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Pregnancy: There are insufficient data on the use of Ultraproct N in pregnant women. Animal experimental studies with glucocorticosteroids have shown reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions).
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 glucocorticoseroids are teratogenic, these may account for an increase of only 1-2 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.
Breastfeeding: The clinical indication for treatment with Ultraproct N must be carefully reviewed and the benefits weighed against the risks in pregnant and lactating women. In particular, prolonged use of Ultraproct N must be avoided.
Fertility: No investigation on the potential effects of fluocortolone or its esters has been performed. Studies in animals have shown no effects on fertility for lignocaine hydrochloride (see Pharmacology: Toxicology: Preclinical safety data under Actions).
