Pexion (imepitoin) - QN03AX90
Updated on site: 09-Feb-2018
|Manufacturer:||Boehringer Ingelheim Vetmedica GmbH|
This is a summary of the European public assessment report (EPAR) for Pexion. It explains how the Agency assessed this veterinary medicine to recommend its authorisation in the European Union (EU) and its conditions of use. It is not intended to provide practical advice on how to use Pexion.
For practical information about using Pexion, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
What is Pexion and what is it used for?
Pexion is a veterinary medicine used in dogs to reduce the frequency of generalised seizures (fits affecting most or all of the brain) due to epilepsy of unknown causes (idiopathic). It should be used after careful evaluation of alternative treatment options. Pexion contains the active substance imepitoin.
How is Pexion used?
Pexion is available as tablets and can only be obtained with a prescription. The dose is calculated according to the dog’s weight: treatment with Pexion should be started at a dose of 10 mg per kg bodyweight twice a day. If seizures are not adequately controlled after one week, the veterinary surgeon may increase the dose by 50 – 100%, to a maximum of 30 mg per kg bodyweight twice a day.
How does Pexion work?
The active substance in Pexion, imepitoin, is an
What benefits of Pexion have been shown in studies?
In an EU field study involving 226 dogs Pexion at a dose of 10 - 30 mg/kg twice daily reduced the average number of generalised seizures from 2.3 to 1.1 per month after 20 weeks of treatment. This compared with a reduction of 2.4 seizures to 1.1 per month with phenobarbital (another
In a second US field study involving 151 dogs, Pexion treatment for 12 weeks at a fixed dose of 30 mg/kg twice daily resulted in 21% of dogs (21 out of 99) being free of generalised seizures compared to 8% of dogs (4 out of 52) given a dummy treatment. 25% of dogs did not respond to Pexion treatment and had the same or an increased number of seizures.
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What are the risks associated with Pexion?
Mild and generally
Pexion must not be used in dogs with severely impaired liver, kidney or heart function.
The effectiveness of Pexion to treat dogs with status epilepticus and cluster seizures has not been studied. Therefore, Pexion should not be used as a primary treatment for dogs with cluster seizures (group of seizures occurring close together) and status epilepticus (continual seizures).
For a full list of all
What are the precautions for the person who gives the medicine or comes into contact with the animal?
In case of accidental ingestion, especially by a child, medical advice should be sought immediately and the package leaflet or label shown to the doctor.
To prevent accidental ingestion, the bottle cap should be replaced immediately after withdrawing the required number of tablets for one dose.
Why is Pexion approved?
The Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Pexion’s benefits are greater than its risks and recommended that it be approved for use in the EU.
Other information about Pexion:
The European Commission granted a marketing authorisation valid throughout the EU for Pexion on 25 February 2013.
The full EPAR for Pexion can be found on the Agency’s website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports. For more information about treatment with Pexion, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
This summary was last updated in June 2017.