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Amikacin sulfate parenteral

Updated 2 Feb 2023 | Aminoglycosides


Solution for injection containing amikacin (as amikacin sulfate).

Drugs List

  • amikacin 100mg/2ml injection
  • amikacin 500mg/2ml injection
  • AMIKIN 100mg/2ml injection
  • Therapeutic Indications


    Antibiotic sensitive infections

    Infections caused by Gram-negative organisms, including those resistant to gentamicin and tobramycin. Amikacin is active against a broad spectrum of Gram-negative organisms, including Pseudomonas spp., Escherichia coli., indole-positive and indole-negative Proteus spp., Klebsiella-Enterobacter-Serratia spp, Salmonella, Shigella, Acinetobacter, Minea-Herellae, Citrobacter freundii and Providencia spp.

    Amikacin may also be indicated for the treatment of known or suspected staphylococcal disease. The principal Gram-positive organism sensitive to amikacin is Staphylococcus aureus, including methicillin-resistant strains.

    Unlicensed Uses

    Pseudomonal lung infection in cystic fibrosis


    At the recommended dosage level, uncomplicated infections should respond to therapy within 24 to 48 hours. The usual duration of treatment is 7 to 10 days, if treatment needs to be extended, amikacin should be re-evaluated.

    A once-daily, high-dose regimen of an amikacin should be avoided in patients with endocarditis or burns of more than 20% of the total body surface area.


    15mg/kg as a single daily dose or 7.5mg/kg every 12 hours.
    Maximum dose should not exceed 1.5g a day. Patients with endocarditis or febrile neutropenia, dosing should be administered twice a day.

    Life-threatening infections and/or those caused by Pseudomonas
    If considered necessary, the dose may be increased to 500mg every 8 hours .
    Maximum dose should not exceed 1.5g a day. The course of treatment should not exceed 10 days with a total maximum dose of 15g.

    Urinary tract infections (other than those caused by Pseudomonas)
    7.5mg/kg daily, in two equally divided doses (equivalent to 250mg twice a day).
    A urinary alkalinising agent may be administered concurrently to increase pH and consequently enhance amikacin activity.

    Intraperitoneal use
    May be used as an irrigant after recovery from anaesthesia in concentrations of 0.25% (2.5mg/ml).

    If instillation is required, a single dose of 500mg is diluted in 20ml of sterile distilled water and may be instilled through a polyethylene catheter sutured into the wound at closure. If possible, instillation should be postponed until the patient has fully recovered from the effects of the anaesthesia and muscle-relaxing drugs.

    Other routes of administration
    Amikacin in concentrations of 0.25% (2.5mg/ml) may be used satisfactorily as an irrigating solution in abscess cavities, the pleural space, the peritoneum, and the cerebral ventricles.


    Children aged 12 to 18 years:
    (See Dosage; Adult)

    Children aged 1 month to 12 years:
    15mg/kg to 20mg/kg daily, administered by intramuscular injection or by slow intravenous infusion as a single dose or as 7.5mg/kg every 12 hours.
    Patients with endocarditis or febrile neutropenia, dosing should be administered twice a day.

    Children under 1 month
    Initial dose: 10mg/kg.
    Maintenance dose: 7.5mg/kg every 12 hours.

    Premature infants
    7.5mg/kg every 12 hours for 7 to 10 days.
    If there is no sign of response within 3 to 5 days, treatment should be discontinued and reassessed.

    Pseudomonal lung infection in cystic fibrosis (unlicensed)
    Children aged 1 month to 18 years
    10mg/kg every 8 hours administered by slow intravenous injection or infusion, over a period of 3 to 5 minutes.
    Maximum dose should not exceed 500mg every 8 hours.

    Patients with Renal Impairment

    In patients with impaired renal function, the daily dose should be reduced and/or the intervals between doses increased to avoid accumulation of the drug. A once-daily, high-dose regimen of an amikacin should be avoided in patients with creatinine clearance less than 50mL/minute.

    A suggested method for estimating dosage in patients with known or suspected diminished renal function is to multiply the serum creatinine concentration (in mg/100ml) by 9 and use the resulting figure as the interval in hours between doses. The recommended dose is 7.5mg/kg by intramuscular administration.

    Interval between 7.5mg/kg doses is given in hours:
    Serum creatinine concentration = 1.5mg/100 ml - Interval between doses 13.5 hours
    Serum creatinine concentration = 2mg/100 ml - Interval between doses 18 hours
    Serum creatinine concentration = 2.5mg/100 ml - Interval between doses 22.5 hours
    Serum creatinine concentration = 3mg/100 ml - Interval between doses 27 hours
    Serum creatinine concentration = 3.5mg/100 ml - Interval between doses 31.5 hours
    Serum creatinine concentration = 4mg/100 ml - Interval between doses 36 hours
    Serum creatinine concentration = 4.5mg/100 ml - Interval between doses 40.5 hours
    Serum creatinine concentration = 5mg/100 ml - Interval between doses 45 hours
    Serum creatinine concentration = 5.5mg/100 ml - Interval between doses 49.5 hours
    Serum creatinine concentration = 6mg/100 ml - Interval between doses 54 hours


    Amikacin can be given by intramuscular injection, or by intravenous injection or infusion. Amikacin is also suitable for intraperitoneal use, however this is not recommended in young children. The intraperitoneal use of amikacin is not recommended in patients under the influence of anaesthesia or muscle-relaxants as neuromuscular blockade and consequent respiratory depression may occur.

