Страна: США
мова: англійська
Джерело: NLM (National Library of Medicine)
RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7)
Zydus Pharmaceuticals USA Inc.
RANITIDINE HYDROCHLORIDE
RANITIDINE 25 mg in 1 mL
INTRAMUSCULAR
PRESCRIPTION DRUG
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.
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.
Abbreviated New Drug Application
RANITIDINE HYDROCHLORIDE - RANITIDINE HYDROCHLORIDE INJECTION ZYDUS PHARMACEUTICALS USA INC. ---------- 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 Прочитайте повний документ