Aminoglycoside — Neonatal Sepsis / Gram-Negative Infections in Children Pregnancy: Gentamicin crosses the placenta with a risk of fetal ototoxicity (vestibulocochlear nerve damage) and/or renal damage. 'Gentamicin should not be used in pregnancy, except in case of life-threatening situations where expected benefits outweigh possible risks' — in such cases monitor maternal serum gentamicin concentrations and the infant's hearing and renal function. Excreted in breast milk and detected in low concentrations in the serum of breast-fed infants; if the infant's serum concentration exceeds 1 microgram/ml either breast-feeding or therapy may need to be discontinued under medical supervision (§4.6).

Gentamicin (Paediatric)

Brand names: Cidomycin, Genticin

Paediatric use of gentamicin, an aminoglycoside antibiotic, for serious Gram-negative and certain other infections including neonatal sepsis, usually given intravenously.

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: 3–5 mg/kg/day in adults with normal renal function, depending on the severity of infection

Route: Intravenous or intramuscular — the recommended dose and precautions for IM and IV administration are identical. IV should be injected directly into a vein or into the drip set tubing over no less than three minutes; if given by infusion, over 20–30 minutes in no greater volume of fluid than 100 ml (up to 60 minutes, in particular for once-daily dosing). Once-daily dosing should only be administered through the intravenous route

Frequency: As one single daily dose (preferred) or in two divided doses

SOURCE: eMC UK SPC, productName 'Cidomycin 80mg/2ml Solution for Injection', §4.2. VERBATIM: 'The recommended dose in adults with normal renal function is 3 – 5 mg/kg/day, depending on the severity of infection, administered as one single dose (preferred) or in two divided doses.' Dose should be adjusted according to clinical response and serum concentration levels; dose calculations should be based on IDEAL BODY WEIGHT. A dosing frequency of more than twice daily may be adopted for some specific pathogens or sites of infection as recommended in national and local guidance. Once daily dosing is NOT recommended in cases of endocarditis, depending on the responsible pathogens — follow national and local guidance for endocarditis. In patients with normal renal function, 160 mg once daily may be used for the treatment of urinary tract infections. MONITORING (§4.2): regular serum concentration monitoring is recommended for all patients, especially the elderly, newborns, obesity, impaired renal function and cystic fibrosis — 'Gentamicin should not be prescribed if serum concentrations cannot be monitored.' Trough levels measured at the end of a dosing interval should not exceed 1 mg/L for once-daily dosing or 2 mg/L for multiple daily dosing; levels above these indicate the need to EXTEND the dose interval, not reduce the dose. Peak levels should be measured one hour after an IV or IM bolus, or 30 minutes after the end of an infusion — a plasma concentration below 4 mg/L indicates the dose is likely inadequate; above 10 mg/L indicates increased risk of toxicity, particularly ototoxicity. ELDERLY: may be more susceptible to aminoglycoside toxicity; monitor closely with frequent serum levels, renal function and signs of ototoxicity. Duration of therapy should be the shortest possible compatible with clinical recovery. In significant obesity, monitor levels closely and consider a dose reduction (§4.4). Source §4.4 was truncated at the source-fetch limit and §4.5 (interactions) was not retrieved in this bundle.

Paediatric dose

Route: Intravenous or intramuscular (identical dose and precautions for both routes; once-daily dosing intravenously only)

Frequency: As one single daily dose (preferred) or in two divided doses; newborns are given the required daily dose in one single dose because of the longer half-life

Max: No absolute cap is stated in the source. Dosing is bounded by serum monitoring: trough should not exceed 1 mg/L (once daily) or 2 mg/L (multiple daily dosing); peak above 10 mg/L indicates increased risk of toxicity and a dose reduction should be considered

dosePerKg is left null because the SPC gives DAILY DOSE RANGES by age band, not a single per-kg figure. VERBATIM §4.2 'Paediatric population': 'The daily dose recommended in children aged 1 year and above and adolescents with normal renal function, is 3 – 6 mg/kg/day as one single dose (preferred) or two divided doses. The daily dose in infants after the first month of life is 4.5 – 7.5 mg/kg/day as one single dose (preferred) or two divided doses. The daily dose in neonates and pre-term infants (aged 0 – 4 weeks old) is 4 – 7 mg/kg/day. Due to the longer half-life, newborns are given the required daily dose in one single dose.' Serum level monitoring is specifically emphasised in newborns (§4.2) and neonates/infants are listed as a risk factor for ototoxicity (§4.4). Renal impairment in children requires dose reduction and/or interval extension guided by plasma levels. Verify all under-18 dosing against a children's formulary.

