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Anticonvulsant (SV2A Ligand) Pregnancy: §4.6: a large amount of post-marketing data on levetiracetam monotherapy in pregnancy (more than 1800 exposures) does not suggest an increase in the risk of major congenital malformations, and registry data in over 1000 exposed children do not suggest an increased risk of autism spectrum disorders or intellectual disability. Levetiracetam can be used during pregnancy if, after careful assessment, it is considered clinically needed, at the lowest effective dose. Plasma concentrations fall during pregnancy, most markedly in the third trimester (up to 60% of pre-pregnancy baseline). Sudden discontinuation should be avoided. Levetiracetam is excreted in human breast milk, so breast-feeding is not recommended; if treatment is needed during breastfeeding the benefit/risk should be weighed.

Levetiracetam (Paediatric)

Brand names: Keppra

Levetiracetam (paediatric) is an antiepileptic drug used in children for focal seizures and, as adjunctive therapy, for myoclonic and primary generalised tonic-clonic seizures. This page covers its use in the paediatric population.

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: Initial therapeutic dose 500 mg twice daily (a lower initial dose of 250 mg twice daily may be given based on physician assessment, increased to 500 mg twice daily after two weeks); depending on clinical response and tolerability the daily dose can be increased up to 1500 mg twice daily
Route: Intravenous infusion — the recommended dose must be diluted in at least 100 ml of a compatible diluent and administered as a 15-minute intravenous infusion (this SPC is the IV concentrate; §4.2 states therapy can be initiated with either intravenous or oral administration and conversion between them can be done directly without titration, maintaining the total daily dose and frequency)
Frequency: Twice daily
Max: 1500 mg twice daily
IMPORTANT SOURCE CAVEAT: the fetched SPC is the intravenous product — UK SPC (eMC) for Levetiracetam 100 mg/ml concentrate for solution for infusion, §4.2 (https://www.medicines.org.uk/emc/product/11035/smpc). If the page needs oral tablet/solution posology, confirm against the corresponding oral SPC (the SPC states IV and oral are directly interchangeable at the same total daily dose). The adult regimen applies to adults (≥18 years) and adolescents (12 to 17 years) weighing 50 kg or more. Dose changes can be made in 250 mg or 500 mg twice daily increases or decreases every two to four weeks. DURATION: there is no experience with administration of intravenous levetiracetam for longer than 4 days. DISCONTINUATION: withdraw gradually — in adults and adolescents weighing more than 50 kg, 500 mg decreases twice daily every two to four weeks; in children and adolescents weighing less than 50 kg, the dose decrease should not exceed 10 mg/kg twice daily every two weeks. HEPATIC IMPAIRMENT: no dose adjustment in mild to moderate impairment; in severe hepatic impairment creatinine clearance may underestimate renal insufficiency, so a 50% reduction of the daily maintenance dose is recommended when creatinine clearance is <60 ml/min/1.73 m². ELDERLY: adjustment recommended in elderly patients with compromised renal function. MONOTHERAPY: safety and efficacy of the IV concentrate in children and adolescents below 16 years as monotherapy have not been established; adolescents 16–17 years weighing 50 kg or more with newly diagnosed partial onset seizures are dosed as adults.

Paediatric dose

Dose: 10 mg/kg
Route: Intravenous infusion (diluted in at least 100 ml of compatible diluent, given over 15 minutes)
Frequency: Twice daily
Max: Up to 30 mg/kg twice daily; dose in children and adolescents weighing 50 kg or more is the same as in adults (maximum 1500 mg twice daily)
SPC §4.2, add-on therapy for children aged 4 to 11 years and adolescents (12 to 17 years) weighing less than 50 kg: 'The initial therapeutic dose is 10 mg/kg twice daily. Depending upon the clinical response and tolerability, the dose can be increased up to 30 mg/kg twice daily. Dose changes should not exceed increases or decreases of 10 mg/kg twice daily every two weeks. The lowest effective dose should be used.' Worked examples from the SPC table (starting dose / maximum dose): 15 kg — 150 mg twice daily / 450 mg twice daily; 20 kg — 200 mg twice daily / 600 mg twice daily; 25 kg — 250 mg twice daily / 750 mg twice daily; from 50 kg — 500 mg twice daily / 1500 mg twice daily. Children weighing 25 kg or less should preferably start treatment with levetiracetam 100 mg/ml oral solution. Safety and efficacy of this IV concentrate in infants and children less than 4 years have not been established and no posology recommendation can be made. Renal impairment in children/adolescents under 50 kg (CLcr ml/min/1.73 m²): normal >80 — 10 to 30 mg/kg twice daily; mild 50–79 — 10 to 20 mg/kg twice daily; moderate 30–49 — 5 to 15 mg/kg twice daily; severe <30 — 5 to 10 mg/kg twice daily; end-stage renal disease on dialysis — 10 to 20 mg/kg once daily, with a 15 mg/kg loading dose on the first day and a 5 to 10 mg/kg supplemental dose following dialysis. Verify all paediatric dosing against a children's formulary before prescribing.

