What is Levetiracetam Ratiopharm?
Levetiracetam ratiopharm is a medicine that contains the active substance levetiracetam, available as oblong tablets (250 mg, 500 mg, 750 mg and 1 000 mg) and in oral suspension (100 mg / ml).
Levetiracetam ratiopharm is a "generic medicine", ie a medicine similar to a "reference medicine" already authorized in the European Union (Keppra).
What is Levetiracetam Ratiopharm used for?
Levetiracetam ratiopharm as a single agent (alone) is indicated in the treatment of partial onset seizures with or without secondary generalization in patients from 16 years of age with newly diagnosed epilepsy. This type of epilepsy, due to excessive electrical activity in an area of the brain, is characterized by symptoms such as sudden spasmodic movements of a part of the body, alteration in hearing, smell or sight, numbness or sudden fear. Secondary generalization arises later when hyperactivity expands to the whole brain.
Levetiracetam ratiopharm is also indicated as an adjunctive therapy to other antiepileptic medicines in the treatment of:
- partial onset crisis with or without secondary generalization in patients from one month of life;
- myoclonic seizures (short and sudden spasms of a muscle or a group of muscles) in patients from 12 years of age with juvenile myoclonic epilepsy;
- primary generalized tonic-clonic seizures (major crises, 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).
How is Levetiracetam Ratiopharm used?
In monotherapy the recommended starting dose of Levetiracetam ratiopharm is 250 mg twice a day, which can be increased after two weeks up to 500 mg twice a day. Depending on the patient's response, the dosage can be further increased every two weeks, up to a maximum dose of 1 500 mg twice a day.
When Levetiracetam ratiopharm is combined with another anti-epileptic therapy, in patients over 12 years of age, weighing at least 50 kg, the starting dose 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 initial dose is 10 mg per kilogram of body weight twice a day; this dose can be increased up to 30 mg / kg twice a day. Use of the oral solution is recommended at the start of therapy in children under the age of six or weighing less than 25 kg. In infants aged between one and six months, the starting dose is 7 mg / kg twice a day in an oral solution. The daily dose can be increased up to 21 mg / kg twice a day.
The dosage should be decreased in patients with reduced kidney function (eg elderly patients).
Levetiracetam ratiopharm tablets should be swallowed with liquid. The oral solution can be diluted in a glass of water before taking.
How does Levetiracetam Ratiopharm work?
The active substance in Levetiracetam ratiopharm, levetiracetam, is an anti-epileptic medicine. Epilepsy is due to excessive electrical activity in the brain. The precise modes of action of levetiracetam are not yet fully known; the principle seems to interfere with a protein (the 2A protein of the synaptic vesicle) that is located in the space between the nerves and intervenes in the release of chemical transmitters from nerve cells. This allows Levetiracetam ratiopharm to stabilize electrical activity in the brain and prevent seizures.
How has Levetiracetam Ratiopharm been studied?
Since Levetiracetam ratiopharm is a generic medicine, the studies conducted were limited to verifying its bioequivalence with the reference medicine, namely Keppra. Two drugs are bioequivalent if, once placed in the body, they produce the same levels of active ingredient.
What are the benefits and risks of Levetiracetam Ratiopharm?
Because Levetiracetam ratiopharm is a generic medicine and is bioequivalent to the reference medicine, it is believed that the benefits and risks associated with it are the same as the reference medicine.
Why has Levetiracetam Ratiopharm been approved?
The CHMP (Committee for Medicinal Products for Human Use) concluded that, in line with EU requirements, it was shown that Levetiracetam ratiopharm is qualitatively comparable and bioequivalent to Keppra. Therefore, the CHMP considered that, like Keppra, the benefits outweigh the identified risks and recommended that it be given marketing authorization.
Further information on Levetiracetam Ratiopharm
On 26 August 2011, the European Commission issued a marketing authorization for Levetiracetam ratiopharm, valid throughout the European Union.
For more information about treatment with Levetiracetam ratiopharm, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
The full EPAR of the reference medicine is also found on the Agency's website.
Last update of this summary: 06-2011.
