AVA-FENOFIBRATE MICRO CAPSULE

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

FENOFIBRATE

Disponible depuis:

AVANSTRA INC

Code ATC:

C10AB05

DCI (Dénomination commune internationale):

FENOFIBRATE

Dosage:

200MG

forme pharmaceutique:

CAPSULE

Composition:

FENOFIBRATE 200MG

Mode d'administration:

ORAL

Unités en paquet:

100

Type d'ordonnance:

Prescription

Domaine thérapeutique:

FRIBIC ACID DERIVATIVES

Descriptif du produit:

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

Statut de autorisation:

CANCELLED POST MARKET

Date de l'autorisation:

2014-08-21

Résumé des caractéristiques du produit

PRODUCT MONOGRAPH
AVA-FENOFIBRATE MICRO
FENOFIBRATE CAPSULES
200 MG
LIPID METABOLISM REGULATOR
AVANSTRA INC.
DATE OF PREPARATION:
10761 – 25
TH NE, SUITE 110, BUILDING “B”
FEBRUARY 21, 2011
CALGARY, ALBERTA
T2C 3C2
CONTROL NO.: 145193
- 1 -
PRODUCT MONOGRAPH
AVA-FENOFIBRATE MICRO
Fenofibrate Capsules
200 mg
THERAPEUTIC CLASSIFICATION
Lipid Metabolism Regulator
ACTIONS AND CLINICAL PHARMACOLOGY
Fenofibrate 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
of fenofibrate produce
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.
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 hydrolyzed
into fenofibric acid, the
active metabolite.
- 2 -
Fenofibrate's absorption is low and variable when the product is
administered under fasting condi-
tions. 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 half-life. Therefore, the
dose of fenofibr