STERI-STAT

Clinical safety rating: caution

Comprehensive clinical and safety monograph for STERI-STAT (STERI-STAT).

How it works

Binds to the 50S ribosomal subunit of bacteria, inhibiting protein synthesis by blocking peptide bond formation and translocation.

What the body does with it

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.

Classification & Brands

Dosing & administration

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.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for STERI-STAT (STERI-STAT).

Breastfeeding	Not systemically absorbed; unlikely to be excreted into breast milk. M/P ratio not applicable. Considered compatible with breastfeeding with standard topical use.
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

Warnings & precautions

■ FDA Black Box Warning

None

Side Effect Profile

Serious Effects

Absolute Contraindications

Hypersensitivity to steri-stat or any component; concomitant use with CYP3A4 substrates that have a narrow therapeutic index (e.g., pimozide, ergot alkaloids) due to risk of increased exposure.

Clinical Precautions

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.

Clinical Tips & Counseling

Drug interactions

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STERI-STAT

Clinical safety rating: caution

Comprehensive clinical and safety monograph for STERI-STAT (STERI-STAT).

How it works

Binds to the 50S ribosomal subunit of bacteria, inhibiting protein synthesis by blocking peptide bond formation and translocation.

What the body does with it

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.

Classification & Brands

Dosing & administration

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.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for STERI-STAT (STERI-STAT).

Breastfeeding	Not systemically absorbed; unlikely to be excreted into breast milk. M/P ratio not applicable. Considered compatible with breastfeeding with standard topical use.
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

Warnings & precautions

■ FDA Black Box Warning

None

Side Effect Profile

Serious Effects

Absolute Contraindications

Hypersensitivity to steri-stat or any component; concomitant use with CYP3A4 substrates that have a narrow therapeutic index (e.g., pimozide, ergot alkaloids) due to risk of increased exposure.