Plain-language summary, compiled from the cited regulatory records
Amikacin is an antibiotic used for the short-term treatment of serious infections caused by susceptible Gram-negative bacteria [1]. These bacteria include Pseudomonas species, Escherichia coli, Proteus species, Providencia species, Klebsiella-Enterobacter-Serratia species, and Acinetobacter species [1]. It has also shown effectiveness in treating bacterial septicemia, including in newborns [1]. Amikacin belongs to the drug class of other antibiotics for topical use [1].
This medication is available under various brand names [1]. There were no adverse event reports for this drug in the last 12 months [2].
This is not medical advice. Consult a qualified healthcare professional.
GBOfficial regulatory label· revised May 15, 2026[1]
1). – Nosocomial lower respiratory tract infections including hospital- acquired pneumonia (HAP) and ventilator-associated pneumonia (VAP), – Complicated and recurrent urinary tract infections including pyelonephritis, – Complicate intra-abdominal infections including peritonitis, – Acute bacterial skin and skin structure infections including burn-wound infections, – Bacterial endocarditis (only in combination with other antibiotics).
Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above. Consideration should be given to official guidance on the appropriate use of antibacterial agents.
How to take
CACanada· Health Canada
6 products
Uses
CAOfficial regulatory label· revised March 22, 2025[2]
AND CLINICAL USE
Amikacin Sulfate Injection is indicated in the short-term treatment of serious infections due to susceptible strains of Pseudomonas species, Escherichia coli, Proteus species, Klebsiella - Enterobacter - Serratia species, Providencia species, Salmonella species, Citrobacter species and Staphylococcus aureus.
Clinical effectiveness has been shown in bacteremia, septicemia (including neonatal sepsis), osteomyelitis, septic arthritis; respiratory tract, urinary tract, intra-abdominal (including peritonitis) infections and soft tissue abscesses.
Appropriate bacteriological studies should be performed in order to identify and determine the susceptibility of the causative organism. Relevant surgical procedures should be performed when indicated. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Amikacin Sulfate Injection and other antibacterial drugs, Amikacin Sulfate Injection should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria.
USUnited States· FDA
1 product
Uses
USOfficial regulatory label· revised April 8, 2024[3]
INDICATIONS AND USAGE
Amikacin Sulfate Injection is indicated in the short-term treatment of serious infections due to susceptible strains of Gram-negative bacteria, including Pseudomonas species, Escherichia coli , species of indole-positive and indole-negative Proteus , Providencia species, Klebsiella-Enterobacter-Serratia species, and Acinetobacter ( Mima-Herellea ) species.
Clinical studies have shown Amikacin Sulfate Injection to be effective in bacterial septicemia (including neonatal sepsis); in serious infections of the respiratory tract, bones and joints, central nervous system (including meningitis) and skin and soft tissue; intra-abdominal infections (including peritonitis); and in burns and post-operative infections (including post-vascular surgery).
Clinical studies have shown amikacin also to be effective in serious complicated and recurrent urinary tract infections due to these organisms. Aminoglycosides, including Amikacin Sulfate Injection are not indicated in uncomplicated initial episodes of urinary tract infections unless the causative organisms are not susceptible to antibiotics having less potential toxicity.
EUEuropean Union· EMA
1 product
Uses
EUOfficial regulatory label· revised October 14, 2025[4]
1). Consideration should be given to official guidance on the appropriate use of antibacterial agents. ARIKAYCE liposomal should be used in conjunction with other antibacterial agents active against Mycobacterium avium Complex lung infections.
How to take
EU
Drug interactions
Known interactions involving Amikacin. Select one for details. This list is informational and not a complete interaction checker.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
[2]Health Canada (DPD) · 02486717 · revised March 22, 2025
[3]FDA DailyMed · 0b56f6df-a05d-45… · revised April 8, 2024 [PDF]
[4]European Medicines Agency · EMEA/H/C/005264 · revised October 14, 2025
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.
GBOfficial regulatory label· revised May 15, 2026[1]
Posology Amikacin Kabi is commonly used in combination with other appropriate antibiotics to cover the bacterial spectrum encountered in the respective infection. The dosage as well as the use of amikacin would notably depend on the type of infection and the patient status.
Local therapeutic guidance should be taken into consideration. e. 5 mg/kg body weight every 12 hours. 5 g. In endocarditis and in febrile neutropenic patients dosing should be twice daily, as there is not enough data to support once daily dosing.
5 mg/kg body weight every 12 hours. In endocarditis and in febrile neutropenic patients dosing should be twice daily, as there is not enough data to support once daily dosing. 2). 2). 00 ml Accuracy of dosing is improved if Amikacin 5 mg/ml solution for infusion is administered with an Accuracy of dosing is improved if Amikacin 5 mg/ml solution for infusion is administered with an infusion pump.
