Posted on 23.08.2018 in the General category
Keppra xr is not indicated in children below 12 years of age.
The administration of levetiracetam to patients with renal impairment may require dose adjustmentIn patients with severely impaired hepatic functionassessment of renal function is recommended before dose selectionsee section 4.2
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:
This study was too small to adequately characterize the adverse reactions that could be expected to result in discontinuation of treatment in this populationIt is expected that the adverse reactions that would lead to discontinuation in this population would be similar to those resulting in discontinuation in other epilepsy trialssee tables 4 and 8
Postmarketing data from several prospective pregnancy registries have documented outcomes in over 1,000 women exposed to levetiracetam monotherapy during the first trimester of pregnancyOverallthese data do not suggest a substantial increase in the risk for major congenital malformationsalthough a teratogenic risk cannot be completely excludedTherapy with multiple antiepileptic medicinal products is associated with a higher risk of congenital malformations than monotherapy andthereforemonotherapy should be consideredStudies in animals have shown reproductive toxicitysee section 5.3
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