200-mg Salmon colored tablet imprinted with ""E 262"" on one side
Rufinamide (ru-FIN-uh-mide) is the generic name (non-brand name) of a seizure medicine.
In the United States, the Food and Drug Administration (FDA) approved rufinamide in 2008 to be used as an add-on (adjunctive) seizure medicine in children 4 years and older and adults with the Lennox-Gastaut (LGS) syndrome In European countries, rufinamide is marketed under the brand name Inovelon.
100, 200, and 400-milligrams (mg)
Used to Treat
- Lennox-Gastaut Syndrome
Banzel is marketed in the United States by Eisai, Inc. The name or appearance may differ in other places. The dose (measured in milligrams, abbreviated ""mg"") will usually be the same. These descriptions apply to the U.S. versions:
Inovelon® is available in European Union countries as tablets in three different strengths: 100, 200, and 400-milligrams (mg). These tablets should be swallowed whole and not chewed.
How to Take and Store
See package insert.
Follow the doctor’s directions. Call if you have any questions.
Store at room temperature (below 86°F, 30°C). Protect the tablets from moisture. Don't keep them in the bathroom, where it's damp.
A forgotten dose should be taken right away, unless it is almost time for the next one. In that case, just use one dose, not a double dose, and call the doctor's office for more advice.
Do your best to follow the doctor's directions. The more often a medicine must be taken, the greater the chance of forgetting. If you forget doses often, it may be a good idea to get a special pillbox or watch with an alarm to remind you.
Taking the right amount of seizure medicine on time every single day is the most important step in preventing seizures!
Brain cells need to work (fire) at a certain rate to function normally. During a seizure, brain cells are forced to work much more rapidly than normal. Rufinamide helps prevent brain cells from working as fast as a seizure requires them to. In this way, seizures can be stopped when they are just beginning.
After medicine is swallowed, it must be absorbed into the blood so it can move throughout the body. The process of absorbing, digesting, and excreting a medicine or food is called metabolism. The way the body metabolizes a particular medicine affects how often it must be taken. It also determines whether it will interact with other medicines or be affected by conditions such as liver disease.
Because of the way rufinamide is broken down (digested), it is possible that other drugs would affect it. Also, rufinamide could potentially affect the metabolism of other drugs that are digested in the liver (as many are), including birth control pills.
So things can get complicated, which is why the doctor needs to know about everything that a person takes—prescription drugs, over-the-counter medications, vitamins and other dietary supplements, and herbs. In most cases, all the medicines can be used if the amounts are adjusted to allow for these changes.
Doctors have studied patients with Lennox-Gastaut syndrome aged 4 to 30 years to find out how well rufinamide controls seizures when added to other seizure medicines. Here are some of the findings from this study:
Patients in this study had 90 or more seizures in the month before beginning rufinamide, including drop seizures, tonic-clonic seizures and atypical absence seizures. Some patients received rufinamide and others received placebo. The patients who received rufinamide had a 33% reduction in total numbers of seizures compared to before they took rufinamide, while the patients who took placebo had a 12% reduction. The reduction of tonic-clonic seizures in patients who received rufinamide was 43%.
Two studies looked at the effectiveness of rufinamide in controlling partial seizures when added to other seizure medicines in adolescents and adults. Doses of 400 mg/day and higher, up to 3200 mg/day, were effective. In one of these studies, patients who received rufinamide had a 20% reduction in partial seizures compared to before they took rufinamide, while the patients who took placebo had a 2% increase.
What do these results mean?
These promising results are not always matched in everyday life. Sometimes patients don't take all their medicine on time, or the individual's seizures cannot be controlled at a dose of rufinamide that can be taken without side effects. Because of individual differences, there is no ""best"" amount for everyone. Adjustments are often needed to reduce seizures or side effects.
