藥碼
NEB02
藥名
Nebivolol 錠劑 5 mg
英文商品名
Nebilet 錠劑 5 mg
中文商品名
耐比洛錠5毫克
螢幕名
Nebilet 錠劑 5 mg
劑型
Tab
規格
5mg/tab
成分
藥理分類
β-Adrenergic Blocking Agents
健保碼
BC26700100
ATC碼
適應症
Hypertension: Management of hypertension.
藥理
Highly-selective inhibitor of beta1-adrenergic receptors
藥動學
Absorption: Rapid
Distribution: Vd: 8 to 12 L/kg
Protein binding: ~98%, primarily to albumin
Metabolism: Hepatic（via glucuronidation and CYP2D6）.Extensive first-pass metabolism to multiple active metabolites with variable activity.
Bioavailability: ~12% (extensive metabolizers); 96% (poor metabolizers).
Half-life elimination: Terminal: 12 hours (extensive metabolizers) or 19 hours (poor metabolizers); up to 32 hours has been reported in poor metabolizers.
Time to peak, plasma: 1.5 to 4 hours
Excretion: Urine (extensive metabolizers: 38%; poor metabolizers: 67%; <0.5% of total dose as unchanged drug); feces (extensive metabolizers: 44%; poor metabolizers: 13%; <0.5% of total dose as unchanged drug)
Distribution: Vd: 8 to 12 L/kg
Protein binding: ~98%, primarily to albumin
Metabolism: Hepatic（via glucuronidation and CYP2D6）.Extensive first-pass metabolism to multiple active metabolites with variable activity.
Bioavailability: ~12% (extensive metabolizers); 96% (poor metabolizers).
Half-life elimination: Terminal: 12 hours (extensive metabolizers) or 19 hours (poor metabolizers); up to 32 hours has been reported in poor metabolizers.
Time to peak, plasma: 1.5 to 4 hours
Excretion: Urine (extensive metabolizers: 38%; poor metabolizers: 67%; <0.5% of total dose as unchanged drug); feces (extensive metabolizers: 44%; poor metabolizers: 13%; <0.5% of total dose as unchanged drug)
禁忌症
Severe bradycardia
Heart block greater than first-degree (except in patients with a functioning artificial pacemaker)
Cardiogenic shock
Decompensated heart failure
Sick sinus syndrome (unless a permanent pacemaker is in place)
Severe hepatic impairment (Child-Pugh class C)
Documentation of allergenic cross-reactivity for beta-blockers is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.
Sinoatrial block
Rare hereditary conditions of Galactose intolerance
Congenital lactase deficiency or glucose-galactose malabsorption.
懷孕分類
1.Outcome information following maternal use of nebivolol in pregnancy is limited.
2. If maternal use of a beta-blocker is needed, fetal growth should be monitored during pregnancy and the newborn should be monitored for 48 hours after delivery for bradycardia, hypoglycemia, and respiratory depression
3.仿單：not recommened
2. If maternal use of a beta-blocker is needed, fetal growth should be monitored during pregnancy and the newborn should be monitored for 48 hours after delivery for bradycardia, hypoglycemia, and respiratory depression
3.仿單：not recommened
哺乳分類
1.It is not known if nebivolol is present in breast milk.
2.Breastfeeding is not recommended by the manufacturer due to the potential for beta-blockers to produce serious effects on breastfed infants, especially bradycardia.
2.Breastfeeding is not recommended by the manufacturer due to the potential for beta-blockers to produce serious effects on breastfed infants, especially bradycardia.
副作用
Central nervous system: Headache (6% to 9%), fatigue (dose-related; 2% to 5%), dizziness (2% to 4%), insomnia (1%), paresthesia
Dermatologic: Skin rash (?1%)
Endocrine & metabolic: Decreased HDL cholesterol, hypercholesterolemia, increased serum triglycerides, increased uric acid
Gastrointestinal: Diarrhea (dose-related; 2% to 3%), nausea (1% to 3%), abdominal pain
Hematologic & oncologic: Decreased platelet count
Neuromuscular & skeletal: Weakness
Renal: Increased blood urea nitrogen
Respiratory: Dyspnea (?1%)
劑量和給藥方法
Hypertension (alternative agent): Oral: Initial: 5 mg once daily; titrate as needed at 2-week intervals based on patient response to a maximum dose of 40 mg once daily (ACC/AHA [Whelton 2017]).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
小兒調整劑量
仿單：not recommened
腎功能調整劑量
CrCl 50 to 80 mL/minute：There are no dosage adjustments provided in the manufacturer’s labeling; however, dose adjustment does not appear necessary. Following a single 5 mg dose in patients with CrCl 50 to 80 mL/minute, nebivolol clearance was unchanged.
CrCl 30 to 50 mL/minute：There are no dosage adjustments provided in the manufacturer’s labeling; however, dose adjustment is likely not necessary. Following a single 5 mg dose in patients with moderate impairment, reduction in nebivolol clearance was negligible (~17%).
CrCl <30 mL/minute：Initial: 2.5 mg once daily; if initial response is inadequate, may increase cautiously.
Hemodialysis： There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).
CrCl 30 to 50 mL/minute：There are no dosage adjustments provided in the manufacturer’s labeling; however, dose adjustment is likely not necessary. Following a single 5 mg dose in patients with moderate impairment, reduction in nebivolol clearance was negligible (~17%).
CrCl <30 mL/minute：Initial: 2.5 mg once daily; if initial response is inadequate, may increase cautiously.
Hemodialysis： There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).
肝功能調整劑量
Mild impairment (Child-Pugh class A): There are no dosage adjustments provided in the manufacturer’s labeling; use caution.
Moderate impairment (Child-Pugh class B): Initial: 2.5 mg once daily; if initial response is inadequate, may increase cautiously.
Severe impairment (Child-Pugh class C): Use is contraindicated.
Moderate impairment (Child-Pugh class B): Initial: 2.5 mg once daily; if initial response is inadequate, may increase cautiously.
Severe impairment (Child-Pugh class C): Use is contraindicated.
安定性
藥袋資訊
臨床用途
原發性高血壓
主要副作用
頭暈或頭昏眼花、疲倦、水腫、噁心、腹瀉等
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 E4 | 小庫 E1 | 藥庫 口F11
藥品外觀
顏色
13
形狀
01
剝痕
Y
標記1
十
標記2
其他
健保藥價
3.54
自費價
4.71
仿單
資料庫
健保給付規定