Summary of Use during Lactation

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]

Drug Levels

Maternal Levels. 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.[2] Other authors used data from this study to calculate the amount excreted in milk to be 5.5% of the weight-adjusted maternal dosage.[3]

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 breast-fed infant would receive a dose of 4.3% (range 2.2 to 6.7%) of the maternal weight-adjusted dose.[3]

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

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]

Effects on Lactation and Breastmilk

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]

Alternate Drugs to Consider

Oxymetazoline

References

1.

Johnson HM, Eglash A, Mitchell KB, et al. ABM Clinical Protocol #32: Management of hyperlactation. Breastfeed Med. 2020;15:129–34. [PubMed: 32031417]

2.

Findlay JW, Butz RF, Sailstad JM, et al. Pseudoephedrine and triprolidine in plasma and breast milk of nursing mothers. Br J Clin Pharmacol. 1984;18:901–6. [PMC free article: PMC1463694] [PubMed: 6529531]

3.

Aljazaf K, Hale TW, Ilett KF, et al. Pseudoephedrine: effects on milk production in women and estimation of infant exposure via breastmilk. Br J Clin Pharmacol. 2003;56:18–24. [PMC free article: PMC1884328] [PubMed: 12848771]

4.

Ito S, Blajchman A, Stephenson M, et al. Prospective follow-up of adverse reactions in breast-fed infants exposed to maternal medication. Am J Obstet Gynecol. 1993;168:1393–9. [PubMed: 8498418]

5.

Soussan C, Gouraud A, Portolan G, et al. Drug-induced adverse reactions via breastfeeding: A descriptive study in the French Pharmacovigilance Database. Eur J Clin Pharmacol. 2014;70:1361–6. [PubMed: 25183382]

Substance Name

Pseudoephedrine

CAS Registry Number

90-82-4

Drug Class

Breast Feeding

Lactation

Adrenergic Agents

Adrenergic Alpha-Agonists

Central Nervous System Stimulants

Sympathomimetics

Vasoconstrictor Agents