Orally administered retinoids have been associated with congenital abnormalities. When used in accordance with the prescribing information, topically administered retinoids are generally assumed to result in low systemic exposure due to minimal dermal absorption. However, there could be individual factors (e.g., damaged skin barrier, excessive use) that contribute to an increased systemic exposure.
Pregnancy: Animal studies by the oral route have shown reproductive toxicity at high systemic exposure.
Clinical experience with locally applied Differin products in pregnancy is limited but the few available data do not indicate harmful effects on pregnancy or on the health of the foetus exposed in early pregnancy. Differin products should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Due to the limited available data and because a very weak cutaneous passage of adapalene is possible, Adapalene (Differin) should not be used during pregnancy. In case of unexpected pregnancy, treatment should be discontinued.
Physicians should ensure that female patients are not pregnant or trying to conceive before prescribing Adapalene (Differin) products.
Cream: Differin is contraindicated (see Contraindications) in pregnancy, or in women planning a pregnancy. If the product is used during pregnancy, or if the patient becomes pregnant while taking this drug, treatment should be discontinued.
Lactation: It is not known whether Adapalene (Differin) products are excreted in animal or human milk after cutaneous application of Adapalene (Differin) products. In animal studies, infant rats suckled by mother with circulating levels of adapalene at least 300 times those demonstrated in clinical use developed normally. Because many drugs are excreted in human milk, caution should be exercised when Adapalene (Differin) products are administered to a nursing woman.
Adapalene (Differin) can be used during breastfeeding. To avoid contact exposure of the infant, application of Adapalene (Differin) to the chest should be avoided when used during breast-feeding.
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