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The relationship between trough drug concentrations and ductal closure in preterm infants treated with three-dose-oral ibuprofen.

Authors
Type
Published Article
Journal
The Journal of Maternal-Fetal & Neonatal Medicine
1476-4954
Publisher
Informa UK (Taylor & Francis)
Publication Date
Volume
26
Issue
13
Pages
1306–1310
Identifiers
DOI: 10.3109/14767058.2013.784739
PMID: 23488980
Source
Medline
License
Unknown

Abstract

The aim of the present study was to characterize the pharmacokinetic profile of oral ibuprofen on consecutive 3 d by trough serum levels, and if possible to define a cut-off level for ductal closure in preterm infants. The study enrolled 20 preterm infants with gestational age ≤30 weeks, birth weight <1250 g and hemodynamically significant patent ductus arteriosus (hsPDA). Patients received oral ibuprofen at an initial dose of 10 mg/kg, followed by 5 mg/kg at 24 and 48 h. Patients were compared for serum ibuprofen levels in addition to their demographic and clinical data in case of their response to the treatment. hsPDA closed in 16 (80%) of the patients. Although mean ibuprofen levels on consecutive 3 d showed a plateau in general, ibuprofen serum levels on the first treatment day were statistically low in patients with unclosed hsPDA (p = 0.003). The optimal cut-off value for serum ibuprofen level on the first treatment day was measured as 5.5 mg/l with 100% sensitivity and 93% specificity. Serum ibuprofen level on the first treatment day seems to be an important factor for a successful ductal closure. Target concentration approach by the evaluation of trough level may be applicable to real-time dosing strategy.

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