Maximum daily dose:
The daily dose of amikacin is based on body weight, consequently the maximum dose should equally be based on body weight unless otherwise justified. 5 g per day but should not be administered for a period longer than 10 days and only under constant monitoring.
A maximum total adult dose of 15 g should not be exceeded; other aminoglycoside treatment given previously must be included in this calculation. Due to the requirement for dose adjustments once daily dosing of amikacin is not recommended for patients with febrile neutropenia, renal failure.
Duration of treatment The total duration of therapy should be limited to 7 to 10 days, depending on severity of infection. In severe and complicated infections, where treatment with amikacin exceeds 10 days, the suitability of treatment with amikacin should be re-evaluated, as eventual treatment continuation requires the monitoring of serum amikacin levels and of renal, auditory and vestibular functions.
Patients with infections caused by susceptible microorganisms should respond to therapy within 24 to 48 hours with the recommended dosage regime. When no clinical response is seen within three to five days an alternative therapy should be considered.
Monitoring advice Assessment of renal function should be performed at the start of therapy and should be re- evaluated at regular intervals during treatment. Monitoring of amikacin plasma concentrations is strongly recommended in all patients, and especially in the elderly, newborns, obese patients and those with renal impairment or cystic fibrosis.
4). Blood samples are taken at the end of a dosage interval (trough level) and 30- 90 minutes after the end of the infusion (peak level). In case of multiple daily doses, peak levels should not exceed 30 - 35 micrograms/ml. The trough level should be less than 10 micrograms/ml.
For once daily dose regimens, local guidelines on serum concentration monitoring should be considered. Patients with impaired renal function Renal function should be monitored in all patients receiving amikacin and is mandatory in those with renal impairment.
Note:
Once daily administration of amikacin is not recommended in patients with renal function disorders (creatinine clearance <50 ml/min). In renal impairment with a glomerular filtration rate of less than 70 ml/minute, dose reduction or longer dose intervals are advised, because an accumulation of amikacin can be expected.
5 mg/kg body weight. The dose interval for individual patients is calculated as 9 times the serum creatinine level. 5 mg/kg body weight) must be administered every 2 x 9 = 18 hours. 5 mg/kg body weight. The values presented in the following table may be taken as guidance.
Creatinine clearance Daily dose of […]
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
GBOfficial regulatory label· Adverse reactions· revised May 15, 2026[1]
Under certain conditions amikacin shows ototoxic and/or nephrotoxic effects. Renal impairment is uncommonly observed in patients treated with amikacin and is usually reversible upon withdrawal of the medicinal product.
Important note on therapy:
Renal impairment and hearing impairment due to neurological effects can be for the most part avoided with the observance of precautionary measures. Control renal status as well as the senses of hearing and equilibrium before, during and after therapy.
Maintain adequate hydration and ensure adequate urine production. 2). The adverse reactions considered at least possibly related to treatment are listed below by body system organ class and absolute frequency. The following terminologies have been used in order to classify the occurrence of undesirable effects: – Very common (≥ 1/10) – Common (≥1/100 to < 1/10) – Uncommon (≥ 1/1,000 to < 1/100) – Rare (≥ 1/10,000 to < 1/1,000) – Very rare (< 1/10,000) – Not known (cannot be estimated from the available data) Infections and infestations: Uncommon: Superinfection or colonisation (with resistant microbes or yeast-like fungi) Blood and lymphatic system disorders: Rare: anaemia, leukopaenia, granulocytopenia, thrombocytopenia, eosinophilia Immune system disorders: Rare: Hypersensitivity reactions3 Very rare: Anaphylactic shock Not known Cross-allergy between aminoglycosides Metabolism and nutrition disorders: Rare: Hypomagnesaemia Nervous system disorders: Uncommon: Dizziness1, vertigo1 Rare: Headache, migraine, paraesthesia, tremor Eye disorders: Uncommon: Nystagmus1 Rare: Blindness5, retinal infarction5 Ear and labyrinth disorders: Uncommon: Tinnitus1, pressure in the ears1, hearing impairment1 Very rare: Deafness1 Vascular disorders: Rare: Hypotension Respiratory, thoracic and mediastinal disorders: Rare: Respiratory function depression4 Very rare: Respiratory paralysis4 Not known: Apnoea, bronchospasm Gastrointestinal disorders: Uncommon: Nausea1 Rare: Vomiting Skin and subcutaneous tissue disorders: Rare: Skin rash, exanthema, pruritus, urticaria (hypersensitivity reactions)3 Musculoskeletal and connective tissue disorders: Rare: Arthralgia Very rare: Neuromuscular blockage Renal or urinary disorders: Uncommon: Damage to renal tubuli2, renal impairment2 Very rare: Toxic nephropathy, acute renal failure General disorders and administration site conditions: Rare: Drug-related fever3 Investigations: Rare: Aspartate aminotransferase increased, Alanine aminotransferase increased, alkaline phosphatase increased (slight and transient) Further information on particular undesirable effects (1) These effects were seen in particular when the recommended dosage level was exceeded, in treatment lasting longer than 10 days, or when the dose was not adequately reduced for patients with renal dysfunction.
