NIFEDIPINE tablet, film coated, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

A-S Medication Solutions

INN (International Name):

NIFEDIPINE

Composition:

NIFEDIPINE 30 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Nifedipine Extended-Release Tablets 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:

Product: 50090-0695 NDC: 50090-0695-0 30 TABLET, FILM COATED, EXTENDED RELEASE in a BOTTLE NDC: 50090-0695-2 90 TABLET, FILM COATED, EXTENDED RELEASE in a BOTTLE Product: 50090-0697 NDC: 50090-0697-2 90 TABLET, FILM COATED, EXTENDED RELEASE in a BOTTLE

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

NIFEDIPINE- NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE
A-S MEDICATION SOLUTIONS
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NIFEDIPINE
EXTENDED-RELEASE TABLETS
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, 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
consist of an external coat and an
internal core. Both contain nifedipine, the coat as a slow release
formulation and the core as a fast
release formulation. Nifedipine Extended-Release Tablets contain
either: 30, 60, or 90 mg of
nifedipine for once-a-day oral administration.
Inert ingredients in the formulation are: hydroxypropylcellulose,
lactose, corn starch, crospovidone,
microcrystalline cellulose, silicon dioxide, and magnesium stearate.
The inert ingredients in the film
coating for Nifedipine Extended-Release Tablets 30 mg and 60 mg are:
hypromellose, polyethylene
glycol, ferric oxide, and titanium dioxide. The inert ingredients in
the film coating for Nifedipine
Extended-Release Tablets 90 mg are: hypromellose, polyethylene glycol
and ferric oxide.
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 arteri