Emedastine and Breastfeeding

Summary of use during lactation

Emedastine is no longer marketed United States, but is available in other countries. Preliminary data indicate that oral administration of 2 mg daily produces low levels in milk and does not affect the breastfed infant. When used as an eye drop, emedastine would not be expected to cause any adverse effects in breastfed infants. To substantially diminish the amount of drug that reaches the breastmilk after using eye drops, place pressure over the tear duct by the corner of the eye for 1 minute or more, then remove the excess solution with an absorbent tissue.

Drug levels in milk and infant serum

Maternal Levels. A woman was prescribed emedastine difumarate 2 mg once daily and pranlukast hydrate 112.5 mg twice daily during pregnancy and postpartum. Emedastine concentration in milk were measured on days 1 to 4 postpartum. Emedastine concentrations at 9.3 and 12.3 hours after a dose were 0.44 and 0.13 mcg/L, respectively. At 20.3, 22.5, and 23.3 hours after a dose, milk concentrations were 0.09, 0.07, and 0.06 mcg/L, respectively.[1] Infant Levels. Relevant published information was not found as of the revision date.

Effects in breastfed infants

A woman was prescribed emedastine difumarate 2 mg once daily and pranlukast hydrate 112.5 mg twice daily during pregnancy and postpartum. Her infant was breastfed and no adverse effects were noted.[1]

Effects on lactation and breastmilk

Relevant published information was not found as of the revision date.

Alternative drugs to consider

(Oral Antihistamine) Cetirizine, Desloratadine, Fexofenadine, Levocetirizine, Loratadine

References

1. Saito J, Yakuwa N, Sasaki A, et al. Emedastine during pregnancy and lactation: Emedastine levels in maternal serum, cord blood, breast milk, and neonatal serum. Breastfeed Med 2020;15:809-12.33035080 PubMed