RANITIDINE HYDROCHLORIDE- ranitidine hydrochloride capsule

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

AvKARE, Inc

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

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. -

Produktsammanfattning:

Ranitidine Capsules, for oral administration, are available as: 150 mg: Opaque caramel hard gelatin capsules, imprinted with “AC” on cap and “535” on body in black ink, filled with pale yellow to brownish powder, and supplied as: NDC 42291-766-50 bottles of 500 capsules 300 mg: Opaque caramel hard gelatin capsules, imprinted with “AC” on cap and “536” on body in black ink, filled with pale yellow to brownish powder, and supplied as: NDC 42291-767-50 bottles of 500 capsules Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] in a dry place. Protect from light. Replace cap securely after each opening. Dispense in a tight, light-resistant container. Manufactured for: AvKARE, Inc. Pulaski, TN 38478 Mfg. Rev. 03/19 AV 07/19 (P)

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

RANITIDINE HYDROCHLORIDE- RANITIDINE HYDROCHLORIDE CAPSULE
AVKARE, INC
----------
RANITIDINE CAPSULES
RX ONLY
DESCRIPTION
Ranitidine hydrochloride (HCl), 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, 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, crystalline practically
odorless powder. It is very soluble in
water and sparingly soluble in alcohol.
Each capsule, for oral administration contains 168 mg or 336 mg of
ranitidine hydrochloride equivalent
to 150 mg and 300 mg of ranitidine, respectively. Inactive
ingredients: magnesium stearate,
microcrystalline cellulose, and sodium starch glycolate. The capsule
shell contains FD&C blue 1,
FD&C red 40, FD&C yellow 6, gelatin, titanium dioxide and sodium
lauryl sulfate. The capsule shells
are imprinted with edible ink black containing black iron oxide,
potassium hydroxide, propylene glycol,
shellac and strong ammonia solution.
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 a anticholinergic agent.
PHARMACOKINETICS
Absorption
Ranitidine capsules 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 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.