מדינה: ארצות הברית
שפה: אנגלית
מקור: NLM (National Library of Medicine)
NIFEDIPINE (UNII: I9ZF7L6G2L) (NIFEDIPINE - UNII:I9ZF7L6G2L)
Preferred Pharmaceuticals Inc.
NIFEDIPINE
NIFEDIPINE 90 mg
ORAL
PRESCRIPTION DRUG
Nifedipine Extended-release Tablet is 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 Tablet 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 Tablet is indicated for the management of chronic st
Nifedipine Extended-release Tablets 90 mg are round, biconvex, pink coated tablets imprinted with "KU 262 in black ink. They are supplied as follows: Bottles of 30 Tablets NDC 68788-6856-3 Bottles of 60 Tablets NDC 68788-6856-6 Bottles of 90 Tablets NDC 68788-6856-9 Bottles of 100 Tablets NDC 68788-6856-1 Store at 20°-25°C (68°-77°F) (See USP Controlled Room Temperature). Protect from moisture, humidity, and light. For Medical Information Contact: Medical Affairs Department Phone: 1-844-834-0530 Distributed by: Kremers Urban Pharmaceuticals Inc., a subsidiary of Lannett Company, Inc. Seymour, IN 47274 Made in the USA CIA70797J Rev. 01/16 Repackaged By: Preferred Pharmaceuticals Inc.
Abbreviated New Drug Application
NIFEDIPINE- NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE PREFERRED PHARMACEUTICALS INC. ---------- NIFEDIPINE EXTENDED-RELEASE TABLETS, USP NIFEDIPINE _EXTENDED-RELEASE TABLETS, USP_ _ FOR ORAL USE_ _RX ONLY_ CIA70797J Rev. 01/16 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 346.33. Nifedipine Extended-release Tablet is formulated as a once-a-day extended-release tablet for oral administration designed to deliver 30, 60, or 90 mg of nifedipine. Inert ingredients in the formulations are: black iron oxide; cellulose acetate; colloidal silicon dioxide; hypromellose; lactose monohydrate; magnesium stearate; microcrystalline cellulose; polyethylene glycol; polyethylene oxide; polysorbate; povidone; propylene glycol; red ferric oxide; sodium chloride; titanium dioxide; triacetin. 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. As water from the gastrointestinal tract enters the tablet, pressure increases in the core of the tablet, releasing drug through the precision laser-drilled tablet orifice in the one side of the tablet. 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 of the tablet core and fluid in the gastrointestinal tract. Drug delivery is essentially constant as long as the osmotic gradient r קרא את המסמך השלם