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Serious dermatological reactionsincluding Stevens-Johnson syndromeSJSand toxic epidermal necrolysisTENhave been reported in both pediatric and adult patients treated with KEPPRAThe median time of onset is reported to be 14 to 17 daysbut cases have been reported at least four months after initiation of treatmentRecurrence of the serious skin reactions following rechallenge with KEPPRA has also been reportedKEPPRA should be discontinued at the first sign of a rashunless the rash is clearly not drug-relatedIf signs or symptoms suggest SJS/TENuse of this drug should not be resumed and alternative therapy should be considered.
Keppra was as effective as carbamazepine in keeping patients free of seizures when taken on its own for partial onset seizuresIn both groups73of the patients experienced no seizures for six months once on an adequate doseAs an add-on treatmentKeppra was more effective than placebo:
Pre-marketing data from clinical studies conducted in adults indicate that levetiracetam did not influence the serum concentrations of existing antiepileptic medicinal productsphenytoincarbamazepinevalproic acidphenobarbitallamotriginegabapentin and primidoneand that these antiepileptic medicinal products did not influence the pharmacokinetics of levetiracetam.
Patients should be monitored for these signs and symptoms and advised not to drive or operate machinery until they have gained sufficient experience on KEPPRA to gauge whether it could adversely affect their ability to drive or operate machinery.
Potential drug interactions between KEPPRA and other AEDscarbamazepinegabapentinlamotriginephenobarbitalphenytoinprimidone and valproatewere also assessed by evaluating the serum concentrations of levetiracetam and these AEDs during placebo-controlled clinical studiesThese data indicate that levetiracetam does not influence the plasma concentration of other AEDs and that these AEDs do not influence the pharmacokinetics of levetiracetam.
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this disparity between the keppra and placebo treatment groups was not observed in the studies of older children or in adults.