RANITIDINE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

State of Florida DOH Central Pharmacy

INN (International Name):

RANITIDINE

Composition:

RANITIDINE 150 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Ranitidine tablets 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 for

Product summary:

150 mg tablets: peach to light-brown colored, round unscored tablets debossed“Par 544” on one side and plain on the othe. 300 mg tablets: peach to light-brown colored, oval unscored tablets debossed “Par 545” on one side and plain on the other. They are supplied by State of Florida DOH Central Pharmacy as follows: Store at 15°-30°C (59°-86°F) in a dry place. Protect from light. Replace cap securely after opening. Dispense in a tight, light-resistant container as defined in the USP. Manufactured by: PAR PHARMACEUTICAL COMPANIES, INC. Spring Valley, NY 10977 This Product was Repackaged By: State of Florida DOH Central Pharmacy 104-2 Hamilton Park Drive Tallahassee, FL 32304 United States

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

RANITIDINE - RANITIDINE TABLET
STATE OF FLORIDA DOH CENTRAL PHARMACY
----------
DESCRIPTION
Ranitidine hydrochloride (HCl), USP, 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-ethene-diamine,
HCl. It has the following structural formula:
The molecular formula is C
H N O S•HCl, representing a molecular weight of 350.87.
Ranitidine HCl is a white to pale yellow, crystalline substance that
is soluble in water. It has a slightly
bitter taste and sulfurlike odor.
Each tablet, for oral administration, contains 168 mg or 336 mg of
ranitidine hydrochloride equivalent to
150 mg or 300 mg of ranitidine, respectively. In addition, each tablet
contains the following inactive
ingredients: FD&C Yellow No. 6 Aluminum Lake, hypromellose, lactose
monohydrate, magnesium
stearate, microcrystalline cellulose, pregelatinized starch, synthetic
yellow iron oxide, titanium dioxide
and triethyl citrate.
CLINICAL PHARMACOLOGY
Ranitidine is a competitive, reversible inhibitor of the action of
histamine at the histamine H2-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 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 ranitidine, probably by
delaying gastric emptying and transit
time. In one study, simultaneous administration of high-potency
antacid (150 mmol) in fasting subjects
has been reported to decrease the absorption of ranitidine.
DISTRIBUTION:The volume of distribution is about 1.4 L/kg. Serum
protein binding averages 15%.
METABOLISM:In humans, the N-oxide is the principal metabolite in the
urine; however, this amoun