What is the recommended dose of itraconazole (antifungal medication) for treating fungal infections in children?

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Itraconazole Dosing in Children

The recommended dose of itraconazole for treating fungal infections in children is 6-10 mg/kg/day orally (maximum 400 mg daily), with specific dosing based on the type of infection and child's age. 1

Dosing Guidelines by Age and Infection Type

Children ≤12 years

  • Cutaneous/Lymphocutaneous infections: 6-10 mg/kg/day orally (maximum 400 mg daily) 1, 2
  • Systemic/Disseminated infections: 10 mg/kg/day orally (maximum 400 mg daily) 1, 3
  • Children in this age group often require doses above the standard 5 mg/kg/day recommendation to achieve therapeutic levels 2

Children >12 years

  • Cutaneous/Lymphocutaneous infections: 200 mg twice daily 1
  • Systemic/Disseminated infections: 200 mg twice daily 1

Duration of Treatment

  • Cutaneous fungal infections: 6-12 months 1, 4
  • Systemic/Disseminated infections: At least 12 months 1
  • Sporotrichosis: 6-10 mg/kg/day (maximum 400 mg daily) for at least 12 months 1

Formulation Considerations

  • Itraconazole oral solution is preferred for younger children and those with difficulty swallowing capsules 5
  • Itraconazole cyclodextrin oral solution should not be used interchangeably with capsules 1
  • Capsules are generally ineffective for treating esophageal disease 1

Therapeutic Drug Monitoring

  • Serum levels should be measured after 2 weeks of therapy to ensure adequate drug exposure 1, 2
  • Target trough concentration should be ≥0.5 mg/L 2
  • Poor attainment of target levels is common in children <12 years, requiring dose adjustments 2

Special Considerations

  • For severe infections, initial therapy with amphotericin B (0.7-1.0 mg/kg/day) followed by step-down to itraconazole is recommended 1
  • Itraconazole should be avoided during pregnancy; amphotericin B is the preferred agent 1
  • Potential for significant pharmacokinetic interactions between protease inhibitors or non-nucleoside reverse transcriptase inhibitors with itraconazole requires cautious use 1

Common Pitfalls and Caveats

  • Children ≤12 years often need higher weight-based dosing (median 6.2 mg/kg/day) compared to older children (3.9 mg/kg/day) 2
  • Subtherapeutic levels are common (76.8% of treatment courses) and often not addressed with appropriate dose adjustments 2
  • Gastrointestinal symptoms (15.2%) and hepatotoxicity (6.5%) are the most common adverse events 2
  • Accumulation occurs with repeated dosing; steady state is typically reached after 14 days of treatment 5

By following these dosing guidelines and monitoring serum levels appropriately, itraconazole can be an effective and safe treatment for fungal infections in children when used at the correct dose for age and infection type.

References

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Research

Itraconazole Dosing and Drug Monitoring at a Tertiary Children's Hospital.

The Pediatric infectious disease journal, 2019

Research

Efficacy and safety of itraconazole use in infants.

World journal of pediatrics : WJP, 2016

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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