Aminoglycoside — Drug-Resistant Gram-Negative / MDR-TB Pregnancy: Safety in pregnancy has not been established. Aminoglycosides cross the placenta and can cause foetal harm — there have been reports of total, irreversible, bilateral congenital deafness in children whose mothers received streptomycin during pregnancy, and adverse effects on the foetus or newborn have been reported with other aminoglycosides. Give to pregnant women and neonatal infants only when clearly needed and under medical supervision, and apprise the patient of the potential hazard to the foetus. Amikacin is excreted in human milk — decide whether to discontinue breast-feeding or to discontinue therapy.

Amikacin

Brand names: Amikin

Amikacin is an aminoglycoside antibiotic, usually reserved for serious aerobic Gram-negative infection resistant to gentamicin, and used as part of combination regimens for some mycobacterial disease. It is given parenterally and requires careful monitoring.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: 15 mg/kg/day for adults and adolescents with normal renal function (creatinine clearance 50 mL/min or greater), given as a single daily dose or divided into 2 equal doses of 7.5 mg/kg every 12 hours

Route: Intramuscular or intravenous. The intramuscular route is preferred for most infections; in life-threatening infections, or where intramuscular injection is not feasible, give intravenously as a slow bolus over 2 to 3 minutes or as an infusion (0.25% solution over 30 minutes). Intravenous solutions are administered to adults over a 30 to 60 minute period

Frequency: Once daily, or 7.5 mg/kg 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

Max: The total daily dose should not exceed 1.5 g. Total daily dose by all routes of administration should not exceed 15-20 mg/kg/day. A maximum total adult dose of 15 g should not be exceeded

Source: eMC SPC for Amikacin 250 mg/ml Injection (bundle is byte-identical to the one supplied for id 'amikacin'). Obtain the patient's pre-treatment bodyweight to calculate the correct dosage, and estimate renal function (serum creatinine or calculated endogenous creatinine clearance; blood urea nitrogen is much less reliable) before and periodically during therapy. Where possible measure both peak and trough serum amikacin concentrations intermittently: avoid peaks (30-90 minutes after injection) above 35 micrograms/mL and troughs (just prior to the next dose) above 10 micrograms/mL, and adjust the dose accordingly; with once-daily dosing in patients with normal renal function peak concentrations may exceed 35 micrograms/mL. Usual duration of treatment is 7 to 10 days; uncomplicated infections due to sensitive organisms should respond within 24 to 48 hours, and if there is no clinical response within 3 to 5 days consider alternative therapy and recheck susceptibility. If treatment beyond 10 days is considered, re-evaluate and monitor renal, auditory and vestibular function plus serum amikacin levels. Life-threatening infections and/or those caused by Pseudomonas: the adult dose may be increased to 500 mg every eight hours, but should never exceed 1.5 g/day nor be given for longer than 10 days. Urinary tract infections other than Pseudomonas infections: 7.5 mg/kg/day in two equally divided doses (equivalent to 250 mg twice daily in adults); a urinary alkalinising agent may be given concurrently as activity is enhanced by increasing the pH. Intraperitoneal use (after exploration for established peritonitis or faecal spill) and irrigation of abscess cavities, the pleural space, the peritoneum and the cerebral ventricles: 0.25% (2.5 mg/mL) — intraperitoneal use is not recommended in young children. Do not physically premix amikacin with other drugs. Suitable diluents for intravenous use are normal saline and 5% dextrose in water; once diluted the solution must be used as soon as possible and NOT STORED. Elderly: assess renal function wherever possible and adjust dosage as for renal impairment. Safety for treatment periods longer than 14 days has not been established; obtain a pre-treatment audiogram and repeat during therapy if therapy is expected to last 7 days or more in renal impairment, or 10 days in other patients. NOT IN SOURCE: this SPC contains no MDR-tuberculosis regimen — the page's prior 'TB (MDR)' dosing is not traceable to this bundle and must be sourced separately. PROVENANCE CAVEAT: §4.5 (interactions) was not included in this bundle, and §4.4 and §4.8 are marked truncated at the source-fetch limit — do not treat the fetched text as the complete posology or safety profile.

Paediatric dose

Route: Intramuscular or intravenous (slow intravenous infusion). Infuse normally over 30 to 60 minutes; infants should receive a 1 to 2 hour infusion. In paediatric patients the amount of diluent used will depend on the amount of amikacin tolerated by the patient

Frequency: Once a day, or 7.5 mg/kg every 12 hours. In endocarditis and in febrile neutropenic patients dosing should be twice daily

Max: Total daily dose by all routes of administration should not exceed 15-20 mg/kg/day

Children 4 weeks to 12 years with normal renal function: 15-20 mg/kg/day, which may be given as 15-20 mg/kg once a day, or as 7.5 mg/kg every 12 hours (stated as a range in the SPC, so no single per-kg figure is recorded here). Neonates: an initial loading dose of 10 mg/kg followed by 7.5 mg/kg every 12 hours. Premature infants: 7.5 mg/kg every 12 hours. Adults and children over 12 years follow the adult regimen. Usual duration of treatment is 7 to 10 days. Verify against a children's formulary.

