RANITIDINE 150 MG- ranitidine tablet, film coated RANITIDINE 300 MG- ranitidine tablet, film coated

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Vivimed Labs Limited

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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–Ellision 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 been

Podsumowanie produktu:

Ranitidine Tablets USP, 150 mg are Peach colored, five sided, biconvex, film coated tablets debossed with  on one side and  on the other side. They are available in bottles of 30 (62980-514-01), 60 (62980-514-02), 180 (62980-514-03) , 500 (62980-514-04) and 5 x 7’s (unit–dose tablets) (62980-514-06). Ranitidine Tablets USP, 300 mg are Yellow colored, capsule shaped, biconvex, film coated tablets debossed with  on one side and plain on the other side. They are available in bottles of 30 (62980-515-01), 60 (62980-515-02), 250(62980-515-03) and 5 x 7’s (unit–dose tablets) (62980-515-05). Store between 15º and 30ºC (59º and 86º F) in a dry place. Protect from light. Replace cap securely after each opening. Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107, 108, SIDCO Pharmaceutical Complex, Alathur, Kanchipuram Dist – 603 110, Tamilnadu, India. Distributed by: Vivimed Labs USA, 1100 Cornwall Road, Suite 160, Monmouth Junction, NJ 08852, USA. MULTISTIX is a registered trademark of Bayer Healthcare LLC. Revision: 02/2018

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

RANITIDINE 150 MG- RANITIDINE TABLET, FILM COATED
RANITIDINE 300 MG- RANITIDINE TABLET, FILM COATED
VIVIMED LABS LIMITED
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RANITIDINE TABLETS USP, 150 MG
RANITIDINE TABLETS USP, 300 MG
DESCRIPTION
The active ingredient in Ranitidine Tablets USP, 150 mg and Ranitidine
Tablets USP, 300 mg is
ranitidine hydrochloride (HCl) USP, a histamine H2-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 structue:
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 sulfur like odor.
Each Ranitidine Tablet USP, 150 mg for oral administration contains
168 mg of ranitidine HCl
equivalent to 150 mg of ranitidine. Each tablet also contains the
inactive ingredients Colloidal Silicon
Dioxide (Aerosil 200 NF), Croscarmellose Sodium NF (Ac-Di-Sol), FD&C
Yellow #6/ Sunset Yellow
FCF Aluminium Lake, glyceryl monostearate, Iron oxide yellow,
Magnesium stearate NF (Ligamed MF-
2-V), Microcrystalline Cellulose NF (Avicel PH-112), Polyvinyl
alcohol,Purified Water USP, Sodium
Lauryl Sulfate, Talc and Titanium Dioxide.
Each Ranitidine Tablet USP, 300 mg for oral administration contains
336 mg of ranitidine HCl
equivalent to 300 mg of ranitidine. Each tablet also contains the
inactive ingredients Colloidal Silicon
Dioxide (Aerosil 200 NF), Croscarmellose Sodium NF (Ac-Di-Sol), D&C
Yellow # 10 Aluminium
Lake, Glyceryl monostearate, Magnesium stearate NF (Ligamed MF-2-V),
Microcrystalline Cellulose
NF (Avicel PH-112), Polyvinyl alcohol, Purified Water USP, Sodium
Lauryl Sulfate, Talc and Titanium
Dioxide.
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 Tabl