Prednisone Pharmacokinetics During Pregnancy and Lactation

Rachel J. Ryu, Thomas R. Easterling, Steve N. Caritis, Raman Venkataramanan, Jason G. Umans, Mahmoud S. Ahmed, Shannon Clark, Ira Kantrowitz-Gordon, Karen Hays, Brooke Bennett, Matthew T. Honaker, Kenneth E. Thummel, Danny D. Shen, Mary F. Hebert

Research output: Contribution to journalArticle

4 Scopus citations


To evaluate the steady-state pharmacokinetics of prednisone and its metabolite prednisolone in pregnant and lactating female subjects, 19 subjects received prednisone (4-40 mg/day orally) in early (n = 3), mid (n = 9), and late (n = 13) pregnancy as well as postpartum with (n = 2) and without (n = 5) lactation. Serial blood and urine samples were collected over 1 dosing interval. Prednisone and its metabolite, prednisolone, steady-state noncompartmental pharmacokinetic parameters were estimated. During pregnancy, prednisone apparent oral clearance increased with dose (35.1 ± 11.4 L/h with 5 mg, 52.6 ± 5.2 L/h with 10 mg, and 64.3 ± 6.9 L/h with 20 mg, P =.001). Similarly, unbound prednisone apparent oral clearance increased with dose. In addition, prednisolone renal clearance increased with dose (0.3 ± 0.3 L/h with 5 mg, 0.5 ± 0.4 L/h with 10 mg, and 1.3 ± 1.1 L/h with 20 mg, P =.002). Higher prednisone (r = 0.57, P ≤.05) and prednisolone (r = 0.75, P ≤.05) concentrations led to a higher percentage of unbound drug. Breast-milk/plasma area under the concentration-time curve ratios were 0.5-0.6 for prednisone and 0.02-0.03 for prednisolone. Relative infant doses were 0.35% to 0.53% and 0.09% to 0.18%, for prednisone and prednisolone, respectively. Prednisone and prednisolone exhibit dose- and concentration-dependent pharmacokinetics during pregnancy, and infant exposure to these agents via breast milk is minimal.

Original languageEnglish (US)
Pages (from-to)1223-1232
Number of pages10
JournalJournal of clinical pharmacology
Issue number9
StatePublished - Sep 2018


  • breast milk
  • pharmacokinetics
  • prednisolone
  • prednisone
  • pregnancy

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)

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  • Cite this

    Ryu, R. J., Easterling, T. R., Caritis, S. N., Venkataramanan, R., Umans, J. G., Ahmed, M. S., Clark, S., Kantrowitz-Gordon, I., Hays, K., Bennett, B., Honaker, M. T., Thummel, K. E., Shen, D. D., & Hebert, M. F. (2018). Prednisone Pharmacokinetics During Pregnancy and Lactation. Journal of clinical pharmacology, 58(9), 1223-1232.