Aspirin

The recommended dose of TRUVADA in adults and in pediatric patients 12 years of age and older with body weight greater than or equal to 35 kg (greater than or equal to 77 lb) is one tablet (containing 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) once daily taken orally with or without food.

The dose of TRUVADA in HIV-1 uninfected adults is one tablet (containing 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) once daily taken orally with or without food.

Treatment of HIV-1 Infection

Significantly increased drug exposures occurred when EMTRIVA or VIREAD were administered to subjects with moderate to severe renal impairment [See EMTRIVA or VIREAD Package Insert]. Therefore, adjust the dosing interval of TRUVADA in HIV-1 infected adult patients with baseline creatinine clearance 30–49 mL/min using the recommendations in Table 1. These dosing interval recommendations are based on modeling of single-dose pharmacokinetic data in non-HIV infected subjects. The safety and effectiveness of these dosing interval adjustment recommendations have not been clinically evaluated in patients with moderate renal impairment, therefore clinical response to treatment and renal function should be closely monitored in these patients [See Warnings and Precautions (5.3)] .

No dose adjustment is necessary for HIV-1 infected patients with mild renal impairment (creatinine clearance 50–80 mL/min). No data are available to make dose recommendations in pediatric patients with renal impairment.No dose adjustment is necessary for HIV-1 infected patients with mild renal impairment (creatinine clearance 50–80 mL/min). No data are available to make dose recommendations in pediatric patients with renal impairment.

Routine monitoring of estimated creatinine clearance, serum phosphorus, urine glucose, and urine protein should be performed in all individuals with mild renal impairment . Routine monitoring of estimated creatinine clearance, serum phosphorus, urine glucose, and urine protein should be performed in all individuals with mild renal impairment [See Warnings and Precautions (5.3)] .

Pre-exposure Prophylaxis

Do not use TRUVADA for a PrEP indication in HIV-1 uninfected individuals with estimated creatinine clearance below 60 mL/min [See Warnings and Precautions (5.3)] .

Routine monitoring of estimated creatinine clearance, serum phosphorus, urine glucose, and urine protein should be performed in all individuals with mild renal impairment. If a decrease in estimated creatinine clearance is observed in uninfected individuals while using TRUVADA for PrEP, evaluate potential causes and re-assess potential risks and benefits of continued use [See Warnings and Precautions (5.3)] .

drink a full glass of water with each doseadults 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 doctorchildren under 12 years: consult a doctor

■ drink a full glass of water with each does ■ adults and children 12 years and over: take 1 to 2 tablets every 4 hours not to exceed 12 tablets in 24 hours unless directed by a doctor ■ children under 12 years: consult a doctor

There is currently no dosage information available for this product. We apologize for any inconvenience.

Adults and childre: (12 years and older)

Take 1 or 2 tablets with water every 4 hours as needed. Do not take more than 12 tablets in 24 hours, or as directed by a doctor.

Children under 12 years:

Do not give to children under 12 years of age.

■ drink a full glass of water with each does ■ adults: 1 to 2 tablets with water. Dosage may be repeated every 4 hours, not to exceed 12 tablets in 24 hours. ■ children under 12: consult a doctor.

■ drink a full glass of water with each does ■ 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

Adults and children: ( 12 years and older) Take 1 or 2 tablets with water every 4 hours as needed. Do not take more than 12 tablets in 24 hours, or as directed by a doctor.

Children under 12 years: Do not give to children under 12 years of age.

Administer orally 1/2 to 1 1/2 boluses to mature beef cattle, dairy cattle and horses two to three times daily and 1/2 bolus to calves and foals two times daily. Lubricate each bolus with mineral oil prior to oral administration. Discontinue treatment if any unusual symptoms should appear. Allow animals ample supply of fresh, clean water after administration.

Drink with a full glass of water with each dose

OTHER INFORMATION

Store at 15°-30°C (59°-86°F). Do not use if imprinted seal under cap is missing or damaged.

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.

