Levetiracetam Dexcel 250, 500, 1000

/ Dexcel Pharma Technologies Ltd

Monotherapy:
Adults and adolescents from 16 years of age: 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. The maximum dose is 1500 mg twice daily.
Add-on therapy:
Adults (≥18 years) and adolescents (12 to 17 years) weighing 50 kg or more: The initial therapeutic dose is 500 mg twice daily. This dose can be started on the first day of treatment. Depending upon the clinical response and tolerability, the daily dose can be increased up to 1,500 mg twice daily. Dose changes can be made in 500 mg twice daily increases or decreases every two to four weeks.
Special population:
Elderly (65 years and older)
Adjustment of the dose is recommended in elderly patients with compromised renal function.
Renal impairment
The daily dose must be individualised according to renal function.
Children aged 6 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.
Add-on therapy for children (4 to 11 years) and adolescents (12 to 17 years) weighing less than 50 kg
For children 6 years and above, the medicine should be used for doses under 250 mg, for doses not multiple of 250 mg when dosing recommendation is not achievable by taking multiple tablets and for patients unable to swallow tablets.
The lowest effective dose should be used. The starting dose for a child or adolescent of 25kg should be 250mg twice daily with a maximum dose of 750mg twice daily.
Dose in children 50 kg or greater is the same as in adults.
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.
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Levetiracetam is indicated as monotherapy in the treatment of partial onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy.
Levetiracetam is indicated as adjunctive therapy:
– In the treatment of partial onset seizures with or without secondary generalisation in adults and children from 4 years of age with epilepsy.
– In the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy.
– In the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with Idiopathic Generalised Epilepsy.

Hypersensitivity to levetiracetam or other pyrrolidone derivatives or any of the excipients.
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Please refer to the license holder for further details.

Please refer to the license holder for further details.

Please refer to the license holder for further details.

Please refer to the license holder for further details.

Please refer to the license holder for further details.