Pepcid (Famotidine) - Indications and Dosage

INDICATIONS AND USAGE

PEPCID is indicated in:

1. Short term treatment of active duodenal ulcer. Most adult patients heal within 4 weeks; there is rarely reason to use PEPCID at full dosage for longer than 6 to 8 weeks. Studies have not assessed the safety of famotidine in uncomplicated active duodenal ulcer for periods of more than eight weeks.
2. Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of an active ulcer. Controlled studies in adults have not extended beyond one year.
3. Short term treatment of active benign gastric ulcer. Most adult patients heal within 6 weeks. Studies have not assessed the safety or efficacy of famotidine in uncomplicated active benign gastric ulcer for periods of more than 8 weeks.
4. Short term treatment of gastroesophageal reflux disease (GERD). PEPCID is indicated for short term treatment of patients with symptoms of GERD (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies).
   PEPCID is also indicated for the short term treatment of esophagitis due to GERD including erosive or ulcerative disease diagnosed by endoscopy (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies).
5. Treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison Syndrome, multiple endocrine adenomas) (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies).

DOSAGE AND ADMINISTRATION

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 PEPCID 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 1-16 years of age 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 PEPCID 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.

ORAL SUSPENSION

PEPCID Oral Suspension may be substituted for PEPCID Tablets in any of the above indications. Each five mL contains 40 mg of famotidine after constitution of the powder with 46 mL of Purified Water as directed.

DIRECTIONS FOR PREPARING PEPCID ORAL SUSPENSION

Prepare suspension at time of dispensing. Slowly add 46 mL of Purified Water. Shake vigorously for 5-10 seconds immediately after adding the water and immediately before use.

STABILITY OF PEPCID FOR ORAL SUSPENSION

Unused constituted oral suspension should be discarded after 30 days.

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 PEPCID 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 PEPCID 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 PEPCID in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.

HOW SUPPLIED

No. 3535--PEPCID Tablets, 20 mg, are beige colored, U-shaped, film-coated tablets coded MSD 963 on one side and PEPCID on the other. They are supplied as follows:

NDC 0006-0963-31 unit of use bottles of 30

NDC 0006-0963-94 unit of use bottles of 90

NDC 0006-0963-58 unit of use bottles of 100

NDC 0006-0963-28 unit dose package of 100

NDC 0006-0963-82 bottles of 1,000

NDC 0006-0963-87 bottles of 10,000

NDC 0006-0963-72 carton of 25 UNIBLISTER™ cards of 31 tablets each.

No. 3536--PEPCID Tablets, 40 mg, are light brownish-orange, U-shaped, film-coated tablets coded MSD 964 on one side and PEPCID on the other. They are supplied as follows:

NDC 0006-0964-31 unit of use bottles of 30

NDC 0006-0964-94 unit of use bottles of 90

NDC 0006-0964-58 unit of use bottles of 100

NDC 0006-0964-28 unit dose package of 100

NDC 0006-0964-82 bottles of 1,000

NDC 0006-0964-87 bottles of 10,000

NDC 0006-0964-72 carton of 25 UNIBLISTER™ cards of 31 tablets each.

No. 3538--PEPCID for Oral Suspension is a white to off-white powder containing 400 mg of famotidine for constitution. When constituted as directed, PEPCID for Oral Suspension is a smooth, mobile, off-white, homogeneous suspension with a cherry-banana-mint flavor, containing 40 mg of famotidine per 5 mL.

NDC 0006-3538-92, bottles containing 400 mg famotidine.

STORAGE

Store PEPCID Tablets at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Store PEPCID for Oral Suspension dry powder and suspension at 25°C (77°F); excursions permitted to 15-30°C(59-86°F) [see USP Controlled Room Temperature]. Suspension: Protect from freezing. Discard unused suspension after 30 days.

7825036 Issued June 2002

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