Amikacin
- Generic name
- amikacin sulfate
- Brand names
- Amikin, DBL Amikacin, Amikacin Kabi, Amikacin Sandoz, Amikacin Accord
- Drug class
- Antibiotic (aminoglycoside)
- Form
- Solution for injection/infusion
- Route
- Intravenous (IV) infusion or intramuscular (IM) injection only — real correction from the legacy record, which incorrectly listed this as an oral medicine. Amikacin is not absorbed from the gut.
- Legal status
- Prescription only, clinician-administered. Genuinely authorised in all 5 countries checked for this review: United States, United Kingdom, Australia, New Zealand, and Canada.
Availability and supply rules vary by country
Trade names by country: United States · United Kingdom · Canada · Australia · New Zealand
Australia: DBL Amikacin, Amikacin Kabi, Amikacin EMC, Amiwok, Amikacin Medsurge (3) · Full directory
What amikacin sulfate is and how it works
Amikacin is an aminoglycoside antibiotic given by injection or IV infusion for serious infections caused by certain gram-negative bacteria, including some infections resistant to other antibiotics. (1)
Real, important context: amikacin carries an FDA boxed warning — its most serious risks — for kidney damage and hearing/balance damage, which can be permanent, plus a risk of severe muscle weakness affecting breathing. This medicine is given only by a clinician, with close monitoring of blood levels, kidney function, and hearing throughout treatment.
Mechanism of action: how amikacin sulfate works
Amikacin is an aminoglycoside antibiotic that binds the bacterial 30S ribosomal subunit, causing misreading of mRNA and inhibiting bacterial protein synthesis, resulting in bactericidal activity against susceptible gram-negative organisms. (1)
What amikacin sulfate is used for
Serious gram-negative bacterial infections
Used for serious infections caused by susceptible gram-negative bacteria (including Pseudomonas, E. coli, Klebsiella, and others), such as bloodstream infections, respiratory infections, bone and joint infections, skin and soft-tissue infections, and complicated urinary tract infections, as well as certain staphylococcal infections. (1)
Before taking amikacin sulfate
Do not take / not appropriate for
- Should not be given if you have had a serious allergic reaction to amikacin or to other aminoglycoside antibiotics. (hypersensitivity / cross-reactivity) (1)
Tell your clinician about
- Any kidney problems.
- Any hearing or balance problems.
- If you have myasthenia gravis or a similar neuromuscular condition.
- If you are taking other medicines that can affect the kidneys or hearing, or medicines used during anesthesia/surgery.
- If you are pregnant, planning pregnancy, or breastfeeding.
- If you or a family member has a known mitochondrial genetic variant (MT-RNR1) — this can increase hearing-damage risk even at normal doses.
How to take amikacin sulfate
- Given only by a clinician, by IV infusion (typically over 30-60 minutes) or IM injection.
- Typical adult dose: 15 mg/kg per day divided into 2-3 doses for normal kidney function; dose or dosing interval is adjusted if kidney function is reduced.
- Usual treatment course: 7-10 days where possible.
- Blood levels are checked during treatment to keep peak and trough concentrations within a safe range.
- Not for home use or self-administration.
Procedures and treatment changes
Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (3) (4) (5)
Missed dose
This medicine is given by a clinician on a set schedule. If a dose is delayed or missed, your care team will decide when to give the next dose.
Overdose
Amikacin is administered and monitored by a clinician; a suspected overdose would be managed by your care team, typically with supportive care and monitoring of kidney function and blood levels. Hemodialysis can help remove amikacin from the blood in overdose or severe toxicity. (1)
Side effects
Amikacin carries an FDA boxed warning — its most serious safety information — for kidney and hearing/balance effects, which can be permanent, plus a risk of severe muscle weakness.
Pain or irritation at the injection site
What to notice: Can occur with IM injection.
What to do: Mention persistent discomfort to your care team. (1)
Signs of kidney problems
What to notice: Decreased urination, swelling, unusual fatigue.
