Reviewed by Drs Emma Best, Lesley Voss & Mariam Buksh
June 2013
Administration Newborn Drug Protocol Index Newborn Services Home Page


Dose and Administration

  1. 15mg/kg IV as a daily dose every 24 hours, given as an infusion over 30 minutes 4 , 6, 7, 8
  2. Obtain trough level prior to the second dose (<34 weeks corrected gestational age) or prior to the third dose (>34 weeks corrected gestational age) and withhold the dose while result is awaited. See Special Considerations below.


  1. Suspected or proven late-onset neonatal sepsis.

Contraindications and Precautions

  1. Hypersensitivity to amikacin/other aminoglycosides.
  2. Extreme caution in neonates with renal dysfunction.
  3. Caution in concurrent therapy with cephalosporins, potent diuretics such as furosemide and neuromuscular blocking agents.
  4. Concurrent administration with other ototoxic and/or nephrotoxic drugs.
  5. Patients with muscular disorders eg. myasthenia gravis. The curare-like effect at the neuromuscular junction, which may occur with aminoglycosides, can aggravate the muscle weakness in these conditions.1

Clinical Pharmacology 1, 4 

Amikacin is a semi-synthetic aminoglycoside antibiotic which is thought to distribute mainly into extracellular fluid in neonates. It is 11% protein bound (adults) and excreted unchanged predominantly by glomerular filtration in the kidneys. The half life is 7-14 hours in babies (postmenstrual age < 30 weeks) and 4-7 hours at a postmenstrual age of 40 weeks.

Amikacin has in vitro activity against gram-negative organisms (including Pseudomonas spp., Proteus spp., Klebsiella, Enterobacter, Serratia spp., Citrobacter, E.Coli.) and gram-positive Staphylococcus aureus including the methicillin-resistant strains. When indicated, concomitant therapy with a penicillin type drug may be necessary to cover for gram-positive organisms such as Streptococci.

Possible Adverse Effects 1, 5

  1. Ototoxicity, both vestibular and auditory, is seen mainly with co-existing renal impairment, high doses of amikacin and/or prolonged therapy. The risk is increased with dehydration and previous/current exposure to another ototoxic agent. Amikacin affects auditory function to a greater extent than gentamicin. Aminoglycoside induced ototoxicity is usually irreversible.
  2. Renal impairment, azotemia, oliguria.
  3. Hepatotoxicity.
  4. Laboratory test interference may occur with: bilirubin (↑), Na+ (↓), K+ (↓), Platelets (↓), and others (see data sheet).

Drug Interactions 1, 2, 3

  • Possible increased risk of nephrotoxicity and ototoxicity.
  • Possible increase in amikacin levels and potentiation of toxicity.
Pancuronium and other neuromuscular blocking agents
  • Possible increase and prolongation of neuromuscular blockade. Risk possibly increased with co-existing renal disease and hypocalcaemia, and those with pre-existing muscular weakness. Amikacin has a lower neuromuscular blocking potential than gentamicin.
Vancomycin, gentamicin (and other aminoglycosides)
  • Possible potentiation of nephrotoxicity and ototoxicity.

Special Considerations

  1. Monitor: renal function, hydration.
  2. Adjust dosing intervals to 36-48 hourly if trough levels are above the acceptable limits or in infants with suspected/proven renal impairment, or reduced clearance due to extreme prematurity and/or dose intervals in infants with suspected/proven renal impairment, or reduced clearance due to extreme immaturity.
  3. If significant renal impairment, or if there are other risk factors (e.g. multiple nephrotoxic or ototoxic medications used concurrently or a prolonged treatment course) consider stopping amikacin.