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Keppra Approved to Treat Seizures


Keppra is a medicine that contains the active substance levetiracetam. It is available as tablets (250 mg, 500 mg, 750 mg and 1,000 mg), as an oral solution (100 mg/ml), and as a concentrate that is made up into a solution for infusion (drip into a vein, 100 mg/ml).

 

Keppra can be used on its own in patients from 16 years of age with newly diagnosed epilepsy, to treat partial-onset seizures (fits) with or without secondary generalisation. This is a type of epilepsy where too much electrical activity in one side of the brain causes symptoms such as sudden, jerky movements of one part of the body, distorted hearing, sense of smell or vision, numbness, or a sudden sense of fear. Secondary generalisation occurs when the overactivity later reaches the whole brain.
Keppra can also be used as an add-on to other anti epileptic medicines to treat:
 
partial-onset seizures with or without generalisation in patients from one month of age;
myoclonic seizures (short, shock-like jerks of a muscle or group of muscles) in patients from 12 years of age with juvenile myoclonic epilepsy;
primary generalised tonic-clonic seizures (major fits, including loss of consciousness) in patients from 12 years of age with idiopathic generalised epilepsy (the type of epilepsy that is thought to have a genetic cause).
The medicine can only be obtained with a prescription.
 
 
When Keppra is used on its own, the starting dose is 250 mg twice a day, increasing two weeks later to 500 mg twice a day. The dose can be further increased at two-week intervals according to the patient’s response, to a maximum dose of 1500 mg twice a day.
 
When Keppra is added to another anti epileptic treatment, 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 1500 mg twice a day. In patients aged between six months and 17 years weighing less than 50 kg, the starting dose is 10 mg per kilogram 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 their kidneys (such as older patients). Keppra  tablets are swallowed with liquid. Keppra can be given as an infusion using the same doses at the same frequency when using the tablets or the oral solution is not possible. The use of the infusion should be temporary.
 
How does Keppra work?
The active substance in Keppra , levetiracetam, is an anti epileptic medicine. Epilepsy is caused by excessive electrical activity in the brain. The exact way in which levetiracetam works is still unclear but it seems to interfere with a protein called synaptic vesicle protein 2A, which is found in the spaces between nerves and is involved in the release of chemical messengers from nerve cells. This helps Keppra to stabilise electrical activity in the brain and prevent seizures.
 
 
Keppra was as effective as carbamazepine in keeping patients free of seizures when taken on its own for partial onset seizures. In both groups, 73% of the patients experienced no seizures for six months once on an adequate dose.
As an add-on treatment, Keppra was more effective than placebo:
for partial onset seizures, placebo treatment reduced the weekly number of seizures by 6 to 7%, while the reduction with Keppra at a dose of 1,000 mg per day was between 18 and 33%, depending on the study. With Keppra at a dose of 2,000 mg, the reduction was 27%, and with 3,000 mg, it was around 39%. Keppra was also more effective than placebo in children;
for myoclonic seizures, the number of seizure days per week was halved in 58% of the patients receiving Keppra and in 23% of the patients receiving placebo;
for tonic-clonic seizures, the number of seizures fell by an average of 28% in the patients receiving placebo, compared with 57% in those receiving Keppra. However, there were too few patients aged below 12 years to support the use of Keppra for this type of seizure in this age group.
The most common side effects with Keppra (seen in more than 1 patient in 10) are somnolence (sleepiness), and asthenia (weakness) or fatigue (tiredness). For the full list of all side effects reported with Keppra, see the package leaflet.
 
Keppra should not be used in people who may be hypersensitive (allergic) to levetiracetam, to other pyrrolidone derivatives (medicines with a similar structure to levetiracetam), or to any of the other ingredients.
 
The CHMP decided that Keppra’s benefits are greater than its risks and recommended that it be given marketing authorisation.
 
More brand names available:
Levetiracetam Accord
Levetiracetam Actavis
Levetiracetam ratiopharm
Levetiracetam Teva 
Matever
 

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Edited By: Scientific Section


Source :

European Medicines Agency






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