Safety of Montelukast and Cetirizine During Breastfeeding
Both montelukast and cetirizine are safe to use during breastfeeding, with montelukast having particularly strong evidence showing only 0.68% of the maternal dose reaches the infant, and cetirizine being one of the preferred antihistamines with extensive safety data. 1, 2, 3
Montelukast Safety Profile
Montelukast excretion into breast milk is extremely low and poses minimal risk to the nursing infant. 2, 3
- Only approximately 1% of the maternal dose passes into breast milk, with peak concentrations occurring at 4 hours post-dose 2, 3
- The relative infant dose is just 0.68% of the weight-adjusted maternal dose, which is far below therapeutic ranges for infants 3
- Average milk concentrations are only 5.3 ng/mL, with maximum concentrations reaching 9.7 ng/mL 3
- Extensive metabolism and plasma protein binding further limit infant exposure beyond the already minimal milk transfer 2
Expert consensus strongly supports montelukast use during lactation, with multiple guideline societies stating that the benefits of breastfeeding overwhelm any theoretical risk of exposure. 2
Practical Recommendations for Montelukast
- Continue breastfeeding without interruption while taking montelukast 2
- If desired, consider breastfeeding immediately before taking the medication to further minimize infant exposure, though this is not necessary given the already negligible transfer 2, 4
- No monitoring of the infant is required 3
Cetirizine Safety Profile
Cetirizine is one of the preferred second-generation antihistamines for use during breastfeeding, with extensive accumulated safety data. 1, 4
- The European Respiratory Society and other guideline societies specifically recommend cetirizine (along with loratadine) as preferred antihistamines due to their established safety records 1, 4
- The 2005 NAEPP Expert Panel Report identifies cetirizine as a current second-generation antihistamine of choice for lactating women 1
- Cetirizine is classified as "compatible" with breastfeeding by major guideline societies 1
Important Caveat About Antihistamines
- Antihistamines may theoretically reduce milk production, though this is not well-established clinically 1
- Monitor for any changes in milk supply, particularly in the early postpartum period when lactation is being established 1
Comparative Evidence Quality
The evidence supporting montelukast safety during breastfeeding is stronger than for many other medications, with both high-quality research studies and multiple guideline endorsements. 2, 3
- Montelukast has direct pharmacokinetic data from a 2017 study measuring actual drug levels in breast milk 3
- Multiple international guideline societies (American Academy of Pediatrics, European Respiratory Society) have reviewed and endorsed its safety 1, 2
- Cetirizine has decades of clinical use data supporting its safety profile 1, 4
Clinical Context for Combined Use
Both medications can be used simultaneously during breastfeeding if clinically indicated for asthma and allergic rhinitis management. 1
- Montelukast is effective for both asthma control and allergic rhinitis treatment 1, 5
- Cetirizine provides additional symptomatic relief for allergic rhinitis symptoms 1, 5
- The combination of a leukotriene receptor antagonist with an antihistamine may provide superior symptom control compared to either agent alone 6