfer the suspension to an amber glass medicine bottle with a child-resistant closure. • The prepared suspension should be labeled with the following information “Shake well before using. Store suspension between 2º to 8ºC (36º to 46ºF) in a refrigerator. Discard after 28 days.”*The amount of cherry flavor added is as instructed by the suppliers of the cherry flavor.
2.4 Patients With Renal Impairment
Dosage recommendations for adult patients with reduced renal function are provided in Table 1 [see Use in Specific Populations (8.5 , 8.6), Clinical Pharmacology (12.3)]. Data are not available for the use of valacyclovir tablets, USP in pediatric patients with a creatinine clearance <50 mL/min/1.73 m2.
Table 1.Valacyclovir Tablets, USP Dosage Recommendations for Adults With Renal Impairment
Indications
Normal Dosage Regimen (Creatinine Clearance ≥50 mL/min)
Creatinine Clearance (mL/min)
30 to 49
10 to 29
<10
Cold sores (Herpes labialis)
Do not exceed 1 day of treatment.
Two 2 gram doses taken 12 hours apart
Two 1 gram doses taken 12 hours apart
Two 500 mg doses taken 12 hours apart
500 mg single dose
Genital herpes:
Initial episode
1 gram every 12 hours
no reduction
1 gram every 24 hours
500 mg every 24 hours
Genital herpes:
Recurrent episode
500 mg every 12 hours
no reduction
500 mg every 24 hours
500 mg every 24 hours
Genital herpes:
Suppressive therapy Immunocompetent patients1 gram every 24 hours
no reduction
500 mg every 24 hours
500 mg every 24 hours
Alternate dose for immunocompetent patients with ≤9 recurrences/ year500 mg every 24 hours
no reduction
500 mg every 48 hours
500 mg every 48 hours
HIV-infected patients500 mg every 12 hours
no reduction
500 mg every 24 hours
500 mg every 24 hours
Herpes zoster
1 gram every 8 hours
1 gram every 12 hours
1 gram every 24 hours
500 mg every 24 hours
Hemodialysis
Patients requiring hemodialysis should receive the recommended dose of valacyclovir tablets, USP after hemodialysis. During hemodialysis, the half-life of acyclovir after administration of valacyclovir tablets, USP is approximately 4 hours. About one third of acyclovir in the body is removed by dialysis during a 4-hour hemodialysis session.
Peritoneal Dialysis
There is no information specific to administration of valacyclovir tablets, USP in patients receiving peritoneal dialysis. The effect of chronic ambulatory peritoneal dialysis (CAPD) and continuous arteriovenous hemofiltration/dialysis (CAVHD) on acyclovir pharmacokinetics has been studied. The removal of acyclovir after CAPD and CAVHD is less pronounced than with hemodialysis, and the pharmacokinetic parameters closely resemble those observed in patients with end-stage renal disease (ESRD) not receiving hemodialysis. Therefore, supplemental doses of valacyclovir tablets, USP should not be required following CAPD or CAVHD.
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![Cyclobenzaprine Hydrochloride Tablet, Film Coated [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=7ccfab67-8393-4af0-9023-97a785f7cb6f&name=d448f424-1370-4077-8f33-f78659b2b2c9-02.jpg)
Cyclobenzaprine Hydrochloride
For most patients, the recommended dose of cyclobenzaprine hydrochloride tablets is 5 mg three times a day. Based on individual patient response, the dose may be increased to 10 mg three times a day. Use of cyclobenzaprine hydrochloride tablets for periods longer than two or three weeks is not recommended (see INDICATIONS AND USAGE).
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).
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![Cyclobenzaprine Hydrochloride Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=e2f44c02-d3aa-4f12-bedb-2497cdc28a58&name=163c8ef5-cf00-4045-a2f8-36fd1906eea0-02.jpg)
Cyclobenzaprine Hydrochloride
For most patients, the recommended dose of cyclobenzaprine hydrochloride tablets is 5 mg three times a day. Based on individual patient response, the dose may be increased to either 7.5 or 10 mg three times a day. Use of cyclobenzaprine hydrochloride tablets for periods longer than two or three weeks is not recommended. (see INDICATIONS AND USAGE).
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).
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![Clotrimazole Cream [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=0e696120-8cc9-40f1-a03e-9c681b3790b2&name=image-01.jpg)
Clotrimazole
• before using this product, read the enclosed pamphlet• fill the applicator and insert one applicatorful of cream into the vagina, preferably at bedtime. Repeat this procedure 7 days in a row. Wash applicator after each use.• for relief of external vulvar itching, squeeze a small amount of cream onto your finger and gently spread the cream onto the irritated area of the vulva. Use once or twice a day for up to 7 days as needed to relieve external vulvar itching. The cream should not be used for vulvar itching due to causes other than a yeast infection.
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![Telmisartan And Amlodipine Tablet [Mylan Pharmaceuticals Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=e8f4d01d-73ca-4a04-9682-1f3a7c3a26c6&name=losartanpotassiumusp-figure-09.jpg)
Telmisartan And Amlodipine
Adult Hypertensive Patients
Losartan potassium tablets may be administered with other antihypertensive agents, and with or without food.
Dosing must be individualized. The usual starting dose of losartan potassium tablets is 50 mg once daily, with 25 mg used in patients with possible depletion of intravascular volume (e.g., patients treated with diuretics) (see WARNINGS, Hypotension ─ Volume-Depleted Patients) and patients with a history of hepatic impairment (see PRECAUTIONS, General). Losartan potassium tablets can be administered once or twice daily with total daily doses ranging from 25 mg to 100 mg.
If the antihypertensive effect measured at trough using once-a-day dosing is inadequate, a twice-a-day regimen at the same total daily dose or an increase in dose may give a more satisfactory response. The effect of losartan is substantially present within one week but in some studies the maximal effect occurred in 3-6 weeks (see CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects, Hypertension).
If blood pressure is not controlled by losartan potassium tablets alone, a low dose of a diuretic may be added. Hydrochlorothiazide has been shown to have an additive effect (see CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects, Hypertension).
No initial dosage adjustment is necessary for elderly patients or for patients with renal impairment, including patients on dialysis.
Pediatric Hypertensive Patients greater than or equal to 6 years of age
The usual recommended starting dose is 0.7 mg/kg once daily (up to 50 mg total) administered as a tablet or a suspension (see Preparation of Suspension). Dosage should be adjusted according to blood pressure response. Doses above 1.4 mg/kg (or in excess of 100 mg) daily have not been studied in pediatric patients (See CLINICAL PHARMACOLOGY, Pharmacokinetics, Special Populations and Pharmacodynamics and Clinical Effects, and WARNINGS, Hypotension ─ Volume-Depleted Patients.)
Losartan potassium tablets are not recommended in pediatric patients less than 6 years of age or in pediatric patients with glomerular filtration rate less than 30 mL/min/1.73 m2 (see CLINICAL PHARMACOLOGY, Pharmacokinetics, Special Populations, Pharmacodynamics and Clinical Effects, and PRECAUTIONS).
Preparation of Suspension (for 200 mL of a 2.5 mg/mL suspension)
Add 10 mL of Purified Water USP to an 8 ounce (240 mL) amber polyethylene terephthalate (PET) bottle containing ten 50 mg losartan potassium tablets. Immediately shake for at least 2 minutes. Let the concentrate stand for 1 hour and then shake for 1 minute to disperse the tablet contents. Separately prepare a 50/50 volumetric mixture of Ora-PlusTM and Ora-Sweet SFTM. Add 190 mL of the 50/50 Ora-PlusTM/Ora-Sweet SFTM mixture to the tablet and water slurry in the PET bottle and shake for 1 minute to disperse the ingredients. The suspension should be refrigerated at 2-8°C (36-46°F) and can be stored for up to 4 weeks. Shake the suspension prior to each use and return promptly to the refrigerator.
Hypertensive Patients with Left Ventricular Hypertrophy
The usual starting dose is 50 mg of losartan potassium tablets once daily. Hydrochlorothiazide 12.5 mg daily should be added and/or the dose of losartan potassium tablets should be increased to 100 mg once daily followed by an increase in hydrochlorothiazide to 25 mg once daily based on blood pressure response (see CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects, Reduction in the Risk of Stroke).
Nephropathy in Type 2 Diabetic Patients
The usual starting dose is 50 mg once daily. The dose should be increased to 100 mg once daily based on blood pressure response (see CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects, Nephropathy in Type 2 Diabetic Patients). Losartan potassium tablets may be administered with insulin and other commonly used hypoglycemic agents (e.g., sulfonylureas, glitazones and glucosidase inhibitors).
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![Diclofenac Sodium Tablet, Delayed Release [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=e780534f-5b33-42f8-ae35-ccf8ee652035&name=image-01.jpg)
Diclofenac Sodium
Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with diclofenac sodium delayed-release tablets, the dose and frequency should be adjusted to suit an individual patient’s needs.
For the relief of osteoarthritis, the recommended dosage is 100-150 mg/day in divided doses (50 mg b.i.d. or t.i.d., or 75 mg b.i.d.).
For the relief of rheumatoid arthritis, the recommended dosage is 150-200 mg/day in divided doses (50 mg t.i.d. or q.i.d., or 75 mg b.i.d.).
For the relief of ankylosing spondylitis, the recommended dosage is 100-125 mg/day, administered as 25 mg q.i.d., with an extra 25-mg dose at bedtime if necessary.
Different formulations of diclofenac (diclofenac sodium enteric-coated tablets; diclofenac sodium extended-release tablets, diclofenac potassium immediate-release tablets) are not necessarily bioequivalent even if the milligram strength is the same.
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Diazepam
Dosage should be individualized for maximum beneficial effect. While the usual daily dosages given below will meet the needs of most patients, there will be some who may require higher doses. In such cases, dosage should be increased cautiously to avoid adverse effects.
ADULTS: USUAL DAILY DOSE:Management of Anxiety Disorders and Relief of Symptoms of Anxiety.
Depending upon severity of symptoms – 2 mg to 10 mg, 2 to 4 times daily
Symptomatic Relief in Acute Alcohol Withdrawal.
10 mg, 3 or 4 times during the first 24 hours, reducing to 5 mg, 3 or 4 times daily as needed
Adjunctively for Relief of Skeletal Muscle Spasm.
2 mg to 10 mg, 3 or 4 times daily
Adjunctively in Convulsive Disorders.
2 mg to 10 mg, 2 to 4 times daily
Geriatric Patients, or in the presence of debilitating disease.
2 mg to 2½ mg, 1 or 2 times daily initially; increase gradually as needed and tolerated
PEDIATRIC PATIENTS:
Because of varied responses to CNS-acting drugs, initiate therapy with lowest dose and increase as required. Not for use in pediatric patients under 6 months.
1 mg to 2½ mg, 3 or 4 times daily initially; increase gradually as needed and tolerated
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![Divalproex Sodium Tablet, Extended Release [Dr. Reddy’s Laboratories Ltd]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=d134544e-e54c-41fd-8c89-d7f017fb0829&name=butalbital_acetaminophen_and_caffeine-4.jpg)
Divalproex Sodium
One or 2 tablets every 4 hours as needed. Total daily dosage should not exceed 6 tablets.
Extended and repeated use of Butalbital, Acetaminophen, and Caffeine Tablets USP is not recommended because of the potential for physical dependence.
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![Allopurinol Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=e054ec39-06e2-43ec-88cc-28095f76c6f5&name=allopurinolranbaxy-figure-03.jpg)
Allopurinol
The dosage of allopurinol tablets to accomplish full control of gout and to lower serum uric acid to normal or near-normal levels varies with the severity of the disease. The average is 200 to 300 mg/day for patients with mild gout and 400 to 600 mg/day for those with moderately severe tophaceous gout. The appropriate dosage may be administered in divided doses or as a single equivalent dose with the 300 mg tablet. Dosage requirements in excess of 300 mg should be administered in divided doses. The minimal effective dosage is 100 to 200 mg daily and the maximal recommended dosage is 800 mg daily. To reduce the possibility of flare-up of acute gouty attacks, it is recommended that the patient start with a low dose of allopurinol tablets (100 mg daily) and increase at weekly intervals by 100 mg until a serum uric acid level of 6 mg/dL or less is attained but without exceeding the maximal recommended dosage.
Normal serum urate levels are usually achieved in 1 to 3 weeks. The upper limit of normal is about 7 mg/dL for men and postmenopausal women and 6 mg/dL for premenopausal women. Too much reliance should not be placed on a single serum uric acid determination since, for technical reasons, estimation of uric acid may be difficult. By selecting the appropriate dosage and, in certain patients, using uricosuric agents concurrently, it is possible to reduce serum uric acid to normal or, if desired, to as low as 2 to 3 mg/dL and keep it there indefinitely.
While adjusting the dosage of allopurinol tablets in patients who are being treated with colchicine and/or anti-inflammatory agents, it is wise to continue the latter therapy until serum uric acid has been normalized and there has been freedom from acute gouty attacks for several months.
In transferring a patient from a uricosuric agent to allopurinol tablets, the dose of the uricosuric agent should be gradually reduced over a period of several weeks and the dose of allopurinol tablets gradually increased to the required dose needed to maintain a normal serum uric acid level.
It should also be noted that allopurinol tablets are generally better tolerated if taken following meals. A fluid intake sufficient to yield a daily urinary output of at least 2 liters and the maintenance of a neutral or, preferably, slightly alkaline urine are desirable.
Since allopurinol tablets and its metabolites are primarily eliminated only by the kidney, accumulation of the drug can occur in renal failure, and the dose of allopurinol tablets should consequently be reduced. With a creatinine clearance of 10 to 20 mL/min, a daily dosage of 200 mg of allopurinol tablets is suitable. When the creatinine clearance is less than 10 mL/min, the daily dosage should not exceed 100 mg. With extreme renal impairment (creatinine clearance less than 3 mL/min) the interval between doses may also need to be lengthened.
The correct size and frequency of dosage for maintaining the serum uric acid just within the normal range is best determined by using the serum uric acid level as an index.
For the prevention of uric acid nephropathy during the vigorous therapy of neoplastic disease, treatment with 600 to 800 mg daily for 2 or 3 days is advisable together with a high fluid intake. Otherwise similar considerations to the above recommendations for treating patients with gout govern the regulation of dosage for maintenance purposes in secondary hyperuricemia.
The dose of allopurinol tablets recommended for management of recurrent calcium oxalate stones in hyperuricosuric patients is 200 to 300 mg/day in divided doses or as the single equivalent. This dose may be adjusted up or down depending upon the resultant control of the hyperuricosuria based upon subsequent 24 hour urinary urate determinations. Clinical experience suggests that patients with recurrent calcium oxalate stones may also benefit from dietary changes such as the reduction of animal protein, sodium, refined sugars, oxalate-rich foods, and excessive calcium intake, as well as an increase in oral fluids and dietary fiber.
Children, 6 to 10 years of age, with secondary hyperuricemia associated with malignancies may be given 300 mg allopurinol tablets daily while those under 6 years are generally given 150 mg daily. The response is evaluated after approximately 48 hours of therapy and a dosage adjustment is made if necessary.
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![Acetaminophen For Children (Acetaminophen) Suppository [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=6444d200-e32c-4848-80c3-6a23a213fbad&name=image-01.jpg)
Acetaminophen For Children
• this product does not contain directions or warnings for adult use • do not use more than directed • remove wrapper • carefully insert suppository well up into the rectum
Dosing Chart
Age
Dose
under 3 years
Do not use unless directed by a doctor
3 to 6 years
Use a suppository every 4 to 6 hours (maximum of 5 doses in 24 hours)
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![Alprazolam Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=f3380741-6778-4295-bcb2-2cf66be50b2c&name=b96af437-dcf3-41c7-bc71-3dd0a7de0346-05.jpg)
Alprazolam
Dosage should be individualized for maximum beneficial effect. While the usual daily dosages given below will meet the needs of most patients, there will be some who require doses greater than 4 mg/day. In such cases, dosage should be increased cautiously to avoid adverse effects.
Anxiety Disorders And Transient Symptoms Of Anxiety
Treatment for patients with anxiety should be initiated with a dose of 0.25 to 0.5 mg given three times daily. The dose may be increased to achieve a maximum therapeutic effect, at intervals of 3 to 4 days, to a maximum daily dose of 4 mg, given in divided doses. The lowest possible effective dose should be employed and the need for continued treatment reassessed frequently. The risk of dependence may increase with dose and duration of treatment.
In all patients, dosage should be reduced gradually when discontinuing therapy or when decreasing the daily dosage. Although there are no systematically collected data to support a specific discontinuation schedule, it is suggested that the daily dosage be decreased by no more than 0.5 mg every 3 days. Some patients may require an even slower dosage reduction.
Panic Disorder
The successful treatment of many panic disorder patients has required the use of alprazolam at doses greater than 4 mg daily. In controlled trials conducted to establish the efficacy of alprazolam in panic disorder, doses in the range of 1 to 10 mg daily were used. The mean dosage employed was approximately 5 to 6 mg daily. Among the approximately 1700 patients participating in the panic disorder development program, about 300 received alprazolam in dosages of greater than 7 mg/day, including approximately 100 patients who received maximum dosages of greater than 9 mg/day. Occasional patients required as much as 10 mg a day to achieve a successful response.
Dose Titration
Treatment may be initiated with a dose of 0.5 mg three times daily. Depending on the response, the dose may be increased at intervals of 3 to 4 days in increments of no more than 1 mg per day. Slower titration to the dose levels greater than 4 mg/day may be advisable to allow full expression of the pharmacodynamic effect of alprazolam. To lessen the possibility of interdose symptoms, the times of administration should be distributed as evenly as possible throughout the waking hours, that is, on a three or four times per day schedule.
Generally, therapy should be initiated at a low dose to minimize the risk of adverse responses in patients especially sensitive to the drug. Dose should be advanced until an acceptable therapeutic response (ie, a substantial reduction in or total elimination of panic attacks) is achieved, intolerance occurs, or the maximum recommended dose is attained.
