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Epinastine ophthalmic Pregnancy and Breastfeeding Warnings

Epinastine ophthalmic is also known as: Elestat

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. "Product Information. Elestat (epinastine ophthalmic)." Allergan Inc, Irvine, CA.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL:" ([cited 2013 -]):

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