NICARDIPINE HYDROCHLORIDE capsule

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

ANI Pharmaceuticals, Inc.

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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 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 is 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.

Dettagli prodotto:

Nicardipine Hydrochloride Capsules 20 mg are available as hard gelatin capsules with an opaque light green cap and opaque light green body imprinted ‘ANI 205’ in black ink. They are supplied in bottles of 90 (NDC 62559-205-90). Nicardipine Hydrochloride Capsules 30 mg are available as hard gelatin capsules with an opaque green cap and opaque light green body imprinted ‘ANI 206’ in black ink. They are supplied in bottles of 90 (NDC 62559-206-90). Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] and dispense in light-resistant containers. All brand names listed are the registered trademarks of their respective owners and are not trademarks of ANI Pharmaceuticals, Inc. Distributed by: ANI Pharmaceuticals, Inc. Baudette, MN 56623 10623 Rev 12/22

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

NICARDIPINE HYDROCHLORIDE- NICARDIPINE HYDROCHLORIDE CAPSULE
ANI PHARMACEUTICALS, INC.
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NICARDIPINE HYDROCHLORIDE CAPSULES
DESCRIPTION
Nicardipine hydrochloride capsules for oral administration each
contain 20 mg or 30 mg
of nicardipine hydrochloride USP. 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 USP 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.
Nicardipine hydrochloride capsules are available in hard gelatin
capsules containing 20
mg or 30 mg nicardipine hydrochloride USP with magnesium stearate and
pregelatinized
starch as the inactive ingredients. The 20 mg strength is provided in
opaque, light green
capsules while the 30 mg strength is provided in capsules with an
opaque green cap and
opaque light green body. The capsule shells contain gelatin, titanium
dioxide, D&C Yellow
#10, and FD&C Green #3; the 30 mg capsule shells also contain FD&C
Blue #1. The
black imprinting ink contains shellac, propylene glycol, ammonia,
black iron oxide and
potassium hydroxide.
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
conc