Dose Maintenance
For patients receiving doses greater than 4 mg/day, periodic reassessment and consideration of dosage reduction is advised. In a controlled postmarketing dose-response study, patients treated with doses of alprazolam greater than 4 mg/day for 3 months were able to taper to 50% of their total maintenance dose without apparent loss of clinical benefit. Because of the danger of withdrawal, abrupt discontinuation of treatment should be avoided. (See WARNINGS, PRECAUTIONS, DRUG ABUSE AND DEPENDENCE.)
The necessary duration of treatment for panic disorder patients responding to alprazolam is unknown. After a period of extended freedom from attacks, a carefully supervised tapered discontinuation may be attempted, but there is evidence that this may often be difficult to accomplish without recurrence of symptoms and/or the manifestation of withdrawal phenomena.
Dose Reduction
Because of the danger of withdrawal, abrupt discontinuation of treatment should be avoided (see WARNINGS, PRECAUTIONS, DRUG ABUSE AND DEPENDENCE).
In all patients, dosage should be reduced gradually when discontinuing therapy or when decreasing the daily dosage. Although there are no systematically collected data to support a specific discontinuation schedule, it is suggested that the daily dosage be decreased by no more than 0.5 mg every three days. Some patients may require an even slower dosage reduction.
In any case, reduction of dose must be undertaken under close supervision and must be gradual. If significant withdrawal symptoms develop, the previous dosing schedule should be reinstituted and, only after stabilization, should a less rapid schedule of discontinuation be attempted. In a controlled postmarketing discontinuation study of panic disorder patients which compared this recommended taper schedule with a slower taper schedule, no difference was observed between the groups in the proportion of patients who tapered to zero dose; however, the slower schedule was associated with a reduction in symptoms associated with a withdrawal syndrome. It is suggested that the dose be reduced by no more than 0.5 mg every 3 days, with the understanding that some patients may benefit from an even more gradual discontinuation. Some patients may prove resistant to all discontinuation regimens.
Dosing In Special Populations
In elderly patients, in patients with advanced liver disease or in patients with debilitating disease, the usual starting dose is 0.25 mg, given two or three times daily. This may be gradually increased if needed and tolerated. The elderly may be especially sensitive to the effects of benzodiazepines. If side effects occur at the recommended starting dose, the dose may be lowered.
Instructions To Be Given To Patients For Use/Handling Alprazolam Orally Disintegrating Tablets
Just prior to administration, with dry hands, remove the tablet from the bottle. Immediately place the alprazolam orally disintegrating tablet on top of the tongue where it will disintegrate and be swallowed with saliva. Administration with liquid is not necessary.
Discard any cotton that was included in the bottle and reseal the bottle tightly to prevent introducing moisture that might cause the tablets to disintegrate.
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![Alprazolam Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=634e3ab5-1c6c-423c-9346-9b127cf9646e&name=2fdc1220-1fb7-4e69-82d6-69377bfe2ed7-05.jpg)
Alprazolam
Dosage should be individualized for maximum beneficial effect. While the usual daily dosages given below will meet the needs of most patients, there will be some who require doses greater than 4 mg/day. In such cases, dosage should be increased cautiously to avoid adverse effects.
Anxiety Disorders and Transient Symptoms of Anxiety
Treatment for patients with anxiety should be initiated with a dose of 0.25 to 0.5 mg given three times daily. The dose may be increased to achieve a maximum therapeutic effect, at intervals of 3 to 4 days, to a maximum daily dose of 4 mg, given in divided doses. The lowest possible effective dose should be employed and the need for continued treatment reassessed frequently. The risk of dependence may increase with dose and duration of treatment.
In all patients, dosage should be reduced gradually when discontinuing therapy or when decreasing the daily dosage. Although there are no systematically collected data to support a specific discontinuation schedule, it is suggested that the daily dosage be decreased by no more than 0.5 mg every three days. Some patients may require an even slower dosage reduction.
Panic Disorder
The successful treatment of many panic disorder patients has required the use of alprazolam at doses greater than 4 mg daily. In controlled trials conducted to establish the efficacy of alprazolam in panic disorder, doses in the range of 1 to 10 mg daily were used. The mean dosage employed was approximately 5 to 6 mg daily. Among the approximately 1700 patients participating in the panic disorder development program, about 300 received alprazolam in dosages of greater than 7 mg/day, including approximately 100 patients who received maximum dosages of greater than 9 mg/day. Occasional patients required as much as 10 mg a day to achieve a successful response.
Dose Titration
Treatment may be initiated with a dose of 0.5 mg three times daily. Depending on the response, the dose may be increased at intervals of 3 to 4 days in increments of no more than 1 mg per day. Slower titration to the dose levels greater than 4 mg/day may be advisable to allow full expression of the pharmacodynamic effect of alprazolam. To lessen the possibility of interdose symptoms, the times of administration should be distributed as evenly as possible throughout the waking hours, that is, on a three or four times per day schedule.
Generally, therapy should be initiated at a low dose to minimize the risk of adverse responses in patients especially sensitive to the drug. Dose should be advanced until an acceptable therapeutic response (ie, a substantial reduction in or total elimination of panic attacks) is achieved, intolerance occurs, or the maximum recommended dose is attained.
Dose Maintenance
For patients receiving doses greater than 4 mg/day, periodic reassessment and consideration of dosage reduction is advised. In a controlled postmarketing dose-response study, patients treated with doses of alprazolam greater than 4 mg/day for 3 months were able to taper to 50% of their total maintenance dose without apparent loss of clinical benefit. Because of the danger of withdrawal, abrupt discontinuation of treatment should be avoided. (See WARNINGS, PRECAUTIONS, DRUG ABUSE AND DEPENDENCE.)
The necessary duration of treatment for panic disorder patients responding to alprazolam is unknown. After a period of extended freedom from attacks, a carefully supervised tapered discontinuation may be attempted, but there is evidence that this may often be difficult to accomplish without recurrence of symptoms and/or the manifestation of withdrawal phenomena.
Dose Reduction
Because of the danger of withdrawal, abrupt discontinuation of treatment should be avoided (see WARNINGS, PRECAUTIONS, DRUG ABUSE AND DEPENDENCE).
In all patients, dosage should be reduced gradually when discontinuing therapy or when decreasing the daily dosage. Although there are no systematically collected data to support a specific discontinuation schedule, it is suggested that the daily dosage be decreased by no more than 0.5 mg every three days. Some patients may require an even slower dosage reduction.
In any case, reduction of dose must be undertaken under close supervision and must be gradual. If significant withdrawal symptoms develop, the previous dosing schedule should be reinstituted and, only after stabilization, should a less rapid schedule of discontinuation be attempted. In a controlled postmarketing discontinuation study of panic disorder patients which compared this recommended taper schedule with a slower taper schedule, no difference was observed between the groups in the proportion of patients who tapered to zero dose; however, the slower schedule was associated with a reduction in symptoms associated with a withdrawal syndrome. It is suggested that the dose be reduced by no more than 0.5 mg every 3 days, with the understanding that some patients may benefit from an even more gradual discontinuation. Some patients may prove resistant to all discontinuation regimens.
Dosing in Special Populations
In elderly patients, in patients with advanced liver disease or in patients with debilitating disease, the usual starting dose is 0.25 mg, given two or three times daily. This may be gradually increased if needed and tolerated. The elderly may be especially sensitive to the effects of benzodiazepines. If side effects occur at the recommended starting dose, the dose may be lowered.
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![Extra Strength Qpap (Acetaminophen) Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=beb90934-9ec4-4bb4-90a4-29d17cacc4e8&name=image-01.jpg)
Extra Strength Qpap
Directions
• do not take more than directed (see overdose warning).adults and children 12 years and over
take 2 tablets every 4 to 6 hours while symptoms last, not more than 8 tablets in 24 hours, do not take for more than 10 days unless directed by a doctor
children under 12 years
do not use adult Extra Strength product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.
Other Information • store at room temperature 15° to 30°C (59° to 86°F) • you may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811 -
![Albuterol Sulfate Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=d8f090fb-c591-4d6a-98b7-925b0bb17c38&name=albuterol-02.jpg)
Albuterol Sulfate
The following dosages of albuterol tablets are expressed in terms of albuterol base.
Usual Dosage
Adults and Children Over 12 Years of Age
The usual starting dosage for adults and children 12 years and older is 2 or 4 mg three or four times a day.
Children 6 to 12 Years of Age
The usual starting dosage for children 6 to 12 years of age is 2 mg three or four times a day.
Dosage Adjustment
Adults and Children Over 12 Years of Age
For adults and children 12 years and older, a dosage above 4 mg four times a day should be used only when the patient fails to respond. If a favorable response does not occur with the 4 mg initial dosage, it should be cautiously increased stepwise up to a maximum of 8 mg four times a day as tolerated.
Children 6 to 12 Years of Age Who Fail to Respond to the Initial Starting Dosage of 2 mg Four Times a Day
For children from 6 to 12 years of age who fail to respond to the initial starting dosage of 2 mg four times a day, the dosage may be cautiously increased stepwise, but not to exceed 24 mg/day (given in divided doses).
Elderly Patients and Those Sensitive to Beta-adrenergic Stimulators
An initial dosage of 2 mg three or four times a day is recommended for elderly patients and for those with a history of unusual sensitivity to beta-adrenergic stimulators. If adequate bronchodilation is not obtained, dosage may be increased gradually to as much as 8 mg three or four times a day.
The total daily dose should not exceed 32 mg in adults and children 12 years and older.
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![Allopurinol Tablet, Coated [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=3df46df4-8b14-459f-949b-dc1f94a07330&name=AllopurinolTablets100mg.jpg)
Allopurinol
The dosage of allopurinol to accomplish full control of gout and to lower serum uric acid to normal or near-normal levels varies with the severity of the disease. The average is 200 to 300 mg per day for patients with mild gout and 400 to 600 mg per day for those with moderately severe tophaceous gout. The appropriate dosage may be administered in divided doses or as a single equivalent dose with the 300 mg tablet. Dosage requirements in excess of 300 mg should be administered in divided doses. The maximal recommended dosage is 800 mg daily. To reduce the possibility of flareup of acute gouty attacks, it is recommended that the patient start with a low dose of allopurinol (100 mg daily) and increase at weekly intervals by 100 mg until a serum uric acid level of 6 mg/dL or less is attained but without exceeding the maximal recommended dosage.
Normal serum urate levels are usually achieved in one to three weeks. The upper limit of normal is about 7 mg/dL for men and postmenopausal women and 6 mg/dL for premenopausal women. Too much reliance should not be placed on a single serum uric acid determination since, for technical reasons, estimation of uric acid may be difficult. By selecting the appropriate dosage and, in certain patients, using uricosuric agents concurrently, it is possible to reduce serum uric acid to normal or, if desired, to as low as 2 to 3 mg/dL and keep it there indefinitely.
While adjusting the dosage of allopurinol in patients who are being treated with colchicine and/or anti-inflammatory agents, it is wise to continue the latter therapy until serum uric acid has been normalized and there has been freedom from acute gouty attacks for several months.
In transferring a patient from a uricosuric agent to allopurinol, the dose of the uricosuric agent should be gradually reduced over a period of several weeks and the dose of allopurinol gradually increased to the required dose needed to maintain a normal serum uric acid level.
It should also be noted that allopurinol is generally better tolerated if taken following meals. A fluid intake sufficient to yield a daily urinary output of at least two liters and the maintenance of a neutral or, preferably, slightly alkaline urine are desirable.
Since allopurinol and its metabolites are primarily eliminated only by the kidney, accumulation of the drug can occur in renal failure, and the dose of allopurinol should consequently be reduced. With a creatinine clearance of 10 to 20 mL/min, a daily dosage of 200 mg of allopurinol is suitable. When the creatinine clearance is less than 10 mL/min, the daily dosage should not exceed 100 mg. With extreme renal impairment (creatinine clear- ance less than 3 mL/min) the interval between doses may also need to be lengthened.
The correct size and frequency of dosage for maintaining the serum uric acid just within the normal range are best determined by using the serum uric acid level as an index.
For the prevention of uric acid nephropathy during the vigorous therapy of neoplastic disease, treatment with 600 to 800 mg daily for two or three days is advisable together with a high fluid intake. Otherwise similar considerations to the above recommendations for treating patients with gout govern the regulation of dosage for maintenance purposes in secondary hyperuricemia.
The dose of allopurinol recommended for management of recurrent calcium oxalate stones in hyperuricosuric patients is 200 to 300 mg/day in divided doses or as the single equivalent. This dose may be adjusted up or down depending upon the resultant control of the hyperuricosuria based upon subsequent 24 hour urinary urate determinations. Clinical experience suggests that patients with recurrent calcium oxalate stones may also benefit from dietary changes such as the reduction of animal protein, sodium, refined sugars, oxalate-rich foods, and excessive calcium intake as well as an increase in oral fluids and dietary fiber.
Children, 6 to 10 years of age, with secondary hyperuricemia associated with malignancies may be given 300 mg allopurinol daily while those under 6 years are generally given 150 mg daily. The response is evaluated after approximately 48 hours of therapy and a dosage adjustment is made if necessary.
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![Extra Strength Mapap (Acetaminophen) Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=e27b1cb6-cfa0-47dc-9301-bf68f0695491&name=image-01.jpg)
Extra Strength Mapap
Do not take more than the directed (see overdose warning)
Adults and children 12 years and over:
• Take 2 tablets every 6 hours while symptoms last. • Do not take more than 6 tablets in 24 hours unless directed by a doctor • Do not take for more than 10 days unless directed by a doctorChildren under 12 years: Do not use adult Extra Strength product in children under 12 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage.
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Acetaminophen
Do not take more than directed (see overdose warning)
Adults and children 12 years and over:
• take 2 tablets every 6 hours while symptoms last • do not take more than 6 tablets in 24 hours unless directed by a doctor • do not take for more than 10 days unless directed by a doctor.Children under 12 years: ask a doctor.
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![Amoxicillin And Clavulanate Potassium Tablet, Film Coated [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=93ee142f-e09c-444a-822a-3ff69f5b29e2&name=image-03.jpg)
Amoxicillin And Clavulanate Potassium
Amoxicillin and Clavulanate Potassium Tablets, Amoxicillin and Clavulanate Potassium for Oral Suspension, and Amoxicillin and Clavulanate Potassium Tablets (Chewable) may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when Amoxicillin and Clavulanate Potassium Tablets, Amoxicillin and Clavulanate Potassium for Oral Suspension, and Amoxicillin and Clavulanate Potassium Tablets (Chewable) are administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, Amoxicillin and Clavulanate Potassium Tablets, Amoxicillin and Clavulanate Potassium for Oral Suspension, and Amoxicillin and Clavulanate Potassium Tablets (Chewable) should be taken at the start of a meal.
2.1 Adults
The usual adult dose is one 500 mg/125 mg Amoxicillin and Clavulanate Potassium Tablet every 12 hours or one 250 mg/125 mg Amoxicillin and Clavulanate Potassium Tablet every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one 875 mg/125 mg Amoxicillin and Clavulanate Potassium Tablet every 12 hours or one 500 mg/125 mg Amoxicillin and Clavulanate Potassium Tablet every 8 hours. Adults who have difficulty swallowing may be given the 125 mg/31.25 mg per 5 mL or 250 mg/62.5 mg per 5 mL suspension in place of the 500 mg/125 mg tablet. The 200 mg/28.5 mg per 5 mL suspension or the 400 mg/57 mg per 5 mL suspension may be used in place of the 875 mg/125 mg tablet.
Two 250 mg/125 mg Amoxicillin and Clavulanate Potassium Tablets should not be substituted for one 500 mg/125 mg Amoxicillin and Clavulanate Potassium Tablet. Since both the 250 mg/125 mg and 500 mg/125 mg Amoxicillin and Clavulanate Potassium Tablets contain the same amount of clavulanic acid (125 mg, as the potassium salt), two 250 mg/125 mg tablets are not equivalent to one 500 mg/125 mg Amoxicillin and Clavulanate Potassium Tablet.
The 250 mg/125 mg Amoxicillin and Clavulanate Potassium Tablet and the 250 mg/62.5 mg chewable tablet should not be substituted for each other, as they are not interchangeable. The 250 mg/125 mg Amoxicillin and Clavulanate Potassium Tablet and the 250 mg/62.5 mg chewable tablet do not contain the same amount of clavulanic acid (as the potassium salt). The 250 mg/125 mg Amoxicillin and Clavulanate Potassium Tablet contains 125 mg of clavulanic acid, whereas the 250 mg/62.5 mg chewable tablet contains 62.5 mg of clavulanic acid.
2.2 Pediatric Patients
Based on the amoxicillin component, Amoxicillin and Clavulanate Potassium for Oral Suspension should be dosed as follows:
Neonates and Infants Aged < 12 Weeks (< 3 Months): The recommended dose of Amoxicillin and Clavulanate Potassium for Oral Suspension is 30 mg/kg/day divided every 12 hours, based on the amoxicillin component. Experience with the 200 mg/28.5 mg per 5 mL formulation in this age group is limited, and thus, use of the 125 mg/31.25 mg per 5 mL oral suspension is recommended.
Patients Aged 12 Weeks (3 Months) and Older: See dosing regimens provided in Table 1. The every 12 hour regimen is recommended as it is associated with significantly less diarrhea [see Clinical Studies (14.2)]. However, the every 12 hour suspension (200 mg/5 mL and 400 mg/5 mL) and chewable tablets (200 mg/28.5 mg per 5 mL and 400 mg/57 mg per 5 mL) and chewable tablets (200 mg/28.5 mg and 400 mg/57 mg) contain aspartame and should not be used by phenylketonurics. [see Warnings and Precautions (5.6)]
* Each strength of suspension of Amoxicillin and Clavulanate Potassium for Oral Suspension is available as a chewable tablet for use by older children. † Duration of therapy studied and recommended for acute otitis media is 10 days.Table 1: Dosing in Patients Aged 12 Weeks (3 Months) and Older
INFECTION
DOSING REGIMEN
Every 12 hours
Every 8 hours
200 mg/28.5 mg per 5 mL or 400 mg/57 mg per 5 mL oral suspension*
125 mg/31.25 mg per 5 mL or 250 mg/62.5 mg per 5 mL oral suspensiona
Otitis media†, sinusitis, lower respiratory tract infections, and more severe infections
45 mg/kg/day every 12 hours
40 mg/kg/day every 8 hours
Less severe infections
25 mg/kg/day every 12 hours
20 mg/kg/day every 8 hours
Patients Weighing 40 kg or More: Pediatric patients weighing 40 kg or more should be dosed according to adult recommendations.
