TEVA-GEMFIBROZIL CAPSULE

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

GEMFIBROZIL

제공처:

TEVA CANADA LIMITED

ATC 코드:

C10AB04

INN (국제 이름):

GEMFIBROZIL

복용량:

300MG

약제 형태:

CAPSULE

구성:

GEMFIBROZIL 300MG

관리 경로:

ORAL

패키지 단위:

100/250/500/1000

처방전 유형:

Prescription

치료 영역:

FRIBIC ACID DERIVATIVES

제품 요약:

Active ingredient group (AIG) number: 0116135001; AHFS:

승인 상태:

CANCELLED POST MARKET

승인 날짜:

2022-10-27

제품 특성 요약

PRODUCT MONOGRAPH
TEVA-GEMFIBROZIL
(Gemfibrozil)
300 mg Gemfibrozil Capsules U.S.P.
600 mg Gemfibrozil Tablets U.S.P.
Antihyperlipidemic Agent
Teva Canada Limited
Date of Revision:
30 Novopharm Court
June 29, 2015
Toronto, Canada
M1B 2K9
Control # 184837
PRODUCT MONOGRAPH
TEVA-GEMFIBROZIL
(Gemfibrozil)
300 mg Gemfibrozil Capsules U.S.P.
600 mg Gemfibrozil Tablets U.S.P.
THERAPEUTIC CLASSIFICATION
Antihyperlipidemic Agent
ACTION AND CLINICAL PHARMACOLOGY
Gemfibrozil is a lipid regulating agent which decreases serum
triglycerides and total cholesterol, and
increases high density lipoprotein cholesterol. The lipid-lowering
changes occur primarily in the
very low density lipoprotein (VLDL) fraction (S
f
20 - 400) rich in triglycerides and to a lesser extent
in the low density lipoprotein (LDL) fraction (S
f
0 - 20) rich in cholesterol. Gemfibrozil treatment
of patients with elevated triglycerides due to Type IV
hyperlipoproteinemia may cause a rise in
LDL-cholesterol. In addition, gemfibrozil increases the high density
lipoprotein (HDL) cholesterol
subfractions, HDL
2
and HDL
3
, as well as apolipoproteins AI and AII.
Epidemiological studies have shown that both low HDL-cholesterol and
high LDL-cholesterol are
independent risk factors for coronary heart disease. Depending on the
type of hyperlipidemia,
pharmacological intervention with gemfibrozil raises HDL-cholesterol
and may lower
LDL-cholesterol, and may be associated with reduced morbidity due to
coronary heart disease as
- 2 -
reported in the Helsinki Heart Study, a 5 year primary prevention
Phase IV clinical trial (N.
Engl.J.Med. 317:1237-1245, 1987).
The mechanism of action has not been definitely established. In man,
gemfibrozil has been shown
to inhibit peripheral lipolysis and to decrease the hepatic extraction
of free fatty acids, thus reducing
hepatic triglyceride production. Gemfibrozil also inhibits the
synthesis and increases clearance of
VLDL carrier apolipoprotein B, leading to a decrease in VLDL.
Animal studies suggest that gemfibrozil may, in addi