Question

I am a breastfeeding mother and i want to know if it is safe to use (+-)-Azelastine? Is (+-)-Azelastine safe for nursing mother and child? Does (+-)-Azelastine extracts into breast milk? Does (+-)-Azelastine has any long term or short term side effects on infants? Can (+-)-Azelastine influence milk supply or can (+-)-Azelastine decrease milk supply in lactating mothers?

(+-)-Azelastine lactation summary

(+-)-Azelastine usage has low risk in breastfeeding
  • DrLact safety Score for (+-)-Azelastine is 3 out of 8 which is considered Low Risk as per our analyses.
  • A safety Score of 3 indicates that usage of (+-)-Azelastine may cause some minor side effects in breastfed baby.
  • Our study of different scientific research indicates that (+-)-Azelastine may cause moderate to no side effects in lactating mother.
  • Most of scientific studies and research papers declaring usage of (+-)-Azelastine low risk in breastfeeding are based on normal dosage and may not hold true for higher dosage.
  • While using (+-)-Azelastine We suggest monitoring child for possible reactions. It is also important to understand that side effects vary largely based on age of breastfed child and time of medication in addition to dosage.
  • Score calculated using the DrLact safety Version 1.2 model, this score ranges from 0 to 8 and measures overall safety of drug in lactation. Scores are primarily calculated using publicly available case studies, research papers, other scientific journals and publically available data.

Answer by Dr. Ru: About (+-)-Azelastine usage in lactation

Second generation anti-histaminic drug with low sedative effect. Used for ophthalmic and nasal topical administration. On last update no relevant published data related to breastfeeding were found. A small dose together with a low plama level of most nasal and ophthalmologic compounds make that a significant excretion into breast milk would be unlikely.

Answer by DrLact: About (+-)-Azelastine usage in lactation

Small occasional doses of (+-)-Azelastine nasal spray would not be expected to cause any adverse effects in breastfed infants. Larger doses or more prolonged use of the nasal spray may cause drowsiness and other effects in the infant or decrease the milk supply, particularly in combination with a sympathomimetic such as pseudoephedrine or before lactation is well established. Infant rejection of the breast might occur because of the bitter taste of the drug. The oral, nonsedating antihistamines are preferred alternatives. Because absorption from the eye is limited, (+-)-Azelastine 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.

(+-)-Azelastine Side Effects in Breastfeeding

Relevant published information on (+-)-Azelastine was not found as of the revision date. 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.[1]

(+-)-Azelastine Possible Effects in Breastfeeding

Antihistamines in relatively high doses given by injection can decrease basal serum prolactin in nonlactating women and in early postpartum women.[2][3] However, suckling-induced prolactin secretion is not affected by antihistamine pretreatment of postpartum mothers.[2] Whether lower oral doses of antihistamines 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.
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