国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
NICARDIPINE HYDROCHLORIDE (UNII: K5BC5011K3) (NICARDIPINE - UNII:CZ5312222S)
Wockhardt Limited
NICARDIPINE HYDROCHLORIDE
NICARDIPINE HYDROCHLORIDE 2.5 mg in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
Nicardipine hydrochloride injection is indicated for the short-term treatment of hypertension when oral therapy is not feasible or not desirable. For prolonged control of blood pressure, transfer patients to oral medication as soon as their clinical condition permits (see "DOSAGE AND ADMINISTRATION") Nicardipine hydrochloride injection is contraindicated in patients with advanced aortic stenosis because part of the effect of nicardipine hydrochloride injection is secondary to reduced afterload. Reduction of diastolic pressure in these patients may worsen rather than improve myocardial oxygen balance.
Nicardipine hydrochloride injection 25 mg/10 mL (2.5 mg/mL) single dose vials are available in cartons of 1 and cartons of 10 as follows: 25 mg (2.5 mg/mL), NDC 64679-631-01 Package of 1 vial NDC 64679-631-02 Packages of 10 vials Store at 20°-25°C (68°-77°F), (See USP Controlled Room Temperature.) Freezing does not adversely affect the product, but exposure to elevated temperatures should be avoided. Protect from light. Store vials in carton until used.
Abbreviated New Drug Application
NICARDIPINE HYDROCHLORIDE- NICARDIPINE HYDROCHLORIDE INJECTION WOCKHARDT LIMITED ---------- NICARDIPINE HYDROCHLORIDE INJECTION RX ONLY DESCRIPTION Nicardipine hydrochloride injection is a calcium ion influx inhibitor (slow channel blocker or calcium channel blocker). Nicardipine hydrochloride injection for intravenous administration contains 2.5 mg/mL of nicardipine hydrochloride. Nicardipine hydrochloride is a dihydropyridine derivative with IUPAC (International Union of Pure and Applied Chemistry) chemical name (±)-2-(benzyl-methyl amino) ethyl methyl 1,4 dihydro-2,6-dimethyl-4-(m-nitrophenyl)-3,-5-pyridinedicarboxylate monohydrochloride and has the following structure: Nicardipine hydrochloride is a greenish-yellow, odorless, crystalline powder that melts at about 184°C-189°C. It is freely soluble in chloroform, methanol, and glacial acetic acid, sparingly soluble in anhydrous ethanol, slightly soluble in n-butanol, water, 0.01 M potassium dihydrogen phosphate, acetone and dioxane, very slightly soluble in ethyl acetate, and practically insoluble in benzene, ether, and hexane. It has a molecular weight of 515.99. Nicardipine hydrochloride injection is available as a sterile, non-pyrogenic, clear, yellow solution in 10 mL vials for intravenous infusion after dilution. Each mL contains 2.5 mg nicardipine hydrochloride in Water for Injection, USP with 48 mg Sorbitol, NF, buffered to pH 3.5 with 0.525 mg citric acid monohydrate, USP and 0.09 mg sodium hydroxide, NF. Additional citric acid and/or sodium hydroxide may have been added to adjust pH. CLINICAL PHARMACOLOGY MECHANISM OF ACTION Nicardipine inhibits the transmembrane influx of calcium ions into cardiac muscle and smooth muscle without changing serum calcium concentrations. The contractile processes of cardiac muscle and vascular smooth muscle are dependent upon the movement of extracellular calcium ions into these cells through specific ion channels. The effects of nicardipine are more selective to vascular smooth muscle than cardiac muscle. In animal 阅读完整的文件