RANITIDINE- ranitidine tablet, film coated

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Teva Pharmaceuticals USA, Inc.

INN (שם בינלאומי):

RANITIDINE HYDROCHLORIDE

הרכב:

RANITIDINE 150 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

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 are available as beige, unscored, round, film-coated tablets debossed 4357” on one side and “150” on the other side containing 150 mg ranitidine as ranitidine hydrochloride packaged in bottles of 60 and 500 tablets. Ranitidine Tablets USP, 300 mg are available as beige, unscored, oval, film-coated tablets debossed 4358” on one side and “300” on the other side containing 300 mg ranitidine as ranitidine hydrochloride packaged in bottles of 30, and 100 tablets. PHARMACIST: Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Store at 20° to 25°C (68° to 77°F) in a dry place [See USP Controlled Room Temperature]. PROTECT FROM LIGHT Replace cap securely after each opening. Rev. B 10/2009 Manufactured In India By: EMCURE PHARMACEUTICALS LTD. Hinjwadi, Pune, India Manufactured For: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 RANITIDINE TABLETS USP

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

RANITIDINE- RANITIDINE TABLET, FILM COATED
TEVA PHARMACEUTICALS USA, INC.
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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 de