famotidine

FDA Drug Profile — acid relief, Pepcid, dg health heartburn prevention, famotidine, careone acid relief

Drug Details

Generic Name
famotidine
Brand Names
acid relief, Pepcid, dg health heartburn prevention, famotidine, careone acid relief, dg health acid reducer, acid reducer, FAMOTIDINE, Famotidine, basic care acid reducer, equate famotidine, heartburn relief, basic care heartburn prevention, topcare acid reducer, Acid Controller, acid controller
Application Number
ANDA077351
Sponsor
Patheon Inc.
NDC Codes
30
Dosage Forms
TABLET, FILM COATED, POWDER, FOR SUSPENSION, INJECTION, SOLUTION
Routes
ORAL, INTRAVENOUS
Active Ingredients
FAMOTIDINE

Indications and Usage

INDICATIONS AND USAGE Famotidine Injection is supplied as a premixed solution in GALAXY plastic containers and is intended for intravenous use only. Famotidine Injection is indicated in some hospitalized patients with pathological hypersecretory conditions or intractable ulcers, or as an alternative to the oral dosage forms for short term use in patients who are unable to take oral medication for the following conditions: 1. Short term treatment of active duodenal ulcer. Most adult patients heal within 4 weeks; there is rarely reason to use famotidine 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). Famotidine is indicated for short term treatment of patients with symptoms of GERD (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies ). Famotidine 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 ).