RANITIDINE syrup

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Pharmaceutical Associates, Inc.

INN (International Name):

RANITIDINE

Composition:

RANITIDINE 15 mg in 1 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Ranitidine Syrup (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 studie

Product summary:

Ranitidine Syrup (Ranitidine Oral Solution USP), a clear, pale yellow, spearmint-flavored liquid, contains 16.8 mg of ranitidine hydrochloride equivalent to 15 mg of ranitidine per 1 mL of oral solution (75 mg/5 mL) supplied in: Store at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature). Do not freeze. Dispense in tight, light-resistant containers as defined in the USP/NF.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

RANITIDINE- RANITIDINE SYRUP
PHARMACEUTICAL ASSOCIATES, INC.
----------
RANITIDINE SYRUP
(RANITIDINE ORAL SOLUTION USP)
RX ONLY
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 1 mL of Ranitidine Syrup (Ranitidine Oral Solution USP) contains
16.8 mg of
ranitidine HCl equivalent to 15 mg of ranitidine. Ranitidine Syrup
(Ranitidine Oral Solution
USP) also contains the inactive ingredients dibasic sodium phosphate,
hydroxyethylcellulose, methylparaben, purified water, sodium chloride,
sodium
saccharin, spearmint flavor, sucrose and may contain monobasic sodium
phosphate.
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 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. The oral solution 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
2
13
22
4
3
2
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