País: Canadà
Idioma: anglès
Font: Health Canada
FENOFIBRATE
SANIS HEALTH INC
C10AB05
FENOFIBRATE
200MG
CAPSULE
FENOFIBRATE 200MG
ORAL
30/100
Prescription
FRIBIC ACID DERIVATIVES
Active ingredient group (AIG) number: 0118895001; AHFS:
CANCELLED POST MARKET
2017-07-31
Page 1 of 38 PRODUCT MONOGRAPH PR FENOFIBRATE MICRO FENOFIBRATE, MICRONIZED FORMULATION Capsules (200 mg) LIPID METABOLISM REGULATOR Sanis Health Inc. Date of revision: 333 Champlain Street, Suite 102 February 13, 2014 Dieppe, New Brunswick E1A 1P2 Submission Control number: 171447 Page 2 of 38 PRODUCT MONOGRAPH PR FENOFIBRATE MICRO fenofibrate, micronized formulation THERAPEUTIC CLASSIFICATION Lipid Metabolism Regulator ACTIONS AND CLINICAL PHARMACOLOGY FENOFIBRATE MICRO (fenofibrate, micronized formulation) 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 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 Fenofibric acid is extensively bound (> 99 %) to Llegiu el document complet