NIFEDIPINE EXTENDED RELEASE- 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:

Par Pharmaceutical, Inc.

INN (International Name):

NIFEDIPINE

Composition:

NIFEDIPINE 30 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Nifedipine extended-release tablets, USP are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents. Concomitant administration with strong P450 inducers, such as rifampin, are contraindicated since the efficacy of nifedipine tablets could be significantly reduced. (See PRECAUTIONS , Drug Interactions . ) Nifedipine must not be used in cases of cardiogenic shock. Nifedipine is contraindicated in patients with a known hypersensitivity to any component of the tablet.

Product summary:

Nifedipine Extended-Release Tablets, USP are supplied as 30 mg and 60 mg round, biconvex, film-coated tablets which are 11 mm in diameter and 6 mm in height.  The different strengths can be identified as follows: Nifedipine extended-release tablets, USP are supplied in: The tablets should be protected from light and moisture and stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in tight, light-resistant containers. Manufactured for: Par Pharmaceutical Companies Inc. Spring Valley, NY 10977 U.S.A. Issued: 09/2012 OS677-01-47-01 XX-XXXX

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NIFEDIPINE EXTENDED RELEASE- NIFEDIPINE TABLET, EXTENDED RELEASE
PAR PHARMACEUTICAL, INC.
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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, USP 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: colloidal silicon dioxide,
hypromellose, lactose monohydrate,
magnesium stearate. The inert ingredients in the film coating are:
hypromellose, polydextrose,
polyethylene glycol 8000, triacetin, yellow iron oxide and titanium
dioxide.
Product meets USP dissolution test #6.
CLINICAL PHARMACOLOGY
Nifedipine, USP 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, 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