Reboxetine is not approved for marketing in the United States by the US Food and Drug Administration, but is available in other countries. Limited information indicates that maternal doses of up to 10 mg daily produce low levels in milk and appear to not result in any adverse effects in breastfed infants. Until more data are available, reboxetine should be used with careful monitoring during breastfeeding.
Four women with postpartum depression had been taking reboxetine in an average dose of 6.5 mg daily (range 4 to 10 mg daily) equivalent to 79 mcg/kg daily (range 44 to 172 mcg/kg daily) for an average of 2.5 months (range 1.3 to 4.1 months). The mothers collected fore- and hindmilk samples before the first daily dose and with each infant feeding throughout 24 hours (7 to 8 times). Average peak milk reboxetine levels of 16 mcg/L (range 10 to 21 mcg/L) occurred at an average of 4.3 hours (range 1 to 8.8 hours) after the dose. The mean of the average plasma concentrations was 11.3 mcg/L (range 6.7 to 16.3 mcg/L). The infant dosage averaged 1.7 mcg/kg daily (range 1 to 2.4 mcg/kg daily) which was 2% (range 1.4 to 2.5%) of the maternal weight-adjusted dosage.
Four infants whose mothers had postpartum depression had been breastfed (extent not stated) for 1.3 to 2.1 months during maternal reboxetine therapy at an average dose of 6.5 mg (79 mcg/kg) daily. The infant dosage was calculated to be 1.7 mcg/kg daily (range 1 to 2.4 mcg/kg daily). Individual infant plasma levels obtained (times not stated) were 2.3, 2.6, 5 and undetectable (<4) mcg/L. The mean of the average maternal plasma concentrations was 192 mcg/L.
Effects in Breastfed Infants:
Four infants whose mothers had postpartum depression had been breastfed (extent not stated) for 1.3 to 2.1 months during maternal reboxetine therapy at an average dose of 6.5 mg (79 mcg/kg) daily. One of the mothers was also taking escitalopram 20 mg daily and another was takingsertraline300 mg daily. None of the infants exhibited any adverse reactions. Three of the infants had normal Denver developmental scores; the fourth whose mother was taking reboxetine had a developmental age of only 71% of normal, but the problem predated maternal reboxetine therapy.
Possible Effects on Lactation:
Reboxetine increased serum prolactin in male subjects. The relevance of this finding to nursing mothers is not clear. The prolactin level in a mother with established lactation may not affect her ability to breastfeed.
1. Hackett LP, Ilett KF, Rampono J et al. Transfer of reboxetine into breastmilk, its plasma concentrations and lack of adverse effects in the breastfed infant. Eur J Clin Pharmacol. 2006;62:633-8. PMID:16699799 2. Coker F, Taylor D. Antidepressant-induced hyperprolactinaemia: incidence, mechanisms and management. CNS Drugs. 2010;24:563-74. PMID:20527996
CAS Registry Number:
Adrenergic Uptake Inhibitors
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