RANITIDINE HYDROCHLORIDE 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:

State of Florida DOH Central Pharmacy

INN (International Name):

RANITIDINE HYDROCHLORIDE

Composition:

RANITIDINE HYDROCHLORIDE 150 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Ranitidine is indicated in: - 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. - 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. - The treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome and systemic mastocytosis). - 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. - Maintenance therapy for gastric ulcer patients at reduced dosage after healing of acute ulcers. Placebo-controlled studies have been carried out for 1 year. -

Product summary:

Ranitidine Tablets, USP for oral administration, are available as: 150 mg: round, off-white, unscored tablets, film-coated pink, debossed GG 705 on one side and plain on the reverse side. 300 mg: round, off-white, unscored tablets, film-coated orange, debossed GG 706 on one side and plain on the reverse side. Ranitidine Capsules, for oral administration, are available as: 150 mg: Opaque caramel capsules, imprinted GG 614 in white ink, filled with off-white powder. 300 mg: Opaque caramel capsules, imprinted GG 615 in white ink, filled with off-white powder. They are supplied by State of Florida DOH Central Pharmacy as follows: Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature) in a dry place. Protect from light. Replace cap securely after each opening. Dispense in a tight, light-resistant container.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

RANITIDINE HYDROCHLORIDE - RANITIDINE HYDROCHLORIDE TABLET, FILM
COATED
STATE OF FLORIDA DOH CENTRAL PHARMACY
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RANITIDINE TABLETS, USP AND RANITIDINE CAPSULES
DESCRIPTION
Ranitidine hydrochloride (HCl), is 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 tablet, for oral administration contains 168 mg or 336 mg of
ranitidine hydrochloride equivalent to
150 mg and 300 mg of ranitidine, respectively. Inactive ingredients: D
& C Red #30 Aluminum Lake,
hydroxypropyl cellulose, hydroxypropyl methylcellulose, magnesium
stearate, microcrystalline
cellulose, triethyl citrate, sodium starch glycolate, titanium dioxide
and flavoring. The 300 MG also
contains: D & C Yellow #10 Aluminum Lake.
Each capsule, for oral administration contains 168 mg or 336 mg of
ranitidine hydrochloride equivalent
to 150 mg and 300 mg of ranitidine, respectively. Inactive
ingredients: Ammonium hydroxide, colloidal
silicon dioxide, corn starch, FD & C Blue #1, FD & C Red #40, FD & C
Yellow #6, gelatin,
magnesium stearate, pharmaceutical glaze, propylene glycol, silicon
dioxide, simethicone, sodium
lauryl sulfate, sodium starch glycolate, and titanium dioxide.
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 a anticholinergic agent.
PHARMACOKINETICS
ABS ORPTION
Ranitidine tablets and ranitidine capsules 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