藥碼
BOB01
藥名
Polymyxin B Sulfate 針 500 KIU
英文商品名
Bobimixyn 針 500 KIU/Vial
中文商品名
寶比黴素凍晶注射劑
螢幕名
Bobimixyn 針 500 KIU/Vial
劑型
Inj
規格
成分
藥理分類
Misc. Antibacterials
健保碼
AC61557277
ATC碼
適應症
Treatment of serious infections caused by extensively drug-resistant Gram-negative organisms, including Acinetobacter baumannii and difficult-to-treat Pseudomonas aeruginosa, when other antibacterial agents cannot be used.
Polymyxin B is generally administered in combination with another active antimicrobial agent. Colistimethate is preferred when a polymyxin is required for urinary tract infection because polymyxin B achieves limited urinary concentrations.
Polymyxin B is generally administered in combination with another active antimicrobial agent. Colistimethate is preferred when a polymyxin is required for urinary tract infection because polymyxin B achieves limited urinary concentrations.
藥理
Polymyxin B is a cyclic polypeptide bactericidal antibiotic. It binds to phospholipids and lipopolysaccharides in the outer membrane of Gram-negative bacteria, alters membrane permeability, and causes leakage of intracellular constituents and bacterial cell death.
藥動學
Distribution :
Poor tissue penetration; central volume of distribution approximately 0.09 L/kg and peripheral volume of distribution approximately 0.33 L/kg in critically ill adults. Penetration into CSF and ocular fluid is limited.
Protein binding : Approximately 60%; 79% to 92% in critically ill patients.
Half-life : Approximately 10.1 to 13.6 hours.
Excretion :
Predominantly nonrenal; urinary excretion of unchanged drug is limited.
Pharmacodynamics
Concentration-dependent activity. Proposed target exposure is AUCCCCC approximately 50 to 100 mg·hour/L or average steady-state concentration of 2 to 4 mg/L. AUCCCCC >100 mg·hour/L is associated with an increased risk of nephrotoxicity.
Poor tissue penetration; central volume of distribution approximately 0.09 L/kg and peripheral volume of distribution approximately 0.33 L/kg in critically ill adults. Penetration into CSF and ocular fluid is limited.
Protein binding : Approximately 60%; 79% to 92% in critically ill patients.
Half-life : Approximately 10.1 to 13.6 hours.
Excretion :
Predominantly nonrenal; urinary excretion of unchanged drug is limited.
Pharmacodynamics
Concentration-dependent activity. Proposed target exposure is AUCCCCC approximately 50 to 100 mg·hour/L or average steady-state concentration of 2 to 4 mg/L. AUCCCCC >100 mg·hour/L is associated with an increased risk of nephrotoxicity.
禁忌症
Hypersensitivity to polymyxin B or any component of the formulation.
懷孕分類
No formal pregnancy category is assigned. Safety during human pregnancy has not been established, and data from systemic use are limited. Because polymyxin B is relatively toxic compared with other antibiotics, systemic use during pregnancy is not recommended unless the anticipated benefit outweighs the potential fetal risk.
哺乳分類
It is unknown whether polymyxin B is present in human milk. If present, clinically significant absorption by an infant with a normal gastrointestinal tract is unlikely. Consider the maternal need for treatment and the potential risk to the breastfed infant.
副作用
Dermatologic: Desquamation, skin hyperpigmentation, urticaria
Endocrine & metabolic: Albuminuria, hypocalcemia, hypochloremia, hypokalemia, hypomagnesemia, hyponatremia
Gastrointestinal:Clostridioides difficile-associated diarrhea
Genitourinary: Azotemia
Local: Local thrombophlebitis (IV injection site), pain at injection site (IM injection site)
Nervous system: Drug fever, meningism (with intrathecal administration), neurotoxicity (including asthenia, ataxia, blurred vision, dizziness, drowsiness, facial flushing, irritability, numbness of extremities, peripheral paresthesia [including oral paresthesia and stocking glove])
Neuromuscular & skeletal:Rhabdomyolysis, state of neuromuscular blockade (including respiratory paralysis)
Renal: Casts in urine, nephrotoxicity, renal tubular disease
Endocrine & metabolic: Albuminuria, hypocalcemia, hypochloremia, hypokalemia, hypomagnesemia, hyponatremia
Gastrointestinal:Clostridioides difficile-associated diarrhea
Genitourinary: Azotemia
Local: Local thrombophlebitis (IV injection site), pain at injection site (IM injection site)
Nervous system: Drug fever, meningism (with intrathecal administration), neurotoxicity (including asthenia, ataxia, blurred vision, dizziness, drowsiness, facial flushing, irritability, numbness of extremities, peripheral paresthesia [including oral paresthesia and stocking glove])
Neuromuscular & skeletal:Rhabdomyolysis, state of neuromuscular blockade (including respiratory paralysis)
Renal: Casts in urine, nephrotoxicity, renal tubular disease
劑量和給藥方法
Unit conversion : 10,000 units = 1 mg; one vial contains 500,000 units.
