藥碼
SYM03
藥名
Naldemedine 錠 0.2 mg
英文商品名
Symproic 錠 0.2 mg
中文商品名
適秘效膜衣錠0.2毫克
螢幕名
Symproic 錠 0.2 mg
劑型
Tab
規格
0.2mg/tab
成分
藥理分類
Cathatics & Laxatives
健保碼
ATC碼
適應症
Opioid-induced constipation
藥理
藥動學
Absorption
Time to peak:0.75 hours; 2.5 hours (with food)
Distribution
1. Vd:155 L
2. Protein binding:93% to 94%
Metabolism
CYP3A to nor-naldemedine (major); UGT1A3 to naldemedine 3-G (minor); also undergoes cleavage in the GI tract to form benzamidine and naldemedine carboxylic acid.
Excretion
Urine (57%; 16% to 18% as unchanged drug; 32% as benzamidine metabolite); feces (35%; 20% as benzamidine metabolite)
Pharmakodynamics
Half-life Elimination:11 hours
Time to peak:0.75 hours; 2.5 hours (with food)
Distribution
1. Vd:155 L
2. Protein binding:93% to 94%
Metabolism
CYP3A to nor-naldemedine (major); UGT1A3 to naldemedine 3-G (minor); also undergoes cleavage in the GI tract to form benzamidine and naldemedine carboxylic acid.
Excretion
Urine (57%; 16% to 18% as unchanged drug; 32% as benzamidine metabolite); feces (35%; 20% as benzamidine metabolite)
Pharmakodynamics
Half-life Elimination:11 hours
禁忌症
Hypersensitivity to naldemedine or any component of the formulation; GI obstruction (known or suspected) or at increased risk of recurrent obstruction.
懷孕分類
Adverse events were observed in some animal reproduction studies. Based on animal data, naldemedine may cross the placenta and cause opioid withdrawal in the fetus if administered during pregnancy.
哺乳分類
It is not known if naldemedine is present in breast milk.
副作用
>10%:
Gastrointestinal: Abdominal pain (8%), diarrhea (7%)
1% to 10%:
Gastrointestinal: Nausea (4%), vomiting (3%), gastroenteritis (2%)
<1%
postmarketing, and/or case reports: Hypersensitivity reaction
Gastrointestinal: Abdominal pain (8%), diarrhea (7%)
1% to 10%:
Gastrointestinal: Nausea (4%), vomiting (3%), gastroenteritis (2%)
<1%
postmarketing, and/or case reports: Hypersensitivity reaction
劑量和給藥方法
Opioid-induced constipation: Oral:
0.2 mg once daily. Discontinue treatment if opioid pain medication is discontinued.
0.2 mg once daily. Discontinue treatment if opioid pain medication is discontinued.
小兒調整劑量
腎功能調整劑量
No dosage adjustment necessary.
肝功能調整劑量
Mild to moderate impairment (Child-Pugh classes A and B):
No dosage adjustment necessary.
Severe impairment (Child-Pugh class C):
Avoid use (has not been studied).
No dosage adjustment necessary.
Severe impairment (Child-Pugh class C):
Avoid use (has not been studied).
安定性
藥袋資訊
臨床用途
成人因鴉片類藥物引起之便秘
主要副作用
腹瀉、腹痛、噁心、嘔吐等
泡製方法
儲存方式
請置於 15-30℃ 乾燥處儲存
注意事項
其他說明
藥局 W4 | 藥庫 口G21
藥品外觀
顏色
07
形狀
02
剝痕
標記1
@ 222
標記2
0.2
其他
健保藥價
0
自費價
85
仿單
資料庫
健保給付規定