What is Levetiracetam Accord?
Levetiracetam Accord is a medicine that contains the active substance levetiracetam. It is available as tablets (250 mg, 500 mg, 750 mg and 1 000 mg).
Levetiracetam Accord is a "generic medicine". This means that Levetiracetam Accord is similar to a "reference medicine" already authorized in the European Union (EU) called Keppra.
What is Levetiracetam Accord used for?
Levetiracetam Accord can be used on its own in patients starting from 16 years of age with newly diagnosed epilepsy, in the treatment of partial onset seizures with or without secondary generalization. It is a type of epilepsy in which excessive electrical activity in one part of the brain causes symptoms such as sudden spasmodic movements of a part of the body, hearing problems, smell or sight, numbness or sudden sense of fear. Secondary generalization occurs when hyperactivity expands subsequently to the whole brain.
Levetiracetam Accord may also be indicated as an adjunctive therapy to other antiepileptic medicines in the treatment of:
- partial onset crisis with or without generalization in patients from one month of age;
myoclonic seizures (short, jerky contractions of a muscle or group of muscles) in patients from 12 years of age with juvenile myoclonic epilepsy;
- primary generalized tonic-clonic seizures (more severe crises, in which the loss of consciousness occurs) in patients from 12 years of age with idiopathic generalized epilepsy (the type of epilepsy believed to be of genetic origin).
The medicine can only be obtained with a prescription
How is Levetiracetam Accord used?
In monotherapy Levetiracetam Accord should be given at an initial dose of 250 mg twice a day, which should be increased to 500 mg twice a day after two weeks. The dose can be further increased every two weeks based on the patient's response up to a maximum dose of 1 500 mg twice a day.
When Levetiracetam Accord is added to another anti-epileptic therapy, the starting dose in patients over 12 years weighing more than 50 kg is 500 mg twice a day. The daily dose can be increased up to 1 500 mg twice a day. In patients between six months and 17 years of age who weigh less than 50 kg, the starting dose is 10 mg per kilogram of body weight twice a day, which can be increased up to 30 mg / kg twice a day.
Lower doses are used in patients who have problems with kidney function (such as elderly patients). Levetiracetam Accord tablets should be swallowed with liquid.
How does Levetiracetam Accord work?
The active substance in Levetiracetam Accord, levetiracetam, is an anti-epileptic medicine. Epilepsy is caused by excessive electrical activity in the brain. The exact mode of action of levetiracetam is still not entirely clear; however, levetiracetam appears to interfere with a protein called synaptic vesicle protein 2A, which is located in the space between the nerves and intervenes in the release of chemical transmitters from nerve cells. This allows Levetiracetam Accord to stabilize electrical activity in the brain and prevent seizures.
How has Levetiracetam Accord been studied?
Because Levetiracetam Accord is a generic medicine, studies in patients have been limited to tests to determine its bioequivalence to the reference medicine, Keppra. Two medicines are bioequivalent when they produce the same levels of active ingredient in the body.
What are the benefits and risks of Levetiracetam Accord?
Because Levetiracetam Accord is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are considered to be the same as those of the reference medicine.
Why has Levetiracetam Accord been approved?
The CHMP concluded that, in accordance with EU requirements, Levetiracetam Accord has been shown to have comparable quality and to be bioequivalent to Keppra. Therefore, the CHMP considered that, as in the case of Keppra, the benefits outweigh the identified risks and recommended the granting of a marketing authorization for Levetiracetam Accord.
Further information on Levetiracetam Accord
On 3 October 2011, the European Commission issued a marketing authorization for Levetiracetam Accord, valid throughout the European Union.
For more information about treatment with Levetiracetam Accord, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
The full EPAR for the reference medicine can also be found on the Agency's website.
Last update of this summary: 08-2011.
