PMS-GEMFIBROZIL TABLET

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

GEMFIBROZIL

Dostupno od:

PHARMASCIENCE INC

ATC koda:

C10AB04

INN (International ime):

GEMFIBROZIL

Doziranje:

600MG

Farmaceutski oblik:

TABLET

Sastav:

GEMFIBROZIL 600MG

Administracija rute:

ORAL

Jedinice u paketu:

100/250/500

Tip recepta:

Prescription

Područje terapije:

FRIBIC ACID DERIVATIVES

Proizvod sažetak:

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

Status autorizacije:

APPROVED

Datum autorizacije:

2013-03-12

Svojstava lijeka

PRODUCT MONOGRAPH
PR
PMS-GEMFIBROZIL
(Gemfibrozil Tablets, USP)
600 mg Tablets
ANTIHYPERLIPIDEMIC AGENT
PHARMASCIENCE INC.
Date of Preparation:
6111 Royalmount Avenue, suite 100
March 1, 2013
Montreal, Quebec
H4P 2T4
Control Number: 162594
Page 2 of 35
PRODUCT MONOGRAPH
PR
PMS-GEMFIBROZIL
Gemfibrozil Tablets USP
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
Page 3 of 35
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 addition to elevating
HDL cholesterol (HD