Country: মার্কিন যুক্তরাষ্ট্র
ভাষা: ইংরেজি
সূত্র: NLM (National Library of Medicine)
NIFEDIPINE (UNII: I9ZF7L6G2L) (NIFEDIPINE - UNII:I9ZF7L6G2L)
Aphena Pharma Solutions - Tennessee, 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. Adalat is contraindicated in patients with a known hypersensitivity to any component of the tablet.
Repackaged by Aphena Pharma Solutions - TN. See Repackaging Information for available configurations. Adalat CC extended release tablets are supplied as 30 mg, 60 mg, and 90 mg round film coated tablets. The different strengths can be identified as follows: 30 mg Pink 30 on one side and ADALAT CC on the other side 60 mg Salmon 60 on one side and ADALAT CC on the other side 90 mg Dark Red 90 on one side and ADALAT CC on the other side Adalat® CC Tablets are supplied in: Bottles of 100 30 mg 50419-701-05 60 mg 50419-702-05 90 mg 50419-703-05 Bottles of 1000 30 mg 50419-701-10 60 mg 50419-702-10 The tablets should be protected from light and moisture and stored below 86°F (30°C). Dispense in tight, light-resistant containers. Manufactured for: Bayer HealthCare Pharmaceuticals Inc. Wayne, NJ 07470 Manufactured in Germany Adalat is a registered trademark of Bayer Aktiengesellschaft. Rx Only ©2011 Bayer HealthCare Pharmaceuticals Inc. Printed in U.S.A. The following are representative examples of ADALAT labeling. See the "How Supplied" section for a complete listing of all components.
New Drug Application
ADALAT CC- NIFEDIPINE TABLET, FILM COATED APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ---------- ADALAT CC (NIFEDIPINE) EXTENDED RELEASE TABLETS FOR ORAL USE DESCRIPTION Adalat CC is 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 is a yellow crystalline substance, practically insoluble in water but soluble in ethanol. It has a molecular weight of 346.3. Adalat CC tablets consist of an external coat and an internal core. Both contain nifedipine, the coat as a slow release formulation and the core as a fast release formulation. Adalat CC tablets contain either: 30, 60, or 90 mg of nifedipine for once-a-day oral administration. Inert ingredients in the formulation are: hydroxypropylcellulose, lactose, corn starch, crospovidone, microcrystalline cellulose, silicon dioxide, and magnesium stearate. The inert ingredients in the film coating for Adalat CC 30 and 60 are: hypromellose, polyethylene glycol, ferric oxide, and titanium dioxide. The inert ingredients in the film coating for Adalat CC 90 are: hypromellose, polyethylene glycol and ferric oxide 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. 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 সম্পূর্ণ নথি পড়ুন