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Emedastine ophthalmic Pregnancy and Breastfeeding Warnings

Emedastine ophthalmic is also known as: Emadine

Medically reviewed on Sep 17, 2018

Emedastine ophthalmic Pregnancy Warnings

Animal studies using doses up to 15,000 times the maximum human ophthalmic dose have revealed no evidence of teratogenicity. Increased external, visceral and skeletal anomalies were observed in rats at doses 70,000 times the maximum recommended ocular dose. There are no controlled data in human pregnancy.

US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

This drug should be used during pregnancy only if clearly needed.

US FDA pregnancy category: B

See references

Emedastine ophthalmic Breastfeeding Warnings

Caution is recommended.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comment:
Apply pressure to the tear duct by the corner of the eye for at least 1 minute after eye drop instillation to limit systemic absorption; blot excess solution with tissue.

While this drug has been shown present in animal milk, it is not expected to cause harmful effects in human nursing infants. This drug is not expected to be absorbed systematically through topical ocular administration.

See references

References for pregnancy information

  1. "Product Information. Emadine (emedastine ophthalmic)." Alcon Laboratories Inc, Fort Worth, TX.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  3. "Product Information. Emadine (emedastine ophthalmic)." Alcon Laboratories Inc, Fort Worth, TX.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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