Excretion of paroxetine into breast milk

J Clin Psychiatry. 1999 Aug;60(8):519-23. doi: 10.4088/jcp.v60n0803.

Abstract

Background: The study was carried out to quantify the excretion of the selective serotonin reuptake inhibitor paroxetine in breast milk.

Method: In 6 lactating women, the concentrations of paroxetine in breast milk and serum were studied at the times for assumed minimum (24 hours after dose intake) and maximum (4-7 hours after dose intake) drug levels in milk. Moreover, a seventh subject was studied with frequent and regular sampling throughout a dose interval of 24 hours at 2 different dose levels.

Results: The mean milk/serum concentration ratios in the first 6 subjects ranged from 0.39 to 1.11 (overall mean +/- SD = 0.69 +/- 0.29), and the mean estimated dose to the infants ranged from 0.7% to 2.9% (overall mean +/- SD = 1.4% +/- 0.79%) of the weight-adjusted maternal dose. Based on area-under-the-curve data from the seventh subject, the milk/serum concentration ratio was 0.69 at a dose of 20 mg/day and 0.72 at a dose of 40 mg/day; the estimated relative doses to the infant were 1.0% and 2.0%, respectively. The mean increase in milk paroxetine concentrations from assumed minimum to assumed maximum was 61% (range, 4%-172%; p < .01). The mean paroxetine concentration in hindmilk was 78% higher than in foremilk (range, 16%-169%; p < .01), an increase that was parallel to the increase in milk triglyceride levels (r = 0.83, p = .005). No adverse drug reactions or unusual behaviors were reported in the infants.

Conclusion: The study indicates that the relative dose to a suckling infant for paroxetine is lower than that reported for fluoxetine and citalopram and higher than that reported for sertraline and fluvoxamine.

Publication types

  • Comparative Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Breast Feeding / adverse effects*
  • Citalopram / pharmacokinetics
  • Depressive Disorder / drug therapy*
  • Depressive Disorder / metabolism
  • Dose-Response Relationship, Drug
  • Female
  • Fluoxetine / pharmacokinetics
  • Fluvoxamine / pharmacokinetics
  • Humans
  • Lactation / blood
  • Lactation / drug effects
  • Lactation / metabolism
  • Milk, Human / chemistry*
  • Milk, Human / drug effects
  • Milk, Human / metabolism
  • Panic Disorder / drug therapy
  • Panic Disorder / metabolism
  • Paroxetine / analysis
  • Paroxetine / blood
  • Paroxetine / pharmacokinetics*
  • Serotonin Uptake Inhibitors / analysis
  • Serotonin Uptake Inhibitors / blood
  • Serotonin Uptake Inhibitors / pharmacokinetics*
  • Sertraline / pharmacokinetics
  • Triglycerides / analysis
  • Triglycerides / blood

Substances

  • Serotonin Uptake Inhibitors
  • Triglycerides
  • Fluoxetine
  • Citalopram
  • Paroxetine
  • Fluvoxamine
  • Sertraline