PRO-FENO-SUPER - 100 TABLET

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

FENOFIBRATE

Tilgjengelig fra:

PRO DOC LIMITEE

ATC-kode:

C10AB05

INN (International Name):

FENOFIBRATE

Dosering :

100MG

Legemiddelform:

TABLET

Sammensetning:

FENOFIBRATE 100MG

Administreringsrute:

ORAL

Enheter i pakken:

100

Resept typen:

Prescription

Terapeutisk område:

FRIBIC ACID DERIVATIVES

Produkt oppsummering:

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

Autorisasjon status:

CANCELLED POST MARKET

Autorisasjon dato:

2019-06-25

Preparatomtale

PRODUCT MONOGRAPH
PR
PRO-FENO-SUPER – 100
PR
PRO-FENO-SUPER – 160
PR
PRO-FENO-SUPER – 200
Fenofibrate Film-Coated Tablets
Pro Doc Standard
100 mg, 160 mg and 200 mg
LIPID METABOLISM REGULATOR
PRO DOC LTÉE
DATE OF REVISION:
2925, boul. Industriel
September 12, 2014
Laval, Quebec
H7L 3W9
CONTROL # 177779
PRODUCT MONOGRAPH
Pr
PRO-FENO-SUPER – 100
Pr
PRO-FENO-SUPER – 160
Pr
PRO-FENO-SUPER – 200
Fenofibrate Film-Coated Tablets
Pro Doc Standard
100 mg, 160 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 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 low density lipoproteins
cholesterol, and a substantial reduction in the triglyceride content
of very low density
lipoproteins.
Fenofibrate is a fibric acid derivative whose lipid modifying effects
reported in humans are
mediated by the activation of a specific nuclear receptor called
peroxisome proliferator activated
receptor alpha (PPAR), which produces:
•
a reduction in apo C-III, and therefore a reduction in the level of
dense atherogenic LDL
particles;
•
a stimulation of mitochondrial beta-oxidation, and therefore a
reduction in triglyceride
secretion;
•
a rise in lipoprotein lipase production, and therefore an acceleration
of triglyceride rich
lipoprotein breakdown;
•
a rise in apo A-I and apo A-II production, and a corresponding rise in
HDL.
Metabolism and Excretion
After oral administration, fenofibrate is rapidly hydrolyzed to
fenofibric acid.
In man it is mainly excreted through the kidney. Half-life i