Country: Bandaríkin
Tungumál: enska
Heimild: NLM (National Library of Medicine)
FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8)
Clinical Solutions Wholesale, LLC
FAMOTIDINE
FAMOTIDINE 20 mg
ORAL
PRESCRIPTION DRUG
Famotidine tablets USP are indicated in: 1. Short-term treatment of active duodenal ulcer. Most adult patients heal within 4 weeks; there is rarely reason to use famotidine tablets USP 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. Stu
Famotidine Tablets USP, 20 mg are yellow, rounded square shaped, biconvex, film-coated tablets debossed with ‘CC’ on one side and ‘60’ on the other side. Bottles of 30 NDC 65862-859-30 Bottles of 100 NDC 65862-859-01 Bottles of 500 NDC 65862-859-05 Bottles of 1,000 NDC 65862-859-99 10 x 10 Unit-dose Tablets NDC 65862-859-78 Famotidine Tablets USP, 40 mg are white, rounded square shaped, biconvex, film-coated tablets debossed with ‘CC’ on one side and ‘61’ on the other side. Bottles of 30 NDC 65862-860-30 Bottles of 100 NDC 65862-860-01 Bottles of 500 NDC 65862-860-05 Bottles of 1,000 NDC 65862-860-99 10 x 10 Unit-dose Tablets NDC 65862-860-78 Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a USP tight, light-resistant container. Manufactured for: Aurobindo Pharma USA, Inc. 2400 Route 130 North Dayton, NJ 08810 Manufactured by: Aurobindo Pharma Limited Unit-VII (SEZ) Mahaboob Nagar (Dt)-509302 India Issued: March 2015 Repackaged by: Clinical Solutions Wholesale Franklin, TN 37067
Abbreviated New Drug Application
FAMOTIDINE- FAMOTIDINE TABLET, FILM COATED CLINICAL SOLUTIONS WHOLESALE, LLC ---------- FAMOTIDINE TABLETS USP RX ONLY 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 337.43. Its structural formula is: Famotidine USP is a white to pale yellowish white crystalline powder 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 USP and the following inactive ingredients: carnauba wax, corn starch, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, talc, and titanium dioxide. In addition the 20 mg tablets contain red iron oxide, and yellow iron oxide. 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. 2 8 15 7 2 3 2 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 s Lestu allt skjalið