Banzel (rufinamide) is a seizure medication, also called an anti-epileptic or anticonvulsant.
Banzel is used together with other medicines to treat seizures caused by Lennox-Gastaut syndrome, a severe form of childhood epilepsy that also causes developmental and behavior problems.
Banzel is for use in adults and children who are at least 1 year old.
Important information
You should not use Banzel if you have a severe liver disease, or a genetic heart rhythm disorder called "Short QT syndrome."
Before taking Banzel, tell your doctor if you have heart disease, liver disease, kidney disease (or if you are on dialysis), or a history of depression, mental illness, or suicidal thoughts or actions.
You may have thoughts about suicide while taking this medication. Your doctor will need to check you at regular visits. Do not miss any scheduled appointments.
Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, depression, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, agitated, hostile, aggressive, restless, irritable, hyperactive, talkative, or have thoughts about suicide or hurting yourself.
Do not stop using Banzel suddenly or you may have increased seizures.
Some people have thoughts about suicide while taking seizure medication. Stay alert to changes in your mood or symptoms.
Before taking this medicine
You should not use Banzel if you are allergic to rufinamide, or if you have:
To make sure Banzel is safe for you, tell your doctor if you have:
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heart disease;
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liver disease;
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kidney disease (or if you are on dialysis); or
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a history of depression, mental illness, or suicidal thoughts or actions.
You may have thoughts about suicide while taking Banzel. Your doctor should check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.
Do not start or stop taking seizure medication during pregnancy without your doctor"s advice. Having a seizure during pregnancy could harm both mother and baby. Tell your doctor right away if you become pregnant.
If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of Banzel on the baby.
Banzel can make hormonal birth control less effective. Use a barrier form of birth control (condom or diaphragm with spermicide). Hormonal contraception (birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective enough to prevent pregnancy during your treatment.
Rufinamide may pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using Banzel.
Banzel should not be given to a child younger than 1 year old.
How should I take Banzel?
Take Banzel exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than recommended.
Take Banzel with food.
The Banzel tablet may be swallowed whole, crushed, or cut in half.
Shake the oral suspension (liquid) well just before you measure a dose.
Measure the Banzel oral suspension using the dosing syringe and bottle adapter provided with this medicine. Insert the adapter into the bottle and snap it into place. Insert the syringe into the adapter and turn the bottle upside down. To measure your dose, pull the plunger to the correct number of milliliters marked on the side of the syringe. Rinse the syringe with water after each use.
Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.
Contact your doctor if your seizures get worse or you have them more often while taking Banzel.
Do not stop using Banzel suddenly, even if you feel fine. Stopping suddenly may cause increased seizures. Follow your doctor"s instructions about tapering your dose.
Wear a medical alert tag or carry an ID card stating that you take Banzel. Any medical care provider who treats you should know that you take seizure medication.
Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.
Store the liquid medicine in an upright position. Do not try to remove the bottle adapter once it is in place. The cap will fit properly over the bottle adapter.
Use Banzel regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.
Banzel dosing information
Usual Adult Dose for Lennox-Gastaut Syndrome:
Initial dose: 400 to 800 mg orally per day administered in 2 equally divided doses in the morning and evening
The dose should be increased by 400 to 800 mg per day every 2 days until a maximum daily dose of 3200 mg/day, administered in 2 equally divided doses is reached. It is not known whether doses lower than 3200 mg are effective.
Use: For adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in pediatric patients 1 year of age and older and in adults
Usual Pediatric Dose for Lennox-Gastaut Syndrome:
1 year of age and older:
Initial dose: 10 mg/kg/day orally administered in 2 equally divided doses in the morning and evening
The dose should be increased by approximately 10 mg/kg every other day to a target dose of 45 mg/kg/day or 3200 mg/day, whichever is less, administered in 2 equally divided doses. It is not known whether doses lower than the target dose are effective.
Use: For adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in pediatric patients 1 year of age and older
What happens if I miss a dose?
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while taking Banzel?
Banzel may impair your thinking or reactions. Avoid driving or operating machinery until you know how this medicine will affect you.
Drinking alcohol can increase certain side effects of Banzel.
Banzel side effects
Get emergency medical help if you have signs of an allergic reaction to Banzel: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Seek medical treatment if you have a skin rash with other symptoms of a serious allergic reaction that can affect other parts of your body, including:
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fever;
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dark urine, blood in your urine;
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swollen glands, sore throat;
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extreme weakness or tiredness;
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unusual bruising or bleeding;
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muscle pain; or
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jaundice (yellowing of the skin or eyes).
Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, depression, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, agitated, hostile, aggressive, restless, irritable, hyperactive, talkative, or have thoughts about suicide or hurting yourself.
Call your doctor at once if you have:
Common Banzel side effects may include:
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headache;
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dizziness, drowsiness;
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nausea, vomiting; or
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feeling tired.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
See also: Side effects (in more detail)
What other drugs will affect Banzel?
Taking this medicine with other drugs that make you sleepy can worsen this effect. Ask your doctor before taking Banzel with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.
Tell your doctor about all your current seizure medicines and any you start or stop using, especially:
This list is not complete. Other drugs may interact with rufinamide, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.
