Itraconazole Safety During Breastfeeding
Itraconazole is possibly safe during breastfeeding, but should be used with caution as the drug is excreted in breast milk at low concentrations and may accumulate over time. 1
Evidence on Itraconazole in Breast Milk
- Itraconazole is excreted in breast milk, with the amount present being less than the neonatal dosage 1
- The drug is poorly absorbed orally, which reduces potential exposure to the breastfed infant 1
- According to the FDA drug label, itraconazole is excreted in human milk, requiring careful consideration of benefits versus risks 2
Recommendations for Breastfeeding Mothers
- Unlike fluconazole (which is considered compatible with breastfeeding by the American Academy of Pediatrics), women should not consider breastfeeding while receiving itraconazole 1
- The European Respiratory Society/Thoracic Society of Australia and New Zealand (ERS/TSANZ) task force classifies itraconazole as "possibly safe" during breastfeeding, but notes there is limited information available in nursing mothers 1
- Oral and local use of itraconazole may be acceptable during lactation in some circumstances, but requires careful consideration 1
Comparison with Other Antifungals
- Fluconazole is generally considered more compatible with breastfeeding than itraconazole, with the American Academy of Pediatrics explicitly stating it is compatible with breastfeeding 1
- Nystatin is classified as "compatible" with breastfeeding, though any excess cream should be removed from nipples before nursing 1
- Posaconazole and voriconazole should be avoided during breastfeeding due to potential toxicity concerns and lack of safety data 1
Clinical Considerations and Monitoring
- If itraconazole must be used during breastfeeding, monitor the infant for potential adverse effects including gastrointestinal symptoms 3, 4
- The safety profile of itraconazole in infants is generally similar to that in adults, but caution is still warranted 3
- Consider the severity of the maternal fungal infection when weighing risks versus benefits of itraconazole therapy during breastfeeding 1
Important Caveats
- Itraconazole may accumulate in breast milk over time with prolonged use 1
- The U.S. Public Health Service Centers for Disease Control and Prevention advises HIV-infected women not to breastfeed regardless of antifungal therapy to avoid potential transmission of HIV 2
- For superficial fungal infections, consider topical antifungal alternatives that would minimize systemic exposure to the infant 5, 6
When treating a breastfeeding mother with a fungal infection, carefully consider whether the benefits of itraconazole therapy outweigh the potential risks to the infant. If possible, alternative antifungals with better safety profiles during lactation should be considered.