RANITIDINE IMMEDIATE RELEASE- ranitidine tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Proficient Rx LP

INN (International Name):

RANITIDINE HYDROCHLORIDE

Composition:

RANITIDINE 300 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Ranitidine tablets, USP is 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 is contraindicated for patients known to have hypersensitivity to the drug or any of the ingredients (see PRECAUTIONS).

Product summary:

Ranitidine tablets, USP 300 mg (ranitidine HCl USP equivalent to 300 mg of ranitidine) are brown coloured, circular shaped, biconvex, beveled edge film-coated tablets debossed with “S on one side and plain on the other side.                                                                                                                                                                                                                                                                              430”                                                                              They are available in bottles of 30 (NDC 63187-855-30), 60 (NDC 63187-855-60) and 90 (NDC 63187-855-90) tablets. Store at 20° to 25° C (68° and 77° F); excursions permitted between 15° and 30° C (59° and 86° F) [see USP Controlled Room Temperature]. Protect from light. Replace cap securely after each opening. Manufactured by: Strides Shasun Limited, Unit II, R.S. No: 32, 33/11 and 34/2, PIMS Road, Periyakalapet, Puducherry-605 014, India. Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320 Revised: November 2016

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

RANITIDINE IMMEDIATE RELEASE- RANITIDINE TABLET
PROFICIENT RX LP
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RANITIDINE TABLETS, USP FILM COATED
STRIDES SHASUN LIMITED
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 crystalline powder that
is soluble in water. It has a
slightly bitter taste and sulfur-like odor.
Each ranitidine tablets, 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 magnesium stearate,
microcrystalline cellulose, croscarmellose sodium, silicon dioxide,
hypromellose, titanium dioxide,
triacetin, and iron oxide red.
Each ranitidine tablets, 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 magnesium stearate,
microcrystalline cellulose, croscarmellose sodium, silicon dioxide,
hypromellose, titanium dioxide,
triacetin, and iron oxide red.
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 with an intravenous (IV)
injection with mean peak levels of 440 to 545 ng/mL occurring 2 to 3
hours after a 150-mg dose. The
syrup is bioequivalent to the tablets. Absorption is not significantly
impaired by the administration of
food or antacids. Propantheline slightly delays and increases peak
blood lev