藥碼
PHE04
藥名
Phenobarbital 錠劑 30 mg
英文商品名
Phenobarbital 錠劑 30 mg
中文商品名
苯巴比特魯錠
螢幕名
Phenobarbital 錠劑 30 mg
劑型
Tab
規格
30mg/tab
成分
藥理分類
Anticonvulsant-Barbiturates
健保碼
NC134191G0
ATC碼
藥品圖片
外觀圖片
適應症
【藥品性質提示】
根據 2019 AGS Beers Criteria,本藥品為【潛在不適當用藥 (PIM)】,不建議用於老年人。

Sedation: Use as a sedative
Seizures: Management of generalized tonic-clonic, status epilepticus, and partial seizures
藥理
Anticonvulsant:Long-acting Barbiturates
藥動學
  • Onset of action: ?60 minutes.
  • Duration:10 to 12 hours.
  • Absorption:Adults:
    Rapid and complete.
    Newborns: Delayed and incomplete.
  • Distribution: Vd:Neonates: 0.85 ± 0.059 L/kg
    2 to 3 months: 0.857 ± 0.089 L/kg
    4 to 12 months: 0.57 ± 0.046 L/kg
    1 to 5 years: 0.666 ± 0.073 L/kg
    Adults: 0.61 L/kg (Patsalos 2018).
  • Protein binding:Neonates and young infants: 36% to 43%
    Adults: 48%
  • Metabolism: Hepatic by oxidation via CYP2C9 and to a lesser extent via CYP2C19 and CYP2E1, and by N-glucosidation
  • Bioavailability:Neonates and young infants: ~48.9
    Adults: 90%
  • Half-life elimination:?10 days of life: 114.2 ± 43 hours.
    11 to 30 days of life: 73.19 ± 24.17 hours.
    2 to 3 months: 62.9 ± 5.2 hours.
    4 to 12 months: 63.2 ± 4.2 hours.
    1 to 5 years: 68.5 ± 3.2 hour.
    Adults: ~79 hours (range: 53 to 118 hours).
  • Time to peak, serum: Newborns: 1.5 to 6 hours.
    Adults: 2 to 4 hours.
  • Excretion: Urine (25% to 50% as unchanged drug); feces (minimal).
  • 禁忌症
    Hypersensitivity to phenobarbital
    Barbiturates or any component of the formulation
    Marked hepatic impairment
    Dyspnea or airway obstruction
    Porphyria (manifest and latent)
    Use in patients with a history of sedative/hypnotic addiction
    Nephritic patients (large doses)
    懷孕分類
    D
    1.Phenobarbital crosses the placenta.Barbiturates can be detected in the placenta, fetal liver, and fetal brain.
    2.An increased incidence of fetal abnormalities may occur following maternal use. When used during the third trimester of pregnancy, withdrawal symptoms may occur in the neonate, including seizures and hyperirritability.
    3.should be avoided during pregnancy.
    哺乳分類
    should be taken with caution.
    Phenobarbital is excreted in breast milk. A delayed interest in breast-feeding may occur in infants exposed in utero. Infantile spasms and other withdrawal symptoms have been reported following the abrupt discontinuation of breast-feeding.
    副作用
    Cardiovascular: Bradycardia, hypotension, syncope
    Central nervous system: Agitation, anxiety, ataxia, central nervous system stimulation, central nervous system depression, confusion, dizziness, drowsiness, hallucination, hangover effect, headache, impaired judgement, insomnia, lethargy, nervousness, nightmares
    Dermatologic: Exfoliative dermatitis, skin rash, Stevens-Johnson syndrome
    Gastrointestinal: Constipation, nausea, vomiting
    Genitourinary: Oliguria
    Hematologic & oncologic: Agranulocytosis, thrombocytopenia, megaloblastic anemia
    Local: Pain at injection site
    Neuromuscular & skeletal: Hyperkinesia, laryngospasm
    Respiratory: Apnea (especially with rapid IV use), hypoventilation, respiratory depression
    劑量和給藥方法
  • Sedation:30 to 120 mg/day in 2 to 3 divided doses; maximum: 400 mg/day
  • Preoperative sedation: IM: 100 to 200 mg 60 to 90 minutes before surgery
  • Seizures: Maintenance dose:Usual dosage range (limited data available): 2 mg/kg/day in divided doses (Murphy 2010; Winter 2010). Note: Dosage should be individualized based upon clinical response and serum concentration; 2 mg/kg/day typically produces a steady-state level of 20 mg/L.
    Manufacturer's labeling: Oral: Dosing in the prescribing information may not reflect current clinical practice. 60 to 200 mg/day or 50 to 100 mg 2 to 3 times daily.
  • 小兒調整劑量
  • Seizures, maintenance therapy: Maintenance dose usually starts 12 hours after loading dose: Dosage should be individualized based upon clinical response and serum concentration; once-daily doses usually administered at bedtime in children and adolescents.
    Manufacturer's labeling: Infants, Children, and Adolescents:3 to 6 mg/kg/day.
    Alternate dosing: Limited data available
    Initial:
    Infants and Children ?5 years: 3 to 5 mg/kg/day in 1 to 2 divided doses.
    Children >5 years and Adolescents: 2 to 3 mg/kg/day in 1 to 2 divided doses.
  • Hyperbilirubinemia (conjugated): Limited data available:Infants and Children: Usual range: 3 to 8 mg/kg/day in 2 to 3 divided doses; doses up to 10 mg/kg/day in divided doses have been used in case reports; for the treatment of hyperbilirubinemia in Crigler-Najjar Syndrome, a dose of 5 mg/kg/day has been used to reduce serum bilirubin concentrations.
    not recommended for management of biliary cirrhosis due to sedation and other adverse effects.
  • 腎功能調整劑量
    There are no specific dosage adjustments provided in the manufacturer's labeling; reduced doses are recommended.The following guidelines have been recommended by some clinicians:
    CrCl ?10 mL/minute: No dosage adjustment necessary.
    CrCl <10 mL/minute: Administer dose every 12 to 16 hours.
    Hemodialysis (moderately dialyzable [20% to 50%]): Administer dose before dialysis and 50% of dose after dialysis.
    Peritoneal dialysis: 35% to 40% removed; administer 50% of normal dose.
    Continuous renal replacement therapy (CRRT): Administer normal dose and monitor levels.
    肝功能調整劑量
    There are no specific dosage adjustments provided in manufacturer's labeling.
    Phenobarbital exposure is increased with hepatic impairment; reduced doses are recommended; use with caution.
    安定性
    仿單:本藥應包裝於緊密容器,儲存於陰涼(15-30℃)乾燥且孩童不易取得處所。
    藥袋資訊
    臨床用途
    抗癲癇劑、治療新生兒黃疸
    主要副作用
    嗜睡、頭暈、倦怠無力、運動失調等,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 Q3 | 藥庫 管D
    藥品外觀
    顏色
    18
    形狀
    02
    剝痕
    Y
    標記1
    H.T
    標記2
    088
    其他
    健保藥價
    2
    自費價
    2.66
    仿單
    資料庫
    健保給付規定