Initial symptoms of vestibular disturbances are dizziness, nausea and vomiting. The clinical examination often reveals a nystagmus. Vestibular disturbances are reversible in almost any case. The first symptoms of cochlear dysfunction often include a loss of high-tone perception (≥4,000 Hertz) that precedes hearing loss and is detected only by audiometry.
(2)Another uncommon adverse effect is damage to the renal tubules with renal impairment. The mechanism of renal damage involves accumulation in the lysosomes, phospholipase inhibition and necrosis of tubular cells after repeated administration of amikacin.
Once daily dosing may reduce the risk of nephrotoxicity. Renal damage is reversible to varying degrees but exacerbates the risk of accumulation which may cause or intensify ototoxic effects. An increase in the serum creatinine concentration, the presence of albumin, red and white blood cells or cylinders in urine, uraemia and oliguria are possible.
(3)Rare adverse effects are hypersensitivity reactions such as exanthema, itching, hives, and drug fever. (4)In rare cases, if intravenous infusion of the medicinal product is too fast, respiratory functions may be seriously depressed.
5). (5) Amikacin is not formulated for intavitreal use. Blindness and retinal infarction have been reported following intravitreous administration (injection into the eye) of amikacin. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
GBOfficial regulatory label· Warnings and precautions· revised May 15, 2026[1]
Caution is necessary on administration to patients with renal impairment, to patients with auditory or vestibular damage, to patients with neuromuscular disorders, and if patients were treated with another aminoglycoside active substance immediately prior to amikacin.
Neuro/Ototoxicity Neurotoxicity, manifested as vestibular and/or bilateral auditory ototoxicity, can occur in patients treated with aminoglycosides. The risk of aminoglycoside-induced ototoxicity is greater in patients with impaired renal function, or in those whose therapy is prolonged over 5-7 days of treatment, even in healthy patients.
High frequency deafness usually occurs first and can be detected only by audiometric testing. Vertigo and loss of balance may occur and may be evidence of vestibular injury. Other manifestations of neurotoxicity may include numbness, skin tingling, muscle twitching and convulsions.
Patients developing cochlear or vestibular damage may not have symptoms during therapy to warn them of developing eighth nerve toxicity, and total or partial irreversible bilateral deafness or disabling vertigo may occur after the medicinal product has been discontinued.
Aminoglycoside-induced ototoxicity is usually irreversible. The use of amikacin in patients with a history of allergy to aminoglycosides or in patients who may have subclinical renal or eighth nerve damage induced by prior administration of nephrotoxic and/or ototoxic agents should be considered with caution, as toxicity may be additive.
In these patients amikacin should be used only if, in the opinion of the physician, therapeutic advantages outweigh the potential risks. There is an increased risk of ototoxicity in patients with mitochondrial DNA mutations (particularly the nucleotide 1555 A to G substitution in the 12S rRNA gene), even if aminoglycoside serum levels are within the recommended range during treatment.
Alternative treatment options should be considered in such patients. In patients with a family history of relevant mutations or aminoglycoside induced deafness, alternative treatments or genetic testing prior to administration, should be considered.
Renal toxicity Aminoglycosides are potentially nephrotoxic. Renal toxicity is independent of plasma obtained at the peak (Cmax). The toxic effects of aminoglycosides, including amikacin, are more frequent in patients with renal impairment, if doses in excess of those recommended are administered, and if the recommended duration of treatment is exceeded.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
GBOfficial regulatory label· Contraindications· revised May 15, 2026[1]
1. - Hypersensitivity to other aminoglycosides.
This is not medical advice. Consult a qualified healthcare professional.
When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
CONTRAINDICATIONS Amikacin Sulfate Injection is contraindicated in those patients with known allergy to amikacin or any components. A history of hypersensitivity or serious toxic reactions to aminoglycosides may contraindicate the use of any aminoglycoside because of the known cross-sensitivities of patients to drugs in this class.
