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Drugline nr 22661

Publicerat 2004-12-14

Question

Is hydroxyzine and fexofenadine treatment compatible with breast- feeding? A 28-year-old woman delivered twins two days ago. Now she presents with severe exanthema and pruritus. The dermatologist suggests treatment with hydroxyzine and fexofenadine. The attending physician is concerned with possible adverse effects in the suckling infants.

Answer

Hydroxyzine is a first-generation, histamine H1-receptor antagonist with relatively mild sedative and antimuscarinic properties that has been used as an anxiolytic drug and for treatment of pruritus and urticaria (1). Its metabolism gives rise to an active antihistamine metabolite cetrizine (2). We could not find any clinical trials published so far on the excretion of either hydroxyzine or its active metabolite cetrizine in human milk. Fexofenadine is an active metabolite of terfenadine, another first-generation histamine H1-receptor antagonist (3). The only reference source pertaining to the issue of fexofenadine and lactation was the clinical study of its pro-drug terfenadine, which was administered to breast-feeding mothers in a dose of 60 mg every 12 h, for a period of 48 h. Although terfenadine could not be detected either in plasma or milk, its active metabolite fexofenadine could. The suckling infant would be exposed to an estimated 0.45 per cent of the maternal weight-adjusted dose (4). In reference to the case in question, if the mother is treated with a daily dose of 180 mg of fexofenadine, the infant will receive just 13.5 microgram per kg per day, which in a 5-kg-weighing child amounts only 67.5 microgram per day. There are only two retrospective clinical trials that describe the incidence of adverse reactions in suckling infants of mothers treated during the breast-feeding period with antihistamines (5). It amounted 9.4 and 22.6 per cent, respectively, with irritability being the most common one. These clinical trials are, however, of less reliability, since they were based on subjective mother's evaluation of their infant's behaviour (5).

Conclusion

There are no sufficient clinical data that could advocate use of hydroxyzine during lactation. Based on extrapolated data from terfenadine, this drug's active metabolite fexofenadine is acceptable. If the mother is treated with a 180 mg daily dose, the infant will receive just 13.5 microgram per kg per day, which in a 5-kg-weighing child amounts only 67.5 microgram per day. Such an exposure of a suckling infant is practically negligible.

Stojiljkovic M
Damkier P

References

  1. Hydroxyzine. In: MARTINDALE - The Complete Drug Reference Thomson MICROMEDEX, Greenwood Village, Colorado (Edition expires 04/12).
  2. Simons FE, Simons KJ. Pharmacokinetic optimisation of histamine H1-receptor antagonist therapy. Clin Pharmacokinet 1991 Nov;21(5):372-93.
  3. Fexofenadine. Drug evaluation monographs. Thomson MICROMEDEX, Greenwood Village, Colorado (Edition expires 04/12).
  4. Lucas BD, Purdy CY, Scarim SK, Benjamin S, Abel SR, Hilleman DE. Terfenadine pharmacokinetics in breast milk in lactating women. Clin Pharmacol Ther 1995 Apr;57(4):398-402.
  5. Hydroxyzine. REPROTOX(R) in Reprorisk System. Thomson MICROMEDEX, Greenwood Village, Colorado (Edition expires 04/12).

Senast ändrad 2018-09-20