RANITIDINE HYDROCHLORIDE injection

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

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

Հասանելի է:

Zydus Pharmaceuticals USA Inc.

INN (Միջազգային անվանումը):

RANITIDINE HYDROCHLORIDE

Կազմը:

RANITIDINE 25 mg in 1 mL

Կառավարման երթուղին:

INTRAMUSCULAR

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

Ranitidine injection is indicated in some hospitalized patients with pathological hypersecretory conditions or intractable duodenal ulcers, or as an alternative to the oral dosage form for short-term use in patients who are unable to take oral medication. Ranitidine injection is contraindicated for patients known to have hypersensitivity to the drug.

Ապրանքի ամփոփագիր:

Ranitidine Injection USP, 25 mg/mL, containing phenol 0.5% as preservative, is available as follows: NDC 68382-422-02, 2-mL single-dose vials (10 Vials per carton) NDC 68382-423-06, 6-mL multi-dose vials (Single) Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Do not freeze. Protect from light. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat; however, brief exposure up to 40°C does not adversely affect the product. Protect from freezing. $ MULTISTIX® is the registered trademark of Siemens healthcare diagnostics.

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Ապրանքի հատկությունները

RANITIDINE HYDROCHLORIDE - RANITIDINE HYDROCHLORIDE INJECTION
ZYDUS PHARMACEUTICALS USA INC.
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RANITIDINE INJECTION, USP
DESCRIPTION
The active ingredient in ranitidine injection is ranitidine
hydrochloride (HCl), 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,
hydrochloride. It has the
following structure:
FIGURE01
The molecular formula is C
H
N O S•HCl, representing a molecular weight of 350.87.
Ranitidine hydrochloride, USP is a white to pale yellow, granular
substance that is soluble
in water.
Ranitidine injection, USP is a clear, colorless to yellow,
nonpyrogenic liquid. The yellow
color of the liquid tends to intensify without adversely affecting
potency. The pH of the
injection solution is 6.7 to 7.3.
STERILE INJECTION FOR INTRAMUSCULAR OR INTRAVENOUS ADMINISTRATION
Each 1 mL of aqueous solution contains ranitidine 25 mg (as the
hydrochloride); phenol
5 mg as preservative; and 0.96 mg of monobasic potassium phosphate and
2.4 mg of
dibasic sodium phosphate as buffers.
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 absorbed very rapidly after intramuscular
(IM) injection. Mean
peak levels of 576 ng/mL occur within 15 minutes or less following a
50 mg IM dose.
Absorption from IM sites is virtually complete, with a bioavailability
of 90% to 100%
compared with intravenous (IV) administration. Following oral
administration, the
2
13
22
4
3
2
bioavailability of ranitidine is 50%.
DISTRIBUTION
The volume of distribution is about 1.4 L/kg. Serum protein binding
averages 15%.
METABOLISM
In humans, the N-oxide is the principal metabolite in the urine;
however, this amounts to
<4