Monotherapy of focal seizures with or without secondary generalization

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 generalization.

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
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.
Neurosurgery
The oral starting dose of LEV is 500 mg twice daily. After 72 h the dose escalated to 1,000 mg twice daily in the case of further seizures more than 24 h after dose escalated to 1,250 mg twice daily and after 3 additional days to 1,500 mg twice daily. On the day of surgery, oral dose followed by an intravenous infusion at the same dose as the last oral dose. The intravenous application scheduled for 36 h or until oral application is possible again. The following oral dose should be equal to the last intravenous dose. If a seizure occurred more than 72 h after surgery at a dose of 2,000 mg/day, dose escalation is performed as described above. If further seizures occurred after dose escalation to 3,000 mg/day.

• Hepatic Impairment
• Renal Impairment

Pregnancy: Monitoring Clinical Response Should Be Monitored During Pregnancy—plasma Concentrations Decrease During Pregnancy (by up To 60% in The Third Trimester).

Breast Feeding present in Milk— Advise to Avoid.

Hepatic Impairment caution in Severe Impairment.

Dose Adjustments maintenance Dose Reduction of 50% in Severe Impairment if Creatinine Clearance Is Less than 60 ml/minute/1.73m2

Renal Impairment

Dose Adjustments

In Children reduce Dose if Estimated Glomerular Filtration Rate Less than 80m L/minute/1.73m²

In Adults maximum 2 g Daily if egfr 50–80 ml/minute/1.73m². Maximum 1.5 g Daily if egfr 30–50 ml/minute/1.73m². Maximum 1 g Daily if egfr Less than 30 ml/minute/1.73m²

Common or very common: Anxiety, Decreased appetite, Asthenia, Abnormal behavior cough, Depression, Diarrhoea, Dizziness, Drowsiness, Gastrointestinal discomfort, Headache, Increased risk of infection, Insomnia, Altered mood, Movement disorders, Nausea, Skin reactions, Vertigo, Vomiting

Uncommon Alopecia, Concentration impaired, Confusion, Hallucination, Leukopenia, Muscle weakness, Myalgia, Paranesthesia, Psychotic disorder, Suicidal behaviors, Thrombocytopenia vision disorders, Weight changes

Rare or very rare acute kidney injury, Agranulocytosis, hepatic disorders, Hyponatremia, Neutropenia, pancreatitis, Pancytopenia, Personality disorder, rhabdomyolysis, Severe cutaneous adverse reactions (SCARs), Thinking abnormal

Store in a cool and dry place

5 ml Vial

Directions for Administration for Injection

With intravenous use for intravenous infusion dilute requisite dose with at least 100 ml glucose 5% or sodium chloride 0.9%; give over 15 minutes.