APO-GEMFIBROZIL TABLET

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

GEMFIBROZIL

Dostupno od:

APOTEX INC

ATC koda:

C10AB04

INN (International ime):

GEMFIBROZIL

Doziranje:

600MG

Farmaceutski oblik:

TABLET

Sastav:

GEMFIBROZIL 600MG

Administracija rute:

ORAL

Jedinice u paketu:

100/500

Tip recepta:

Prescription

Područje terapije:

FRIBIC ACID DERIVATIVES

Proizvod sažetak:

Active ingredient group (AIG) number: 0116135002; AHFS:

Status autorizacije:

MARKETED

Datum autorizacije:

1993-12-31

Svojstava lijeka

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