Land: USA
Sprog: engelsk
Kilde: NLM (National Library of Medicine)
nifedipine (UNII: I9ZF7L6G2L) (nifedipine - UNII:I9ZF7L6G2L)
Lake Erie Medical DBA Quality Care Products LLC
nifedipine
nifedipine 90 mg
ORAL
PRESCRIPTION DRUG
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 extended-release tableta are contraindicated in patients with a known hypersensitivity to any component of the tablet. The safety and effectiveness of nifedipine in pediatric patients have not been established. Although small pharmacokinetic studies have identified an increased half-life and increased Cmax and AUC (see CLINICAL PHARMACOLOGY: Pharmacokinetics and Metabolism ), clinical studies of nifedipine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually startin
Nifedipine Extended-Release Tablets, USP, are supplied as 90 mg round film-coated tablets as follows: 90 mg Yellow 90 mg unscored, round, film-coated tablets, engraved with "B" on one side and "90" on the other side. Nifedipine Extended-Release Tablets, USP, are supplied in: 55700-258-30 The tablets should be protected from light and moisture and stored at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Dispense in tight, light-resistant containers.
Abbreviated New Drug Application
NIFEDIPINE- NIFEDIPINE TABLET, EXTENDED RELEASE LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC ---------- NIFEDIPINE EXTENDED-RELEASE TABLETS, USP 90 MG Rx only For Oral Use DESCRIPTION Nifedipine extended-release tablets are an extended release tablet dosage form of the calcium channel blocker nifedipine. The product is provided as a general matrix tablet with a polymer coating. Nifedipine is 3,5-pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4-(2_-_nitrophenyl)-, dimethyl ester. The molecular formula is 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 contain 90 mg of nifedipine for once- a-day oral administration. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, ethylcellulose, hydroxyethyl cellulose, hydroxypropyl methylcellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium lauryl sulfate, titanium dioxide, and triacetin. Contains FD&C Yellow No. 5 (tartrazine) as a color additive. Nifedipine extended-release tablets meet USP Dissolution Test 7. CLINICAL PHARMACOLOGY Nifedipine 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. 17 18 2 6 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 increase Læs hele dokumentet