국가: 미국
언어: 영어
출처: NLM (National Library of Medicine)
FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8)
Blenheim Pharmacal, Inc.
FAMOTIDINE
FAMOTIDINE 20 mg
ORAL
PRESCRIPTION DRUG
Famotidine is indicated in: - 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. - 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. - 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. - 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 i
Famotidine Tablets USP (white round tablets) containing 20mg of famotidine and engraved with . Bottle of 30 (NDC 61442-121-30) Bottle of 100 (NDC 61442-121-01) Bottle of 500 (NDC 61442-121-05) Bottle of 1,000 (NDC 61442-121-10) Famotidine Tablets USP (white round tablets) containing 40mg of famotidine and engraved with . Bottle of 30 (NDC 61442-122-30) Bottle of 100 (NDC 61442-122-01) Bottle of 500 (NDC 61442-122-05) Bottle of 1,000 (NDC 61442-122-10) Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Manufactured and Distributed by: Carlsbad Technology, Inc. Carlsbad, CA 92008 Revised: 06/12 CTI-12 Rev. C
Abbreviated New Drug Application
FAMOTIDINE- FAMOTIDINE TABLET BLENHEIM PHARMACAL, INC. ---------- FAMOTIDINE TABLETS USP 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%, respectively, for a period of at least 10 hours. The same doses given in the morning suppressed food-stimulated acid secretion in all subjects. The mean suppression was 76% and 84%, respectively 3 to 5 hours after administration, and 25% and 30%, respectively 8 to 10 hours after administration. In some subjects who received the 20 mg dose, however, the antisecretory effect was dissipated within 6-8 hours. There was no cumulative effect with repeated doses. The nocturnal intragastric pH was raised by evening doses of 20 and 40 mg of famotidine to mean values of 5.0 and 6.4, respectively. When famotidine was given after breakfast, the basal daytime interdigestive pH at 3 and 8 hours after 20 or 40 mg of famotidine was raised to about 5. Famotidine had little or no effect on fasting or postprandial serum gastrin levels. Gastric emptying and exocrine pancreatic function were not affected by famotidine. OTHER EFFECTS Systemic effects of famotidine in the CNS, cardiovascular, respiratory or endocri 전체 문서 읽기