Pays: États-Unis
Langue: anglais
Source: NLM (National Library of Medicine)
RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7)
Proficient Rx LP
RANITIDINE HYDROCHLORIDE
RANITIDINE 150 mg
ORAL
PRESCRIPTION DRUG
Ranitidine tablets USP are indicated in: Concomitant antacids should be given as needed for pain relief to patients with active duodenal ulcer; active, benign gastric ulcer; hypersecretory states; GERD; and erosive esophagitis. Ranitidine tablets USP are contraindicated for patients known to have hypersensitivity to the drug or any of the ingredients (see PRECAUTIONS ).
Ranitidine tablets USP 150 mg (ranitidine HCl USP equivalent to 150 mg of ranitidine) are pink colored, circular, biconvex, beveled edge film coated tablets with “G51” engraved on one side and “150” on the other side. They are available in bottles of 10 (NDC 63187-091-10)30 (NDC 63187-091-30) and 60 (NDC 63187-091-60) tablets. Ranitidine tablets USP 300 mg (ranitidine HCl USP equivalent to 300 mg of ranitidine) are pink colored, circular, biconvex, beveled edge film coated tablets with “G51 ” engraved on one side and “300 ” on the other side. They are available in bottles of 60 (NDC 63187-159-60) tablets.
Abbreviated New Drug Application
RANITIDINE- RANITIDINE TABLET, FILM COATED PROFICIENT RX LP ---------- RANITIDINE TABLETS USP, 150 MG AND 300 MG PRESCRIBING INFORMATION DESCRIPTION The active ingredient in ranitidine tablets USP 150 mg and 300 mg 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 USP is a white to pale yellow, granular substance that is soluble in water. It has a slightly bitter taste and sulfur like odor. Each ranitidine tablet USP 150 mg for oral administration contains 168 mg of ranitidine HCl USP equivalent to 150 mg of ranitidine. Each tablet also contains the inactive ingredients microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, FD&C Red # 40 Aluminum Lake, hypromellose, titanium dioxide, triacetin. Each ranitidine tablet USP 300 mg for oral administration contains 336 mg of ranitidine HCl USP equivalent to 300 mg of ranitidine. Each tablet also contains the inactive ingredients microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, FD&C Red # 40 Aluminum Lake, hypromellose, titanium dioxide, triacetin. 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 : 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 del Lire le document complet