Aminoglycoside — Drug-Resistant Gram-Negative / MDR-TB Pregnancy: Safety in pregnancy not established; aminoglycosides cross the placenta and can cause fetal harm (reports of congenital deafness with other aminoglycosides). Administer only when clearly needed and under medical supervision. Decide whether to discontinue breast-feeding or 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 (adults and children over 12 years with normal renal function, creatinine clearance >=50 ml/min)

Route: intramuscular or intravenous (slow bolus over 2-3 min, or infusion over 30 min)

Frequency: as a single daily dose, or divided into 2 equal doses (7.5 mg/kg every 12 hours)

Max: 1.5 g total daily dose

Obtain pre-treatment bodyweight for dose calculation and estimate renal function before/during therapy. In endocarditis and in febrile neutropenic patients, dose twice daily (insufficient data to support once-daily dosing). Aim to keep peak concentrations (30-90 min post-injection) below 35 mcg/ml and trough (just before next dose) below 10 mcg/ml; adjust dose to serum levels. IM route preferred for most infections; IV in life-threatening infections. Safety beyond 14 days not established.

Paediatric dose

Dose: 15 mg/kg

Route: intramuscular or intravenous (slow infusion)

Frequency: once a day (15-20 mg/kg/day range); or 7.5 mg/kg every 12 hours

Children 4 weeks to 12 years with normal renal function: 15-20 mg/kg/day given as 15-20 mg/kg once daily, or 7.5 mg/kg q12h. In endocarditis and febrile neutropenic patients, dose twice daily. Neonates: initial loading dose 10 mg/kg followed by 7.5 mg/kg q12h. Premature infants: 7.5 mg/kg (dosing interval truncated in source - clinician to confirm from full SPC).

Dose adjustments

Renal

Reduce dosage if evidence of renal dysfunction. Caution in pre-existing renal insufficiency; assess renal function before and daily during treatment. Stop treatment if azotaemia increases or urinary 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.

Paediatric weight-based calculator

Patient weight (kg)

Verify in a children's formulary

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/hypersensitivity to amikacin or any component of the formulation
History of hypersensitivity or serious toxic reactions to aminoglycosides (cross-sensitivity within class)
Myasthenia gravis (aminoglycosides may impair neuromuscular transmission)

Side effects

Nausea, vomiting (uncommon)
Rash (uncommon)
Ototoxicity - tinnitus, hypoacusis, deafness (rare / not known)
Nephrotoxicity - acute renal failure, toxic nephropathy, raised creatinine, albuminuria (rare / not known)
Anaphylactic response, hypersensitivity (not known)

Interactions

Other neurotoxic or nephrotoxic products (e.g. bacitracin, cisplatin, amphotericin B, cephaloridine, paromomycin, viomycin, polymyxin B, colistin, vancomycin) - concurrent/sequential oral or topical use

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.

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