If seizures continue to occur, the doctor first may suggest a change in the dosage of rufinamide. If that doesn’t work, the next step may be discontinue rufinamide or to add another seizure medicine. There is no best “combination” of seizure medicines.
Most people who take rufinamide don't have too much trouble with side effects.
The most common complaints during clinical studies of adults with partial seizures (usually mild to moderate in severity) were:
- Sleepiness (somnolence)
Less common complaints were double vision and trouble with balance.
The most common complaints during clinical studies of patients with Lennox-Gastaut syndrome (usually mild to moderate in severity) were:
- Sleepiness (somnolence)
Less commonly, a rash occurred.
Sometimes the doctor can help with these side effects by changing the prescription:
- reducing the overall amount of rufinamide
- prescribing smaller doses, taken more often
No one should stop taking rufinamide or change the amount they take without their doctor's guidance.
People who have just started taking rufinamide (or who have just started taking a larger amount) should be careful during activities that might be dangerous, until they know whether they are having any side effects.
Some people, especially children, who took rufinamide in the clinical studies developed serious reactions, particularly when rufinamide was first taken. The symptoms vary, but could include fever, rash, swelling of the lymph nodes, abnormal liver function, and blood in the urine. If any of these occur, tell the doctor or nurse immediately.
Long-term side effects
Because rufinamide is relatively new, it is not know if there are any long-term side effects.
Some people, especially children, who took rufinamide in the clinical studies developed serious reactions, particularly when rufinamide was first taken. The symptoms varied, but could include fever, rash, swelling of the lymph nodes, abnormal liver function, and blood in the urine.
Rufinamide ( Banzel) has been found to aggravate a serious underlying heart condition known as short QT syndrome. It is likely that your neurologist will obtain an electrocardiogram (ECG) to screen for that condition. If you or your family member have a family history of heart troubles, please let your doctor know.
If any of these occur, tell the doctor or nurse immediately, but don't stop using the rufinamide unless the doctor says so.
On July 10, 2008, an advisory panel was convened by the Food and Drug Administration (FDA) to review data that the FDA had previously collected from drug studies showing an association between many of the antiepileptic drugs (AEDs) and suicidal ideation and behavior, which together are called suicidality. According to the FDA’s Alert, among the patients with epilepsy in these drug studies, 1 out of 1000 people taking the placebo (inactive substance) showed suicidality compared to approximately 3.5 out of 1000 people who took an AED. The FDA advisory panel voted to accept the FDA's data at its meeting on July 10. The FDA has provided the following information for patients, family members, and caregivers at www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm100192.htm.
- Taking antiepileptic medicines may increase the risk of having suicidal thoughts or actions;
- Do not make any changes to the medication regimen without first talking with the responsible healthcare professional;
- Pay close attention to any day-to-day changes in mood, behavior and actions. These changes can happen very quickly so it is important to be mindful of any sudden differences.
- Be aware of common warning signs that might be a signal for risk of suicide. Some of these are:
- Talking or thinking about wanting to hurt yourself or end your life
- Withdrawing from friends and family
- Becoming depressed or having your depression get worse
- Becoming preoccupied with death and dying
- Giving away prized possessions
We again urge patients and families to contact their doctor before stopping an epilepsy medication because this may possibly lead to seizures and worsening of mood.
Often doctors find that medicines are useful for more than one purpose. At this time, no other uses for rufinamide are known.
People with types of epilepsy other than partial seizures or Lennox-Gastaut syndrome, for example Juvenile Myoclonic Epilepsy, should probably not take rufinamide until further clinical studies are done for these other types of epilepsy. If you have any questions about what type of epilepsy you have, ask your doctor.
Sometimes a medication changes the way the body absorbs, digests, or excretes another one. This is true not only for prescription medicines, but also for over-the-counter medicines, dietary supplements, herbal products, a few kinds of food (such as grapefruit juice), and even cigarettes!
Any time a doctor suggests a new prescription, be sure to talk about what other medicines are already in use. If two medications affect each other, the doctor may want to prescribe something else or change the amount to be taken.
