CRITAM

*Monotherapy of focal seizures with or without secondary Generalization:* ORAL BY INTRAVENOUS INF: Adult & Children 16 yrs: 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 generalization:* Adult: Initially 250 mg twice daily, then increased insteps of 500 mg twice daily (max. per dose 1.5 g twice daily), dose to be increased every 2-4 weeks. Children 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. Children 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; 12-17 years (body-weight 50 kg and above): Initially250 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 IV INF: Adult: Initially 250 mg twice daily, then increased insteps of 500 mg twice daily (max. per dose 1.5 g twice daily), dose to be increased every 2-4 weeks. Children 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; 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. *Adjunctive therapy of myoclonic seizures and tonic-clonic Seizures:* ORAL OR BY IV INF: Adult: Initially 250 mg twice daily, then increased insteps of 500 mg twice daily (max. per dose 1.5 g twice daily), dose to be increased every 2-4 weeks. Children 12-17 yrs (body-weight up to 50 kg): Initially10 mg/kg once daily, then increased in steps of up to 10 mg/kg twice daily (max. per dose30 mg/kg twice daily), dose to be increased every2 weeks; 12-17 yrs (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.

Dilute prescribed dose in 100 ml of a compatible diluent and infuse over 15 min,

Renal or severe hepatic impairment. Withdraw slowly. Elderly.

Aggression, agitation, anorexia, anxiety, ataxia, convulsion, depression, diarrhoea, dizziness, drowsiness, dyspepsia, headache, insomnia, irritability, malaise, nasopharyngitis, nausea, rash, tremor, vertigo, vomiting, 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