NIFEDIPINE tablet, extended release

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Bryant Ranch Prepack

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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 management of chron

Resumen del producto:

NDC: 71335-1550-1: 30 Tablets in a BOTTLE NDC: 71335-1550-2: 100 Tablets in a BOTTLE NDC: 71335-1550-3: 90 Tablets in a BOTTLE NDC: 71335-1550-4: 60 Tablets in a BOTTLE NDC: 71335-1550-5: 7 Tablets in a BOTTLE

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

NIFEDIPINE- NIFEDIPINE TABLET, EXTENDED RELEASE
BRYANT RANCH PREPACK
----------
NIFEDIPINE EXTENDED -RELEASE TABLETS, USP
FOR ORAL USE
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 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 nifedipine extended-release tablet
formulation are lactose
monohydrate, microcrystalline cellulose, hypromellose, hydroxyethyl
cellulose,
ethylcellulose, sodium lauryl sulfate, magnesium stearate, methacrylic
acid and methyl
methacrylate copolymer, polyethylene glycol, talc, polyvinyl alcohol,
titanium
dioxide(30mg and 60mg), iron oxide yellow, iron oxide red, lecithin
(soya) (30 mg and 90
mg), iron oxide black (30 mg and 90 mg).
SYSTEM COMPONENTS AND PERFORMANCE
Nifedipine extended-release tablet is designed for once-a-day oral
administration. The
extended-release tablet uses two release-rate controlling mechanisms:
a primary
polymer matrix core composed of drug with excipients and a secondary
enteric coating
surrounding the core. Upon swallowing, water is taken up through the
enteric coating
membrane into the primary core matrix, and the enteric coating
membrane will dissolve
at rising gastrointestinal pH value, which in turn slowly releases the
drug from the
formulation.
17
18
2
6
FDA approved dissolution test specifications differ from USP.
CLINICAL PHARMACOLOGY
Nifedipine is a calcium ion influx inhibitor (slow-channel blocker or
calcium ion antagonist)
and inhibits the transmembrane influx of calcium ions into cardiac
muscle and smooth
muscle. The contractile processes of cardiac muscle