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:

STAT RX USA LLC

INN (국제 이름):

NIFEDIPINE

구성:

NIFEDIPINE 60 mg

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

Nifedipine extended-release tablets are indicated for the management of vasospastic angina confirmed by any of the following criteria: 1) classical pattern of angina at rest accompanied by ST segment elevation, 2) angina or coronary artery spasm provoked by ergonovine, or 3) angiographically demonstrated coronary artery spasm. In those patients who have had angiography, the presence of significant fixed obstructive disease is not incompatible with the diagnosis of vasospastic angina, provided that the above criteria are satisfied. Nifedipine extended-release tablets may also be used where the clinical presentation suggests a possible vasospastic component, but where vasospasm has not been confirmed, e.g., where pain has a variable threshold on exertion, or in unstable angina where electrocardiographic findings are compatible with intermittent vasospasm, or when angina is refractory to nitrates and/or adequate doses of beta-blockers. Nifedipine extended-release tablets are indicated for the manage

제품 요약:

Nifedipine Extended-release Tablets, USP are available containing 30 mg, 60 mg or 90 mg of nifedipine, USP. The 30 mg tablets are supplied as light pink film-coated, round, unscored tablets with M over 030 imprinted in black ink on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-0480-01 bottles of 100 tablets NDC 0378-0480-30 bottles of 300 tablets The 60 mg tablets are supplied as light pink film-coated, round, unscored tablets with M over 060 imprinted in black ink on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-0481-01 bottles of 100 tablets NDC 0378-0481-30 bottles of 300 tablets The 90 mg tablets are supplied as light pink film-coated, round, unscored tablets with M over 090 imprinted in black ink on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-0494-01 bottles of 100 tablets NDC 0378-0494-30 bottles of 300 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture, humidity and light. Dispense in a tight light-resistant container as defined in the USP using a child-resistant closure. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. REVISED MAY 2011 NFER:R2

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

NIFEDIPINE - NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE
STAT RX USA LLC
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DESCRIPTION
Nifedipine is a drug belonging to a class of pharmacological agents
known as the calcium channel
blockers. Nifedipine is dimethyl
1,4-dihydro-2,6-dimethyl-4-(_o_-nitrophenyl)-3,5-pyridinedicarboxylate,
C
H N O , and has the structural formula:
Nifedipine, USP is a yellow powder, practically insoluble in water but
soluble in ethanol. It has a
molecular weight of 346.33. Nifedipine extended-release tablets, USP
are formulated as a once-a-day
controlled-release tablet for oral administration designed to deliver
30 mg, 60 mg or 90 mg of
nifedipine.
Inert ingredients in the formulations are: black iron oxide, cellulose
acetate, ferric oxide,
hydroxypropyl cellulose, hypromellose, magnesium stearate,
polyethylene glycol, polyethylene oxide,
polyvinyl alcohol, propylene glycol, red iron oxide, sodium chloride,
talc, titanium dioxide and yellow
iron oxide.
_Meets USP Dissolution Test 8_.
SYSTEM COMPONENTS AND PERFORMANCE
Nifedipine extended-release tablets are similar in appearance to a
conventional tablet. It consists,
however, of a semipermeable membrane surrounding an osmotically active
drug core. The core itself is
divided into two layers: an “active” layer containing the drug,
and a “push” layer containing
pharmacologically inert (but osmotically active) components. As water
from the gastrointestinal tract
enters the tablet, pressure increases in the osmotic layer and
“pushes” against the drug layer, releasing
drug through the precision laser-drilled tablet orifice in the active
layer.
Nifedipine extended-release tablets are designed to provide nifedipine
at an approximately constant rate
over 24 hours. This controlled rate of drug delivery into the
gastrointestinal lumen is independent of pH
or gastrointestinal motility. Nifedipine extended-release tablets
depend for its action on the existence of
an osmotic gradient between the contents of the bi-layer core and
fluid in the gastrointestinal tract. Drug