VANCOCIN HYDROCHLORIDE
Clinical safety rating: caution
Comprehensive clinical and safety monograph for VANCOCIN HYDROCHLORIDE (VANCOCIN HYDROCHLORIDE).
Vancomycin inhibits bacterial cell wall synthesis by binding to the D-alanyl-D-alanine terminus of cell wall precursor units, thereby preventing polymerization and cross-linking of peptidoglycan.
| Metabolism | Vancomycin is not significantly metabolized; it is excreted primarily unchanged in urine via glomerular filtration. |
| Excretion | Primarily renal (glomerular filtration): 80-90% of dose excreted unchanged in urine within 24 hours. Minor biliary/fecal elimination (<5%). |
| Half-life | Terminal elimination half-life: 4-6 hours in adults with normal renal function; prolonged to 7-9 days in anuric patients, necessitating therapeutic drug monitoring. |
| Protein binding | 10-50% (variable, concentration-dependent), primarily to albumin. |
| Volume of Distribution | 0.2-0.3 L/kg in adults, indicating distribution mainly into extracellular fluid; increases in critically ill patients (up to 0.6 L/kg). |
| Bioavailability | Oral: <10% (negligible systemic absorption); used only for oral treatment of C. difficile infection. IV: 100%. |
| Onset of Action | IV: Rapid (within minutes for bactericidal effect). Oral: Minimal systemic absorption; onset of local GI action within hours. Not for systemic infections orally. |
| Duration of Action | IV: Duration of bactericidal activity correlates with AUC/MIC ratio; dosing interval typically 6-12 hours depending on renal function. Oral: Local GI effects persist throughout dosing interval. |
15-20 mg/kg IV every 8-12 hours; maximum single dose 2 g. Target trough 10-20 mcg/mL.
| Dosage form | INJECTABLE |
| Renal impairment | CrCl >50 mL/min: 15-20 mg/kg IV q8-12h; CrCl 20-49: 15-20 mg/kg IV q24h; CrCl 10-19: 15-20 mg/kg IV q24-48h; CrCl <10: 15-20 mg/kg IV q48-96h or dosing based on serum concentrations. |
| Liver impairment | No specific adjustment required; vancomycin is primarily renally excreted. |
| Pediatric use | Neonates: 10-15 mg/kg IV q8-24h based on postmenstrual age; Infants/children: 15 mg/kg IV q6h (target peak 25-40 mcg/mL, trough 5-15 mcg/mL). |
| Geriatric use | Increased risk of nephrotoxicity; initiate at 10-15 mg/kg IV q12h and adjust based on CrCl and trough levels. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for VANCOCIN HYDROCHLORIDE (VANCOCIN HYDROCHLORIDE).
| Breastfeeding | Vancomycin is excreted into human breast milk in trace amounts. The milk-to-plasma ratio is approximately 0.1–0.3. Oral bioavailability in the infant is poor, so systemic effects are unlikely. However, caution is advised due to potential alteration of infant gut flora and interference with culture results. The manufacturer recommends cautious use during breastfeeding. |
| Teratogenic Risk | Vancomycin is not absorbed orally and systemic exposure is minimal; however, when administered intravenously, it crosses the placenta. Animal studies have not shown direct or indirect harmful effects with respect to reproductive toxicity. There are no adequate and well-controlled studies in pregnant women. Based on available data, vancomycin is generally considered low risk for teratogenicity across all trimesters, but should be used only if clearly needed. |
■ FDA Black Box Warning
No FDA black box warning.
| Serious Effects |
["Hypersensitivity to vancomycin or any component of the formulation"]
| Precautions | ["Nephrotoxicity: Risk of renal impairment, especially with high doses or concurrent nephrotoxic drugs; monitor renal function.","Ototoxicity: May cause hearing loss, which may be reversible or progressive; monitor audiometric function.","Severe dermatologic reactions: Including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS); discontinue if severe reactions occur.","Red Man Syndrome: Infusion-related histamine release causing flushing, pruritus, and hypotension; slow infusion rate and premedicate if necessary.","Monitor serum trough concentrations to avoid toxicity; adjust dosing in renal impairment."] |
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| Fetal Monitoring | Monitor maternal renal function (serum creatinine, BUN) and vancomycin trough levels periodically (target 15–20 mcg/mL for serious infections). Assess for infusion-related reactions (Red Man Syndrome) during IV administration. Fetal monitoring includes ultrasound for growth and well-being if prolonged therapy is used. Auditory monitoring is not routinely required but may be considered with high cumulative doses. |
| Fertility Effects | No known adverse effects on fertility in animal studies. Human data are insufficient; vancomycin is not associated with impaired fertility based on available evidence. |