Futatreat Film Coated Tablets
Levetiracetam 250, 500 and 750 mg
Usage and indications:
Futatreat is indicated as monotheraby in the treatment of partial onset seizure with or without secondary generalization 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 generalization in adults and children 4 years of age and older with epilepsy.
Futatreat is indicated as adjunctive therapy in the treatment of myoclonic seizure in adults and adolescent 12 years of age and older with juvenile myoclonic epilepsy.
In the treatment of primary generalized tonic clonic seizures in adults and adolescent from 12 years of age with idiopathic generalized epilepsy
Dosage and administration:
Treatment should be initiated with a daily dose of 1000 mg/day in two divided doses, additional dosing increments may be given (1000 mg/day additional every two weeks) to a maximum recommended daily dose of 3000 mg. Futatreat is given orally with or without food.
Pediatric patients ages 4 to <16 years:
Treatment should be initiated with a daily dose of 20 mg/kg in two divided dose.
The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg in two divided doses.
Dose in adult patients with impaired renal function
Futatreat dosing must be individualized according to the patient's renal function status (creatinine clearance) as the following:
Occur in less than 1% of patients
Futatreat is well tolerated and lacks many of traditional side effects associated with AEDs.
Nervous system disorder:
Somnolence, amnesia, ataxia, convulsion, dizziness, headache, hyperkinesias, tremors, balance disorder, disturbance in attention and memory impairment.
Asthenia and fatigue.
Agitation, depression, emotional liability, hostility/aggression-insomnia, nervousness, irritability and personality disorder and abnormal thinking.
Dyspepsia, nausea, vomiting and diarrhea.
Metabolism and Nutrition disorder:
Anorexia and weight increase.
Ear and Eye disorders:
Vertigo and Diplopia.
Musculoskeletal and connective tissue:
Skin and subcutaneous tissue:
rash and eczema.
Blood and lymphatic:
Injury and poisoning:
Infections and Infestations:
Warnings and precautions:
If Levetiracetam has to be discontinued it is recommended to withdraw it gradually, available data in children did not suggest impact on growth and puberty. However long term effect on learning, intelligence growth & endocrine function. Puberty childbearing potential in children remains unknown.
An increase in seizure frequency of more than 25% was reported in 14% of Levetiracetam treated adult and pediatric patients with partial onset seizers whereas it was reported in 26% and 21% of placebo treated adult and pediatric patients respectively upon withdrawal of Levetiracetam. When Levetiracetam was used to treat primary generalized tonic clonic seizure in adults and adolescents with idiopathic generalized epilepsy, there was no effect on the frequency of absence.
In adults, Levetiracetam use is associated with the occurrence of central nervouse system adverse events that can be classified into the following categories:
1- Somnolence and fatigue.
2- Coordination difficulties.
3- Behavioral abnormalities.
Futatreat 250 mg is supplied in a carton box of 1-2 Al-PVC blisters each of 10 film coated tablets.
Futatreat 500 mg is supplied in a carton box of 1-2 Al-PVC blisters each of 10 film coated tablets.
Futatreat 750 mg is supplied in a carton box of 1-2 Al-PVC blisters each of 10 film coated tablets.