Land: Kanada
Språk: engelska
Källa: Health Canada
FENOFIBRATE
AVANSTRA INC
C10AB05
FENOFIBRATE
200MG
CAPSULE
FENOFIBRATE 200MG
ORAL
100
Prescription
FRIBIC ACID DERIVATIVES
Active ingredient group (AIG) number: 0118895001; AHFS:
CANCELLED POST MARKET
2014-08-21
PRODUCT MONOGRAPH AVA-FENOFIBRATE MICRO FENOFIBRATE CAPSULES 200 MG LIPID METABOLISM REGULATOR AVANSTRA INC. DATE OF PREPARATION: 10761 – 25 TH NE, SUITE 110, BUILDING “B” FEBRUARY 21, 2011 CALGARY, ALBERTA T2C 3C2 CONTROL NO.: 145193 - 1 - PRODUCT MONOGRAPH AVA-FENOFIBRATE MICRO Fenofibrate Capsules 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 total low density lipoproteins cholesterol, and a substantial reduction in the triglyceride content of very low density lipoproteins. 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. After oral administration with food, fenofibrate is rapidly hydrolyzed into fenofibric acid, the active metabolite. - 2 - Fenofibrate's absorption is low and variable when the product is administered under fasting condi- tions. Fenofibrate's absorption is increased when the compound is given with food. 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 fenofibr Läs hela dokumentet