Страна: Канада
мова: англійська
Джерело: Health Canada
FENOFIBRATE
PRO DOC LIMITEE
C10AB05
FENOFIBRATE
100MG
TABLET
FENOFIBRATE 100MG
ORAL
100
Prescription
FRIBIC ACID DERIVATIVES
Active ingredient group (AIG) number: 0118895002; AHFS:
CANCELLED POST MARKET
2019-06-25
PRODUCT MONOGRAPH PR PRO-FENO-SUPER – 100 PR PRO-FENO-SUPER – 160 PR PRO-FENO-SUPER – 200 Fenofibrate Film-Coated Tablets Pro Doc Standard 100 mg, 160 mg and 200 mg LIPID METABOLISM REGULATOR PRO DOC LTÉE DATE OF REVISION: 2925, boul. Industriel September 12, 2014 Laval, Quebec H7L 3W9 CONTROL # 177779 PRODUCT MONOGRAPH Pr PRO-FENO-SUPER – 100 Pr PRO-FENO-SUPER – 160 Pr PRO-FENO-SUPER – 200 Fenofibrate Film-Coated Tablets Pro Doc Standard 100 mg, 160 mg and 200 mg THERAPEUTIC CLASSIFICATION Lipid Metabolism Regulator ACTIONS AND CLINICAL PHARMACOLOGY Fenofibrate lowers elevated serum lipids by decreasing the low-density lipoprotein (LDL) fraction rich in cholesterol and the very low-density lipoprotein (VLDL) fraction rich in triglycerides. In addition, fenofibrate increases the high-density lipoprotein (HDL) cholesterol fraction. Fenofibrate appears to have a greater depressant effect on the very low density lipoproteins (VLDL) than on the low density lipoproteins (LDL). Therapeutic doses of fenofibrate produce variable elevations of HDL cholesterol, a reduction in the content of the low density lipoproteins cholesterol, and a substantial reduction in the triglyceride content of very low density lipoproteins. Fenofibrate is a fibric acid derivative whose lipid modifying effects reported in humans are mediated by the activation of a specific nuclear receptor called peroxisome proliferator activated receptor alpha (PPAR), which produces: • a reduction in apo C-III, and therefore a reduction in the level of dense atherogenic LDL particles; • a stimulation of mitochondrial beta-oxidation, and therefore a reduction in triglyceride secretion; • a rise in lipoprotein lipase production, and therefore an acceleration of triglyceride rich lipoprotein breakdown; • a rise in apo A-I and apo A-II production, and a corresponding rise in HDL. Metabolism and Excretion After oral administration, fenofibrate is rapidly hydrolyzed to fenofibric acid. In man it is mainly excreted through the kidney. Half-life i Прочитайте повний документ