藥碼
INO01
藥名
Rufinamide 錠劑 200 mg
英文商品名
臨採 Inovelon 錠劑 200 mg
中文商品名
克雷葛 膜衣錠 200毫克
螢幕名
臨採 Inovelon 錠劑 200 mg
劑型
Tab
規格
Tab 200mg
成分
藥理分類
Misc. Anticonvulsants
健保碼
BC26777100
ATC碼
藥品圖片
外觀圖片
適應症
【藥品庫存】
本藥品為臨時採購藥品,經院長核可後,限定特定科別、病人使用。

【藥品性質提示】
根據 2019 AGS Beers Criteria,本藥品為【潛在不適當用藥 (PIM)】,不建議用於有骨折風險之老年人(除非用於癲癇、調節情緒)。

治療癲癇 Lennox-Gastaut syndrome
Adjunctive treatment of seizures associated with Lennox-Gastaut syndrome in adults and children 1 year and older
藥理
Anticonvulsant, Triazole Derivative
A triazole-derivative antiepileptic whose exact mechanism is unknown. In vitro, it prolongs the inactive state of the sodium channels, thereby limiting repetitive firing of sodium-dependent action potentials mediating anticonvulsant effects.
藥動學
Absorption:
1. Slow; increased with food
2. Bioavailability: Extent decreased with increased dose
Distribution:
1. Vd: ~50 L
2. Protein binding: 34%, primarily to albumin (27%)
Metabolism:
Extensively via carboxylesterase-mediated hydrolysis of the carboxylamide group to CGP 47292 (inactive metabolite); weak inhibitor of CYP2E1 and weak inducer of CYP3A4
Excretion:
Urine (85%, ~66% as CGP 47292, 2% as unchanged drug)
Pharmacodynamics:
1. Half-life elimination: ~6 to 10 hours
2. Time to peak, plasma: 4 to 6 hours
禁忌症
Patients with familial short QT syndrome
懷孕分類
Adverse effects were seen in animal reproduction studies.
哺乳分類
It is not known if rufinamide is present in breast milk.
副作用
Cardiovascular: Shortened QT interval (46% to 65%; dose related)
Central nervous system: Headache (adults 27%, children 16%), drowsiness (11% to 24%), dizziness (3% to 19%), fatigue (9% to 16%)
Gastrointestinal: Vomiting (children 17%, adults 5%), nausea (7% to 12%)
劑量和給藥方法
400 to 800 mg daily in 2 equally divided doses; increase dose by 400 to 800 mg daily every other day to a maximum dose of 3,200 mg daily in 2 equally divided doses
小兒調整劑量
Children and Adolescents <17 years:
1. Initial: 10 mg/kg/day in 2 equally divided doses; increase dose by ~10 mg/kg increments every other day to a target daily dose of 45 mg/kg/day in 2 equally divided doses
2. Maximum daily dose: 3,200 mg/day; effectiveness of doses lower than the target dose is unknown
Adolescents ≤17 years:
1. Initial: 400 to 800 mg/day in 2 equally divided doses; increase dose by 400 to 800 mg daily every other day to a maximum daily dose of 3,200 mg/day in 2 equally divided doses
2. Effectiveness of doses lower than 3,200 mg/day is unknown
腎功能調整劑量
1. CrCl <30 mL/minute: No dosage adjustment necessary.
2. Hemodialysis: Noo dosage adjustments provided in the manufacturer's labeling. However, consider dosage adjustment for loss of drug.
肝功能調整劑量
1. Mild to moderate impairment (Child-Pugh score 5 to 9): Use with caution.
2. Severe impairment (Child-Pugh score 10 to 15): There are no dosage adjustments provided in the manufacturer's labeling (has not been studied); use is not recommended.
安定性
藥袋資訊
臨床用途
Lennox-Gastaut 症候群相關癲癇發作之輔助治療
主要副作用
頭暈、頭痛、噁心、嗜睡、疲倦等
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 Y6 | 藥庫 口D11
藥品外觀
顏色
19
形狀
03
剝痕
Y
標記1
?262
標記2
其他
健保藥價
26.2
自費價
34.85
仿單
資料庫
健保給付規定