PMS-FENOFIBRATE MICRO CAPSULE

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

FENOFIBRATE

Available from:

PHARMASCIENCE INC

ATC code:

C10AB05

INN (International Name):

FENOFIBRATE

Dosage:

200MG

Pharmaceutical form:

CAPSULE

Composition:

FENOFIBRATE 200MG

Administration route:

ORAL

Units in package:

30/100

Prescription type:

Prescription

Therapeutic area:

FRIBIC ACID DERIVATIVES

Product summary:

Active ingredient group (AIG) number: 0118895001; AHFS:

Authorization status:

APPROVED

Authorization date:

2005-11-23

Summary of Product characteristics

PRODUCT MONOGRAPH
pms-FENOFIBRATE MICRO
(fenofibrate micronized)
200 mg Capsules
Antihyperlipidemic Agent
Pharmascience Inc.
Date of Preparation:
6111 Royalmount Ave., Suite 100
November 18, 2005
Montreal, PQ
H4P 2T4
Control # 102363
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PRODUCT MONOGRAPH
pms-FENOFIBRATE MICRO
(fenofibrate micronized)
200 mg Capsules
THERAPEUTIC CLASSIFICATION
Lipid Metabolism Regulator
ACTIONS AND CLINICAL PHARMACOLOGY
Fenofibrate (brand name pms-FENOFIBRATE MICRO) lowers elevated serum
lipids by
decreasing the low density lipoprotein (LDL) fraction rich in
cholesterol and the very low
density lipoprotein (VLDL) fraction rich in triglycerides. In
addition, fenofibrate increases the
high density lipoprotein (HDL) cholesterol fraction.
Fenofibrate appears to have a greater depressant effect on the very
low density lipoproteins
(VLDL) than on the low density lipoproteins (LDL). Therapeutic doses o
f fenofibrate produces
variable elevations of HDL cholesterol, a reduction in the content of
the total low density
lipoproteins cholesterol, and a substantial reduction in the
triglyceride content of very low
density lipoproteins.
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The mechanism of action of fenofibrate has not been definitively
established. Work carried out
to date suggests that fenofibrate:
$
enhances the liver elimination of cholesterol as bile salts,
$
inhibits the biosynthesis of triglycerides and enhances the catabolism
of VLDL by
increasing the activity of lipoprotein lipase,
$
has an inhibitory effect on the biosynthesis of cholesterol by
modulating the activity of
HMG-CoA reductase.
After oral administration with food, fenofibrate is rapidly hydrolysed
into fenofibric acid, the
active metabolite.
Fenofibrate
=
s absorption is low and variable when the product is administered
under fasting
conditions. Fenofibrate's absorption is increased when the compound is
given with food. In man
it is mainly excreted through the kidney. Half-life is about 20 hours.
In patients with severe
renal failure, significant accumulation was observed with a large
increase in the