Skip to Content
Get key facts and figures about chronic dry eye

Epinastine ophthalmic Pregnancy and Breastfeeding Warnings

Epinastine ophthalmic is also known as: Elestat

Medically reviewed on June 12, 2018

Epinastine ophthalmic Pregnancy Warnings

Benefit should outweigh risk.

US FDA pregnancy category: C

A study in rats using maternally toxic oral doses (150,000 times the recommended ocular human dose) has not revealed embryofetal effects. However, at 90,000 the recommended ocular human, reduced pup weight was observed. Resorptions and abortions have been reported in rabbits with oral doses at 55,000 times the recommended ocular human dose.

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

Epinastine 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.

See references

References for pregnancy information

  1. "Product Information. Elestat (epinastine ophthalmic)." Allergan Inc, Irvine, CA.
  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. "Product Information. Elestat (epinastine ophthalmic)." Allergan Inc, Irvine, CA.
  3. 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 -]):

Further information

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

Hide