RANITIDINE HYDROCHLORIDE- ranitidine hydrochloride solution

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

Ranitidine Hydrochloride (UNII: BK76465IHM) (Ranitidine - UNII:884KT10YB7)

Sẵn có từ:

Precision Dose Inc.

INN (Tên quốc tế):

Ranitidine Hydrochloride

Thành phần:

Ranitidine 15 mg in 1 mL

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

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 carrie

Tóm tắt sản phẩm:

Ranitidine Oral Solution USP, a clear peppermint flavored liquid, contains 16.8 mg of ranitidine HCl, USP equivalent to 15 mg of ranitidine per 1 mL (75 mg/5 mL). NDC 68094-204-61 10 mL per unit dose cup One hundred (100) cups per shipper NDC 68094-204-62 10 mL per unit dose cup Thirty (30) cups per shipper Store between 4° and 25°C (39° and 77°F). Dispense in tight, light-resistant containers as defined in the USP/NF. Do not freeze.

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

RANITIDINE HYDROCHLORIDE- RANITIDINE HYDROCHLORIDE SOLUTION
PRECISION DOSE INC.
----------
RANITIDINE SYRUP
(RANITIDINE ORAL SOLUTION, USP)
150 MG/10 ML
RX ONLY
DESCRIPTION
The active ingredient in 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, USP 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, USP contains 16.8 mg of
ranitidine HCl, USP equivalent to 15
mg of ranitidine. Ranitidine Oral Solution, USP 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
Absorption
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, 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
absor