The 250 mg/125 mg Amoxicillin and Clavulanate Potassium Tablets should not be used until the child weighs at least 40 kg, due to the different amoxicillin to clavulanic acid ratios in the 250 mg/125 mg Amoxicillin and Clavulanate Potassium Tablets (250/125) versus the 250 mg/62.5 mg Amoxicillin and Clavulanate Potassium Tablets (Chewable) (250/62.5).
2.3 Patients With Renal Impairment
Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Renal impairment patients with a glomerular filtration rate of < 30 mL/min should not receive the 875 mg/125 mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg/125 mg or 250 mg/125 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection.
Hemodialysis patients should receive 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.
2.4 Directions for Mixing Oral Suspension
Prepare a suspension at time of dispensing as follows: Tap bottle until all the powder flows freely. Add approximately 2/3 of the total amount of water for reconstitution (see Table 2 below) and shake vigorously to suspend powder. Add remainder of the water and again shake vigorously.
Table 2: Amount of Water for Mixing Oral Suspension
Strength
Bottle Size
Amount of Water for Reconstitution
Contents of Each Teaspoonful (5 mL)
200 mg/28.5 mg per 5 mL
100 mL
92 mL
200 mg amoxicillin and 28.5 mg of clavulanic acid as the potassium salt
400 mg/57 mg per 5 mL
100 mL
87 mL
400 mg amoxicillin and 57 mg of clavulanic acid as the potassium salt
Note: Shake oral suspension well before using. Reconstituted suspension must be stored under refrigeration and discarded after 10 days.
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![Amitriptyline Hydrochloride Tablet, Film Coated [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=2f54e764-22b8-4d5a-a7ce-2e8f3a151ee0&name=amitrip-2.jpg)
Amitriptyline Hydrochloride
Dosage should be initiated at a low level and increased gradually, noting carefully the clinical response and any evidence of intolerance.
Initial Dosage for Adults:
For outpatients 75 mg of amitriptyline HCl a day in divided doses is usually satisfactory. If necessary, this may be increased to a total of 150 mg per day. Increases are made preferably in the late afternoon and/or bedtime doses. A sedative effect may be apparent before the antidepressant effect is noted, but an adequate therapeutic effect may take as long as 30 days to develop.
An alternate method of initiating therapy in outpatients is to begin with 50 to 100 mg amitriptyline HCl at bedtime. This may be increased by 25 or 50 mg as necessary in the bedtime dose to a total of 150 mg per day.
Hospitalized patients may require 100 mg a day initially. This can be increased gradually to 200 mg a day if necessary. A small number of hospitalized patients may need as much as 300 mg a day.
Adolescent and Elderly Patients:
In general, lower dosages are recommended for these patients. Ten mg 3 times a day with 20 mg at bedtime may be satisfactory in adolescent and elderly patients who do not tolerate higher dosages.
Maintenance:
The usual maintenance dosage of amitriptyline HCl is 50 to 100 mg per day. In some patients 40 mg per day is sufficient. For maintenance therapy the total daily dosage may be given in a single dose preferably at bedtime. When satisfactory improvement has been reached, dosage should be reduced to the lowest amount that will maintain relief of symptoms. It is appropriate to continue maintenance therapy 3 months or longer to lessen the possibility of relapse.
Usage in Pediatric Patients
In view of the lack of experience with the use of this drug in pediatric patients, it is not recommended at the present time for patients under 12 years of age.
Plasma Levels
Because of the wide variation in the absorption and distribution of tricyclic antidepressants in body fluids, it is difficult to directly correlate plasma levels and therapeutic effect. However, determination of plasma levels may be useful in identifying patients who appear to have toxic effects and may have excessively high levels, or those in whom lack of absorption or noncompliance is suspected. Because of increased intestinal transit time and decreased hepatic metabolism in elderly patients, plasma levels are generally higher for a given oral dose of amitriptyline hydrochloride than in younger patients. Elderly patients should be monitored carefully and quantitative serum levels obtained as clinically appropriate. Adjustment in dosage should be made according to the patient's clinical response and not on the basis of plasma levels.**
Initial Dosage for Adults:
For outpatients 75 mg of amitriptyline HCl a day in divided doses is usually satisfactory. If necessary, this may be increased to a total of 150 mg per day. Increases are made preferably in the late afternoon and/or bedtime doses. A sedative effect may be apparent before the antidepressant effect is noted, but an adequate therapeutic effect may take as long as 30 days to develop.
An alternate method of initiating therapy in outpatients is to begin with 50 to 100 mg amitriptyline HCl at bedtime. This may be increased by 25 or 50 mg as necessary in the bedtime dose to a total of 150 mg per day.
Hospitalized patients may require 100 mg a day initially. This can be increased gradually to 200 mg a day if necessary. A small number of hospitalized patients may need as much as 300 mg a day.
Adolescent and Elderly Patients:
In general, lower dosages are recommended for these patients. Ten mg 3 times a day with 20 mg at bedtime may be satisfactory in adolescent and elderly patients who do not tolerate higher dosages.
Maintenance:
The usual maintenance dosage of amitriptyline HCl is 50 to 100 mg per day. In some patients 40 mg per day is sufficient. For maintenance therapy the total daily dosage may be given in a single dose preferably at bedtime. When satisfactory improvement has been reached, dosage should be reduced to the lowest amount that will maintain relief of symptoms. It is appropriate to continue maintenance therapy 3 months or longer to lessen the possibility of relapse.
Usage in Pediatric Patients
In view of the lack of experience with the use of this drug in pediatric patients, it is not recommended at the present time for patients under 12 years of age.
Plasma Levels
Because of the wide variation in the absorption and distribution of tricyclic antidepressants in body fluids, it is difficult to directly correlate plasma levels and therapeutic effect. However, determination of plasma levels may be useful in identifying patients who appear to have toxic effects and may have excessively high levels, or those in whom lack of absorption or noncompliance is suspected. Because of increased intestinal transit time and decreased hepatic metabolism in elderly patients, plasma levels are generally higher for a given oral dose of amitriptyline hydrochloride than in younger patients. Elderly patients should be monitored carefully and quantitative serum levels obtained as clinically appropriate. Adjustment in dosage should be made according to the patient's clinical response and not on the basis of plasma levels.**
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![Amoxicillin And Clavulanate Potassium Tablet, Film Coated [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=18578298-2487-4ef2-bd22-0043518fa9ee&name=500-mg-20-tab-label.jpg)
Amoxicillin And Clavulanate Potassium
Amoxicillin and Clavulanate Potassium may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when Amoxicillin and Clavulanate Potassium is administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, Amoxicillin and Clavulanate Potassium should be taken at the start of a meal.
2.1 Adults
The usual adult dose is one 500-mg tablet of Amoxicillin and Clavulanate Potassium every 12 hours or one 250-mg tablet of Amoxicillin and Clavulanate Potassium every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one 875-mg tablet of Amoxicillin and Clavulanate Potassium every 12 hours or one 500-mg tablet of Amoxicillin and Clavulanate Potassium every 8 hours. Adults who have difficulty swallowing may be given the 125 mg/5 mL or 250 mg/5 mL suspension in place of the 500-mg tablet. The 200 mg/5 mL suspension or the 400 mg/5 mL suspension may be used in place of the 875-mg tablet.
Two 250-mg tablets of Amoxicillin and Clavulanate Potassium should not be substituted for one 500-mg tablet of Amoxicillin and Clavulanate Potassium. Since both the 250-mg and 500-mg tablets of Amoxicillin and Clavulanate Potassium contain the same amount of clavulanic acid (125 mg, as the potassium salt), two 250-mg tablets are not equivalent to one 500-mg tablet of Amoxicillin and Clavulanate Potassium.
The 250-mg tablet of Amoxicillin and Clavulanate Potassium and the 250-mg chewable tablet should not be substituted for each other, as they are not interchangeable. The 250-mg tablet of Amoxicillin and Clavulanate Potassium and the 250-mg chewable tablet do not contain the same amount of clavulanic acid (as the potassium salt). The 250-mg tablet of Amoxicillin and Clavulanate Potassium contains 125 mg of clavulanic acid, whereas the 250-mg chewable tablet contains 62.5 mg of clavulanic acid.
2.2 Pediatric Patients
Based on the amoxicillin component, Amoxicillin and Clavulanate Potassium should be dosed as follows:
Neonates and Infants Aged <12 weeks (<3 months): The recommended dose of Amoxicillin and Clavulanate Potassium is 30 mg/kg/day divided every 12 hours, based on the amoxicillin component. Experience with the 200 mg/5 mL formulation in this age group is limited, and thus, use of the 125 mg/5 mL oral suspension is recommended.
Patients Aged 12 weeks (3 months) and Older: See dosing regimens provided in Table 1. The every 12 hour regimen is recommended as it is associated with significantly less diarrhea [see Clinical Studies (14.2)]. However, the every 12 hour suspension (200 mg/5 mL and 400 mg/5 mL) and chewable tablets (200 mg and 400 mg) contain aspartame and should not be used by phenylketonurics. [see Warnings and Precautions (5.6)]
Table 1: Dosing in Patients Aged 12 weeks (3 months) and Older
INFECTION
DOSING REGIMEN
Every 12 hours
Every 8 hours
200 mg/5 mL or 400 mg/5 mL oral suspensiona
125 mg/5 mL or 250 mg/5 mL oral suspensiona
Otitis mediab, sinusitis, lower respiratory tract infections, and more severe infections
45 mg/kg/day every 12 hours
40 mg/kg/day every 8 hours
Less severe infections
25 mg/kg/day every 12 hours
20 mg/kg/day every 8 hours
a Each strength of suspension of Amoxicillin and Clavulanate Potassium is available as a chewable tablet for use by older children.
b Duration of therapy studied and recommended for acute otitis media is 10 days.
Patients Weighing 40 kg or More: Pediatric patients weighing 40 kg or more should be dosed according to adult recommendations.
The 250-mg tablet of Amoxicillin and Clavulanate Potassium should not be used until the child weighs at least 40 kg,due to the different amoxicillin to clavulanic acid ratios in the 250-mg tablet of Amoxicillin and Clavulanate Potassium (250/125) versus the 250-mg chewable tablet of Amoxicillin and Clavulanate Potassium (250/62.5).
2.3 Patients with Renal Impairment
Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Renal impairment patients with a glomerular filtration rate of <30 mL/min should not receive the 875‑mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.
Hemodialysis patients should receive 500 mg or 250 mg every 24 hours,depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.
2.4 Directions for Mixing Oral Suspension
Prepare a suspension at time of dispensing as follows: Tap bottle until all the powder flows freely. Add approximately 2/3 of the total amount of water for reconstitution (see Table 2 below) and shake vigorously to suspend powder. Add remainder of the water and again shake vigorously.
Table 2: Amount of Water for Mixing Oral Suspension
Strength
Bottle Size
Amount of Waterfor Reconstitution
Contents of EachTeaspoonful (5 mL)
125 mg/5 mL
75 mL100 mL150 mL
67 mL90 mL134 mL
125 mg amoxicillin and 31.25 mg of clavulanic acid as the potassium salt
200 mg/5 mL
50 mL75 mL100 mL
50 mL75 mL95 mL
200 mg amoxicillin and 28.5 mg of clavulanic acid as the potassium salt
250 mg/5 mL
75 mL100 mL150 mL
65 mL87 mL130 mL
250 mg amoxicillin and 62.5 mg of clavulanic acid as the potassium salt
400 mg/5 mL
50 mL75 mL100 mL
50 mL70 mL90 mL
400 mg amoxicillin and 57.0 mg of clavulanic acid as the potassium salt
Note: Shake oral suspension well before using. Reconstituted suspension must be stored under refrigeration and discarded after 10 days.
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![Amoxicillin And Clavulanate Potassium Tablet, Film Coated [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=3426b6df-4eef-4be6-b5ff-11c79aaa605b&name=amoxiclav-fig3.jpg)
Amoxicillin And Clavulanate Potassium
Amoxicillin and clavulanate potassium tablets may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when amoxicillin and clavulanate potassium tablets are administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium tablets should be taken at the start of a meal.
2.1 Adults
The usual adult dose is one amoxicillin and clavulanate potassium tablet 500 mg/125 mg every 12 hours or one amoxicillin and clavulanate potassium tablet 250 mg/125 mg every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one amoxicillin and clavulanate potassium tablet 875 mg/125 mg every 12 hours or one amoxicillin and clavulanate potassium tablet 500 mg/125 mg every 8 hours. Adults who have difficulty swallowing may be given the 125 mg/31.25 mg per 5 mL or 250 mg/62.5 mg per 5 mL suspension in place of the 500 mg/125 mg tablet. The 200 mg/28.5 mg per 5 mL suspension or the 400 mg/57 mg per 5 mL suspension may be used in place of the 875 mg/125 mg tablet.Two amoxicillin and clavulanate potassium tablets 250 mg/125 mg should not be substituted for one amoxicillin and clavulanate potassium tablet 500 mg/125 mg. Since both the amoxicillin and clavulanate potassium tablets 250 mg/125 mg and 500 mg/125 mg contain the same amount of clavulanic acid (125 mg, as the potassium salt), two 250 mg/125 mg tablets are not equivalent to one amoxicillin and clavulanate potassium tablet 500 mg/125 mg.The amoxicillin and clavulanate potassium tablet 250 mg/125 mg and the 250 mg/62.5 mg chewable tablet should not be substituted for each other, as they are not interchangeable. The amoxicillin and clavulanate potassium tablet 250 mg/125 mg and the 250 mg/62.5 mg chewable tablet do not contain the same amount of clavulanic acid (as the potassium salt). The amoxicillin and clavulanate potassium tablet 250 mg/125 mg contains 125 mg of clavulanic acid, whereas the 250 mg/62.5 mg chewable tablet contains 62.5 mg of clavulanic acid.
2.2 Pediatric Patients
Based on the amoxicillin component, amoxicillin and clavulanate potassium tablets should be dosed as follows:Neonates and Infants Aged <12 weeks (<3 months): The recommended dose of amoxicillin and clavulanate potassium tablets is 30 mg/kg/day divided every 12 hours, based on the amoxicillin component. Experience with the 200 mg/28.5 mg per 5 mL formulation in this age group is limited, and thus, use of the 125 mg/31.25 mg per 5 mL oral suspension is recommended.Patients Aged 12 weeks (3 months) and Older: See dosing regimens provided in Table 1. The every 12 hour regimen is recommended as it is associated with significantly less diarrhea [see Clinical Studies (14.2)]. However, the every 12 hour suspension (200 mg/28.5 mg per 5 mL and 400 mg/57 mg per 5 mL) and chewable tablets (200 mg/28.5 mg and 400 mg/57 mg) contain aspartame and should not be used by phenylketonurics.
Table 1: Dosing in Patients Aged 12 weeks (3 months) and Older a Each strength of suspension of amoxicillin and clavulanate potassium is available as a chewable tablet for use by older children.b Duration of therapy studied and recommended for acute otitis media is 10 days.INFECTION
DOSING REGIMEN
Every 12 hours
Every 8 hours
200 mg/28.5 mg per 5 mL or 400 mg/57 mg per 5 mL oral suspensiona
125 mg/31.25 mg per 5 mL or 250 mg/62.5 mg per 5 mL oral suspensiona
Otitis mediab, sinusitis, lower respiratory tract infections, and more severe infections
45 mg/kg/day every 12 hours
40 mg/kg/day every 8 hours
Less severe infections
25 mg/kg/day every 12 hours
20 mg/kg/day every 8 hours
Patients Weighing 40 kg or More: Pediatric patients weighing 40 kg or more should be dosed according to adult recommendations.The amoxicillin and clavulanate potassium tablet 250 mg/125 mg should not be used until the child weighs at least 40 kg, due to the different amoxicillin to clavulanic acid ratios in the amoxicillin and clavulanate potassium tablet 250 mg/125 mg versus the amoxicillin and clavulanate potassium chewable tablet 250 mg/62.5 mg.
2.3 Patients with Renal Impairment
Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Renal impairment patients with a glomerular filtration rate of <30 mL/min should not receive the amoxicillin and clavulanate potassium tablets 875 mg/125 mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive amoxicillin and clavulanate potassium tablets 500 mg/125 mg or 250 mg/125 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive amoxicillin and clavulanate potassium tablets 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection.Hemodialysis patients should receive amoxicillin and clavulanate potassium tablets 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.
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![Amitriptyline Hydrochloride Tablet, Film Coated [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=60e95c23-9070-4420-8ecb-a7a1ca8fe143&name=5c69f6ab-e7f6-4063-8d4b-2874578d2eaa-01.jpg)
Amitriptyline Hydrochloride
Oral Dosage
Dosage should be initiated at a low level and increased gradually, noting carefully the clinical response and any evidence of intolerance.
Initial Dosage for Adults
For outpatients, 75 mg of amitriptyline HCl a day in divided doses is usually satisfactory. If necessary, this may be increased to a total of 150 mg per day. Increases are made preferably in the late afternoon and/or bedtime doses. A sedative effect may be apparent before the antidepressant effect is noted, but an adequate therapeutic effect may take as long as 30 days to develop.
An alternate method of initiating therapy in outpatients is to begin with 50 to 100 mg amitriptyline HCl at bedtime. This may be increased by 25 or 50 mg as necessary in the bedtime dose to a total of 150 mg per day.
Hospitalized patients may require 100 mg a day initially. This can be increased gradually to 200 mg a day if necessary. A small number of hospitalized patients may need as much as 300 mg a day.