    For most infections the intramuscular route is preferred. However, in life-threatening infections, or in patients for whom intramuscular injection is not feasible, the intravenous route by slow bolus injection (over 2 to 3 minutes) or infusion (diluted and given over 30 minutes) may be used.

    Intravenous administration in paediatric patients
    The solution should normally be infused over a 30 to 60 minute period. Infants should receive a 1 to 2 hour infusion.

    Therapeutic Drug Monitoring

    Multiple dose regimen
    One hour ('peak') serum concentration should not exceed 30mg/litre; pre-dose ('trough') concentration should be less than 10mg/litre.

    Once daily dose regimen
    Pre-dose ('tough') concentration should be less than 5mg/litre.


    Myasthenia gravis

    Precautions and Warnings

    Auditory impairment
    Muscle weakness
    Neuromuscular disorder
    Renal impairment
    Vestibular impairment
    Vestibulocochlear nerve damage due to ototoxic agents

    Correct dehydration before commencing therapy
    Reduce dose in patients with creatinine clearance below 50ml/min
    Advise ability to drive/operate machinery may be affected by side effects
    Consult national/regional policy on the use of anti-infectives
    Maintain adequate hydration during therapy
    Not all routes are licensed for all age groups
    Contains sulfite. Discontinue if hypersensitivity reactions occur
    Evaluate renal function before and during treatment
    Monitor auditory and vestibular function
    Monitor peak and trough serum levels
    Monitor periodically for overgrowth of non-susceptible organisms
    Monitor renal function in elderly patients
    Advise patient to report hearing loss or tinnitus
    If renal irritation appears consider increased hydration and dose reduction
    Potentially ototoxic and nephrotoxic
    Reduce dose or discontinue treatment if ototoxicity occurs
    Discontinue if azotaemia and oliguria develop
    Discontinue or interrupt therapy if nephrotoxicity occurs
    If no clinical response after 3-5 days consider alternative treatment
    In obese patients dosing should be based on ideal weight
    Length of treatment should not exceed 10 days

    If treatment is expected to last 7 days or more in patients with renal impairment or 10 days in other patients, a pre-treatment audiogram should be obtained and repeated during the treatment period. Discontinue amikacin if tinnitus or subjective hearing loss develops, or if repeated audiograms show significant loss of high frequency response.

    Aminoglycosides may impair neuromuscular transmission and should be used with caution in patients with muscular disorders such as Parkinsonism. Large doses given during surgery have resulted in a transient myasthenic syndrome in patients with normal neuromuscular function.

    Concurrent use with other potentially nephrotoxic or ototoxic drugs should be avoided, or where this is not possible, monitor carefully. The risk of ototoxicity is increased when amikacin is used with rapidly acting diuretic drugs, particularly when the diuretic is administered intravenously. Irreversible deafness may occur.

    Pregnancy and Lactation


    Use amikacin with caution during pregnancy.

    The manufacturer advises caution if amikacin is used during pregnancy. Amikacin should not be used during pregnancy unless for life-threatening infections. If given, serum amikacin concentration monitoring is essential.

    Aminoglycosides rapidly cross the placenta into the foetal circulation and amniotic fluid. After parenteral administration the foetal plasma concentrations vary from 20 - 40% of the maternal plasma concentration. Administration of aminoglycosides to pregnant women may result in accumulation of the drug in foetal plasma, amniotic fluid, and the kidneys. With amikacin use there is also a potential risk of ototoxicity in the foetus. Reports of total, irreversible, bilateral congenital deafness in children whose mothers received streptomycin or kanamycin during pregnancy have been documented. Although adverse effects on the foetus or newborns have not been reported in pregnant women treated with other aminoglycosides, the potential for harm exists.


    Use amikacin with caution during breastfeeding.

    The manufacturer advisees that the patient either discontinues amikacin or discontinues breastfeeding. Amikacin is poorly excreted into breast milk. It is known that newborn infants absorb small amounts of other aminoglycosides, with serum levels far below those attained when treating infections in the newborn hence systemic effects of amikacin are unlikely. Older infants would be expected to absorb even less amikacin. Monitor for possible effects on the gastrointestinal flora, such as diarrhoea, candidiasis or rarely, blood in the stool.

    Side Effects

    Acute renal failure
    Anaphylactic reaction
    Anaphylactic shock
    Anaphylactoid reaction
    Drug fever
    Hearing loss
    Hypersensitivity reactions
    Loss of balance
    Muscle twitch
    Neuromuscular block
    Renal irritation (albumin, casts, and red or white blood cells)
    Renal toxicity
    Serum creatinine increased
    Skin tingling
    Vestibular and auditory damage


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: May 2020

    Reference Sources

    Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

    Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

    Medications and Mothers' Milk, 14th Edition (2010) Hale, T. Hale Publishing, Amarillo, Texas.

    Summary of Product Characteristics: Amikacin 250 mg/ml injection. Hospira UK Ltd. Revised August 2015.
    Summary of Product Characteristics: Amikin injection 100mg/2ml. Vianex S.A. Revised March 2019.

    NICE Evidence Services Available at: Last accessed: 19 May 2020

    US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
    Available at:
    Amikacin Last revised: 31 October 2018
    Last accessed: 19 May 2020

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