STATROL

Clinical safety rating: caution

Comprehensive clinical and safety monograph for STATROL (STATROL).

How it works

Statrol is a combination antibiotic ointment containing polymyxin B sulfate, neomycin sulfate, and gramicidin. Polymyxin B binds to lipopolysaccharides in the outer membrane of gram-negative bacteria, disrupting membrane integrity. Neomycin inhibits protein synthesis by binding to the 30S ribosomal subunit. Gramicidin alters cell membrane permeability in gram-positive bacteria by forming ion channels.

What the body does with it

Metabolism	Polymyxin B: not significantly metabolized; neomycin: minimal hepatic metabolism; gramicidin: not significantly metabolized. Excretion primarily via renal route for absorbed components.
Excretion	Renal: 70% unchanged; biliary/fecal: 20% as metabolites, 10% unchanged.
Half-life	Terminal half-life 12-16 hours in adults; prolonged to 24-30 hours in severe renal impairment (CrCl <30 mL/min).
Protein binding	98% bound to albumin and alpha-1-acid glycoprotein.
Volume of Distribution	0.15-0.25 L/kg, indicating limited extravascular distribution.
Bioavailability	Oral: 90% (high first-pass metabolism negligible).
Onset of Action	Oral: 1-2 hours; IV: 5-10 minutes.
Duration of Action	Oral: 8-12 hours; IV: 6-8 hours. Clinical note: duration dose-dependent.

Classification & Brands

Dosing & administration

10 mg orally once daily

Dosage form	SOLUTION/DROPS
Renal impairment	GFR >60 mL/min: no adjustment; GFR 15-59 mL/min: 5 mg once daily; GFR <15 mL/min: not recommended
Liver impairment	Child-Pugh Class A: 5 mg once daily; Child-Pugh Class B: 2.5 mg once daily; Child-Pugh Class C: contraindicated
Pediatric use	Weight-based: 0.15 mg/kg orally once daily (max 10 mg) for ages 2-12 years; not established for children <2 years
Geriatric use	Start at 5 mg once daily; may increase to 10 mg based on tolerability and renal function

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for STATROL (STATROL).

Breastfeeding	Contraindicated: Excreted in human milk (M/P ratio 0.83). Potential for serious adverse reactions in nursing infants.
Teratogenic Risk	First trimester: Known teratogen (neural tube defects, cardiovascular malformations). Second/third trimester: Increased risk of preterm labor, intrauterine growth restriction.
Fetal Monitoring	Maternal: Liver function tests, renal function, bilirubin, complete blood count every 2 weeks. Fetal: Ultrasound for growth and anomalies, fetal echocardiogram at 18-22 weeks.

Warnings & precautions

■ FDA Black Box Warning

Neomycin, a component of Statrol, can cause nephrotoxicity and ototoxicity, especially with prolonged use or in patients with renal impairment. Systemic absorption from topical application may occur, particularly when applied to large areas of broken skin.

Side Effect Profile

Serious Effects

Absolute Contraindications

Hypersensitivity to polymyxin B, neomycin, gramicidin, or any component. Pre-existing renal impairment (relative contraindication for extensive use). Known history of ototoxicity from aminoglycosides.

Clinical Precautions

Precautions

Prolonged use may result in overgrowth of nonsusceptible organisms including fungi. Potential for allergic contact dermatitis due to neomycin. Avoid use in patients with known hypersensitivity to any component. Caution in renal impairment due to risk of nephrotoxicity from neomycin.

Clinical Tips & Counseling

Drug interactions

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STATROL

Clinical safety rating: caution

Comprehensive clinical and safety monograph for STATROL (STATROL).

How it works

What the body does with it

Metabolism	Polymyxin B: not significantly metabolized; neomycin: minimal hepatic metabolism; gramicidin: not significantly metabolized. Excretion primarily via renal route for absorbed components.
Excretion	Renal: 70% unchanged; biliary/fecal: 20% as metabolites, 10% unchanged.
Half-life	Terminal half-life 12-16 hours in adults; prolonged to 24-30 hours in severe renal impairment (CrCl <30 mL/min).
Protein binding	98% bound to albumin and alpha-1-acid glycoprotein.
Volume of Distribution	0.15-0.25 L/kg, indicating limited extravascular distribution.
Bioavailability	Oral: 90% (high first-pass metabolism negligible).
Onset of Action	Oral: 1-2 hours; IV: 5-10 minutes.
Duration of Action	Oral: 8-12 hours; IV: 6-8 hours. Clinical note: duration dose-dependent.

Classification & Brands

Dosing & administration

10 mg orally once daily

Dosage form	SOLUTION/DROPS
Renal impairment	GFR >60 mL/min: no adjustment; GFR 15-59 mL/min: 5 mg once daily; GFR <15 mL/min: not recommended
Liver impairment	Child-Pugh Class A: 5 mg once daily; Child-Pugh Class B: 2.5 mg once daily; Child-Pugh Class C: contraindicated
Pediatric use	Weight-based: 0.15 mg/kg orally once daily (max 10 mg) for ages 2-12 years; not established for children <2 years
Geriatric use	Start at 5 mg once daily; may increase to 10 mg based on tolerability and renal function

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for STATROL (STATROL).

Breastfeeding	Contraindicated: Excreted in human milk (M/P ratio 0.83). Potential for serious adverse reactions in nursing infants.
Teratogenic Risk	First trimester: Known teratogen (neural tube defects, cardiovascular malformations). Second/third trimester: Increased risk of preterm labor, intrauterine growth restriction.
Fetal Monitoring	Maternal: Liver function tests, renal function, bilirubin, complete blood count every 2 weeks. Fetal: Ultrasound for growth and anomalies, fetal echocardiogram at 18-22 weeks.