RANITIDINE HYDROCHLORIDE capsule

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

Dr. Reddy's Laboratories Limited

ІПН (Міжнародна Ім'я):

Ranitidine hydrochloride

Склад:

ranitidine 150 mg

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

  Ranitidine is indicated in:   1. 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. 2. 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. 3.The treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome and systemic mastocytosis). 4. 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. 5.Maintenance therapy for gastric ulcer patients at reduced dosage after healing of acute ulcers. Placebo-controlled studi

Огляд продуктів:

Ranitidine Hydrochloride Capsules 150 mg White to pale yellow powder filled in size '3', hard gelatin capsules with opaque light brown colored cap and opaque light brown colored body, imprinted 'CD' on cap and '129' on body, with black ink. The capsules are supplied in bottles of 60's and 500's.   Bottles of 60 NDC 55111-129-60 Bottles of 500 NDC 55111-129-05   Ranitidine Hydrochloride Capsules 300 mg White to pale yellow powder filled in size '1', hard gelatin capsules with opaque light brown colored cap and opaque light brown colored body, imprinted 'CD' on cap and '130' on body, with black ink. The capsules are supplied in bottles of 30's and 100's.   Bottles of 30 NDC55111-130-30 Bottles of 100 NDC 55111-130-01 Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature] in a dry place. Protect from light. Dispense in a tight, light resistant container. Rx Only Manufactured by: Dr. Reddy’s Laboratories Limited Bachupally – 500 090 INDIA Revised: 0517

Статус Авторизація:

Abbreviated New Drug Application

Характеристики продукта

RANITIDINE HYDROCHLORIDE- RANITIDINE HYDROCHLORIDE CAPSULE
DR. REDDY'S LABORATORIES LIMITED
----------
RANITIDINE HYDROCHLORIDE CAPSULES, 150 MG AND 300 MG
DESCRIPTION
Ranitidine hydrochloride (HCl) 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,
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 hydrochloride USP is a white to pale yellow, crystalline
practically odorless powder, is
sensitive to light and moisture. It is very soluble in water and
sparingly soluble in alcohol.
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 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