RANITIDINE - ranitidine syrup

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Unit Dose Services

INN (International namn):

RANITIDINE HYDROCHLORIDE

Sammansättning:

RANITIDINE 15 mg in 1 mL

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

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 carried

Produktsammanfattning:

NDC:50436-0291-1 in a SYRINGE, PLASTIC of 1 SYRUPS

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

RANITIDINE - RANITIDINE SYRUP
UNIT DOSE SERVICES
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RANITIDINE SYRUP (RANITIDINE ORAL SOLUTION, USP)
DESCRIPTION
CLINICAL PHARMACOLOGY
_PHARMACOKINETICS_
ABS ORPTION
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:
2
The molecular formula is C H N O S•HCl, representing a molecular
weight of 350.87.
132243
Ranitidine HCl is a white to pale yellow crystalline powder that is
very soluble in water and
sparingly soluble in alcohol.
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 7.5%
alcohol, butylparaben, dibasic sodium phosphate, hypromellose,
monobasic potassium
phosphate, natural & artificial mint flavor, propylparaben, purified
water, saccharin sodium,
sodium chloride, and sorbitol solution.
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.
2
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. The oral solution formulation is bioequivalent to the tablets.
Absorption is not
significantly impaired by the administration of food or antacids.
Propantheline slightly
DIS TRIBUTION
METABOLIS M
EXCRETION
GERIATRICS
PEDIATRICS
TABLE 1. RANITIDINE PHARMACOKINETICS IN PEDIATRIC PATIENTS FOLLOWING
ORAL DOSING
Population (age)
n
Dosage Form
Cmax
Tmax
delays and increases peak blood levels of ranitidine, probably by
delaying gastric emptying
and transit time. In one study, simultaneous administration of
high