Land: Vereinigte Staaten
Sprache: Englisch
Quelle: NLM (National Library of Medicine)
NIFEDIPINE (UNII: I9ZF7L6G2L) (NIFEDIPINE - UNII:I9ZF7L6G2L)
REMEDYREPACK INC.
NIFEDIPINE
NIFEDIPINE 30 mg
ORAL
PRESCRIPTION DRUG
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. - (Classical Effort-Associated Angina) (Classical Effort-Associated Angina
Nifedipine Extended-Release Tablets USP are supplied as 30 mg round, biconvex, rose-pink, film-coated tablets with “T011” in black ink on one side and plain on the other side: Bottles of 100: (NDC 24979-011-01) Bottles of 300: (NDC 24979-011-12) Nifedipine extended-release tablets USP are supplied as 60 mg round, biconvex, rose-pink, film-coated tablets with “T010” in black ink on one side and plain on the other side: Bottles of 100: (NDC 24979-010-01) Bottles of 300: (NDC 24979-010-12) Nifedipine extended-release tablets USP are supplied as 90 mg round, biconvex, rose-pink, film-coated tablets with “T009” in black ink on one side and plain on the other side: Bottles of 100: (NDC 24979-009-01) Bottles of 300: (NDC 24979-009-12) Store at 20° to 25°C (68° to 77°F). [see USP Controlled Room Temperature] Protect from moisture and humidity. Manufactured for: TWi Pharmaceuticals USA, Inc. Paramus, NJ 07652 Manufactured by: China Chemical & Pharmaceutical Co., Ltd. Tainan City, 72042, Taiwan OS011 01/2017
Abbreviated New Drug Application
NIFEDIPINE- NIFEDIPINE TABLET, EXTENDED RELEASE REMEDYREPACK INC. ---------- NIFEDIPINE EXTENDED-RELEASE TABLETS, USP 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 GITS (Gastrointestinal Therapeutic System) tablet is 17 18 2 6 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; ferric oxide; hypromellose; magnesium stearate; polyethylene glycol; polyethylene oxide; potassium chloride; povidone; sodium chloride; titanium dioxide; propylene glycol and black iron oxide. The USP Dissolution Test is pending. 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 gastro Lesen Sie das vollständige Dokument