諾瑞心寧持續性藥效錠 500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)
12-06-2021
公众评估报告 公众评估报告 (PAR)
12-06-2020

有效成分:

Ranolazine

可用日期:

東生華製藥股份有限公司 台北市南港區園區街3之1號3樓之1 (53093421)

ATC代码:

C01EB18

药物剂型:

持續性藥效錠

组成:

Ranolazine (2800100100) MG

每包单位数:

PVC/ACLAR-AL 鋁箔盒裝

类:

製 劑

处方类型:

須由醫師處方使用

厂商:

LUPIN LIMITED 15B, PHASE1A, VERNA INDUSTRIAL AREA, VERNA, GOA-403722, INDIA IN

治疗领域:

ranolazine

疗效迹象:

治療穩定心絞痛(stable angina):已使用第一線心絞痛藥(如β受體阻斷劑及/或鈣離子阻斷劑)未能適當控制或無法耐受第一線心絞痛用藥的穩定心絞痛(stable angina)病人,ranolazine可作為併用或替代治療以改善症狀。

產品總結:

有效日期: 2025/03/16; 英文品名: Rancad Extended Release Tablets 500mg

授权日期:

2020-03-16

资料单张

                                500
027827
Rancad
®
Extended Release Tablets 500 mg 1000
027828
Rancad
®
Extended Release Tablets 1000 mg
1
stable angina
β
stable angina
Ranolazine
2
2.1
500
1000
1000
2
2.2
[
7.1
]
CYP3A
diltiazem verapamil
erythromycin
500
CYP3A [
47.1
]
P-
P-gp inhibitors
cyclosporine
[
7.1
]
3
• 500 L31 LU
• 1000 L32 LU
4
•
CYP3A
[
7.1
]
•
CYP3A [
7.1
]
• [
8.5
]
5
(
)
5.1 QT
Ranolazine
I
kr
QTc
proarrhythmia
[
13.2
]
Ranolazine > 1000
QT
potassium channel variants
QT
QT
QT
QT
5.2
CrCL<30mL/min
Ranolazine
(
)
Ranolazine [
8.6
]
CrCL<60mL/min
Ranolazine
Ranolazine
6
(
)
6.1
2,018
Ranolazine
Ranolazine
1,026
CARISAERICAMARISA
12
1,251
Ranolazine
Ranolazine
1
1,227
2
613
3
531
4
326
Ranolazine
6%
3%
Ranolazine 1.3% vs 0.1%
1% vs 0%
0.5% vs 0%
1000
> 4%
Ranolazine
6.2%
5.5%
4.5%
4.4%
Ranolazine
0.5%-4%
–
–
–
–
–
–
–
–
–
–
–
–
<0.5%
Ranolazine
Ranolazine
proarrhythmic effect
[
13.2
]
Ranolazine
0.1 mg/dL
Ranolazine
Ranolazine
BUN
Ranolazine 1000
RanolazineBUN
[
5.2
(8.6)
]
6.2
Ranolazine
–
Ranolazine
Ranolazine
–
–
–
–
7
(
)
7.1 RANOLAZINE
CYP3A
Ranolazine
CYP3A
ketoconazoleitraconazole
clarithromycin
nefazodone
nelfinavir
ritonavirindinavir
saquinavir
[
411.3
]
CYP3A
CYP3A
Ranolazine
500
CYP3A
diltiazem verapamil
erythromycin
fluconazole
[
2.211.3
]
P- P-GP INHIBITORS
Ranolazine
P-
cyclosporine
Ranolazine
P-
cyclosporine
Ranolazine
[
2.2
]
CYP3A
Ranolazine
CYP3A
rifampinrifabutinrifapentin
phenobarbital
phenytoin
carbamazepine
(St. John s wort)
[
411.3
]
7.2 RANOLAZINE
CYP3A
simvastatin
Ranolazine
Ranolazine
simvastatin
20
CYP3A
lovastatin
CYP3A
cyclosporinetacrolimus
sirolimus
Ranolazine
[
11.3
]
P- P-GP
Ranolazine
digoxin
digoxin
digoxin
[
11.3
]
CYP2D6
Ranolazine
CYP2D6
OCT2
Ranolazine 1000
metformin
metformin
Ranolazine 1000
metformin
1700
metformin
Ranolazine 500
metformin
metformin
[
11.3
]
8
(
)
8.1
Ranolazine
MRHD
4
2-4%
15-20%
-
Ranolazine
AUC
MRHD
4
MRHD
AUC
8.2
Ranolazine
Ranolazine
[
8.1
]
Ranolazine
Ranolazine
6
20
Ranolazine
60 mg/kg/day
AUC
MRHD
Ranolazine
8.3
8.4

                                
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