Land: Canada
Sprog: engelsk
Kilde: Health Canada
FENOFIBRATE
NU-PHARM INC
C10AB05
FENOFIBRATE
67MG
CAPSULE
FENOFIBRATE 67MG
ORAL
30/100/500
Prescription
FRIBIC ACID DERIVATIVES
Active ingredient group (AIG) number: 0118895003; AHFS:
CANCELLED (UNRETURNED ANNUAL)
2018-03-28
PRODUCT MONOGRAPH NU-FENO-MICRO FENOFIBRATE CAPSULES 67 MG AND 200 MG NU-FENOFIBRATE FENOFIBRATE CAPSULES 100 MG LIPID METABOLISM REGULATOR NU-PHARM INC. DATE OF PREPARATION: 50 MURAL STREET, UNIT 1 & 2 OCTOBER 9, 2009 RICHMOND HILL, ONTARIO L4B 1E4 CONTROL#: 133275 - 1 - PRODUCT MONOGRAPH NU-FENO-MICRO Fenofibrate Capsules 67 mg and 200 mg NU-FENOFIBRATE Fenofibrate Capsules 100 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. - 2 - After oral administration with food, fenofibrate is rapidly hydrolyzed into fenofibric acid, the active metabolite. Fenofibrate's absorption is low and variable when the product is administered under fasting conditions. 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 observe Læs hele dokumentet