RANITIDINE - ranitidine syrup

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Sandoz Inc.

INN (International Name):

RANITIDINE

Composition:

RANITIDINE 15 mg in 1 mL

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Ranitidine oral solution, USP 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 carri

Product summary:

Ranitidine Oral Solution, USP, is a clear, pale yellow, peppermint-flavored liquid. Each mL contains 16.8 mg of ranitidine hydrochloride equivalent to 15 mg of ranitidine supplied in bottles of 16 fluid ounces (one pint) (NDC 0781-6087-16). Store between 4° and 25°C (39° and 77°F) [see USP Controlled Room Temperature]. Do not freeze. Dispense in tight, light-resistant containers as defined in the USP/NF. Call your doctor for medical advice about side effects.  You may report side effects to FDA at 1-800-FDA-1088. Manufactured by TOLMAR Inc. Fort Collins, CO 80526 for Sandoz Inc. Princeton, NJ 08540 44431 Rev. 0 10/10 MULTISTIX is a registered trademark of Bayer Healthcare LLC.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

RANITIDINE - RANITIDINE SYRUP
SANDOZ INC.
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RANITIDINE ORAL SOLUTION, USP
DESCRIPTION
The active ingredient in ranitidine syrup (ranitidine oral solution,
USP) 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 mL of ranitidine oral solution, USP contains 16.8 mg of
ranitidine HCl equivalent to 15 mg of
ranitidine. Ranitidine oral solution, USP also contains the inactive
ingredients alcohol, butylparaben,
dibasic sodium phosphate heptahydrate, hypromellose, peppermint
flavor, monobasic potassium
phosphate, propylparaben, purified water, saccharin sodium, sodium
chloride, and sorbitol.
CLINICAL PHARMACOLOGY
Ranitidine oral solution, USP is a competitive, reversible inhibitor
of the action of histamine at the
histamine H -receptors, including receptors on the gastric cells.
Ranitidine oral solution, USP does not
lower serum Ca++ in hypercalcemic states. Ranitidine oral solution,
USP is not an anticholinergic agent.
_PHARMACOKINETICS_
_ABSORPTION: _Ranitidine oral solution, USP 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. The oral solution formulation is bioequivalent to the
tablets. 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 oral solution, USP.
_DISTRIBUTIO