Dose adjustments

Renal

In patients with creatinine clearance below 50 mL/min, administration of the recommended total daily dose as a single daily dose is not desirable because of protracted exposure to high trough concentrations. Adjust either by giving normal doses at prolonged intervals or reduced doses at fixed intervals, monitoring serum amikacin concentrations wherever possible. Prolonged-interval method: if creatinine clearance is unavailable and the patient is stable, the dosage interval in hours for the normal single 7.5 mg/kg dose can be calculated by multiplying the serum creatinine (mg/100 mL) by nine — e.g. serum creatinine 2 mg/100 mL means 7.5 mg/kg every 18 hours. Fixed-interval method: initiate with a normal 7.5 mg/kg loading dose, then reduce the 12-hourly maintenance dose in proportion to the reduction in creatinine clearance (an alternative rough guide is to divide the normally recommended dose by the serum creatinine). Check serum creatinine frequently as renal function may alter appreciably during therapy, and modify the regimen when dialysis is being performed. Reduce the dose if evidence of renal dysfunction occurs (urinary casts, white or red cells, albuminuria, decreased creatinine clearance, decreased urine specific gravity, increased BUN or serum creatinine, oliguria); stop treatment if azotaemia increases or urine output progressively decreases.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

US labelling (FDA)

Reference — US labelling, may differ from UK

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 …

Source: US FDA prescribing information (openFDA / DailyMed), label dated 2024-04-08. Accessed 2026-06-12. US dosing and indications can differ from UK practice — use UK sources for prescribing decisions.

Contraindications

Known allergy to amikacin or any component of the formulation; hypersensitivity to the active substance or any excipient
A history of hypersensitivity or serious toxic reactions to aminoglycosides may contraindicate the use of any aminoglycoside because of known cross-sensitivity within the class
Myasthenia gravis — aminoglycosides may impair neuromuscular transmission

Side effects

Ototoxicity — tinnitus, hypoacusis, balance disorder (rare); deafness and sensorineural deafness (frequency not known). Amikacin primarily affects auditory function; cochlear damage includes high-frequency deafness and usually occurs before clinical hearing loss is detectable
Nephrotoxicity — acute renal failure, toxic nephropathy, cells in urine (not known); oliguria, increased blood creatinine, albuminuria, azotaemia, red and white blood cells in urine (rare). Renal function changes are usually reversible on discontinuation
Neuromuscular blockade — paralysis and apnoea (not known); tremor, paraesthesia, muscle twitching (rare)
Nausea, vomiting and rash (uncommon); pruritus and urticaria (rare)
Anaphylactic response (anaphylactic reaction, anaphylactic shock, anaphylactoid reaction) and hypersensitivity (frequency not known); rare anaemia, eosinophilia, hypomagnesaemia, hypotension, arthralgia, pyrexia

Interactions

Concurrent and/or sequential oral or topical use of other neurotoxic or nephrotoxic products, particularly bacitracin, cisplatin, amphotericin B, cephaloridine, paromomycin, viomycin, polymyxin B, colistin or vancomycin (stated in SPC §4.4; §4.5 was not retrieved in this bundle and the §4.4 list is truncated at the source-fetch limit)

Clinical monograph

How it works

It binds the bacterial 30S ribosomal subunit, causing misreading of messenger RNA and inhibiting protein synthesis, giving concentration-dependent bactericidal activity against many Gram-negative organisms; its structure resists several enzymes that inactivate other aminoglycosides.

Prescribing in practice

It is nephrotoxic and ototoxic — both auditory and vestibular damage can occur and may be irreversible — so it requires therapeutic drug monitoring and renal monitoring, with greater risk alongside other nephrotoxic or ototoxic drugs.
Doses must be adjusted for renal function and guided by levels; cumulative exposure (high troughs, prolonged courses) drives toxicity.
Use caution in myasthenia gravis and other neuromuscular disorders, as aminoglycosides can impair neuromuscular transmission.

Monitoring

Monitor serum amikacin levels (to guide dosing and avoid accumulation), renal function, and hearing and balance during treatment, especially with prolonged courses or pre-existing impairment.

Counselling the patient

Report any new hearing loss, ringing in the ears, dizziness or unsteadiness promptly.
Report a marked reduction in urine output or other signs of kidney problems.

Evidence & guidelines

Reserved for gentamicin-resistant Gram-negative infection and adjunctive mycobacterial therapy per local antimicrobial and specialist guidance, within antibiotic-stewardship principles.

Reference: WHO MDR-TB Treatment Guidelines 2022; BSAC Aminoglycoside TDM Guidelines; PHE Antibiotic Guidelines; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

Calculators

Pathways