RANITIDINE tablet

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

Wockhardt USA LLC.

INN (국제 이름):

RANITIDINE HYDROCHLORIDE

구성:

RANITIDINE 150 mg

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

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 ou

제품 요약:

Ranitidine Tablets USP 150 mg (ranitidine HCl equivalent to 150 mg of ranitidine) are orange colored, film-coated, irregular hexagonal-shaped tablets debossed with "W" on one side and plain on other side.                          447 They are available in following packs. PACKS                                     NDC NUMBER 10 Tablets                                     64679-447-01 60 Tablets                                     64679-447-04 100 Tablets                                   64679-447-02 10 X 10's Blister Pack                  64679-447-03 500 Tablets                                   64679-447-06 Ranitidine Tablets USP 300 mg (ranitidine HCl equivalent to 300 mg of ranitidine) are white to off white, film-coated, capsule-shaped tablets debossed with "W742" on one side and plain on other side. They are available in following packs. PACKS                                NDC NUMBER 30 Tablets                                     64679-742-01 100 Tablets                                   64679-742-04 250 Tablets                                   64679-742-02 10 X 10's Blister Pack                64679-742-03 Store between 20° and 25°C (68°and 77°F) in a dry place. Protect from light. Replace cap securely after each opening.  Bottle contains desiccant. Rx only MULTISTIX is a registered trademark of Bayer Healthcare LLC. Manufactured By: Wockhardt Limited Mumbai, India. Distributed By: Wockhardt USA LLC. 20 Waterview Blvd. Parsippany, NJ 07054 USA. Iss.210711

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

RANITIDINE- RANITIDINE TABLET
WOCKHARDT USA LLC.
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RANITIDINE TABLETS USP, 150 MG AND 300 MG
PRESCRIBING INFORMATION
DESCRIPTION
The active ingredient in ranitidine tablets 150 mg and 300 mg is
ranitidine hydrochloride (HCl), USP, a
histamine H 2-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 2N O S•HCl, representing a molecular weight of 350.87.
Ranitidine HCl is a white to pale yellow, crystalline practically
odorless powder, very soluble in water,
sparingly soluble in alcohol.
Each ranitidine tablet 150 mg for oral administration contains 168 mg
of ranitidine HCl equivalent to 150
mg of ranitidine. Each tablet also contains the inactive ingredients
microcrystalline cellulose,
croscarmellose sodium, magnesium stearate, colloidal silicon dioxide,
hypromellose, titanium dioxide,
diethyl phthalate, FD&C yellow # 6 and iron oxide red.
Each Ranitidine Tablet 300 mg for oral administration contains 336 mg
of ranitidine HCl equivalent to
300 mg of ranitidine. Each tablet also contains the inactive
ingredients microcrystalline cellulose,
croscarmellose sodium, magnesium stearate, colloidal silicon dioxide,
hypromellose, titanium dioxide,
and diethyl phthalate.
CLINICAL PHARMACOLOGY
Ranitidine is a competitive, reversible inhibitor of the action of
histamine at the histamine H2-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
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