RANITIDINE tablet

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

Preferred Pharmaceuticals, Inc

INN (국제 이름):

RANITIDINE HYDROCHLORIDE

구성:

RANITIDINE 150 mg

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

Ranitidine Tablets, USP are indicated in: Concomitant antacids should be given as needed for pain relief to patients with active duodenal ulcer; active, benign gastric ulcer; hypersecretory states; GERD; and erosive esophagitis. Ranitidine Tablets, USP are contraindicated for patients known to have hypersensitivity to the drug or any of the ingredients (see PRECAUTIONS ).

제품 요약:

Ranitidine Tablets, USP 150 mg (ranitidine HCl equivalent to 150 mg of ranitidine) are supplied as orange, round, biconvex aqueous film-coated tablets debossed “IP 253” on one side and plain on the reverse.  They are available as follows: Bottle of 30 – 68788-9875-3 Bottle of 60 – 68788-9875-6 Bottle of 90 – 68788-9875-9 Bottle of 100 – 68788-9875-1 Bottle of 120 – 68788-9875-8 Ranitidine Tablets, USP 300 mg (ranitidine HCl equivalent to 300 mg of ranitidine) are supplied as yellow, capsule-shaped aqueous film-coated tablets debossed “IP 254” on one side and plain on the reverse.  They are available as follows: Bottle of 14 – 68788-9874-1 Bottle of 30 – 68788-9874-3 Bottle of 60 – 68788-9874-6 Bottle of 90 – 68788-9874-9 Bottle of 100 – 68788-9874-0 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] in a dry place. Dispense in a tight, light-resistant container as defined in the USP.  Protect from light. Replace cap securely after each opening. Distributed by: Amneal Pharmaceuticals Bridgewater, NJ 08807 Rev. 09-2015-02 Repackaged By: Preferred Pharmaceuticals Inc.

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

RANITIDINE- RANITIDINE TABLET
PREFERRED PHARMACEUTICALS, INC
----------
RANITIDINE TABLETS, USP
RX ONLY
DESCRIPTION
The active ingredient in Ranitidine Tablets, USP 150 mg and Ranitidine
Tablets, USP 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 is a white to pale yellow, granular substance that is soluble in
water. It has a slightly bitter taste and
sulfurlike odor.
Each Ranitidine Tablets, USP 150 mg for oral administration contains
167.4 mg of ranitidine HCl
equivalent to 150 mg of ranitidine. Each tablet also contains the
inactive ingredients colloidal silicon
dioxide, croscarmellose sodium, hypromellose, magnesium stearate,
microcrystalline cellulose,
polydextrose, titanium dioxide, triethyl citrate and FD&C Yellow #6.
Each Ranitidine Tablets, USP 300 mg for oral administration contains
334.8 mg of ranitidine HCl
equivalent to 300 mg of ranitidine. Each tablet also contains the
inactive ingredients colloidal silicon
dioxide, croscarmellose sodium, hypromellose, magnesium stearate,
microcrystalline cellulose,
polydextrose, titanium dioxide, triethyl citrate and D&C Yellow #10.
CLINICAL PHARMACOLOGY
Ranitidine Tablets, USP are a competitive, reversible inhibitor of the
action of histamine at the
histamine H -receptors, including receptors on the gastric cells.
Ranitidine Tablets, USP do not lower
serum Ca
in hypercalcemic states. Ranitidine Tablets, USP are not an
anticholinergic agent.
PHARMACOKINETICS: _ABSORPTION:_ Ranitidine Tablets, USP 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