RANITIDINE solution

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

Atlantic Biologicals Corps

ІПН (Міжнародна Ім'я):

RANITIDINE HYDROCHLORIDE

Склад:

RANITIDINE 15 mg in 1 mL

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

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

Статус Авторизація:

Abbreviated New Drug Application

Характеристики продукта

RANITIDINE - RANITIDINE SOLUTION
ATLANTIC BIOLOGICALS CORPS
----------
RANITIDINE SYRUP (RANITIDINE ORAL SOLUTION, USP) 15 MG/ML
RX ONLY
DESCRIPTION
The active ingredient in Ranitidine Oral Solution 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 Oral Solution contains 16.8 mg of ranitidine
HCl equivalent to 15 mg of
ranitidine. Ranitidine Oral Solution also contains the inactive
ingredients butylparaben, dibasic sodium
phosphate, hypromellose, monobasic sodium phosphate, natural
peppermint extract, propylene glycol,
propylparaben, purified water, saccharin sodium, sodium chloride, and
sorbitol solution.
CLINICAL PHARMACOLOGY
Ranitidine hydrochloride is a competitive, reversible inhibitor of the
action of histamine at the histamine
H -receptors, including receptors on the gastric cells. Ranitidine
hydrochloride does not lower serum
Ca in hypercalcemic states. Ranitidine hydrochloride is not an
anticholinergic agent.
PHARMACOKINETICS
: Ranitidine hydrochloride 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 hydrochloride, 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 hydrochloride. _ABSOR