Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Vancomycin

Generic name
Vancomycin
Brand name
ATC Code
J01XA01

Pharmacokinetics in children

Very poor absorption after oral administration.

T½ =
Neonates of < 2000 g:
< 1 week: 6-11 hours
1-4 weeks: 5-11 hours
Neonates of > 2000 grams:
< 1 week: 6-7 hours
1-4 weeks: 5-6 hours
Children: 2.2-3 hours
Adults: 5-11 hours
Very poor absorption after oral administration.

Vd =
Neonates: 0.38-0.97 l/kg (neonates of various gestational ages) [Jacqz-Aigrain 2013]
3 months-18 yrs: 0.63 ± 0.36 l/kg [Le 2013]

Cl =
Neonates: 0.038-0.084 l/kg/hr [Jacqz-Aigrain 2013]
3 months-18 yrs: 0.12 ± 0.04 l/kg/hr [Le 2013]

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dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

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Available formulations

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Dosages

Bacterial infections
  • Intravenous
    • < 1 week and weight at birth < 2.5 kg
      • Initial dose  20 mg/kg/day in 2 doses. Run in over 1-2 hours. Subsequent dosing guided by TDM.

      • There is currently no consensus about the dosage for full-term neonates and premature infants. Studies into this are ongoing and when more is known, the dosage will be adjusted in line with the results of the research.

        ...read more
    • 1 week up to 4 weeks and weight at birth < 2.5 kg
      • Initial dose: 30 mg/kg/day in 3 doses. Allow to run in over 1-2 hours.  Subsequent dosing guided by TDM.

      • There is currently no consensus about the dosage for full-term neonates and premature infants. Studies into this are ongoing and when more is known, the dosage will be adjusted in line with the results of the research.

        ...read more
    • < 1 week and weight at birth ≥ 2.5 kg
      • Initial dose 32 mg/kg/day in 4 doses. Allow to run in over 1-2 hours. Subsequent dosing guided by TDM.

      • There is currently no consensus about the dosage for full-term neonates and premature infants. Studies into this are ongoing and when more is known, the dosage will be adjusted in line with the results of the research.

        ...read more
    • 1 week up to 4 weeks and weight at birth ≥ 2.5 kg
      • Initial dose: 48 mg/kg/day in 4 doses. Allow to run in over 1-2 hours. Subsequent dosing based on TDM.

      • There is currently no consensus about the dosage for full-term neonates and premature infants. Studies into this are ongoing and when more is known, the dosage will be adjusted in line with the results of the research.

        ...read more
    • 1 month up to 18 years
      [3] [4] [8] [10] [12] [15] [17] [22] [26]
      • Initial dose: 60 mg/kg/day in 4 doses. Max: 4 g/day. Allow to run in over 1-2 hours. ALTERNATIVE: per continuous infusion.
        Subsequent dosing guided by TDM

        .
Fever in neutropenia, shunt infection
  • Intravenous
    • 1 month up to 18 years
      [3] [26]
      • Initial dose: 60 mg/kg/day in 4 doses. Max: 4 g/day. Allow to run in over 1-2 hours. Subsequent dosing guided by TDM.
Perioperative prophylaxis and prophylaxis of endocarditis in hypersensitivity to penicillin or treatment with penicillin in the 7 days before the procedure
  • Intravenous
    • 1 month up to 18 years
      [3] [23] [26]
      • 1-2 hours before the procedure: 15 mg/kg/dose The dose should be repeated if the procedure lasts longer than 12 hours. Max single dose: 1 g/dose.
Infection of the central nervous system (intraventricular administration)
  • Intraventricular
    • 1 month up to 18 years
      • 10 mg/dose Once daily or once every 2 days.

