銳思定® 膜衣錠 0.25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)

有效成分:

brexpiprazole

可用日期:

台灣大塚製藥股份有限公司 台北市中山區復興北路378號11樓 (14001297)

ATC代码:

N05AX16

药物剂型:

膜衣錠

组成:

brexpiprazole (2816300100) MG

每包单位数:

裸錠大桶裝;;塑膠瓶裝(HDPE)

类:

製　劑

处方类型:

須由醫師處方使用

厂商:

Sharp Packaging Services, LLC 7451 KEEBLER WAY , ALLENTOWN , PENNSYLVANIA 18106 , USA US

治疗领域:

brexpiprazole

疗效迹象:

思覺失調症

產品總結:

有效日期: 2028/03/27; 英文品名: REXULTI® (brexpiprazole) tablets 0.25 mg

授权日期:

2018-03-27

资料单张

®
REXULTI
® (BREXPIPRAZOLE) TABLETS
0.25
027363
0.5
027364
1
027365
2
027366
3
027367
4
027368
REXULTI
[
(5.1)]
1
Ɣ
[
(14.1)]
2
2.1
REXULTI
1
4
1
[
(12.3)]
REXULTI
2
4
5
7
2
8
4
4
2.2
&KLOG3XJKVFRUH• 
3
[
(8.6)
(12.3)]
2.3
(
[CLcr] <60
/
)
3
[
(8.7)
(12.3)]
2.4 CYP2D6
(POOR METABOLIZERS)
CYP
P450 (CYP) 2D6
CYP3A4
CYP2D6
CYP3A4
(
1)
REXULTI
CYP3A4
1~2
REXULTI
[
(7.1)
(12.3)]
1CYP2D6
(POOR METABOLIZERS)
CYP3A4
CYP2D6
/
CYP3A4
REXULTI
REXULTI
CYP2D6
CYP2D6
CYP2D6
/
CYP3A4
CYP2D6
/
CYP3A4
CYP2D6
CYP3A4
/
CYP2D6
/
CYP3A4
CYP3A4
CYP3A4
1~2
3
REXULTI
6
(
2)
2REXULTI
/
0.25
BRX0.25
0.5
BRX0.5
1
BRX1
2
BRX2
3
BRX3
4
BRX4
4
brexpiprazole
REXULTI
(anaphylaxis)
5
5.1
17
(
10
)
1.6~1.7
10
4.5%
2.6%
(
)
(
:
)
REXULTI
[
(5.2)]
5.2
risperidonearipiprazole
olanzapine
(
)
(transient ischemic attack)
REXULTI
[
(5.1)]
5.3 (NMS)
REXULTI
(NMS)
(
)
(NMS)
REXULTI
5.4 (TARDIVE DYSKINESIA)
(
)
REXULTI
: (1)
(2)
REXULTI
REXULTI
5.5
REXULTI
/
REXULTI
6
(<100 mg/dL)
• PJG/
• 
<126 mg/dL)
REXULTI
REXULTI
8%
17%
10%
6
REXULTI
3
3
6
1
/
2
/
4
/
PJG/WR
• PJG/
and <500 mg/dL)
6%
(15/253)*
10%
(7/72)*
8%
(19/232)*
10%
(22/226)*
/
PJG/WR• PJG/
0%
(0/303)*
0%
(0/94)*
0%
(0/283)*
0.4%
(1/283)*
*
n/N
N=
n=
6% (
)
2% (
)
REXULTI
17% (
)
REXULTI
13%
0.4%
0.6%
(
REXULTI)
4
6
• 
4
6
N=362
1
/
N=120
2
/
N=362
4
/
N=362
(
)
+0.2
+1.0
+1.2
+1.2
(
) • 
(*N/N)
4%
(15/362)*
10%
(12/120) *
11%
(38/362) *
10%
(37/362) *
*
n/N
N=
n= • 
0.6%
REXULTI
26
1.3
52
2
20% • 
10% • 
5.6
REXULTI
:
REXULTI

(
)
(WBC)
(Absolute neutrophil countANC)
(WBC)
(ANC)
(CBC)
(WBC)
REXULTI
<1000/mm
3
REXULTI
(WBC)
5.8
REXULTI
(2% vs. 2%)
(0.4% vs. 0.2%)
(0.1% vs. 0%)
(
)
(
)
REXULTI
5.9
REXULTI
5.10
REXULTI
5.11
REXULTI
5.12
(
REXULTI)
5.13
REXULTI
6
(
)
REXULTI
5%
3%
(
)
REXULTI
6
‡
[
(5.1)]
‡
[
(5.2)]
‡ (NMS)
[
(5.3)]
‡
[
(5.4)]
‡
[
(5.5)]
‡
[
(5.6)]
‡
[
(5.7)]
‡
[
(5.8)]
‡
[
(5.9)]
‡
[
(5.10)]
‡
[
(5.11)]
‡
[
(5.12)]
‡
[
(5.13)]
6.1
REXULTI
852
(18
65
)
6
REXULTI
1
2
4
[
(14.1)]
(
6
)
REXULTI