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Aminoglycoside Antibiotic 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 a parenteral aminoglycoside antibiotic used for serious Gram-negative infections, including those caused by organisms resistant to other aminoglycosides, and as part of regimens for certain mycobacterial infections.

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. (US label: uncomplicated urinary tract infections, a dose of 250 mg twice daily may be used.)

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

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).

Verify in a children's formulary

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 irreversibly to the bacterial 30S ribosomal subunit, causing misreading of mRNA and inhibition of protein synthesis, producing concentration-dependent bactericidal activity.

Prescribing in practice

  • Nephrotoxicity and irreversible ototoxicity, including vestibular and auditory damage, are the key risks, so therapeutic drug monitoring with dose adjustment for renal function and treatment duration is essential.
  • Avoid where possible concurrent nephrotoxic or ototoxic agents, and use with particular caution in the elderly and those with pre-existing renal or auditory impairment.
  • It can potentiate neuromuscular blockade, so caution is needed in myasthenia gravis and with neuromuscular blocking agents.

Monitoring

Monitor serum amikacin concentrations, renal function and, where prolonged, auditory and vestibular function throughout treatment.

Counselling the patient

  • Report any hearing changes, ringing in the ears, dizziness or balance problems promptly.
  • Tell the team about reduced urine output or new swelling.
  • Blood tests are needed to keep the drug level in the safe range.

Evidence & guidelines

Aminoglycoside therapeutic drug monitoring to minimise nephro- and ototoxicity is standard UK practice, supported by national antimicrobial and prescribing guidance.

Reference: BSAC Guidelines on aminoglycoside use (2011, updated); NICE NG33 (TB, 2016 updated); PHE/UKHSA AMR 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).

Related

Curated clinical cross-links plus same-class fallbacks.