      • Only after consultation with a bacteriologist/infectiologist.
Enterocolitis as a result of staphylococci and pseudomembranous colitis
  • Oral
    • 1 month up to 18 years
      [24]
      • 40 mg/kg/day in 3 - 4 doses. Max: 2 g/day.
Therapeutic Drug Monitoring (TDM) directive
  • Intravenous
    • 0 years up to 18 years

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Renal impaiment in children > 3 months

 

GFR Initial dose Subsequent dosing
50-80 ml/min/1.73 m2 15 mg/kg/dose every 8 hours Guided by TDM TDM. Consult local protocol
(General instruction: determine peak and trough concentration within 24 hours of first dose)
30-50 ml/min/1.73 m2 15 mg/kg/dose every 8-12 hours Op geleide van TDM. Raadpleeg lokaal protocol
(General instruction: determine peak and trough concentration within 24 hours of first dose)
10-30 ml/min/1.73 m2 15 mg/kg/dose every 12-24 hours Op geleide van TDM. Raadpleeg lokaal protocol
General instruction: determine a peak concentration after the first dose and trough concentration before the 2nd dose
<10 ml/min/1.73 m2 15 mg/kg/dose every 24 hours Op geleide van TDM. Raadpleeg lokaal protocol
(General instruction: determine a peak concentration after the first dose and trough concentration before the 2nd dose)
Hemodialyse  15 mg/kg/dose after dialysis Op geleide van TDM. Raadpleeg lokaal protocol
General instruction: determine a peak concentration after the first dose and second concentration within 24 hours)

Le 2014; Zhang 2016; Smit 2021; Chung 2021.

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The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

Thrombocytopenia, neutropenia, phlebitis, skin conditions, ototoxicity, DRESS syndrome, nephrotoxicity.
‘Red man syndrome’ (RMS) occurs commonly in children (approx. 14%). Risk factors are: age > 2 years, having previously had RMS, vancomycin dose ≥ 10 mg/kg, vancomycin concentration: ≥ 5 mg/ml and previous use of antihistamines.
Trough levels up to 20 µg/ml do not give an elevated risk of nephrotoxicity compared to trough levels up to 15 µg/ml. Risk factors for nephrotoxicity occurring are a greater length of treatment, the use of vasopressors and the use of AV-ECMO.

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The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications

No information available on specific contra indications in children.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions in children

Inflow rate 1-2 hours. ‘Red man syndrome’ can occur if the drug is administered too quickly. Determine the creatinine at least twice a week. Extra checks in premature infants/children because of the immaturity of the kidneys.
Using vancomycin present a risk of colonization occurring with ESBL-producing Klebsiella in the gastrointestinal tracts of neonates.
Concomitant use with anaesthetics in children linked to erythema and anaphylactoid responses. If administration of vancomycin is needed as surgical prophylaxis, it is recommended that the anaesthetic should be administered after completion of the vancomycin infusion.
Note: children who are obese or overweight are more likely to develop elevated levels.

If patients do not achieve the desired serum concentration on intermittent intravenous (IIV) therapy, switching them to continuous intravenous (CIV) therapy is an option. Note: the total daily dose of vancomycin is lower for CIV than for IIV.

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Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

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Polymyxins
J01XB01
Nitrofuran derivatives
J01XE01
Other antibacterials
J01XX08
J01XX01

