Levetiracetam is an anti-epileptic drug indicated for monotherapy or adjunctive therapy of focal seizures, and adjunctive therapy of myoclonic and tonic clonic seizures.
UCB (Pharma) Limited have contacted healthcare professionals to alert them to the possibility of accidental overdose with Keppra (levetiracetam) oral solution 100mg/ml.
Levetiracetam overdose can result in serious adverse effects including drowsiness, agitation, reduced level of consciousness, respiratory depression and coma. The majority of reported cases have involved children aged between 6 months and 11 years.
Identified causes of reported overdoses include:
- Use of an inappropriate dosing syringe.
- Misunderstanding how to accurately measure the dose.
The following advice has been provided to healthcare professionals to minimise the risk of further accidental overdose:
- Prescribers should always prescribe the dose in mg with a ml equivalence based on the correct age of the patient.
- Prescribers and pharmacists should advise the patient and/or carer on how to measure the prescribed dose at every supply.
- Patients and/or carers should be advised to only use the syringe supplied with the medicine. Once the bottle is empty the syringe should be discarded.
- Pharmacists should ensure that the appropriate presentation of oral solution is dispensed. Keppra oral solution 100mg/ml is available in the following presentations:
- 150ml bottle with 1ml syringe for infants aged from 1 month to less than 6 months.
- 150ml bottle with 3ml syringe for children 6 months to less than 4 years, and below 50kg.
- 300ml bottle with 10ml syringe for children 4 years and older, and below 50kg.
- 300ml bottle with 10ml syringe for children, adolescents and adults 50kg and over.
UCB have advised that the Patient Information Leaflet for Keppra oral solution and the outer packaging of the product will be updated to improve the clarity of the dose recommendations and to avoid confusion about the appropriate bottle size and syringe. This revision should be completed around May 2017.
To further reduce the risk of errors in dosing manufacturers who market more than one presentation of levetiracetam oral solution have been encouraged to use colour codes and pictograms to clearly differentiate the products, state the age range the product is intended for, and to include details of the dosing device that should be used with the product.