WARNINGS Patients receiving Amikacin Sulfate Injection should be under close observation and evaluation because of the potential ototoxicity and nephrotoxicity associated with its use. Safety for treatment periods which are longer than 14 days has not been established.
Neurotoxicity, manifested as vestibular and/or bilateral auditory ototoxicity, can occur in patients treated with aminoglycosides. The risk of aminoglycoside-induced ototoxicity is greater in patients with impaired renal function, and in those who receive high doses, or in those whose therapy is prolonged.
High frequency deafness usually occurs first and can be detected only by audiometric testing. Vertigo may occur and may be evidence of vestibular injury. Other manifestations of neurotoxicity may include numbness, skin tingling, muscle twitching and convulsions.
The risk of ototoxicity due to aminoglycosides increases with the degree of exposure to either persistently high peak or high trough serum concentrations. Patients developing cochlear or vestibular damage may not have symptoms during therapy to warn them of developing eighth nerve toxicity, and total or partial irreversible bilateral deafness or disabling aminoglycoside-induced Page 4 of 23 ototoxicity is usually irreversible.
Aminoglycosides are potentially nephrotoxic. The risk of nephrotoxicity is greater in patients with impaired renal function, and in those who receive high doses, or in those whose therapy is prolonged. Renal and eighth-cranial nerve function should be closely monitored especially in patients with known or suspected renal impairment at the onset of therapy, and also in those whose renal function is initially normal but who develop signs of renal dysfunction during therapy.
Serum concentrations of amikacin should be monitored when feasible to assure adequate levels and to avoid potentially toxic levels. Urine should be examined for decreased specific gravity, increased excretion of proteins, and the presence of cells or casts.
Blood urea nitrogen, serum creatinine, or creatinine clearance should be measured periodically. Serial audiograms should be obtained where feasible in patients old enough to be tested, particularly high risk patients. Evidence of ototoxicity (dizziness, vertigo, tinnitus, roaring in the ears, and hearing loss) or nephrotoxicity requires discontinuation of the drug or dosage adjustment.
Concurrent and/or sequential systemic, oral, or topical use of other neurotoxic or nephrotoxic products, particularly bacitracin, cisplatin, amphotericin B, cephaloridine, paromomycin, viomycin, polymyxin B, colistin, vancomycin, or other aminoglycosides should be avoided.
Other factors that may cause increase risk of toxicity are advanced age and dehydration. The concurrent use of Amikacin Sulfate Injection with potent diuretics (ethacrynic acid, or furosemide) should be avoided since diuretics by themselves may cause ototoxicity.
In addition, when administered IV, diuretics may enhance aminoglycoside toxicity by altering antibiotic concentrations in serum and tissue. Neuromuscular blockade and respiratory paralysis have been reported following parenteral injection, topical instillation (as in orthopedic and abdominal irrigation or in local treatment of empyema), and following oral use of aminoglycosides.
The possibility of respiratory paralysis should be considered if aminoglycosides are administered by any route, especially in patients receiving anesthetics, neuromuscular blocking agents such as tubocurarine, succinylcholine, decamethonium, or in patients receiving massive transfusions of citrate anticoagulated blood.
If neuromuscular blockage occurs, calcium salts may reverse respiratory paralysis, but mechanical respiratory assistance may be necessary. Amikacin Sulfate Injection contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people.
The overall prevalence of sulfite sensitivity in the general population is uncommon and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic subjects. Page 5 of 23 If Amikacin Sulfate Injection is used concurrently with other antibacterial agents to treat mixed or superinfections, it should not be […]
Bacteriologic studies should be performed to identify causative organisms and their susceptibilities to amikacin. Amikacin may be considered as initial therapy in suspected Gram-negative infections and therapy may be instituted before obtaining the results of susceptibility testing.
Clinical trials demonstrated that amikacin was effective in infections caused by gentamicin- and/or tobramycin-resistant strains of Gram-negative organisms, particularly Proteus rettgeri , Providencia stuartii , Serratia marcescens , and Pseudomonas aeruginosa .
The decision to continue therapy with the drug should be based on results of the susceptibility tests, the severity of the infection, the response of the patient and the important additional considerations contained in the WARNINGS box above.
Amikacin has also been shown to be effective in staphylococcal infections and may be considered as initial therapy under certain conditions in the treatment of known or suspected staphylococcal disease such as, severe infections where the causative organism may be either a Gram-negative bacterium or a staphylococcus, infections due to susceptible strains of staphylococci in patients allergic to other antibiotics, and in mixed staphylococci/Gram-negative infections.
