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Dose and administration

Neonatal seizures unresponsive to first-line agents


PLEASE NOTE: There are TWO strengths of Levetiracetam injection:

  • NEOLEV Trail stock - Levetiracetam 15mg/ml
  • Keppra or Levetiracetam-Rex - Levetiracetam 100mg/ml

The use of levetiracetam in neonates is unlicensed. Limited data are available1-7. Consult a paediatric neurologist for prescribing advice BEFORE prescribing levetiracetam

This guideline covers in neonates 36 weeks gestation and over.

Loading Dose:  40mg/kg

Maintenance Dose:

  Postnatal Age Dose Dosing Interval
Intravenous / Oral  < 7 days  10mg/kg q 8h
>7 days 20mg/kg q 12h
  • Reduce dose in renal failure.
  • In most cases, patients should be switched to oral levetiracetam as soon as they can be enterally fed.
  • Intravenous and oral levetiracetam have equivalent bioavailability and dosing regimen.


Neonatal seizures unresponsive to first-line agents


Hypersensitivity to levetriacetam or any component of the formulation

Clinical pharmacology

Levetiracetam is an antiepileptic drug used in the treatment of refractory neonatal seizures. The precise mechanism by which levetiracetam exerts its antiepileptic effect is unknown. However, several studies have suggested the mechanism may involve one or more of the following central pharmacologic effects: inhibition of voltage-dependent N-type calcium channels; facilitation of GABA-ergic inhibitory transmission through displacement of negative modulators; reduction of delayed rectifier potassium current; and/or binding to synaptic proteins which modulate neurotransmitter release3,4.

Intravenous administration leads to peak serum levels 1 hour earlier than oral administration and therefore intravenous administration is the preferred route for the treatment of acute seizures and in neonates who are nil by mouth.

Possible adverse effects

  • Somnolence, tremor, infection, rash
  • Pancreatitis, hepatic failure, and hepatitis.2,3 Consider monitoring of liver function tests, in patients with other risk factors for hepatic impairment.

Special considerations

  • Prior to initiation, the use of levetiracetam in neonates should be discussed with a paediatric neurologist.
  • After initial management, ongoing use of levetiracetam should be restricted to patients at high risk of seizure recurrence.
  • Levetiracetam is not recommended for administration via the subcutaneous or intramuscular route.
  • Renal and/or severe hepatic impairment - reduce dose.
  • Monitor:
    Renal function and Full Blood Count
    Liver Function Tests if considered necessary
  • It is not necessary to perform routine drug levels

Management of Levetiracetam administration


PLEASE NOTE: There are TWO strengths of Levetiracetam injection:

  • NEOLEV Trail stock - Levetiracetam 15mg/ml
  • Keppra or Levetiracetam-Rex - Levetiracetam 100mg/ml

Oral: 100mg/ml oral suspension (prepared by Pharmacy)

The injection is unlicensed in New Zealand and is supplied under section 29 of the Medicines Act.


Charted on the prescription chart in mg/dose.



  1. Ensure patient is well hydrated before and during administration.
  2. Dilute to 10 mg/mL in glucose 5 % or sodium chloride 0.9%.
  3. Infuse over 15 minutes.
  4. Do not use if solution contains particulate matter or is discoloured.
  5. Flush line with sodium chloride 0.9% before and after administration of levetiracetam.

To prepare a solution of 10mg/ml

Levetiracetam 1ml
Diluent to be added 9ml
Final Concentration 10mg/ml

Oral liquid

  1. Manufactured by Pharmacy.
  2. Oral solution may be further diluted with water if necessary.
  3. Oral solution is fully funded in community pharmacies. Contact ward pharmacist prior to discharge.

Nursing considerations

  • Observe for signs of adverse effects.
  • Monitor fluid balance closely.
  • Do not administer the injection undiluted via the intravenous route.
  • Assess and document any signs of seizure activity.


  • Unopened vials should be stored at room temperature (25ยบC)
  • Discard unused portions of opened vials.
  • Oral liquid - refer to bottle label for storage and expiry details


  1. Sharpe C, Capparelli E, Mower M et al. A seven-day study of the pharmacokinetics of intravenous levetiracetam in neonates: marked changes in the pharmacokinetics occur during the first week of life. Paediatric Research 2012;72:43-9
  2. Phelps SJ, Hagemann TM, Lee KR, Thompson AJ. Pediatric Injectable Drugs, The Teddy Bear Book (10th ed.). Bethesda: American Society of Health-System Pharmacists, 2013.
  3. Taketomo CK, Hodding JH, Kraus DM (eds). Pediatric & Neonatal Dosage Handbook (19th ed.). Hudson (OH): Lexi-Comp, 2012.
  4. Sweetman SC (ed). Martindale: The Complete Drug Reference (37th ed.) London: Pharmaceutical Press, 2011.
  5. Levetiracetam-Rex data sheet. Auckland: Rex Medical Limited, 2012.
  6. Paediatric Injectable Guidelines (4th ed.). Melbourne: Royal Children's Hospital, 2011.
  7. Ramantani, G, Ikonomidou C, Walter B et al. Levetiracetam: safety and efficacy in neonatal seizures. European Journal of Paediatric Neurology, 2011; 15: 1-7.
  8. Merhar SL, Schibler KR, Sherwin CM et al. Pharmacokinetics of levetiracetam in neonates with seizures. J Pediatr 2011; 159:152-4.

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Document Control

  • Date last published: 26 February 2015
  • Document type: Drug Dosage Guideline
  • Services responsible: ADHB Pharmacy, Neonatology, Paediatric Neurology
  • Editor: Sarah Bellhouse
  • Review frequency: 2 years