NIFEDIPINE tablet film coated extended release

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

REMEDYREPACK INC.

INN (국제 이름):

NIFEDIPINE

구성:

NIFEDIPINE 90 mg

처방전 유형:

PRESCRIPTION DRUG

승인 상태:

New Drug Application Authorized Generic

제품 특성 요약

NIFEDIPINE- NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE
REMEDYREPACK INC.
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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 arterial
vaso