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:

NCS HealthCare of KY, LLC dba Vangard Labs

INN (International Name):

RANITIDINE HYDROCHLORIDE

Composition:

RANITIDINE 150 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

    Ranitidine tablets USP 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 car

Product summary:

    Ranitidine tablets USP 150 mg (ranitidine HCl USP equivalent to 150 mg of ranitidine) are pink colored, circular, biconvex, beveled edge film coated tablets with “G51” engraved on one side, “150” on the other side. They are available in blistercards of 30 (NDC 0615-8021-39), blistercards of 15 (NDC 0615-8021-05) and unit dose boxes of 30 (NDC 0615-8021-30) tablets.     Ranitidine tablets USP 300 mg (ranitidine HCl USP equivalent to 300 mg of ranitidine) are pink colored, circular, biconvex, beveled edge film coated tablets with “G51” engraved on one side “300” on the other side.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

RANITIDINE- RANITIDINE TABLET, FILM COATED
NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS
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RANITIDINE TABLETS USP, 150 MG AND 300 MG
PRESCRIBING INFORMATION
DESCRIPTION
The active ingredient in ranitidine tablets USP 150 mg and 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 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
Ranitidine is a competitive, reversible inhibitor of the action of
histamine at the
histamine H -receptors, including receptors on the gastric cells.
Ranitidine does not
lower serum Ca++ in hypercalcemic states. Ranitidine is not an
anticholinergic agent.
PHARMACOKINETICS:
_ABSORPTION:_ Ranitidine is 50% absorbed after oral administration,
compared to an
2
13
22
4
3
2
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
bl