Fsc Laboratories, Inc.
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Fsc Laboratories, Inc. Drugs
Cefaclor For Suspension
Cefaclor is administered orally.
The usual adult dosage is 250 mg every 8 hours. For more severe infections (such as pneumonia) or those caused by less susceptible organisms, doses may be doubled.
The usual recommended daily dosage for pediatric patients is 20 mg/kg/day in divided doses every 8 hours. In more serious infections, otitis media, and infections caused by less susceptible organisms, 40 mg/kg/day are recommended, with a maximum dosage of 1 g/day.Table 3: Cefaclor for Oral Suspension, USP 20 mg/kg/day Weight 125 mg/5 mL 250 mg/5 mL 9 kg 1/2 tsp t.i.d. 18 kg 1 tsp t.i.d. 1/2 tsp t.i.d. 40 mg/kg/day 9 kg 1 tsp t.i.d. 1/2 tsp t.i.d. 18 kg 1 tsp t.i.d.
B.I.D. Treatment Option
For the treatment of otitis media and pharyngitis, the total daily dosage may be divided and administered every 12 hours.Table 4: Cefaclor for Oral Suspension, USP 20 mg/kg/day(Pharyngitis) Weight 375 mg/5 mL 18 kg 1/2 tsp b.i.d. 40 mg/kg/day(Otitis Media) 9 kg 1/2 tsp b.i.d. 18 kg 1 tsp b.i.d.
Cefaclor may be administered in the presence of impaired renal function. Under such a condition, the dosage usually is unchanged (see PRECAUTIONS).
In the treatment of β-hemolytic streptococcal infections, a therapeutic dosage of cefaclor should be administered for at least 10 days.
Directions for Mixing
Add appropriate water volume as indicated in the following table in two portions to dry mixture in the bottle. Shake well after each addition.
Each 5 mL (approximately one teaspoonful) will then contain Cefaclor, USP, monohydrate equivalent to 125 mg, 250 mg or 375 mg anhydrous cefaclor, respectively, as shown in the following table.
Oversize bottle provides extra space for shaking.Table 5: Cefaclor For Oral Suspension, USP StrengthPackage Size(when mixed) Water Volume to Add Anhydrous Cefaclor/5 mL(approx. one teaspoonful) 125 mg/5 mL 150 mL 106 mL 125 mg 250 mg/5 mL 150 mL 106 mL 250 mg 375 mg/5 mL 100 mL 68 mL 375 mg
Amphetamines should be administered at the lowest effective dosage and dosage should be individually adjusted. Late evening doses should be avoided because of the resulting insomnia.
Usual dose is 5 mg to 60 mg per day in divided doses, depending on the individual patient response.
Narcolepsy seldom occurs in children under 12 years of age; however, when it does, ProCentra® (dextroamphetamine sulfate) Oral Solution may be used. The suggested initial dose for patients aged 6 to 12 is 5 mg daily; daily dose may be raised in increments of 5 mg at weekly intervals until optimal response is obtained. In patients 12 years of age and older, start with 10 mg daily; daily dosage may be raised in increments of 10 mg at weekly intervals until optimal response is obtained. If bothersome adverse reactions appear (e.g., insomnia or anorexia), dosage should be reduced. Give first dose on awakening; additional doses (1 or 2) at intervals of 4 to 6 hours.
Attention Deficit Disorder with Hyperactivity
Not recommended for pediatric patients under 3 years of age.
In pediatric patients from 3 to 5 years of age, start with 2.5 mg daily; daily dosage may be raised in increments of 2.5 mg at weekly intervals until optimal response is obtained.
In pediatric patients 6 years of age and older, start with 5 mg once or twice daily; daily dosage may be raised in increments of 5 mg at weekly intervals until optimal response is obtained. Only in rare cases will it be necessary to exceed a total of 40 mg per day.
Give first dose on awakening; additional doses (1 or 2) at intervals of 4 to 6 hours.
Where possible, drug administration should be interrupted occasionally to determine if there is a recurrence of behavioral symptoms sufficient to require continued therapy.
The dosage of Karbinal ER should be individualized based on the severity of the condition and the response of the patient. Start with lower doses and increase as needed and tolerated.
Administer Karbinal ER by the oral route only. Measure Karbinal ER with an accurate milliliter measuring device. A household teaspoon is not an accurate measuring device and could lead to overdosage. A pharmacist can provide an appropriate measuring device and can provide instructions for measuring the correct dose. [see Warnings and Precautions (5.5)]
Adults and Adolescents 12 years of age and older:
7.5 mL to 20 mL (6 to 16 mg) every 12 hours
Children 2 to 11 years of age (approximately 0.2 to 0.4 mg/kg/day):
2 to 3 years: 3.75 mL to 5 mL (3 to 4 mg) every 12 hours
4 to 5 years: 3.75 mL to 10 mL (3 to 8 mg) every 12 hours
6 to 11 years: 7.5 mL to 15 mL (6 to 12 mg) every 12 hours
Acute Otitis Media in Pediatric Patients
The recommended dose for pediatric patients with acute otitis media is 10 mg/kg trimethoprim per 24 hours, given in divided doses every 12 hours for 10 days. The following table is a guideline for the attainment of this dosage:Pediatric patients 6 months of age or older Weight Dose (every 12 hours) lb kg tsp mL 11 5 ½ 2.5 22 10 1 5 33 15 1½ 7.5 44 20 2 10 55 25 2½ 12.5 66 30 3 15 77 35 3½ 17.5 ≥88 ≥40 4 20
Uncomplicated Urinary Tract Infections
The usual oral adult dosage is 100 mg (10 mL) every 12 hours or 200 mg (20 mL) every 24 hours, each for 10 days.
Patients with Impaired Renal Function
The use of trimethoprim in patients with a creatinine clearance of less than 15 mL/min is not recommended. Patients with a creatinine clearance of 15 to 30 mL/min should receive half the dose recommended for patients of the same age with normal renal function.
2.1 Healing of Erosive or Ulcerative GERD in Adults
The recommended adult oral dose is one ACIPHEX 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 ACIPHEX may be considered.
2.2 Maintenance of Healing of Erosive or Ulcerative GERD in Adults
The recommended adult oral dose is one ACIPHEX 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 ACIPHEX 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 ACIPHEX 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 ACIPHEX 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 AdultsTABLE 1 THREE DRUG REGIMEN* All three medications should be taken twice daily with the morning and evening meals. * It is important that patients comply with the full 7-day regimen [ see Clinical Studies (14.5)]. ACIPHEX 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 ACIPHEX 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 ACIPHEX 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)].
2.8 Treatment of GERD in Pediatric Patients 1 to 11 Years of AgeLess than 15 kg: 5 mg once daily for up to 12 weeks with the option to increase to 10 mg if inadequate response [see Clinical Studies (14.7)]. 15 kg or more: 10 mg once daily for up to 12 weeks [see 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 RecommendationsTABLE 2 ADMINISTRATION RECOMMENDATIONS Formulation 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. Delayed-Release Capsule Pediatric patients 1 to 11 years of age The dose should be taken 30 minutes before a meal.The granules should not be chewed or crushed. Open capsule and sprinkle entire contents on a small amount of soft food (e.g. applesauce, fruit or vegetable based baby food, or yogurt) or empty contents into a small amount of liquid (e.g. infant formula, apple juice, or pediatric electrolyte solution). The whole dose should be taken within 15 minutes of preparation.Food or liquid should be at or below room temperature. Do not store mixture for future use.
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