Last update May 8, 2022

D04AA32; R06AA02

Very Low Risk

Safe. Compatible. Minimal risk for breastfeeding and infant.

It is a first generation antihistamine drug (Ethanolamine) with a strong sedative effect.  Used in allergic conditions and in motion sickness. Oral administration 3 to 4 times a day

Its large volume of distribution possibly explains the negligible passage into breast milk observed. (Rindi 1951)

No problems have been observed in infants whose mothers took it for a long time (Kaya 2014), except for an isolated case of sedation. (Ito 1993)

The absorption from ingested mother's milk to the infant's plasma is hampered by a low oral bioavailability.

Neither a decrease of milk production nor alteration of Prolactin release have been shown with the use of this drug. (Butler 2014)

For both, the mother and the infant is safer the use of antihistamine medication with higher safety levels without sedative effect (Butler 2014), especially when the child is a premature or younger than 1 month old.

Expert authors consider the use of this medication possibly safe during lactation. (Hale, LactMed, Briggs 2015, Schaefer 2015, Rowe 2013, Nice 2000)

When used while breastfeeding do it with the lower dose as possible and avoid a long-term use.

Check up for feeding difficulty and somnolence in the infant. Bed-sharing with the infant is not recommended for parents who are on this medication. (UNICEF 2018, 2017, 2014, 2013 y 2006, Landa 2012, ABM 2008)


See below the information of this related product:

  • Dimenhydrinate ( Safe. Compatible. Minimal risk for breastfeeding and infant.)

Alternatives

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

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

D04AA32; R06AA02 is Diphenhydramine in ATC Code/s.

Is written in other languages:

D04AA32; R06AA02 is also known as

Group

D04AA32; R06AA02 belongs to this group or family:

Tradenames

Main tradenames from several countries containing D04AA32; R06AA02 in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 40 - 60 %
Molecular weight 255 daltons
Protein Binding 78 - 85 %
VD 3.3 - 6.8 l/Kg
pKa 8.8 -
Tmax 2 - 3 hours
2.4 - 9.3 hours
Theoretical Dose < 0.015 mg/Kg/d
Relative Dose 0.45 - 1.2 %
Ped.Relat.Dose 0.3 %

References

  1. Hale TW. Medications & Mothers' Milk. 1991- . Springer Publishing Company. Available from https://www.halesmeds.com Consulted on March 17, 2022 Full text (link to original source)
  2. LactMed. Drugs and Lactation Database (LactMed). Internet. Bethesda (MD): National Library of Medicine (US); 2006-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK501922/ 2006 - Consulted on March 15, 2022 Full text (link to original source)
  3. UNICEF UK. Caring for your baby at night. A guide for parents. 2018 Full text (link to original source) Full text (in our servers)
  4. 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)
  5. Schaefer C, Peters P, Miller RK. Drugs During Pregnancy and Lactation. Treatment options and risk assessment. Elsevier, Third Edition. 2015
  6. Briggs GG, Freeman RK, Towers CV, Forinash AB. Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk. Wolters Kluwer Health. Tenth edition (acces on line) 2015
  7. 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)
  8. Kaya FD. A patient with dimenhydrinate dependence: A case report. Klin Psikofarmakol Bull. 2014;24:184–7 Abstract Full text (link to original source)
  9. Butler DC, Heller MM, Murase JE. Safety of dermatologic medications in pregnancy and lactation: Part II. Lactation. J Am Acad Dermatol. 2014 Mar;70(3):417.e1-10; quiz 427. Abstract
  10. 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)
  11. Rowe H, Baker T, Hale TW. Maternal medication, drug use, and breastfeeding. Pediatr Clin North Am. 2013 Feb;60(1):275-94. Abstract
  12. 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)
  13. 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)
  14. 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)
  15. UNICEF UK. Compartiendo la cama con tu bebé. Guía para madres que amamantan. Folleto 2006 Full text (in our servers)
  16. del Cuvillo A, Mullol J, Bartra J, Dávila I, Jáuregui I, Montoro J, Sastre J, Valero AL. Comparative pharmacology of the H1 antihistamines. J Investig Allergol Clin Immunol. 2006;16 Suppl 1:3-12. Review. No abstract available. Abstract Full text (link to original source) Full text (in our servers)
  17. 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
  18. AEMPS. Difenhidramina. Ficha técnica. 2000 Full text (in our servers)
  19. 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
  20. Paton DM, Webster DR. Clinical pharmacokinetics of H1-receptor antagonists (the antihistamines). Clin Pharmacokinet. 1985 Nov-Dec;10(6):477-97. Review. Abstract
  21. Rindi V. La eliminazione degli antistaminici di sintesi con il latte e l'azione latto-goga de questi. Riv Ital Ginecol. 1951;34:147-57. (cit. Hale)

Total visits

67

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 us at elactancia.org@gmail.com

e-lactancia is a resource recommended by AELAMA of Spain

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