■ drink a full glass of water with each dose ■ adults and children 12 years and over: take 1 to 2 tablets every 4 hours not to exceed 12 tablets in 24 hours unless directed by a doctor ■ Children under 12 years: consult a doctor

Drink a full glass of water with each dose. Swallow whole; do not chew or crush. Do not exceed recommend 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: ask a doctor.

■ to be administered only under adult supervision ■ if possible use weight to dose, otherwise use age ■ repeat every 4 hours, while symptoms persist, up to a maximum of five doses in 24 hours or as directed by a doctor ■ drink a full glass of water with each does

■ drink a full glass of water with each does ■ adults and children 12 years and over: take 1 to 2 tablets every 4 hours not to exceed 12 tablets in 24 hours unless directed by a doctor ■ children under 12 years: consult a doctor

drink a full glass of water with each dose

Vaginal candidiasis:  The recommended dosage of fluconazole for vaginal candidiasis is 150 mg as a single oral 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.

The following dose equivalency scheme should generally provide equivalent exposure in pediatric and adult patients:

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.

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: 

Patients on regular dialysis should receive 100% of the recommended dose after each dialysis; on non-dialysis days, patients should receive a reduced dose according to their creatinine clearance.

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 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     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.)

Fluconazole tablets are administered orally. Fluconazole tablets can be taken with or without food.

DOSE: Administer orally.  To mature horses and cattle give 6 - 12 tablets; to foals and calves 2 to 4 tablets; to sheep and swine, 1/4 to 1 tablet, as indicated.  Allow animals to drink water after administration.

Administer orally.

Cattle, Horses: 5 - 60 gm (0.2 oz.)
Calves, Foals:  0.5 - 6.0 gm
Sheep, Swine:  1 - 3 gm
Poultry:  0.15% Level in Ration

Mature Horses and Cattle, administer orally 1 to 3 Boluses two to three times daily.  Lubricate bolus and administer with balling gun.  Allow Animals ample supply of fresh clean water after administration.

Each Bolus contains:

Mature Horses and Cattle, administer orally 1 to 3 Boluses two to three times daily. Lubricate bolus and administer with balling gun.  Allow animals ample supply of fresh clean water after administration.

Mature Horses and Cattle, administer orally 1 to 3 boluses two to three times daily.  Lubricate bolus and administer with balling gun.  Allow animals ample supply of fresh clean water after 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

Drink a full glass of water with each dose.  Adults and children 12 years and over; take 1 to 2 tablets every 4 hours while symptoms last.  Do not take more than 12 tablets in 24 hours unless directed by a doctor.  Children under 12 years; consult a doctor.

Not for use in lactating dairy animals.

Do not exceed 48 tablets in 24 hours or as directed by a doctor.

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.

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.

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.

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 m 2. 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:

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.

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.

Directions: Do not take more than directed.

Adults and children 12 years of age and over:

Children under 12 years of age: ask a doctor

DRINK A FULL GLASS OF WATER WITH EACH DOSE

Lubricate tablets and administer orally.

Adult Horses-3 to 6 tablets
Adult Cattle-8 to 12 tablets
Foals and Calves-1 to 2 tablets
Sheep-1/2 to 1 tablet
Swine-1/4 to 1/2 tablet

Allow animals to drink water immediately after administration. Adjust dosage depending on body weight and observed response. Dosage may be repeated at 12-hour intervals if necessary.

Administer orally

Cattle, Horses: 5 - 60 gm
(Approx. 1/3 to 4 Tablespoons)
Calves, Foals:  0.5 - 6.0 gm
(Approx. 1/10 to 1 teaspoon)
Sheep, Swine:  1 - 3 gm
(Approx. 1/10 to 1/2 teaspoon)
Poultry:  0.15% Level in Ration

Mature Horses and Cattle, administer orally 1/2 to 1 1/2 Boluses two to three times daily.  Lubricate bolus and administer with balling gun.  Allow Animals ample supply of fresh clean water after administration.

