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Azelastine ophthalmic Pregnancy and Breastfeeding Warnings

Azelastine ophthalmic is also known as: Optivar

Azelastine ophthalmic Pregnancy Warnings

Azelastine ophthalmic has been assigned to pregnancy category C by the FDA. Animal studies have revealed evidence of embryotoxicity, fetotoxicity, and teratogenicity with high oral doses (25,000 to 57,000 times the recommended human ocular dose). Systemic absorption is low after ocular administration (plasma concentration range: 0.02 to 0.25 ng/mL). There are no controlled data in human pregnancy. Azelastine ophthalmic is only recommended for use during pregnancy when benefit outweighs risk.

Azelastine ophthalmic Breastfeeding Warnings

There are no data on the excretion of azelastine into human milk. Systemic absorption is low following ocular administration (plasma concentration range: 0.02 to 0.25 ng/mL). The manufacturer recommends caution when administering azelastine ophthalmic to nursing women.

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