Last update July 1, 2015

Doxylamine

High Risk

Poorly safe. Evaluate carefully. Use safer alternative or interrupt breastfeeding 3 to 7 T ½ (elimination half-lives). Read the Comment.

It is a first generation antihistamine drug which is related to ethanolamine, with sedative and anti-muscarinic effects. It has been used as hypnotic and for vomiting relief.

At latest update, relevant published data on excretion into breast milk were not found.

Pharmacokinetic characteristics would favour that it may be excreted into breast milk in significant amount. On a telephone survey, 10% of infants whose mothers were on several types of antihistamine medication have suffered of colicky pain and irritability that disappeared without treatment.

For both treatment of mothers and infants would be safer the use of tested antihistamine medication without sedative effect, especially in prematures and infants younger than 1 month of age.

Whenever used while breastfeeding, the use of the lower effective dose and for the shortest time as possible is recommended.

Follow-up for somnolence and feeding troubles should be warranted.

Bed-sharing is not recommended when the mother is on this medication.

Alternatives

  • Cisapride (Moderately safe. Probably compatible. Mild risk possible. Follow up recommended. Read the Comment.)
  • Dimenhydrinate ( Safe. Compatible. Minimal risk for breastfeeding and infant.)
  • Diphenhydramine ( Safe. Compatible. Minimal risk for breastfeeding and infant.)
  • Domperidone ( Safe. Compatible. Minimal risk for breastfeeding and infant.)
  • Lorazepam ( Safe. Compatible. Minimal risk for breastfeeding and infant.)

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. The pharmaceutical industry contraindicates breastfeeding, mistakenly and without scientific reasons, in most of the drug data sheets.

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

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Other names

Doxylamine is also known as


Doxylamine in other languages or writings:

Group

Doxylamine belongs to this group or family:

Tradenames

Main tradenames from several countries containing Doxylamine in its composition:

List of 35 tradenames

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 100 %
Molecular weight 389 daltons
Protein Binding 24 %
VD 2.7 l/Kg
Tmax 2 - 3 hours
T½ 10 - 13 hours

References

  1. UNICEF UK. Caring for your baby at night. A guide for parents. 2018 Full text (link to original source) Full text (in our servers)
  2. UNICEF. Ball H, Blair PS. (For UNICEF UK). Caring for your baby at night. Health professional´s guide. 2017 Full text (link to original source) Full text (in our servers)
  3. UNICEF UK. Statement on co-sleeping following publication of new NICE postnatal guidance. Infosheet. 2014 Full text (link to original source) Full text (in our servers)
  4. UNICEF UK Baby Friendly Initiative statement on Bed-sharing when parents do not smoke: is there a risk of SIDS? An individual level analysis of five major case-control studies. None 2013 Full text (link to original source) Full text (in our servers)
  5. Rowe H, Baker T, Hale TW. Maternal medication, drug use, and breastfeeding. Pediatr Clin North Am. 2013 Feb;60(1):275-94. Abstract
  6. L.Landa Rivera, M.Díaz-Gómez, A.Gómez Papi, J.M.Paricio Talayero, C.Pallás Alonso, M.T.Hernández Aguilar, J.Aguayo Maldonado, J.M.Arena Ansotegui, S.Ares Segura, A.Jiménez Moya, J.J.Lasarte Velillas, J.Martín Calama, M.D.Romero Escós. El colecho favorece la práctica de la lactancia materna y no aumenta el riesgo de muerte súbita del lactante. Dormir con los padres. Rev Pediatr Aten Primaria. 14:53-60 2012 Full text (link to original source) Full text (in our servers)
  7. AEMPS. Doxilamina. Ficha técnica. 2010 Full text (in our servers)
  8. ABM - The Academy of Breastfeeding Medicine Protocol Committee. ABM Clinical Protocol #6: Guideline on Co-Sleeping and Breastfeeding. Breastfeeding Medicine 2008 Abstract Full text (link to original source) Full text (in our servers)
  9. NZ. Doxylamine. Drug Summary. 2008 Full text (in our servers)
  10. ABM - Comité de protocolos de la Academia médica de lactancia materna (Academy of Breastfeeding Medicine). Protocolo Clínico de la ABM #6: Lineamientos sobre la práctica de dormir al bebé junto con la madre y la lactancia materna Revisión, marzo de 2008. Breastfeeding Medicine 2008 Full text (link to original source) Full text (in our servers)
  11. UNICEF UK. Compartiendo la cama con tu bebé. Guía para madres que amamantan. Folleto 2006 Full text (in our servers)
  12. 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
  13. 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
  14. Luna BG, Scavone JM, Greenblatt DJ. Doxylamine and diphenhydramine pharmacokinetics in women on low-dose estrogen oral contraceptives. J Clin Pharmacol. 1989 Abstract
  15. Friedman H, Greenblatt DJ. The pharmacokinetics of doxylamine: use of automated gas chromatography with nitrogen-phosphorus detection. J Clin Pharmacol. 1985 Abstract

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