Because of the way rufinamide is broken down (digested), it is possible that other drugs would affect it. Also, rufinamide could potentially affect the metabolism of other drugs that are digested in the liver (as many are), including birth control pills. This is why the doctor needs to know about everything that a person takes—prescription drugs, over-the-counter medications, vitamins and other dietary supplements, and herbs. In most cases, all the medicines can be used if the amounts are adjusted to allow for these changes.
Rufinamide has been studied in children as young as 4 years of age with Lennox-Gastaut syndrome. The doses ranged up to 45 mg/kg each day in two divided doses. The most common side effects were sleepiness and vomiting.
Because rufinamide is relatively new, there is no available information on its safety when taken during pregnancy on the mother or the fetus.
In the United States, the Food and Drug Administration (FDA) assigns each medication to a "Pregnancy Category" according to whether it has been proven to be harmful in pregnancy. Because rufinamide is not approved in the United States as of May 15, 2007, the FDA has not assigned it to a Pregnancy Category.
All women who are capable of becoming pregnant should take the vitamin called folic acid every day because it helps to prevent birth defects called neural tube defects, malformations of the brain or spinal cord. Women with epilepsy who are pregnant or thinking about becoming pregnant should talk to their doctor about the medications they are taking. Because taking more than one seizure medicine may increase the risk of birth defects, doctors sometimes gradually reduce the number or amount of seizure medicines taken by women planning for pregnancy. This is not done routinely, however. The risk of seizures increases when medications are withdrawn, and seizures—particularly complex partial seizures and tonic-clonic seizures—can injure the baby. Because having these types of seizures may harm the baby, it’s important not to stop taking seizure medicines or reduce the amount without the doctor’s OK.
Most seniors take more medicines than younger people, so there’s a greater risk that the medicines may affect each other. Usually seniors can continue to take all the medicines they need, including rufinamide, without trouble if the doctor changes the amount of some of them to make up for the way they affect each other. Make sure the doctor knows about all the medicines, vitamins, herbs, and other remedies that are being used.
It does not appear that seniors metabolize rufinamide more slowly than younger adults do. It is not clear whether seniors are more likely to experience side effects, however.
Seniors could potentially face more danger from side effects because they are more likely to be seriously hurt if they fall or have another kind of accident, so doctors may be cautious with the starting dose and rate of dosage increase. It’s especially important for seniors keep the doctor informed about any changes that they notice.
The best amount is the amount that completely controls seizures without causing troublesome side effects. It depends on many factors, which are different for every individual, so no single dose works best for everyone. Follow the doctor's directions. Call if you have any questions.
No one should stop taking rufinamide or change the amount they take without talking to the doctor first. Stopping any seizure medicine all at once could potentially cause a serious and possibly life-threatening problem due to increased seizures.
Don’t use more than the doctor prescribes. If a little extra (such as one or two extra tablets) is taken by accident, call the doctor for advice. For a larger overdose, call a poison control center or emergency room right away unless you have special instructions from the doctor.
There are no formal dosage recommendations for rufinamide in the United States. In countries where rufinamide is approved for use, the doctor may start by prescribing a low dose to avoid side effects.
In children, the dosages used in clinical studies started at 1 mg/kg each day and ranged up to 45 mg/kg each day. In studies of patients with partial seizures, the initial rufinamide dosage ranged from 200 to 1600 mg each day, and final doses ranged up to 3200 mg each. Patients took rufinamide twice a day in these studies.
In the United States, companies that manufacture medicines are required to publish certain kinds of information about each product. This document is commonly known as a “package insert” because it is usually included with each package of the medicine.
You can also read these documents (also called "prescribing information") online. The U.S. package insert for Banzel (rufinamide) is found at:
Some of the information may differ in other countries.
To learn how to read and understand a package insert, see "How to read a package insert."