Levetiracetam: Indication, Dosage, Side Effect, Precaution

Generic Medicine Info Patient Medicine Information

This information is not country-specific. Please refer to the local prescribing information.

Generic Medicine Info

Indications and Dosage

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

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.

Pregnancy Category (US FDA)

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

Storage

Store between 20-25°C.

MIMS Class

Anticonvulsants

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.

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