NICARDIPINE HYDROCHLORIDE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Avera McKennan Hospital

INN (International Name):

NICARDIPINE HYDROCHLORIDE

Composition:

NICARDIPINE HYDROCHLORIDE 30 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NICARDIPINE HYDROCHLORIDE- NICARDIPINE HYDROCHLORIDE CAPSULE
AVERA MCKENNAN HOSPITAL
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DESCRIPTION
Nicardipine hydrochloride capsules for oral administration each
contain 20 mg or 30 mg of nicardipine
hydrochloride. Nicardipine hydrochloride is 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 structural
formula:
NICARDIPINE HYDROCHLORIDE C
H N O •HCL
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.
Each capsule, for oral administration, contains 20 mg or 30 mg of
nicardipine hydrochloride, USP. In
addition, each capsule contains the following inactive ingredients:
colloidal silicon dioxide, gelatin,
magnesium stearate, pharmaceutical glaze, pregelatinized starch,
propylene glycol, silicon dioxide,
sodium lauryl sulfate, synthetic black iron oxide, FD&C Blue No.2
Aluminum Lake, FD&C Red No.40
Aluminum Lake, FD&C Blue No.1 Aluminum Lake, and D&C Yellow No.10
Aluminum Lake. The
colorants used in the 20 mg capsules are titanium dioxide, D&C Yellow
No.10, and FD&C Green No.3.
The colorants used in the 30 mg capsules are titanium dioxide, yellow
iron oxide, and FD&C Green
No.3.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Nicardipine is a calcium entry blocker (slow channel blocker or
calcium ion antagonist) which inhibits
the transmembrane influx of calcium ions into cardiac muscle and
smooth muscle