Is fluconazole (Diflucan) safe during breastfeeding?

From the Guidelines

Diflucan (fluconazole) is generally considered compatible with breastfeeding for most indications. For typical yeast infections, a single 150 mg dose is usually safe while nursing, with minimal amounts reaching the infant through breast milk, as noted in the study published in the European Respiratory Journal 1. The estimated amount of fluconazole that reaches a nursing infant is significantly below therapeutic doses used for infants, typically less than 10% of the weight-adjusted maternal dose. Most infants will not experience adverse effects, though monitoring for potential side effects like diarrhea, vomiting, or rash is prudent.

Some key points to consider when breastfeeding while taking Diflucan include:

• The amount of fluconazole present in breast milk is less than the neonatal dosage, as indicated in the study 1.
• Problems have not been seen in breastfed infants from mothers treated with oral fluconazole, according to the study 1.
• For mothers with premature infants or those with liver or kidney problems, extra caution may be warranted, and a healthcare provider should be consulted for personalized advice.
• The American Academy of Pediatrics has indicated that breastfeeding while receiving fluconazole is likely safe for the newborn, as mentioned in the study 1.

If you're concerned about breastfeeding while taking Diflucan, you can time your doses to minimize exposure by taking the medication immediately after nursing. It's essential to discuss your specific situation with your healthcare provider to determine the best course of action for you and your baby.

From the FDA Drug Label

Fluconazole was present in low levels in breast milk following administration of a single 150 mg dose, based on data from a study in 10 breastfeeding women who temporarily or permanently discontinued breastfeeding 5 days to 19 months postpartum The estimated daily infant dose of fluconazole from breast milk (assuming mean milk consumption of 150 mL/kg/day) based on the mean peak milk concentration (2.61 mcg/mL [range: 1.57 to 3.65 mcg/mL] at 5.2 hours post-dose) was 0. 39 mg/kg/day, which is approximately 13% of the recommended pediatric dose for oropharyngeal candidiasis. A published survey of 96 breastfeeding women who were treated with fluconazole 150 mg every other day (average of 7. 3 capsules [range 1 to 29 capsules]) for lactation-associated candida of the breasts reported no serious adverse reactions in infants. Caution should be exercised when fluconazole is administered to a nursing woman.

Key Points:

• Fluconazole is present in low levels in breast milk after a single 150 mg dose.
• The estimated daily infant dose from breast milk is approximately 13% of the recommended pediatric dose for oropharyngeal candidiasis.
• A survey of 96 breastfeeding women treated with fluconazole reported no serious adverse reactions in infants.
• Caution should be exercised when administering fluconazole to a nursing woman 2 2.

From the Research

Diflucan in Breastfeeding

• The use of Diflucan (fluconazole) during breastfeeding has been studied, and available data are reassuring 3.
• Fluconazole is used in the treatment of fungal diseases in infants and has a good safety profile, suggesting that it is safe for use during breastfeeding 3.
• There is no need to interrupt breastfeeding when a mother is treated with fluconazole, as the drug is not expected to cause harm to the infant 3.
• The disposition of maternal drugs in breast milk is described by several key parameters, including relative infant dose (RID), which is a function of milk-to-plasma drug concentration ratio and maternal drug clearance 4.
• Most drugs, including fluconazole, show RID values of <10%, indicating that drug concentrations in infant serum do not reach a level known to be therapeutic in adults unless drug clearance is markedly lower than the adult level on a weight basis 4.

Safety of Fluconazole During Breastfeeding

• Fluconazole is an azole compound that has been shown to be effective and well-tolerated in the prevention of fungal infections in immunocompromised hosts 5.
• The choice of antifungal agent for prophylaxis in immunocompromised patients remains controversial, but azole compounds such as fluconazole appear to be more effective and better tolerated than nystatin suspension 5.
• Fluconazole has been shown to be effective in the treatment of cutaneous candidiasis, with similar efficacy to topical clotrimazole and oral ketoconazole 6.
• The safety profile of fluconazole is generally good, with adverse effects limited to nausea and vomiting and transient elevations in hepatic transaminases 5, 6.