Држава: Канада
Језик: Енглески
Извор: Health Canada
FENOFIBRATE
AA PHARMA INC
C10AB05
FENOFIBRATE
67MG
CAPSULE
FENOFIBRATE 67MG
ORAL
15G/50G
Prescription
FRIBIC ACID DERIVATIVES
Active ingredient group (AIG) number: 0118895003; AHFS:
APPROVED
2001-01-11
PRODUCT MONOGRAPH PR AA-FENO-MICRO Fenofibrate Capsules 67 mg and 200 mg fenofibrate, micronized formulation House Standard PR FENOFIBRATE Fenofibrate Capsules 100 mg fenofibrate, non-micronized formulation House Standard LIPID METABOLISM REGULATOR AA PHARMA INC. DATE OF PREPARATION: 1165 Creditstone Road Unit #1 OCTOBER 08, 2019 Vaughan, Ontario L4K 4N7 CONTROL NO.: 230394 Page 2 of 37 PRODUCT MONOGRAPH PR AA-FENO-MICRO Fenofibrate Capsules 67 mg and 200 mg fenofibrate, micronized formulation House Standard PR FENOFIBRATE Fenofibrate Capsules 100 mg fenofibrate, non-micronized formulation House Standard 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 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 l Прочитајте комплетан документ