Fluconazole (Diflucan) Use in Pediatric Patients
Yes, pediatric patients can take fluconazole (Diflucan) with appropriate age-based dosing adjustments, as it is FDA-approved for multiple indications in children and has established safety and efficacy data for pediatric use. 1
Approved Indications and Dosing
Oropharyngeal Candidiasis
- For children 6 months and older: 6 mg/kg on first day, followed by 3 mg/kg once daily 1
- Treatment should continue for at least 2 weeks to prevent relapse 1
Esophageal Candidiasis
- For children 6 months and older: 6 mg/kg on first day, followed by 3 mg/kg once daily 1
- Doses up to 12 mg/kg/day may be used based on clinical response 1
- Minimum treatment duration: 3 weeks and at least 2 weeks following symptom resolution 1
Systemic Candida Infections
Dosing varies by age:
- 3 months or older: Loading dose of 25 mg/kg (max 800 mg) on first day, followed by 12 mg/kg daily (max 400 mg) 1
- Birth to 3 months with gestational age ≥30 weeks: 25 mg/kg on first day, followed by 12 mg/kg daily 1
- Birth to 3 months with gestational age <30 weeks: 25 mg/kg on first day, followed by 9 mg/kg daily 1
Cryptococcal Meningitis
- Loading dose: 12 mg/kg on first day 1
- Maintenance: 6 mg/kg once daily 1
- Duration: 10-12 weeks after CSF becomes culture negative 1
- For suppression in HIV-infected children: 6 mg/kg once daily 1
Age-Specific Pharmacokinetic Considerations
Neonates and Infants
- Neonates have a prolonged half-life (55-90 hours) compared to adults (30 hours) 2
- Volume of distribution is 2-3 fold higher in neonates than adults, falling to <1 L/kg by 3 months of age 2
- For very-low-birth-weight infants, fluconazole may accumulate due to immature renal function 2
- During first 2 weeks of life, dose should be administered every 72 hours; in weeks 2-4, every 48 hours; after 4 weeks, daily dosing is appropriate 3
Children
- Children have more rapid clearance (half-life ~14 hours) than adults 2
- For life-threatening infections in children, consider 6 mg/kg every 12 hours 2
Special Populations
Children on ECMO
- 3 months and older: 35 mg/kg loading dose (max 800 mg), followed by 12 mg/kg daily (max 400 mg) 1
- Birth to 3 months with gestational age <30 weeks: 35 mg/kg loading dose, followed by 9 mg/kg daily 1
- Birth to 3 months with gestational age ≥30 weeks: 35 mg/kg loading dose, followed by 12 mg/kg daily 1
Renal Impairment
- Dosage reduction required based on creatinine clearance 1
- For children with renal insufficiency, dosage reduction should parallel adult recommendations 1
- Creatinine clearance estimation formula for children: K × linear length or height (cm) ÷ serum creatinine (mg/100 mL) 1
- K = 0.55 for children older than 1 year
- K = 0.45 for infants
Prophylaxis Recommendations
Allogeneic HSCT
- Fluconazole 8-12 mg/kg daily IV or orally from day 0 until day +75 post-transplant (A-I) 2
- Should only be used if institutional incidence of invasive mold infections is low 2
AML and Recurrent Leukemia
- Fluconazole 8-12 mg/kg IV or orally after last dose of chemotherapy until neutrophil recovery (A-I) 2
Primary Prophylaxis in HIV-Infected Infants
- Not indicated (DII) 2
Safety Profile
- Fluconazole is generally well-tolerated in pediatric populations 4
- Common side effects include diarrhea, vomiting, and elevated liver enzymes 4
- Safety has been established in studies of 577 children ages 1 day to 17 years receiving doses of 1-15 mg/kg/day 1
- Therapeutic drug monitoring recommended when using higher doses to maintain concentrations between 4-20 μg/mL 3
Important Precautions
Species-specific considerations: Fluconazole lacks activity against Candida krusei (intrinsic resistance) and often has reduced activity against Candida glabrata 5
Pregnancy: Use with caution in pregnant patients as high doses have been associated with fetal abnormalities in animal studies 1
Drug interactions: Consider potential interactions with other medications, particularly in patients receiving chemotherapy or immunosuppressants 2
Duration of therapy: Inadequate treatment duration may lead to recurrence of infection 1
Fluconazole has maintained its position as a first-line treatment option for many cases of invasive candidiasis in pediatric patients over the past decades, with established efficacy and safety data supporting its use 5.