In certain severe infections such as neonatal sepsis, concomitant therapy with a penicillin-type drug may be indicated because of the possibility of infections due to Gram-positive organisms such as streptococci or pneumococci. To reduce the development of drug-resistant bacteria and maintain the effectiveness of amikacin and other antibacterial drugs, amikacin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
How to take
USOfficial regulatory label· revised April 8, 2024[3]
DOSAGE AND ADMINISTRATION
The patient’s pretreatment body weight should be obtained for calculation of correct dosage. Amikacin Sulfate Injection may be given intramuscularly or intravenously. The status of renal function should be estimated by measurement of the serum creatinine concentration or calculation of the endogenous creatinine clearance rate.
The blood urea nitrogen (BUN) is much less reliable for this purpose. Reassessment of renal function should be made periodically during therapy. Whenever possible, amikacin concentrations in serum should be measured to assure adequate but not excessive levels.
It is desirable to measure both peak and trough serum concentrations intermittently during therapy. Peak concentrations (30 to 90 minutes after injection) above 35 micrograms per mL and trough concentrations (just prior to the next dose) above 10 micrograms per mL should be avoided.
Dosage should be adjusted as indicated. 5 mg/kg q12h or 5 mg/kg q8h. 5 gram/day. 5 mg/kg every 12 hours. The usual duration of treatment is 7 to 10 days. It is desirable to limit the duration of treatment to short term whenever feasible.
The total daily dose by all routes of administration should not exceed 15 mg/kg/day. In difficult and complicated infections where treatment beyond 10 days is considered, the use of amikacin should be reevaluated. If continued, amikacin serum levels, and renal, auditory, and vestibular functions should be monitored.
At the recommended dosage level, uncomplicated infections due to amikacin-sensitive organisms should respond in 24 to 48 hours. If definite clinical response does not occur within 3 to 5 days, therapy should be stopped and the antibiotic susceptibility pattern of the invading organism should be rechecked.
Failure of the infection to respond may be due to resistance of the organism or to the presence of septic foci requiring surgical drainage. When amikacin is indicated in uncomplicated urinary tract infections, a dose of 250 mg twice daily may be used.
5 mg 475 mg 220 100 750 mg 500 mg Intramuscular Administration for Patients with Impaired Renal Function Whenever possible, serum amikacin concentrations should be monitored by appropriate assay procedures. Doses may be adjusted in patients with impaired renal function either by administering normal doses at prolonged intervals or by administering reduced doses at a fixed interval.
Both methods are based on the patient’s creatinine clearance or serum creatinine values since these have been found to correlate with aminoglycoside half-lives in patients with diminished renal function. These dosage schedules must be used in conjunction with careful clinical and laboratory observations of the patient and should be modified as necessary.
Neither method should be used when dialysis is being performed. 5 mg/kg) should be administered every 18 hours. Reduced Dosage at Fixed Time Intervals When renal function is impaired and it is desirable to administer amikacin at a fixed time interval, dosage must be reduced.
In these patients, serum amikacin concentrations should be measured to assure accurate administration of amikacin and to avoid concentrations above 35 mcg/mL. If serum assay determinations are not available and the patient’s condition is stable, serum creatinine and creatinine clearance values are the most readily available indicators of the degree of renal impairment to use as a guide for dosage.
5 mg/kg, as a loading dose. This loading dose is the same as the normally recommended dose which would be calculated for a patient with a normal renal function as described above. To determine the size of maintenance doses administered every 12 hours, the loading dose should be reduced in proportion to the reduction in the patient’s creatinine clearance rate: Maintenance Dose Every 12 hours = observed CC in mL/min X Calculated loading dose in mg normal CC in mL/min (CC - creatinine clearance rate) An alternate rough guide for determining reduced dosage at 12-hour intervals (for patients whose steady state serum creatinine values are known) is to divide the normally recommended dose by the patient’s serum creatinine.
The above dosage schedules are not intended to be rigid recommendations but are provided as guides to dosage when the measurement of amikacin serum levels is not feasible. Intravenous Administration The individual dose, the total daily dose, and the total cumulative dose of amikacin sulfate are identical to the dose recommended for intramuscular administration.
9% sodium chloride injection or 5% dextrose injection or any of the compatible solutions listed below. The solution is administered to adults over a 30 to 60 minute period. The total daily dose should not exceed 15 mg/kg/day and may be divided into either 2 or 3 equally-divided doses at equally-divided intervals.
In pediatric patients the amount of fluid used will depend on the amount of amikacin ordered for the patient. It should be a sufficient amount to infuse the Amikacin Sulfate Injection over a 30 to 60 minute period. Infants should receive a 1 to 2 hour infusion.
