LIPIDIL SUPRA 100 MG TABLET

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

FENOFIBRATE

متاح من:

LABORATOIRES FOURNIER S.A.S.

ATC رمز:

C10AB05

INN (الاسم الدولي):

FENOFIBRATE

جرعة:

100MG

الشكل الصيدلاني:

TABLET

تركيب:

FENOFIBRATE 100MG

طريقة التعاطي:

ORAL

الوحدات في الحزمة:

30

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

FRIBIC ACID DERIVATIVES

ملخص المنتج:

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

الوضع إذن:

CANCELLED POST MARKET

تاريخ الترخيص:

2014-01-29

خصائص المنتج

1
PRODUCT MONOGRAPH
PR
LIPIDIL SUPRA
®
fenofibrate, microcoated formulation
film-coated tablets (160 mg)
LIPID METABOLISM REGULATOR
Laboratoires Fournier SAS
42 rue Rouget de Lisle
92150 Suresnes, France
Distributed by: Fournier Pharma Inc.
8401 Trans-Canada Highway
Saint-Laurent, Quebec
H4S 1Z1
Date of Preparation:
February 28, 2000
Date of Previous Revision:
November 13, 2013
Date of Revision: February 5, 2014
Submission Control No.:165706
® Lipidil Supra: Registered Trademark Fournier Industrie et Santé
Suresnes France; Licensed use by Fournier Pharma Inc., Saint-Laurent,
Quebec, H4S 1Z1
2
PRODUCT MONOGRAPH
PR
LIPIDIL SUPRA
®
fenofibrate, microcoated formulation
THERAPEUTIC CLASSIFICATION
Lipid Metabolism Regulator
ACTIONS AND CLINICAL PHARMACOLOGY
LIPIDIL SUPRA
®
(fenofibrate, microcoated formulation)
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.
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
α
), 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.
Metabolism and Excret