Epiduo Forte Use In Pregnancy & Lactation

Epiduo Forte 0.3% / 2.5% gel should be given to women of childbearing potential only if highly effective contraception is used during treatment and for 1 month after discontinuation of treatment.
Pregnancy: There are no or limited amount of data from the use of adapalene in pregnant women.
Studies in animals by the oral route have shown reproductive toxicity at high systemic exposure (see Pharmacology: Toxicology: Preclinical safety data under Actions).
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 weak cutaneous passage of adapalene is possible, Epiduo Forte 0.3% / 2.5% gel should not be used during pregnancy or in women of childbearing potential not using a birth-control method.
In case of unexpected pregnancy, treatment should be discontinued.
Breastfeeding: No study on animal or human milk transfer was conducted after cutaneous application of Epiduo Forte 0.3% / 2.5% gel. Available pharmacokinetic data in rats have shown excretion of adapalene in milk after oral or intravenous administration of adapalene.
A risk to the suckling child cannot be excluded.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Epiduo Forte 0.3% / 2.5% Gel therapy weighing the benefit of breast-feeding for the child and the benefit of therapy for the woman.
To avoid contact exposure of the infant, application of Epiduo Forte 0.3% / 2.5% gel to the chest should be avoided when used during breast-feeding.
Fertility: No human fertility studies were conducted with Epiduo Forte 0.3% / 2.5% gel.
However, no effects of adapalene or benzoyl peroxide on fertility were found in rats in reproductive studies.