LIPIDIL MICRO CAPSULE

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

FENOFIBRATE

Available from:

BGP PHARMA ULC

ATC code:

C10AB05

INN (International Name):

FENOFIBRATE

Dosage:

200MG

Pharmaceutical form:

CAPSULE

Composition:

FENOFIBRATE 200MG

Administration route:

ORAL

Units in package:

30

Prescription type:

Prescription

Therapeutic area:

FRIBIC ACID DERIVATIVES

Product summary:

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

Authorization status:

CANCELLED POST MARKET

Authorization date:

2016-11-09

Summary of Product characteristics

PRODUCT MONOGRAPH
PR
LIPIDIL MICRO
®
fenofibrate, micronized formulation
Capsules (200 mg)
LIPID METABOLISM REGULATOR
BGP Pharma ULC
8401 Trans-Canada Highway
Saint-Laurent, Quebec
H4S 1Z1
Date of Preparation:
October 15, 2015
Submission Control No.: 187779
®
Lipidil Micro: Registered Trademark Fournier Industrie et Santé,
Suresnes, France; Licensed use by BGP
Pharma ULC, Saint-Laurent, Quebec, H4S 1Z1
2
PRODUCT MONOGRAPH
Pr
LIPIDIL
MICRO
®
fenofibrate, micronized formulation
THERAPEUTIC CLASSIFICATION
Lipid Metabolism Regulator
ACTIONS AND CLINICAL PHARMACOLOGY
LIPIDIL MICRO
®
(fenofibrate, micronized formulation) 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 VLDL
than on the low density
lipoproteins (LDL). Therapeutic doses of fenofibrate produce
elevations of HDL cholesterol,
a reduction in the content of the low density lipoproteins
cholesterol, and a substantial
reduction in the triglyceride content of VLDL.
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.
Metabolism and Excretion
After oral administration with food, fenofibrate is rapidly hydrolysed
to fenofibric acid, the
active metabolite. 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 half-life. Therefore, the dose of fenofibrate may
need to be redu