Riik: Ameerika Ühendriigid
keel: inglise
Allikas: NLM (National Library of Medicine)
RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7)
GlaxoSmithKline LLC
RANITIDINE HYDROCHLORIDE
RANITIDINE 150 mg
PRESCRIPTION DRUG
New Drug Application
ZANTAC- RANITIDINE HYDROCHLORIDE TABLET, FILM COATED GLAXOSMITHKLINE LLC ---------- ZANTAC 150 (RANITIDINE HYDROCHLORIDE) TABLETS, USP ZANTAC 300 (RANITIDINE HYDROCHLORIDE) TABLETS, USP DESCRIPTION The active ingredient in ZANTAC 150 Tablets and ZANTAC 300 Tablets is ranitidine hydrochloride (HCl), USP, a histamine H -receptor antagonist. Chemically it is N[2-[[[5-[(dimethylamino)methyl]-2- furanyl]methyl]thio]ethyl]-N′-methyl-2-nitro-1,1-ethenediamine, HCl. It has the following structure: The empirical formula is C H N O S•HCl, representing a molecular weight of 350.87. Ranitidine HCl is a white to pale yellow granular substance that is soluble in water. It has a slightly bitter taste and sulfur-like odor. Each ZANTAC 150 Tablet for oral administration contains 168 mg of ranitidine HCl equivalent to 150 mg of ranitidine. Each tablet also contains the inactive ingredients FD&C Yellow No. 6 Aluminum Lake, hypromellose, magnesium stearate, microcrystalline cellulose, titanium dioxide, triacetin, and yellow iron oxide. Each ZANTAC 300 Tablet for oral administration contains 336 mg of ranitidine HCl equivalent to 300 mg of ranitidine. Each tablet also contains the inactive ingredients croscarmellose sodium, D&C Yellow No. 10 Aluminum Lake, hypromellose, magnesium stearate, microcrystalline cellulose, titanium dioxide, and triacetin. CLINICAL PHARMACOLOGY ZANTAC is a competitive, reversible inhibitor of the action of histamine at the histamine H -receptors, including receptors on the gastric cells. ZANTAC does not lower serum Ca++ in hypercalcemic states. ZANTAC is not an anticholinergic agent. PHARMACOKINETICS : _ABSORPTION:_ ZANTAC is 50% absorbed after oral administration, compared with an intravenous (IV) injection with mean peak levels of 440 to 545 ng/mL occurring 2 to 3 hours after a 150-mg dose. The syrup is bioequivalent to the tablets. Absorption is not significantly impaired by the administration of food or antacids. Propantheline slightly delays and increases peak blood levels of ranitidine, probably b Lugege kogu dokumenti