RANITIDINE tablet, film coated

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

NuCare Pharmaceuticals, Inc.

Designación común internacional (DCI):

RANITIDINE HYDROCHLORIDE

Composición:

RANITIDINE 150 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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

Resumen del producto:

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 20 (NDC 66267-188-20), 30 (NDC 66267-188-30), 60 (NDC 66267-188-60), 90 (NDC 66267-188-90), and 180 (NDC 66267-188-92) tablets.

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

RANITIDINE- RANITIDINE TABLET, FILM COATED
NUCARE PHARMACEUTICALS, INC.
----------
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 :
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, pro