Nchi: Kanada
Lugha: Kiingereza
Chanzo: Health Canada
FELODIPINE
SANOFI-AVENTIS CANADA INC
C08CA02
FELODIPINE
5MG
TABLET (EXTENDED-RELEASE)
FELODIPINE 5MG
ORAL
30
Prescription
DIHYDROPYRIDINES
Active ingredient group (AIG) number: 0121733002; AHFS:
CANCELLED POST MARKET
2014-06-23
PRODUCT MONOGRAPH RENEDIL ® (Felodipine) Extended Release Tablets 2.5 mg, 5 mg, 10 mg Antihypertensive Agent sanofi-aventis Canada Inc. Date of Preparation: 2150 St. Elzear Blvd. West April 26, 2006 Laval, Quebec H7L 4A8 Submission Control No. 105393 s-a Version 1.0 dated 2 NAME OF DRUG RENEDIL ® (felodipine) Extended Release Tablets (2.5, 5 and 10 mg) THERAPEUTIC CLASSIFICATION Antihypertensive Agent ACTION AND CLINICAL PHARMACOLOGY RENEDIL (felodipine) is a calcium ion influx inhibitor (calcium channel blocker). Felodipine is a member of the dihydropyridine class of calcium channel blockers. Mechanism of Action The therapeutic effect of this group of drugs is believed to be related to their specific cellular action of selectively inhibiting transmembrane influx of calcium ions into cardiac muscle and vascular smooth muscle. The contractile processes of these tissues are dependent upon the movement of extracellular calcium into the cells through specific ion channels. Felodipine blocks transmembrane influx of calcium through the slow channel without affecting to any significant degree the transmembrane influx of sodium through the fast channel. This results in a reduction of free calcium ions available within cells of the above tissues. 3 Felodipine does not alter total serum calcium. _In vitro _studies show that the effects of felodipine on contractile mechanisms are selective, with greater effects on vascular smooth muscle than on cardiac muscle. Negative inotropic effects can be detected _in vitro_, but such effects have not been seen in intact animals. The effect of felodipine on blood pressure in man is principally a consequence of a dose-related decrease in peripheral vascular resistance, with a modest reflex increase in heart rate (see ACTION AND CLINICAL PHARMACOLOGY - Pharmacodynamics). Pharmacokinetics Felodipine is completely absorbed from the gastrointestinal tract after oral administration. Due to rapid biotransformation of felodipine during its first pass through the portal circulation the system Soma hati kamili