Last update: June 12, 2019

Pseudoephedrine Hydrochloride

Low Risk for breastfeeding


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

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.


See below the information of this related product:

Alternatives

Suggestions made at e-lactancia are done by APILAM´s pediatricians and pharmacists, 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 Hydrochloride is also known as Pseudoephedrine. Here it is a list of alternative known names::


Pseudoephedrine Hydrochloride in other languages or writings:

Group

Pseudoephedrine Hydrochloride belongs to this group or family:

Tradenames

Main tradenames from several countries containing Pseudoephedrine Hydrochloride in its composition:

Pharmacokinetics

Variable Value Unit
Bioavailability 90 %
Molecular weight 165 daltons
VD 2,6 - 5 l/Kg
Tmax 1 - 3 hours
T1/2 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) %
Relat.Ped.Dose 4,3 (2,2 - 6,7) %

References

  1. 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)
  2. 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)
  3. 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
  4. Eglash A. Treatment of maternal hypergalactia. Breastfeed Med. 2014 Abstract Full text (link to original source) Full text (in our servers)
  5. Amir LH, Pirotta MV, Raval M. Breastfeeding--evidence based guidelines for the use of medicines. Aust Fam Physician. 2011 Abstract Full text (link to original source) Full text (in our servers)
  6. 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)
  7. 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)
  8. 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
  9. Mitchell JL. Use of cough and cold preparations during breastfeeding. J Hum Lact. 1999 Abstract
  10. 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
  11. Ghaeli P, Kaufman MB. Oral antihistamines/decongestants and breastfeeding. J Hum Lact. 1993 Abstract
  12. Kanfer I, Dowse R, Vuma V. Pharmacokinetics of oral decongestants. Pharmacotherapy. 1993 Abstract
  13. 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
  14. 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)

Total visits

7,171

Help us improve this entry

How to cite this entry

Do you need more information or did not found what you were looking for?

   Write to us at elactancia.org@gmail.com

e-lactancia is a resource recommended by Instituto de Salud Infantil, Grecia-Institute of Child's Health in Greece

Would you like to recommend the use of e-lactancia? Write to us at corporate mail of APILAM