Adolescent and Elderly Patients
In general, lower dosages are recommended for these patients. Ten mg 3 times a day with 20 mg at bedtime may be satisfactory in adolescent and elderly patients who do not tolerate higher dosages.
Maintenance
The usual maintenance dosage of amitriptyline HCl is 50 to 100 mg per day. In some patients, 40 mg per day is sufficient. For maintenance therapy, the total daily dosage may be given in a single dose, preferably at bedtime. When satisfactory improvement has been reached, dosage should be reduced to the lowest amount that will maintain relief of symptoms. It is appropriate to continue maintenance therapy 3 months or longer to lessen the possibility of relapse.
Usage in Pediatric Patients
In view of the lack of experience with the use of this drug in pediatric patients, it is not recommended at the present time for patients under 12 years of age.
Plasma Levels
Because of the wide variation in the absorption and distribution of tricyclic antidepressants in body fluids, it is difficult to directly correlate plasma levels and therapeutic effect. However, determination of plasma levels may be useful in identifying patients who appear to have toxic effects and may have excessively high levels, or those in whom lack of absorption or noncompliance is suspected. Because of increased intestinal transit time and decreased hepatic metabolism in elderly patients, plasma levels are generally higher for a given oral dose of amitriptyline hydrochloride than in younger patients. Elderly patients should be monitored carefully and quantitative serum levels obtained as clinically appropriate. Adjustments in dosage should be made according to the patient’s clinical response and not on the basis of plasma levels.2
2 Hollister, L.E.; Monitoring Tricyclic Antidepressant Plasma Concentrations. JAMA 1979; 241(23):2530-2533. -
![Amoxicillin And Clavulanate Potassium Powder, For Suspension [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=fe527503-14dd-4472-902f-e663bd33b272&name=400-mg-75-ml-label.jpg)
Amoxicillin And Clavulanate Potassium
Amoxicillin and Clavulanate Potassium may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when Amoxicillin and Clavulanate Potassium is administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, Amoxicillin and Clavulanate Potassium should be taken at the start of a meal.
2.1 Adults
The usual adult dose is one 500-mg tablet of Amoxicillin and Clavulanate Potassium every 12 hours or one 250-mg tablet of Amoxicillin and Clavulanate Potassium every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one 875-mg tablet of Amoxicillin and Clavulanate Potassium every 12 hours or one 500-mg tablet of Amoxicillin and Clavulanate Potassium every 8 hours. Adults who have difficulty swallowing may be given the 125 mg/5 mL or 250 mg/5 mL suspension in place of the 500-mg tablet. The 200 mg/5 mL suspension or the 400 mg/5 mL suspension may be used in place of the 875-mg tablet.
Two 250-mg tablets of Amoxicillin and Clavulanate Potassium should not be substituted for one 500-mg tablet of Amoxicillin and Clavulanate Potassium. Since both the 250-mg and 500-mg tablets of Amoxicillin and Clavulanate Potassium contain the same amount of clavulanic acid (125 mg, as the potassium salt), two 250-mg tablets are not equivalent to one 500-mg tablet of Amoxicillin and Clavulanate Potassium.
The 250-mg tablet of Amoxicillin and Clavulanate Potassium and the 250-mg chewable tablet should not be substituted for each other, as they are not interchangeable. The 250-mg tablet of Amoxicillin and Clavulanate Potassium and the 250-mg chewable tablet do not contain the same amount of clavulanic acid (as the potassium salt). The 250-mg tablet of Amoxicillin and Clavulanate Potassium contains 125 mg of clavulanic acid, whereas the 250-mg chewable tablet contains 62.5 mg of clavulanic acid.
2.2 Pediatric Patients
Based on the amoxicillin component, Amoxicillin and Clavulanate Potassium should be dosed as follows:
Neonates and Infants Aged <12 weeks (<3 months): The recommended dose of Amoxicillin and Clavulanate Potassium is 30 mg/kg/day divided every 12 hours, based on the amoxicillin component. Experience with the 200 mg/5 mL formulation in this age group is limited, and thus, use of the 125 mg/5 mL oral suspension is recommended.
Patients Aged 12 weeks (3 months) and Older: See dosing regimens provided in Table 1. The every 12 hour regimen is recommended as it is associated with significantly less diarrhea [see Clinical Studies (14.2)]. However, the every 12 hour suspension (200 mg/5 mL and 400 mg/5 mL) and chewable tablets (200 mg and 400 mg) contain aspartame and should not be used by phenylketonurics. [see Warnings and Precautions (5.6)]
Table 1: Dosing in Patients Aged 12 weeks (3 months) and Older
INFECTION
DOSING REGIMEN
Every 12 hours
Every 8 hours
200 mg/5 mL or 400 mg/5 mL oral suspensiona
125 mg/5 mL or 250 mg/5 mL oral suspensiona
Otitis mediab, sinusitis, lower respiratory tract infections, and more severe infections
45 mg/kg/day every 12 hours
40 mg/kg/day every 8 hours
Less severe infections
25 mg/kg/day every 12 hours
20 mg/kg/day every 8 hours
a Each strength of suspension of Amoxicillin and Clavulanate Potassium is available as a chewable tablet for use by older children.
b Duration of therapy studied and recommended for acute otitis media is 10 days.
Patients Weighing 40 kg or More: Pediatric patients weighing 40 kg or more should be dosed according to adult recommendations.
The 250-mg tablet of Amoxicillin and Clavulanate Potassium should not be used until the child weighs at least 40 kg,due to the different amoxicillin to clavulanic acid ratios in the 250-mg tablet of Amoxicillin and Clavulanate Potassium (250/125) versus the 250-mg chewable tablet of Amoxicillin and Clavulanate Potassium (250/62.5).
2.3 Patients with Renal Impairment
Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Renal impairment patients with a glomerular filtration rate of <30 mL/min should not receive the 875‑mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.
Hemodialysis patients should receive 500 mg or 250 mg every 24 hours,depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.
2.4 Directions for Mixing Oral Suspension
Prepare a suspension at time of dispensing as follows: Tap bottle until all the powder flows freely. Add approximately 2/3 of the total amount of water for reconstitution (see Table 2 below) and shake vigorously to suspend powder. Add remainder of the water and again shake vigorously.
Table 2: Amount of Water for Mixing Oral Suspension
Strength
Bottle Size
Amount of Waterfor Reconstitution
Contents of EachTeaspoonful (5 mL)
125 mg/5 mL
75 mL100 mL150 mL
67 mL90 mL134 mL
125 mg amoxicillin and 31.25 mg of clavulanic acid as the potassium salt
200 mg/5 mL
50 mL75 mL100 mL
50 mL75 mL95 mL
200 mg amoxicillin and 28.5 mg of clavulanic acid as the potassium salt
250 mg/5 mL
75 mL100 mL150 mL
65 mL87 mL130 mL
250 mg amoxicillin and 62.5 mg of clavulanic acid as the potassium salt
400 mg/5 mL
50 mL75 mL100 mL
50 mL70 mL90 mL
400 mg amoxicillin and 57.0 mg of clavulanic acid as the potassium salt
Note: Shake oral suspension well before using. Reconstituted suspension must be stored under refrigeration and discarded after 10 days.
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Amoxicillin And Clavulanate Potassium
Amoxicillin and clavulanate potassium for oral suspension may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when amoxicillin and clavulanate potassium for oral suspension is administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium for oral suspension should be taken at the start of a meal.
2.1 Adults
The usual adult dose is one amoxicillin and clavulanate potassium 500 mg/125 mg tablet every 12 hours or one amoxicillin and clavulanate potassium 250 mg/125 mg tablet every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one amoxicillin and clavulanate potassium 875 mg/125 mg tablet every 12 hours or one amoxicillin and clavulanate potassium 500 mg/125 mg tablet every 8 hours. Adults who have difficulty swallowing may be given the 125 mg/31.25 mg per 5 mL or 250 mg/62.5 mg per 5 mL suspension in place of the 500 mg/125 mg tablet. The 200 mg/28.5 mg per 5 mL suspension or the 400 mg/57 mg per 5 mL suspension may be used in place of the 875 mg/125 mg tablet.Two amoxicillin and clavulanate potassium 250 mg/125 mg tablets should not be substituted for one amoxicillin and clavulanate potassium 500 mg/125 mg tablet. Since both the amoxicillin and clavulanate potassium 250 mg/125 mg and 500 mg/125 mg tablets contain the same amount of clavulanic acid (125 mg, as the potassium salt), two 250 mg/125 mg tablets are not equivalent to one amoxicillin and clavulanate potassium 500 mg/125 mg tablet.The amoxicillin and clavulanate potassium 250 mg/125 mg tablet and the 250 mg/62.5 mg chewable tablet should not be substituted for each other, as they are not interchangeable. The amoxicillin and clavulanate potassium 250 mg/125 mg tablet and the 250 mg/62.5 mg chewable tablet do not contain the same amount of clavulanic acid (as the potassium salt). The amoxicillin and clavulanate potassium 250 mg/125 mg tablet contains 125 mg of clavulanic acid, whereas the 250 mg/62.5 mg chewable tablet contains 62.5 mg of clavulanic acid.
2.2 Pediatric Patients
Based on the amoxicillin component, amoxicillin and clavulanate potassium for oral suspension should be dosed as follows:Neonates and Infants Aged <12 weeks (<3 months): The recommended dose of amoxicillin and clavulanate potassium for oral suspension is 30 mg/kg/day divided every 12 hours, based on the amoxicillin component. Experience with the 200 mg/28.5 mg per 5 mL formulation in this age group is limited, and thus, use of the 125 mg/31.25 mg per 5 mL oral suspension is recommended.Patients Aged 12 weeks (3 months) and Older: See dosing regimens provided in Table 1. The every 12 hour regimen is recommended as it is associated with significantly less diarrhea [see Clinical Studies (14.2)]. However, the every 12 hour suspension (200 mg/28.5 mg per 5 mL and 400 mg/57 mg per 5 mL) and chewable tablets (200 mg/28.5 mg and 400 mg/57 mg) contain aspartame and should not be used by phenylketonurics [see Warnings and Precautions (5.6)].
Table 1: Dosing in Patients Aged 12 weeks (3 months) and Older a Each strength of suspension of amoxicillin and clavulanate potassium is available as a chewable tablet for use by older children. b Duration of therapy studied and recommended for acute otitis media is 10 days.INFECTION
DOSING REGIMEN
Every 12 hours
Every 8 hours
200 mg/28.5 mg per 5 mL or 400 mg/57 mg per 5 mL oral suspensiona
125 mg/31.25 mg per 5 mL or 250 mg/62.5 mg per 5 mL oral suspensiona
Otitis mediab, sinusitis, lower respiratory tract infections, and more severe infections
45 mg/kg/day every 12 hours
40 mg/kg/day every 8 hours
Less severe infections
25 mg/kg/day every 12 hours
20 mg/kg/day every 8 hours
Patients Weighing 40 kg or More: Pediatric patients weighing 40 kg or more should be dosed according to adult recommendations.The amoxicillin and clavulanate potassium 250 mg/125 mg tablet should not be used until the child weighs at least 40 kg, due to the different amoxicillin to clavulanic acid ratios in the amoxicillin and clavulanate potassium 250 mg/125 mg tablet versus the amoxicillin and clavulanate potassium 250 mg/62.5 mg chewable tablet.
2.3 Patients with Renal Impairment
Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Renal impairment patients with a glomerular filtration rate of <30 mL/min should not receive the dose of amoxicillin and clavulanate potassium tablets 875 mg/125 mg. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive amoxicillin and clavulanate potassium tablets 500 mg/125 mg or 250 mg/125 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive amoxicillin and clavulanate potassium tablets 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection.Hemodialysis patients should receive amoxicillin and clavulanate potassium tablets 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.
2.4 Directions for Mixing Oral Suspension
Prepare a suspension at time of dispensing as follows: Tap bottle until all the powder flows freely. Add approximately 2/3 of the total amount of water for reconstitution (see Table 2 below) and shake vigorously to suspend powder. Add remainder of the water and again shake vigorously.
Table 2: Amount of Water for Mixing Oral SuspensionStrength
Bottle Size
Amount of Water for Reconstitution
Contents of Each Teaspoonful (5 mL)
200 mg/28.5 mg per 5 mL
50 mL75 mL100 mL
52 mL73 mL98 mL
200 mg amoxicillin and 28.5 mg of clavulanic acid as the potassium salt
400 mg/57 mg per 5 mL
50 mL75 mL100 mL
49 mL70 mL94 mL
400 mg amoxicillin and 57 mg of clavulanic acid as the potassium salt
Note: Shake oral suspension well before using. Reconstituted suspension must be stored under refrigeration and discarded after 10 days.
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Amoxicillin And Clavulanate Potassium
Amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL, does not contain the same amount of clavulanic acid (as the potassium salt) as any of the other amoxicillin and clavulanate potassium suspensions. Amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL contains 42.9 mg of clavulanic acid per 5 mL, whereas the amoxicillin and clavulanate potassium, 200 mg/28.5 mg per 5 mL suspension contains 28.5 mg of clavulanic acid per 5 mL and the 400 mg/57 mg per 5 mL suspension contains 57 mg of clavulanic acid per 5 mL. Therefore, the amoxicillin and clavulanate potassium 200 mg/28.5 mg per 5 mL and 400 mg/57 mg per 5 mL suspensions should not be substituted for amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL, as they are not interchangeable.
Dosage
Pediatric patients 3 months and older Based on the amoxicillin component (600 mg/5 mL), the recommended dose of amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL is 90 mg/kg/day divided every 12 hours, administered for 10 days (see chart below).
Body Weight (kg) Volume of Amoxicillin and Clavulanate Potassium for Oral Suspension, 600 mg/42.9 mg per 5 mL providing 90 mg/kg/day8
3 mL twice daily
12
4.5 mL twice daily
16
6 mL twice daily
20
7.5 mL twice daily
24
9 mL twice daily
28
10.5 mL twice daily
32
12 mL twice daily
36
13.5 mL twice daily
Pediatric patients weighing 40 kg and more Experience with amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL formulation in this group is not available.Adults Experience with amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL formulation in adults is not available and adults who have difficulty swallowing should not be given amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL in place of the amoxicillin and clavulanate potassium 500 mg or 875 mg tablet. Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals (see WARNINGS).Directions for Mixing Oral Suspension Prepare a suspension at time of dispensing as follows: Tap bottle until all the powder flows freely. Add approximately 2/3 of the total amount of water for reconstitution (see table below) and shake vigorously to suspend powder. Add remainder of the water and again shake vigorously.
Amoxicillin and Clavulanate Potassium for Oral Suspension, 600 mg/42.9 mg per 5 mLBottle Size
Amount of WaterRequired for Reconstitution
75 mL
71 mL
125 mL
112 mL
200 mL
176 mL
Each teaspoonful (5 mL) will contain 600 mg amoxicillin as the trihydrate and 42.9 mg of clavulanic acid as the potassium salt.NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING.
Administration
To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL should be taken at the start of a meal. Absorption of clavulanate potassium may be enhanced when amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL is administered at the start of a meal.
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Azithromycin Dihydrate
2.1 Adult Patients
[See Indications and Usage (1.1) and Clinical Pharmacology (12.3)].
Infection*
Recommended Dose/Duration of Therapy
Community-acquired pneumonia Pharyngitis/tonsillitis (second-line therapy) Skin/skin structure (uncomplicated)
500 mg as a single-dose on Day 1, followed by 250 mg once daily on Days 2 through 5
Acute bacterial exacerbations of chronic obstructive pulmonary disease
500 mg once daily for 3 days OR 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5
Acute bacterial sinusitis
500 mg once daily for 3 days
Genital ulcer disease (chancroid)
One single 1 gram dose
Non-gonococcal urethritis and cervicitis
One single 1 gram dose
Gonococcal urethritis and cervicitis
One single 2 gram dose
*DUE TO THE INDICATED ORGANISMS [see Indications and Usage (1.1)]
Azithromycin tablets can be taken with or without food.
2.2 Pediatric Patients1
Infection*
Recommended Dose/Duration of Therapy
Acute otitis media
30 mg/kg as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on Day 1 followed by 5 mg/kg/day on Days 2 through 5.
Acute bacterial sinusitis
10 mg/kg once daily for 3 days.
Community-acquired pneumonia
10 mg/kg as a single dose on Day 1 followed by 5 mg/kg once daily on Days 2 through 5.
Pharyngitis/tonsillitis
12 mg/kg once daily for 5 days.
*DUE TO THE INDICATED ORGANISMS [see Indications and Usage (1.2)] 1see dosing tables below for maximum doses evaluated by indication
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA, ACUTE BACTERIAL SINUSITIS, AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, [see Use in Specific Populations (8.4)]) Based on Body Weight
OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5-Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5.
Weight
100 mg/5 mL
200 mg/5 mL
Total mL per Treatment Course
Total mg per Treatment Course
Kg
Lbs.
Day 1
Days 2 to 5
Day 1
Days 2 to 5
5
11
2.5 mL; (½ tsp)
1.25 mL;(¼ tsp)
7.5 mL
150 mg
10
22
5 mL; (1 tsp)
2.5 mL; (½ tsp)
15 mL
300 mg
20
44
5 mL; (1 tsp)
2.5 mL; (½ tsp)
15 mL
600 mg
30
66
7.5 mL; (1½ tsp)
3.75 mL; (¾ tsp)
22.5 mL
900 mg
40
88
10 mL; (2 tsp)
5 mL; (1 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL; (2½ tsp)
6.25 mL; (1¼ tsp)
37.5 mL
1500 mg
*Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established.
OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)*
Dosing Calculated on 10 mg/kg/day.
Weight
100 mg/5 mL
200 mg/5 mL
Total mL per Treatment Course
Total mg per Treatment Course
Kg
Lbs.
