Epiduo/Epiduo Forte Use In Pregnancy & Lactation

Pregnancy: Animal studies by the oral route have shown reproductive toxicity at high systemic exposure. Clinical experience with locally applied adapalene and benzoyl peroxide in pregnancy is limited but the few available data do not indicate harmful effects in patients exposed in early pregnancy. Due to the limited available data and because a very weak cutaneous passage of adapalene is possible, Adapalene + Benzoyl Peroxide (Epiduo/Epiduo Forte) should not be used during pregnancy. In case of unexpected pregnancy, treatment should be discontinued.
Lactation: No study on animal or human milk transfer was conducted after cutaneous application of Adapalene + Benzoyl Peroxide (Epiduo/Epiduo Forte). No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breast-feeding woman to adapalene and benzoyl peroxide are negligible. Adapalene + Benzoyl Peroxide (Epiduo/Epiduo Forte) can be used during breast-feeding. To avoid contact exposure of the infant, application of Adapalene + Benzoyl Peroxide (Epiduo/Epiduo Forte) to the chest should be avoided when used during breastfeeding.
Fertility: No fertility studies were conducted with Adapalene + Benzoyl Peroxide (Epiduo/Epiduo Forte).
In rat oral studies, 20 mg adapalene/kg/day did not affect the reproductive performance and fertility of F0 males and females, or the growth, development and reproductive function of F1 offspring.
A reproductive and developmental toxicity study conducted in rats exposed groups to oral doses of benzoyl peroxide of up 1000 mg/kg/day (5 mL/kg) showed that Benzoyl peroxide did not induce teratogenicity or effects on reproductive function at doses up to 500 mg/kg/day.