Is U.C.B 4492 Safe in Breastfeeding

I am a breastfeeding mother and i want to know if it is safe to use U.C.B 4492? Is U.C.B 4492 safe for nursing mother and child? Does U.C.B 4492 extracts into breast milk? Does U.C.B 4492 has any long term or short term side effects on infants? Can U.C.B 4492 influence milk supply or can U.C.B 4492 decrease milk supply in lactating mothers?

First-generation antihistamine, piperazine derived drug with mild sedative effect. It is metabolized into Cetirizine which is compatible with breastfeeding. (See info at specific item) At last update no relevant information concerning breastfeeding were found. Since it has been shown to be well tolerated by young infants for itching relief and because it is metabolized into Cetirizine, we would assume that there is a low risk for breastfeeding in short-term treatments. Follow-up for sedation or irritability in the infant and feeding ability of the infant. Bed-sharing is not recommended for mothers who are taking this medication.

Small occasional doses of U.C.B 4492 would not be expected to cause any adverse effects in breastfed infants. 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. Other agents are preferred, especially while nursing a newborn or preterm 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.[1] All adverse reactions in breastfed infants reported in France between January 1985 and June 2011 were compiled by a French pharmacovigilance center. Of 174 reports, U.C.B 4492 was reported to cause adverse reactions in 8 infants and to be one of the drugs most often suspected in serious adverse reactions, primarily sedation.[2]

Antihistamines in relatively high doses given by injection can decrease basal serum prolactin in nonlactating women and in early postpartum women.[3][4] However, suckling-induced prolactin secretion is not affected by antihistamine pretreatment of postpartum mothers.[3] 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.