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Azelaic acid topical Pregnancy and Breastfeeding Warnings

Azelaic acid topical is also known as: Azelex, Finacea, Finevin

Azelaic acid topical Pregnancy Warnings

Azelaic acid topical has been assigned to pregnancy category B by the FDA. There are no controlled data of topically administered azelaic acid in human pregnancy. High-dose animal studies have revealed evidence of embryotoxicity when azelaic acid is given orally. Azelaic acid should only be used during pregnancy when need has been clearly established.

High dose animal studies have revealed evidence of embryotoxicity when azelaic acid is given orally. In addition, slight disturbances in the postnatal development of fetuses was noted in rats at oral doses that generated some maternal toxicity.

Azelaic acid topical Breastfeeding Warnings

Azelaic acid may be excreted into human milk. In vitro, the milk/plasma distribution coefficient was 0.7 and the milk/buffer distribution was 1.0 at azelaic acid concentrations of 25 mcg/mL. However, since less than 4% of a topical dose is absorbed systemically, the amount in milk is expected to be minimal. The manufacturer recommends that caution be used when administering azelaic acid to nursing women.

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