Medicine should only be used with dosing syringe included in the package

Several measures have been put in place to ensure that the correct dosing syringe is used to measure Keppra oral solution, and thus avoid medication errors. Keppra (levetiracetam) is a medicine used to treat epilepsy in adults and children.

In children, the dose of Keppra depends on the child’s bodyweight and age, and the oral solution is the preferred formulation for use in children less than 6 years of age. The medicine is available as a 100 mg/ml solution in either a 150 or 300 ml size bottle, and it comes with a 1, 3 or 10 ml syringe.

Cases of accidental overdose have been reported with levetiracetam oral solution; the majority of cases occurred in children aged between 6 months and 11 years. Most of the cases occurred when the medicine was used with a wrong dosing syringe (e.g. a 10 ml syringe was used instead of a 1 ml one, leading to a 10-fold overdose), or because of a misunderstanding of the caregiver about how to properly measure the dose. Levetiracetam overdose often has no symptoms, but it may cause sleepiness, agitation, difficulty breathing and coma.

To avoid medication errors and the risk of overdose, parents and carers are advised that only the syringe provided with the package should be used to measure the dose of Keppra. The different medicine’s cartons and labels will be coloured differently and clearly indicate the volume of the bottle, the volume of the dosing syringe, and the age range of the child that the medicine should be used for:

Keppra_medication_errors

The package leaflet will also include clearer instructions for parents and carers in order to minimise the risk of using an incorrect dose. Parents and carers are advised always to discard the syringe once the medicine’s bottle is empty.

Posted on the EMA website on 14 October 2016