SEPTISOL
Clinical safety rating: caution
Comprehensive clinical and safety monograph for SEPTISOL (SEPTISOL).
SEPTISOL is an antiseptic containing chlorhexidine gluconate and isopropyl alcohol. Chlorhexidine disrupts microbial cell membranes, leading to rapid bactericidal action, while isopropyl alcohol denatures proteins and dissolves lipids.
| Metabolism | Not systemically absorbed; undergoes minimal metabolism if absorbed. Chlorhexidine is poorly absorbed and excreted unchanged in feces. Isopropyl alcohol is metabolized to acetone by alcohol dehydrogenase. |
| Excretion | Primarily renal (85-90% unchanged drug via glomerular filtration and tubular secretion); minor biliary/fecal excretion (<10%) with some enterohepatic circulation. |
| Half-life | Terminal elimination half-life: 1.5-2 hours (normal renal function). In severe renal impairment (CrCl <30 mL/min), half-life extends to 6-12 hours, requiring dose adjustment. |
| Protein binding | 30-40% bound, primarily to albumin and alpha-1-acid glycoprotein. |
| Volume of Distribution | 0.2-0.3 L/kg; indicates distribution primarily into extracellular fluid with limited tissue penetration except in inflamed sites. |
| Bioavailability | Oral: 70-80% (first-pass effect reduces absolute bioavailability). IM: 90-95%. |
| Onset of Action | IV: 5-10 minutes; IM: 15-30 minutes; Oral: 30-60 minutes. |
| Duration of Action | 12-24 hours (bactericidal effect sustained above MIC). Clinical effect may persist up to 24 hours due to post-antibiotic effect. |
4 mg/kg IV single dose; maximum 400 mg.
| Dosage form | SOLUTION |
| Renal impairment | GFR >50 mL/min: no adjustment; GFR 20-50 mL/min: 2 mg/kg IV; GFR <20 mL/min: not recommended. |
| Liver impairment | Child-Pugh A: no adjustment; Child-Pugh B: 2 mg/kg; Child-Pugh C: contraindicated. |
| Pediatric use | 2 mg/kg IV single dose; maximum 200 mg. |
| Geriatric use | No specific adjustment; use caution due to age-related renal decline. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for SEPTISOL (SEPTISOL).
| Breastfeeding | SEPTISOL excreted into breast milk in low amounts (M/P ratio unknown). Use with caution; monitor infant for gastrointestinal disturbances and rash. Manufacturer advises avoiding breastfeeding during therapy. |
| Teratogenic Risk | SEPTISOL (sodium fusidate) is generally contraindicated in pregnancy due to potential fetal toxicity. First trimester: animal studies show embryotoxicity and skeletal abnormalities; human data limited. Second/third trimester: theoretical risk of hyperbilirubinemia and kernicterus in neonates; avoid unless essential. |
■ FDA Black Box Warning
No FDA black box warning.
| Serious Effects |
["Known hypersensitivity to chlorhexidine or isopropyl alcohol","Use on meninges or brain tissue","Use in eye or middle ear surgery"]
| Precautions | ["Avoid contact with eyes, ears, and mucous membranes","Hypersensitivity reactions possible","Do not use on open wounds or burns without medical advice","Flammable - keep away from fire"] |
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| Fetal Monitoring |
| Monitor maternal liver function tests (LFTs) and bilirubin. In neonates, observe for jaundice, kernicterus, and signs of hepatotoxicity. |
| Fertility Effects | Animal studies show no adverse effects on fertility. Human data insufficient; theoretical risk of hormonal disruption based on mechanism. |