দেশ: মার্কিন যুক্তরাষ্ট্র
ভাষা: ইংরেজি
সূত্র: NLM (National Library of Medicine)
Ranitidine Hydrochloride (UNII: BK76465IHM) (Ranitidine - UNII:884KT10YB7)
McKesson Contract Packaging
Ranitidine Hydrochloride
Ranitidine 150 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
RANITIDINE- RANITIDINE TABLET, FILM COATED MCKESSON CONTRACT PACKAGING ---------- RANITIDINE TABLETS USP DESCRIPTION Ranitidine hydrochloride USP is 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, hydrochloride. 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. The structural formula is: C H N O S•HCl M.W. 350.87 Each tablet, for oral administration, contains 168 mg or 336 mg of ranitidine HCl equivalent to 150 mg or 300 mg of ranitidine, respectively. In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, red iron oxide, titanium dioxide, triethyl citrate and yellow iron oxide. CLINICAL PHARMACOLOGY Ranitidine is a competitive, reversible inhibitor of the action of histamine at the histamine H - receptors, including receptors on the gastric cells. Ranitidine does not lower serum Ca in hypercalcemic states. Ranitidine is not an anticholinergic agent. PHARMACOKINETICS Absorption 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. Distribution 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 amounts to <4% of the 2 13 22 4 3 2 ++ dose. Other metabolites are the S-oxide (1%) and the desme সম্পূর্ণ নথি পড়ুন