Is Cetirizine safe while breastfeeding?

Effects on the breastfed infant

In one telephone follow-up study, mothers reported irritability and colicky symptoms 10% of infants exposed to various antihistamines and drowsiness was reported in 1.6% of infants. None of the reactions required medical attention.[ 8 ] A woman who was nursing (extent not stated) her newborn infant was treated for pemphigus with oral prednisolone 25 mg daily, with the dosage increased over 2 weeks to 60 mg daily. She was also taking cetirizine 10 mg daily and topical betamethasone 0.1% twice daily to the lesions. Because of a poor response, the betamethasone was changed to clobetasol propionate ointment 0.05%. She continued breastfeeding throughout treatment and her infant was developing normally at 8 weeks of age and beyond.[ 9 ] A woman with narcolepsy took sodium oxybate 4 grams each night at 10 pm and 2 am as well as fluoxetine 20 mg and cetirizine 5 mg daily throughout pregnancy and postpartum. She breastfed her infant except for 4 hours after the 10 pm oxybate dose and 4 hours after the 2 am dose. She either pumped breastmilk or breastfed her infant just before each dose of oxybate. The infant was exclusively breastfed or breastmilk fed for 6 months when solids were introduced. The infant was evaluated at 2, 4 and 6 months with the Ages and Stages Questionnaires, which were withing the normal range as were the infant's growth and pediatrician's clinical impressions regarding the infant's growth and development.[ 10 ] Three women taking long-term cetirizine 10 mg daily by mouth while exclusively breastfeeding their 5- to 6-month old infants. The mothers reported no adverse effects in their infants.[ 4 ] Thirty-one women taking cetirizine 10 mg (n = 29) or 20 mg (n = 2) daily reported no adverse effects in 61% of their infants and minor adverse effects fever, sedation, rash, poor feeding, bruising, refusing of the breast or constipation. But mothers attributed these effects to other causes such a cold, weaning or learning to crawl.[ 6 ]

Effects on milk supply

Antihistamines in relatively high doses given by injection can decrease basal serum prolactin in nonlactating women and in early postpartum women.[ 11 , 12 ] However, suckling-induced prolactin secretion is not affected by antihistamine pretreatment of postpartum mothers.[ 11 ] Whether lower oral doses of cetirizine have the same effect on serum prolactin or whether the effects on prolactin have any consequences on breastfeeding success have not been studied. The prolactin level in a mother with established lactation may not affect her ability to breastfeed. In a study of 31 women taking cetirizine 10 mg (n = 29) or 20 mg (n = 2) daily, 10 reported a perceived decrease in milk supply over the prior 3 days.[ 6 ]

Levels in milk

Maternal Levels. Three women who were exclusively breastfeeding their 5- to 6-month-old infants were taking cetirizine 10 mg daily by mouth. Each mother donated milk samples before a dose and 1, 2, 4, 6, 8, 10, 12 and 24 hours after the dose. An average peak level of 49 mcg/L occurred at an average of 2 hours after the dose. The average milk concentration over the 24-hour period was 21.1 mcg/L. An exclusively breastfed infant would receive an average of 3.1 mcg/kg daily or a weight-adjusted dosage of 1.77% of the maternal dosage.[ 4 ] As part of a validation study on analysis of cetirizine and levocetirizine in breastmilk, 252 steady-state milk samples from 228 women taking either cetirizine 5 to 20 mg daily (n = 229) or levocetirizine 5 mg daily (n = 9) were analyzed. Specific dosages and times of milk collection were not given. The median milk concentrations of cetirizine and levocetirizine was 13 mcg/L (range 0.65 to 65 mcg/L; IQR 4.9 to 24.8 mcg/L) in 228 samples. Twenty-four samples had levels below the limit of quantification ( 0.39 mcg/L).[ 5 ] Women taking cetirizine (n = 31) collected complete sample of milk at about 0, 2, 4, 8, 12 and 24 hours after a daily dose and submitted aliquots for analysis. The average milk concentration was 16.8 mcg/L and the half-life in milk was 7 hours. The peak milk concentration averaged 41 mcg/L at an average time of 2.4 hours after a dose. Using the peak milk concentration, the authors calculated that a fully breastfed infant would receive a maximum of 2.5 mcg/kg daily, which represents a relative infant dose of 1.9%.[ 6 ] The authors used the data in this study to create a pharmacokinetic model using NONMEM. The model predicted an average RID of 1.8% and a worst-case RID of 3.4% using peak milk levels.[ 7 ] Infant Levels. Relevant published information was not found as of the revision date.

Alternatives LactMed lists

• Desloratadine
• Fexofenadine
• Levocetirizine
• Loratadine