Is Setir Safe in Breastfeeding

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

Second generation antihistamine, drug derived from piperazine and metabolite of hydroxyzine, with a minimal sedative effect and low toxicity even at higher dose. No short or long-term side effects were found in an infant with a mother who was treated in the first month post delivery for pemphigus (Westermann 2012). Because of a high plasma protein binding capacity, excretion into breast milk seems to be unlikely. The British Society for Allergy and Clinical Immunology and other experts rates it as compatible with breastfeeding (Butler 2014, Powell 2007).

Small occasional doses of Setir are probably acceptable during breastfeeding. Larger doses or more prolonged use 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. The British Society for Allergy and Clinical Immunology recommends Setir at its lowest dose as a preferred choice if an antihistamine is required during breastfeeding.[1] Setir has been used successfully in cases of persistent pain of the breast during breastfeeding.[2] Ophthalmic use of Setir by the mother should pose little risk to the breastfed infant. 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.

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.[3] 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 Setir 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.[4] A woman with narcolepsy took sodium oxybate 4 grams each night at 10 pm and 2 am as well as fluoxetine 20 mg and Setir 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.[5]

Antihistamines in relatively high doses given by injection can decrease basal serum prolactin in nonlactating women and in early postpartum women.[6][7] However, suckling-induced prolactin secretion is not affected by antihistamine pretreatment of postpartum mothers.[6] Whether lower oral doses of Setir 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.