Is Fluconazole (Diflucan) safe during breastfeeding?

From the Guidelines

Fluconazole (Diflucan) is generally considered compatible with breastfeeding, though some caution is advised. For nursing mothers who require treatment for fungal infections, fluconazole passes into breast milk at concentrations similar to maternal plasma levels, but the amount consumed by the infant is significantly lower than therapeutic pediatric doses 1. Most experts and clinical guidelines consider short-term use of fluconazole (such as a single 150mg dose for vaginal candidiasis) to be safe during breastfeeding without interruption of nursing.

Key Considerations

• The benefits of treating the mother's infection typically outweigh the minimal risks to the breastfed infant 1.
• For longer courses or higher doses, monitoring the infant for potential side effects like gastrointestinal disturbances, rash, or elevated liver enzymes may be prudent 1.
• Fluconazole works by inhibiting fungal cell membrane synthesis, and its relatively long half-life provides effective treatment while minimizing the need for frequent dosing, which is particularly beneficial for nursing mothers managing both medication schedules and breastfeeding 1.

Important Notes

• The American Academy of Pediatrics considers fluconazole to be compatible with breastfeeding 1.
• Women should not consider breastfeeding while receiving itraconazole, posaconazole, or voriconazole, for which there are no data 1.

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
• The estimated daily infant dose is approximately 13% of the recommended pediatric dose
• No serious adverse reactions were reported in infants in a survey of 96 breastfeeding women
• Caution should be exercised when administering fluconazole to a nursing woman 2 2

From the Research

Dilfucan with Breastfeeding

• The use of fluconazole (Diflucan) 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 can be used safely during breastfeeding 3.
• There is no need to interrupt breastfeeding when a mother is treated with fluconazole, as the amount of medication that enters breast milk is considered safe for the infant 3.
• When prescribing medications for a breastfeeding patient, those with the lowest risk to the infant should be selected, and dosing should be before the infant's longest sleep interval 4.
• Current, accurate resources such as LactMed can provide safety information for many medications, including fluconazole, and are available free online 4.

Treatment of Vaginal Candidiasis

• Fluconazole is an oral drug of choice for continuous treatment of vaginal yeast infection with the least toxicity 5.
• A single oral dose of fluconazole has been shown to be effective in the treatment of vaginal candidiasis, with a success rate of 72% at long-term assessment 6.
• Fluconazole treatment has been compared to intravaginal clotrimazole, and fluconazole was found to be more effective in the long term and relieved symptoms more rapidly 6.

Medication Safety during Breastfeeding

• The amount of medication that enters breast milk varies based on the maternal serum concentration and the pharmacologic properties of the medication 4.
• Prescribers should use current, accurate resources to determine the safety of medications during breastfeeding, and prioritize the use of medications with the lowest risk to the infant 4.
• Most medications can be used safely during breastfeeding at the recommended dose, but there are exceptions that necessitate caution 7.