Days 1 to 3
Days 1 to 3
5
11
2.5 mL; (½ tsp)
7.5 mL
150 mg
10
22
5 mL; (1 tsp)
15 mL
300 mg
20
44
5 mL; (1 tsp)
15 mL
600 mg
30
66
7.5 mL; (1½ tsp)
22.5 mL
900 mg
40
88
10 mL; (2 tsp)
30 mL
1200 mg
50 and above
110 and above
12.5 mL; (2½ tsp)
37.5 mL
1500 mg
*Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established.
OTITIS MEDIA: (1-Day Regimen)
Dosing Calculated on 30 mg/kg as a single dose.
Weight
200 mg/5 mL
Total mL per Treatment Course
Total mg per Treatment Course
Kg
Lbs.
1-Day Regimen
5
11
3.75 mL; (3/4 tsp)
3.75 mL
150 mg
10
22
7.5 mL; (1½ tsp)
7.5 mL
300 mg
20
44
15 mL; (3 tsp)
15 mL
600 mg
30
66
22.5 mL; (4½ tsp)
22.5 mL
900 mg
40
88
30 mL; (6 tsp)
30 mL
1200 mg
50 and above
110 and above
37.5 mL; (7½ tsp)
37.5 mL
1500 mg
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
Pharyngitis/Tonsillitis
The recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days (See chart below).
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS/TONSILLITIS(Age 2 years and above, [see Use in Specific Populations (8.4)]) Based on Body Weight
PHARYNGITIS/TONSILLITIS: (5-Day Regimen)
Dosing Calculated on 12 mg/kg/day for 5 days.
Weight
200 mg/5 mL
Total mL per Treatment Course
Total mg per Treatment Course
Kg
Lbs.
Day 1 to 5
8
18
2.5 mL; (½ tsp)
12.5 mL
500 mg
17
37
5 mL; (1 tsp)
25 mL
1000 mg
25
55
7.5 mL; (1½ tsp)
37.5 mL
1500 mg
33
73
10 mL; (2 tsp)
50 mL
2000 mg
40
88
12.5 mL; (2½ tsp)
62.5 mL
2500 mg
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Budesonide Suspension
The recommended starting dose and highest recommended dose of budesonide inhalation suspension, based on prior asthma therapy, are listed in the following table.
Previous Therapy
Recommended Starting Dose
Highest Recommended Dose
Bronchodilators alone
0.5 mg total daily dose administered twice daily in divided doses
0.5 mg total daily dose
Inhaled Corticosteroids
0.5 mg total daily dose administered twice daily in divided doses
1 mg total daily dose
Oral Corticosteroids
1 mg total daily dose administered as 0.5 mg twice daily
1 mg total daily dose
2.1 Dosing Recommendations
Dosing recommendations based on previous therapy are as follows:
• Bronchodilators alone: 0.25 mg twice daily • Inhaled corticosteroids: 0.25 mg twice daily up to 0.5 mg twice daily • Oral corticosteroids: 0.5 mg twice dailyIn all patients, it is desirable to downward-titrate to the lowest effective dose once asthma stability is achieved.
2.2 Directions for Use
Budesonide inhalation suspension should be administered via jet nebulizer connected to an air compressor with an adequate air flow, equipped with a mouthpiece or suitable face mask. Ultrasonic nebulizers are not suitable for the adequate administration of budesonide inhalation suspension and, therefore, are NOT recommended.
The effects of mixing budesonide inhalation suspension with other nebulizable medications have not been adequately assessed. Budesonide inhalation suspension should be administered separately in the nebulizer [see Patient Counseling Information, Administration with a jet nebulizer (17.1)].
A Pari-LC-Jet Plus Nebulizer (with face mask or mouthpiece) connected to a Pari Master compressor was used to deliver budesonide inhalation suspension to each patient in 3 U.S. controlled clinical studies. The safety and efficacy of budesonide inhalation suspension delivered by other nebulizers and compressors have not been established.
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Benzonatate
Adults and Children over 10 years of age: Usual dose is one 100 mg or 200 mg capsule three times a day as needed for cough. If necessary to control cough, up to 600 mg daily in three divided doses may be given. Benzonatate Capsules should be swallowed whole. Benzonatate Capsules are not to be broken, chewed, dissolved, cut or crushed.
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Visipaque
Dosage should be individualized for maximum beneficial effect. While the usual daily dosages given below will meet the needs of most patients, there will be some who require doses greater than 4 mg/day. In such cases, dosage should be increased cautiously to avoid adverse effects.
Anxiety Disorders and Transient Symptoms of Anxiety
Treatment for patients with anxiety should be initiated with a dose of 0.25 to 0.5 mg given three times daily. The dose may be increased to achieve a maximum therapeutic effect, at intervals of 3 to 4 days, to a maximum daily dose of 4 mg, given in divided doses. The lowest possible effective dose should be employed and the need for continued treatment reassessed frequently. The risk of dependence may increase with dose and duration of treatment.
In all patients, dosage should be reduced gradually when discontinuing therapy or when decreasing the daily dosage. Although there are no systematically collected data to support a specific discontinuation schedule, it is suggested that the daily dosage be decreased by no more than 0.5 mg every 3 days. Some patients may require an even slower dosage reduction.
Panic Disorder
The successful treatment of many panic disorder patients has required the use of alprazolam tablets at doses greater than 4 mg daily. In controlled trials conducted to establish the efficacy of alprazolam tablets in panic disorder, doses in the range of 1 to 10 mg daily were used. The mean dosage employed was approximately 5 to 6 mg daily. Among the approximately 1700 patients participating in the panic disorder development program, about 300 received alprazolam tablets in dosages of greater than 7 mg/day, including approximately 100 patients who received maximum dosages of greater than 9 mg/day. Occasional patients required as much as 10 mg a day to achieve a successful response.
Dose Titration
Treatment may be initiated with a dose of 0.5 mg three times daily. Depending on the response, the dose may be increased at intervals of 3 to 4 days in increments of no more than 1 mg per day. Slower titration to the dose levels greater than 4 mg/day may be advisable to allow full expression of the pharmacodynamic effect of alprazolam tablets. To lessen the possibility of interdose symptoms, the times of administration should be distributed as evenly as possible throughout the waking hours, that is, on a three or four times per day schedule.
Generally, therapy should be initiated at a low dose to minimize the risk of adverse responses in patients especially sensitive to the drug. Dose should be advanced until an acceptable therapeutic response (i.e., a substantial reduction in or total elimination of panic attacks) is achieved, intolerance occurs, or the maximum recommended dose is attained.
Dose Maintenance
For patients receiving doses greater than 4 mg/day, periodic reassessment and consideration of dosage reduction is advised. In a controlled postmarketing dose-response study, patients treated with doses of alprazolam tablets greater than 4 mg/day for 3 months were able to taper to 50% of their total maintenance dose without apparent loss of clinical benefit. Because of the danger of withdrawal, abrupt discontinuation of treatment should be avoided (see WARNINGS, PRECAUTIONS, DRUG ABUSE AND DEPENDENCE).
The necessary duration of treatment for panic disorder patients responding to alprazolam tablets is unknown. After a period of extended freedom from attacks, a carefully supervised tapered discontinuation may be attempted, but there is evidence that this may often be difficult to accomplish without recurrence of symptoms and/or the manifestation of withdrawal phenomena.
Dose Reduction
Because of the danger of withdrawal, abrupt discontinuation of treatment should be avoided (see WARNINGS, PRECAUTIONS, DRUG ABUSE AND DEPENDENCE).
In all patients, dosage should be reduced gradually when discontinuing therapy or when decreasing the daily dosage. Although there are no systematically collected data to support a specific discontinuation schedule, it is suggested that the daily dosage be decreased by no more than 0.5 mg every three days. Some patients may require an even slower dosage reduction.
In any case, reduction of dose must be undertaken under close supervision and must be gradual. If significant withdrawal symptoms develop, the previous dosing schedule should be reinstituted and, only after stabilization, should a less rapid schedule of discontinuation be attempted. In a controlled postmarketing discontinuation study of panic disorder patients which compared this recommended taper schedule with a slower taper schedule, no difference was observed between the groups in the proportion of patients who tapered to zero dose; however, the slower schedule was associated with a reduction in symptoms associated with a withdrawal syndrome. It is suggested that the dose be reduced by no more than 0.5 mg every 3 days, with the understanding that some patients may benefit from an even more gradual discontinuation. Some patients may prove resistant to all discontinuation regimens.
Dosing in Special Populations
In elderly patients, in patients with advanced liver disease or in patients with debilitating disease, the usual starting dose is 0.25 mg, given two or three times daily. This may be gradually increased if needed and tolerated. The elderly may be especially sensitive to the effects of benzodiazepines. If side effects occur at the recommended starting dose, the dose may be lowered.
Anxiety Disorders and Transient Symptoms of Anxiety
Treatment for patients with anxiety should be initiated with a dose of 0.25 to 0.5 mg given three times daily. The dose may be increased to achieve a maximum therapeutic effect, at intervals of 3 to 4 days, to a maximum daily dose of 4 mg, given in divided doses. The lowest possible effective dose should be employed and the need for continued treatment reassessed frequently. The risk of dependence may increase with dose and duration of treatment.
In all patients, dosage should be reduced gradually when discontinuing therapy or when decreasing the daily dosage. Although there are no systematically collected data to support a specific discontinuation schedule, it is suggested that the daily dosage be decreased by no more than 0.5 mg every 3 days. Some patients may require an even slower dosage reduction.
Panic Disorder
The successful treatment of many panic disorder patients has required the use of alprazolam tablets at doses greater than 4 mg daily. In controlled trials conducted to establish the efficacy of alprazolam tablets in panic disorder, doses in the range of 1 to 10 mg daily were used. The mean dosage employed was approximately 5 to 6 mg daily. Among the approximately 1700 patients participating in the panic disorder development program, about 300 received alprazolam tablets in dosages of greater than 7 mg/day, including approximately 100 patients who received maximum dosages of greater than 9 mg/day. Occasional patients required as much as 10 mg a day to achieve a successful response.
Dose Titration
Treatment may be initiated with a dose of 0.5 mg three times daily. Depending on the response, the dose may be increased at intervals of 3 to 4 days in increments of no more than 1 mg per day. Slower titration to the dose levels greater than 4 mg/day may be advisable to allow full expression of the pharmacodynamic effect of alprazolam tablets. To lessen the possibility of interdose symptoms, the times of administration should be distributed as evenly as possible throughout the waking hours, that is, on a three or four times per day schedule.
Generally, therapy should be initiated at a low dose to minimize the risk of adverse responses in patients especially sensitive to the drug. Dose should be advanced until an acceptable therapeutic response (i.e., a substantial reduction in or total elimination of panic attacks) is achieved, intolerance occurs, or the maximum recommended dose is attained.
Dose Maintenance
For patients receiving doses greater than 4 mg/day, periodic reassessment and consideration of dosage reduction is advised. In a controlled postmarketing dose-response study, patients treated with doses of alprazolam tablets greater than 4 mg/day for 3 months were able to taper to 50% of their total maintenance dose without apparent loss of clinical benefit. Because of the danger of withdrawal, abrupt discontinuation of treatment should be avoided (see WARNINGS, PRECAUTIONS, DRUG ABUSE AND DEPENDENCE).
The necessary duration of treatment for panic disorder patients responding to alprazolam tablets is unknown. After a period of extended freedom from attacks, a carefully supervised tapered discontinuation may be attempted, but there is evidence that this may often be difficult to accomplish without recurrence of symptoms and/or the manifestation of withdrawal phenomena.
Dose Reduction
Because of the danger of withdrawal, abrupt discontinuation of treatment should be avoided (see WARNINGS, PRECAUTIONS, DRUG ABUSE AND DEPENDENCE).
In all patients, dosage should be reduced gradually when discontinuing therapy or when decreasing the daily dosage. Although there are no systematically collected data to support a specific discontinuation schedule, it is suggested that the daily dosage be decreased by no more than 0.5 mg every three days. Some patients may require an even slower dosage reduction.
In any case, reduction of dose must be undertaken under close supervision and must be gradual. If significant withdrawal symptoms develop, the previous dosing schedule should be reinstituted and, only after stabilization, should a less rapid schedule of discontinuation be attempted. In a controlled postmarketing discontinuation study of panic disorder patients which compared this recommended taper schedule with a slower taper schedule, no difference was observed between the groups in the proportion of patients who tapered to zero dose; however, the slower schedule was associated with a reduction in symptoms associated with a withdrawal syndrome. It is suggested that the dose be reduced by no more than 0.5 mg every 3 days, with the understanding that some patients may benefit from an even more gradual discontinuation. Some patients may prove resistant to all discontinuation regimens.
Dosing in Special Populations
In elderly patients, in patients with advanced liver disease or in patients with debilitating disease, the usual starting dose is 0.25 mg, given two or three times daily. This may be gradually increased if needed and tolerated. The elderly may be especially sensitive to the effects of benzodiazepines. If side effects occur at the recommended starting dose, the dose may be lowered.
Dose Titration
Treatment may be initiated with a dose of 0.5 mg three times daily. Depending on the response, the dose may be increased at intervals of 3 to 4 days in increments of no more than 1 mg per day. Slower titration to the dose levels greater than 4 mg/day may be advisable to allow full expression of the pharmacodynamic effect of alprazolam tablets. To lessen the possibility of interdose symptoms, the times of administration should be distributed as evenly as possible throughout the waking hours, that is, on a three or four times per day schedule.
Generally, therapy should be initiated at a low dose to minimize the risk of adverse responses in patients especially sensitive to the drug. Dose should be advanced until an acceptable therapeutic response (i.e., a substantial reduction in or total elimination of panic attacks) is achieved, intolerance occurs, or the maximum recommended dose is attained.
Dose Reduction
Because of the danger of withdrawal, abrupt discontinuation of treatment should be avoided (see WARNINGS, PRECAUTIONS, DRUG ABUSE AND DEPENDENCE).
In all patients, dosage should be reduced gradually when discontinuing therapy or when decreasing the daily dosage. Although there are no systematically collected data to support a specific discontinuation schedule, it is suggested that the daily dosage be decreased by no more than 0.5 mg every three days. Some patients may require an even slower dosage reduction.
In any case, reduction of dose must be undertaken under close supervision and must be gradual. If significant withdrawal symptoms develop, the previous dosing schedule should be reinstituted and, only after stabilization, should a less rapid schedule of discontinuation be attempted. In a controlled postmarketing discontinuation study of panic disorder patients which compared this recommended taper schedule with a slower taper schedule, no difference was observed between the groups in the proportion of patients who tapered to zero dose; however, the slower schedule was associated with a reduction in symptoms associated with a withdrawal syndrome. It is suggested that the dose be reduced by no more than 0.5 mg every 3 days, with the understanding that some patients may benefit from an even more gradual discontinuation. Some patients may prove resistant to all discontinuation regimens.
Dosing in Special Populations
In elderly patients, in patients with advanced liver disease or in patients with debilitating disease, the usual starting dose is 0.25 mg, given two or three times daily. This may be gradually increased if needed and tolerated. The elderly may be especially sensitive to the effects of benzodiazepines. If side effects occur at the recommended starting dose, the dose may be lowered.
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![Benzonatate Capsule, Liquid Filled [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=83233a7e-856c-47d3-b6af-c6c642694486&name=a3fb9637-1de7-45f1-a490-c6b1cb9ea9a9-02.jpg)
Benzonatate
Adults and Children over 10 years of age:
Usual dose is one 100 mg or 200 mg capsule three times a day as needed for cough. If necessary to control cough, up to 600 mg daily in three divided doses may be given. Benzonatate should be swallowed whole. Benzonatate Capsules are not to be broken, chewed, dissolved, cut or crushed.
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![Benzonatate Capsule [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=71cb77d0-f315-4eb4-90b4-36155c1433b4&name=benzonatate-act-200mg-100cc.jpg)
Benzonatate
Adults and Children over 10 years of age: Usual dose is one 100 mg or 200 mg capsule three times a day as needed for cough. If necessary to control cough, up to 600 mg daily in three divided doses may be given. Benzonatate should be swallowed whole. Benzonatate capsules are not to be broken, chewed, dissolved, cut or crushed.
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![Tramadol Hydrochloride And Acetaminophen Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=8a6e1be7-35af-4cab-99d9-4360ff48bf06&name=tramadol-hydrochloride-and-acetaminophen-tablets-u-3.jpg)
Tramadol Hydrochloride And Acetaminophen
For the short-term (five days or less) management of acute pain, the recommended dose of tramadol hydrochloride and acetaminophen tablets, USP is 2 tablets every 4 to 6 hours as needed for pain relief, up to a maximum of 8 tablets per day.
Individualization of Dose
In patients with creatinine clearances of less than 30 mL/min, it is recommended that the dosing interval of tramadol hydrochloride and acetaminophen tablets, USP be increased not to exceed 2 tablets every 12 hours. Dose selection for an elderly patient should be cautious, in view of the potential for greater sensitivity to adverse events.
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![Butalbital, Acetaminophen And Caffeine Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=41fbd224-1239-4d89-8e19-0a300cd66f38&name=butalbital-acetaminophen-caffeine-tablets-4.jpg)
Butalbital
One or 2 tablets every 4 hours as needed. Total daily dosage should not exceed 6 tablets. Extended and repeated use of this product is not recommended because of the potential for physical dependence.
