Budenofalk Rectal Foam Use In Pregnancy & Lactation

Pregnancy: Administration during pregnancy should be avoided unless there are compelling reasons for therapy with Budenofalk 2mg rectal foam. There are few data of pregnancy outcomes after oral administration of budesonide in humans. Although data on the use of inhaled budesonide in a large number of exposed pregnancies indicate no adverse effect, the maximal concentration of budesonide in plasma has to be expected to be higher in the treatment with Budenofalk 2mg rectal foam compared to inhaled budesonide. In pregnant animals, budesonide, like other glucocorticosteroids, has been shown to cause abnormalities of fetal development (see Pharmacology: Toxicology: Preclinical safety data under Actions). The relevance of this to man has not been established.
Breast-feeding: Budesonide is excreted in human milk (data on excretion after inhalative use is available). However, only minor effects on the breast-fed child are anticipated after application of Budenofalk 2mg rectal foam within the therapeutic range. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from budesonide therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Fertility: There are no data on the effect of budesonide on human fertility. Fertility was unaffected following budesonide treatment in animal studies (see Pharmacology: Toxicology: Preclinical safety data under Actions).