LEVETIRACETAM-GH

What it is

Levetiracetam-GH is a film-coated tablet available in strengths of 250 mg, 500 mg or 1000 mg levetiracetam.

Approved indications

— Use in epileptic patients aged 4 years and older, initially as add-on therapy, in the treatment of partial onset seizures with or without secondary generalisation. — Monotherapy in the treatment of partial onset seizures, with or without secondary generalisation, in patients from 16 years of age with newly diagnosed epilepsy. — Add-on therapy in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy (JME). — Add-on therapy in the treatment of primary generalised tonic clonic (PGTC) seizures in adults and children from 4 years of age with Idiopathic Generalised Epilepsy (IGE).

Dosing overview

The daily dose is administered in two equally divided doses. For monotherapy, the recommended starting dose is 250 mg twice daily, which should be increased to an initial therapeutic dose of 500 mg twice daily after two weeks. The dose can be further increased by 250 mg twice daily every two weeks depending upon the clinical response, with a maximum dose of 1500 mg twice daily. For add-on therapy in adults and adolescents aged 12 years or older weighing 50 kg or more, the therapeutic dose is 500 mg twice daily, which can be started on the first day of treatment. Depending upon the clinical response and tolerance, the daily dose can be increased up to 1500 mg twice daily. In children aged 4 to 11 years and adolescents aged 12 to 17 years weighing less than 50 kg, the initial therapeutic dose is 10 mg/kg twice daily. Depending on the clinical response and tolerance, the daily dose can be increased up to 60 mg/kg daily (in two 30 mg/kg doses).

Key safety warnings

Antiepileptic drugs (AED), including levetiracetam, increase the risk of suicidal thoughts or behaviour in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behaviour, and/or any unusual changes in mood or behaviour. Patients, their caregivers, and families should be informed that AEDs increase the risk of suicidal thoughts and behaviour and should be advised of the need to be alert for the emergence or worsening of the signs and symptoms of depression, any unusual changes in mood or behaviour, or the emergence of suicidal thoughts, behaviour, or thoughts about self harm. Levetiracetam may cause changes in behaviour (for example, aggression, agitation, anger, anxiety, apathy, depression, hostility, and irritability) and psychotic symptoms. Patients treated with levetiracetam should be monitored for psychiatric signs and symptoms. Cases of decreased blood cell counts (neutropenia, agranulocytosis, leucopenia, thrombocytopenia and pancytopenia) have been described in association with levetiracetam administration. Complete blood cell counts are advised in patients experiencing important weakness, pyrexia, recurrent infections or coagulation disorders. A paradoxical reaction of worsening of seizure may be observed especially when starting treatment or at increase in dose.

Contraindications

Levetiracetam-GH is contraindicated in patients with hypersensitivity to levetiracetam or other pyrrolidone derivatives or any of the excipients.

Regulatory history

Levetiracetam-GH was first registered on the Australian Register of Therapeutic Goods on 27 July 2010, with three strengths (250 mg, 500 mg and 1000 mg tablet formulations) under licence category RE (Registered).