AA-FENO-MICRO CAPSULE

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

FENOFIBRATE

Available from:

AA PHARMA INC

ATC code:

C10AB05

INN (International Name):

FENOFIBRATE

Dosage:

200MG

Pharmaceutical form:

CAPSULE

Composition:

FENOFIBRATE 200MG

Administration route:

ORAL

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic area:

FRIBIC ACID DERIVATIVES

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2019-10-11

Summary of Product characteristics

PRODUCT MONOGRAPH
PR
AA-FENO-MICRO
Fenofibrate Capsules
67 mg and 200 mg fenofibrate, micronized formulation
House Standard
PR
FENOFIBRATE
Fenofibrate Capsules
100 mg fenofibrate, non-micronized formulation
House Standard
LIPID METABOLISM REGULATOR
AA PHARMA INC.
DATE OF PREPARATION:
1165 Creditstone Road Unit #1
OCTOBER 08, 2019
Vaughan, Ontario
L4K 4N7
CONTROL NO.: 230394
Page 2 of 37
PRODUCT MONOGRAPH
PR
AA-FENO-MICRO
Fenofibrate Capsules
67 mg and 200 mg fenofibrate, micronized formulation
House Standard
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 l