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.

Daily Dose

Patient weight

60 mg/kg/day

(BID dosing)

40 mg/kg/day

(BID dosing)

20 mg/kg/day

(BID dosing)

1500 mg/day (750 mg tablet BID)

1000 mg/day (500 mg tablet BID)

500 mg/day (250 mg tablet BID)

20 – 40 kg

3000 mg/day (2 tablets 750 mg BID)

2000 mg/day (2 tablets 500 mg BID)

1000 mg/day (500 mg tablet BID)

> 40 KG

 

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:

Frequency

Dosage (mg)

 

Creatinine clearance   (ml / min)

Group

Every 12 h

500 to 1.500

80<

Normal

Every 12 h

500 to 1.000

50-80

Mild

Every 12 h

250 to 750

30-50

Moderate

Every 12 h

250 to 500

30>

Severe

Every 24 h

500 to 1.000

--

ESRD patients using dialysis

 

Undesirable effects:

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.

General disorder:

Asthenia and fatigue.

Psychiatric disorders:    

Agitation, depression, emotional liability, hostility/aggression-insomnia, nervousness, irritability and personality disorder and abnormal thinking.

Gastrointestinal disorders:   

Dyspepsia, nausea, vomiting and diarrhea.  

Metabolism and Nutrition disorder:   

Anorexia and weight increase.

Ear and Eye disorders:

Vertigo and Diplopia.

Musculoskeletal and connective tissue:

Myalgia. 

Skin and subcutaneous tissue:

 rash and eczema.

Respiratory disorder:

Cough increase.

Blood and lymphatic:

Thrombocytopenia.

Injury and poisoning:  

accidental injury.  

Infections and Infestations:

 nasopharyngitis.  

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.

Pack:

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.

Price :
  Add To Cart
Back