Страна: Канада
Язык: английский
Источник: Health Canada
FELODIPINE
SANDOZ CANADA INCORPORATED
C08CA02
FELODIPINE
5MG
TABLET (EXTENDED-RELEASE)
FELODIPINE 5MG
ORAL
30/100
Prescription
DIHYDROPYRIDINES
Active ingredient group (AIG) number: 0121733002; AHFS:
APPROVED
2006-08-04
PRODUCT MONOGRAPH PR SANDOZ FELODIPINE (felodipine) Extended Release Tablets 5 mg and 10 mg Manufacturer’s Standard Antihypertensive Agent Sandoz Canada Inc. Date of Revision: March 4, 2015 145 Jules-Léger Boucherville, Quebec J4B 7K8 Control Number: 182441 _Sandoz Felodipine _ _ Page 2 of 35 _ PR SANDOZ FELODIPINE (felodipine) Extended Release Tablets 5 mg and 10 mg THERAPEUTIC CLASSIFICATION Antihypertensive Agent ACTION AND CLINICAL PHARMACOLOGY 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. 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 Прочитать полный документ