Pregnancy: There are no adequate data from its use in pregnant women.
Animal experimental studies with methylprednisolone aceponate have shown embryotoxic and/or teratogenic effects. In general, the use of topical preparations containing corticoids should be avoided during the first trimester of pregnancy. In particular, treating large areas, prolonged use or occlusive dressings should be avoided during pregnancy.
Epidemiological studies suggest that there could possibly be an increased risk of oral clefts among newborns of women who were treated with glucocorticosteroids during the first trimester of pregnancy. The clinical indication for treatment must be carefully reviewed and the benefits weighed against the risks in pregnant women.
Lactation: In rats methylprednisolone aceponate showed practically no transfer to the neonates via the milk. But it is not known if methylprednisolone aceponate is secreted in human milk as systemically administered corticosteroids have been reported to appear in human milk. It is not known whether topical administration could result in sufficient systemic absorption of methylprednisolone aceponate to produce detectable quantities in human milk. Therefore caution should be exercised when administered to a nursing woman.
Nursing mothers should not be treated on the breasts. Treating large areas, prolonged use or occlusive dressings should be avoided during lactation.
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