舒樂津錠劑５公絲

国: 台湾

言語: 中国語

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

有効成分:

PILOCARPINE HCL

から入手可能:

天義企業股份有限公司 台北市復興南路一段１２９號５樓 (22180049)

ATCコード:

N07AX01

医薬品形態:

錠劑

構図:

主成分 () ; PILOCARPINE HCL (5220000310) MG

パッケージ内のユニット:

瓶裝

クラス:

製　劑

処方タイプ:

須由醫師處方使用

製:

AMDIPHARM LIMITED 17 NORTHWOOD HOUSE, NORTHWOOD AVENUE, SANTRY, DUBLIN 9, IRELAND IE

治療領域:

pilocarpine

適応症:

因頭頸部癌放射線治療造成唾腺功能減低而引起的口乾燥症。SJOGREN'S SYNDROME 所引起的口乾燥症。

製品概要:

有效日期: 2027/09/12; 英文品名: SALAGEN TABLETS 5MG

承認日:

2002-09-12

情報リーフレット

●
Pilocarpine hydrochloride 5mg
●
Salagenpilocarpine
hydrochlo-
ridePilocarpine
hydrochloride
pilocarpine hydrochloride
2 ( 3 H ) - F u r a n o n e , 3 - e t h y l d i h y d r o
-4-[(1-methyl-1H-imidazol-5-yl)methyl]-mono-
hydrochloride, (3S-cis)244.72
S a l a g e n 5 m g
pilocarpine hydrochloride
Microcrystalline cellulose
Stearic acid
Opadry White OY-7300
Carnauba wax
●
�
muscarinic
pilocarpine
Pilocarpine
M u s c a r i n i c
a g o n i s t
pilocarpine
pilocarpine
12
5mg
10mg
Salagen
20
1
3~5()
20712
Salagen
1
5mg63%
10mg90%
SJOGREN’S
SYNDROME12
629
Salagen
2.5~7.5mgSalagen
AUC
Salagen
12
()
●
(8a.m.)(6p.m.)5mg
10mgpilocarpine hydrochloride 2
5mg
0.7610mg
1.35Tmax
1.250.85
Cmax15 ng/ml41 ng/ml6
AUC33ng x h/ml(5mg)108ng
x h/ml(10mg)
5Cmax
AUC
2
12
Salagen
Tmax1.47
0.87
Cmax51.859.2ng/ml
Pilocarpine
Pilocarpine
Pilocarpine
pilocarpine acid
Pilocarpine
5~25,000 ng/ml
Pilocarpine
(N=12)
5mg30%
(
AUC)
30%2.1
(
25.4mL/min
9.8~40.8mL/min)(N=8)
Pilocarpine
●
20712(142
65)
58.5
(
17~77)95%
4%1%Salagen
tablets
5mg
10mg
16212
(14265)
57.8
(
27~80
)88%
10%2%
Salagen tablets 2.5mg
5mg10mg
Salagen tablets 5 mg673
6610mg
7
4
Salagen tablets 2.5mg
Salagen tablets 5 mg10 mg
SJOGREN’S SYNDROME
Sjogren’s
Syndrom
Sjogren’s Syndrom
256(14242)12
57
(
24~85)91%
6 %
3 %
Salagen tablets 5mg(20mg/)
5mg
7.5mg
Salagen
“
”
(visual analogue scale
100mm)
55mm
373
(16357)12
55
(
21~84)80%
14%2%4%
2.5mg
pilocarpine
tablets5mg
Salagen
tablets
125mg
2.5mg(10mg/
)
2.5mg(9)
5mg
(16)
10~20mg/
Salagen
●
Sjogren’s Syndrome
●
pilocarpine
(
)
●
pilocarpine
pilocarpine
pilocarpine
pilocarpine
pilocarpine
pilocarpine
(
)
Pilocarpine
pilocarpine
●
Pilocarpine
Pilocarpine
pilocarpine
Pilocarpine
(
)
agonist
5mg
(Child-Pugh score of 5-6)
(Child-Pugh score of 10-15)
Child-Pugh
*Trey, Burns, and Saunders(1966)
Reference: Pugh R.N.H., Murray-Lyon, I.M.,
Dawson, J.L., Pietroni, M.C., Williams, R.
Transection of the Oesophagus for Bleeding
Oesophageal Varices, Brit. J.Surg.,
1973.60:646-9
pilocarpine
pilocarpine
b-
pilocarpine
p