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:

Glenmark Pharmaceuticals Inc., USA

INN (International Name):

RANITIDINE HYDROCHLORIDE

Composition:

RANITIDINE 150 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Ranitidine tablets USP are indicated in: Concomitant antacids should be given as needed for pain relief to patients with active duodenal ulcer; active, benign gastric ulcer; hypersecretory states; GERD; and erosive esophagitis. Ranitidine tablets USP are contraindicated for patients known to have hypersensitivity to the drug or any of the ingredients (see PRECAUTIONS ).

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 and “150” on the other side. They are available in bottles of 60 (NDC 68462-248-60), 100 (NDC 68462-248-01), and 500 (NDC 68462-248-05) 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 and “300” on the other side. They are available in bottles of 30 (NDC 68462-249-30) ,100 (NDC 68462-249-01) and 250 (NDC 68462-249-20) tablets.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

RANITIDINE- RANITIDINE TABLET, FILM COATED
GLENMARK PHARMACEUTICALS INC., USA
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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 :
ABS ORPTION:
Ranitidine 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 blood levels of ranitidin