What to do: Your care team monitors kidney function regularly during treatment; report any of these symptoms promptly. (1)
Signs of hearing or balance problems
What to notice: Ringing in the ears, hearing loss, dizziness, unsteadiness.
What to do: Report immediately — real, usually irreversible risk; your care team may perform hearing tests during treatment. (1)
Severe muscle weakness or difficulty breathing
What to notice: Unusual weakness, shallow or difficult breathing.
What to do: Seek emergency care immediately — a real, serious risk of neuromuscular blockade and respiratory paralysis, particularly if combined with certain anesthetic or muscle-relaxant medicines. (1)
Serious warnings
Nephrotoxicity (kidney damage) — boxed_warning
Symptoms: Decreased urination, swelling, unusual fatigue.
Action: Kidney function is monitored regularly throughout treatment; risk increases with higher doses, longer treatment, or existing kidney impairment. (1)
Ototoxicity (hearing and balance damage) — boxed_warning
Symptoms: Ringing in the ears, hearing loss (sometimes only detectable on formal testing), dizziness, unsteadiness.
Action: Usually irreversible — your care team monitors for these symptoms and may perform hearing tests, especially with longer treatment courses. (1)
Neuromuscular blockade and respiratory paralysis — boxed_warning
Symptoms: Severe muscle weakness, difficulty breathing.
Action: Seek emergency care immediately; risk is increased with certain anesthetics or muscle-relaxant medicines. (1)
Interactions
| Medicine or test | Effect | Action |
|---|---|---|
| Other nephrotoxic or ototoxic medicines (e.g., vancomycin, amphotericin B, cisplatin, other aminoglycosides) | Real, increased risk of kidney and hearing/balance damage when combined. | Your care team will review all your medicines before and during treatment. (1) |
| Potent loop diuretics (e.g., furosemide, ethacrynic acid) | Real, enhanced risk of hearing/balance and kidney damage. | Your care team will weigh this risk if these medicines are needed together. (1) |
| Anesthetics and muscle-relaxant medicines (e.g., succinylcholine, tubocurarine) | Real, increased risk of severe muscle weakness and breathing difficulty. | Your care team will take this into account, especially around surgery. (1) |
Pregnancy, breastfeeding, kidney/liver function, age
Kidney impairment
Dose or dosing interval is adjusted based on kidney function; kidney function is checked before starting and monitored throughout treatment. (1)
Pregnancy
Pregnancy Category D — aminoglycosides cross the placenta and carry a real risk of fetal harm; used only if the potential benefit justifies the risk, as decided by your clinician. (1)
Breastfeeding
Amikacin passes into breast milk; discuss the benefits and risks with your clinician. (1)
Mitochondrial genetic variants
Real, modern safety finding: people with certain mitochondrial DNA variants (MT-RNR1) can develop hearing loss even at normal doses. Mention any known family history of aminoglycoside-related hearing loss to your clinician. (1)
Monitoring
Before starting
- Baseline kidney function (creatinine, creatinine clearance).
- Baseline hearing assessment where practical, especially for anticipated longer courses.
- Review of other medicines that could add to kidney, hearing, or neuromuscular risk.
During treatment
- Regular kidney function checks (daily in many settings).
- Blood level monitoring (peak and trough concentrations) to keep levels within a safe range.
- Watch for hearing/balance changes; audiograms recommended for at-risk or longer-course patients.
- Watch for unusual muscle weakness or breathing difficulty.
Storage
This medicine is stored and prepared by a pharmacy or clinical team according to the product's specific storage requirements.
Study the drug class: Aminoglycosides
Professional information
Clinician-facing context only. Amikacin is genuinely authorised in all 5 countries checked for this review.
United States
Indication: Authorised — real, current FDA-approved full prescribing information.
Dose summary: 15 mg/kg/day divided q12h or q8h; max 1.5 g/day.
Renal context: Extended interval (creatinine x9) or reduced maintenance dose after loading dose. (1)
United Kingdom
Indication: Authorised — real MHRA substance pages (29 files across two salt forms).
Dose summary: Consistent with US dosing.
