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Relationship between amikacin blood concentration and ototoxicity in low birth weight infants

Aiju Endo1, Atsushi Nemoto2, Kazumi Hanawa1

  • 1Department of Pharmacy, Yamanashi Prefectural Central Hospital, Yamanashi, 400-8506, Japan.

Journal of Infection and Chemotherapy : Official Journal of the Japan Society of Chemotherapy
|December 13, 2018
PubMed

Insights

Amikacin (AMK) once daily dosing shows therapeutic effect in low birth weight infants. However, trough concentrations of AMK ≥10 μg/mL are linked to ototoxicity, indicating a need for careful monitoring.

Area of Science:

  • Neonatal pharmacology
  • Pediatric infectious diseases
  • Clinical pharmacokinetics

Background:

  • Amikacin (AMK) is a critical antibiotic for severe infections in low birth weight (LBW) infants.
  • Limited evidence exists on the efficacy and safety of once-daily (OD) AMK dosing in LBW neonates.
  • Therapeutic drug monitoring is essential for optimizing antibiotic therapy in vulnerable infant populations.

Purpose of the Study:

  • To evaluate the therapeutic effectiveness and safety of once-daily Amikacin (AMK) administration in low birth weight (LBW) infants.
  • To investigate the relationship between AMK pharmacokinetic parameters and adverse events, specifically renal dysfunction and ototoxicity.
  • To determine optimal AMK trough concentration thresholds for preventing toxicity in LBW neonates.

Main Methods:

  • Therapeutic drug monitoring of AMK in 20 LBW infants with severe infections.
  • Analysis of clinical data for treatment effectiveness, renal dysfunction (serum creatinine), and ototoxicity.
  • Pharmacokinetic assessment including peak and trough AMK concentrations.
  • Statistical comparison of patient groups based on AMK trough concentration cut-offs.

Main Results:

  • All infants demonstrated therapeutic effectiveness with AMK OD treatment.
  • No significant renal dysfunction was observed, as indicated by stable serum creatinine levels.
  • Ototoxicity occurred in 4 infants, with 3 of these having AMK trough concentrations ≥10 μg/mL.
  • A trough concentration ≥10 μg/mL was significantly associated with ototoxicity, independent of AMK dose.

Conclusions:

  • Once-daily Amikacin is effective for severe infections in LBW infants.
  • Monitoring AMK trough concentrations is crucial to mitigate the risk of ototoxicity.
  • A target trough concentration below 10 μg/mL may be necessary to ensure safety in LBW neonates.

Keywords:
AMKELBWOtotoxicityTDMVLBW

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