Propranolol concentrations after oral administration in term and preterm neonates

L. Filippi, G. Cavallaro, P. Fiorini, S. Malvagia, M. L. Della Bona, E. Giocaliere, P. Bagnoli, M. Dal Monte, F. Mosca, G. Donzelli, G. La Marca

Research output: Contribution to journalArticle

Abstract

Objective: While propranolol pharmacokinetics has been extensively studied in adults, this study reports the first evaluation of propranolol pharmacokinetics in term and preterm neonates. Methods: Propranolol concentrations were measured in four term and 32 preterm newborns treated with oral propranolol at the dose of 0.5 or 0.25mg/kg every 6h by serial dried blood spots. Results: The levels of propranolol, although with high inter-individual variability, were proportional with the administered dose. Pharmacokinetic parameters evaluated at the steady state in newborns treated with 0.5mg/kg/6h showed values of maximal (71.7±29.8ng/mL), minimal (42.2±20.8ng/ mL) and average concentration (60.8±25.0ng/mL), time of maximal concentration (2.6±0.9h) and area under the time-concentration curve (364.7±150.2ng/mL/h) similar to those observed in adults. In both dosing groups, elimination half-life was significantly longer (14.9±4.3 and 15.9±6.1h), and apparent total body clearance (27.2±13.9 and 31.3±13.3mL/kg/min) lower than those reported in adults, suggesting a slower metabolism in newborns. No differences were observed between newborns with different gestational age or different sex. Conclusions: Neonates treated with propranolol-exhibited drug concentrations proportional with the dose, with significant long half-life.

Original languageEnglish
Pages (from-to)833-840
Number of pages8
JournalJournal of Maternal-Fetal and Neonatal Medicine
Volume26
Issue number8
DOIs
Publication statusPublished - May 2013

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Propranolol
Oral Administration
Pharmacokinetics
Half-Life
Gestational Age
Pharmaceutical Preparations

Keywords

  • Beta blocker
  • Newborn
  • Pharmacokinetics
  • Propranolol
  • Retinopathy of prematurity

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Obstetrics and Gynaecology

Cite this

Propranolol concentrations after oral administration in term and preterm neonates. / Filippi, L.; Cavallaro, G.; Fiorini, P.; Malvagia, S.; Della Bona, M. L.; Giocaliere, E.; Bagnoli, P.; Dal Monte, M.; Mosca, F.; Donzelli, G.; La Marca, G.

In: Journal of Maternal-Fetal and Neonatal Medicine, Vol. 26, No. 8, 05.2013, p. 833-840.

Research output: Contribution to journalArticle

Filippi, L, Cavallaro, G, Fiorini, P, Malvagia, S, Della Bona, ML, Giocaliere, E, Bagnoli, P, Dal Monte, M, Mosca, F, Donzelli, G & La Marca, G 2013, 'Propranolol concentrations after oral administration in term and preterm neonates', Journal of Maternal-Fetal and Neonatal Medicine, vol. 26, no. 8, pp. 833-840. https://doi.org/10.3109/14767058.2012.755169
Filippi, L. ; Cavallaro, G. ; Fiorini, P. ; Malvagia, S. ; Della Bona, M. L. ; Giocaliere, E. ; Bagnoli, P. ; Dal Monte, M. ; Mosca, F. ; Donzelli, G. ; La Marca, G. / Propranolol concentrations after oral administration in term and preterm neonates. In: Journal of Maternal-Fetal and Neonatal Medicine. 2013 ; Vol. 26, No. 8. pp. 833-840.
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AU - Fiorini, P.

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AU - Della Bona, M. L.

AU - Giocaliere, E.

AU - Bagnoli, P.

AU - Dal Monte, M.

AU - Mosca, F.

AU - Donzelli, G.

AU - La Marca, G.

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