Itraconazole Dosing in Children

Dosing Guidelines by Age and Infection Type

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, 2
For children ≤12 years with cutaneous/lymphocutaneous infections, the recommended dose is 6-10 mg/kg/day orally (maximum 400 mg daily) 1
For children ≤12 years with systemic/disseminated infections, the recommended dose is 10 mg/kg/day orally (maximum 400 mg daily) 1
For children >12 years with cutaneous/lymphocutaneous or systemic/disseminated infections, the recommended dose is 200 mg twice daily 1

The duration of treatment for cutaneous fungal infections is 6-12 months 1
The duration of treatment for systemic/disseminated infections is at least 12 months 1, 2
The duration of treatment for sporotrichosis is at least 12 months 1

Itraconazole cyclodextrin oral solution should not be used interchangeably with capsules 3
Capsules are generally ineffective for treating esophageal disease 3

For severe infections, initial therapy with amphotericin B (0.7-1.0 mg/kg/day) followed by step-down to itraconazole is recommended 1, 2
Itraconazole should be avoided during pregnancy; amphotericin B is the preferred agent 4
There is a potential for significant pharmacokinetic interactions between protease inhibitors or non-nucleoside reverse transcriptase inhibitors with itraconazole, requiring cautious use 3

For a 10-month-old infant, the American Academy of Pediatrics recommends itraconazole oral suspension dosed at 5 mg/kg/day divided into two doses for prophylaxis or superficial infections, or 10 mg/kg/day divided into two doses for systemic/invasive fungal infections, with mandatory therapeutic drug monitoring after 2 weeks of therapy 5, 6

The Infectious Diseases Society of America recommends that for systemic/invasive fungal infections, itraconazole should be dosed at 10 mg/kg/day divided into two doses, with a loading dose of 10 mg/kg/day in two divided doses on day 1 5, 6
The American Academy of Pediatrics suggests that prophylaxis in high-risk patients, such as post-transplant, should continue until immune recovery or discontinuation of immunosuppression 5, 6

The European Society of Clinical Microbiology and Infectious Diseases advises to exercise extreme caution with concomitant immunosuppressants, such as cyclosporine, tacrolimus, and sirolimus, as itraconazole inhibits cytochrome P450 3A4, potentially increasing immunosuppressant levels 5, 6
For severe or life-threatening invasive fungal infections, the Infectious Diseases Society of America recommends initiating with amphotericin B for 1-2 weeks until clinical improvement, then stepping down to itraconazole 7