Last update: Jan. 29, 2017

Promethazine

Low Risk for breastfeeding


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

1st-generation-antihistamine and phenothiazine-type drug with a strong sedative effect.

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

It may decrease prolactin levels and interfere with milk production during the first few weeks after birth (Pontiroli 1981, Messinis 1985).
Pharmacokinetic data (high volume of distribution and high plasma protein-binding capacity) would render it unlikely a significant passage into the breastmilk.
In addition, a low oral bioavailability would hinder a further passage to infant’s plasma through the ingested breastmilk, except on premature infants and immediate neonatal period when there may be an increased intestinal permeability.
There are doubts about any association with Sudden Infant Death Syndrome (SIDS) (Kahn 1982, Stanton 1983).

It may be considered compatible with breastfeeding on isolated doses such as those used for pre-surgical medication or traveler's dizziness (WHO 2002). Avoid a repeated use as it may cause drowsiness in the infant.
Avoid using it in the immediate neonatal period (first 4 to 6 weeks after birth) and in case of prematurity.

If used, follow-up the infant for drowsiness and feeding issues.

It is not recommended bed-sharing when taking this medication (UNICEF 2006, ABM 2008, Landa 2012, UNICEF 2013).

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

Promethazine is also known as


Promethazine in other languages or writings:

Tradenames

Main tradenames from several countries containing Promethazine in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 13 - 40 %
Molecular weight 284 daltons
Protein Binding 76 - 93 %
VD 15 l/Kg
Tmax 1,5 - 3 hours
T1/2 5 - 15 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. Reece-Stremtan Sarah, Campos Matilde, Kokajko Lauren, and The Academy of Breastfeeding Medicine. Breastfeeding Medicine. ABM Clinical Protocol #15: Analgesia and Anesthesia for the Breastfeeding Mother, Revised 2017. Breastfeeding Medicine. 2017 Full text (link to original source) Full text (in our servers)
  3. 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)
  4. Bordini CA, Roesler C, Carvalho Dde S, Macedo DD, Piovesan É, Melhado EM, Dach F, Kowacs F, Silva Júnior HM, Souza JA, Maciel JA Jr, Carvalho JJ, Speciali JG, Barea LM, Queiroz LP, Ciciarelli MC, Valença MM, Lima MM, Vincent MB. Recommendations for the treatment of migraine attacks - a Brazilian consensus. Arq Neuropsiquiatr. 2016 Abstract Full text (link to original source) Full text (in our servers)
  5. 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)
  6. 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. 2013 Full text (link to original source) Full text (in our servers)
  7. 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)
  8. AEMPS. Prometazina. Ficha técnica. 2012 Full text (in our servers)
  9. 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)
  10. 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)
  11. UNICEF UK. Compartiendo la cama con tu bebé. Guía para madres que amamantan. Folleto 2006 Full text (in our servers)
  12. Mahadevan U, Kane S. American gastroenterological association institute technical review on the use of gastrointestinal medications in pregnancy. Gastroenterology. 2006 Jul;131(1):283-311. Review. Abstract Full text (link to original source) Full text (in our servers)
  13. Solhaug V, Roland PD. Bruk av antihistaminer under graviditet og amming \ [Use of antihistaminics during pregnancy and breast feeding]. Tidsskr Nor Laegeforen. 2004 Abstract Full text (link to original source) Full text (in our servers)
  14. WHO / UNICEF. BREASTFEEDING AND MATERNAL MEDICATION Recommendations for Drugs in the Eleventh WHO Model List of Essential Drugs. Department of Child and Adolescent Health and Development (WHO/UNICEF) 2002 Full text (link to original source) Full text (in our servers)
  15. Messinis IE, Souvatzoglou A, Fais N, Lolis D. Histamine H1 receptor participation in the control of prolactin secretion in postpartum. J Endocrinol Invest. 1985 Apr;8(2):143-6. Abstract
  16. Paton DM, Webster DR. Clinical pharmacokinetics of H1-receptor antagonists (the antihistamines). Clin Pharmacokinet. 1985 Nov-Dec;10(6):477-97. Review. Abstract
  17. Stanton AN. Sudden infant death syndrome and phenothiazines. Pediatrics. 1983 Abstract
  18. Kahn A, Blum D. Phenothiazines and sudden infant death syndrome. Pediatrics. 1982 Abstract
  19. Pontiroli AE, De Castro e Silva E, Mazzoleni F, Alberetto M, Baio G, Pellicciotta G, De Pasqua A, Stella L, Girardi AM, Pozza G. The effect of histamine and H1 and H2 receptors on prolactin and luteinizing hormone release in humans: sex differences and the role of stress. J Clin Endocrinol Metab. 1981 Abstract
  20. KRIS EB. Children born to mothers maintained on pharmacotherapy during pregnancy and postpartum. Recent Adv Biol Psychiatry. 1961 Abstract

Total visits

10,657

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 La Liga de la Leche de México from Mexico

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