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References

  1. Hartwig NC, et al, Vademecum pediatrische antimicrobiële therapie, 2005
  2. Endocarditis Profylaxe Commissie Nederlandse Hartstichting, Preventie bacteriele endocarditis, Herziening augustus 2008
  3. Pfizer BV, SmPC Vancocin (RVG 105369) 28-02-2021, www.geneesmiddeleninformatiebank.nl
  4. Frymoyer A et al., Prediction of vancomycin pharmacodynamics in children with invasive methicillin-resistant Staphylococcus aureus infections: a Monte Carlo simulation. , Clin Ther, 2010, Mar;32(3), 534-42
  5. Vella-Brincat et al, Are gentamicin and/or vancomycin associated with ototoxicity in the neonate? A retrospective audit., Neonatology., 2011, 100(2), 186-93
  6. Ofek-Shlomai N et al, Gastrointestinal colonization with ESBL-producing Klebsiella in preterm babies--is vancomycin to blame?, J Clin Microbiol Infect Dis, 2012, Apr;31(4), 567-70
  7. Myers AL et al, Defining risk factors for red man syndrome in children and adults., Pediatr Infect Dis J. , 2012, May;31(5), 464-8
  8. Fung L., Continuous infusion vancomycin for treatment of methicillin-resistant Staphylococcus aureus in cystic fibrosis patients., Ann Pharmacother, 2012, Oct;46(10):, e26
  9. Kitcharoensakkul et al, Vancomycin-induced DRESS with evidence of T-cell activation in a 22-month-old patient. , Allergy Asthma Immunol, 2012, Oct;109(4), 280-1
  10. McKamy et al, Evaluation of a pediatric continuous-infusion vancomycin therapy guideline, Am J Health Syst Pharm, 2012, Dec 1;69(23), 2066-71
  11. Jacqz-Aigrain E et al. , Use of antibacterial agents in the neonate: 50 years of experience with vancomycin administration. , Semin Fetal Neonatal Med, 2013, Feb;18(1), 28-34
  12. Le J et al, Improved vancomycin dosing in children using area under the curve exposure., Pediatr Infect Dis J., 2013, Apr;32(4)
  13. Cies et al, Nephrotoxicity in Patients with Vancomycin Trough Concentrations of 15–20 ?g/ml in a Pediatric Intensive Care Unit, Pharmacotherapy., 2013, Apr;33(4), 392-400
  14. Linder N et al. , Duration of vancomycin treatment for coagulase-negative Staphylococcus sepsis in very low birth weight infants. , J Clin Pharmacol, 2013, Jul;76(1), 58-64
  15. Madigan T et al., The effect of age and weight on vancomycin serum trough concentrations in pediatric patients., Pharmacotherapy., 2013, Dec;33(12), 1264-72
  16. Heble DE Jr et al , Vancomycin trough concentrations in overweight or obese pediatric patients., Pharmacotherapy, 2013, Dec;33(12), 1273-7
  17. Cole TS et al , Vancomycin dosing in children: what is the question?, Arch Dis Child, 2013, Dec;98(12), 994-7
  18. Taketomo, Pediatric & neonatal dosage handbook , 20th edition
  19. Nederlandse Vereniging voor Neurologie , Richtlijn Bacteriele Meningitis, 2013
  20. NVZA, Richtlijn TDM Vancomycine , mei 2014
  21. ErasmusMC-Sophia, protocol Vancomycine , juli 2014
  22. Janssen, E. et al., Towards Rational Dosing Algorithms for Vancomycin in Neonates and Infants Based on Population Pharmacokinetic Modeling, Antimicrob Agents Chemother, 2015, Dec 7;60(2), 1013-21
  23. Ingrande, J, et al., Pharmacokinetics of cefazolin and vancomycin in infants undergoing open-heart surgery with cardiopulmonary bypass, Anesth Analg, 2019, 128(5), 935-943
  24. Noridem, SmPC Vancomycin Noridem 500 mg Plv. f. e. Konz. z. Herst. e. Inflsg. (1-30789), https://www.univadis.at/, 01/2018
  25. Astro, SmPC Vancocin 500 mg Plv. f. e. Konz. z. Herst. e. Inflsg. + e. Lsg. z. Einn. (17126), https://www.univadis.at/, 12/2018
  26. Sandoz BV, SmPC vancomycine 500 mg/1000 mg IV (RVG 101505/101509) 15-01-2021, www.geneesmiddeleninformatiebank.nl
  27. Zhang H, et al., Pharmacokinetic Characteristics and Clinical Outcomes of Vancomycin in Young Children With Various Degrees of Renal Function., J Clin Pharmacol. , 2016, 56(6), 740-8
  28. Chung E, et al., Pharmacokinetics of Vancomycin in Pediatric Patients Receiving Intermittent Hemodialysis or Hemodiafiltration., Kidney Int Rep, 2021, 6(4), 1003-14
  29. Le J, et al., Population-Based Pharmacokinetic Modeling of Vancomycin in Children with Renal Insufficiency., J Pharmacol Clin Toxicol. , 2014, 2(1):, 1017-26
  30. Smit C, et al. , Dosing Recommendations for Vancomycin in Children and Adolescents with Varying Levels of Obesity and Renal Dysfunction: a Population Pharmacokinetic Study in 1892 Children Aged 1-18 Years., Aaps j., 2021, 23(3):, 53

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Changes

Changes