NU-FENO-MICRO CAPSULE

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

FENOFIBRATE

Disponible depuis:

NU-PHARM 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 (UNRETURNED ANNUAL)

Date de l'autorisation:

2018-03-28

Résumé des caractéristiques du produit

PRODUCT MONOGRAPH
NU-FENO-MICRO
FENOFIBRATE CAPSULES
67 MG AND 200 MG
NU-FENOFIBRATE
FENOFIBRATE CAPSULES
100 MG
LIPID METABOLISM REGULATOR
NU-PHARM INC.
DATE OF PREPARATION:
50 MURAL STREET, UNIT 1 & 2
OCTOBER 9, 2009
RICHMOND HILL, ONTARIO
L4B 1E4
CONTROL#: 133275
- 1 -
PRODUCT MONOGRAPH
NU-FENO-MICRO
Fenofibrate Capsules
67 mg and 200 mg
NU-FENOFIBRATE
Fenofibrate Capsules
100 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.
- 2 -
After oral administration with food, fenofibrate is rapidly hydrolyzed
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 observe