Amikacin should not be physically premixed with other drugs but should be administered separately according to the recommended dose and route. 25 and 5 mg/mL, solutions aged for 60 days at 4°C and then stored at 25°C had utility times of 24 hours.
At the same concentrations, solutions frozen and aged for 30 days at -15°C, thawed, and stored at 25°C had utility times of 24 hours. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
Aminoglycosides administered by any of the above routes should not be physically premixed with other drugs but should be administered separately. Because of the potential toxicity of aminoglycosides, “fixed dosage” recommendations which are not based upon body weight are not advised.
Rather, it is essential to calculate the dosage to fit the needs of each patient.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
USOfficial regulatory label· Adverse reactions· revised April 8, 2024[3]
ADVERSE REACTIONS
All aminoglycosides have the potential to induce auditory, vestibular, and renal toxicity and neuromuscular blockade (see WARNINGS box). They occur more frequently in patients with present or past history of renal impairment, of treatment with other ototoxic or nephrotoxic drugs, and in patients treated for longer periods and/or with higher doses than recommended.
Neurotoxicity-Ototoxicity Toxic effects on the eighth cranial nerve can result in hearing loss, loss of balance, or both. Amikacin primarily affects auditory function. Cochlear damage includes high frequency deafness and usually occurs before clinical hearing loss can be detected.
Neurotoxicity-Neuromuscular Blockade Acute muscular paralysis and apnea can occur following treatment with aminoglycoside drugs. Nephrotoxicity Elevation of serum creatinine, albuminuria, presence of red and white cells, casts, azotemia, and oliguria have been reported.
Renal function changes are usually reversible when the drug is discontinued. As would be expected with any aminoglycoside, reports of toxic nephropathy and acute renal failure have been received during postmarketing surveillance. Other In addition to those described above, other adverse reactions which have been reported on rare occasions are skin rash, drug fever, headache, paresthesia, tremor, nausea and vomiting, eosinophilia, arthralgia, anemia, hypotension and hypomagnesemia.
Macular infarction sometimes leading to permanent loss of vision has been reported following intravitreous administration (injection into the eye) of amikacin.
USOfficial regulatory label· Warnings and precautions· revised April 8, 2024[3]
WARNINGS
See WARNINGS box above. Aminoglycosides can cause fetal harm when administered to a pregnant woman. Aminoglycosides cross the placenta and there have been several reports of total irreversible, bilateral congenital deafness in children whose mothers received streptomycin during pregnancy.
Although serious side effects to the fetus or newborns have not been reported in the treatment of pregnant women with other aminoglycosides, the potential for harm exists. Reproduction studies of amikacin have been performed in rats and mice and revealed no evidence of impaired fertility or harm to the fetus due to amikacin.
There are no well controlled studies in pregnant women, but investigational experience does not include any positive evidence of adverse effects to the fetus. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.
Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low.
Sulfite sensitivity is seen more frequently in asthmatic than nonasthmatic people. Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Amikacin Sulfate Injection, and may range in severity from mild diarrhea to fatal colitis.
Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile . C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy.
CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated.
1555A>G variant. Ototoxicity occurred in some patients even when their aminoglycoside serum levels were within the recommended range. Mitochondrial DNA variants are present in less than 1 % of the general US population, and the proportion of the variant carriers who may develop ototoxicity as well as the severity of ototoxicity is unknown.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
USOfficial regulatory label· Contraindications· revised April 8, 2024[3]
CONTRAINDICATIONS A history of hypersensitivity to amikacin is a contraindication for its use. A history of hypersensitivity or serious toxic reactions to aminoglycosides may contraindicate the use of any other aminoglycoside because of the known cross-sensitivities of patients to drugs in this class.
This is not medical advice. Consult a qualified healthcare professional.
ARIKAYCE liposomal treatment should be initiated and managed by physicians experienced in the treatment of non-tuberculous lung disease due to Mycobacterium avium Complex. Posology The recommended dose is one vial (590 mg) administered once daily, by oral inhalation.
Duration of treatment Treatment with inhaled liposomal amikacin, as part of a combination antibacterial regimen, should be continued for 12 months after sputum culture conversion. Treatment with inhaled liposomal amikacin should not continue beyond a maximum of 6 months if sputum culture conversion (SCC) has not been confirmed by then.
The maximum duration of treatment with inhaled liposomal amikacin should not exceed 18 months. Missed doses If a daily dose of amikacin is missed, the next dose should be administered the next day. A double dose should not be given to make up for the missed dose.
Elderly No dose adjustment is required. 3 Hepatic impairment Inhaled liposomal amikacin has not been studied in patients with hepatic impairment. No dose adjustments based on hepatic impairment are required since amikacin is not hepatically metabolised.
