Travocort Use In Pregnancy & Lactation

Pregnancy: There are no data from the use of isoconazole nitrate/diflucortolone-21-valerate in pregnant women.
Studies in animals (mice, rats and rabbits) have shown reproductive toxicity for diflucortolone-21-valerate. In general, the use of topical preparations containing glucocorticoids 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 bean increased risk of oral clefts among newborns of women who were treated with glucocorticoids during the first trimester of pregnancy.
The clinical indication for treatment with Travocort must be carefully reviewed and the benefits weighed against the risks in pregnant women.
Lactation: It is unknown whether isoconazole nitrate/diflucortolone-21-valerate are excreted in human milk. A risk to the suckling child cannot be excluded.
Nursing mothers should not be treated on the breasts. Treating large areas, prolonged use or occlusive dressings should be avoided during lactation.
The clinical indication for treatment with Travocort must be carefully reviewed and the benefits weighed against the risks in lactating women.