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Azelastine ophthalmic Pregnancy and Breastfeeding Warnings

Azelastine ophthalmic is also known as: Optivar

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

References for pregnancy information

  1. "Product Information. Optivar (azelastine ophthalmic)" Muro Pharmaceuticals Inc, Tewksbury, MA.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0

References for breastfeeding information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. "Product Information. Optivar (azelastine ophthalmic)" Muro Pharmaceuticals Inc, Tewksbury, MA.

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