RANITIDINE solution

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

ATLANTIC BIOLOGICALS CORP.

INN (International Adı):

Ranitidine

Kompozisyon:

Ranitidine 15 mg in 1 mL

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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

Ürün özeti:

NDC:17856-0727-4 in a CUP of 5 SOLUTIONS Store at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature). Dispense in tight, light-resistant containers as defined in the USP/NF.

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

RANITIDINE- RANITIDINE SOLUTION
ATLANTIC BIOLOGICALS CORP.
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RANITIDINE SYRUP (RANITIDINE ORAL SOLUTION USP)
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
hydrochloride 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 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 1.4 L/kg. Seru