FENOFIBRATE CAPSULE

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

FENOFIBRATE

제공처:

AA PHARMA INC

ATC 코드:

C10AB05

INN (국제 이름):

FENOFIBRATE

복용량:

100MG

약제 형태:

CAPSULE

구성:

FENOFIBRATE 100MG

관리 경로:

ORAL

패키지 단위:

250ML

처방전 유형:

Prescription

치료 영역:

FRIBIC ACID DERIVATIVES

제품 요약:

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

승인 상태:

APPROVED

승인 날짜:

2022-01-05

제품 특성 요약

PRODUCT MONOGRAPH
PR
FENOFIBRATE
Fenofibrate Capsules
100 mg fenofibrate, non-micronized formulation
House Standard
LIPID METABOLISM REGULATOR
SUBMISSION CONTROL NO.: 259429
AA PHARMA INC.
1165 CREDITSTONE ROAD, UNIT #1
VAUGHAN,
ONTARIO
L4K 4N7
DATE OF PREPARATION:
JANUARY 5, 2022
Page 2 of 36
PRODUCT MONOGRAPH
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 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 (> 99 %) to plasm