Pregnancy & Lactation : הריון/הנקה

4.6 Fertility, pregnancy and lactation
Pregnancy

Clinical data on the use of Daktacort ceam Cream in pregnancy are limited. In animals, corticosteroids are known to cross the placenta and consequently can affect the foetus (see Section 5.3). Administration of corticosteroids to pregnant animals can cause abnormalities of foetal development. The relevance of these findings to humans has not been established.

As a precautionary measure, it is preferable to avoid the use of Daktacort ceam during pregnancy. Treatment of large surfaces and the application under occlusive dressing is not recommended


Breastfeeding
There are no adequate and well-controlled studies on the topical administration of Daktacort ceam during breastfeeding. It is not known whether concomitant topical administration of Daktacort ceam to the skin could result in sufficient systemic absorption to produce detectable quantities of hydrocortisone and miconazole in breast milk in humans.

A risk to the newborn child cannot be excluded.

A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Daktacort ceam therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman. Treatment of large surfaces and the application under occlusive dressing is not recommended.