RANITIDINE IMMEDIATE RELEASE- ranitidine tablet

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7)

から入手可能:

Strides Pharma Science Limited

INN（国際名）:

RANITIDINE HYDROCHLORIDE

構図:

RANITIDINE 150 mg

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

Ranitidine tablets, USP is indicated in: - Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks. Trials available to date have not assessed the safety of ranitidine in uncomplicated duodenal ulcer for periods of more than 8 weeks. - Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers. No placebo-controlled comparative studies have been carried out for periods of longer than 1 year. - The treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome and systemic mastocytosis). - Short-term treatment of active, benign gastric ulcer. Most patients heal within 6 weeks and the usefulness of further treatment has not been demonstrated. Trials available to date have not assessed the safety of ranitidine in uncomplicated, benign gastric ulcer for periods of more than 6 weeks. - Maintenance therapy for gastric ulcer patients at reduced dosage after healing of acute ulcers. Placebo-controlled trials have been carried out for

製品概要:

Ranitidine tablets, USP 150 mg (ranitidine HCI USP equivalent to 150 mg of ranitidine) are brown coloured, circular shaped, biconvex, beveled edge film-coated tablets debossed with "S/429" on one side and plain on the other side. They are available in bottles of 60 (NDC 64380-803-03, 64380-936-03 ), 100 (NDC 64380-803-06, 64380-936-06), 500 (NDC 64380-803-07, 64380-936-07) and 1000 (NDC 64380-803-08, 64380-936-08) tablets. Ranitidine tablets, USP 300 mg (ranitidine HCI USP equivalent to 300 mg of ranitidine) are brown coloured, circular shaped, biconvex, beveled edge film-coated tablets debossed with "S/430" on one side and plain on the other side. They are available in bottles of 30 (NDC 64380-804-04, 64380-937-04), 100 (NDC 64380-804-06, 64380-937-06) and 250 (NDC 64380-804-38, 64380-937-38) tablets. Store at 20° to 25° C (68° and 77°F); excursions permitted between 15° and 30° C (59° and 86°F) [see USP Controlled Room Temperature]. Protect from light. Replace cap securely after each opening. Distributed by: Strides Pharma Inc. East Brunswick, NJ 08816 Revised: 06/ 2019

認証ステータス:

Abbreviated New Drug Application

製品の特徴

RANITIDINE IMMEDIATE RELEASE- RANITIDINE TABLET
STRIDES PHARMA SCIENCE LIMITED
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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 crystalline powder that
is soluble in water. It has a
slightly bitter taste and sulfur-like odor.
Each ranitidine tablets, 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 magnesium stearate,
microcrystalline cellulose, croscarmellose sodium, colloidal silicon
dioxide, hypromellose, titanium
dioxide, triacetin, and iron oxide red.
Each ranitidine tablets, 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 magnesium stearate,
microcrystalline cellulose, croscarmellose sodium, colloidal silicon
dioxide, hypromellose, titanium
dioxide, triacetin, and iron oxide red.
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 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