RANITIDINE tablet

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

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

MAH:

Contract Pharmacy Services-PA

INN:

RANITIDINE HYDROCHLORIDE

composition:

RANITIDINE 150 mg

administration_route:

ORAL

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

Ranitidine Tablets, USP are indicated in: - Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks. Studies 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. Studies 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 studies have been carried out

leaflet_short:

Ranitidine Tablets, USP 150 mg (ranitidine HCl equivalent to 150 mg of ranitidine) are supplied as orange, round, biconvex aqueous film-coated tablets debossed “IP 253” on one side and plain on the reverse. They are available as follows: NDC 67046-651-07 blisterpacks of 7 NDC 67046-651-14 blisterpacks of 14 NDC 67046-651-15 blisterpacks of 15 NDC 67046-651-20 blisterpacks of 20 NDC 67046-651-21 blisterpacks of 21 NDC 67046-651-28 blisterpacks of 28 NDC 67046-651-30 blisterpacks of 30 NDC 67046-651-60 blisterpacks of 60 Ranitidine Tablets, USP 300 mg (ranitidine HCl equivalent to 300 mg of ranitidine) are supplied as yellow, capsule-shaped aqueous film-coated tablets debossed “IP 254” on one side and plain on the reverse. They are available as follows: NDC 67046-652-07 blisterpacks of 7 NDC 67046-652-14 blisterpacks of 14 NDC 67046-652-15 blisterpacks of 15 NDC 67046-652-20 blisterpacks of 20 NDC 67046-652-21 blisterpacks of 21 NDC 67046-652-28 blisterpacks of 28 NDC 67046-652-30 blisterpacks of 30 NDC 67046-652-60 blisterpacks of 60 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] in a dry place. Dispense in a tight, light-resistant container as defined in the USP. Protect from light. Replace cap securely after each opening. Distributed by: Amneal Pharmaceuticals Bridgewater, NJ 08807 Rev. 09-2015-02

authorization_status:

Abbreviated New Drug Application

SPC

RANITIDINE- RANITIDINE TABLET
CONTRACT PHARMACY SERVICES-PA
----------
651 RANITIDINE 150 MG
652 RANITIDINE 300 MG
RANITIDINE TABLETS, USP
RX ONLY
DESCRIPTION
The active ingredient in Ranitidine Tablets, USP 150 mg and Ranitidine
Tablets, USP 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 is a white to pale yellow, granular substance that is soluble in
water. It has a slightly bitter taste and
sulfurlike odor.
Each Ranitidine Tablets, USP 150 mg for oral administration contains
167.4 mg of ranitidine HCl
equivalent to 150 mg of ranitidine. Each tablet also contains the
inactive ingredients colloidal silicon
dioxide, croscarmellose sodium, hypromellose, magnesium stearate,
microcrystalline cellulose,
polydextrose, titanium dioxide, triethyl citrate and FD&C Yellow #6.
Each Ranitidine Tablets, USP 300 mg for oral administration contains
334.8 mg of ranitidine HCl
equivalent to 300 mg of ranitidine. Each tablet also contains the
inactive ingredients colloidal silicon
dioxide, croscarmellose sodium, hypromellose, magnesium stearate,
microcrystalline cellulose,
polydextrose, titanium dioxide, triethyl citrate and D&C Yellow #10.
CLINICAL PHARMACOLOGY
Ranitidine Tablets, USP are a competitive, reversible inhibitor of the
action of histamine at the
histamine H
-receptors, including receptors on the gastric cells. Ranitidine
Tablets, USP do not lower
serum Ca
in hypercalcemic states. Ranitidine Tablets, USP are not an
anticholinergic agent.
PHARMACOKINETICS: _ABSORPTION:_ Ranitidine Tablets, USP are 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