Extended adjunctive therapy age range from 4 years down to 2 years No evidence drug was effective as adjunctive therapy in patients < 2 years In clinical studies as adjunctive therapy, apparent clearance (L/hr/kg) decreased when age increased such that children 2 to <4 years of age may require up to twice the dose per body weight compared to adults; and children 4 to d12 years of age may require a 50% higher dose per body weight compared to adults Approximately 11% of pediatric patients < 4 years discontinued treatment because of adverse events including convulsions, status epilepticus and ataxia Information on dose, PK parameters, AE profile and clinical studies
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