賽樂治"山德士"膠囊200毫克

国家: 台湾

语言: 中文

来源: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)

资料单张 资料单张 (PIL)
14-09-2021
公众评估报告 公众评估报告 (PAR)
31-03-2020

有效成分:

CELECOXIB

可用日期:

台灣山德士藥業股份有限公司 臺北市中山區民生東路3段2號8樓 (90003886)

ATC代码:

M01AH01

药物剂型:

膠囊劑

组成:

CELECOXIB (2808405200) MG

每包单位数:

鋁箔盒裝

类:

製 劑

处方类型:

須由醫師處方使用

厂商:

Novartis Pharmaceutical Manufacturing LLC VEROVSKOVA 57, 1526 LJUBLJANA, SLOVENIA SI

治疗领域:

celecoxib

疗效迹象:

緩解骨關節炎之症狀與徵兆,緩解成人類風濕性關節炎之症狀與徵兆,緩解成人急性疼痛及治療原發性經痛,緩解僵直性脊椎炎之症狀與徵兆。

產品總結:

有效日期: 2027/04/30; 英文品名: Celecoxib Sandoz Capsule 200mg

授权日期:

2012-04-30

资料单张

                                “
”
200
CELECOXIB SANDOZ CAPSULE 200MG
025684
(GI)
1. NSAIDS
2. (CORONARY ARTERY BYPASS GRAFT, CABG)
14
(GI)
1. NSAIDS(GI)
(GI)
[(5.2)]
1.
Celecoxib SandozCelecoxib Sandoz
[
(5)
]
2.
2.1
Celecoxib Sandoz
Celecoxib Sandoz
[
(5)
]
2.2
200 mg100 mg
2.3
100200 mg
2.4 (AS)
celecoxib200 mg(
)
(
)
400 mg6
2.5
400 mg200 mg200
mg
2.6
(Child-PughB
) celecoxib50%
celecoxib ()
[
(5.5)
(8.5)
(12.3)
]
CYP2C9
/CYP2C9(warfarinphenytoin)CYP2C9
(
CYP2C9*3/*3)celecoxib
[
(8.7)(12.3)
]
3.
200
4.
Celecoxib
• celecoxib
()[
(5.7, 5.9)
]
• aspirinNSAIDsNSAIDs
[
(5.7, 5.8)
]
• (Coronary artery bypass graft, CABG)14[
(5.1)
]
• (sulfonamides)
5.
5.1
(COX-2)NSAIDs
NSAIDs
APC(celecoxib)
celecoxib 400celecoxib 200
3
celecoxib
[
(14.6)
]
celecoxibIbuprofenNaproxen(PRECISION)
COX-2celecoxibNSAIDs naproxen
ibuprofen
(APTC)(
[
]
)
celecoxib 100
naproxen 375
500ibuprofen
600800[
(14.5)
]
aspirin
NSAID
aspirinNASID (
celecoxib)
(GI)[
(5.2)
]
(CABG)
10
14COX-2
14
NSAIDs
NSAIDs20/100
/
NSAIDs12/100
/NSAIDs4
5.2 (GI)
NSAIDs (celecoxib)
(GI)celecoxib
NSAID
5
1
NSAIDs
3
61%
2%4%NSAID
(GI)
/
(GI)NSAIDs(GI)
10NSAIDs(GI)
NSAID(
aspirin)
(SSRI)(GI)
/(GI)
CLASS0.78%aspirin(ASA)
2.19%651.40%ASA 3.06%[
(14.6)
]
NSAID(GI)
•
• NSAID
• (GI)
NSAIDs
• NSAID
(GI)
• (GI)celecoxib
(GI)
• aspirin(GI)[
(7)
]
5.3
NSAID1%ALT
AST(
[ULN]
)
NSAIDs(celecoxib)15%ALT
AST(
ULN)
Celecoxib(
1.23.0)
celecoxib
6% 5%
celecoxib
ALT
AST
0.2%0.3%
(
)
(
)celecoxib
5.4
NSAIDs(celecoxib)
(ACE)thiazideNSAIDs
[
(7)
]
(14.514.6)
celecoxib
NSAID
(BP)
5.5
COX-2NSAIDs
NSAIDS
ACE(ARBS)
CLASS[ (14.6)
]
celecoxib 400 mg(
4
2
)
ibuprofen 800 mgdiclofenac 75 mg9
Kaplan-Meier
4.5%6.9%4.7%
5.6
NSAIDs
NSAIDs
ACEARBNSAIDs
celecoxibCelecoxib
celecoxib
celecoxib[
(7)
]
celecoxib
celecoxib
NSAIDs
(
)
5.7
celecoxibaspirincelecoxib
Celecoxib
sulfonamide
NSAIDs
sulfonamide
[
(4)
(5.8)
]
5.8 ASPIRIN
aspirin
/
aspirinNSAIDsaspirinaspirin
NSAIDscelecoxib
aspirin
[
(4)
]
celecoxib(
aspirin)
5.9
celecoxibStevens-Johnson
(SJS)(TEN)(DRESS)
(AGEP)
celecoxib
CelecoxibNSAIDs
[
(4)
]
5.10
Celecoxi
                                
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