RANITIDINE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Amneal Pharmaceuticals of New York LLC

INN (International Name):

RANITIDINE HYDROCHLORIDE

Composition:

RANITIDINE 150 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Ranitidine Tablets, USP are 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

Product summary:

Ranitidine Tablets, USP 150 mg (ranitidine HCl equivalent to 150 mg of ranitidine) are supplied as orange, round, biconvex aqueous film-coated tablets debossed “IP 253” on one side and plain on the reverse.  They are available as follows: Bottles of 60:              NDC 53746-253-60 Bottles of 100:            NDC 53746-253-01 Bottles of 180:            NDC 53746-253-18 Bottles of 500:            NDC 53746-253-05 Bottles of 1000:          NDC 53746-253-10 Ranitidine Tablets, USP 300 mg (ranitidine HCl equivalent to 300 mg of ranitidine) are supplied as yellow, capsule-shaped aqueous film-coated tablets debossed “IP 254” on one side and plain on the reverse.  They are available as follows: Bottles of 30:              NDC 53746-254-30 Bottles of 100:            NDC 53746-254-01 Bottles of 250:            NDC 53746-254-02 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] in a dry place. Dispense in a tight, light-resistant container as defined in the USP.  Protect from light. Replace cap securely after each opening. Distributed by: Amneal Pharmaceuticals Bridgewater, NJ 08807 Rev. 09-2015-02

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

RANITIDINE- RANITIDINE TABLET
AMNEAL PHARMACEUTICALS OF NEW YORK LLC
----------
RANITIDINE TABLETS, USP
RX ONLY
DESCRIPTION
The active ingredient in Ranitidine Tablets, USP 150 mg and Ranitidine
Tablets, USP 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 is a white to pale yellow, granular substance that is
soluble in water. It has
a slightly bitter taste and sulfurlike odor.
Each Ranitidine Tablets, USP 150 mg for oral administration contains
167.4 mg of
ranitidine HCl equivalent to 150 mg of ranitidine. Each tablet also
contains the inactive
ingredients colloidal silicon dioxide, croscarmellose sodium,
hypromellose, magnesium
stearate, microcrystalline cellulose, polydextrose, titanium dioxide,
triethyl citrate and
FD&C Yellow #6.
Each Ranitidine Tablets, USP 300 mg for oral administration contains
334.8 mg of
ranitidine HCl equivalent to 300 mg of ranitidine. Each tablet also
contains the inactive
ingredients colloidal silicon dioxide, croscarmellose sodium,
hypromellose, magnesium
stearate, microcrystalline cellulose, polydextrose, titanium dioxide,
triethyl citrate and
D&C Yellow #10.
CLINICAL PHARMACOLOGY
Ranitidine Tablets, USP are a competitive, reversible inhibitor of the
action of histamine at
the histamine H -receptors, including receptors on the gastric cells.
Ranitidine Tablets,
USP do not lower serum Ca
in hypercalcemic states. Ranitidine Tablets, USP are not
an anticholinergic agent.
PHARMACOKINETICS: _ABSORPTION:_ Ranitidine Tablets, USP are 50%
absorbed after oral
administration, compared to an intravenous (IV) injection with mean
peak levels of 440
2
13
22
4
3
2
++
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. Propanth