We would like to make parents of children with epilepsy aware of a recent packaging and product change associated with Levetiracetam (Keppra) 150ml oral solution for children aged 6mths to 4 years.
As a result of a change in the type of syringe which is used and packaged with the medication, the Health Product Regulatory Authority have issued a safety notice via a Dear Healthcare Professional communication.
Previously, the medication included a 3ml dosing syringe which could deliver up to 300mg of Levetiracetam. Going forward, this will now be replaced with a new 5ml dosing syringe which can deliver up to 500 mg of Levetiracetam. In addition, the new syringe also has additional graduations marked of 0.25ml compared to the old 3ml syringe.
With these changes, there is a concern of potential medication administration error – which is why this safety notice has issued.
Therefore, prescribers and pharmacists have been advised to alert parents/caregivers to these changes – and to draw their attention to the change of the medication’s presentation at the point of dispensing. In addition, the packaging of the medication has also been changed to inform parents of the syringe change.
Parents should also be aware that the medication with the 3ml dosing syringe may still be in circulation for some time due to existing stock still being available – so should check each prescription received carefully before administering.
The changes in packaging and change in appearance of the syringe can be seen in the images below.
The full safety notice and associated Dear Healthcare Professional communication can be found and read in full by visiting the ‘HPRA’ website.
It is also important to note that there are no changes to the dosing syringes in the following presentations of levetiracetam (Keppra) oral solution:
- 150 mL bottle with 1 mL dosing syringe (for children aged 1 month to 6 months)
- 300 mL bottle with 10 mL dosing syringe (for children aged 4 years and older)
If you have any questions or concerns regarding this, please discuss them with your medical team or dispensing pharmacist. As always, should you require any support or information regarding epilepsy, please do not hesitate to contact your local Community Resource Officer. You can find their details by visiting the ‘Our Local Services’ page of our website.