NICARDIPINE HYDROCHLORIDE capsule

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

PuraCap Laboratories LLC dba Blu Pharmaceuticals

ІПН (Міжнародна Ім'я):

NICARDIPINE HYDROCHLORIDE

Склад:

NICARDIPINE HYDROCHLORIDE 20 mg

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

Nicardipine hydrochloride capsules are indicated for the management of patients with chronic stable angina (effort-associated angina). Nicardipine hydrochloride capsules may be used alone or in combination with beta-blockers. Nicardipine hydrochloride capsules are indicated for the treatment of hypertension. Nicardipine hydrochloride capsules may be used alone or in combination with other antihypertensive drugs. In administering nicardipine hydrochloride it is important to be aware of the relatively large peak to trough differences in blood pressure effect (See DOSAGE AND ADMINISTRATION). Nicardipine hydrochloride capsules are contraindicated in patients with hypersensitivity to the drug. Because part of the effect of nicardipine hydrochloride capsules are secondary to reduced afterload, the drug is also contraindicated in patients with advanced aortic stenosis. Reduction of diastolic pressure in these patients may worsen rather than improve myocardial oxygen balance.

Огляд продуктів:

Nicardipine hydrochloride 20 mg capsules are available in light blue opaque/white opaque hard gelatin capsules imprinted “E501” in black ink on cap and body, filled with yellow powder. These are supplied: NDC: 24658-750-90 Bottles of 90 Capsules Nicardipine hydrochloride 30 mg capsules are available in light blue opaque hard gelatin capsules imprinted “E502” with black ink on cap and body, filled with yellow powder. These are supplied: NDC 24658-751-90 Bottles of 90 Capsules Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense contents in a tight, light-resistant container with a child-resistant closure. The brands listed are trademarks of their respective owners. Distributed by PuraCap Laboratories, LLC DBA Blu Pharmaceuticals Franklin, KY 42134 USA 1-877-264-0258 Manufactured in USA Rev. 08-2017-00 MF501BLUREV08/17 OE2603

Статус Авторизація:

Abbreviated New Drug Application

Характеристики продукта

NICARDIPINE HYDROCHLORIDE- NICARDIPINE HYDROCHLORIDE CAPSULE
PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS
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NICARDIPINE HYDROCHLORIDE CAPSULES 20 MG AND 30 MG
RX ONLY
DESCRIPTION
Nicardipine hydrochloride capsules for oral administration each
contain 20 mg or 30 mg of nicardipine
hydrochloride. Nicardipine hydrochloride capsules are a calcium ion
influx inhibitor (slow channel
blocker or calcium channel blocker).
Nicardipine hydrochloride is a dihydropyridine structure with the
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 it
has the following structure:
Nicardipine hydrochloride is a greenish-yellow, odorless, crystalline
powder that melts at about
169°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.
Each capsule, for oral administration, contains 20 mg or 30 mg of
nicardipine hydrochloride. In
addition, each capsule contains the following inactive ingredients:
magnesium stearate, pregelatinized
starch, titanium dioxide, gelatin and FD&C Blue #1. The colorants used
in the capsules are black iron
oxide, FD&C Blue #2, FD&C Red #40, D&C Yellow #10 and FD&C Blue #1. In
addition, the 30 mg
capsules also contain propylene glycol.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Nicardipine hydrochloride capsules are a calcium entry blocker (slow
channel blocker or calcium ion
antagonist) that 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 cel