NICARDIPINE HYDROCHLORIDE capsule

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Mylan Pharmaceuticals Inc.

INN (mednarodno ime):

NICARDIPINE HYDROCHLORIDE

Sestava:

NICARDIPINE HYDROCHLORIDE 20 mg

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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 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.

Povzetek izdelek:

Nicardipine Hydrochloride Capsules are available containing 20 mg or 30 mg of nicardipine hydrochloride, USP. The 20 mg capsule is a hard-shell gelatin capsule with a medium blue-green opaque cap and an ivory opaque body filled with yellowish powder. The capsule is axially imprinted with MYLAN over 1020 in black ink on both the cap and the body. They are available as follows: NDC 0378-1020-77 bottles of 90 capsules NDC 0378-1020-05 bottles of 500 capsules The 30 mg capsule is a hard-shell gelatin capsule with a bluish green opaque cap and a rich yellow opaque body filled with yellowish powder. The capsule is axially imprinted with MYLAN over 1430 in black ink on both the cap and the body. They are available as follows: NDC 0378-1430-77 bottles of 90 capsules NDC 0378-1430-05 bottles of 500 capsules Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. The brands listed are trademarks of their respective owners. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Revised: 9/2016 NCR:R7

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

NICARDIPINE HYDROCHLORIDE- NICARDIPINE HYDROCHLORIDE CAPSULE
MYLAN PHARMACEUTICALS INC.
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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-(Benzylmethylamino)ethyl methyl
1,4-dihydro-2,6-dimethyl-4-
(_m_-nitrophenyl)-3,5-pyridinedicarboxylate monohydrochloride, and it
has the following structure:
NICARDIPINE HYDROCHLORIDE
Nicardipine hydrochloride, USP is a 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-shell gelatin
capsules containing 20 mg or 30
mg of nicardipine hydrochloride. The 20 mg capsule strength is
provided in a medium blue-green
opaque cap and ivory opaque body, while the 30 mg capsule strength is
provided in a bluish-green
opaque cap and rich yellow body. Each capsule contains the following
inactive ingredients: colloidal
silicon dioxide, gelatin, magnesium stearate, pregelatinized starch
(corn), silicon dioxide, sodium lauryl
sulfate, titanium dioxide and FD&C Green No. 3. The 20 mg capsules
also contain D&C Yellow No.
10. The 30 mg capsules also contain yellow iron oxide.
The black imprinting ink contains the following: D&C Yellow No. 10
Aluminum Lake, FD&C Blue No.
1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40
Aluminum Lake,
pharmaceutical glaze, propylene glycol and synthetic black iron oxide.
CLINICAL PHARMACOLOGY
MECHANISM O