Last update May 6, 2022

Pseudoephedrine

Low Risk

Moderately safe. Probably compatible. Mild risk possible. Follow up recommended. Read the Comment.

Sympathomimetic, stereoisomer of ephedrine, used as a nasal decongestant. Oral administration up to 4 times a day. Marketed on multiple pharmaceutical 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 (Aljazaf 2003, Nice 2000, Kanfer 1993, Findlay 1984) without major problems having been reported in infants whose mothers had received this medication. (Soussan 2014, Aljazaf 2003, Ito 1993)

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. (Johnson 2020, Trimeloni 2016, Eglash 2014)

Nor-pseudoephedrine was found in the urine of infants whose mothers had consumed a stimulant plant called Catha edulis, qat o cat. (Kristiansson 1987)

Although not recommended during lactation by some authors (Amir 2011, Rubin 1986), others think it is compatible. (Nice 2000, Mitchell 1999, Ghaeli 1993, Ito 1993, Findlay 1984)

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.

Some authors consider oral and nasal decongestant drugs dispensable drugs, to be avoided in general, not only during lactation, since they expose patients to serious risks (cardiovascular, neurological and intestinal) to treat a benign alteration such as nasal obstruction , which usually evolves favorably in a few days without medication. (Prescribed 2018)


See below the information of this related product:

Alternatives

  • Azelastine (Moderately safe. Probably compatible. Mild risk possible. Follow up recommended. Read the Comment.)
  • Cetirizine Hydrochloride ( Safe. Compatible. Minimal risk for breastfeeding and infant.)
  • Loratadine ( Safe. Compatible. Minimal risk for breastfeeding and infant.)
  • Phenylephrine (Moderately safe. Probably compatible. Mild risk possible. Follow up recommended. Read the Comment.)

Suggestions made at e-lactancia are done by APILAM team of health professionals, and are based on updated scientific publications. It is not intended to replace the relationship you have with your doctor but to compound it.

Jose Maria Paricio, Founder & President of APILAM/e-Lactancia

Your contribution is essential for this service to continue to exist. We need the generosity of people like you who believe in the benefits of breastfeeding.

Thank you for helping to protect and promote breastfeeding.

José María Paricio, founder of e-lactancia.

Other names

Pseudoephedrine is also known as


Pseudoephedrine in other languages or writings:

Group

Pseudoephedrine belongs to this group or family:

Tradenames

Main tradenames from several countries containing Pseudoephedrine in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 90 %
Molecular weight 165 daltons
VD 2.6 - 5 l/Kg
pKa 13.89 -
Tmax 1 - 3 hours
5 - 8 hours
M/P ratio 2.6 - 3.9 -
Theoretical Dose 0.15 mg/Kg/d
Relative Dose 4.3 (3.3 - 5.4) %
Ped.Relat.Dose 4.3 (2.2 - 6.7) %

References

  1. Johnson HM, Eglash A, Mitchell KB, Leeper K, Smillie CM, Moore-Ostby L, Manson N, Simon L; Academy of Breastfeeding Medicine.. ABM Clinical Protocol #32: Management of Hyperlactation. Breastfeed Med. 2020 Mar;15(3):129-134. Abstract Full text (link to original source)
  2. Redaction Prescrire. Pour mieux soigner, des médicaments à écarter : bilan 2018. Prescrire.org. 2018 Full text (link to original source) Full text (in our servers)
  3. Trimeloni L, Spencer J. Diagnosis and Management of Breast Milk Oversupply. J Am Board Fam Med. 2016 Abstract Full text (link to original source) Full text (in our servers)
  4. Soussan C, Gouraud A, Portolan G, Jean-Pastor MJ, Pecriaux C, Montastruc JL, Damase-Michel C, Lacroix I. Drug-induced adverse reactions via breastfeeding: a descriptive study in the French Pharmacovigilance Database. Eur J Clin Pharmacol. 2014 Abstract
  5. Eglash A. Treatment of maternal hypergalactia. Breastfeed Med. 2014 Abstract Full text (link to original source) Full text (in our servers)
  6. Amir LH, Pirotta MV, Raval M. Breastfeeding--evidence based guidelines for the use of medicines. Aust Fam Physician. 2011 Sep;40(9):684-90. Review. Abstract Full text (link to original source) Full text (in our servers)
  7. Aljazaf K, Hale TW, Ilett KF, Hartmann PE, Mitoulas LR, Kristensen JH, Hackett LP. Pseudoephedrine: effects on milk production in women and estimation of infant exposure via breastmilk. Br J Clin Pharmacol. 2003 Abstract Full text (link to original source) Full text (in our servers)
  8. AAP - American Academy of Pediatrics Committee on Drugs. Transfer of drugs and other chemicals into human milk. Pediatrics. 2001 Sep;108(3):776-89. Abstract Full text (link to original source) Full text (in our servers)
  9. Nice FJ, Snyder JL, Kotansky BC. Breastfeeding and over-the-counter medications. J Hum Lact. 2000 Nov;16(4):319-31. Review. Erratum in: J Hum Lact 2001 Feb;17(1):90. Abstract
  10. Mitchell JL. Use of cough and cold preparations during breastfeeding. J Hum Lact. 1999 Abstract
  11. Kanfer I, Dowse R, Vuma V. Pharmacokinetics of oral decongestants. Pharmacotherapy. 1993 Abstract
  12. Ito S, Blajchman A, Stephenson M, Eliopoulos C, Koren G. Prospective follow-up of adverse reactions in breast-fed infants exposed to maternal medication. Am J Obstet Gynecol. 1993 May;168(5):1393-9. Abstract
  13. Ghaeli P, Kaufman MB. Oral antihistamines/decongestants and breastfeeding. J Hum Lact. 1993 Abstract
  14. Kristiansson B, Abdul Ghani N, Eriksson M, Garle M, Qirbi A. Use of khat in lactating women: a pilot study on breast-milk secretion. J Ethnopharmacol. 1987 Abstract
  15. Findlay JW, Butz RF, Sailstad JM, Warren JT, Welch RM. Pseudoephedrine and triprolidine in plasma and breast milk of nursing mothers. Br J Clin Pharmacol. 1984 Abstract Full text (link to original source) Full text (in our servers)

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