Amikacin sulfate parenteral
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Solution for injection containing amikacin (as amikacin sulfate).
Drugs List
Therapeutic Indications
Uses
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
Dosage
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.
Adults
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
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
Administration
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.
Contraindications
Myasthenia gravis
Precautions and Warnings
Elderly
Neonates
Obesity
Auditory impairment
Breastfeeding
Dehydration
Muscle weakness
Neuromuscular disorder
Parkinsonism
Pregnancy
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
Pregnancy
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.
Lactation
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
Albuminuria
Anaemia
Anaphylactic reaction
Anaphylactic shock
Anaphylactoid reaction
Apnoea
Arthralgia
Azotaemia
Blindness
Bronchospasm
Convulsions
Deafness
Drug fever
Eosinophilia
Headache
Hearing loss
Hypersensitivity reactions
Hypoacusis
Hypocalcaemia
Hypomagnesaemia
Hypotension
Loss of balance
Muscle twitch
Nausea
Nephropathy
Nephrotoxicity
Neuromuscular block
Numbness
Oliguria
Ototoxicity
Paraesthesia
Paralysis
Pruritus
Rash
Renal irritation (albumin, casts, and red or white blood cells)
Renal toxicity
Serum creatinine increased
Skin tingling
Superinfections
Tinnitus
Tremor
Urticaria
Vertigo
Vestibular and auditory damage
Vomiting
Overdosage
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 ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
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: www.nice.org.uk Last accessed: 19 May 2020
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://www.ncbi.nlm.nih.gov/books/NBK501922/
Amikacin Last revised: 31 October 2018
Last accessed: 19 May 2020
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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