Země: Spojené státy
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
NIFEDIPINE (UNII: I9ZF7L6G2L) (NIFEDIPINE - UNII:I9ZF7L6G2L)
NuCare Pharmaceuticals, Inc.
NIFEDIPINE
NIFEDIPINE 90 mg
ORAL
PRESCRIPTION DRUG
Nifedipine extended-release tablets 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 extended-release tablets 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 C max 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 id
Nifedipine Extended-Release Tablets, USP are supplied as 90 mg round film-coated tablets as follows Round Yellow Tablets Engraved: B on one side 90 on the other side 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 RoomTemperature]. Dispense in tight, light-resistant containers. Manufactured by: Valeant Pharmaceuticals International, Inc. Steinbach, MB R5G 1Z7 Canada Distributed by: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA 9495502 20001683 Rev. 06/2016
Abbreviated New Drug Application
NIFEDIPINE- NIFEDIPINE TABLET, EXTENDED RELEASE NUCARE PHARMACEUTICALS, INC. ---------- 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, 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 17 18 2 6 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 c Přečtěte si celý dokument