TAKE TIME OBSERVE LABEL DIRECTIONS

Administer orally

Cattle, Horses: 5 - 60 gm
Calves, Foals:  0.5 - 6.0 gm
Sheep, Swine:  1 - 3 gm
Poultry:  0.15% Level in Ration

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.

DRINK A FULL GLASS OF WATER WITH EACH DOSE.

• adults and children 12 years and over: 1 or 2 tablets every 4 hours while symptoms last, not more than 12 tablets in 24 hours.

• Children under 12 years: ask a doctor

DRINK A FULL GLASS OF WATER WITH EACH DOSE

DRINK A FULL GLASS OF WATER WITH EACH DOSE

DRINK A FULL GLASS OF WATER WITH EACH DOSE

DRINK A FULL GLASS OF WATER WITH EACH DOSE

Dosage should be adjusted according to the severity of the pain and the response of the patient. Aspirin, Caffeine, and Dihydrocodeine Bitartrate Capsule, USP is given orally. The usual adult dose is two capsules every 4 hours as needed for pain.

adults

under 18 years of age

Directions:  - apply liberally before sun exposure  - do not use on infants under  6 months of age.

Directions: 

Drink a full glass of water with each dose

Adults and children 12 years and over:  take 1 to 2 tablets every 4 hours while symptoms last

Do not take more than 12 tablets in 24 hours unless directed by a doctor.

Children under 12 years: consult a doctor

Drink a full glass of water with each dose

Adults and children 12 years and over: take 1 to 2 tablets every 4 hours while symptoms last

Do not take more than 12 tablets in 24 hours unless directed by a doctor.

Children under 12 years: consult a doctor

Adults and Children 12 years and over:

For temporary relief of minor aches and pains, take 4 to 8 tablets every 4 hours while symptoms persist. Do not exceed 48 tablets in 24 hours unless directed by a doctor.

Children under 12 years of age: Do not use unless directed by a doctor.

drink a full glass of water with each dose

Weight (lb)

Age (yr)

Dose (mL or tsp)†

under 24

under 2 years

ask a doctor

24-35

2-3 years

5 mL (1 tsp)

36-47

4-5 years

7.5 mL (1 ½ tsp)

48-59

6-8 years

10 mL (2 tsp)

60-71

9-10 years

12.5 mL (2 ½ tsp)

72-95

11 years

15 mL (3 tsp)

†or as directed by a doctor

Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

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.

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, consul a doctor

All injections in VIAFLEX plastic containers are intended for intravenous administration using sterile and nonpyrogenic equipment.

As directed by a physician. Dosage, rate and duration of administration are to be individualized and dependent upon the indication for use, the patient’s age, weight, concomitant treatment and clinical condition of the patient as well as laboratory determinations.

After opening the container, the contents should be used immediately and should not be stored for a subsequent infusion. Do not reconnect any partially used containers.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

Do not administer unless solution is clear and seal is intact.

Additives may be incompatible with PLASMA-LYTE 148 Injection (Multiple Electrolytes Injection, Type 1, USP). As with all parenteral solutions, compatibility of the additives with the solution must be assessed before addition. Before adding a substance or medication, verify that it is soluble and/or stable in water and that the pH range of PLASMA-LYTE 148 Injection (Multiple Electrolytes Injection, Type 1, USP) is appropriate. After addition, check for a possible color change and/or the appearance of precipitates, insoluble complexes or crystals.

The instructions for use of the medication to be added and other relevant literature must be consulted. Additives known or determined to be incompatible must not be used. When introducing additives to PLASMA-LYTE 148 Injection (Multiple Electrolytes Injection, Type 1, USP), aseptic technique must be used. Mix the solution thoroughly when additives have been introduced. Do not store solutions containing additives.

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.

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).

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).

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.

Drink a full glass of water with each doses

Adults and children 12 years and over: TAKE 1 TO 2 TABLETS EVERY 4 HOURS WHILE SYMPTOMS  LAST.  DO NOT TAKE MORE THAN 12 TABLETS IN 24 HOURS, UNLESS DIRECTED BY A DOCTOR.

