NU-GEMFIBROZIL CAP 300MG CAPSULE

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

GEMFIBROZIL

Disponible depuis:

NU-PHARM INC

Code ATC:

C10AB04

DCI (Dénomination commune internationale):

GEMFIBROZIL

Dosage:

300MG

forme pharmaceutique:

CAPSULE

Composition:

GEMFIBROZIL 300MG

Mode d'administration:

ORAL

Unités en paquet:

100

Type d'ordonnance:

Prescription

Domaine thérapeutique:

FRIBIC ACID DERIVATIVES

Descriptif du produit:

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

Statut de autorisation:

CANCELLED POST MARKET

Date de l'autorisation:

2012-09-04

Résumé des caractéristiques du produit

PRODUCT MONOGRAPH
NU-GEMFIBROZIL
GEMFIBROZIL CAPSULES USP
300 MG
GEMFIBROZIL TABLETS USP
600 MG
ANTIHYPERLIPIDEMIC AGENT
NU
A
PHARM INC.
DATE OF PREPARATION:
50 MURAL STREET, UNITS 1 & 2
November 25, 1993
RICHMOND HILL, ONTARIO
DATE OF REVISION:
L4B 1E4
February 6, 2004
CONTROL# 089327
1
PRODUCT MONOGRAPH
NU-GEMFIBROZIL
Gemfibrozil Capsules USP
300 mg
Gemfibrozil Tablets USP
600 mg
THERAPEUTIC CLASSIFICATION
Antihyperlipidemic Agent
ACTIONS 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
0-20) rich in triglycerides and to a lesser extent
in the low density lipoprotein (LDL) fraction (S
f
20-400) 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.
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.
2
Animal studies suggest that gemfibrozil may, in addition to elevating
HDL cholester