Seizures cause abnormal activity in the brain. Banzel reduces this activity, which may lessen the seizures.
Banzel is a prescription-only medicine available in oral dosage forms.
What Is Banzel Used For?
Banzel is an adjunctive treatment for seizures associated with Lennox-Gastaut syndrome (a severe form of epilepsy causing several seizures, behavioral disturbances, and developmental delays) in children 1 year or older and adults.
Brand Name(s): Banzel
Drug Availability: Prescription
Therapeutic Classification: Anticonvulsants
Available Generically: Yes
Controlled Substance: No
Administration Route: Oral
Active Ingredient: Rufinamide
Dosage Form(s): Tablet and oral suspension
Lennox-Gastaut syndrome affects children, adolescents, and adults with multiple types of seizures that vary among individuals. It’s a severe form of epilepsy beginning in early childhood, usually before age 4. It can be complicated to treat. Combinations of seizure medications and other treatments may be used to improve seizure control and other associated disorders.
How to Take Banzel?
Read the instructions on your prescription label every time you get a refill, and ask your healthcare provider or pharmacist if you have any questions.
Banzel is available only on prescription. Take one tablet with food twice a day or as prescribed. Swallow the tablet whole, break it in half on the score mark, or crush it. When taking oral suspension, shake the bottle well before use. Measure the dose with the bottle adapter and dosing syringes provided. Take your dose at around the same time daily to avoid missing it. Take exactly as prescribed. Do not take more, less, or more often than prescribed.
Your healthcare provider may change (increase) your dose depending on your condition. Please do not change your dose on your own, as it can cause severe side effects. Banzel may help to control your condition but will not cure it. Continue to take your medicine even if you feel well. Do not suddenly stop taking Banzel. It can worsen your seizures. Instead, your healthcare provider will reduce your dose periodically before stopping the drug to avoid withdrawal effects.
Storage
Store Banzel tablets and oral suspension at 59 to 86 degrees Fahrenheit (F). Place the tablets in a dry place.
For the oral suspension:
Secure the cap tightly after use. Keep the bottle in the upright positionUse within 90 days of first opening the bottle.
Keep your medications out of the reach of children and pets, ideally locked in a cabinet or closet.
If you plan to travel with Banzel, get familiar with your final destination’s regulations. In general, be sure to make a copy of your Banzel prescription. If possible, keep your medication in its original container from your pharmacy with your name on the label.
Do not keep unwanted or expired medicines. Discard all unused and expired drugs, but do not pour them down the drain or in the toilet. Ask your pharmacist or healthcare provider about the best ways to dispose of this medicine. And check out drug take-back programs in your area.
Off-Label Uses
Banzel is used off-label to treat partial seizures (occur only in one area of your brain) that aren’t related to LGS. Partial seizures may cause muscles to contract, hallucinations, sweating, or nausea.
What Are the Side Effects of Banzel?
This is not a complete list of side effects and others may occur. A healthcare provider can advise you on side effects. If you experience other effects, contact your pharmacist or a healthcare provider. You may report side effects to the Food and Drug Administration (FDA) at fda.gov/medwatch or 800-FDA-1088.
Common Side Effects
Banzel may cause some common side effects, such as:
Dizziness Headache Fatigue Nausea and Vomiting Sleepiness Tiredness
Severe Side Effects
Banzel may cause some severe side effects that need medical attention. Contact your healthcare provider immediately if you develop any signs of a severe reaction. Call 911 if your symptoms feel life-threatening.
Serious side effects and their symptoms include:
FeverSore throatSwollen glandsRashHivesItchingSwelling of the face, lips, tongue, or eyesTrouble breathingBlurred or double visionYellowing of the skin or eyesDark-colored urineLight-colored stoolUnusual bruising or bleeding Severe fatigue or muscle painFrequent or worsening seizures
Like other antileptic drugs, Banzel may cause suicidal thoughts in 1 in 500 people. Immediately seek help if you feel any negative thoughts or think of committing suicide, have worsening or new anxiety or depression, or harm yourself in any other way.
Dosage: How Much Banzel Should I Take?
Modifications
The following modifications (changes) should be kept in mind when using Banzel:
If you experience a serious side effect, you or your healthcare provider may send a report to the FDA’s MedWatch Adverse Event Reporting Program or by phone (800-332-1088).
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
For oral dosage forms (suspension or tablets): For seizures: Adults—At first, 400 to 800 milligrams (mg) per day, taken in two divided doses. Your doctor may gradually increase your dose if needed. However, the dose is usually not more than 3200 mg per day. Children 1 year of age and older—Dose is based on body weight and must be determined by your doctor. The starting dose is 10 milligrams (mg) per kilogram (kg) of body weight per day, taken in two divided doses. Your doctor may gradually increase your dose if needed. However, the dose is usually not more than 45 mg/kg/day or 3200 mg per day. Children younger than 1 year of age—Use and dose must be determined by your doctor.
Severe allergic reaction: Avoid using Banzel if you have a known allergy to it or its ingredients.
Pregnancy: We don’t know enough about the safety and effectiveness of Banzel in pregnant people and their unborn fetuses. Discuss with your healthcare provider if you plan to become pregnant or are pregnant, and weigh the benefits and risks of taking Banzel during your pregnancy.
Breastfeeding: There is not enough data available We don’t know enough about the safety of Banzel in human breastmilk and nursing babies. Talk with your healthcare provider if you plan to breastfeed, and weigh the benefits and risks of the clinical need of Banzel for the mother and its effects on the nursing child.
