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Prednisone Pharmacokinetics During Pregnancy and Lactation
- Source :
- Journal of clinical pharmacology. 58(9)
- Publication Year :
- 2017
-
Abstract
- 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.
- Subjects :
- medicine.medical_specialty
Urine
Breast milk
030226 pharmacology & pharmacy
Gastroenterology
Article
03 medical and health sciences
0302 clinical medicine
Pharmacokinetics
Prednisone
Pregnancy
Internal medicine
Lactation
medicine
Humans
Pharmacology (medical)
Glucocorticoids
Pharmacology
030219 obstetrics & reproductive medicine
business.industry
Postpartum Period
Infant exposure
medicine.disease
medicine.anatomical_structure
Area Under Curve
Prednisolone
Female
business
medicine.drug
Half-Life
Subjects
Details
- ISSN :
- 15524604
- Volume :
- 58
- Issue :
- 9
- Database :
- OpenAIRE
- Journal :
- Journal of clinical pharmacology
- Accession number :
- edsair.doi.dedup.....93c2b26b9945d2ec935fc048372995be