INDICATIONS AND USAGE
PEPCID is indicated in:
- Short term treatment of active duodenal ulcer. Most 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.
- Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of an active ulcer.Controlled studies have not extended beyond one year.
- Short term treatment of active benign gastric ulcer. Most 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.
- Short term treatment of gastroesophageal reflux disease (GERD). PEPCID is indicated for short term treatment of patients with symptoms of GERD.PEPCID is also indicated for the short term treatment of esophagitis due to GERD including erosive or ulcerative disease diagnosed by endoscopy.
- Treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison Syndrome, multiple endocrine adenomas).
CONTRAINDICATIONS
Hypersensitivity to any component of these products.
PRECAUTIONS
General
Symptomatic response to therapy with PEPCID does not preclude the presence of gastric malignancy.
Patients with Severe Renal Insufficiency
Longer intervals between doses or lower doses may need to be used in patients with severe renal insufficiency (creatinine clearance <10 mL/min) to adjust for the longer elimination half-life of famotidine. However, currently, no drug-related toxicity has been found with high plasma concentrations of famotidine.
Information for Patients
The patient should be instructed to shake the oral suspension vigorously for 5-10 seconds prior to each use. Unused constituted oral suspension should be discarded after 30 days.
Patients should be instructed to leave the PEPCID RPD Orally Disintegrating Tablet in the unopened package until the time of use. Patients should then open the tablet blister pack with dry hands, place the tablet on the tongue to dissolve and be swallowed with saliva. No water is needed for taking the tablet.
Phenylketonurics: Phenylketonuric patients should be informed that PEPCID RPD contains phenylalanine 1.05 mg per 20 mg orally disintegrating tablet and 2.10 mg per 40 mg orally disintegrating tablet.
Drug Interactions
No drug interactions have been identified. Studies with famotidine in man, in animal models, and in vitro have shown no significant interference with the disposition of compounds metabolized by the hepatic microsomal enzymes, e.g., cytochrome P450 system. Compounds tested in man include warfarin, theophylline, phenytoin, diazepam, aminopyrine and antipyrine. Indocyanine green as an index of hepatic drug extraction has been tested and no significant effects have been found.
Carcinogenesis, Mutagenesis, Impairment of Fertility
In a 106 week study in rats and a 92 week study in mice given oral doses of up to 2000 mg/kg/day (approximately 2500 times the recommended human dose for active duodenal ulcer), there was no evidence of carcinogenic potential for PEPCID.
Famotidine was negative in the microbial mutagen test (Ames test) using Salmonella typhimurium and Escherichia coli with or without rat liver enzyme activation at concentrations up to 10,000 mcg/plate. In in vivo studies in mice, with a micronucleus test and a chromosomal aberration test, no evidence of a mutagenic effect was observed.
In studies with rats given oral doses of up to 2000 mg/kg/day or intravenous doses of up to 200 mg/kg/day, fertility and reproductive performance were not affected.
Pregnancy
Pregnancy Category B
Reproductive studies have been performed in rats and rabbits at oral doses of up to 2000 and 500 mg/kg/day, respectively, and in both species at I.V. doses of up to 200 mg/kg/day, and have revealed no significant evidence of impaired fertility or harm to the fetus due to PEPCID. While no direct fetotoxic effects have been observed, sporadic abortions occurring only in mothers displaying marked decreased food intake were seen in some rabbits at oral doses of 200 mg/kg/day (250 times the usual human dose) or higher.
There are, however, no adequate or well-controlled studies in pregnant women. Becauseanimal reproductive studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Nursing Mothers
Studies performed in lactating rats have shown that famotidine is secreted into breast milk. Transient growth depression was observed in young rats suckling from mothers treated with maternotoxic doses of at least 600 times the usual human dose. Famotidine is detectable in human milk. Because of the potential for serious adverse reactions in nursing infants from PEPCID, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric Use
Safety and effectiveness in children have not been established.
Use in Elderly Patients
No dosage adjustment is required based on age. Dosage adjustment in the case of severe renal impairment may be necessary.