Montelukast Levels and Effects while Breastfeeding
Summary of Use during Lactation
Very low levels of montelukast appear in breastmilk. Montelukast is approved for use in children as young as 6 months of age and has been used in neonates in dosages far greater than the amounts in breastmilk. Amounts ingested by the infant would not be expected to cause any adverse effects in breastfed infants. International guidelines consider that leukotriene receptor antagonists can be used during breastfeeding.[1,2]
Drug Levels
Maternal Levels. Seven women were given a 10 mg dose of montelukast and provide milk samples before the dose and at 6 times over the next 12 hours. Average peak milk concentration of the drug were 9.74 mcg/L at an average of 4 hours after the dose. The average milk concentration was 5.3 mcg/L which resulted in an average daily infant dosage of 0.79 mcg/kg (range 0.4 to 1.4 mcg/kg daily) or 0.68% of the weight-adjusted maternal dosage.[3]
Infant Levels. Relevant published information was not found as of the revision date.
Effects in Breastfed Infants
Relevant published information was not found as of the revision date.
Effects on Lactation and Breastmilk
Relevant published information was not found as of the revision date.
Middleton PG, Gade EJ, Aguilera C, et al. ERS/TSANZ Task Force Statement on the management of reproduction and pregnancy in women with airways diseases. Eur Respir J 2020;55:1901208 [PubMed: 31699837]
2.
Bendien SA, de Kruif MD, Feitsma H, et al. Summary of the Dutch Multidisciplinary Practice Guideline on Asthma and Pregnancy. J Allergy Clin Immunol Pract 2024;12:1751-62 [PubMed: 38513758]
3.
Datta P, Rewers-Felkins K, Baker T, et al. Transfer of montelukast into human milk during lactation. Breastfeed Med 2017;12:54-7 [PubMed: 28002678]
Substance Identification
Substance Name
Montelukast
CAS Registry Number
158966-92-8
Drug Class
Breast Feeding
Lactation
Milk, Human
Anti-Asthmatic Agents
Leukotriene Antagonists
Disclaimer: Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.
