NIFEDIPINE tablet film coated extended release

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

NIFEDIPINE (UNII: I9ZF7L6G2L) (NIFEDIPINE - UNII:I9ZF7L6G2L)

Disponible depuis:

Teva Pharmaceuticals USA Inc

DCI (Dénomination commune internationale):

NIFEDIPINE

Composition:

NIFEDIPINE 30 mg

Type d'ordonnance:

PRESCRIPTION DRUG

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

NIFEDIPINE- NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE
TEVA PHARMACEUTICALS USA INC
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NIFEDIPINE EXTENDED-RELEASE TABLETS, USP
RX ONLY
_FOR ORAL USE_
20000238
Rev. 05/2015
DESCRIPTION
Nifedipine is a drug belonging to a class of pharmacological agents
known as the calcium channel
blockers. Nifedipine is 3,5-pyridinedicarboxylic acid,
1,4-dihydro-2,6-dimethyl-4-(2-nitrophenyl)-,
dimethyl ester, C
H N O , and has the structural formula:
Nifedipine is a yellow crystalline substance, practically insoluble in
water but soluble in ethanol. It has
a molecular weight of 346.3. Each extended-release tablet is
formulated as a once-a-day controlled-
release tablet for oral administration designed to deliver 30 or 60 mg
of nifedipine.
Inert ingredients in the formulations are: anhydrous lactose,
colloidal silicon dioxide, ethylcellulose,
hydroxyethyl cellulose, hypromellose, magnesium stearate, methacrylic
acid copolymer type A,
methacrylic acid copolymer type B, microcrystalline cellulose,
polyethylene glycol, red ferric oxide,
sodium lauryl sulfate, talc, and titanium dioxide.
Nifedipine Extended-release Tablets meet USP Dissolution Test 3.
CLINICAL PHARMACOLOGY
Nifedipine is a calcium ion influx inhibitor (slow-channel blocker or
calcium ion antagonist) and inhibits
the transmembrane influx of calcium ions into cardiac muscle and
smooth muscle. 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. Nifedipine selectively inhibits
calcium ion influx across the cell membrane of cardiac muscle and
vascular smooth muscle without
altering serum calcium concentrations.
MECHANISM OF ACTION
A) ANGINA
17
18
2
6
The precise mechanisms by which inhibition of calcium influx relieves
angina has not been fully
determined, but includes at least the following two mechanisms:
1) RELAXATION AND PREVENTION OF CORONARY ARTERY SPASM
Nifedipine dilates the main coronary arteries and coronary arterioles,
b