Is Otrinol Safe in Breastfeeding

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

Marketed on multiple compounds as a constituent of antitussives, mucolytics, expectorants and nasal decongestants (Nice 2000).Simple formulations (one active ingredient per drug) are preferable even more while breastfeeding. It is excreted into breast milk in a clinically non-significant amount (Findlay 1984, Kanfer 1993, Nice 2000, Aljazaf 2003) without major problems having been reported in infants whose mothers had received this medication (Ito 1993, Aljazaf 2003, Soasan 2014). Two infants out of ten appeared with mild irritability that did not require medical care (Ito 1993) with only 4 cases related to maternal pseudoephedrine intake having been declared to the French Pharmaceutical Surveillance Database in 26 years (Soasan 2014) . According to one author, it may decrease the milk production, hence a high intake of fluids is recommended to the mother (Nice 2000). Pseudoephedrine produced a variable and non-significant decrease on prolactin levels along with a variable decrease (between 3% and 59%, on average 25%, and a median 15%) on milk production in 8 women whose infants were beyond neonatal period (Aljazaf 2003).Based on the latter single work (Aljazaf 2003), it has been speculated with the use of pseudoephedrine to treat hypergalactia, galactorrhea and to inhibit milk production (Eglash 2014, Trimeloni 2016). Nor-pseudoephedrine was found in the urine of infants whose mothers had consumed a stimulant plant called Catha edulis o cat (Kristiansson 1987). Although not recommended during lactation by some authors (Rubin 1986, Amir 2011), others think it is compatible (Findlay 1984, Ghaeli 1993, Ito 1993, Mitchell 1999, Nice 2000). The American Academy of Pediatrics considers it to be a medication usually compatible with breastfeeding (AAP 2001). It is suggested the use of a lowest effective dose as possible avoiding a long-term use. Monitor milk production, especially if associated with use of Triprolidine (see specific info) during the neonatal period.

Although the small amounts of pseudoephedrine in breastmilk are unlikely to harm the nursing infant, it may cause irritability occasionally. A single dose of pseudoephedrine decreases milk production acutely and repeated use seems to interfere with lactation. Mothers with newborns whose lactation is not yet well established or in mothers who are having difficulties producing sufficient milk should not receive pseudoephedrine. A treatment scheme has been reported for mothers with hypergalactia that uses pseudoephedrine to decrease milk supply.[1]

Mothers reported irritability was reported in 20% of infants exposed to pseudoephedrine in one study of breastfeeding mothers.[4] 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, pseudoephedrine was reported to cause adverse reactions in 4 infants, primarily agitation.[5]

After a single dose of pseudoephedrine 60 mg orally in 8 nursing mothers, there was a mean 24% decrease in milk production over the following 24 hours. No change in blood flow to the breast was detected that could explain the decreased milk production; there was a 13.5% decrease in serum prolactin after pseudoephedrine, but this change did not achieve statistical significance. Oxytocin levels were not measured.[3]