RATIO-FENOFIBRATE MC CAPSULE

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

FENOFIBRATE

Dostępny od:

TEVA CANADA LIMITED

Kod ATC:

C10AB05

INN (International Nazwa):

FENOFIBRATE

Dawkowanie:

200MG

Forma farmaceutyczna:

CAPSULE

Skład:

FENOFIBRATE 200MG

Droga podania:

ORAL

Sztuk w opakowaniu:

30/100

Typ recepty:

Prescription

Dziedzina terapeutyczna:

FRIBIC ACID DERIVATIVES

Podsumowanie produktu:

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

Status autoryzacji:

CANCELLED POST MARKET

Data autoryzacji:

2019-09-16

Charakterystyka produktu

PRODUCT MONOGRAPH
Pr
RATIO-FENOFIBRATE MC
Fenofibrate Capsules
67 mg and 200 mg
Lipid Metabolism Regulator
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada M1B 2K9
Control No. 176744
Date of Revision:
September 9, 2014
_ _
_ _
_Page 2 of 39_
PRODUCT MONOGRAPH
PR
RATIO-FENOFIBRATE MC
FENOFIBRATE CAPSULES
67 MG AND 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 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
_ _
_ _
_Page 3 of 39_
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
Fenofibrate acid is extensively bound (>99%) to plasma albumin. This
binding is not saturable.
Absorption
Fenofibrat