Nchi: Kanada
Lugha: Kiingereza
Chanzo: Health Canada
FENOFIBRATE
TEVA CANADA LIMITED
C10AB05
FENOFIBRATE
200MG
CAPSULE
FENOFIBRATE 200MG
ORAL
30/100
Prescription
FRIBIC ACID DERIVATIVES
Active ingredient group (AIG) number: 0118895001; AHFS:
CANCELLED POST MARKET
2019-09-16
PRODUCT MONOGRAPH Pr RATIO-FENOFIBRATE MC Fenofibrate Capsules 67 mg and 200 mg Lipid Metabolism Regulator Teva Canada Limited 30 Novopharm Court Toronto, Ontario Canada M1B 2K9 Control No. 176744 Date of Revision: September 9, 2014 _ _ _ _ _Page 2 of 39_ PRODUCT MONOGRAPH PR RATIO-FENOFIBRATE MC FENOFIBRATE CAPSULES 67 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 VLDL than on the low density lipoproteins (LDL). Therapeutic doses of fenofibrate produce elevations of HDL cholesterol, a reduction in the content of the low density lipoproteins cholesterol, and a substantial reduction in the triglyceride content of VLDL. The mechanism of action of fenofibrate has not been definitively established. Work carried out to date suggests that fenofibrate: enhances the liver elimination of cholesterol as bile salts; inhibits the biosynthesis of triglycerides and enhances the catabolism of VLDL by increasing the activity of lipoprotein lipase; has an inhibitory effect on the biosynthesis of cholesterol by modulating the activity of HMG-CoA reductase. Metabolism and Excretion After oral administration with food, fenofibrate is rapidly hydrolysed to fenofibric acid, the active _ _ _ _ _Page 3 of 39_ metabolite. In man it is mainly excreted through the kidney. Half-life is about 20 hours. In patients with severe renal failure, significant accumulation was observed with a large increase in half-life. Therefore, the dose of fenofibrate may need to be reduced, depending on the rate of creatinine clearance. Distribution Fenofibrate acid is extensively bound (>99%) to plasma albumin. This binding is not saturable. Absorption Fenofibrat Soma hati kamili