NIFEDIPINE tablet extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

McKesson Packaging Services Business Unit of McKesson Corporation

INN (International Name):

Nifedipine

Composition:

Nifedipine 30 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NIFEDIPINE- NIFEDIPINE TABLET, EXTENDED RELEASE
MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION
----------
NIFEDIPINE ER 30MG & 60MG TABLETS
Rx Only
Revised: 05/07
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, 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 either 30 or 60 mg of
nifedipine for once-a-day oral administration.
Inert ingredients in the formulation are: colloidial silicon dioxide,
hypromellose, lactose monohydrate,
magnesium stearate. The inert ingredients in the film coating are:
hypromellose, polydextrose,
polyethylene glycol, triacetin, yellow iron oxide, and titanium
dioxide.
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 vasodilatation and, consequently, a reduction in
peripheral vascular resistance. The
increased peripheral vascular resistance that is 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 cytosolic free cal