Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2017 Sep;12(11):1001-1016.
doi: 10.2217/fmb-2017-0058. Epub 2017 Jul 31.

Dosing antibiotics in neonates: review of the pharmacokinetic data

Affiliations

Dosing antibiotics in neonates: review of the pharmacokinetic data

Nazario D Rivera-Chaparro et al. Future Microbiol. 2017 Sep.

Abstract

Antibiotics are often used in neonates despite the absence of relevant dosing information in drug labels. For neonatal dosing, clinicians must extrapolate data from studies for adults and older children, who have strikingly different physiologies. As a result, dosing extrapolation can lead to increased toxicity or efficacy failures in neonates. Driven by these differences and recent legislation mandating the study of drugs in children and neonates, an increasing number of pharmacokinetic studies of antibiotics are being performed in neonates. These studies have led to new dosing recommendations with particular consideration for neonate body size and maturation. Herein, we highlight the available pharmacokinetic data for commonly used systemic antibiotics in neonates.

Keywords: aminoglycoside; anti-infective agents; carbapenem; cephalosporins; drug dosing; infant; neonate; pharmacokinetics; preterm; β-lactams.

PubMed Disclaimer

Conflict of interest statement

Financial & competing interests disclosure

ND Rivera-Chaparro is supported by training grant T32 from the National Institute of Child Health and Human Development (T32GM086330-06). R Greenberg receives salary support from the National Institutes of Health (NIH) (HHSN 275201000003I, HHSN272201300017I) and from the US FDA (HHSF223201610082C). M Cohen-Wolkowiez receives support for research from the NIH (1R01-HD076676-01A1), the National Center for Advancing Translational Sciences of the NIH (UL1TR001117), the National Institute of Allergy and Infectious Diseases (HHSN272201500006I and HHSN272201300017I), the National Institute for Child Health and Human Development of the NIH (HHSN275201000003I), the US FDA (1U01FD004858-01), the Biomedical Advanced Research and Development Authority (BARDA; HHSO100201300009C), the nonprofit organization Thrasher Research Fund (www.thrasherresearch.org), and from industry for drug development in adults and children (www.dcri.duke.edu/research/coi.jsp). The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Similar articles

Cited by

References

    1. Laughon MM, Benjamin DK, Jr, Capparelli EV, et al. Innovative clinical trial design for pediatric therapeutics. Expert Rev. Clin. Pharmacol. 2011;4(5):643–652. - PMC - PubMed
    2. •• Addresses problems with clinical trial design in pediatrics and gives examples of successful solutions.

    1. Smits A, Annaert P, Allegaert K. Drug disposition and clinical pratice in neonates: cross talk between developmental physiology and pharmacology. Int. J. Pharm. 2013;452(1–2):8–13. - PubMed
    1. Kimland E, Odlind V. Off-label drug use in pediatric patients. Clin. Pharmacol. Ther. 2012;91(5):796–801. - PubMed
    2. • Demonstrates the growing need for pediatric drug trials by discussing the extensive off-label use of drugs in children.

    1. Hsieh EM, Hornik CP, Clark RH, Laughon MM, Benjamin DK, Jr, Smith PB. Medication use in the neonatal intensive care unit. Am. J. Perinatol. 2014;31(9):811–821. - PMC - PubMed
    2. •• Evaluates the most commonly used medications in the neonatal intensive care unit and how exposure to certain medications is changing.

    1. Koren G. Therapeutic drug monitoring principles in the neonate. National Academy of CLinical Biochemistry. Clin. Chem. 1997;43(1):222–227. - PubMed

MeSH terms