Kommersiellt obunden läkemedelsinformation riktad till läkare och sjukvårdspersonal

Drugline nr 23098

Publicerat 2006-11-08

Question

Is reboxetine compatible with breast-feeding?

Answer

Reboxetine is a selective noradrenergic uptake inhibitor with a half-life of 13 hours and a bioavailability of at least 60% (1). It has a pKa of 8.34, a high plasma protein binding (97%) and a low lipophilicity (2).

There is only one published study, where transfer of reboxetine to breast milk has been investigated. Four mother-infant pairs were studied. The mothers had been treated with reboxetine a mean of 2.5 months, and the median single daily dose of reboxetine was 6 mg (range 4-10 mg). The mothers´ average maximum plasma concentration was 245 ug/l (range 181-330 ug/l), which is similar to previous reports and consistent with the dose. The mean milk/plasma ratio was only 0.06, and the total relative infant dose was in average 2% (range 1.4-2.5%) of the maternal weight-adjusted dose. Blood samples were taken from the four breastfed infants. In one of the infants reboxetine was undetectable, and in the other three the concentrations were 2.6 ug/l, 2.3 ug/l and 5 ug/l, respectively. None of the infants had any drug-related adverse effects (2).

Conclusion

Reboxetine is excreted into breast milk. Based on four cases, the total relative infant dose has been calculated to be 1.4-2-5% of the maternal weight-adjusted dose. No adverse effects have been observed. Based on these four cases, reboxetine seems to be compatible with breast-feeding. However, the infant should be observed for undesirable effects.

Jansson Å
Böttiger Y

References

  1. Edronax. Summary of Product Characteristics (SPC). Pfizer
  2. Hackett LP, Ilett KF, Rampono J, Kristensen JH, Kohan R. Transfer of reboxetine into breastmilk, its plasma concentrations and lack of adverse effects in the breastfed infant. Eur J Clin Pharmacol 2006;62(8):633-638

Senast ändrad 2018-09-20