Children under 12 years: CONSULT A DOCTOR.

INDICATION

DOSAGE AND ADMINISTRATION

Initiation of Procedural Sedation

For adult patients: a loading infusion of one mcg/kg over 10 minutes. For less invasive procedures such as ophthalmic surgery, a loading infusion of 0.5 mcg/kg given over 10 minutes may be suitable.

For awake fiberoptic intubation in adult patients: a loading infusion of one mcg/kg over 10 minutes.

For patients over 65 years of age: a loading infusion of 0.5 mcg/ kg over 10 minutes [see Use in Specific Populations (8.5)].

For adult patients with impaired hepatic function: a dose reduction should be considered [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].

Maintenance of Procedural Sedation

For adult patients: the maintenance infusion is generally initiated at 0.6 mcg/kg/hour and titrated to achieve desired clinical effect with doses ranging from 0.2 to 1 mcg/kg/hour. The rate of the maintenance infusion should be adjusted to achieve the targeted level of sedation.

For awake fiberoptic intubation in adult patients: a maintenance infusion of 0.7 mcg/kg/hour is recommended until the endotracheal tube is secured.

For adult patients over 65 years of age: a dose reduction should be considered [see Use in Specific Populations (8.5)].

For patients with impaired hepatic function: a dose reduction should be considered [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].

Due to possible pharmacodynamic interactions, a reduction in dosage of dexmedetomidine hydrochloride injection or other concomitant anesthetics, sedatives, hypnotics or opioids may be required when co-administered [see Drug Interactions (7.1)].

Dosage reductions may need to be considered for adult patients with hepatic impairment, and geriatric patients [see Warnings and Precautions (5.7), Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].

Strict aseptic technique must always be maintained during handling of dexmedetomidine hydrochloride injection.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Dexmedetomidine hydrochloride injection must be diluted with 0.9% sodium chloride injection to achieve required concentration (4 mcg/mL) prior to administration. Preparation of solutions is the same, whether for the loading dose or maintenance infusion.

To prepare the infusion, withdraw 2 mL of dexmedetomidine hydrochloride injection and add to 48 mL of 0.9% sodium chloride injection to a total of 50 mL. Shake gently to mix well.

Dexmedetomidine hydrochloride injection infusion should not be coadministered through the same intravenous catheter with blood or plasma because physical compatibility has not been established.

Dexmedetomidine hydrochloride injection has been shown to be incompatible when administered with the following drugs: amphotericin B, diazepam.

Dexmedetomidine hydrochloride injection has been shown to be compatible when administered with the following intravenous fluids:

Compatibility studies have demonstrated the potential for absorption of dexmedetomidine hydrochloride to some types of natural rubber. Although dexmedetomidine hydrochloride injection is dosed to effect, it is advisable to use administration components made with synthetic or coated natural rubber gaskets.

Directions:  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

Directions:  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

Mature Horses and Cattle, administer orally 1/2 to 1 1/2 boluses two to three times daily.  Lubricate bolus and administer with balling gun.  Allow animals ample supply of fresh clean water after administration.

Drink a full glass of water with each dose.Adults and children 12 years and over; take 1 to 2 tablets every 4 hours while symptoms last.Do not take more than 12 tablets in 24 hours unless directed by a doctor.Children under 12 years; consult a doctor.

DRINK A FULL GLASS OF WATER WITH EACH DOSE

Do not exceed recommended dosage

Adults and children 12 years and older:

children under 12 years: consult a doctor.

• 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

drink a full glass of water with each dose

age

dose

adults and children 12 years and over

10 – 20 mL every 4 hours

children under 12 years

do not use

Drink a full glass of water with each dose

Adults and children 12 years and over: TAKE 1 TO 2 TABLETS EVERY 4 HOURS WHILE SYMPTOMS LAST.  DO NOT TAKE MORE THAN 12 TABLETS IN 24 HOURS, UNLESS DIRECTED BY A DOCTOR.

Children under 12 years: CONSULT A DOCTOR.