Levetiracetam 100mg / ml
Usage and indications:
Futatreat 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.
Futatreat is indicated as adjunctive therapy
• In the treatment of partial onset seizures with or without secondary generalisation in adults, children and infants from 1 month 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.
Dosage and Administration:
Monotherapy for 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 for 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.
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.
Infections and infestations:
Very common: Nasopharyngitis
Blood and lymphatic system disorders:
Uncommon: Thrombocytopenia, leukopenia.
Rare: Pancytopenia, neutropenia.
Metabolism and nutrition disorders:
Uncommon: Weight decreased, weight increase
Common: Depression, hostility/aggression, anxiety, insomnia, nervousness/irritability.
Uncommon: Suicide attempt, suicidal ideation, psychotic disorder, abnormal behaviour, hallucination, anger, confusional state, affect lability/mood swings, agitation.
Rare: Completed suicide, personality disorder, thinking abnormal.
Nervous system disorders:
Very common: Somnolence, headache.
Common: Convulsion, balance disorder, dizziness, lethargy, tremor.
Uncommon: Amnesia, memory impairment, coordination abnormal/ataxia, paraesthesia, disturbance in attention
Rare: Choreoathetosis, dyskinesia, hyperkinesia.
Uncommon: Diplopia, vision blurred.
Ear and labyrinth disorders:
Respiratory, thoracic and mediastinal disorders:
Common: Abdominal pain, diarrhoea, dyspepsia, vomiting, nausea.
Uncommon: Liver function test abnormal.
Rare: Hepatic failure, hepatitis.
Skin and subcutaneous tissue disorders:
Uncommon: Alopecia, eczema, pruritus.
Rare: Toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme.
Musculoskeletal and connective tissue disorders:
Uncommon: Muscular weakness, myalgia.
General disorders and administration site conditions:
Injury, poisoning and procedural complications:
Warnings and precautions:
Pack: Carton box containing amber glass (Type II ) bottle of 100 ml syrup covered with plastic