Renal impairment Inhaled liposomal amikacin has not been studied in patients with renal impairment. 4). Paediatric population The safety and efficacy of inhaled liposomal amikacin in paediatric patients below 18 years of age have not been established.
No data are available. Method of administration Inhalation use Inhaled liposomal amikacin must only be used with the Lamira Nebuliser System (nebuliser handset, aerosol head and controller). 6. It must not be administered by any other route or using any other type of inhalation delivery system.
The amount delivered to the lungs will depend upon patient factors. 3 mg/min assuming the nebulisation time of 14 minutes. 0 μm as determined using the next generation impactor method.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
EUOfficial regulatory label· Adverse reactions· revised October 14, 2025[4]
2%). 9%). 0%). Tabulated list of adverse reactions Adverse drug reactions in Table 1 are listed according to system organ classes in MedDRA based on clinical trials and post marketing data. Within each system organ class, the following definitions apply to the frequency terminology used hereafter: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known: (cannot be estimated from the available data).
Table 1 – Summary of adverse reactions System Organ Class Adverse reactions Frequency category Infections and infestations Infective exacerbation of bronchiectasis Common Laryngitis Common Oral candidiasis Common Immune system disorders Anaphylactic reactions Not known Hypersensitivity reactions Not known Psychiatric disorders Anxiety Uncommon Nervous system disorders Headache Common Dizziness Common Dysgeusia Common Aphonia Common Balance disorder Common Ear and labyrinth disorders Tinnitus Common Deafness Common Respiratory, thoracic and mediastinal Dysphonia Very common disorders Dyspnoea Very common Cough Very common Haemoptysis Very common 7 System Organ Class Adverse reactions Frequency category Oropharyngeal pain Common Allergic alveolitis Common Chronic Obstructive Pulmonary Disease Common Wheezing Common Productive cough Common Sputum increased Common Bronchospasm Common Pneumonitis Common Vocal cord inflammation Common Throat irritation Common Pharyngeal swelling Not known Nasal dryness Not known Epistaxis Not known Rhinorrhoea Not known Sneezing Not known Nasal Congestion Not known Gastrointestinal disorders Diarrhoea Common Nausea Common Vomiting Common Dry mouth Common Decrease of appetite Common Dysphagia Not known Glossitis Not known Glossodynia Not known Salivary hypersecretion Not known Stomatitis Not known Abdominal pain Not known Abdominal pain upper Not known Abdominal discomfort Not known Abdominal distension Not known Skin and subcutaneous tissue disorders Rash Common Pruritus Common Musculoskeletal and connective tissue disorders Myalgia Common Arthralgia Common Renal and urinary disorders Renal impairment Common General disorders and administration site conditions Fatigue Common Pyrexia Common Chest discomfort Common Investigations Weight decreased Common Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 8 professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
EUOfficial regulatory label· Warnings and precautions· revised October 14, 2025[4]
Anaphylaxis and hypersensitivity reactions Serious and potentially life-threatening hypersensitivity reactions, including anaphylaxis, have been reported in patients taking inhaled liposomal amikacin. Before therapy with inhaled liposomal amikacin is instituted, an evaluation for previous hypersensitivity reactions to aminoglycosides should take place.
If anaphylaxis or a hypersensitivity reaction occurs, inhaled liposomal amikacin should be discontinued and appropriate supportive measures should be instituted. 8). 4 If allergic alveolitis occurs, treatment with inhaled liposomal amikacin should be discontinued and patients should be treated as medically appropriate.
Bronchospasm Bronchospasm has been reported with the use of inhaled liposomal amikacin in clinical studies. In patients with a history of reactive airway disease, asthma or bronchospasm, inhaled liposomal amikacin should be administered after using a short-acting bronchodilator.
8). Exacerbation of underlying pulmonary disease In clinical trials, exacerbation of underlying pulmonary disease (chronic obstructive pulmonary disease, infective exacerbation of chronic obstructive pulmonary disease, infective exacerbation of bronchiectasis) was reported with a higher frequency in patients treated with inhaled liposomal amikacin compared with patients not receiving inhaled liposomal amikacin.
Caution should be exercised when initiating inhaled liposomal amikacin in patients presenting with these underlying conditions. Discontinuation of treatment with inhaled liposomal amikacin should be considered if signs of exacerbation are observed.
Ototoxicity In clinical trials, ototoxicity, (including deafness, dizziness, presyncope, tinnitus, and vertigo) was reported with a higher frequency in patients treated with inhaled liposomal amikacin compared with patients not receiving inhaled liposomal amikacin.