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![Bupropion Hydrochloride Tablet, Film Coated, Extended Release [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=b0294cf3-9a22-4120-9a7b-95a8a8518240&name=150mg-label.jpg)
Bupropion Hydrochloride
General Dosing Considerations: It is particularly important to administer bupropion hydrochloride extended-release tablets (SR) in a manner most likely to minimize the risk of seizure (see WARNINGS). Gradual escalation in dosage is also important if agitation, motor restlessness, and insomnia, often seen during the initial days of treatment, are to be minimized. If necessary, these effects may be managed by temporary reduction of dose or the short-term administration of an intermediate to long-acting sedative hypnotic. A sedative hypnotic usually is not required beyond the first week of treatment. Insomnia may also be minimized by avoiding bedtime doses. If distressing, untoward effects supervene, dose escalation should be stopped.Bupropion hydrochloride extended-release tablets (SR) should be swallowed whole and not crushed, divided, or chewed.Initial Treatment: The usual adult target dose for bupropion hydrochloride extended-release tablets (SR) is 300 mg/day, given as 150 mg twice daily. Dosing with bupropion hydrochloride extended-release tablets (SR) should begin at 150 mg/day given as a single daily dose in the morning. If the 150 mg initial dose is adequately tolerated, an increase to the 300 mg/day target dose, given as 150 mg twice daily, may be made as early as day 4 of dosing. There should be an interval of at least 8 hours between successive doses.Increasing the Dosage Above 300 mg/day: As with other antidepressants, the full antidepressant effect of bupropion hydrochloride extended-release tablets (SR) may not be evident until 4 weeks of treatment or longer. An increase in dosage to the maximum of 400 mg/day, given as 200 mg twice daily, may be considered for patients in whom no clinical improvement is noted after several weeks of treatment at 300 mg/day.Maintenance Treatment: It is generally agreed that acute episodes of depression require several months or longer of sustained pharmacological therapy beyond response to the acute episode. In a study in which patients with major depressive disorder, recurrent type, who had responded during 8 weeks of acute treatment with bupropion were assigned randomly to placebo or to the same dose of bupropion (150 mg twice daily) during 44 weeks of maintenance treatment as they had received during the acute stabilization phase, longer-term efficacy was demonstrated (see CLINICAL TRIALS under CLINICAL PHARMACOLOGY). Based on these limited data, it is unknown whether or not the dose of bupropion needed for maintenance treatment is identical to the dose needed to achieve an initial response. Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment.Dosage Adjustment for Patients with Impaired Hepatic Function: Bupropion should be used with extreme caution in patients with severe hepatic cirrhosis. The dose should not exceed 100 mg every day or 150 mg every other day in these patients. Bupropion should be used with caution in patients with hepatic impairment (including mild-to-moderate hepatic cirrhosis) and a reduced frequency and/or dose should be considered in patients with mild-to-moderate hepatic cirrhosis (see CLINICAL PHARMACOLOGY, WARNINGS, and PRECAUTIONS).Dosage Adjustment for Patients with Impaired Renal Function: Bupropion should be used with caution in patients with renal impairment and a reduced frequency and/or dose should be considered (see CLINICAL PHARMACOLOGY and PRECAUTIONS).
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![Tramadol Hydrochloride Capsule, Extended Release [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=40644857-0b2d-4fe5-9f6a-d0e864e94a94&name=Tramadol500Caps.jpg)
Tramadol Hydrochloride
2.1 General Dosing Considerations
Tramadol Hydrochloride Extended-Release is an extended-release formulation intended for once a day dosing in adults aged 18 years and older. The tablets must be swallowed whole with liquid and must not be split, chewed, dissolved or crushed. Chewing, crushing or splitting the tablet could result in the uncontrolled delivery of tramadol, in overdose and death [see WARNINGS AND PRECAUTIONS (5.11), DRUG ABUSE AND DEPENDENCE (9), and OVERDOSE (10.1)].
Do not administer Tramadol Hydrochloride Extended-Release at a dose exceeding 300 mg per day. Do not use Tramadol Hydrochloride Extended-Release more than once daily or concomitantly with other tramadol products [see WARNINGS AND PRECAUTIONS (5.12)].
2.2 Patients Not Currently on Tramadol Immediate-Release Products
Initiate treatment with Tramadol Hydrochloride Extended-Release at a dose of 100 mg once daily and titrated up as necessary to 150 mg, 200 mg and 300 mg every five days to achieve a balance between relief of pain and tolerability.
2.3 Patients Currently on Tramadol Immediate-Release Products
Calculate the 24-hour tramadol IR dose and initiate a total daily dose of Tramadol Hydrochloride Extended-Release rounded down to the next lowest 100 mg increment. The dose may subsequently be individualized according to patient need. Due to limitations in flexibility of dose selection with Tramadol Hydrochloride Extended-Release, some patients maintained on tramadol IR products may not be able to convert to Tramadol Hydrochloride Extended-Release.
2.4 Patients 65 Years of Age and Older
Initiate dosing of an elderly patient (over 65 years of age) should be initiated cautiously, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function and of concomitant disease or other drug therapy. Tramadol Hydrochloride Extended-Release should be administered with even greater caution in patients over 75 years, due to the greater frequency of adverse events seen in this population.
2.5 Patients with Renal Impairment
The limited availability of dose strengths and once daily dosing of Tramadol Hydrochloride Extended-Release do not permit the dosing flexibility required for safe use in patients with severe renal impairment. Do not use Tramadol Hydrochloride Extended-Release in patients with creatinine clearance less than 30 mL/min [see USE IN SPECIFIC POPULATIONS (8.6) and CLINICAL PHARMACOLOGY (12.3)].
2.6 Patients with Hepatic Impairment
The limited availability of dose strengths and once daily dosing of tramadol hydrochloride extended-release capsules do not permit the dosing flexibility required for safe use in patients with severe hepatic impairment. Do not use Tramadol Hydrochloride Extended-Release in patients with severe hepatic impairment (Child-Pugh Class C) [see USE IN SPECIFIC POPULATIONS (8.7) and CLINICAL PHARMACOLOGY (12.3)].
2.7 Discontinuation of Treatment
Withdrawal symptoms may occur if Tramadol Hydrochloride Extended-Release is discontinued abruptly. Clinical experience with tramadol suggests that withdrawal symptoms may be reduced by tapering Tramadol Hydrochloride Extended-Release [see WARNINGS AND PRECAUTIONS (5.10) and DRUG ABUSE AND DEPENDENCE (9.3)].
2.8 Food Effects
Tramadol Hydrochloride Extended-Release may be taken without regard to food [see CLINICAL PHARMACOLOGY (12.3)].
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![Hydrocodone Bitartrate And Acetaminophen Tablet [American Health Packaging]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=8752e76c-1220-48b2-b394-7536245707e1&name=DContainer.jpg)
Hydrocodone Bitartrate And Acetaminophen
Omeprazole delayed-release capsules should be taken before eating. In the clinical trials, antacids were used concomitantly with omeprazole.
Patients should be informed that the omeprazole delayed-release capsule should be swallowed whole.
For patients unable to swallow an intact capsule, alternative administration options are available [See Dosage and Administration(2.8)].
2.1 Short-Term Treatment of Active Duodenal Ulcer
The recommended adult oral dose of omeprazole delayed-release capsules is 20 mg once daily. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.
2.2 H. pylori Eradication for the Reduction of the Risk of Duodenal Ulcer Recurrence
Triple Therapy (omeprazole/clarithromycin/amoxicillin) — The recommended adult oral regimen is omeprazole delayed-release capsules 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.
Dual Therapy (omeprazole/clarithromycin) — The recommended adult oral regimen is omeprazole delayed-release capsuels 40 mg once daily plus clarithromycin 500 mg three times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.
2.3 Gastric Ulcer
The recommended adult oral dose is 40 mg once daily for 4 to 8 weeks.
2.4 Gastroesophageal Reflux Disease (GERD)
The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.
2.5 Maintenance of Healing of Erosive Esophagitis
The recommended adult oral dose is 20 mg daily. Controlled studies do not extend beyond 12 months. [SeeClinical Studies(14.4)]
2.6 Pathological Hypersecretory Conditions
The dosage of omeprazole delayed-release capsules in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with omeprazole delayed-release capsules for more than 5 years.
2.7 Pediatric Patients
For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 2 to 16 years of age is as follows:
Patient Weight Omeprazole Daily Dose10 < 20 kg
10 mg
≥ 20 kg
20 mg
On a per kg basis, the doses of omeprazole required to heal erosive esophagitis in pediatric patients are greater than those for adults.
Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule [See Dosage and Administration (2.8)].
2.8 Alternative Administration Options
Omeprazole is available as a delayed-release capsule.
For patients who have difficulty swallowing capsules, the contents of an omeprazole delayed-release capsule can be added to applesauce. One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the pellets inside the capsule should be carefully emptied on the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the pellets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellets/applesauce mixture should not be stored for future use.
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![Carisoprodol Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=a8d61975-6d26-417e-8d1a-c9949e8970bf&name=carisoprodol-2.jpg)
Carisoprodol
The recommended dose of carisoprodol is 250 mg to 350 mg three times a day and at bedtime. The recommended maximum duration of carisoprodol use is up to two or three weeks.
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![Cephalexin Capsule [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=139646a5-daaa-4d9d-b513-3c1439b9146f&name=cephalexin-fig2.jpg)
Cephalexin
Cephalexin capsules are administered orally.Adults — The adult dosage ranges from 1 to 4 g daily in divided doses. The usual adult dose is 250 mg every 6 hours. For the following infections, a dosage of 500 mg may be administered every 12 hours: streptococcal pharyngitis, skin and skin structure infections, and uncomplicated cystitis in patients over 15 years of age. Cystitis therapy should be continued for 7 to 14 days. For more severe infections or those caused by less susceptible organisms, larger doses may be needed. If daily doses of cephalexin greater than 4 g are required, parenteral cephalosporins, in appropriate doses, should be considered.Pediatric Patients — The usual recommended daily dosage for pediatric patients is 25 to 50 mg/kg in divided doses. For streptococcal pharyngitis in patients over 1 year of age and for skin and skin structure infections, the total daily dose may be divided and administered every 12 hours.In severe infections, the dosage may be doubled.In the therapy of otitis media, clinical studies have shown that a dosage of 75 to 100 mg/kg/day in 4 divided doses is required.In the treatment of β-hemolytic streptococcal infections, a therapeutic dosage of cephalexin should be administered for at least 10 days.
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![Carbidopa And Levodopa Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=9b993fc7-e026-4749-b785-cbd3b9c29003&name=image-04.jpg)
Carbidopa And Levodopa
The optimum daily dosage of carbidopa and levodopa tablets USP must be determined by careful titration in each patient. Carbidopa and levodopa tablets USP are available in a 1:4 ratio of carbidopa to levodopa (25 mg/100 mg) as well as 1:10 ratio (25 mg/250 mg and 10 mg/100 mg). Tablets of the two ratios may be given separately or combined as needed to provide the optimum dosage.
Studies show that peripheral dopa decarboxylase is saturated by carbidopa at approximately 70 to 100 mg a day. Patients receiving less than this amount of carbidopa are more likely to experience nausea and vomiting.
Usual Initial Dosage
Dosage is best initiated with one carbidopa and levodopa tablet USP, 25 mg/100 mg three times a day. This dosage schedule provides 75 mg of carbidopa per day. Dosage may be increased by one tablet every day or every other day, as necessary, until a dosage of eight carbidopa and levodopa tablets USP, 25 mg/100 mg a day is reached.
If carbidopa and levodopa tablets USP, 10 mg/100 mg are used, dosage may be initiated with one tablet three or four times a day. However, this will not provide an adequate amount of carbidopa for many patients. Dosage may be increased by one tablet every day or every other day until a total of eight tablets (2 tablets q.i.d.) is reached.
How to Transfer Patients From Levodopa
Levodopa must be discontinued at least twelve hours before starting this combination product. A daily dosage of carbidopa and levodopa tablets USP should be chosen that will provide approximately 25% of the previous levodopa dosage. Patients who are taking less than 1500 mg of levodopa a day should be started on one carbidopa and levodopa tablet USP, 25 mg/100 mg three or four times a day. The suggested starting dosage for most patients taking more than 1500 mg of levodopa is one carbidopa and levodopa tablet USP, 25 mg/250 mg three or four times a day.
Maintenance
Therapy should be individualized and adjusted according to the desired therapeutic response. At least 70 to 100 mg of carbidopa per day should be provided. When a greater proportion of carbidopa is required, one carbidopa and levodopa tablet USP, 25 mg/100 mg may be substituted for each carbidopa and levodopa tablet USP, 10 mg/100 mg. When more levodopa is required, each carbidopa and levodopa tablet USP, 25 mg/250 mg should be substituted for a carbidopa and levodopa tablet USP, 25 mg/100 mg or a carbidopa and levodopa tablet USP, 10 mg/100 mg. If necessary, the dosage of carbidopa and levodopa tablets USP, 25 mg/250 mg may be increased by one-half or one tablet every day or every other day to a maximum of eight tablets a day. Experience with total daily dosages of carbidopa greater than 200 mg is limited.
Because both therapeutic and adverse responses occur more rapidly with this combination product than with levodopa alone, patients should be monitored closely during the dose adjustment period. Specifically, involuntary movements will occur more rapidly with carbidopa and levodopa than with levodopa. The occurrence of involuntary movements may require dosage reduction. Blepharospasm may be a useful early sign of excess dosage in some patients.
Addition of Other Antiparkinsonian Medications
Standard drugs for Parkinson’s disease, other than levodopa without a decarboxylase inhibitor, may be used concomitantly while carbidopa and levodopa therapy is being administered, although dosage adjustments may be required.
Interruption of Therapy
Sporadic cases of hyperpyrexia and confusion have been associated with dose reductions and withdrawal of carbidopa and levodopa tablets USP. Patients should be observed carefully if abrupt reduction or discontinuation of carbidopa and levodopa tablets USP is required, especially if the patient is receiving neuroleptics (see WARNINGS).
If general anesthesia is required, carbidopa and levodopa therapy may be continued as long as the patient is permitted to take fluids and medication by mouth. If therapy is interrupted temporarily, the patient should be observed for symptoms resembling NMS, and the usual daily dosage may be administered as soon as the patient is able to take oral medication.
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![Cetirizine Hydrochloride Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=3fc53b32-704b-4586-aa8c-26a2a71a155a&name=image-01.jpg)
Cetirizine Hydrochloride
Adults and children 6 years and over
one 10 mg tablet once daily, do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less sever symptoms.
Adults 65 years and over
Ask a doctor
Children under 6 years of age
Ask a doctor
Consumers with liver or kidney disease
Ask a doctor
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![Cephalexin Capsule [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=88c0130e-d901-43da-bd37-14704be586d5&name=1b102629-ae66-4455-8d26-4aff82e5f933-03.jpg)
Cephalexin
Cephalexin is administered orally.
Adults: The adult dosage ranges from 1 to 4 g daily in divided doses. The usual adult dose is 250 mg every 6 hours. For the following infections, a dosage of 500 mg may be administered every 12 hours: streptococcal pharyngitis, skin and skin structure infections, and uncomplicated cystitis in patients over 15 years of age. Cystitis therapy should be continued for 7 to 14 days. For more severe infections or those caused by less susceptible organisms, larger doses may be needed. If daily doses of cephalexin greater than 4 g are required, parenteral cephalosporins, in appropriate doses, should be considered.
Pediatric Patients: The usual recommended daily dosage for pediatric patients is 25 to 50 mg/kg in divided doses. For streptococcal pharyngitis in patients over 1 year of age and for skin and skin structure infections, the total daily dose may be divided and administered every 12 hours.
In severe infections, the dosage may be doubled.
In the therapy of otitis media, clinical studies have shown that a dosage of 75 to 100 mg/kg/day in 4 divided doses is required.
In the treatment of ß-hemolytic streptococcal infections, a therapeutic dosage of cephalexin should be administered for at least 10 days.
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![Cephalexin Capsule [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=981e3b45-0fd0-4198-a6e0-fead314c85a9&name=981e3b45-0fd0-4198-a6e0-fead314c85a9-02.jpg)
Cephalexin
Cephalexin capsules, USP are administered orally.
Adults — The adult dosage ranges from 1 to 4 g daily in divided doses. The usual adult dose is 250 mg every 6 hours. For the following infections, a dosage of 500 mg may be administered every 12 hours: streptococcal pharyngitis, skin and skin structure infections, and uncomplicated cystitis in patients over 15 years of age. Cystitis therapy should be continued for 7 to 14 days. For more severe infections or those caused by less susceptible organisms, larger doses may be needed. If daily doses of cephalexin capsule, USP greater than 4 g are required, parenteral cephalosporins, in appropriate doses, should be considered.
Pediatric Patients — The usual recommended daily dosage for pediatric patients is 25 to 50 mg/kg in divided doses. For streptococcal pharyngitis in patients over 1 year of age and for skin and skin structure infections, the total daily dose may be divided and administered every 12 hours.
In severe infections, the dosage may be doubled.
In the therapy of otitis media, clinical studies have shown that a dosage of 75 to 100 mg/kg/day in 4 divided doses is required.
In the treatment of β‑hemolytic streptococcal infections, a therapeutic dosage of cephalexin capsules should be administered for at least 10 days.
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![Up And Up Nicotine Polacrilex (Nicotine Polacrilex) Lozenge [Target Corporation]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=108c9168-c33d-47e8-89a9-0d8ec9d45ce6&name=3665d266-c322-45b4-9e56-caa6035b092c-03.jpg)
Up And Up Nicotine Polacrilex
The recommended dosage regimen for the treatment of bacterial conjunctivitis is:
Days 1 and 2 Instill one to two drops every two to four hours in the affected eye(s).
Days 3 through 7 Instill one to two drops four times daily.
The recommended dosage regimen for the treatment of bacterial corneal ulcer is:
Days 1 and 2 Instill one to two drops into the affected eye every 30 minutes, while awake.
Awaken at approximately four and six hours after retiring and instill one to two drops.
Days 3 through 7 to 9 Instill one to two drops hourly, while awake.
Days 7 to 9 through Instill one to two drops, four times daily.treatment completion
DO NOT USE IF IMPRINTED “Protective Seal” WITH YELLOW IS NOT INTACT.
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![Cefuroxime Axetil Tablet, Film Coated [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=bb93e48c-b988-4eac-83d5-1c82aeb951d1&name=cefaxetiltablets-figure-01.jpg)
Cefuroxime Axetil
NOTE: CEFUROXIME AXETIL TABLETS AND CEFUROXIME AXETIL FOR ORAL SUSPENSION ARE NOT BIOEQUIVALENT AND ARE NOT SUBSTITUTABLE ON A MILLIGRAM-PER-MILLIGRAM BASIS (SEE CLINICAL PHARMACOLOGY).
