LOPID CAP 300MG CAPSULE

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

GEMFIBROZIL

Tilgjengelig fra:

PFIZER CANADA ULC

ATC-kode:

C10AB04

INN (International Name):

GEMFIBROZIL

Dosering :

300MG

Legemiddelform:

CAPSULE

Sammensetning:

GEMFIBROZIL 300MG

Administreringsrute:

ORAL

Enheter i pakken:

100/250

Resept typen:

Prescription

Terapeutisk område:

FRIBIC ACID DERIVATIVES

Produkt oppsummering:

Active ingredient group (AIG) number: 0116135001; AHFS:

Autorisasjon status:

CANCELLED POST MARKET

Autorisasjon dato:

2013-07-18

Preparatomtale

PRESCRIBING INFORMATION
PR
LOPID
®
GEMFIBROZIL CAPSULES USP
GEMFIBROZIL TABLETS USP
300 MG CAPSULES & 600 MG TABLETS
ANTIHYPERLIPIDEMIC AGENT
®
Warner-Lambert Company
DATE OF REVISION:
Pfizer Canada Inc. Licensee
January 22, 2010
17 300 Trans-Canada Highway
Kirkland, Quebec H9J 2M5
Pfizer Canada Inc. 2009
Control# 131842
2
PRESCRIBING INFORMATION
LOPID
®
GEMFIBROZIL CAPSULES USP
GEMFIBROZIL TABLETS USP
300 MG CAPSULES & 600 MG TABLETS
PHARMACOLOGICAL CLASSIFICATION
Antihyperlipidemic Agent
ACTIONS
LOPID (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. LOPID
treatment of patients with elevated triglycerides due to Type IV
hyperlipoproteinemia may cause a
rise in LDL-cholesterol. In addition, LOPID 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 LOPID 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,
LOPID has been shown to
inhibit peripheral lipolysis and to decrease the hepatic extraction of
free fatty acids, thus reducing
hepatic triglyceride production. LOPID also inhibits the synthesis and
increases clearance of VLDL
carrier apolipoprotein B, leading to a decrease in VLDL.
3
Animal studies suggest that LOPI