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:

bryant ranch prepack

INN (International Name):

NIFEDIPINE

Composition:

NIFEDIPINE 30 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

ADALAT® CC is 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, C17 H18 N2 O6 , 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. ADALAT CC 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. ADALAT CC 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 are: hypromellose, polyethylene glycol, ferric oxide, and titanium dioxide.

Product summary:

Afeditab® CR, 30 mg, is available as round, brownish-red, film-coated, unscored tablets, imprinted with ELN 30 , and are supplied in bottles of 100 and 500. Afeditab® CR, 60 mg, is available as round, brownish-red, film-coated, unscored tablets, imprinted with ELN 60 , and are supplied in bottles of 100 and 500. The tablets should be protected from light and moisture and stored below 30°C (86°F). Dispense in tight, light resistant containers as defined in USP/NF. Manufactured for: Watson Laboratories, Inc. Corona, CA 92880 USA Manufactured by: Elan Pharma International Ltd. Athlone, Co. Westmeath, Ireland Rev. 09/07                                                                                                              CP0346D

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NIFEDIPINE - NIFEDIPINE TABLET, EXTENDED RELEASE
BRYANT RANCH PREPACK
----------
NIFEDIPINEER30MG
DESCRIPTION
ADALAT CC is 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. ADALAT CC 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.
ADALAT CC 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 are: hypromellose, polyethylene glycol, ferric oxide, and
titanium dioxide.
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.
INDICATIONS AND USAGE
ADALAT CC is indicated for the treatment of hypertension. It may be
used alone or in combination with
other antihypertensive agents
CONTRADICTIONS
Known hypersensitivity to nifedipine.
WARNINGS
Excessive Hypotension:
Although in most patients the hypotensive effect of nifedipine is
modest and well tolerated, occasional
patients have had excessive and poorly tolerated hypotension. These
responses have