Xamiol Use In Pregnancy & Lactation

Pregnancy: There are no adequate data from the use of Xamiol Gel in pregnant women. Studies in animals with glucocorticoids have shown reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions), but a number of epidemiological studies (less than 300 pregnancy outcomes) have not revealed congenital anomalies among infants born to women treated with corticosteroids during pregnancy. The potential risk for humans is uncertain. Therefore, during pregnancy, Xamiol Gel should only be used when the potential benefit justifies the potential risk.
Breast-feeding: Betamethasone passes into breast milk, but risk of an adverse effect on the infant seems unlikely with therapeutic doses. There are no data on the excretion of calcipotriol in breast milk. Caution should be exercised when prescribing Xamiol Gel to women who breast-feed. The patient should be instructed not to use Xamiol Gel on the breast when breast-feeding.
Fertility: Studies in rats with oral doses of calcipotriol or betamethasone dipropionate demonstrated no impairment of male and female fertility.