Table 4. Cefuroxime Axetil Tablets(May be administered without regard to meals.) *The safety and effectiveness of Cefuroxime Axetil Tablets administered for less than 10 days in patients with acute exacerbations of chronic bronchitis have not been established.Population/Infection
Dosage
Duration (days)
Adolescents and Adults (13 years and older)
Pharyngitis/tonsillitisAcute bacterial maxillary sinusitisAcute bacterial exacerbations of chronic bronchitis Secondary bacterial infections of acute bronchitis Uncomplicated skin and skin-structure infections Uncomplicated urinary tract infectionsUncomplicated gonorrhea Early Lyme disease
250 mg b.i.d.250 mg b.i.d.250 or 500 mg b.i.d.250 or 500 mg b.i.d.250 or 500 mg b.i.d.125 or 250 mg b.i.d.1,000 mg once500 mg b.i.d.
101010*5-10107-10single dose20
Pediatric Patients (who can swallow tablets whole)
Acute otitis media Acute bacterial maxillary sinusitis
250 mg b.i.d.250 mg b.i.d.
1010
Patients with Renal Failure
The safety and efficacy of cefuroxime axetil in patients with renal failure have not been established. Since cefuroxime is renally eliminated, its half-life will be prolonged in patients with renal failure.
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![Betamethasone Dipropionate Cream [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=5683885d-461c-4e7e-bbe8-dc231d706192&name=24300c32-d6e9-41e1-bda5-5c8438ad8114-02.jpg)
Betamethasone Dipropionate
Apply a thin film of Betamethasone Dipropionate Cream (Augmented), 0.05% to the affected skin areas once or twice daily. Treatment with Betamethasone Dipropionate Cream (Augmented), 0.05% should be limited to 45 g per week.
Betamethasone Dipropionate Cream (Augmented), 0.05% is not to be used with occlusive dressings.
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![Citalopram Hydrobromide Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=b52acd68-fed1-4680-9eaf-b72e7dcba6fb&name=citalopram-figure-04.jpg)
Citalopram Hydrobromide
Citalopram tablets should be administered once daily, in the morning or evening, with or without food.
Initial Treatment
Citalopram tablets (citalopram HBr) should be administered at an initial dose of 20 mg once daily, with an increase to a maximum dose of 40 mg/day at an interval of no less than one week. Doses above 40 mg/day are not recommended due to the risk of QT prolongation. Additionally, the only study pertinent to dose response for effectiveness did not demonstrate an advantage for the 60 mg/day dose over the 40 mg/day dose.
Special Populations
20 mg/day is the maximum recommended dose for patients who are greater than 60 years of age, patients with hepatic impairment, and for CYP2C19 poor metabolizers or those patients taking cimetidine or another CYP2C19 inhibitor. (see WARNINGS)
No dosage adjustment is necessary for patients with mild or moderate renal impairment. Citalopram should be used with caution in patients with severe renal impairment.
Treatment of Pregnant Women During the Third Trimester
Neonates exposed to citalopram and other SSRIs or SNRIs, late in the third trimester, have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding (see PRECAUTIONS). When treating pregnant women with citalopram during the third trimester, the physician should carefully consider the potential risks and benefits of treatment.
Maintenance Treatment
It is generally agreed that acute episodes of depression require several months or longer of sustained pharmacologic therapy. Systematic evaluation of citalopram in two studies has shown that its antidepressant efficacy is maintained for periods of up to 24 weeks following 6 or 8 weeks of initial treatment (32 weeks total). In one study, patients were assigned randomly to placebo or to the same dose of citalopram (20-60 mg/day) during maintenance treatment as they had received during the acute stabilization phase, while in the other study, patients were assigned randomly to continuation of citalopram 20 or 40 mg/day, or placebo, for maintenance treatment. In the latter study, the rates of relapse to depression were similar for the two dose groups (see Clinical Trials under CLINICAL PHARMACOLOGY). Based on these limited data, it is not known whether the dose of citalopram needed to maintain euthymia is identical to the dose needed to induce remission. If adverse reactions are bothersome, a decrease in dose to 20 mg/day can be considered.
Discontinuation of Treatment with Citalopram
Symptoms associated with discontinuation of citalopram and other SSRIs and SNRIs have been reported (see PRECAUTIONS). Patients should be monitored for these symptoms when discontinuing treatment. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate.
Switching a Patient To or From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders
At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with citalopram. Conversely, at least 14 days should be allowed after stopping citalopram before starting an MAOI intended to treat psyachiatric disorders (see CONTRAINDICATIONS).
Use of citalopram with Other MAOIs, Such as Linezolid or Methylene Blue
Do not start citalopram in a patient who is being treated with linezolid or intravenous methylene blue because there is an increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered (see CONTRAINDICATIONS).
In some cases, a patient already receiving citalopram therapy may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, citalopram should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for 2 weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with citalopram may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue (see WARNINGS).
The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with citalopram is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use (see WARNINGS).
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![Clobetasol Propionate Cream [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=bb220bb0-8b82-4acf-87ac-9ac8c3c66d25&name=clobetasol-03.jpg)
Clobetasol Propionate
Apply a thin layer of clobetasol propionate gel, cream or ointment to the affected skin areas twice daily and rub in gently and completely. (See INDICATIONS AND USAGE.)
Clobetasol propionate gel, cream and ointment are super-high potency topical corticosteroids; therefore, treatment should be limited to 2 consecutive weeks, and amounts greater than 50 g per week should not be used.
As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.
Clobetasol propionate gel, cream or ointment should not be used with occlusive dressings.
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![Clonazepam Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=4d586471-8b20-4899-94ad-31e0a519e99e&name=43a9ccda-d479-4a45-a5f3-89ad4690d4a5-04.jpg)
Clonazepam
Clonazepam tablets should be administered with water by swallowing the tablet whole.
Seizure Disorders: Adults: The initial dose for adults with seizure disorders should not exceed 1.5 mg/day divided into three doses. Dosage may be increased in increments of 0.5 to
1 mg every 3 days until seizures are adequately controlled or until side effects preclude any further increase. Maintenance dosage must be individualized for each patient depending upon response. Maximum recommended daily dose is 20 mg.
The use of multiple anticonvulsants may result in an increase of depressant adverse effects. This should be considered before adding clonazepam to an existing anticonvulsant regimen.
Pediatric Patients: Clonazepam is administered orally. In order to minimize drowsiness, the initial dose for infants and children (up to 10 years of age or 30 kg of body weight) should be between 0.01 and 0.03 mg/kg/day but not to exceed 0.05 mg/kg/day given in two or three divided doses. Dosage should be increased by no more than 0.25 to 0.5 mg every third day until a daily maintenance dose of 0.1 to 0.2 mg/kg of body weight has been reached, unless seizures are controlled or side effects preclude further increase. Whenever possible, the daily dose should be divided into three equal doses. If doses are not equally divided, the largest dose should be given before retiring.
Geriatric Patients: There is no clinical trial experience with clonazepam in seizure disorder patients 65 years of age and older. In general, elderly patients should be started on low doses of clonazepam and observed closely (see PRECAUTIONS: Geriatric Use).
Panic Disorder: Adults: The initial dose for adults with panic disorder is 0.25 mg bid. An increase to the target dose for most patients of 1 mg/day may be made after 3 days. The recommended dose of 1 mg/day is based on the results from a fixed dose study in which the optimal effect was seen at 1 mg/day. Higher doses of 2, 3 and 4 mg/day in that study were less effective than the 1 mg/day dose and were associated with more adverse effects. Nevertheless, it is possible that some individual patients may benefit from doses of up to a maximum dose of 4 mg/day, and in those instances, the dose may be increased in increments of 0.125 to 0.25 mg bid every 3 days until panic disorder is controlled or until side effects make further increases undesired. To reduce the inconvenience of somnolence, administration of one dose at bedtime may be desirable.
Treatment should be discontinued gradually, with a decrease of 0.125 mg bid every 3 days, until the drug is completely withdrawn.
There is no body of evidence available to answer the question of how long the patient treated with clonazepam should remain on it. Therefore, the physician who elects to use clonazepam for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.
Pediatric Patients: There is no clinical trial experience with clonazepam in panic disorder patients under 18 years of age.
Geriatric Patients: There is no clinical trial experience with clonazepam in panic disorder patients 65 years of age and older. In general, elderly patients should be started on low doses of clonazepam and observed closely (see PRECAUTIONS: Geriatric Use).
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![Clobetasol Propionate Cream [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=109b741f-624e-455c-97ff-2ad0034182df&name=f2bd30cb-4acf-46a4-b1ef-014d74f4d9f1-02.jpg)
Clobetasol Propionate
Apply a thin layer of clobetasol propionate cream or ointment to the affected skin areas twice daily and rub in gently and completely (see INDICATIONS AND USAGE).
Clobetasol propionate cream and ointment are super-high potency topical corticosteroids; therefore, treatment should be limited to 2 consecutive weeks and amounts greater than 50 g/week should not be used.
As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.
Clobetasol propionate cream and ointment should not be used with occlusive dressings.
Geriatric Use
In studies where geriatric patients (65 years of age or older, see PRECAUTIONS) have been treated with clobetasol propionate cream or ointment, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended.
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![Clobetasol Propionate Ointment [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=d33126cb-f912-4b86-a7e7-54031dd06ebf&name=d33126cb-f912-4b86-a7e7-54031dd06ebf-02.jpg)
Clobetasol Propionate Ointment
Apply a thin layer of clobetasol propionate gel, cream or ointment to the affected skin areas twice daily and rub in gently and completely. (See INDICATIONS AND USAGE.)
Clobetasol propionate gel, cream and ointment are super-high potency topical corticosteroids; therefore, treatment should be limited to 2 consecutive weeks, and amounts greater than 50 g per week should not be used.
As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.
Clobetasol propionate gel, cream and ointment should not be used with occlusive dressings.
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![Metronidazole Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=799a763f-7a70-4351-aa75-c96c1e44cbbf&name=MetronidazoleTablets,USP250mg.jpg)
Metronidazole
Trichomoniasis:
In the Female:
One-day treatment -two grams of Metronidazole Tablets, given either as a single dose or in two divided doses of one gram each given in the same day.
Seven-day course of treatment -250 mg three times daily for seven consecutive days. There is some indication from controlled comparative studies that cure rates as determined by vaginal smears and signs and symptoms, may be higher after a seven-day course of treatment than after a one-day treatment regimen.
The dosage regimen should be individualized. Single-dose treatment can assure compliance, especially if administered under supervision, in those patients who cannot be relied on to continue the seven-day regimen. A seven-day course of treatment may minimize reinfection by protecting the patient long enough for the sexual contacts to obtain appropriate treatment. Further, some patients may tolerate one treatment regimen better than the other.
Pregnant patients should not be treated during the first trimester. (see CONTRAINDICATIONS) In pregnant patients in whom alternative treatment has been inadequate, the one-day course of therapy should not be used, as it results in higher serum levels which can reach the fetal circulation (see PRECAUTIONS, Pregnancy).
When repeat courses of the drug are required, it is recommended that an interval of four to six weeks elapse between courses and that the presence of the trichomonad be reconfirmed by appropriate laboratory measures. Total and differential leukocyte counts should be made before and after re-treatment.
In the Male: Treatment should be individualized as for the female.
Amebiasis:
Adults:
For acute intestinal amebiasis (acute amebic dysentery): 750 mg orally three times daily for 5 to 10 days.
For amebic liver abscess: 500 mg or 750 mg orally three times daily for 5 to 10 days.
Pediatric patients: 35 to 50 mg/kg/24 hours, divided into three doses, orally for 10 days.
Anaerobic Bacterial Infections
In the treatment of most serious anaerobic infections, intravenous metronidazole is usually administered initially.
The usual adult oral dosage is 7.5 mg/kg every six hours (approx. 500 mg for a 70-kg adult). A maximum of 4 g should not be exceeded during a 24-hour period.
The usual duration of therapy is 7 to 10 days; however, infections of the bone and joint, lower respiratory tract, and endocardium may require longer treatment.
Dosage Adjustments
Patients with Severe Hepatic Impairment
For patients with severe hepatic impairment (Child-Pugh C), the dose of metronidazole tablets should be reduced by 50% (see CLINICAL PHARMACOLOGY and PRECAUTIONS).
Patients Undergoing Hemodialysis:
Hemodialysis removes significant amounts of metronidazole and its metabolites from systemic circulation. The clearance of metronidazole will depend on the type of dialysis membrane used, the duration of the dialysis session, and other factors. If the administration of metronidazole cannot be separated from the hemodialysis session, supplementation of metronidazole dosage following the hemodialysis session should be considered, depending on the patient’s clinical situation (see CLINICAL PHARMACOLOGY).
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![Clonazepam Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=198df9a6-1567-45ac-81f7-704737fe9f44&name=198df9a6-1567-45ac-81f7-704737fe9f44-02.jpg)
Clonazepam
Clonazepam is available as a tablet. The tablets should be administered with water by swallowing the tablet whole.
Seizure Disorders:
Adults:
The initial dose for adults with seizure disorders should not exceed 1.5 mg/day divided into three doses. Dosage may be increased in increments of 0.5 to 1 mg every 3 days until seizures are adequately controlled or until side effects preclude any further increase. Maintenance dosage must be individualized for each patient depending upon response. Maximum recommended daily dose is 20 mg.
The use of multiple anticonvulsants may result in an increase of depressant adverse effects. This should be considered before adding clonazepam to an existing anticonvulsant regimen.
Pediatric Patients:
Clonazepam is administered orally. In order to minimize drowsiness, the initial dose for infants and children (up to 10 years of age or 30 kg of body weight) should be between 0.01 and 0.03 mg/kg/day but not to exceed 0.05 mg/kg/day given in two or three divided doses. Dosage should be increased by no more than 0.25 to 0.5 mg every third day until a daily maintenance dose of 0.1 to 0.2 mg/kg of body weight has been reached, unless seizures are controlled or side effects preclude further increase. Whenever possible, the daily dose should be divided into three equal doses. If doses are not equally divided, the largest dose should be given before retiring.
Geriatric Patients:
There is no clinical trial experience with clonazepam in seizure disorder patients 65 years of age and older. In general, elderly patients should be started on low doses of clonazepam and observed closely (see PRECAUTIONS: Geriatric Use).
Panic Disorder:
Adults:
The initial dose for adults with panic disorder is 0.25 mg bid. An increase to the target dose for most patients of 1 mg/day may be made after 3 days. The recommended dose of 1 mg/day is based on the results from a fixed dose study in which the optimal effect was seen at 1 mg/day. Higher doses of 2, 3 and 4 mg/day in that study were less effective than the 1 mg/day dose and were associated with more adverse effects. Nevertheless, it is possible that some individual patients may benefit from doses of up to a maximum dose of 4 mg/day, and in those instances, the dose may be increased in increments of 0.125 to 0.25 mg bid every 3 days until panic disorder is controlled or until side effects make further increases undesired. To reduce the inconvenience of somnolence, administration of one dose at bedtime may be desirable.
Treatment should be discontinued gradually, with a decrease of 0.125 mg bid every 3 days, until the drug is completely withdrawn.
There is no body of evidence available to answer the question of how long the patient treated with clonazepam should remain on it. Therefore, the physician who elects to use clonazepam for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
Pediatric Patients:
There is no clinical trial experience with clonazepam in panic disorder patients under 18 years of age.
Geriatric Patients:
There is no clinical trial experience with clonazepam in panic disorder patients 65 years of age and older. In general, elderly patients should be started on low doses of clonazepam and observed closely (see PRECAUTIONS: Geriatric Use).
Seizure Disorders:
Adults:
The initial dose for adults with seizure disorders should not exceed 1.5 mg/day divided into three doses. Dosage may be increased in increments of 0.5 to 1 mg every 3 days until seizures are adequately controlled or until side effects preclude any further increase. Maintenance dosage must be individualized for each patient depending upon response. Maximum recommended daily dose is 20 mg.
The use of multiple anticonvulsants may result in an increase of depressant adverse effects. This should be considered before adding clonazepam to an existing anticonvulsant regimen.
Pediatric Patients:
Clonazepam is administered orally. In order to minimize drowsiness, the initial dose for infants and children (up to 10 years of age or 30 kg of body weight) should be between 0.01 and 0.03 mg/kg/day but not to exceed 0.05 mg/kg/day given in two or three divided doses. Dosage should be increased by no more than 0.25 to 0.5 mg every third day until a daily maintenance dose of 0.1 to 0.2 mg/kg of body weight has been reached, unless seizures are controlled or side effects preclude further increase. Whenever possible, the daily dose should be divided into three equal doses. If doses are not equally divided, the largest dose should be given before retiring.
Geriatric Patients:
There is no clinical trial experience with clonazepam in seizure disorder patients 65 years of age and older. In general, elderly patients should be started on low doses of clonazepam and observed closely (see PRECAUTIONS: Geriatric Use).
Adults:
The initial dose for adults with seizure disorders should not exceed 1.5 mg/day divided into three doses. Dosage may be increased in increments of 0.5 to 1 mg every 3 days until seizures are adequately controlled or until side effects preclude any further increase. Maintenance dosage must be individualized for each patient depending upon response. Maximum recommended daily dose is 20 mg.
The use of multiple anticonvulsants may result in an increase of depressant adverse effects. This should be considered before adding clonazepam to an existing anticonvulsant regimen.
Panic Disorder:
Adults:
The initial dose for adults with panic disorder is 0.25 mg bid. An increase to the target dose for most patients of 1 mg/day may be made after 3 days. The recommended dose of 1 mg/day is based on the results from a fixed dose study in which the optimal effect was seen at 1 mg/day. Higher doses of 2, 3 and 4 mg/day in that study were less effective than the 1 mg/day dose and were associated with more adverse effects. Nevertheless, it is possible that some individual patients may benefit from doses of up to a maximum dose of 4 mg/day, and in those instances, the dose may be increased in increments of 0.125 to 0.25 mg bid every 3 days until panic disorder is controlled or until side effects make further increases undesired. To reduce the inconvenience of somnolence, administration of one dose at bedtime may be desirable.
