Страна: Соединенные Штаты
Язык: английский
Источник: NLM (National Library of Medicine)
famotidine (UNII: 5QZO15J2Z8) (famotidine - UNII:5QZO15J2Z8)
Preferred Pharmaceuticals, Inc.
ORAL
PRESCRIPTION DRUG
Famotidine is indicated in: 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
Famotidine tablets, USP 20 mg are yellow, film coated, round shaped tablet with ‘C’ on one side and plain on other side. Bottle of 30 - 68788-9220-3 Bottle of 60 -68788-9220-6 Bottle of 90 - 68788-9220-9 Bottle of 100 - 68788-9220-1 Bottle of 120- 68788-9220-8 Storage Preserve in well-closed, light-resistant containers. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature ]. Rx only Manufactured by:Dr.Reddy's Laboratories Limited Bachepalli - 502 325, INDIA Revised: 0410 Repackaged by Preferred Pharmaceuticals, Inc Anaheim, CA 92807
Abbreviated New Drug Application
FAMOTIDINE- FAMOTIDINE TABLET, FILM COATED PREFERRED PHARMACEUTICALS, INC. ---------- FAMOTIDINE TABLETS 20MG DESCRIPTION The active ingredient in famotidine tablets, USP is a histamine H -receptor antagonist. Famotidine is N’(aminosulfonyl)-3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl]thio]propanimidamide. The molecular formula of famotidine is C H N O S and its molecular weight is 337.45. Its structural formula is: Famotidine is a white to pale yellow crystalline compound that is freely soluble in glacial acetic acid, slightly soluble in methanol, very slightly soluble in water, and practically insoluble in ethanol. Each tablet for oral administration contains either 20 mg or 40 mg of famotidine and the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, Opadry OY 52945 Yellow, pregelatinized starch and talc. The composition of Opadry OY 52945 Yellow, used for film coating of famotidine tablets, is as follows: hydroxypropyl methylcellulose, polyethylene glycol 400, synthetic yellow iron oxide and titanium dioxide. CLINICAL PHARMACOLOGY IN ADULTS GI EFFECTS Famotidine is a competitive inhibitor of histamine H receptors. The primary clinically important pharmacologic activity of famotidine is inhibition of gastric secretion. Both the acid concentration and volume of gastric secretion are suppressed by famotidine, while changes in pepsin secretion are proportional to volume output. In normal volunteers and hypersecretors, famotidine inhibited basal and nocturnal gastric secretion, as well as secretion stimulated by food and pentagastrin. After oral administration, the onset of the antisecretory effect occurred within one hour; the maximum effect was dose-dependent, occurring within one to three hours. Duration of inhibition of secretion by doses of 20 and 40 mg was 10 to 12 hours. Single evening oral doses of 20 and 40 mg inhibited basal and nocturnal acid secretion in all subjects; mean nocturnal gastric acid secretion was inhibited by 86% and 94%, r Прочитать полный документ