Information about Keppra.

KEPPRA is indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 1 month of age and older with epilepsy.

There is no specific antidote for overdose with KEPPRAIf indicatedelimination of unabsorbed drug should be attempted by emesis or gastric lavageusual precautions should be observed to maintain airwayGeneral supportive care of the patient is indicated including monitoring of vital signs and observation of the patient’s clinical statusA Certified Poison Control Center should be contacted for up to date information on the management of overdose with KEPPRA.

A randomized double-blindplacebo-controlled study was performed to assess the neurocognitive and behavioral effects of KEPPRA as adjunctive therapy in pediatric patients4 to 16 years of ageThe results from an exploratory analysis indicated a worsening in KEPPRA-treated patients on aggressive behaviorone of eight behavior dimensionsas measured in a standardized and systematic way using a validated instrumentthe Achenbach Child Behavior ChecklistCBCL/6-18

The CLcr in ml/min/1.73 m 2 may be estimated from serum creatininemg/dldeterminationfor young adolescentschildren and infantsusing the following formulaSchwartz formula

Immediate-releaseKeppraSpritam500 mg IV/PO q12hrmay increase q2week by 500 mg/dose to recommended dose of 1500 mg q12hr.

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KEPPRA is indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy.

Table 9Adverse Reactions in a Placebo-ControlledAdd-On Study in Patients 4 Years of Age and Older with PGTC Seizures.

In the controlled clinical study that included patients 4 years of age and older with PGTC seizuresthe most common adverse reaction in patients receiving KEPPRA in combination with other AEDsfor events with rates greater than placebowas nasopharyngitis.

The most common side effects with Keppraseen in more than 1 patient in 10are nasopharyngitisinflammation of the nose and throatsomnolencesleepinessand headacheFor the full list of all side effects reported with Kepprasee the package leaflet.

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