Dose changes should not exceed increases or decreases of 10 mg/kg twice daily every two weeks. In both these paediatric age ranges, these data are supplemented with the post-marketing experience of the use of levetiracetam.In addition, 101 infants aged less than 12 months have been exposed in a post authorization safety study. informational and educational purposes only. KEPPRA injection should be administered as a 15-minute IV infusion. 2002
Other unidentified components accounted only for 0.6 % of the dose.In human hepatocytes in culture, levetiracetam had little or no effect on CYP1A2, SULT1E1 or UGT1A1. The patients had to present with unprovoked partial seizures or with generalized tonic-clonic seizures only. - Sodium chloride 9 mg/ml (0.9%) solution for injectionMedicinal product with particulate matter or discoloration should not be used.Any unused medicinal product or waste material should be disposed of in accordance with local requirements.Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.5th Floor, Hyde Park, Hayes, 3, 11 Millington Road, Hayes, UB3 4AZ, UKTo bookmark a medicine you must sign up and log in.To view the changes to a medicine you must sign up and log in.
Blood methotrexate and levetiracetam levels should be carefully monitored in patients treated concomitantly with the two drugsLevetiracetam 1,000 mg daily did not influence the pharmacokinetics of oral contraceptives (ethinyl-estradiol and levonorgestrel); endocrine parameters (luteinizing hormone and progesterone) were not modified.
Any unused portion of the KEPPRA injection vial contents should be discarded. A double-blind, placebo-controlled paediatric safety study with a non-inferiority design has assessed the cognitive and neuropsychological effects of levetiracetam in children 4 to 16 years of age with partial onset seizures. Levetiracetam induces seizure protection in a broad range of animal models of partial and primary generalised seizures without having a pro-convulsant effect. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.Somnolence, agitation, aggression, depressed level of consciousness, respiratory depression and coma were observed with levetiracetam overdoses.There is no specific antidote for levetiracetam. A 250 to 500 mg supplemental PO or IV dose is recommended after dialysis.
Results related to behavioural and emotional functioning indicated a worsening in levetiracetam treated patients on aggressive behaviour as measured in a standardized and systematic way using a validated instrument (CBCL – Achenbach Child Behavior Checklist). If a smaller volume is required (e.g. (2) Dose in children and adolescents 50 kg or more is the same as in adults.The safety and efficacy of Levetiracetam SUN concentrate for solution for infusion in infants and children less than 4 years have not been established.Currently available data are described in sections 4.8, 5.1, and 5.2 but no recommendation on a posology can be made.Levetiracetam SUN concentrate is for intravenous use only and the recommended dose must be diluted in at least 100 ml of a compatible diluent and administered intravenously as a 15-minute intravenous infusion (see section 6.6).Hypersensitivity to the active substance or other pyrrolidone derivatives or to any of the excipients listed in section 6.1.The administration of levetiracetam to patients with renal impairment may require dose adjustment. For Child 16–17 years. Complete blood cell counts are advised in patients experiencing important weakness, pyrexia, recurrent infections or coagulation disorders (section 4.8).Suicide, suicide attempt, suicidal ideation and behaviour have been reported in patients treated with anti-epileptic agents (including levetiracetam). Levetiracetam 2,000 mg daily did not influence the pharmacokinetics of digoxin and warfarin; prothrombin times were not modified. pediatric patients), the amount of diluent should be calculated to not exceed a maximum levetiracetam concentration of 15 mg per mL of diluted solution. The mechanism of this risk is not known.Therefore patients should be monitored for signs of depression and/or suicidal ideation and behaviours and appropriate treatment should be considered.