DOM-GEMFIBROZIL TABLET

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

GEMFIBROZIL

Pieejams no:

DOMINION PHARMACAL

ATĶ kods:

C10AB04

SNN (starptautisko nepatentēto nosaukumu):

GEMFIBROZIL

Deva:

600MG

Zāļu forma:

TABLET

Kompozīcija:

GEMFIBROZIL 600MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

300

Receptes veids:

Prescription

Ārstniecības joma:

FRIBIC ACID DERIVATIVES

Produktu pārskats:

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

Autorizācija statuss:

CANCELLED POST MARKET

Autorizācija datums:

2013-04-05

Produkta apraksts

PRODUCT MONOGRAPH
PR
DOM-GEMFIBROZIL
Gemfibrozil Capsules and Tablets, USP
300 mg Capsules and 600 mg Tablets
ANTIHYPERLIPIDEMIC AGENT
DOMINION PHARMACAL
6111 Royalmount Ave., Suite 100
Montréal, Canada
H4P 2T4
Date of Revision:
February 6, 2013
Control Number: 161865
2
PRODUCT MONOGRAPH
PR
DOM-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 ad