Treatment should be discontinued gradually, with a decrease of 0.125 mg bid every 3 days, until the drug is completely withdrawn.
There is no body of evidence available to answer the question of how long the patient treated with clonazepam should remain on it. Therefore, the physician who elects to use clonazepam for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
Pediatric Patients:
There is no clinical trial experience with clonazepam in panic disorder patients under 18 years of age.
Geriatric Patients:
There is no clinical trial experience with clonazepam in panic disorder patients 65 years of age and older. In general, elderly patients should be started on low doses of clonazepam and observed closely (see PRECAUTIONS: Geriatric Use).
Adults:
The initial dose for adults with panic disorder is 0.25 mg bid. An increase to the target dose for most patients of 1 mg/day may be made after 3 days. The recommended dose of 1 mg/day is based on the results from a fixed dose study in which the optimal effect was seen at 1 mg/day. Higher doses of 2, 3 and 4 mg/day in that study were less effective than the 1 mg/day dose and were associated with more adverse effects. Nevertheless, it is possible that some individual patients may benefit from doses of up to a maximum dose of 4 mg/day, and in those instances, the dose may be increased in increments of 0.125 to 0.25 mg bid every 3 days until panic disorder is controlled or until side effects make further increases undesired. To reduce the inconvenience of somnolence, administration of one dose at bedtime may be desirable.
Treatment should be discontinued gradually, with a decrease of 0.125 mg bid every 3 days, until the drug is completely withdrawn.
There is no body of evidence available to answer the question of how long the patient treated with clonazepam should remain on it. Therefore, the physician who elects to use clonazepam for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
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![Virtussin Ac (Codeine Phosphate And Guaifenesin) Liquid [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=fe6ed22b-f41f-4fae-9092-6c1253e09bd6&name=image-01.jpg)
Virtussin Ac
• do not exceed 6 doses in 24 hours.
Adults and children 12 years of age and over:
2 tsp (10 mL) every 4 hours, or as directed by a doctor.
Children 6 to under 12 years of age:
1 tsp (5 mL) every 4 hours, or as directed by a doctor.
Children under 6 years of age:
Consult a doctor.
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![Levothyroxine Sodium Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=cadf4802-b53f-419c-a775-82af525887e4&name=image-01.jpg)
Levothyroxine Sodium
General Principles
The goal of replacement therapy is to achieve and maintain a clinical and biochemical euthyroid state. The goal of suppressive therapy is to inhibit growth and/or function of abnormal thyroid tissue. The dose of Levothyroxine sodium tablets, USP that is adequate to achieve these goals depends on a variety of factors including the patient’s age, body weight, cardiovascular status, concomitant medical conditions, including pregnancy, concomitant medications, and the specific nature of the condition being treated (see WARNINGS and PRECAUTIONS). Hence, the following recommendations serve only as dosing guidelines. Dosing must be individualized and adjustments made based on periodic assessment of the patient’s clinical response and laboratory parameters (see PRECAUTIONS, Laboratory Tests).
Levothyroxine sodium tablets, USP are administered as a single daily dose, preferably one-half to one-hour before breakfast. Levothyroxine sodium tablets, USP should be taken at least 4 hours apart from drugs that are known to interfere with its absorption (see PRECAUTIONS, Drug Interactions). Levothyroxine sodium tablets, USP should be taken with a full glass of water, (see Information for Patients).
Due to the long half-life of levothyroxine, the peak therapeutic effect at a given dose of Levothyroxine sodium tablets, USP may not be attained for 4-6 weeks.
Caution should be exercised when administering Levothyroxine sodium tablets, USP to patients with underlying cardiovascular disease, to the elderly, and to those with concomitant adrenal insufficiency (see PRECAUTIONS).
Specific Patient Populations
Hypothyroidism in Adults and in Children in Whom Growth and Puberty are Complete (see WARNINGS and PRECAUTIONS, Laboratory Tests)
Therapy may begin at full replacement doses in otherwise healthy individuals who are at low risk of coronary artery disease. The average full replacement dose of levothyroxine sodium is approximately 1.7 mcg/kg/day (e.g., 100-125 mcg/day for a 70 kg adult). Older patients may require less than 1 mcg/kg/day. Levothyroxine sodium doses greater than 200 mcg/day are seldom required. An inadequate response to daily doses ≥ 300 mcg/day is rare and may indicate poor compliance, malabsorption, and/or drug interactions.
For most patients older than 50 years or for patients under 50 years of age with underlying cardiac disease, an initial starting dose of 25-50 mcg/day of levothyroxine sodium is recommended, with gradual increments in dose at 6-8 week intervals, as needed. The recommended starting dose of levothyroxine sodium in elderly patients with cardiac disease is 12.5-25 mcg/day, with gradual dose increments at 4-6 week intervals. The levothyroxine sodium dose is generally adjusted in 12.5-25 mcg increments until the patient with primary hypothyroidism is clinically euthyroid and the serum TSH has normalized.
In patients with severe hypothyroidism, the recommended initial levothyroxine sodium dose is 12.5-25 mcg/day with increases of 25 mcg/day every 2-4 weeks, accompanied by clinical and laboratory assessment, until the TSH level is normalized.
In patients with secondary (pituitary) or tertiary (hypothalamic) hypothyroidism, the levothyroxine sodium dose should be titrated until the patient is clinically euthyroid and the serum free-T4 level is restored to the upper half of the normal range.
Pediatric Dosage – Congenital or Acquired Hypothyroidism (see PRECAUTIONS, Laboratory Tests)
General Principles
In general, levothyroxine therapy should be instituted at full replacement doses as soon as possible. Delays in diagnosis and institution of therapy may have deleterious effects on the child’s intellectual and physical growth and development.
Undertreatment and overtreatment should be avoided (see PRECAUTIONS, Pediatric Use).
Levothyroxine sodium tablets, USP may be administered to infants and children who cannot swallow intact tablets by crushing the tablet and suspending the freshly crushed tablet in a small amount (5-10 mL or 1-2 teaspoons) of water. This suspension can be administered by spoon or dropper. DO NOT STORE THE SUSPENSION. Foods that decrease absorption of levothyroxine, such as soybean infant formula, should not be used for administering levothyroxine sodium tablets (see PRECAUTIONS , Drug-Food Interactions).
Newborns
The recommended starting dose of levothyroxine sodium in newborn infants is 10-15 mcg/kg/day. A lower starting dose (e.g., 25 mcg/day) should be considered in infants at risk for cardiac failure, and the dose should be increased in 4-6 weeks as needed based on clinical and laboratory response to treatment. In infants with very low (< 5 mcg/dL) or undetectable serum T4 concentrations, the recommended initial starting dose is 50 mcg/day of levothyroxine sodium.
Infants and Children
Levothyroxine therapy is usually initiated at full replacement doses, with the recommended dose per body weight decreasing with age (see Table 3). However, in children with chronic or severe hypothyroidism, an initial dose of 25 mcg/day of levothyroxine sodium is recommended with increments of 25 mcg every 2-4 weeks until the desired effect is achieved.
Hyperactivity in an older child can be minimized if the starting dose is one-fourth of the recommended full replacement dose, and the dose is then increased on a weekly basis by an amount equal to one-fourth the full-recommended replacement dose until the full recommended replacement dose is reached.
Table 3: Levothyroxine Sodium Dosing Guidelines for Pediatric HypothyroidismAGE
Daily Dose Per Kg Body Weighta
0-3 months
10-15 mcg/kg/day
3-6 months
8-10 mcg/kg/day
6-12 months
6-8 mcg/kg/day
1-5 years
5-6 mcg/kg/day
6-12 years
4-5 mcg/kg/day
>12 years but growth and puberty incomplete
2-3 mcg/kg/day
Growth and puberty complete
1.7 mcg/kg/day
a The dose should be adjusted based on clinical response and laboratory parameters (see PRECAUTIONS, Laboratory Tests and Pediatric Use).
Pregnancy- Pregnancy may increase levothyroxine requirements (see Pregnancy).
Subclinical Hypothyroidism- If this condition is treated, a lower levothyroxine sodium dose (e.g., 1 mcg/kg/day) than that used for full replacement may be adequate to normalize the serum TSH level. Patients who are not treated should be monitored yearly for changes in clinical status and thyroid laboratory parameters.
TSH Suppression in Well-differentiated Thyroid Cancer and Thyroid Nodules –The target level for TSH suppression in these conditions has not been established with controlled studies. In addition, the efficacy of TSH suppression for benign nodular disease is controversial. Therefore, the dose of Levothyroxine sodium tablets, USP used for TSH suppression should be individualized based on the specific disease and the patient being treated.
In the treatment of well-differentiated (papillary and follicular) thyroid cancer, levothyroxine is used as an adjunct to surgery and radioiodine therapy. Generally, TSH is suppressed to <0.1 mU/L, and this usually requires a levothyroxine sodium dose of greater than 2 mcg/kg/day. However, in patients with high-risk tumors, the target level for TSH suppression may be <0.01 mU/L.
In the treatment of benign nodules and nontoxic multinodular goiter, TSH is generally suppressed to a higher target (e.g., 0.1 to either 0.5 or 1.0 mU/L) than that used for the treatment of thyroid cancer. Levothyroxine sodium is contraindicated if the serum TSH is already suppressed due to the risk of precipitating overt thyrotoxicosis (see CONTRAINDICATIONS, WARNINGS and PRECAUTIONS).
Myxedema Coma – Myxedema coma is a life-threatening emergency characterized by poor circulation and hypometabolism, and may result in unpredictable absorption of levothyroxine sodium from the gastrointestinal tract. Therefore, oral thyroid hormone drug products are not recommended to treat this condition. Intravenous levothyroxine sodium should be administered.
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![Heparin Sodium Injection, Solution [Safecor Health, Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=093d61e0-645f-4ddd-8483-fef855dff764&name=losartan-fig6.jpg)
Heparin Sodium
Adult Hypertensive Patients Losartan potassium tablets USP may be administered with other antihypertensive agents, and with or without food.Dosing must be individualized. The usual starting dose of losartan potassium tablets USP is 50 mg once daily, with 25 mg used in patients with possible depletion of intravascular volume (e.g., patients treated with diuretics) (see WARNINGS, Hypotension ― Volume-Depleted Patients) and patients with a history of hepatic impairment (see PRECAUTIONS, General). Losartan potassium tablets USP can be administered once or twice daily with total daily doses ranging from 25 mg to 100 mg.If the antihypertensive effect measured at trough using once-a-day dosing is inadequate, a twice-a-day regimen at the same total daily dose or an increase in dose may give a more satisfactory response. The effect of losartan is substantially present within one week but in some studies the maximal effect occurred in 3 to 6 weeks (see CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects, Hypertension).If blood pressure is not controlled by losartan potassium tablets USP alone, a low dose of a diuretic may be added. Hydrochlorothiazide has been shown to have an additive effect (see CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects, Hypertension).No initial dosage adjustment is necessary for elderly patients or for patients with renal impairment, including patients on dialysis.Pediatric Hypertensive Patients greater than or equal to 6 years of age The usual recommended starting dose is 0.7 mg/kg once daily (up to 50 mg total) administered as a tablet or a suspension (see Preparation of Suspension). Dosage should be adjusted according to blood pressure response. Doses above 1.4 mg/kg (or in excess of 100 mg) daily have not been studied in pediatric patients. (See CLINICAL PHARMACOLOGY, Pharmacokinetics, Special Populations and Pharmacodynamics and Clinical Effects, and WARNINGS, Hypotension ― Volume-Depleted Patients.)Losartan potassium tablets USP are not recommended in pediatric patients less than 6 years of age or in pediatric patients with glomerular filtration rate less than 30 mL/min/1.73 m2 (see CLINICAL PHARMACOLOGY, Pharmacokinetics, Special Populations, Pharmacodynamics and Clinical Effects, and PRECAUTIONS).
Preparation of Suspension (for 200 mL of a 2.5 mg/mL suspension)
Add 10 mL of Purified Water USP to an 8 ounce (240 mL) amber polyethylene terephthalate (PET) bottle containing ten 50 mg losartan potassium tablets USP. Immediately shake for at least 2 minutes. Let the concentrate stand for 1 hour and then shake for 1 minute to disperse the tablet contents. Separately prepare a 50/50 volumetric mixture of Ora-Plus™ and Ora-Sweet SF™. Add 190 mL of the 50/50 Ora-Plus™/Ora-Sweet SF™ mixture to the tablet and water slurry in the PET bottle and shake for 1 minute to disperse the ingredients. The suspension should be refrigerated at 2 to 8°C (36 to 46°F) and can be stored for up to 4 weeks. Shake the suspension prior to each use and return promptly to the refrigerator.Ora-Plus™ and Ora-Sweet SF™ are the trademarks of Paddock Laboratories, Inc.
Hypertensive Patients with Left Ventricular Hypertrophy
The usual starting dose is 50 mg of losartan potassium tablets USP once daily. Hydrochlorothiazide 12.5 mg daily should be added and/or the dose of losartan potassium tablets USP should be increased to 100 mg once daily followed by an increase in hydrochlorothiazide to 25 mg once daily based on blood pressure response (see CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects, Reduction in the Risk of Stroke).
Nephropathy in Type 2 Diabetic Patients
The usual starting dose is 50 mg once daily. The dose should be increased to 100 mg once daily based on blood pressure response (see CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects, Nephropathy in Type 2 Diabetic Patients). Losartan potassium tablets USP may be administered with insulin and other commonly used hypoglycemic agents (e.g., sulfonylureas, glitazones and glucosidase inhibitors).
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![Escitalopram (Escitalopram Oxalate) Tablet, Film Coated [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=297e889d-d22b-476f-b4d8-3a51636fedd4&name=escitalopram-fig5.jpg)
Escitalopram
Escitalopram tablets should be administered once daily, in the morning or evening, with or without food.
2.1 Major Depressive Disorder
Initial Treatment Adolescents The recommended dose of escitalopram tablets is 10 mg once daily. A flexible-dose trial of escitalopram tablets (10 to 20 mg/day) demonstrated the effectiveness of escitalopram tablets [see Clinical Studies (14.1)]. If the dose is increased to 20 mg, this should occur after a minimum of three weeks.Adults The recommended dose of escitalopram tablets is 10 mg once daily. A fixed-dose trial of escitalopram tablets demonstrated the effectiveness of both 10 mg and 20 mg of escitalopram tablets, but failed to demonstrate a greater benefit of 20 mg over 10 mg [see Clinical Studies (14.1)]. If the dose is increased to 20 mg, this should occur after a minimum of one week.Maintenance Treatment It is generally agreed that acute episodes of major depressive disorder require several months or longer of sustained pharmacological therapy beyond response to the acute episode. Systematic evaluation of continuing escitalopram tablets 10 or 20 mg/day in adults patients with major depressive disorder who responded while taking escitalopram tablets during an 8-week, acute-treatment phase demonstrated a benefit of such maintenance treatment [see Clinical Studies (14.1)]. Nevertheless, the physician who elects to use escitalopram tablets for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient. Patients should be periodically reassessed to determine the need for maintenance treatment.
2.2 Generalized Anxiety Disorder
Initial Treatment Adults The recommended starting dose of escitalopram tablets is 10 mg once daily. If the dose is increased to 20 mg, this should occur after a minimum of one week.Maintenance Treatment Generalized anxiety disorder is recognized as a chronic condition. The efficacy of escitalopram tablets in the treatment of GAD beyond 8 weeks has not been systematically studied. The physician who elects to use escitalopram tablets for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
2.3 Special Populations
10 mg/day is the recommended dose for most elderly patients and patients with hepatic impairment.No dosage adjustment is necessary for patients with mild or moderate renal impairment. Escitalopram tablets should be used with caution in patients with severe renal impairment.
2.4 Discontinuation of Treatment with Escitalopram Tablets
Symptoms associated with discontinuation of escitalopram tablets and other SSRIs and SNRIs have been reported [see Warnings and Precautions (5.3)]. Patients should be monitored for these symptoms when discontinuing treatment. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate.
2.5 Switching a Patient To or From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders
At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with escitalopram tablets. Conversely, at least 14 days should be allowed after stopping escitalopram tablets before starting an MAOI intended to treat psychiatric disorders [see Contraindications (4.1)].
2.6 Use of Escitalopram Tablets with Other MAOIs such as Linezolid or Methylene Blue
Do not start escitalopram tablets in a patient who is being treated with linezolid or intravenous methylene blue because there is an increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered [see Contraindications (4.1)]. In some cases, a patient already receiving escitalopram tablets therapy may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, escitalopram tablets should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for 2 weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with escitalopram tablets may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue [see Warnings and Precautions (5.2)].The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with escitalopram tablets is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use [see Warnings and Precautions (5.2)].
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![Lancome Paris Bienfait Multivital Broad Spectrum Spf 30 Sunscreen 24 Hour Moisturization Antioxidant And Vitamin Enriched (Avobenzone, Octisalate And Octocrylene) Lotion [L’oreal Usa Products Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=47baa471-b3b5-431b-a2e5-e302c4c7a8f8&name=lorazepam-3.jpg)
Lancome Paris Bienfait Multivital Broad Spectrum Spf 30 Sunscreen 24 Hour Moisturization Antioxidant And Vitamin Enriched
Lorazepam is administered orally. For optimal results, dose, frequency of administration, and duration of therapy should be individualized according to patient response. To facilitate this, 0.5 mg, 1 mg, and 2 mg tablets are available.
The usual range is 2 to 6 mg/day given in divided doses, the largest dose being taken before bedtime, but the daily dosage may vary from 1 to 10 mg/day.
For anxiety, most patients require an initial dose of 2 to 3 mg/day given b.i.d. or t.i.d.
For insomnia due to anxiety or transient situational stress, a single daily dose of 2 to 4 mg may be given, usually at bedtime.
For elderly or debilitated patients, an initial dosage of 1 to 2 mg/day in divided doses is recommended, to be adjusted as needed and tolerated.
The dosage of lorazepam should be increased gradually when needed to help avoid adverse effects. When higher dosage is indicated, the evening dose should be increased before the daytime doses.
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