What is Levetiracetam Teva?
Levetiracetam Teva is a medicine that contains the active substance levetiracetam. It is available as oblong tablets (250 mg, 500 mg, 750 mg and 1, 000 mg). Levetiracetam Teva is a "generic medicine", which means that it is similar to a "reference medicine" already authorized in the European Union (EU) called Keppra.
What is Levetiracetam Teva used for?
Levetiracetam Teva can be used on its own in patients from 16 years of age with newly diagnosed epilepsy, in the treatment of partial onset seizures in the presence or absence of 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 Teva may also be indicated as an adjunctive therapy to other anti-epileptic medicines in the treatment of:
- partial onset crisis with or without generalization in patients from 1 month of age;
- myoclonic seizures (short burst 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, even with loss of consciousness) 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 Teva used?
The starting dose of Levetiracetam Teva alone is 250 mg twice a day, which is increased to 500 mg twice a day after two weeks. The dose can be further increased every two weeks depending on the patient's response, up to a maximum dose of 1 500 mg twice a day. When Levetiracetam Teva is added to another antiepileptic 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. The starting dose, in patients between six months and 17 years of age weighing less than 50 kg, is 10 mg per kilogram of body weight twice a day, which can be increased up to 30 mg / kg twice a day . The tablets are not suitable for babies and children under the age of 6 or weighing less than 25 kg; in such cases an oral solution is recommended. Lower doses are used in patients who have problems with kidney function (such as elderly patients). Levetiracetam Teva tablets should be swallowed with liquid.
How does Levetiracetam Teva work?
The active substance in Levetiracetam Teva, 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 seems to interfere with a protein, called the 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 helps Levetiracetam Teva stabilize electrical activity in the brain and prevent seizures.
How has Levetiracetam Teva been studied?
Because Levetiracetam Teva is a generic medicine, studies in patients have been limited to tests to determine the bioequivalence of the medicine 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 Teva?
Because Levetiracetam Teva is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as those of the reference medicine.
Why has Levetiracetam Teva been approved?
The CHMP (Committee for Medicinal Products for Human Use) concluded that, in accordance with EU requirements, Levetiracetam Teva has been shown to have comparable quality and to be bioequivalent to Keppra. Therefore, the CHMP is of the opinion that, as in the case of Keppra, the benefits outweigh the identified risks. The Committee recommended the granting of a marketing authorization for Levetiracetam Teva.
More information on Levetiracetam Teva
On 26 August 2011, the European Commission issued a marketing authorization for Levetiracetam Teva, valid throughout the European Union. For more information about treatment with Levetiracetam Teva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. The full EPAR for the reference medicine can be found on the Agency's website. Last update of this summary: 06-2011.