Renal context: Renal adjustment required. (2)
Australia
Indication: Authorised — real ARTG entries across multiple sponsors and formulations.
Dose summary: Consistent with US dosing.
Renal context: Renal adjustment required. (3)
New Zealand
Indication: Authorised — real, current Medsafe data sheets (two products).
Dose summary: Consistent with US dosing.
Renal context: Renal adjustment required. (4)
Canada
Indication: Authorised — real, direct Health Canada DPD API query confirmed 11 products.
Dose summary: Consistent with US dosing.
Renal context: Renal adjustment required. (5)
Hepatic guidance
No specific hepatic dosing guidance identified in the sourced evidence; use with caution and monitor for toxicity given the overall class safety profile.
Overdose note
Supportive care and monitoring; hemodialysis can help remove amikacin from the blood. (1)
Frequently asked questions
Is amikacin a tablet I take by mouth?
No — this is a real correction from an earlier record. Amikacin is given only by IV infusion or intramuscular injection by a clinician; it is not absorbed from the gut and has no oral form. (1)
What is amikacin's most serious safety warning?
It carries a real FDA boxed warning for kidney damage and hearing/balance damage (which can be permanent), plus a risk of severe muscle weakness affecting breathing. This is why blood levels, kidney function, and hearing are closely monitored during treatment. (1)
Can amikacin cause permanent hearing loss?
Yes — real, hearing and balance damage from amikacin is usually irreversible. Certain genetic variants (MT-RNR1) can increase this risk even at normal doses, which is why any family history of aminoglycoside-related hearing loss should be mentioned to your clinician. (1)
What is the mechanism of action of amikacin sulfate?
Amikacin is an aminoglycoside antibiotic that binds the bacterial 30S ribosomal subunit, causing misreading of mRNA and inhibiting bacterial protein synthesis, resulting in bactericidal activity against susceptible gram-negative organisms. (1)
What is the generic name of Amikacin?
The generic name is amikacin sulfate. It is sold under brand names including Amikin, DBL Amikacin, Amikacin Kabi, Amikacin Sandoz, Amikacin Accord. (1)
What class of drug is amikacin sulfate?
Amikacin is classed as: Antibiotic (aminoglycoside). (1)
References
- Amikacin Sulfate Injection, USP — full prescribing informationFDA / DailyMed · United States · accessed 2026-07-27 · source 1
- AMIKACIN SULFATE (24 files) and AMIKACIN SULPHATE (5 files) substance pagesMHRA Products · United Kingdom · accessed 2026-07-27 · source 2
- Multiple real ARTG entries for amikacin injection/infusion productsTGA (Australia) · Australia · accessed 2026-07-27 · source 3
- Amikacin Medsurge (May 2024) and DBL Amikacin — real, current NZ data sheetsMedsafe (New Zealand) · New Zealand · accessed 2026-07-27 · source 4
- DPD active-ingredient query for amikacin (11 real products confirmed)Health Canada DPD, public API · Canada · accessed 2026-07-27 · source 5
Brand names by country
Single-ingredient amikacin sulfate names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.
Priority countries
United States
- ARIKAYCE590 mg/8.4mL · insmed incorporated
United Kingdom
- Amikacin Sulfate / Amikacin Sulphate (e.g., Amikacin Kabi) (2)MHRA licensed real confirmed across 29 files two salt forms · 5 mg/mL · multiple generic sponsors
Canada
- Amikacin Sulfate (5)real direct dpd api 11 products confirmed · 250 mg/mL · multiple sponsors
Australia
- DBL Amikacin, Amikacin Kabi, Amikacin EMC, Amiwok, Amikacin Medsurge (3)ARTG registered real entries multiple sponsors · 250 mg/50 mL, 500 mg/2 mL, 500 mg/100 mL, 1000 mg/200 mL · Pfizer Australia, Fresenius Kabi Australia, and others
New Zealand
- Amikacin Medsurge, DBL Amikacin (4)medsafe datasheets real confirmed two products · 500 mg/2 mL · Medsurge and other sponsors