Dose adjustments

Renal

In impaired renal function the recommended daily dose must be decreased and adjusted to renal function, by reducing the dose and/or increasing the dose interval, with frequent monitoring of peak and trough concentrations and renal function. Nomograms based on age, weight and renal function are available; follow local guidance. No clear recommendation can be made for once-daily dosing — dosing should be guided by plasma concentration levels; for moderate renal impairment the dose interval should be at least 24 hours and extended according to the degree of impairment. Limited data in severe renal impairment (creatinine clearance below 30 ml/min) after once-daily dosing. ADULT MULTIPLE-DAILY-DOSE TABLE (§4.2): creatinine clearance above 70 ml/min — 80 mg 8-hourly; 30–70 ml/min — 80 mg 12-hourly; 10–30 ml/min — 80 mg daily; 5–10 ml/min — 80 mg every 48 hours; twice-weekly intermittent haemodialysis (below 5 ml/min) — 80 mg after dialysis. Use 60 mg instead of 80 mg if body weight is under 60 kg.

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.

Contraindications

Hypersensitivity to the active substance or to any of the excipients
Myasthenia gravis

Side effects

Vomiting (very common); stomatitis and nausea (not known)
Ototoxicity — vestibular damage, transitory hearing loss, irreversible hearing loss and deafness (not known); increased risk in patients with mitochondrial DNA mutations even when serum levels are within range (§4.4)
Nephrotoxicity, usually reversible (not known); acute renal failure and Fanconi-like syndrome after a prolonged course of high dose (very rare)
Hypersensitivity, anaphylaxis/anaphylactic reaction including anaphylactic shock (not known); Stevens-Johnson syndrome, toxic epidermal necrolysis, rash, purpura, urticaria, pruritus
Antibiotic-associated colitis including pseudomembranous colitis, superinfection with gentamicin-resistant bacteria, hypomagnesaemia on prolonged therapy, central neuropathy (convulsions, lethargy, encephalopathy) and peripheral neuropathy (all not known)

Interactions

Other ototoxic drugs — irreversible hearing loss and deafness reported particularly after exposure to ototoxic drugs or in the presence of renal dysfunction (§4.8)
Other nephrotoxic influences — risk of both ototoxicity and nephrotoxicity relates to total exposure; monitor vestibular, cochlear and renal function before, during and shortly after treatment (§4.4)
Drugs that inhibit peristalsis — should not be administered if diarrhoea or pseudomembranous colitis develops during or immediately after treatment (§4.4)
NOTE: SPC §4.5 (interaction with other medicinal products) was NOT retrieved in this source bundle — the clinician must verify the full interaction list before publishing

Clinical monograph

How it works

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

Prescribing in practice

Gentamicin is nephrotoxic and ototoxic (including irreversible vestibular and auditory damage), so therapeutic drug monitoring with measured levels is essential, particularly in neonates and renal impairment.
Neonatal dosing intervals are extended because of immature renal clearance and must be confirmed against a children's formulary and local neonatal protocols.
Avoid or use additional caution with other nephrotoxic or ototoxic drugs given concurrently.

Monitoring

Monitor gentamicin serum concentrations alongside renal function, and assess for auditory or vestibular toxicity during therapy.

Counselling the patient

Explain to parents that blood levels are taken to keep the dose safe and effective.
Report any hearing change, balance problems or reduced urine output.
Mention any family history of hearing loss, as some individuals are especially susceptible.

Evidence & guidelines

Gentamicin with therapeutic drug monitoring is standard for serious Gram-negative and neonatal infection per the SPC and neonatal/paediatric infection guidance.

Reference: BPNG Neonatal Formulary; PHE Neonatal Sepsis Guidelines; NICE NG195 (Neonatal Infection); 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