Although the small amounts of pseudoephedrine in breastmilk are unlikely to harm the nursing infant, it may cause occasional irritability. 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 mothers who are having difficulties producing sufficient milk should not receive pseudoephedrine.
A single oral dose of 60 mg of pseudoephedrine in 3 women resulted in peak milk levels of less than 1 mg/L 1 hour after the dose. Other authors used data from this study to calculate the amount excreted in milk to be 5.5% of the weight-adjusted maternal dosage. After a 60 mg oral dose of immediate-release pseudoephedrine, peak milk levels averaging 698 mcg/L occurred 1.7 hours after the dose, and half-life in milk was 5.5 hours. A fully breastfed infant would receive a dose of 4.3% (range 2.2 to 6.7%) of the maternal weight-adjusted dose.
Relevant published information was not found as of the revision date.
Effects in Breastfed Infants:
Irritability was reported in 20% of infants exposed to pseudoephedrine in one study of breastfeeding mothers.
Possible Effects on Lactation:
After a single dose of pseudoephedrine 60 mg orally in 8 nursing mothers, there was a mean 24% decrease in milk production. 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.
1. Findlay JW, Butz RF et al. Pseudoephedrine and triprolidine in plasma and breast milk of nursing mothers. Br J Clin Pharmacol. 1984;18:901-6. PMID:6529531 2. Aljazaf K, Hale TW et al. Pseudoephedrine: effects on milk production in women and estimation of infant exposure via breastmilk. Br J Clin Pharmacol. 2003;56:18-24. PMID:12848771 3. Ito S, Blajchman A et al. Prospective follow-up of adverse reactions in breast-fed infants exposed to maternal medication. Am J Obstet Gynecol. 1993;168:1393-9. PMID:8498418
CAS Registry Number:
Central Nervous System Stimulants
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