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Drugs and Lactation Database (LactMed®) [Internet]. Bethesda (MD): National Institute of Child Health and Human Development; 2006-.
CASRN: 158966-92-8
Drug Levels and Effects
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. A task force respiratory experts from Europe, Australia and New Zealand found that these drugs are probably safe during breastfeeding.[1] No special precautions are required.
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.[2]
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.
Alternate Drugs to Consider
Beclomethasone, Cromolyn, Terbutaline, Theophylline, Zafirlukast
References
- 1.
- 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.
- 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
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- Identification, synthesis, isolation and spectral characterization of potential impurities of montelukast sodium.[J Pharm Biomed Anal. 2008]Identification, synthesis, isolation and spectral characterization of potential impurities of montelukast sodium.Saravanan M, Siva Kumari K, Pratap Reddy P, Naidu MN, Moses Babu J, Srivastava AK, Lakshmi Kumar T, Chandra Sekhar BV, Satyanarayana B. J Pharm Biomed Anal. 2008 Nov 4; 48(3):708-15. Epub 2008 Jul 16.
- Metabolic profiles of montelukast sodium (Singulair), a potent cysteinyl leukotriene1 receptor antagonist, in human plasma and bile.[Drug Metab Dispos. 1997]Metabolic profiles of montelukast sodium (Singulair), a potent cysteinyl leukotriene1 receptor antagonist, in human plasma and bile.Balani SK, Xu X, Pratha V, Koss MA, Amin RD, Dufresne C, Miller RR, Arison BH, Doss GA, Chiba M, et al. Drug Metab Dispos. 1997 Nov; 25(11):1282-7.
- Pharmacology of montelukast sodium (Singulair), a potent and selective leukotriene D4 receptor antagonist.[Can J Physiol Pharmacol. 1995]Pharmacology of montelukast sodium (Singulair), a potent and selective leukotriene D4 receptor antagonist.Jones TR, Labelle M, Belley M, Champion E, Charette L, Evans J, Ford-Hutchinson AW, Gauthier JY, Lord A, Masson P. Can J Physiol Pharmacol. 1995 Feb; 73(2):191-201.
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