Xyloproct Use In Pregnancy & Lactation

Pregnancy: Adequate data from treatment of pregnant women with Xyloproct is not available.
Hydrocortisone: Even though effects on foetus and newborn have been observed after per oral long-term treatment, still the systemic exposure is judged to be so low after topical treatment on a limited area that no corticosteroid induced effects are expected.
Lidocaine: Animal studies are not complete concerning effects on pregnancy, embryonal development, delivery and development after birth (see Pharmacology: Toxicology: Preclinical safety data under Actions). It is reasonable to presume that lidocaine has been used by a large number of pregnant women and women of child-bearing potential. No direct disorders of the reproduction process, such as increased frequency of malformation or direct or indirect effects on foetus have been reported.
However, the risks to humans are not investigated. Therefore, the lowest dose possible and the shortest possible duration of treatment should be aimed at during treatment with Xyloproct during pregnancy.
Lactation: Lidocaine and hydrocortisone acetate pass into breast milk, but the risk of effects on the child appears unlikely with therapeutic doses.