What is Levetiracetam Teva?
Levetiracetam Teva is a medicine that contains the active substance levetiracetam. It is available in oblong tablets (250 mg, 500 mg, 750 mg and 1,000 mg). Levetiracetam Teva is a 'generic medicine' which means 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, to treat 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 one part of the body, impaired hearing, smell or vision, numbness or a sudden sense of fear. Secondary generalization occurs." occurs when hyperactivity subsequently expands to the entire brain. Levetiracetam Teva may also be indicated as add-on therapy to other antiepileptic medicines in the treatment of:
- partial onset seizures with or without generalization in patients from 1 month of age;
- myoclonic seizures (short jerking 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 seizures, including 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 as monotherapy is 250 mg twice a day, which is increased to 500 mg twice a day after two weeks. The dose may be further increased every two weeks based on the patient's response, up to a maximum dose of 1,500 mg twice daily. When Levetiracetam Teva is added to another antiepileptic therapy, the starting dose in patients over 12 years of age who weigh more than 50 kg is 500 mg twice a day. The daily dose can be increased up to 1,500 mg two times a day. The starting dose, in patients between six months and 17 years of age who weigh 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 infants and children under 6 years of age 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 modes of action of levetiracetam are not yet fully understood: however, levetiracetam appears to interfere with a protein, called synaptic vesicle protein 2A, which is found in the space between nerves and is involved 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, the studies in patients were limited to tests to establish that the medicine was bioequivalent to the reference medicine Keppra. Two medicines are bioequivalent when they produce the same levels of the active substance 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 assumed to be 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 that Levetiracetam Teva be given a Marketing Authorization.
More information about Levetiracetam Teva
On 26 August 2011, the European Commission granted a "Marketing Authorization" for Levetiracetam Teva, valid throughout the European Union. For more information on Levetiracetam Teva therapy, please read the package leaflet (included with the EPAR) or consult your doctor or pharmacist. The full EPAR version of the reference medicine can be found on the Agency's website. Last update of this summary: 06-2011.
The information on Levetiracetam Teva published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
