国: アメリカ合衆国
言語: 英語
ソース: NLM (National Library of Medicine)
FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8)
Cardinal Health
FAMOTIDINE
FAMOTIDINE 20 mg
ORAL
PRESCRIPTION DRUG
Famotidine tablets are indicated in: Hypersensitivity to any component of this product. Cross sensitivity in this class of compounds has been observed. Therefore, famotidine should not be administered to patients with a history of hypersensitivity to other H2 -receptor antagonists.
Abbreviated New Drug Application
FAMOTIDINE- FAMOTIDINE TABLET, FILM COATED CARDINAL HEALTH ---------- DESCRIPTION Famotidine 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, USP 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. Each tablet also contains the following inactive ingredients: D&C Yellow No. 10 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, pregelatinized starch (corn), sodium lauryl sulfate, sodium starch glycolate and titanium dioxide. In addition the 20 mg tablet contains FD&C Blue No. 2 Aluminum Lake and triacetin and the 40 mg tablet contains FD&C Blue No. 1 Aluminum Lake and glyceryl triacetate. 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 1 to 3 hours. Duration of inhibition of secretion by doses of 20 mg and 40 mg was 10 to 12 hours. Single evening oral doses of 20 mg and 40 mg inhibited basal and nocturnal acid secretion in all subjec 完全なドキュメントを読む