RANITIDINE- ranitidine hydrochloride solution

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Lannett Company, Inc.

Designación común internacional (DCI):

RANITIDINE HYDROCHLORIDE

Composición:

RANITIDINE 15 mg in 1 mL

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Ranitidine oral solution 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 out

Resumen del producto:

Ranitidine Oral Solution, a clear, peppermint-flavored liquid, contains 16.8 mg of ranitidine HCl equivalent to 15 mg of ranitidine per 1 mL (75 mg/5 mL) in bottles of 16 fluid ounces (one pint) (NDC 54838-550-80). Store between 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F)[See USP Controlled Room Temperature]. Do not freeze. Dispense in tight, light-resistant containers as defined in the USP/NF. Distributed by: Lannett Company, Inc. Philadelphia, PA 19154 Rev. 09/17 10-1107

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

RANITIDINE- RANITIDINE HYDROCHLORIDE SOLUTION
LANNETT COMPANY, INC.
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RANITIDINE SYRUP
(RANITIDINE ORAL SOLUTION, USP)
15 MG PER ML
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 acesulfame-K, dibasic sodium phosphate, glycerin,
peppermint flavor, propylene
glycol, propylparaben, purified water, methylparaben, monobasic sodium
phosphate, sodium saccharin,
and water (Purified).
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 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: