国: カナダ
言語: 英語
ソース: Health Canada
GEMFIBROZIL
PHARMASCIENCE INC
C10AB04
GEMFIBROZIL
300MG
CAPSULE
GEMFIBROZIL 300MG
ORAL
100/250/500
Prescription
FRIBIC ACID DERIVATIVES
Active ingredient group (AIG) number: 0116135001; AHFS:
APPROVED
1999-04-15
PRODUCT MONOGRAPH PR PMS-GEMFIBROZIL Gemfibrozil Capsules and Tablets, USP 300 mg Capsules and 600 mg Tablets ANTIHYPERLIPIDEMIC AGENT PHARMASCIENCE INC. 6111 Royalmount Ave., Suite 100 Montréal, Canada H4P 2T4 Date of Revision: October 30, 2012 Control Number: 1 57115 2 PRODUCT MONOGRAPH PR PMS-GEMFIBROZIL Gemfibrozil Capsules and Tablets, USP 300 mg Capsules & 600 mg Tablets THERAPEUTIC CLASSIFICATION Antihyperlipidemic Agent ACTION AND CLINICAL PHARMACOLOGY 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 AI and AII. 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 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 a 完全なドキュメントを読む