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 90 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 follows: 90 mg– Each beige, round tablet debossed with and “152” on one side and plain on the other side contains 90 mg of nifedipine, USP. Tablets are supplied in bottles of 100 (NDC 49884-679-01) with a child-resistant closure and bottles of 500 (NDC 49884-679-05) without a child-resistant closure. 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 OS679-01-47-01 40-9215

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 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 cytosolic free calcium