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. |
| Molecular Weight | 1449.27 |
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 | Crosses placenta; use only if clearly needed and benefit outweighs risk. No evidence of embryotoxicity in animal studies; limited human data suggest safety. |
| 2nd trimester | Crosses placenta; use only if clearly needed. No known teratogenic effects; avoid prolonged use. |
| 3rd trimester | Crosses placenta; use only if clearly needed. No known fetal harm; monitor for neonatal ototoxicity or nephrotoxicity if maternal use near term. |
Clinical note
Comprehensive clinical and safety monograph for VANCOCIN HYDROCHLORIDE (VANCOCIN HYDROCHLORIDE).
| Placental transfer | Vancomycin crosses the placenta with fetal serum concentrations approximately 50-80% of maternal levels. |
| Breastfeeding | Vancomycin is excreted into breast milk in very small amounts (<1% of maternal dose). Oral absorption is poor; unlikely to cause adverse effects in the infant. Use with caution in mothers of infants with colitis or renal impairment. |
■ FDA Black Box Warning
No FDA black box warning.
| Serious Effects |
Hypersensitivity to vancomycin or any componentConcurrent use of other ototoxic or nephrotoxic agents (relative, but often considered absolute in clinical practice)
| 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. |
| Food/Dietary | No significant food interactions known. Oral vancomycin should be taken with or without food, but consistency is recommended. Avoid alcohol due to potential disulfiram-like reaction. |
Loading safety data…
| Lactation Rating | L2 (Safer) - Limited data, unlikely to cause harm. |
| 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. |
| 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. |
| Clinical Pearls | Vancomycin is a tricyclic glycopeptide antibiotic that inhibits cell wall synthesis in gram-positive bacteria. Therapeutic drug monitoring (TDM) is essential to avoid nephrotoxicity and ototoxicity; target trough levels 15-20 mcg/mL for serious infections. Red man syndrome (histamine release) can be mitigated by slow infusion over at least 60 min and premedication with antihistamines. Vancomycin exhibits time-dependent killing; optimal efficacy correlates with AUC24/MIC ratio ≥400. Use with caution in renal impairment; adjust dosing based on creatinine clearance. Oral vancomycin is indicated for C. difficile infection but is not absorbed systemically. |
| Patient Advice | Take the oral capsule whole; do not crush or chew. · Complete the full course of therapy even if you feel better. · Report any hearing loss, ringing in ears, dizziness, or changes in urination immediately. · During IV infusion, inform your nurse if you develop rash, itching, or flushing (Red Man Syndrome). · Avoid alcohol while on vancomycin, especially with oral formulation, to prevent disulfiram-like reaction. · Stay well hydrated to reduce risk of kidney injury. · Do not stop or change dose without consulting your doctor. |