Levetiracetam


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : PO/IV Adjunct in seizures Initial: 500 mg bid on the 1st day. Adjust dose gradually. Max: 1,500 mg bid. Monotherapy for partial seizures w/ or w/o secondary generalisation Recommended starting dose: 250 mg bid, increased to an initial therapeutic dose of 500 mg bid after 2 wk. Adjust dose gradually. Max: 1,500 mg bid.
Dosage Details
Intravenous
Adjunct in seizures
Adult: For partial seizures w/ or w/o secondary generalisation; myoclonic seizures (w/ juvenile myoclonic epilepsy); primary generalised tonic-clonic seizures (w/ idiopathic generalised epilepsy): Initially, 500 mg bid on the 1st day. Adjust dose in increments or decrements of 500 mg bid at 2-4 wk intervals. Admin by infusion over 15 min. Max: 1,500 mg bid. Max duration: 4 days.
Child: 1 to <6 mth Initially, 14 mg/kg daily, may adjust in increments of 14 mg/kg at 2-wk intervals. Max: 42 mg/kg daily; ≥6 mth <50 kg: Initially, 20 mg/kg daily, may adjust in increments of 20 mg/kg at 2-wk intervals. Max: 60 mg/kg daily. To be given via infusion over 15 min.

Intravenous
Monotherapy for partial seizures with or without secondary generalisation
Adult: Recommended starting dose is 250 mg bid, increased to an initial therapeutic dose of 500 mg bid after 2 wk. May further increase by 250 mg bid every 2 wk depending upon response. Admin by infusion over 15 min. Max: 1,500 mg bid. Max duration: 4 days.

Oral
Monotherapy for partial seizures with or without secondary generalisation
Adult: Recommended starting dose is 250 mg bid, increased to an initial therapeutic dose of 500 mg bid after 2 wk. May further increase by 250 mg bid every 2 wk depending upon response. Max: 1,500 mg bid.

Oral
Adjunct in seizures
Adult: For partial seizures w/ or w/o secondary generalisation; myoclonic seizures (w/ juvenile myoclonic epilepsy); primary generalised tonic-clonic seizures (w/ idiopathic generalised epilepsy): Initially, 500 mg bid on the 1st day. Adjust dose in increments or decrements of 500 mg bid at 2-4 wk intervals. Max: 1,500 mg bid.
Child: 1 to <6 mth Initially, 14 mg/kg daily, may adjust in increments of 14 mg/kg at 2-wk intervals. Max: 42 mg/kg daily; ≥6 mth <50 kg: Initially, 20 mg/kg daily, may adjust in increments of 20 mg/kg at 2-wk intervals. Max: 60 mg/kg daily.
Renal Impairment
ESRD patients undergoing dialysis: Loading dose of 750 mg, followed by 500-1,000 mg once daily; supplemental dose of 250-500 mg after dialysis.
CrCl (mL/min) Dosage
<30 250-500 mg bid.
30-49 250-750 mg bid.
50-79 500-1,000 mg bid.
Hepatic Impairment
Severe: Reduce dose by 50%.
Administration
May be taken with or without food. Oral soln may be taken directly or diluted in a glass of water.
Reconstitution
Intravenous:
Dilute dose in 100 mL of suitable diluent (e.g. NaCl 0.9%, lactated Ringer's or dextrose 5% inj).
Special Precautions
Avoid abrupt withdrawal. Renal and/or severe hepatic impairment. Pregnancy and lactation.
Adverse Reactions
Somnolence, weakness, dizziness, anorexia, diarrhoea, dyspepsia, nausea, wt gain or loss, myalgia, ataxia, headache, amnesia, depression, emotional lability, insomnia, nervousness, tremor, vertigo, diplopia, rash; paraesthesia, pancreatitis, hepatic failure, hepatitis, common colds, upper resp tract infections, alopecia, blood dyscrasias (e.g. neutropenia, pancytopenia, thrombocytopenia). Rarely, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis.
IV/Parenteral/PO: C
Patient Counseling Information
This drug may cause somnolence or other CNS related symptoms, if affected, do not drive or operate machinery.
MonitoringParameters
Monitor for emergence or worsening of depression, suicidal thoughts or behaviour and/or unusual changes in mood or behaviour.
Overdosage
Symptoms: Somnolence, agitation, aggression, depressed level of consciousness, resp depression, coma. Management: Symptomatic and supportive treatment. Empty the stomach by gastric lavage or induction of emesis. May perform haemodialysis.
Drug Interactions
Increased or prolonged blood methotrexate concentration to potentially toxic levels.
Action
Description: The exact mechanism of anticonvulsant effect is unknown. Studies show that levetiracetam affects intraneuronal Ca levels by partial inhibition of N-type Ca currents and by reducing the release of Ca from intraneuronal stores; facilitates GABA-ergic inhibitory transmission through displacement of negative modulators; reduces delayed rectifier K current; and/or binds to synaptic proteins which modulate neurotransmitter release.
Pharmacokinetics:
Absorption: Rapidly absorbed from GI tract. Bioavailability: Approx 100%. Time to peak plasma concentration: W/in 1.3 hr.
Distribution: Distributed in breast milk. Volume of distribution: 0.5-0.7 L/kg. Plasma protein binding: <10%.
Metabolism: Not extensively metabolised; 24% of the dose is metabolised by enzymatic hydrolysis into inactive metabolites.
Excretion: Via urine (approx 95%) both as unchanged drug and metabolites; faeces (0.3%). Plasma elimination half-life: Approx 7 hr.
Chemical Structure

Chemical Structure Image
Levetiracetam

Source: National Center for Biotechnology Information. PubChem Database. Levetiracetam, CID=5284583, https://pubchem.ncbi.nlm.nih.gov/compound/Levetiracetam (accessed on Jan. 22, 2020)

Storage
Store between 20-25°C.
MIMS Class
ATC Classification
N03AX14 - levetiracetam ; Belongs to the class of other antiepileptics.
References
Anon. Levetiracetam. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 02/11/2015.

Buckingham R (ed). Levetiracetam. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 02/11/2015.

Joint Formulary Committee. Levetiracetam. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 02/11/2015.

Keppra Tablets, Oral Solution and Extended-Release Tablets. U.S. FDA. https://www.fda.gov. Accessed 02/11/2015.

McEvoy GK, Snow EK, Miller J et al (eds). Levetiracetam. AHFS Drug Information (AHFS DI) [online]. American Society of Health-System Pharmacists (ASHP). https://www.medicinescomplete.com. Accessed 02/11/2015.

Disclaimer: This information is independently developed by MIMS based on Levetiracetam from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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