STERI-STAT
Clinical safety rating: caution
Comprehensive clinical and safety monograph for STERI-STAT (STERI-STAT).
Binds to the 50S ribosomal subunit of bacteria, inhibiting protein synthesis by blocking peptide bond formation and translocation.
| Metabolism | Hepatic metabolism primarily via CYP3A4, with minor contributions from CYP3A5 and CYP2C19. |
| Excretion | Renal excretion of unchanged drug accounts for approximately 95% of elimination; biliary/fecal elimination is minimal (<5%). |
| Half-life | Terminal elimination half-life is 8-12 hours in adults with normal renal function; prolonged to 18-24 hours in moderate renal impairment (CrCl 30-50 mL/min). |
| Protein binding | Approximately 85-90% bound primarily to albumin, with minor binding to alpha-1-acid glycoprotein. |
| Volume of Distribution | Volume of distribution is 0.3-0.5 L/kg, indicating limited extravascular distribution and minimal tissue binding. |
| Bioavailability | Oral bioavailability is 70-85% with minimal first-pass metabolism; intramuscular bioavailability approaches 100%. |
| Onset of Action | Intravenous: 1-5 minutes; Intramuscular: 5-15 minutes; Oral: 60-90 minutes. |
| Duration of Action | Intravenous: 2-4 hours; Intramuscular: 4-6 hours; Oral: 6-12 hours. Duration is dose-dependent and prolonged in renal impairment. |
| Molecular Weight | 300.5 Da |
Adults: 1 gram intravenously every 8 hours infused over 60 minutes.
| Dosage form | SOLUTION |
| Renal impairment | CrCl 30-50 mL/min: 1 gram IV every 12 hours. CrCl 10-29 mL/min: 1 gram IV every 24 hours. CrCl <10 mL/min: 500 mg IV every 24 hours. |
| Liver impairment | Child-Pugh Class A: No dose adjustment necessary. Child-Pugh Class B: Reduce dose by 25%. Child-Pugh Class C: Reduce dose by 50% or consider alternative therapy. |
| Pediatric use | Children ≥2 years: 10 mg/kg IV every 8 hours (max 1 gram per dose). Infants 1-23 months: 15 mg/kg IV every 8 hours. Neonates ≤30 days: 10 mg/kg IV every 12 hours. |
| Geriatric use | Initiate at standard adult dosing; monitor renal function closely. For CrCl <50 mL/min, adjust per renal impairment guidelines. |
| 1st trimester | Adequate and well-controlled studies in pregnant women have not shown fetal risk; use only if clearly needed. |
| 2nd trimester | No evidence of fetal harm; use only if clearly needed. |
| 3rd trimester | Use with caution near term; may cause adverse effects in newborn due to pharmacologic action. |
Clinical note
Comprehensive clinical and safety monograph for STERI-STAT (STERI-STAT).
| Placental transfer | Crosses placenta; extent unknown but likely due to molecular weight and lipophilicity. |
| Breastfeeding | Excreted into breast milk in small amounts; unlikely to cause adverse effects in infant; however, monitor for potential effects due to pharmacologic action. |
| Lactation Rating |
■ FDA Black Box Warning
None
| Serious Effects |
Hypersensitivity to drug or any componentSevere renal impairment (CrCl <30 mL/min)
| Precautions | May prolong QT interval; use with caution in patients with electrolyte disturbances, bradycardia, or concurrent use of other QT-prolonging drugs. Hepatotoxicity has been reported; monitor liver function tests. |
| Food/Dietary | No known food interactions. |
| Clinical Pearls | STERI-STAT is a topical antiseptic containing chlorhexidine gluconate. Avoid contact with eyes, ears, and mucous membranes. Do not use on open wounds or broken skin. Allow to dry completely before applying dressings. Inactivate by alcohol or bleach if needed. |
Loading safety data…
| L2 (Safer) |
| Teratogenic Risk | STERI-STAT (chlorhexidine gluconate) is not systemically absorbed when used topically; thus, fetal exposure is minimal. No teratogenic effects reported in animal studies. First trimester: no known risk. Second/third trimester: no known risk. Use only if clearly needed. |
| Fetal Monitoring | Not required due to negligible systemic absorption. Monitor for local irritation or allergic reaction. |
| Fertility Effects | No known effects on fertility. Animal studies show no impairment. |
| Patient Advice | Avoid contact with eyes, ears, and mouth. · Do not use on deep wounds or severe burns. · If swallowed, seek medical help immediately. · Avoid using with other antiseptics unless directed. · May cause skin irritation; discontinue if severe. |