There have been no adequate and well-controlled studies of the use of fluconazole in pregnant women. During pregnancy, the use of fluconazole should be avoided, except in cases of severe and potentially life-threatening fungal infections, when the expected benefit of treatment to the mother outweighs the possible risk to the fetus.
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It is necessary to consider effective methods of contraception in women of childbearing age during the entire period of treatment and for about a week (5-6 half-lives) after taking the last dose of the drug.
Cases of spontaneous abortion and the development of congenital anomalies have been reported in infants whose mothers received fluconazole at a dose of 150 mg once or repeatedly in the first trimester of pregnancy. Cases of multiple congenital malformations have been described in newborns whose mothers received high-dose fluconazole therapy (400-800 mg / day) for most or all of the first trimester. The following developmental disorders were noted: brachycephaly, malformation of the facial part of the skull, malformation of the cranial vault, cleft palate, curvature of the femur, thinning and lengthening of the ribs, arthrogryposis, and congenital heart defects.
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Fluconazole is found in breast milk at concentrations close to plasma levels. T1 / 2 of the drug from breast milk is approximately equal to T1 / 2 of plasma – 30 hours The estimated dose of fluconazole absorbed by the infant (taking into account the fact that the average amount of milk consumed is 150 ml / kg daily), and calculated in accordance with the average Cmax of the drug in breast milk, is 0.39 mg / kg / day, which is approximately equal to 40% of the recommended neonatal dose (for children under 2 weeks of age) or 13% of the recommended infant dose for the treatment of mucosal candidiasis.
Breastfeeding can be continued after taking a single 150 mg dose of fluconazole. It is not recommended to breastfeed after multiple or high doses of fluconazole. When deciding on the appointment of the drug Diflucan® against the background of breastfeeding, the following factors should be taken into account: the benefits of breastfeeding for the health and development of the infant, together with the clinical indications for prescribing the drug Diflucan® and the possibility of any potential side effects in the infant or the effect of concomitant pathology of the mother on the health of the baby.