Tinnitus was the most commonly reported ototoxicity related adverse reaction. Auditory and vestibular function should be monitored periodically in all patients and frequent monitoring is advised in patients with known or suspected auditory or vestibular dysfunction.
If ototoxicity occurs during treatment, consideration should be given to discontinuing inhaled liposomal amikacin. There is an increased risk of ototoxicity in patients with mitochondrial DNA mutations (particularly the nucleotide 1555 A to G substitution in the 12S rRNA gene), even if aminoglycoside serum levels are within the recommended range during treatment.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
EUOfficial regulatory label· Contraindications· revised October 14, 2025[4]
1. Hypersensitivity to soya. Co-administration with any aminoglycoside administered via any route of administration. Severe renal impairment.
This is not medical advice. Consult a qualified healthcare professional.
The safety of treatment over periods longer than 14 days has not been established. Other factors that increase the risk of aminoglycoside toxicity include advanced age and dehydration. Daily doses should be reduced and/or the interval between doses extended in the case of signs of renal dysfunction such as: cylindruria, the presence of leukocytes or red blood cells, albuminuria, reduction in creatinine clearance, decreased urine specific gravity, azotaemia, elevation of serum creatinine and oliguria.
Treatment must be discontinued if azotaemia increases or if urine volume decreases gradually. Elderly patients may have reduced renal function which may not be evident in routine screening tests such as BUN (blood urea nitrogen) or serum creatinine.
A creatinine clearance determination may be more useful. Monitoring of renal function in elderly patients during treatment with aminoglycosides is particularly important. During treatment the patient must be well-hydrated and renal function should be determined at the onset of treatment, particularly in patients with renal impairment.
Renal function should also be monitored closely during treatment. It is recommended to perform repeat audiometric examinations, especially in the case of patients at high risk. 2). Evidence of ototoxicity (dizziness, vertigo, tinnitus, roaring in the ears, and hearing loss) or nephrotoxicity requires discontinuation of the medicinal product or dose adjustment.
Inactivation of the aminoglycoside is clinically significant only in patients with severely impaired renal function. Inactivation may continue in specimens of body fluids collected for assay, resulting in inaccurate aminoglycoside readings.
Such specimens should be properly handled (assayed promptly, frozen, or treated with beta-lactamase). Neuromuscular toxicity Neuromuscular blockade and respiratory paralysis have been reported following parenteral injection, topical instillation (as in orthopaedic and abdominal irrigation or in local treatment of empyema) and following oral use of aminoglycosides.
5). If neuromuscular blockade occurs, calcium salts may reverse respiratory paralysis, but mechanical respiratory assistance may be necessary. Neuromuscular blockade and muscular paralysis have been demonstrated in laboratory animals given high doses of amikacin.
Administration of aminoglycosides to patients with neuromuscular disease such as myasthenia gravis or parkinsonism requires extreme caution, as aminoglycosides act on the neuro-muscular junction similarly to curare and they may thus worsen muscle weakness.
Other Aminoglycosides applied locally as part of a surgical procedure are quickly and nearly completely absorbed (with the exception of the urinary bladder). In association with irrigation of the surgical field using aminoglycoside preparations (regardless of the extent) development of irreversible deafness, renal failure and death due to neuromuscular blockade have been reported.
Paediatric population Aminoglycosides should be used with caution in premature and neonatal infants because of the renal immaturity of these patients and […]
In case of known maternal history of ototoxicity due to aminoglycoside use or a known mitochondrial DNA variant in the patient, consider alternative treatments other than aminoglycosides unless the increased risk of permanent hearing loss is outweighed by the severity of infection and lack of safe and effective alternative therapies.
Alternative treatment options should be considered in such patients. In patients with a maternal history of relevant mutations or aminoglycoside induced deafness, alternative treatments or genetic testing prior to administration should be considered.
Nephrotoxicity Nephrotoxicity was reported in clinical trials in patients treated with inhaled liposomal amikacin. Renal function should be monitored periodically during treatment in all patients and frequent monitoring is advised in patients with pre-existing renal dysfunction.
Consideration should be given to stopping inhaled liposomal amikacin in patients who develop evidence of nephrotoxicity on treatment. 3). Neuromuscular blockade In clinical trials, neuromuscular disorders (reported as muscle weakness, neuropathy peripheral and balance disorder) have been reported with inhaled liposomal amikacin.
Aminoglycosides may 5 aggravate muscle weakness because of a curare-like effect at the neuromuscular junction. Use of inhaled liposomal amikacin in patients with myasthenia gravis is not recommended. Patients with any known or suspected neuromuscular disorders should be closely monitored.
3). Co-administration with any other medicinal product affecting auditory function, vestibular function or renal function (including diuretics) is not recommended.