Praxis Medical Insights

Est. 2024 • Clinical Guidelines Distilled

Made possible by volunteer editors from the University of Calgary & University of Alberta

Last Updated: 10/16/2025

Amikacin Therapy in Newborns

Monitoring Requirements

  • The American Thoracic Society recommends monitoring serum creatinine at baseline and on day 3 of therapy, then twice weekly during month 1, then weekly during month 2 if treatment extends beyond initial course 1, 2
  • The Centers for Disease Control and Prevention guidelines state that nephrotoxicity occurs in 8.7% of patients receiving amikacin, with higher frequency in those with initially elevated creatinine or receiving larger cumulative doses 3

Ototoxicity Surveillance

  • The American Thoracic Society suggests performing baseline brainstem auditory evoked potentials (BAEPs) before initiating therapy when feasible, and repeating BAEPs at day 3 and day 9 of treatment, with final assessment 2 months after completion 1, 2
  • The Centers for Disease Control and Prevention reports that high-frequency hearing loss occurs in 24% of patients receiving amikacin, with higher rates in those receiving longer treatment and higher doses 3

Pregnancy and Fetal Exposure

  • The American College of Obstetricians and Gynecologists states that amikacin is contraindicated in pregnancy due to risk of irreversible bilateral congenital deafness and fetal nephrotoxicity 4, 5, 6

Drug Interactions

  • The American Thoracic Society warns that loop diuretics markedly increase ototoxicity risk, and nephrotoxic agents increase nephrotoxicity 4, 5, 6

Amikacin Treatment Safety and Efficacy in Newborns

Toxicity Risks and Monitoring Requirements

  • The Centers for Disease Control and Prevention, as reported in MMWR Recommendations and Reports, and the American Thoracic Society, as reported in the American Journal of Respiratory and Critical Care Medicine, warn that ototoxicity risk increases significantly with prolonged amikacin treatment and higher doses, with high-frequency hearing loss occurring in 24% of patients, and higher rates in those receiving longer treatment 7, 8
  • The Centers for Disease Control and Prevention, as reported in MMWR Recommendations and Reports, and the American Thoracic Society, as reported in the American Journal of Respiratory and Critical Care Medicine, also state that nephrotoxicity is more common in patients receiving larger total doses, with renal impairment seen in 8.7% of patients receiving amikacin, and higher frequency in those receiving larger cumulative doses 7, 8