Adults over 65: Clinical studies haven’t included a large enough number of people in this age group to see whether they respond differently from younger adults. In general, some people over the age of 65 may have decreased hepatic, renal, or cardiac function or use other medications.
Children: Banzel is approved for use in children 1 year or older.
Other modifications: Dose adjustment is not required in people with severe kidney issues (creatinine clearance < 30 milliliters per minute [mL/min]). However, people undergoing dialysis may need dose adjustments.
Use of Banzel in people with severe liver issues is not recommended. Caution is advised when used in people with mild to moderate liver issues.
Administration modifications: Take Banzel with food.
Missed Dose
If you accidentally forgot your Banzel dose, take it as soon as you remember. If it’s already close to your next scheduled dose, then skip the missed dose and take the following dose at your next scheduled dosing time. Don’t try to double up to make up for the missed dose.
Try to find ways that work for you to help yourself remember to take your medication routinely. If you miss too many doses, Banzel might be less effective at treating your condition.
Overdose: What Happens If I Take Too Much Banzel?
In case of an overdose, seek medical attention immediately.
Precautions
What Are Reasons I Shouldn’t Take Banzel?
Avoid the use of Banzel in people with:
If someone collapses or isn’t breathing after taking Banzel, call 911 immediately.
If you or your child develop any unusual or strange thoughts and behavior while taking this medicine, be sure to discuss it with your doctor. Some changes that have occurred in people taking this medicine are like those seen in people who drink too much alcohol. Other changes might be confusion, worsening of depression, hallucinations (seeing, hearing, or feeling things that are not there), suicidal thoughts, and unusual excitement, nervousness, or irritability.
This medicine may cause some people to become dizzy, drowsy, lightheaded, clumsy, unsteady, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert or able to think or see well.
This medicine may cause serious allergic reactions that may affect several parts of the body (eg, liver, kidneys, or heart). Check with your doctor right away if you or your child have more than one of the following symptoms: a fever, dark-colored urine, headache, rash, itching, extra fluid around the face, stomach pain, swollen, painful, or tender lymph glands in neck, armpit, or groin, unusual tiredness, or yellow eyes or skin.
Do not suddenly stop taking this medicine without checking first with your doctor. Your seizures may return or occur more often if you stop this medicine suddenly. Your doctor may want you to gradually reduce the amount you are using before stopping it completely.
Check with your doctor if you notice any signs of fever, chills, or sore throat. These could be symptoms of an infection resulting from low white blood cell counts.
Birth control pills may not work as well while you are using this medicine. To keep from getting pregnant, use another form of birth control together with your birth control pills. Other forms include condoms, diaphragms, or contraceptive foams or jellies.
Avoid drinking alcohol while taking this medicine.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Familial short QT syndrome (an inherited condition causing irregular heartbeat, dizziness, or sudden death) Severe liver issues
What Other Medications Interact With Banzel?
Use caution when taking Banzel with the following medications:
Antiepileptics: Banzel is used in combination with other antiepileptic drugs (AEDs). However, Banzel may affect the level of other AEDs. On the other hand, AEDs can also affect the level of Banzel in your body. Talk to your healthcare provider when taking drugs such as:
Tegretol (carbamazepine) Phenobarbital Dilantin (phenytoin) Mysoline (primidone) Halcion (triazolam)
Your healthcare provider may change the doses of your drugs or monitor you carefully for side effects.
Hormonal contraceptives: People of childbearing age should be warned about using Banzel with hormonal contraceptives as it may make them less effective. For this reason, additional non-hormonal forms of contraception should be used to avoid unwanted pregnancies.
Valproate: People stabilized on Banzel should begin valproate therapy at a low dose and titrate to a clinically effective dose. Similarly, people taking valproate should start Banzel at a dose lower than 10 milligrams per kilogram (mg/kg) per day in children or 400 milligrams per day in adults.
Talk with your pharmacist or healthcare provider for more detailed information about medication interactions with Banzel.
And be sure to talk with your healthcare provider about any other medicines you take or plan to take, including over-the-counter (OTC), nonprescription products, vitamins, herbs, or plant-based medicines.
What Medications Are Similar?
A combination of antiseizure drugs and other treatments may be used to improve seizures associated with Lennox-Gastaut syndrome.
Similar drugs are:
Onfi (clobazam) Felbatol (felbamate) Lamictal (lamotrigine) Topamax (topiramate) Epidiolex (cannabidiol)
Never use a drug for a reason other than your healthcare provider’s prescription, and do not switch between drugs or their brands without asking.
How Can I Stay Healthy While Taking Banzel?
Lennox-Gastaut syndrome is an epilepsy syndrome that begins in childhood. It can cause multiple drug-resistant seizures, intellectual disability, and growth delays. While living with a neurological condition does have its challenges, there are ways to help improve your or your child’s quality of life. Refer below for some general tips to support your health:
Take Banzel and other drugs as recommended by your healthcare provider. Consider keeping a diary to become more aware of your triggers. Achieve a healthy outcome to prevent worsening of seizures. Avoid drinking alcohol to minimize symptoms or side effects. Check-in. Become aware of your or your child’s thoughts. Seek immediate help if you or anyone taking this drug have suicidal thoughts, depression, anger issues, or anxiety. Consider support groups or working with a mental healthcare professional if you feel uncomfortable or experience any new or worsening mental health symptoms. Asking for help and finding ways to cope with your way of handling the problems will help you to live well with this condition.
