STATROL
Clinical safety rating: caution
Comprehensive clinical and safety monograph for STATROL (STATROL).
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.
| 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. |
| Molecular Weight | 389.4 |
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 |
| 1st trimester | Contraindicated due to risk of teratogenicity; animal studies show fetal abnormalities. |
| 2nd trimester | Contraindicated; may cause fetal harm. |
| 3rd trimester | Contraindicated; risk of neonatal toxicity. |
Clinical note
Comprehensive clinical and safety monograph for STATROL (STATROL).
| Placental transfer | Readily crosses the placenta with fetal concentrations reaching 50-100% of maternal levels. |
| Breastfeeding | Excreted in breast milk; potential for serious adverse reactions in nursing infants; contraindicated. |
| Lactation Rating | L5 (Contraindicated) |
■ 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.
| Serious Effects |
PregnancyLactationHypersensitivity to statinsActive liver disease
| 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. |
| Food/Dietary | Avoid grapefruit juice and grapefruit products; may increase plasma concentrations and risk of toxicity. Reduce intake of high-fat/cholesterol foods. Avoid large amounts of alcohol (≥3 drinks/day) to minimize hepatotoxicity risk. |
Loading safety data…
| 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. |
| Fertility Effects | Reversible impairment of spermatogenesis in males; ovulation inhibition in females. Discontinuation may restore fertility. |
| Clinical Pearls | STATROL is a statin indicated for hyperlipidemia. Monitor hepatic function at baseline and periodically. Avoid use in active liver disease or unexplained transaminase elevations. Myopathy risk increases with concurrent use of CYP3A4 inhibitors (e.g., clarithromycin, itraconazole). Discontinue if CK levels become markedly elevated or if myopathy is suspected. Dose adjustment required in severe renal impairment (CrCl <30 mL/min). Do not exceed 40 mg daily in patients on concomitant fibrates. |
| Patient Advice | Take exactly as prescribed, usually once daily. Do not take double doses if you miss a dose. · Avoid grapefruit juice and grapefruit products while taking this medication. · Report unexplained muscle pain, tenderness, or weakness, especially with dark urine or fever. · Avoid excessive alcohol consumption due to risk of liver damage. · Inform your healthcare provider about all other medications, including over-the-counter drugs (especially niacin, fibrates, and certain antibiotics). · STATROL may cause dizziness or blurred vision; avoid driving until you know how it affects you. · Store at room temperature, protected from light and moisture. |