Fluocortolone

There are insufficient data on the use of fluocortolone in pregnant women. Animal experimental studies with glucocorticosteroids have shown reproductive toxicity.

A number of epidemiological studies suggest that there could possibly be an increased risk of oral clefts among newborns of women who were treated with systemic glucocorticosteroids during the first trimester of pregnancy. Oral clefts are a rare disorder and if systemic glucocorticosteroids are teratogenic, these may account for an increase of only one or two cases per 1000 women treated while pregnant.

Data concerning topical glucocorticosteroid use during pregnancy are insufficient, however, a lower risk might be expected since systemic availability of topically applied glucocorticosteroids is very low.

As a general rule, topical preparations containing glucocorticosteroids should not be applied during the first trimester of pregnancy.

The clinical indication for treatment with fluocortolone must be carefully reviewed and the benefits weighed against the risks in pregnant and lactating women. In particular, prolonged use must be avoided.

No or negligible influence on the ability to drive and use machines.