국가: 미국
언어: 영어
출처: NLM (National Library of Medicine)
NIFEDIPINE (UNII: I9ZF7L6G2L) (NIFEDIPINE - UNII:I9ZF7L6G2L)
Par Pharmaceutical, Inc.
NIFEDIPINE
NIFEDIPINE 30 mg
ORAL
PRESCRIPTION DRUG
Nifedipine extended-release tablets, USP are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents. Concomitant administration with strong P450 inducers, such as rifampin, are contraindicated since the efficacy of nifedipine tablets could be significantly reduced. (See PRECAUTIONS , Drug Interactions . ) Nifedipine must not be used in cases of cardiogenic shock. Nifedipine is contraindicated in patients with a known hypersensitivity to any component of the tablet.
Nifedipine Extended-Release Tablets, USP are supplied as 30 mg and 60 mg round, biconvex, film-coated tablets which are 11 mm in diameter and 6 mm in height. The different strengths can be identified as follows: Nifedipine extended-release tablets, USP are supplied in: The tablets should be protected from light and moisture and stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in tight, light-resistant containers. Manufactured for: Par Pharmaceutical Companies Inc. Spring Valley, NY 10977 U.S.A. Issued: 09/2012 OS677-01-47-01 XX-XXXX
Abbreviated New Drug Application
NIFEDIPINE EXTENDED RELEASE- NIFEDIPINE TABLET, EXTENDED RELEASE PAR PHARMACEUTICAL, INC. ---------- NIFEDIPINE EXTENDED-RELEASE TABLETS, USP FOR ORAL USE RX ONLY DESCRIPTION Nifedipine Extended-Release Tablets, USP are an extended release tablet dosage form of the calcium channel blocker nifedipine. 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, USP 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 contain either 30 or 60 mg of nifedipine for once-a-day oral administration. Inert ingredients in the formulation are: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate. The inert ingredients in the film coating are: hypromellose, polydextrose, polyethylene glycol 8000, triacetin, yellow iron oxide and titanium dioxide. Product meets USP dissolution test #6. CLINICAL PHARMACOLOGY Nifedipine, USP is a calcium ion influx inhibitor (slow-channel blocker or calcium ion antagonist) which inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. The contractile processes of vascular smooth muscle and cardiac muscle are dependent upon the movement of extracellular calcium ions into these cells through specific ion channels. Nifedipine selectively inhibits calcium ion influx across the cell membrane of vascular smooth muscle and cardiac muscle without altering serum calcium concentrations. _MECHANISM OF ACTION_ The mechanism by which nifedipine reduces arterial blood pressure involves peripheral arterial vasodilatation and, consequently, a reduction in peripheral vascular resistance. The increased peripheral vascular resistance, an underlying cause of hypertension, results from an increase in active tension in the vascular smooth muscle. Studies have demonstrated that the increase in active tension reflects an increase in cytosolic free 전체 문서 읽기