Azelastine ophthalmic Pregnancy and Breastfeeding Warnings

Brand names: Optivar

Medically reviewed by Drugs.com. Last updated on Aug 11, 2023.

Azelastine ophthalmic Pregnancy Warnings

This drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus

AU TGA pregnancy category: B3
US FDA pregnancy category: C

Animal studies have revealed evidence of embryotoxicity, foetotoxicity, 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.

AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

See references

Azelastine ophthalmic Breastfeeding Warnings

UK: Not recommended
AU and US: Benefit should outweigh risk

Excreted into human milk: Yes

Comment: To limit systemic absorption, apply pressure to the tear duct for at least 1 minute after eye drop instillation; blot excess solution with tissue.

See references

Further information

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