Last update June 18, 2022

C21 H27 ClN2 O2

Likely Compatibility

Fairly safe. Mild or unlikely adverse effects. Compatible under certain circumstances. Follow-up recommended. Read Commentary.

First-generation antihistamine, piperazine derived drug with mild sedative effect. It is used to treat anxiety, vomiting, itching and urticaria. Authorized use in young infants. Oral or intramuscular administration up to 4 times a day. It is metabolized into Cetirizine, which is compatible with breastfeeding.

At last update no relevant information concerning breastfeeding were found.

Its pharmacokinetic characteristics, high plasma protein binding and very large volume of distribution (del Cuvillo 2006),  make it very unlikely its excretion into breast milk in significant amounts.

Since it has been shown to be well tolerated by young infants for itching relief and because it is metabolized into Cetirizine, we would assume that there is a low risk for breastfeeding in short-term treatments.

Some suspected cases of non-severe sedation have been described in infants of mothers taking hydroxyzine. (Soussan 2014, Ito 1993)

Its dopaminergic effect is anti-prolactin (dopamine inhibits prolactin secretion) and may decrease milk production during the first weeks after delivery. When breastfeeding is well established, prolactin levels are not correlated with milk production (Messinis 1985).

Drowsiness and adequate feeding of the infant should be monitored (Solhaug 2004). Co-sleeping with the baby is not recommended if this drug is being taken (UNICEF 2013, Landa 2012, ABM 2008, UNICEF 2006).


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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.

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Other names

C21 H27 ClN2 O2 is Hydroxyzine in Molecular formula.

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C21 H27 ClN2 O2 is also known as

Groups

C21 H27 ClN2 O2 belongs to these groups or families:

Tradenames

Main tradenames from several countries containing C21 H27 ClN2 O2 in its composition:

List of 55 tradenames

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 80 %
Molecular weight 375 daltons
Protein Binding 93 %
VD 16 ± 3; (13 - 19) l/Kg
pKa 15.1 -
Tmax 2 hours
T½ 7 - 20 hours

References

  1. (ABM): Blair PS, Ball HL, McKenna JJ, Feldman-Winter L, Marinelli KA, Bartick MC; Academy of Breastfeeding Medicine.. Bedsharing and Breastfeeding: The Academy of Breastfeeding Medicine Protocol #6, Revision 2019. Breastfeed Med. 2020 Jan;15(1):5-16. Abstract Full text (link to original source) Full text (in our servers)
  2. UNICEF UK. Caring for your baby at night. A guide for parents. 2018 Full text (link to original source) Full text (in our servers)
  3. AEMPS. Hidroxizina. Ficha técnica. 2017 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. 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
  6. 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)
  7. 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)
  8. Glaxo-S-K. Hydroxyzine. Drug Summary. 2013 Full text (in our servers)
  9. 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)
  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. 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)
  12. UNICEF UK. Compartiendo la cama con tu bebé. Guía para madres que amamantan. Folleto 2006 Full text (in our servers)
  13. 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)
  14. 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)
  15. 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
  16. Paton DM, Webster DR. Clinical pharmacokinetics of H1-receptor antagonists (the antihistamines). Clin Pharmacokinet. 1985 Nov-Dec;10(6):477-97. Review. Abstract

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