国家: 加拿大
语言: 英文
来源: Health Canada
GEMFIBROZIL
APOTEX INC
C10AB04
GEMFIBROZIL
600MG
TABLET
GEMFIBROZIL 600MG
ORAL
100/500
Prescription
FRIBIC ACID DERIVATIVES
Active ingredient group (AIG) number: 0116135002; AHFS:
MARKETED
1993-12-31
0 PRODUCT MONOGRAPH PR APO-GEMFIBROZIL GEMFIBROZIL CAPSULES USP 300 MG GEMFIBROZIL TABLETS USP 600 MG ANTIHYPERLIPIDEMIC AGENT APOTEX INC. DATE OF REVISION: 150 SIGNET DRIVE JANUARY 18, 2011 WESTON, ONTARIO M9L 1T9 CONTROL NO.: 143291 1 PRODUCT MONOGRAPH Pr APO-GEMFIBROZIL Gemfibrozil Capsules USP 300 mg Gemfibrozil Tablets USP 600 mg THERAPEUTIC CLASSIFICATION Antihyperlipidemic Agent ACTIONS Gemfibrozil is a lipid regulating agent which decreases serum triglycerides and total cholesterol, and increases high density lipoprotein cholesterol. The lipid-lowering changes occur primarily in the very low density lipoprotein (VLDL) fraction (S f 20-400) rich in triglycerides and to a lesser extent in the low density lipoprotein (LDL) fraction (S f 0-20) rich in cholesterol. Gemfibrozil treatment of patients with elevated triglycerides due to Type IV hyperlipoproteinemia may cause a rise in LDL-cholesterol. In addition, gemfibrozil increases the high density lipoprotein (HDL) cholesterol subfractions, HDL 2 and HDL 3 , as well as apolipoproteins Al and All. Epidemiological studies have shown that both low HDL-cholesterol and high LDL-cholesterol are independent risk factors for coronary heart disease. Depending on the type of hyperlipidemia, pharmacological intervention with gemfibrozil raises HDL-cholesterol and may lower LDL- cholesterol, and may be associated with reduced morbidity due to coronary heart disease as reported in the Helsinki Heart Study, a 5-year primary prevention Phase IV clinical trial (N. Engl. J. Med. 317:1237-1245, 1987). The mechanism of action has not been definitely established. In man, gemfibrozil has been shown to inhibit peripheral lipolysis and to decrease the hepatic extraction of free fatty acids, thus 2 reducing hepatic triglyceride production. Gemfibrozil also inhibits the synthesis and increases clearance of VLDL carrier apolipoprotein B, leading to a decrease in VLDL. Animal studies suggest that gemfibrozil may, in addition to elevating HDL cholesterol (HDL-C), reduce incorporation of 阅读完整的文件