ranitidine- Ranitidine Hydrochloride tablet, film coated

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

Ranitidine hydrochloride (UNII: BK76465IHM) (Ranitidine - UNII:884KT10YB7)

Saadav alates:

Dr. Reddy's Laboratories Limited

INN (Rahvusvaheline Nimetus):

Ranitidine Hydrochloride

Ravimvorm:

TABLET, FILM COATED

Koostis:

150 mg

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

Ranitidine is 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 for 1 year. -

Toote kokkuvõte:

Ranitidine tablets, USP 150 mg (ranitidine hydrochloride USP equivalent to 150 mg of ranitidine) are yellow colored, round, biconvex film coated tablets, embossed 'C108' on one side and plain on other side and are supplied in bottles of 30, 60, 90, 100, 180, 250, 500, 1000 and unit dose packages of 100 (10 × 10). Ranitidine tablets, USP 300 mg (ranitidine hydrochloride USP equivalent to 300 mg of ranitidine) are yellow colored, capsule shaped, biconvex plain film coated tablets and are supplied in bottles of 30, 60, 90, 100, 180, 250, 500 and unit dose packages of 100 (10 × 10). Store at 20°-25°C (68°-77°F) (See USP Controlled Room Temperature). Protect from light. Replace cap securely after each opening and retain blisters in carton until time of use.

Toote omadused

RANITIDINE- RANITIDINE HYDROCHLORIDE TABLET, FILM COATED
DR. REDDY'S LABORATORIES LIMITED
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RANITIDINE TABLETS, USP
DESCRIPTION
The active ingredient in ranitidine hydrochloride 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 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 equivalent
to 150 mg of ranitidine. Each tablet also contains the inactive
ingredients hypromellose 2910/5cP,
magnesium stearate, microcrystalline cellulose, polyethylene glycol,
titanium dioxide, and synthetic
yellow iron oxide.
Each ranitidine tablets, USP 300 mg for oral administration contains
336 mg of ranitidine HCl equivalent
to 300 mg of ranitidine. Each tablet also contains the inactive
ingredients hypromellose 2910/5cP,
magnesium stearate, microcrystalline cellulose, polyethylene glycol,
titanium dioxide, and synthetic
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, simultaneou