藥碼
ROZ03
藥名
Ramelteon 錠劑 8 mg
英文商品名
Rozerem 錠劑 8 mg
中文商品名
柔速瑞膜衣錠8毫克
螢幕名
Rozerem 錠劑 8 mg
劑型
Tab
規格
成分
藥理分類
Misc. Anoxiolytic, Sedatives, Hypnotics
健保碼
ATC碼
藥品圖片
外觀圖片
適應症
Insomnia, sleep onset 入睡困難失眠
藥理
Hypnotic, Miscellaneous; Melatonin Receptor Agonist
Potent, selective agonist of melatonin receptors MT1 and MT2 (with little affinity for MT3) within the suprachiasmic nucleus of the hypothalamus, an area responsible for determination of circadian rhythms and synchronization of the sleep-wake cycle.
藥動學
  • Onset of action: 30 minutes
  • Absorption: Rapid; high-fat meal delays Tmax and increases AUC (~31%)
  • Distribution: 74 L
  • Protein binding: ~82%
  • Metabolism: Extensive first-pass effect; oxidative metabolism primarily through CYP1A2 and to a lesser extent through CYP2C and CYP3A4; forms active metabolite (M-II)
  • Half-life elimination: 1 to 2.6 hours (Ramelteon); 2 to 5 hours (M-II)
  • Time to peak, plasma: 0.5 to 1.5 hours
  • Excretion: Urine (84%); feces (4%)
  • 禁忌症
    History of angioedema with previous ramelteon therapy (do not rechallenge); concurrent use with fluvoxamine.
    懷孕分類
    C; Adverse events were observed in some animal reproduction studies.
    哺乳分類
    According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.
    副作用
    Dizziness (4% to 5%), somnolence (3% to 5%), fatigue (3% to 4%), insomnia worsened (3%), depression (2%), Nausea (3%), Upper respiratory infection (3%)
    劑量和給藥方法
    Delirium and sleep, ICU related: 8 mg once daily at bedtime
    Insomnia, sleep onset: 8 mg once daily administered, as needed, within 30 minutes of bedtime. Maximum dose: 8 mg/day.
    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/Moderate impairment: There are no dosage adjustments provided in the manufacturer's labeling; use with caution.
    Severe impairment: Use is not recommended.
    安定性
    Store at 25°C; excursions permitted to 15°C to 30°C. Protect from moisture.
    藥袋資訊
    臨床用途
    入睡困難性失眠
    主要副作用
    嗜睡、頭暈、噁心、疲倦、頭痛,本品可能增加跌倒風險,請注意。
    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 V2 | 藥庫 口G11
    藥品外觀
    顏色
    06
    形狀
    02
    剝痕
    N
    標記1
    CT8
    標記2
    其他
    健保藥價
    0
    自費價
    40
    仿單
    資料庫
    健保給付規定