VANCOLED
Clinical safety rating: caution
Comprehensive clinical and safety monograph for VANCOLED (VANCOLED).
Inhibits bacterial cell wall synthesis by binding to D-alanyl-D-alanine terminus of cell wall precursor units, preventing polymerization and cross-linking.
| Metabolism | Primarily eliminated unchanged by glomerular filtration; minimal hepatic metabolism (<5%). Dose adjustment required in renal impairment. |
| Excretion | Primarily renal excretion of unchanged drug via glomerular filtration; >90% of administered dose recovered in urine within 24 hours; minimal biliary/fecal elimination (<5%). |
| Half-life | Terminal elimination half-life in adults with normal renal function: 4–6 hours; in anuria/ESRD: up to 7–9 days; clinical context: dosing interval must be adjusted based on creatinine clearance to avoid accumulation and toxicity. |
| Protein binding | Approximately 10–50% (moderate, variable); bound primarily to albumin and possibly alpha-1-acid glycoprotein. |
| Volume of Distribution | 0.4–1.0 L/kg; extensive distribution into tissues; penetration into skin, bone, liver, kidneys, heart, and lung; poor CNS penetration unless meninges inflamed. |
| Bioavailability | Oral: <10% (negligible systemic absorption); used only for intraluminal GI infections (e.g., C. difficile). |
| Onset of Action | Intravenous: onset within 1 hour; oral (for C. difficile colitis): onset within 24–48 hours due to limited systemic absorption. |
| Duration of Action | Intravenous: duration of bactericidal effect approximately 6–12 hours, correlated with serum trough concentration; oral: local action in colon persists during therapy; clinical notes: AUC/MIC ratio is key PK/PD index. |
| Molecular Weight | 1449.3 |
| Action Class | Glycopeptides |
| Brand Substitutes | Mego 500mg Injection, Vanacin CP 500mg Injection, Vancoray 500mg Injection, G Vanc 500mg Injection, Vantox-CP 500mg Injection |
15-20 mg/kg intravenously every 8-12 hours, with a maximum single dose of 2 g; typical adult dose 1-2 g IV every 12 hours based on renal function and trough monitoring.
| Dosage form | INJECTABLE |
| Renal impairment | For GFR 30-60 mL/min: 15-20 mg/kg IV every 24 hours; for GFR 15-30 mL/min: 15-20 mg/kg IV every 24-48 hours; for GFR <15 mL/min: 15-20 mg/kg IV every 48-96 hours; anuric patients: 10-15 mg/kg IV loading dose, then dose after dialysis. |
| Liver impairment | No specific Child-Pugh based dose adjustments; vancomycin is primarily renally eliminated; no hepatic adjustment recommended. |
| Pediatric use | Neonates: 10-15 mg/kg IV based on postmenstrual age and serum creatinine; Infants and children: 10-20 mg/kg IV every 6-12 hours (typical 15 mg/kg every 6 hours); monitor trough levels. |
| Geriatric use | Reduce initial dose based on renal function; use actual body weight; monitor trough levels and adjust frequency; often start at 15 mg/kg IV every 12-24 hours based on estimated GFR. |
| 1st trimester | Vancomycin crosses the placenta. Limited human data; animal studies show no evidence of teratogenicity. Use only if clearly needed. |
| 2nd trimester | Vancomycin crosses the placenta. No known fetal harm; monitor maternal renal function and serum levels. |
| 3rd trimester | Vancomycin crosses the placenta. No known fetal harm; consider potential for neonatal ototoxicity and nephrotoxicity if used near term. |
Clinical note
Comprehensive clinical and safety monograph for VANCOLED (VANCOLED).
| Placental transfer | Vancomycin crosses the placenta, achieving fetal serum concentrations similar to maternal levels. Placental transfer is facilitated by passive diffusion. |
| Breastfeeding | Vancomycin is poorly absorbed orally; therefore, exposure to the infant via breast milk is minimal. However, caution is advised, especially in neonates with immature renal function. Monitor infant for diarrhea and rash. |
■ FDA Black Box Warning
Rapid intravenous administration may cause hypotension, wheezing, dyspnea, urticaria, pruritus, or ‘Red Man Syndrome’ (erythema, pruritus, flushing). Infusion reactions are minimized by slow IV infusion over at least 60 minutes.
| Serious Effects |
Hypersensitivity to vancomycin
| Precautions | Nephrotoxicity: May occur, especially with high doses or concomitant aminoglycosides, Ototoxicity: Auditory and vestibular toxicity, may be irreversible, Red Man Syndrome: Histamine release, prevented by slow infusion and antihistamines, Thrombocytopenia: Monitor platelet counts, Superinfection: Prolonged use may lead to overgrowth of non-susceptible organisms |
| Food/Dietary | Vancomycin has no known food interactions. For oral vancomycin, avoid alcohol to reduce risk of GI irritation. Maintain adequate hydration during therapy. For IV vancomycin, no dietary restrictions. |
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| Lactation Rating | L3 (Moderately Safe) |
| Teratogenic Risk | FDA Pregnancy Category C. Animal studies show embryocidal effects at high doses; no adequate human studies. Crosses placenta. First trimester: theoretical risk, avoid unless essential. Second and third trimesters: no known teratogenicity, but may cause fetal nephrotoxicity and ototoxicity if maternal levels are excessive. |
| Fetal Monitoring | Monitor maternal serum trough levels for efficacy and toxicity (target trough 15-20 mg/L for serious infections). Assess renal function (serum creatinine, BUN) and hearing (audiometry) in mother and consider neonatal renal function and hearing if prolonged exposure. |
| Fertility Effects | No known adverse effects on fertility based on animal studies and limited human data. |
| Clinical Pearls | Vancomycin (VANCOLED) requires therapeutic drug monitoring (trough levels 10-20 mcg/mL for most infections; 15-20 for MRSA pneumonia, endocarditis, osteomyelitis). Infusion-related adverse effects (Red Man Syndrome) can be mitigated by slowing infusion rate (≥60 minutes per gram) and pre-treatment with antihistamines. Nephrotoxicity risk increases with concurrent nephrotoxic agents (e.g., aminoglycosides, piperacillin-tazobactam, IV contrast). Audiometry monitoring recommended for prolonged therapy or high doses. Vancomycin is poorly absorbed orally; oral formulation for C. difficile colitis only. Use caution in renal impairment; adjust dosing based on CrCl. |
| Patient Advice | Report any signs of infusion reactions like flushing, rash, or itching during the IV infusion to your nurse immediately. · Complete the full course of therapy even if you feel better; do not skip doses. · Vancomycin can affect kidney function; you will have regular blood tests to monitor kidney and drug levels. · Notify your healthcare provider if you experience hearing loss, ringing in the ears, or dizziness. · If taking oral vancomycin for C. difficile, take it as directed with a full glass of water, and finish all medication. |