RANITIDINE HYDROCHLORIDE capsule

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

AvKARE, Inc.

DCI (Dénomination commune internationale):

RANITIDINE HYDROCHLORIDE

Composition:

RANITIDINE 150 mg

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

  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

Descriptif du produit:

Ranitidine Hydrochloride Capsules 150 mg are Size 3, opaque light brown hard gelatin capsules imprinted “CD” and “129” in black edible ink. The capsules are supplied in bottles of 500 (NDC 42291-735-50) Ranitidine Hydrochloride Capsules 300 mg are Size 1, opaque light brown hard gelatin capsulesimprinted “CD” and “130” in black edible ink. The capsules are supplied in bottles of 500 (NDC 42291-736-50) Store at controlled room temperature 15° - 30°C (59° - 86°F) (see USP) in a dry place. Protect from light. Dispense in a tight, light resistant container. Manufactured for: AvKARE, Inc.                  Pulaski, TN 38478 Mfg. Rev. 0205 AV 11/16 (P)

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

RANITIDINE HYDROCHLORIDE- RANITIDINE HYDROCHLORIDE CAPSULE
AVKARE, INC.
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RANITIDINE HYDROCHLORIDE CAPSULES
DESCRIPTION
The active ingredient in Ranitidine Hydrochloride Capsules, 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 structural formula:
The molecular formula is C
H
N
O
S•HCl, representing a molecular weight of 350.87.
Ranitidine HCl is a white to pale yellow, crystalline substance that
is soluble in water. It has a slightly
bitter taste and sulfur-like odor.
Each Ranitidine Hydrochloride capsule, for oral administration,
contains 167.4 mg or 334.8 mg of
ranitidine hydrochloride equivalent to 150 mg or 300 mg of ranitidine,
respectively. In addition, each
capsule contains the following inactive ingredients: Microcrystalline
Cellulose, Sodium Starch
Glycolate, Magnesium Stearate. The capsule shells contain Black Iron
Oxide, Red Iron Oxide T3469,
Yellow Iron Oxide T3506, Titanium Dioxide and Gelatin. The capsule
shells are imprinted with edible
ink.
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.
_DIS