Summary of Use during Lactation

Emedastine is an antihistamine that is not approved for marketing in the United States by the U.S. Food and Drug Administration, 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

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.

Alternate Drugs to Consider

(Oral) Desloratadine, Fexofenadine, 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. [PubMed: 33035080]

Substance Name

Emedastine

CAS Registry Number

87233-61-2

Drug Class

Breast Feeding

Lactation

Antihistamines