Adjunct in partial onset seizures in patients ?1 month old. Adjunct in myoclonic seizures in patients ?12yrs old with juvenile myoclonic epilepsy. Adjunct in primary generalized tonic-clonic seizures in patients ?6yrs old with idiopathic generalized epilepsy.
Antiseizure (antiepileptic)
The precise mechanism(s) by which Levetiracetam exerts its antiepileptic effect is unknown. Levetiracetam showed only minimal activity in submaximal stimulation and in threshold tests. Protection was observed, however, against secondarily generalized activity from focal seizures induced by pilocarpine and kainic acid, two chemo convulsants that induce seizures that mimic some features of human complex partial seizures with secondary generalization. In vitro and in vivo recordings of epileptiform activity from the hippocampus have shown that Levetiracetam inhibits burst firing without affecting normal neuronal excitability, suggesting that Levetiracetam may selectively prevent hyper synchronization of epileptiform burst firing and propagation of seizure activity.
Monotherapy of focal seizures with or without secondary generalisation BY MOUTH, OR BY INTRAVENOUS INFUSION Child 16-17 years: Initially 250 mg once daily for 1 week, then increased to 250 mg twice daily, then increased in steps of 250 mg twice daily (max. per dose 1.5 g twice daily), adjusted according to response, dose to be increased every 2 weeks Adult: Initially 250 mg once daily for 1-2 weeks, then increased to 250 mg twice daily, then increased in steps of 250 mg twice daily (max. per dose 1.5 g twice daily), adjusted according to response, dose to be increased every 2 weeks Adjunctive therapy of focal seizures with or without secondary generalisation BY MOUTH Child 1-5 months: Initially 7 mg/kg once daily, then increased in steps of up to 7 mg/kg twice daily (max. per dose 21 mg/kg twice daily), dose to be increased every 2 weeks Child 6 months-17 years (body-weight up to 50 kg): Initially 10 mg/kg once daily, then increased in steps of up to 10 mg/kg twice daily (max. per dose 30 mg/kg twice daily), dose to be increased every 2 weeks Child 12-17 years (body-weight 50 kg and above): Initially 250 mg twice daily, then increased in steps of 500 mg twice daily (max. per dose 1.5 g twice daily), dose to be increased every 2-4 weeks Adult: Initially 250 mg twice daily, then increased in steps of 500 mg twice daily (max. per dose 1.5 g twice daily), dose to be increased every 2-4 weeks BY INTRAVENOUS INFUSION Child 4-17 years (body-weight up to 50 kg): Initially 10 mg/kg once daily, then increased in steps of up to 10 mg/kg twice daily (max. per dose 30 mg/kg twice daily), dose to be increased every 2 weeks Child 12-17 years (body-weight 50 kg and above): Initially 250 mg twice daily, then increased in steps of 500 mg twice daily (max. per dose 1.5 g twice daily), dose to be increased every 2 weeks Adult: Initially 250 mg twice daily, then increased in steps of 500 mg twice daily (max. per dose 1.5 g twice daily), dose to be increased every 2-4 weeks Adjunctive therapy of myoclonic seizures and tonic-clonic seizures BY MOUTH, OR BY INTRAVENOUS INFUSION Child 12-17 years (body-weight up to 50 kg): Initially 10 mg/kg once daily, then increased in steps of up to 10 mg/kg twice daily (max. per dose 30 mg/kg twice daily), dose to be increased every 2 weeks Child 12-17 years (body-weight 50 kg and above): Initially 250 mg twice daily, then increased in steps of 500 mg twice daily (max. per dose 1.5 g twice daily), dose to be increased every 2 weeks Adult: Initially 250 mg twice daily, then increased in steps of 500 mg twice daily (max. per dose 1.5 g twice daily), dose to be increased every 2-4 weeks
Antiepileptic medicinal products: Pre-marketing data from clinical studies conducted in adults indicate that levetiracetam did not influence the serum concentrations of existing antiepileptic medicinal products (phenytoin, carbamazepine, valproic acid, phenobarbital, lamotrigine, gabapentin and primidone) and that these antiepileptic medicinal products did not influence the pharmacokinetics of levetiracetam.
Probenecid: Probenecid (500 mg four times daily), a renal tubular secretion blocking agent, has been shown to inhibit the renal clearance of the primary metabolite but not of levetiracetam. Nevertheless, the concentration of this metabolite remains low.
Methotrexate: Concomitant administration of levetiracetam and methotrexate has been reported to decrease methotrexate clearance, resulting in increased/prolonged blood methotrexate concentration to potentially toxic levels. Blood methotrexate and levetiracetam levels should be carefully monitored in patients treated concomitantly with the two drugs.
Laxatives: There have been isolated reports of decreased levetiracetam efficacy when the osmotic laxative macrogol has been concomitantly administered with oral levetiracetam. Therefore, macrogol should not be taken orally for one hour before and for one hour after taking levetiracetam.
Food and alcohol: The extent of absorption of levetiracetam was not altered by food, but the rate of absorption was slightly reduced. No data on the interaction of levetiracetam with alcohol are available.
Contraindicated in patients with a hypersensitivity to levetiracetam . Reactions have included anaphylaxis and angioedema. Levetiracetam may cause changes in mood or behavior, problems with coordination, or unusual tiredness or weakness. Tell your doctor right away if you or your child start to feel depressed, anxious, angry, getting upset easily, restless, or have thoughts about hurting yourself. Report any unusual thoughts or behavior that trouble you, especially if they are new or getting worse quickly. This medicine may cause some people to become dizzy, drowsy, tired, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert. Serious skin reactions can occur with this medicine. Check with your doctor right away if you or your child have blistering, peeling, or loosening of the skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills while you are using this medicine.
Common or very common Abdominal pain . aggression . anorexia . anxiety . ataxia . convulsion . cough . depression . diarrhoea . dizziness . drowsiness . dyspepsia . headache . insomnia . irritability . malaise . nasopharyngitis . nausea . rash . tremor . vertigo . vomiting Uncommon Agitation . alopecia . amnesia . blurred vision . confusion . diplopia . eczema . impaired attention . leucopenia . myalgia . paraesthesia . pruritus . psychosis . suicidal ideation . thrombocytopenia . weight changes Rare Agranulocytosis . choreoathetosis . drug reaction with eosinophilia and systemic symptoms (DRESS) . dyskinesia . erythema multiforme . hepatic failure . hyponatraemia . neutropenia . pancreatitis . pancytopenia . Stevens-Johnson syndrome . toxic epidermal necrolysis Frequency not known Completed suicide . pancytopenia
PREGNANCY The dose should be monitored carefully during pregnancy and after birth, and adjustments made on a clinical basis. It is recommended that the fetal growth should be monitored. BREAST FEEDING Present in milk?manufacturer advises avoid.
Somnolence, agitation, aggression, depressed level of consciousness, respiratory depression and coma were observed with levetiracetam overdoses. After an acute overdose, the stomach may be emptied by gastric lavage or by induction of emesis. There is no specifc antidote for levetiracetam. Treatment of an overdose will be symptomatic and may include haemodialysis. The dialyser extraction efficiency is 60 % for levetiracetam and 74% for the primary metabolite.
Store at a cool temperature (not exceeding 25°C) and dry place, protected from light.
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