Are oral antifungals, such as fluconazole (Diflucan), safe for use in pediatric (children) patients?

From the Guidelines

Oral antifungals, such as fluconazole, can be safely used in pediatric patients when prescribed appropriately, with dosing and safety considerations varying by age and specific medication. The use of oral antifungals in children is supported by studies, including a 2009 update by the Infectious Diseases Society of America, which provides guidelines for the management of candidiasis in pediatric patients 1. According to this study, fluconazole is rapidly cleared in children, and to achieve comparable drug exposure, the daily fluconazole dose needs to be doubled, from 6 to 12 mg/kg daily, for children of all ages and neonates.

Key Considerations

• Dosing is weight-based, typically 6-12 mg/kg daily for most indications, with treatment duration varying by infection type 1.
• Liver function should be monitored during treatment, especially for extended courses.
• Other oral antifungals like itraconazole may also be used in children, but medications such as terbinafine and voriconazole have more limited pediatric data and specific age restrictions.
• The safety profile of antifungals in children is generally good, with most adverse effects being mild and reversible, including gastrointestinal symptoms, headache, and rash.

Additional Guidance

A more recent study from 2014 by the British Association of Dermatologists provides guidelines for the management of tinea capitis, which includes the use of fluconazole in children 1. Although fluconazole is not licensed for the treatment of tinea in children aged < 10 years in the U.K., it is licensed for use in all children for mucosal candidiasis. The benefit of treating fungal infections typically outweighs potential risks when these medications are used appropriately under medical supervision. However, all antifungal use in children should be directed by a healthcare provider who can determine the appropriate drug, dose, and duration based on the child's age, weight, and specific infection.

From the FDA Drug Label

The use of fluconazole in children with cryptococcal meningitis, Candida esophagitis, or systemic Candida infections is supported by the efficacy shown for these indications in adults and by the results from several small noncomparative pediatric clinical studies An open-label, randomized, controlled trial has shown fluconazole to be effective in the treatment of oropharyngeal candidiasis in children 6 months to 13 years of age. The safety profile of fluconazole in children has been studied in 577 children ages 1 day to 17 years who received doses ranging from 1 to 15 mg/kg/day for 1 to 1,616 days.

Oral antifungals, such as fluconazole, can be safe for use in pediatric patients.

• The drug label provides evidence of the efficacy and safety of fluconazole in children aged 6 months to 17 years.
• However, efficacy has not been established in infants less than 6 months of age.
• A small number of patients (29) ranging in age from 1 day to 6 months have been treated safely with fluconazole, but more data are needed to confirm safety in this age group 2.

From the Research

Safety of Oral Antifungals in Pediatric Patients

• The safety of oral antifungals, such as fluconazole, in pediatric patients has been evaluated in several studies 3, 4, 5, 6, 7.
• According to a study published in 1999, fluconazole seems to be well tolerated and efficacious against systemic candidosis and candidaemia in children below 1 year of age, including neonates and very low-birthweight infants (VLBWIs) 3.
• Another study published in 1994 found that fluconazole was effective and safe in the treatment of pediatric patients with severe fungal infections, with no treatment-related adverse events requiring termination of treatment 4.
• A prospective study published in 1994 evaluated the efficacy and safety of fluconazole in 173 children with severe fungal infections and found that related or possibly related adverse events occurred in 6% of patients 5.
• The use of fluconazole in pediatric patients is also supported by a review published in 1999, which found that fluconazole is well established as a first-line management option for the treatment and prophylaxis of localized and systemic Candida albicans infections, including in children 6.
• A review published in 2006 found that fluconazole is still a major drug for antifungal prophylaxis in high-risk neonates, as well as an alternative treatment for neonatal candidiasis, and is well tolerated in pediatric patients 7.

Dosage and Administration

• The recommended daily dosage of fluconazole in pediatric patients is 6 mg/kg, with adjustments made for patients with impaired renal function 3.
• In neonates, the dosage should be administered every 72 hours during the first 2 weeks of life, every 48 hours during weeks 2-4 of life, and daily thereafter 3.
• The dosage and administration of fluconazole in pediatric patients should be carefully monitored to ensure therapeutic plasma concentrations and to minimize the risk of adverse events 3, 4, 5.

Efficacy and Tolerability

• The efficacy and tolerability of fluconazole in pediatric patients have been demonstrated in several studies, with clinical cure or improvement achieved in 83% of patients with confirmed fungal infections 5.
• Fluconazole has been found to be effective against a range of fungal pathogens, including Candida albicans, and is well tolerated in pediatric patients, with few adverse events reported 3, 4, 5, 6, 7.