FENOFIBRATE CAPSULE

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

FENOFIBRATE

Verfügbar ab:

AA PHARMA INC

ATC-Code:

C10AB05

INN (Internationale Bezeichnung):

FENOFIBRATE

Dosierung:

100MG

Darreichungsform:

CAPSULE

Zusammensetzung:

FENOFIBRATE 100MG

Verabreichungsweg:

ORAL

Einheiten im Paket:

250ML

Verschreibungstyp:

Prescription

Therapiebereich:

FRIBIC ACID DERIVATIVES

Produktbesonderheiten:

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

Berechtigungsstatus:

APPROVED

Berechtigungsdatum:

2022-01-05

Fachinformation

PRODUCT MONOGRAPH
PR
FENOFIBRATE
Fenofibrate Capsules
100 mg fenofibrate, non-micronized formulation
House Standard
LIPID METABOLISM REGULATOR
SUBMISSION CONTROL NO.: 259429
AA PHARMA INC.
1165 CREDITSTONE ROAD, UNIT #1
VAUGHAN,
ONTARIO
L4K 4N7
DATE OF PREPARATION:
JANUARY 5, 2022
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 plasm