Land: Verenigde Staten
Taal: Engels
Bron: NLM (National Library of Medicine)
RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7)
Cardinal Health
RANITIDINE HYDROCHLORIDE
RANITIDINE 150 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
RANITIDINE- RANITIDINE TABLET CARDINAL HEALTH ---------- RANITIDINE TABLETS DESCRIPTION Ranitidine hydrochloride (HCl), USP, is a histamine H 2-receptor antagonist. Chemically it is N[2-[[[5-[(dimethylamino)methyl]-2-furanyl]methyl]thio]ethyl]- N′-methyl-2-nitro-1,1-ethene-diamine, HCl. It has the following structural formula: The molecular formula is C 13H22N4O3S•HCl, representing a molecular weight of 350.87. Ranitidine HCl is a white to pale yellow, crystalline substance that is soluble in water. It has a slightly bitter taste and sulfurlike odor. Each tablet, for oral administration, contains 168 mg or 336 mg of ranitidine hydrochloride equivalent to 150 mg or 300 mg of ranitidine, respectively. In addition, each tablet contains the following inactive ingredients: FD&C Yellow No. 6 Aluminum Lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, synthetic yellow iron oxide, titanium dioxide and triethyl citrate. CLINICAL PHARMACOLOGY Ranitidine is a competitive, reversible inhibitor of the action of histamine at the histamine H2-receptors, including receptors on the gastric cells. Ranitidine does not lower serum Ca++ in hypercalcemic states. Ranitidine is not an anticholinergic agent. PHARMACOKINETICS : ABS ORPTION: Ranitidine is 50% absorbed after oral administration, compared to an intravenous (IV) injection with mean peak levels of 440 to 545 ng/mL occurring 2 to 3 hours after a 150 mg dose. Absorption is not significantly impaired by the administration of food or antacids. Propantheline slightly delays and increases peak blood levels of ranitidine, probably by delaying gastric emptying and transit time. In one study, simultaneous administration of high-potency antacid (150 mmol) in fasting subjects has been reported to decrease the absorption of ranitidine. DIS TRIBUTION: The volume of distribution is about 1.4 L/kg. Serum protein binding averages 15%. Metabolism: In humans, the N-oxide is the principal metabolite in the urine; however, this amou Lees het volledige document