Q-FENOFIBRATE MICRO CAPSULE

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

FENOFIBRATE

Disponibil de la:

QD PHARMACEUTICALS ULC

Codul ATC:

C10AB05

INN (nume internaţional):

FENOFIBRATE

Dozare:

200MG

Forma farmaceutică:

CAPSULE

Compoziție:

FENOFIBRATE 200MG

Calea de administrare:

ORAL

Unități în pachet:

30/100

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

FRIBIC ACID DERIVATIVES

Rezumat produs:

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

Statutul autorizaţiei:

CANCELLED POST MARKET

Data de autorizare:

2015-08-21

Caracteristicilor produsului

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