Epinastine ophthalmic Pregnancy and Breastfeeding Warnings
Brand names: Elestat
Medically reviewed by Drugs.com. Last updated on Aug 14, 2023.
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.
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 also
References for pregnancy information
- Product Information. Elestat (epinastine ophthalmic). Allergan Inc. 2003.
- Cerner Multum, Inc. UK Summary of Product Characteristics.
References for breastfeeding information
- Product Information. Elestat (epinastine ophthalmic). Allergan Inc. 2003.
- Cerner Multum, Inc. UK Summary of Product Characteristics.
- United States National Library of Medicine. Toxnet. Toxicology Data Network. http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT 2013.
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