For extensively drug-resistant Gram-negative infection :
- Loading dose: 20,000 to 25,000 units/kg IV once.
- Maintenance dose: 12,500 to 15,000 units/kg IV every 12 hours.
- Infuse over 1 hour.
- Calculate the dose using actual body weight in patients with normal BMI.
- Consider adjusted body weight in patients with morbid obesity because clinical data are limited.
- Pharmacokinetic data do not support routine dose capping; however, safety data for individual infusions >2,000,000 units are limited.
- Usually administer in combination with another active antimicrobial agent.
Preparation :
- Dilute each 500,000-unit vial in 300 to 500 mL of D5W or 0.9% sodium chloride.
- Verify the dose and route carefully because prescribing errors may occur when units and milligrams are confused.
- Monitor renal function, urine output, electrolytes, neurologic status, and signs of neuromuscular blockade.
- Avoid concurrent or sequential nephrotoxic or neurotoxic medications when possible.
- Maintenance dose: 12,500 to 15,000 units/kg IV every 12 hours.
- Infuse over 1 hour.
- Calculate the dose using actual body weight in patients with normal BMI.
- Consider adjusted body weight in patients with morbid obesity because clinical data are limited.
- Pharmacokinetic data do not support routine dose capping; however, safety data for individual infusions >2,000,000 units are limited.
- Usually administer in combination with another active antimicrobial agent.
- Verify the dose and route carefully because prescribing errors may occur when units and milligrams are confused.
- Monitor renal function, urine output, electrolytes, neurologic status, and signs of neuromuscular blockade.
- Avoid concurrent or sequential nephrotoxic or neurotoxic medications when possible.
小兒調整劑量
Systemic therapy should be restricted to life-threatening multidrug-resistant infections when less toxic alternatives are ineffective or not tolerated. Pediatric data are limited, and the optimal dose has not been established.
Infants, children, and adolescents:Loading dose: 25,000 units/kg IV once may be considered.
Usual maintenance dose: 25,000 to 30,000 units/kg/day IV divided every 12 hours.
Reported range: 15,000 to 40,000 units/kg/day divided every 12 hours.
Safety data for doses >30,000 units/kg/dose or total daily doses >2,000,000 units are extremely limited.
Infants, children, and adolescents:
腎功能調整劑量
No dosage adjustment is necessary for any degree of kidney dysfunction. Reducing the daily dose may result in subtherapeutic exposure, clinical failure, and resistance.
Administer one of the twice-daily doses after dialysis on dialysis days.
Administer one of the twice-daily doses after dialysis on dialysis days.
肝功能調整劑量
There are no dosage adjustments provided in the manufacturer’s labeling.
安定性
Before reconstitution: Store intact vials at 20°C to 25°C and protect from light.
After reconstitution: Store at 2°C to 8°C. Discard unused solution after 72 hours.
After reconstitution: Store at 2°C to 8°C. Discard unused solution after 72 hours.
藥袋資訊
臨床用途
抗生素
主要副作用
口腔感覺遲鈍、皮膚感覺遲鈍、頭暈、口乾舌燥等。
泡製方法
儲存方式
儲存於25℃以下避光處。調製後可2-8℃冷藏保存72小時。
注意事項
其他說明
藥局 b1 | 藥庫 注B21
藥品外觀
顏色
形狀
剝痕
標記1
標記2
其他
健保藥價
652
自費價
867.16
仿單
資料庫
健保給付規定
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