NIFEDIPINE tablet extended release

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

Nifedipine (UNII: I9ZF7L6G2L) (Nifedipine - UNII:I9ZF7L6G2L)

Tilgængelig fra:

TEVA PHARMACEUTICALS USA

INN (International Name):

Nifedipine

Sammensætning:

Nifedipine 60 mg

Recept type:

PRESCRIPTION DRUG

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

NIFEDIPINE- NIFEDIPINE TABLET, EXTENDED RELEASE
TEVA PHARMACEUTICALS USA
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NIFEDIPINE
EXTENDED-RELEASE TABLETS, USP
60 MG
Rx only
For Oral Use
DESCRIPTION
Nifedipine extended-release tablets are an extended release tablet
dosage form of the calcium channel
blocker nifedipine. Nifedipine is 3,5-pyridinedicarboxylic acid,
1,4-dihydro-2,6-dimethyl-4-
(2_-_nitrophenyl)-, dimethyl ester. The molecular formula is 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. Nifedipine extended-release tablets
contain 60 mg of nifedipine for once-
a-day oral administration.
In addition, each tablet contains the following inactive ingredients:
anhydrous lactose, ethylcellulose,
hydroxyethyl cellulose, hypromellose, magnesium stearate,
microcrystalline cellulose, polyacrylic
dispersion (copolymer of ethyl acrylate and methyl methacrylate),
polyethylene glycol, silicon dioxide,
sodium lauryl sulfate, talc, titanium dioxide, and yellow 10 ferric
oxide.
Nifedipine extended-release tablets meet USP Dissolution Test 4.
CLINICAL PHARMACOLOGY
Nifedipine is a calcium ion influx inhibitor (slow-channel blocker or
calcium ion antagonist) which
inhibits the transmembrane influx of calcium ions into vascular smooth
muscle and cardiac muscle. The
contractile processes of vascular smooth muscle and cardiac 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 vascular
smooth muscle and cardiac muscle
without altering serum calcium concentrations.
MECHANISM OF ACTION
17
18
2
6
The mechanism by which nifedipine reduces arterial blood pressure
involves peripheral arterial
vasodilatation and, consequently, a reduction in peripheral vascular
resistance. The increased peripheral
vascular resistance, an underlying cause of hypertension, results from
an increase in active tension in