Frågedatum: 1995-12-04
RELIS database 1995; id.nr. 12067, DRUGLINE
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What is known about possible risk of breast feeding during treatment with Diflucan (fluconazol)?



Fråga: What is known about possible risk of breast feeding during treatment with Diflucan (fluconazol)?

Sammanfattning: Fluconazole passes through to human breast milk at concentrations similar to plasma. Too little information is available to evaluate the possible risk to the infant when breast feeding during treatment with fluconazole. Individual consideration and alternative treatment is recommended until more knowledge and field´s experience are aquired.

Svar: Fluconazole is an antimycotic agent for systemic use in candida infections and the answer is therefore exlusively dealing with systemic use of fluconazole. A similar question was asked one year ago concerning possible contraindication of treatment with a single dose of 150 mg flucanozole during breast feeding. The question concerned a nursing mother with candida vaginosis(1). The only information found in this case was provided by the manufacturer. In summary, fluconazole passes through to breast milk at concentrations similar to the mothers plasma. A mean plasma concentration of 2.61 ug/ml and a mean milk concentration of 2.71 ug/ml was found after giving a single oral dose of 150 mg fluconazole to ten subjects (2). The plasma concentration six hours after a single dose of 150 mg fluconazole has been estimated to be 2.5 mg/l (3). According to the manufacturer, fluconazole has been used in premature and neonatal infants, dose 6-12 mg/kg body weight, without any serious side effects (1).

In Physicians Desk Reference 1994 nursing is not recommended during treatment with fluconazole (4) and in the Swedish correspondence FASS it is concluded that too little information is available to evaluate the risk to the infant (5). In a recently updated textbook it is concluded that "fluconazole is probably safe to use during breast feeding". This is based on two case reports where fluconazole was given to neonates in doses exceeding the amount they would have received via breast milk. No side-effects were encountered in either infant (6).

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