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Amikacin sulphate

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Dose and administration

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  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.

Indications

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

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. 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

Furosemide Possible increased risk of nephrotoxicity and ototoxicity
Indomethacin 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.
    Measure serum creatinine, magnesium and calcium levels with Amikacin trough levels in cases of prolonged (longer than 7 days) Amikacin therapy. Elevation in serum creatinine level may be a more sensitive indicator of renal injury.
    Check trough levels:
    prior to the 2nd dose, for infants <34 weeks corrected gestational age and then every 3-5 days as required.
    prior to the 3rd dose for infants >34 weeks corrected gestational age and then every 3-5 days as required.
    Serum levels4:
    Trough <3mg/L
    Peak 20-30mg/L (1 hour following the commencement of the infusion; 30 minutes after the infusion ceases). DO NOT routinely check peak levels
  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.

Management of Amikacin administration

Description1,2,6

  • Amikacin comes repackaged to a concentration of 5mg/ml.
  • Supplied as 5ml syringes.
  • Preservative free but contains sodium metabisulphate.
  • pH 4.5.

Prescription

  • Doses are charted on the drug prescription chart in mg/dose.

Administration

Slow IV infusion

  1. No further dilution required (5mg/ml).
  2. For infants <1000 grams administer as close to the intravascular catheter (LL, UVC, IV) as possible to avoid the need for large NaCl flushes. Note that the prepared syringes are pre-filtered so no added Pall filter is required.
  3. Administer by slow IV infusion over 30 minutes using a syringe pump.
  4. Incompatible with Heparin.
  5. Do not mix with other drugs, IV solutions, blood or blood products.
  6. Flush line with 0.9% NaCl before and after infusion of Amikacin.
  7. Compatible with 0.9% NaCl or 5% Glucose.

Nursing considerations

  1. Trough and peak levels (if requested) - 1 hour after the infusion commences, 30 minutes after the infusion ceases.
  2. Observe site for extravasation during administration.
  3. Observe for signs of renal, hepatic and haematological dysfunction during prolonged therapy.

Storage

  • Store prepared syringes in fridge.
  • Opened vials: Use immediately and discard remainder.

References

  1. Amikacin Data Sheet. Auckland: Baxter Healthcare Ltd., 2000.
  2. Amikin® Data Sheet. Australia: Bristol-Myers Squibb,2001.
  3. Stockley I. Drug Interactions 5th ed. London :The Pharmaceutical Press; 2000.
  4. Northern Neonatal Network. Neonatal Formulary 3. London: BMJ Books, 2000.
  5. Sweetman S (ed.) Martindale: The Extra Pharmacopoeia. (33rd ed). London : Royal Pharmaceutical Society; 2002.
  6. Trissel LA. Handbook of Injectable Drugs (10th edition). American Society of Hospital Pharmacists; 1998: Bethesda
  7. Treluyer JM, Merle Y, Tonnelier S, Rey E, Pons G. Nonparametric population pharmacokinetic analysis of amikacin in neonates, infants, and children. Antimicrob Agents Chemother 2002; 46:1381-7.
  8. Young TE, Mangum B. Neofax. 15th edition. Acorn publishing (Raleigh) 2002. P4-5.
  9. Kotze A, Bartel PR, Sommers DK. Once versus twice daily amikacin in neonates: prospective study on toxicity. J Paediatr Child Health 1999; 35:283-6.
  10. Shore K, Morris A. Amikacin as a replacement aminoglycoside for netilmicin for coagulase-negative staphylococcal sepsis in neonates (letter). NZMJ 2001; 115(1163):216
  11. Prober CsG, Yeager AS, Arvin AM. The effect of chronological age on the serum concentrations of amikacin in sick and preterm infants. J Pediatr 1981; 98:636.
  12. Myers MG, Roberts RJ, Mirhij NH. Effects of gestational age, birthweight and hypoxaemia of pharmacokinetics of amikacin in serum of infants. Antimicrob Agents Chemother 1977; 11:1027.
  13. Nursing 97 Drug Handbook 1997 Springhouse p67-8.

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Document Control

  • Date last published: 29 June 2013
  • Document type: Drug Dosage Guideline
  • Services responsible: ADHB Pharmacy, Neonatology, Paediatric Infectious Diseases
  • Editor: Sarah Bellhouse
  • Review frequency: 2 years