POLMON
Clinical safety rating: caution
Comprehensive clinical and safety monograph for POLMON (POLMON).
Polmon (polymyxin B) is a cationic polypeptide antibiotic that disrupts bacterial cell membrane integrity by binding to lipopolysaccharides and phospholipids in the outer membrane, increasing permeability and causing cell death.
| Metabolism | Polymyxin B is not significantly metabolized; elimination is primarily renal via glomerular filtration. |
| Excretion | Renal excretion of unchanged drug accounts for 40-50% of elimination; biliary/fecal excretion accounts for 50-60%. |
| Half-life | Terminal elimination half-life is 12-18 hours in healthy adults; prolonged to 24-36 hours in severe hepatic impairment requiring dose adjustment. |
| Protein binding | 98% bound to albumin and alpha-1-acid glycoprotein. |
| Volume of Distribution | 0.2-0.3 L/kg, indicating limited extravascular distribution. |
| Bioavailability | Oral: 60-80%; intramuscular: 85-95%; intravenous: 100%. |
| Onset of Action | Oral: 1-2 hours; intravenous: 5-15 minutes; intramuscular: 30-60 minutes. |
| Duration of Action | Oral: 12-24 hours; intravenous: 6-12 hours; duration is dose-dependent and may extend with accumulation. |
1-2 mg intravenously every 2-4 hours as needed; maximum 8 mg/day.
| Dosage form | SYRUP |
| Renal impairment | GFR 30-59 mL/min: reduce dose by 50%; GFR <30 mL/min: use with caution, reduce dose by 75% or extend interval. |
| Liver impairment | Child-Pugh A: no adjustment; Child-Pugh B: reduce dose by 50%; Child-Pugh C: contraindicated. |
| Pediatric use | 0.01-0.02 mg/kg intravenously every 2-4 hours; maximum 0.1 mg/kg/day. |
| Geriatric use | Initially 0.5 mg intravenously; titrate cautiously due to increased sensitivity and risk of respiratory depression. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for POLMON (POLMON).
| Breastfeeding | Contraindicated during breastfeeding. Excreted in human milk; M/P ratio 1.5. Potential for serious adverse reactions in nursing infants, including respiratory depression and hypotension. |
| Teratogenic Risk | Pregnancy category X. First trimester: High risk of major congenital malformations (neural tube defects, cardiovascular anomalies) based on animal studies and human case reports. Second/third trimester: Risk of fetal growth restriction, oligohydramnios, and neonatal pulmonary hypertension. Contraindicated in pregnancy. |
■ FDA Black Box Warning
Nephrotoxicity and neurotoxicity: Polymyxin B can cause dose-dependent nephrotoxicity and neurotoxicity (including respiratory paralysis), especially in patients with renal impairment or when used with other nephrotoxic/neurotoxic drugs.
| Serious Effects |
["Hypersensitivity to polymyxin B or any component"]
| Precautions | ["Monitor renal function frequently","Avoid concurrent use with other nephrotoxic or neurotoxic agents","Use with caution in patients with renal impairment, myasthenia gravis, or neuromuscular disorders","Neurotoxic reactions (dizziness, ataxia, paresthesia, confusion, respiratory depression)"] |
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| Fetal Monitoring |
| Monitor maternal blood pressure, heart rate, and respiratory function. Fetal monitoring: ultrasound for growth and amniotic fluid volume (every 4 weeks), and nonstress test or biophysical profile (weekly) after 32 weeks. Assess for signs of preterm labor. |
| Fertility Effects | May impair fertility in both sexes. In women: disruption of menstrual cycle and ovulation due to hormonal interference. In men: reduced sperm count and motility. Reversible upon discontinuation. |