AA-FENO-MICRO CAPSULE

国家: 加拿大

语言: 英文

来源: Health Canada

有效成分:

FENOFIBRATE

可用日期:

AA PHARMA INC

ATC代码:

C10AB05

INN（国际名称）:

FENOFIBRATE

剂量:

67MG

药物剂型:

CAPSULE

组成:

FENOFIBRATE 67MG

给药途径:

ORAL

每包单位数:

15G/50G

处方类型:

Prescription

治疗领域:

FRIBIC ACID DERIVATIVES

產品總結:

Active ingredient group (AIG) number: 0118895003; AHFS:

授权状态:

APPROVED

授权日期:

2001-01-11

产品特点

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