"杏輝"健挺膜衣錠100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)
13-06-2021
公众评估报告 公众评估报告 (PAR)
28-03-2020

有效成分:

SILDENAFIL CITRATE

可用日期:

杏輝藥品工業股份有限公司 宜蘭縣冬山鄉中山村中山路84、84之4、84之6、84之7號、冬山鄉中山村新寮路95、95之1、100之7、100之13、100之15、100之16、103、136號 (42042734)

ATC代码:

G04BE03

药物剂型:

膜衣錠

组成:

SILDENAFIL CITRATE (9200091910) (eq. to Sildenafil.....100mg)MG

每包单位数:

PTP 鋁箔盒裝;;塑膠瓶裝

类:

製 劑

处方类型:

須由醫師處方使用

厂商:

杏輝藥品工業股份有限公司 宜蘭縣冬山鄉中山村中山路84、84之4、84之6、84之7號、冬山鄉中山村新寮路95、95之1、100之7、100之13、100之15、100之16、103、136號 TW

治疗领域:

sildenafil

疗效迹象:

成年男性勃起功能障礙。

產品總結:

有效日期: 2027/06/01; 英文品名: Ganstrong Film Coated Tablets 100mg "Sinphar"

授权日期:

2017-06-01

资料单张

                                Sildenafil citrate
cGMP-specific PDE5 (phosphodiesterase type
5)
cGMP- specific PDE5
PDE
(isoenzyme)
Sildenafil
5-[2-Ethoxy-5-[(4-methylpiperazin-1-yl)sulfonyl]phenyl]-1-methyl-3-propyl-1,6-
dihydro-7H-pyrazolo[4,3-d]pyrimidin-7- one dihydrogen
2-hydroxypropane-1,2,3-tricarboxylate
CAS
171599-83-0
Sildenafil
citrate
C H N O S
666.7
28
38
6
11
Sildenafil citrate
Sildenafil citrate
25
2.6 mg
Sildenafil
Sildenafil Citrate.................
Sildenafil
Sildenafil
(NO)
guanylate cyclase
cyclic guanosine monophosphate
(cGMP)
Sildenafil
cGMP specific phosphodiesterase type 5 (PDE5)
PDE5
cGMP
Sildenafil
Sildenafil
NO
NO/cGMP
PDE5
Sildenafil
cGMP
Sildenafil
100 mg
Sildenafil
100 mg
8.4 mmHg
5.5
mmHg
Sildenafil
cGMP
Sildenafil
100
mg
Famsworth-Munsell 100
PDE6
Sildenafil
PDE5
PDE6
10
PDE5
Sildenafil
Sildenafil
NO
sodium nitroprusside
Sildenafil
PDE5
phosphodiesterase
(PDE's
1,2,3,4,6,7
10
10000
cGMP-
specific phosphodiesterase (PDE3)
Sildenafil
PDE5
PDE3
4000
Sildenafil
30
120
60
41
25
63%
Sildenafil
(25 mg- 100 mg)
Sildenafil
sildenafil
60
29%
Sildenafil
(Vss)
105
Sildenafil
N-desmethyl
96%
16
Sildenafil
(100 mg
1.5
4
Sildenafil
18% 17%
90
0.0002%
Sildenafil
CYP3A4
CYP2C9
Sildenafil
N-demethylation
PDE
Sildenafil
PDE5
50%
Sildenafil
40%
N-desmethyl
4
Sildenafil
41 L/h
3-5
Sildenafil
80%
13%
65
65
Sildenafil
(18-45
)
40%
(Clcr=50-80 mL/min)
(Clcr=30-49 mL/min)
Sildenafil (50 mg)
(Clcr=<30
mL/min)
Sildenafil
AUC (100%)
Cmax (88%)
(Child-Pugh A
B)
Sildenafil
AUC (85%)
Cmax (47%)
Sildenafil
140.45mg(
Sildenafil..............100mg)
PVP K-30
Aerosil 200
Microcrystalline Cellulose
Dibasic Calcium Phosphate
Anhydrous
Croscarmellose Sodium Magnesium Stearate
Water Purified
Opadry
Blue
Opadry 03K19229 Clear
)
Sildenafil
21
6
3000
19
87
(
(IIEF
)
Sildenafil
21
(
)
62% (25 mg)
74% (50
mg)
82% (100 mg)
25%
IIEF
Sildenafil
Sildenafil
59%
43%
83% (
16% 15% 12%
Sildenafil
Ganstrong Film Coated Tablets 100mg
PIC/S GMP
059703
G-12988
+
8 4
SINPHAR PHARMACEUTICAL CO., LTD.
84, CHUNG SHAN ROAD, CHUNG SHAN VILLAGE, TUNG - SHAN SHINE, I - LAN,
T
                                
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