FENOFIBRATE CAPSULE

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

FENOFIBRATE

Disponibil de la:

APOTEX INC

Codul ATC:

C10AB05

INN (nume internaţional):

FENOFIBRATE

Dozare:

100MG

Forma farmaceutică:

CAPSULE

Compoziție:

FENOFIBRATE 100MG

Calea de administrare:

ORAL

Unități în pachet:

100

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

FRIBIC ACID DERIVATIVES

Rezumat produs:

Active ingredient group (AIG) number: 0118895002; AHFS:

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2021-04-16

Caracteristicilor produsului

PRODUCT MONOGRAPH
PR
FENOFIBRATE
Fenofibrate Capsules
100 mg fenofibrate, non-micronized formulation
House Standard
LIPID METABOLISM REGULATOR
APOTEX INC.
150 SIGNET DRIVE
TORONTO, ONTARIO
M9L 1T9
DATE OF PREPARATION:
APRIL 16, 2021
SUBMISSION CONTROL NO.: 245266
Page 2 of 36
PRODUCT MONOGRAPH
PR
FENOFIBRATE
Fenofibrate Capsules
100 mg fenofibrate, non-micronized formulation
House Standard
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 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 albumin. This
bi