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Dose and administration
- 15mg/kg IV as a daily dose every 24 hours, given as an infusion over 30 minutes 4,6,7,8
- 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.
Suspected or proven late-onset neonatal sepsis.
Contraindications and precautions
- Hypersensitivity to amikacin/other aminoglycosides.
- Extreme caution in neonates with renal dysfunction.
- Caution in concurrent therapy with cephalosporins, potent diuretics such as furosemide and neuromuscular blocking agents.
- Concurrent administration with other ototoxic and/or nephrotoxic drugs.
- 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
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
- 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.
- Renal impairment, azotemia, oliguria.
- Laboratory test interference may occur with: bilirubin (↑), Na+ (↓), K+ (↓), Platelets (↓), and others (see data sheet).
|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.|
- Monitor: renal
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.
Peak 20-30mg/L (1 hour following the commencement of the infusion; 30 minutes after the infusion ceases). DO NOT routinely check peak levels
- 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.
- 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
- Amikacin comes repackaged to a concentration of 5mg/ml.
- Supplied as 5ml syringes.
- Preservative free but contains sodium metabisulphate.
- pH 4.5.
- Doses are charted on the drug prescription chart in mg/dose.
Slow IV infusion
- No further dilution required (5mg/ml).
- 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.
- Administer by slow IV infusion over 30 minutes using a syringe pump.
- Incompatible with Heparin.
- Do not mix with other drugs, IV solutions, blood or blood products.
- Flush line with 0.9% NaCl before and after infusion of Amikacin.
- Compatible with 0.9% NaCl or 5% Glucose.
- Trough and peak levels (if requested) - 1 hour after the infusion commences, 30 minutes after the infusion ceases.
- Observe site for extravasation during administration.
- Observe for signs of renal, hepatic and haematological dysfunction during prolonged therapy.
- Store prepared syringes in fridge.
- Opened vials: Use immediately and discard remainder.
- Amikacin Data Sheet. Auckland: Baxter Healthcare Ltd., 2000.
- Amikin® Data Sheet. Australia: Bristol-Myers Squibb,2001.
- Stockley I. Drug Interactions 5th ed. London :The Pharmaceutical Press; 2000.
- Northern Neonatal Network. Neonatal Formulary 3. London: BMJ Books, 2000.
- Sweetman S (ed.) Martindale: The Extra Pharmacopoeia. (33rd ed). London : Royal Pharmaceutical Society; 2002.
- Trissel LA. Handbook of Injectable Drugs (10th edition). American Society of Hospital Pharmacists; 1998: Bethesda
- 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.
- Young TE, Mangum B. Neofax. 15th edition. Acorn publishing (Raleigh) 2002. P4-5.
- 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.
- Shore K, Morris A. Amikacin as a replacement aminoglycoside for netilmicin for coagulase-negative staphylococcal sepsis in neonates (letter). NZMJ 2001; 115(1163):216
- 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.
- 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.
- Nursing 97 Drug Handbook 1997 Springhouse p67-8.
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- 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