Q-FENOFIBRATE MICRO CAPSULE

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

FENOFIBRATE

Available from:

QD PHARMACEUTICALS ULC

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:

CANCELLED POST MARKET

Authorization date:

2015-08-21

Summary of Product characteristics

Page 1 of 38
PRODUCT MONOGRAPH
PR
Q-FENOFIBRATE MICRO
FENOFIBRATE, MICRONIZED FORMULATION
Capsules (200 mg)
LIPID METABOLISM REGULATOR
QD Pharmaceuticals ULC
85 Advance Road
Etobicoke, Ontario
Date of Revision:
M8Z 2S6
February 13, 2014
Submission Control number: 171409
Page 2 of 38
PRODUCT MONOGRAPH
PR
Q-FENOFIBRATE MICRO
fenofibrate, micronized formulation
THERAPEUTIC CLASSIFICATION
Lipid Metabolism Regulator
ACTIONS AND CLINICAL PHARMACOLOGY
Q-FENOFIBRATE 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
reduced, depending on the rate of
creatinine clearance.
Distribution
Fenofibric acid is extensively bound (> 99 %) to plasma