Futatreat        Syrup

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.

Special populations

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.

Undesirable effects: 

Infections and infestations

Very common: Nasopharyngitis  

Rare: Infection       

Blood and lymphatic system disorders:  

Uncommon: Thrombocytopenia, leukopenia.

 Rare: Pancytopenia, neutropenia. 

Metabolism and nutrition disorders:  

Common: Anorexia   

Uncommon: Weight decreased, weight increase

Psychiatric disorders

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.

Eye disorders:

Uncommon: Diplopia, vision blurred.

Ear and labyrinth disorders

Common: Vertigo. 

Respiratory, thoracic and mediastinal disorders:

Common: cough 

Gastrointestinal disorders:

Common: Abdominal pain, diarrhoea, dyspepsia, vomiting, nausea.  

Rare: Pancreatitis.

Hepatobiliary disorders

Uncommon: Liver function test abnormal.

Rare: Hepatic failure, hepatitis. 

Skin and subcutaneous tissue disorders

Common: Rash 

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:

Common: Asthenia/fatigue.  

Injury, poisoning and procedural complications:

Uncommon: Injury.

Warnings and precautions:

  • Discontinuation: In accordance with current clinical practice, if Futatreat has to be discontinued it is recommended to withdraw it gradually (in adults: 500 mg decreases twice daily every two to four weeks; in infants older than 6 months, children and adolescents weighing less than 50 kg: dose decrease should not exceed 10 mg/kg twice daily every two weeks; in infants (less than 6 months): dose decrease should not exceed  7 mg/ kg twice daily every two weeks).
  • Renal insufficiency: The administration of Futatreat to patients with renal impairment may require dose adjustment. In patients with severely impaired hepatic function, assessment of renal function is recommended before dose selection
  • Suicide: Suicide, suicide attempt, suicidal ideation and behaviour have been reported in patients treated with anti-epileptic agents. Patients (and caregivers of patients) should be advised to seek medical advice should signs of depression and/or suicidal ideation or behaviour emerge.
  • Paediatric population: Available data in children did not suggest impact on growth and puberty. However, long term effects on learning, intelligence, growth, endocrine function, puberty and childbearing potential in children remain unknown. The safety and efficacy of Futatreat has not been thoroughly assessed in infants aged less than 1 year. Only 35 infants aged less than 1 year have been exposed in clinical studies of which only 13 were aged < 6 months.
  • Futatreat may cause allergic reaction as it contains Methyl and Propyl paraben.
  • Contact your doctor before taking this product if you have been told that you have an intolerance to sugar.

      Pack: Carton box containing amber glass (Type II ) bottle of 100 ml syrup covered with plastic

 

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