SENTRADINE- ranitidine hydrochloride, choline kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Physician Therapeutics LLC

INN (International Name):

RANITIDINE HYDROCHLORIDE

Composition:

RANITIDINE HYDROCHLORIDE 150 mg

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Ranitidine Tablets, USP 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 studies have b

Product summary:

Ranitidine Tablets, USP 150 mg are orange, round, biconvex aqueous film coated tablets debossed “IP 253” on one side and plain on the reverse. They are available in bottles of 24, 60, 100, 180, 500 and 1000. Ranitidine Tablets, USP 300 mg are yellow, capsule-shaped aqueous film coated tablets debossed “IP 254” on one side and plain on the reverse. They are available in bottles of 24, 30, 100, 250, 500 and 1000. Store at 20° - 25°C (68° - 77°F) (See USP Controlled Room Temperature) in a tight, light resistant container.  Protect from light. Replace cap securely after each opening. Manufactured by: Amneal Pharmaceuticals of NY Hauppauge, NY 11788 Distributed by: Amneal Pharmaceuticals Glasgow, KY 42141 Rev. 11-2009 How Supplied   Sentra PM is supplied in red and white, size 0 capsules in bottles of 60 capsules.   Physician Supervision   Sentra PM is a Medical Food product available by prescription only and must be used while the patient is under ongoing physician supervision.   Sentra PM is supplied to physicians in a recyclable plastic bottle with a child-resistant cap.  U.S. patents pending.   Manufactured by Arizona Nutritional  Supplements, Inc. Chandler AZ 85225  Distributed by Physician Therapeutics LLC, Los Angeles, CA 90077.  www.ptlcentral.com   © Copyright 2003-2006, Physician Therapeutics LLC, all rights reserved   NDC # 68405-1003-02

Authorization status:

unapproved drug other

Summary of Product characteristics

SENTRADINE - RANITIDINE HYDROCHLORIDE, CHOLINE
PHYSICIAN THERAPEUTICS LLC
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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SENTRADINE
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 C13H22N4O3S·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 is a competitive, reversible inhibitor of the
action of histamine at the histamine
H -receptors, including receptors on the gastric cells. Ranitidine
Tablets, USP does not lower serum
Ca
in hypercalcemic states. Ranitidine Tablets, USP is not an
anticholinergic agent.
PHARMACOKINETICS: _ABSORPTION:_ Ranitidine Tablets, USP is 50%
absorbed after oral administration,
compared to an intravenous (IV) injection with mean peak levels of