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:
- Triprolidine Hydrochloride (Very Low Risk)
Very Low Risk
Compatible. Not risky for breastfeeding or infant.
Moderately safe. Mild risk possible. Follow up recommended. Read the Comment.
Poorly safe. Evaluate carefully. Use a safer alternative. Read the Comment.
Very High Risk
Not recommended. Cessation of breastfeeding or alternative.
- Pseudoephedrine Hydrochloride
- Pseudoephedrine Sulfate
- ψευδοεφεδρίνη (Greek)
- بسودوإيفيدرين (Arabic)
- Псевдоэфедрин (Cyrillic)
- 伪麻黄碱 (Chinese)
- プソイドエフェドリン (Japanese)
- C10H15NO (Molecular formula)
- R01BA02 (ATC Code/s)
Drug trade names
- Actifed Composto™
- Actifed™ (France)
- Afrin tablets™
- Benylin Dual Action Dry™
- Chemists Own Sinus Relief™
- Cinfatos Descongestivo™
- Congest Aid™
- Contac Cold Nondrowsy™
- Contac Non Drowsy™
- DayQuil D™
- Decongestant Tablets™
- Demazin Decongestant™
- Demazin Sinus™
- Dimetapp Decongestant™
- Dimetapp Sinus™
- Drinasal S™
- Dristan Allergy™
- Dristan triple acción™
- Drixoral ND™
- Drixoral Non-Drowsy Formula™
- Drixoral™ (Indonesia, United States of America)
- Flutex Decon-S™
- Frenadol PS™
- Iniston Antitusivo y Descongestivo™
- Livzon Ganle (丽珠感乐)™
- Medi-First Sinus Decongestant™
- Meltus Decongestant™
- Multi-Action Actifed Dry Coughs™
- Nastizol™ (Chile)
- NyQuil Hot Therapy™
- NyQuil Nighttime Cold/Flu™
- Reactine Duo™
- Reactine Plus™
- Reactine™ (Italy)
- Refrianex Compuesto™
- Rinomar™ (Belgium)
- Sedofan II™
- Simply Stuffy™
- Sinustop Pro™
- Sinutab II™ (Portugal)
- Sinutab NT™ (Canada)
- Sinutab™ (Argentina, Belgium, Ireland)
- Sudafed Decongestant™ (Canada)
- Triaminic Allergy Congestion™
- ПСЕВДОЕФЕДРИНУ ГІДРОХЛОРИД
- Trimeloni L, Spencer J. Diagnosis and Management of Breast Milk Oversupply. J Am Board Fam Med. 2016Abstract Full text (link to original source) Full text (in our servers)
- 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. 2014Abstract
- Eglash A. Treatment of maternal hypergalactia. Breastfeed Med. 2014Abstract Full text (link to original source) Full text (in our servers)
- Amir LH, Pirotta MV, Raval M. Breastfeeding--evidence based guidelines for the use of medicines. Aust Fam Physician. 2011Abstract Full text (link to original source) Full text (in our servers)
- 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. 2003Abstract Full text (link to original source) Full text (in our servers)
- AAP - American Academy of Pediatrics Committee on Drugs. Transfer of drugs and other chemicals into human milk. Pediatrics. 2001Abstract Full text (link to original source) Full text (in our servers)
- Nice FJ, Snyder JL, Kotansky BC. Breastfeeding and over-the-counter medications. J Hum Lact. 2000Abstract
- Mitchell JL. Use of cough and cold preparations during breastfeeding. J Hum Lact. 1999Abstract
- Ghaeli P, Kaufman MB. Oral antihistamines/decongestants and breastfeeding. J Hum Lact. 1993Abstract
- Kanfer I, Dowse R, Vuma V. Pharmacokinetics of oral decongestants. Pharmacotherapy. 1993Abstract
- 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. 1993Abstract
- 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. 1987Abstract
- 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. 1984Abstract Full text (link to original source) Full text (in our servers)