MYLAN-FENOFIBRATE MICRO CAPSULE

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

FENOFIBRATE

Tersedia dari:

MYLAN PHARMACEUTICALS ULC

Kode ATC:

C10AB05

INN (Nama Internasional):

FENOFIBRATE

Dosis:

200MG

Bentuk farmasi:

CAPSULE

Komposisi:

FENOFIBRATE 200MG

Rute administrasi :

ORAL

Unit dalam paket:

30

Jenis Resep:

Prescription

Area terapi:

FRIBIC ACID DERIVATIVES

Ringkasan produk:

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

Status otorisasi:

CANCELLED POST MARKET

Tanggal Otorisasi:

2017-08-02

Karakteristik produk

Page 1 of 38
PRODUCT MONOGRAPH
PR
MYLAN-FENOFIBRATE MICRO
FENOFIBRATE, MICRONIZED FORMULATION
Capsules (200 mg)
LIPID METABOLISM REGULATOR
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, Ontario
Date of Revision:
M8Z 2S6
November 18, 2013
Submission Control number: 169370
Page 2 of 38
PRODUCT MONOGRAPH
PR
MYLAN-FENOFIBRATE MICRO
fenofibrate, micronized formulation
THERAPEUTIC CLASSIFICATION
Lipid Metabolism Regulator
ACTIONS AND CLINICAL PHARMACOLOGY
MYLAN-FENOFIBRATE MICRO
(fenofibrate, micronized 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.
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 (> 9