Dose adjustments

Renal

The daily dose must be individualised according to renal function. Adults and adolescents weighing 50 kg or more (creatinine clearance ml/min/1.73 m²): normal >80 — 500 to 1500 mg twice daily; mild 50–79 — 500 to 1000 mg twice daily; moderate 30–49 — 250 to 750 mg twice daily; severe <30 — 250 to 500 mg twice daily; end-stage renal disease on dialysis — 500 to 1000 mg once daily, with a 750 mg loading dose on the first day of treatment and a 250 to 500 mg supplemental dose following dialysis. For children and adolescents weighing less than 50 kg see the paedDose notes. In severe hepatic impairment, reduce the daily maintenance dose by 50% when creatinine clearance is <60 ml/min/1.73 m².

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

SPC §4.2, add-on therapy for children aged 4 to 11 years and adolescents (12 to 17 years) weighing less than 50 kg: 'The initial therapeutic dose is 10 mg/kg twice daily. Depending upon the clinical response and tolerability, the dose can be increased up to 30 mg/kg twice daily. Dose changes should not exceed increases or decreases of 10 mg/kg twice daily every two weeks. The lowest effective dose should be used.' Worked examples from the SPC table (starting dose / maximum dose): 15 kg — 150 mg twice daily / 450 mg twice daily; 20 kg — 200 mg twice daily / 600 mg twice daily; 25 kg — 250 mg twice daily / 750 mg twice daily; from 50 kg — 500 mg twice daily / 1500 mg twice daily. Children weighing 25 kg or less should preferably start treatment with levetiracetam 100 mg/ml oral solution. Safety and efficacy of this IV concentrate in infants and children less than 4 years have not been established and no posology recommendation can be made. Renal impairment in children/adolescents under 50 kg (CLcr ml/min/1.73 m²): normal >80 — 10 to 30 mg/kg twice daily; mild 50–79 — 10 to 20 mg/kg twice daily; moderate 30–49 — 5 to 15 mg/kg twice daily; severe <30 — 5 to 10 mg/kg twice daily; end-stage renal disease on dialysis — 10 to 20 mg/kg once daily, with a 15 mg/kg loading dose on the first day and a 5 to 10 mg/kg supplemental dose following dialysis. Verify all paediatric dosing against a children's formulary before prescribing.

Verify in a children's formulary

Contraindications

  • Hypersensitivity to the active substance or other pyrrolidone derivatives, or to any of the excipients

Side effects

  • Very common: nasopharyngitis, somnolence, headache
  • Common: anorexia, depression, hostility/aggression, anxiety, insomnia, nervousness/irritability, convulsion, balance disorder, dizziness, lethargy, tremor, vertigo, cough, abdominal pain, diarrhoea, dyspepsia, vomiting, nausea, fatigue, diplopia, vision blurred
  • Uncommon: thrombocytopenia, leukopenia, weight change, suicide attempt, suicidal ideation, psychotic disorder, abnormal behaviour, hallucination, confusional state, agitation, amnesia, memory impairment, ataxia, paraesthesia, disturbance in attention, abnormal liver function test
  • Rare: pancytopenia, neutropenia, agranulocytosis, DRESS, hypersensitivity including angioedema and anaphylaxis, hyponatraemia, completed suicide, personality disorder, delirium, encephalopathy, seizures aggravated, neuroleptic malignant syndrome, ECG QT prolonged, pancreatitis, hepatic failure, hepatitis, acute kidney injury
  • NOTE: the §4.8 table was truncated at the source-fetch limit — this list is incomplete

Interactions

  • NOTE: §4.5 was not present in the fetched bundle — the entry below is from §4.4; source the full interactions section separately
  • Medicines affecting the QTc interval — levetiracetam should be used with caution in patients concomitantly treated with drugs affecting the QTc interval, in patients with QTc-interval prolongation, and in those with relevant pre-existing cardiac disease or electrolyte disturbances (§4.4)

Clinical monograph

How it works

It binds the synaptic vesicle protein SV2A, modulating neurotransmitter release and reducing the synchronised neuronal firing that drives seizures.

Prescribing in practice

  • The most important paediatric concern is the risk of behavioural and psychiatric adverse effects (irritability, aggression, agitation, mood change and rarely suicidal ideation), which are common in children and should be discussed with families and monitored.
  • Dose adjustment is required in renal impairment because the drug is largely cleared unchanged by the kidneys; dosing is weight-based and should be checked against a children's formulary.
  • It should be withdrawn gradually rather than stopped abruptly to reduce the risk of rebound seizures.

Monitoring

Monitor for behavioural and mood changes, seizure control and renal function; routine plasma-level monitoring is not usually needed.

Counselling the patient

  • Report any new irritability, aggression, low mood or unusual behaviour to the clinical team.
  • Give the medicine regularly and do not stop it suddenly.
  • An oral solution is available for younger children who cannot swallow tablets.

Evidence & guidelines

Paediatric use is supported by NICE epilepsy guidance, with behavioural effects being a well-recognised class consideration.

Reference: ECLIPSE Trial (Lyttle et al, Lancet 2019); NICE NG217; 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.

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