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:

Contract Pharmacy Services-PA

INN (국제 이름):

nifedipine

구성:

nifedipine 30 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 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 management of chronic stable

제품 요약:

Nifedipine Extended-release Tablets are supplied as 30 mg, 60 mg and 90 mg round, biconvex, rose-pink, film-coated tablets. The 30 mg tablet is imprinted with M over 475 on one side of the tablet and blank on the other side. They are available as follows:       NDC 67046-515-30       blister of 30 tablets STORE BELOW 86°F (30°C). PROTECT FROM MOISTURE AND HUMIDITY. Dispense in tight, child-resistant containers (USP).

승인 상태:

New Drug Application

제품 특성 요약

NIFEDIPINE- NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE
CONTRACT PHARMACY SERVICES-PA
----------
NIFEDIPINE
EXTENDED-RELEASE TABLETS
30 MG
RX ONLY
DESCRIPTION
Nifedipine is a drug belonging to a class of pharmacological agents
known as the calcium channel
blockers. 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 are
formulated in Nifedipine GITS.
Nifedipine GITS (Gastrointestinal Therapeutic System) Tablet is
formulated as a once-a-day
controlled-release tablet for oral administration designed to deliver
30, 60, or 90 mg of nifedipine.
Inert ingredients in the formulations are: cellulose acetate;
hydroxypropyl cellulose; hypromellose;
magnesium stearate; polyethylene glycol; polyethylene oxide; red
ferric oxide; sodium chloride;
titanium dioxide.
Meets USP Drug Release Test 1.
SYSTEM COMPONENTS AND PERFORMANCE
Nifedipine extended-release tablet is 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.
17
18
2
6
Nifedipine extended-release tablet is 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 tablet
depends for its action on the existence of
an osmotic gradient between the contents o