RANITIDINE- ranitidine tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

DIRECT RX

INN (International Name):

RANITIDINE HYDROCHLORIDE

Composition:

RANITIDINE 300 mg

Administration route:

ORAL

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 been carried

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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

RANITIDINE- RANITIDINE TABLET, FILM COATED
DIRECT RX
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RANITIDINE
DESCRIPTION SECTION
The active ingredient in ranitidine tablets USP 150 mg and 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 structure:
[Structural Formula for Ranitidine]
The empirical formula is C13H22N4O3S•HCl, representing a molecular
weight of 350.87.
Ranitidine HCl USP 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 USP
equivalent to 150 mg of ranitidine. Each tablet also contains the
inactive ingredients microcrystalline
cellulose, croscarmellose sodium, colloidal silicon dioxide, magnesium
stearate, FD&C Red # 40
Aluminum Lake, hypromellose, titanium dioxide, triacetin.
Each ranitidine tablet USP 300 mg for oral administration contains 336
mg of ranitidine HCl USP
equivalent to 300 mg of ranitidine. Each tablet also contains the
inactive ingredients microcrystalline
cellulose, croscarmellose sodium, colloidal silicon dioxide, magnesium
stearate, FD&C Red # 40
Aluminum Lake, hypromellose, titanium dioxide, triacetin.
CLINICAL PHARMACOLOGY SECTION
Ranitidine Tablets, USP is a competitive, reversible inhibitor of the
action of histamine at the histamine
H2-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 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 b