RANITIDINE- ranitidine tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

REMEDYREPACK INC.

INN (International Name):

RANITIDINE HYDROCHLORIDE

Composition:

RANITIDINE 300 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Ranitidine Tablets are 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 been c

Product summary:

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: Bottles of 60:              NDC 65162-253-06 Bottles of 100:            NDC 65162-253-10 Bottles of 180:            NDC 65162-253-18 Bottles of 500:            NDC 65162-253-50 Bottles of 1000:          NDC 65162-253-11 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: Bottles of 30:              NDC 65162-254-03 Bottles of 100:            NDC 65162-254-10 Bottles of 250:            NDC 65162-254-25 Bottles of 1000:          NDC 65162-254-11 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. Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, INDIA 382220 Or Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Oral Solid Dosage Unit Ahmedabad, India 382213 Distributed by: Amneal Pharmaceuticals Bridgewater, NJ 08807 Rev. 09-2016-01

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

RANITIDINE- RANITIDINE TABLET
REMEDYREPACK 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
sulfur like odor.
Each Ranitidine Tablet, 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 Tablet, 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 are a competitive, reversible inhibitor of the
action of histamine at the histamine H
-
receptors, including receptors on the gastric cells. Ranitidine
Tablets do not lower serum Ca
in
hypercalcemic states. Ranitidine Tablets are not an anticholinergic
agent.
PHARMACOKINETICS
_ABSORPTION:_ Ranitidine Tablets 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 ra