NIFEDIPINE EXTENDED RELEASE tablet

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Lake Erie Medical DBA Quality Care Products LLC

INN (International Name):

NIFEDIPINE

Sammensætning:

NIFEDIPINE 90 mg

Recept type:

PRESCRIPTION DRUG

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

NIFEDIPINE EXTENDED RELEASE- NIFEDIPINE TABLET, EXTENDED RELEASE
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
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NIFEDIPINE EXTENDED-RELEASE TABLETS, USP
FOR ORAL USE
RX ONLY
DESCRIPTION
Nifedipine Extended-Release Tablets, USP 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, 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 90 mg of nifedipine, USP for
once-a-day oral administration.
Inert ingredients in the formulation are: colloidal silicon dioxide,
hypromellose, lactose monohydrate,
magnesium stearate, and povidone. The inert ingredients in the film
coating are: hypromellose,
polydextrose, polyethylene glycol, titanium dioxide, triacetin, and
yellow iron oxide.
Dissolution test is pending.
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_
The mechanism by which nifedipine reduces arterial blood pressure
involves peripheral arterial
17
18
2
6
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
the vascular smooth muscle. Studies have demonstrated that the
increase in active tension reflects an
increase in