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Gentamicin Dosing in Neonates with Normal Renal Function: Trough and Peak Levels

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European Journal of Drug Metabolism and Pharmacokinetics Aims and scope Submit manuscript

Abstract

Background and Objective

Gentamicin is commonly used in neonates, and it requires drug concentration monitoring. The objective of this study was to determine the extent of high trough (≥ 2 mg/l) and therapeutic peak serum gentamicin concentrations (5–12 mg/l) using our current gentamicin regimen and to adjust the dosing regimen accordingly and reassess.

Methods

This was a prospective cohort study of neonates, with normal renal function, who were prescribed gentamicin. Group 1: March 2014–July 2017—gentamicin intravenous (IV) 2.5 mg/kg given every 36 h if < 30 weeks gestational age (GA) and every 24 h if ≥ 30 weeks GA; Group 2: August 2019–February 2020—gentamicin IV 3.5 mg/kg given every 36 h if < 30 weeks GA and every 24 h if ≥ 30 weeks GA. We assessed the number of neonates with aberrant trough and peak serum gentamicin concentrations.

Results

Forty-eight neonates < 30 weeks GA and 34 ≥ 30 weeks GA were given 2.5 mg/kg gentamicin. Eleven (23%) neonates < 30 weeks GA and four (13%) ≥ 30 weeks GA had subtherapeutic peak concentrations (< 5 mg/l); none had supratherapeutic (> 12 mg/l) or toxic trough concentrations (≥ 2 mg/l). Forty-four neonates < 30 weeks GA and 54 ≥ 30 weeks GA were given 3.5 mg/kg gentamicin. Eighty-four (86%) had non-toxic trough concentrations (< 2 mg/l). One (1%) < 30 weeks GA neonate had subtherapeutic (< 5 mg/l) and one (1%) neonate ≥ 30 weeks GA had supratherapeutic (> 12 mg/l) peak concentrations.

Conclusions

Gentamicin regimen of 2.5 mg/kg given every 36 h for neonates < 30 weeks GA and every 24 h for neonates ≥ 30 weeks GA was suboptimal at achieving therapeutic gentamicin peak. Increasing the dosage to 3.5 mg/kg achieved therapeutic peak concentrations in 98% and non-toxic trough concentrations in 86% of all neonates (prior to dose interval adjustment).

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Acknowledgements

Queensland Health Pathology Services and Ms Anje Van Aswegen and Ms Acacia Fairweather for assistance with data collection.

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Authors and Affiliations

  1. Grantley Stable Neonatal Unit, Department of Neonatology, Royal Brisbane and Women’s Hospital, Herston, Brisbane, QLD, 4029, Australia

    Kristin O’Connor, Mark W. Davies, Pieter Koorts, David W. Cartwright & Karen Whitfield

  2. Royal Brisbane Clinical Unit, School of Clinical Medicine, University of Queensland, St Lucia, Australia

    Mark W. Davies

  3. School of Pharmacy, The University of Queensland, Brisbane, QLD, Australia

    Karen Whitfield

Authors
  1. Kristin O’Connor
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  2. Mark W. Davies
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  3. Pieter Koorts
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  4. David W. Cartwright
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  5. Karen Whitfield
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Corresponding author

Correspondence to Mark W. Davies.

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Funding

No source of funding.

Conflict of interest

No conflicts of interest.

Ethics approval

This study received ethical approval from the Royal Brisbane and Women’s Hospital Human Research Ethics Committee (reference no. HREC/13/QRBW/12), and all procedures in this study were in accordance with the 1964 Helsinki Declaration (and its amendments).

Consent to participate

The parent or carer of each infant gave written informed consent for their infant to participate in the study.

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Not applicable.

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Author contributions

MD, KW and DC contributed to the conception and design of this study; KOC and KW performed the statistical analysis and drafted the manuscript; PK, MD and DC critically reviewed the manuscript; MD and KW supervised the whole study process. All authors read and approved the final manuscript.

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O’Connor, K., Davies, M.W., Koorts, P. et al. Gentamicin Dosing in Neonates with Normal Renal Function: Trough and Peak Levels. Eur J Drug Metab Pharmacokinet 46, 677–684 (2021). https://doi.org/10.1007/s13318-021-00708-x

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  • DOI: https://doi.org/10.1007/s13318-021-00708-x

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