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Azelastine nasal Pregnancy and Breastfeeding Warnings

Azelastine nasal is also known as: Astelin, Astepro

Azelastine nasal Pregnancy Warnings

Azelastine has been assigned to pregnancy category C by the FDA. Studies in mice at 280 times the maximal recommended human intranasal dose on a mg/m2 basis have revealed evidence of embryotoxicity, fetotoxicity and teratogenicity. Delayed ossification and fetotoxicity were exhibited in rats at 240 and 550 times the maximal recommended human intranasal dose on a mg/m2 basis, respectively. There are no controlled data in human pregnancy. Azelastine nasal is only recommended for use during pregnancy when there are no alternatives and benefit outweighs risk.

Azelastine nasal Breastfeeding Warnings

There are no data on the excretion of azelastine into human milk. The manufacturer recommends that caution be used when administering azelastine nasal to nursing women.

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