NICARDIPINE HYDROCHLORIDE injection

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

NICARDIPINE HYDROCHLORIDE (UNII: K5BC5011K3) (NICARDIPINE - UNII:CZ5312222S)

متاح من:

Wockhardt Limited

INN (الاسم الدولي):

NICARDIPINE HYDROCHLORIDE

تركيب:

NICARDIPINE HYDROCHLORIDE 2.5 mg in 1 mL

طريقة التعاطي:

INTRAVENOUS

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

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.

ملخص المنتج:

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.

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

NICARDIPINE HYDROCHLORIDE- NICARDIPINE HYDROCHLORIDE INJECTION
WOCKHARDT LIMITED
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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