Rufinamide (Banzel) is an antiepileptic medication that helps control seizures due to a type of epilepsy called Lennox-Gastaut syndrome (LGS). It's approved as add-on treatment to other anti-seizure medications for adults and children 1 year of age and older. Rufinamide (Banzel) is typically taken by mouth twice a day. It comes in tablet and oral suspension form. Rufinamide (Banzel) isn't a controlled substance, but it commonly causes drowsiness and vomiting as side effects.
Seizures related to Lennox-Gastaut syndrome (LGS) - add-on treatment
Rufinamide (Banzel) is an antiepileptic or anti-seizure medication. It's not clear exactly how it works to treat seizures. But we know that the medication slows down the activity of sodium channels in the brain. This might help calm down brain activity, which can help prevent seizures.
Source:Â DailyMed
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
Dizziness
shakiness in the legs, arms, hands, or feet
sleepiness or unusual drowsiness
trembling or shaking of the hands or feet
uncontrolled eye movements
Less common
Attack, assault, or force
black, tarry stools
chills
cough producing mucus
difficult or painful urination
difficulty with breathing
dizziness or lightheadedness
fear or nervousness
feeling of constant movement of self or surroundings
general feeling of discomfort or illness
headache
joint pain
loss of appetite
muscle aches and pains
pain or tenderness around the eyes and cheekbones
rash
restlessness
sensation of spinning
shakiness and unsteady walk
shivering
sores, ulcers, or white spots on the lips or in the mouth
stuffy or runny nose
sweating
swollen glands
tightness in the chest
trouble sitting still
trouble sleeping
trouble walking
unsteadiness, trembling, or other problems with muscle control or coordination
unusual bleeding or bruising
unusual tiredness or weakness
vomiting
Rare
Bleeding gums
blood in the urine or stools
burning while urinating
fainting
inability to hold urine
increased urge to urinate during the night
increased volume of pale, dilute urine
lower back or side pain
pale skin
pinpoint red spots on the skin
pounding, slow heartbeat
sore tongue
swollen, painful, or tender lymph glands in the neck, armpit, or groin
troubled breathing with exertion
waking to urinate at night
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
Blurred vision
double vision
seeing double
Less common
Acid or sour stomach
back pain
belching
change in hearing
decreased appetite
difficulty having a bowel movement (stool)
ear drainage
indigestion
itching skin
stomach discomfort, upset, or pain
upper abdominal or stomach pain
Rare
Increased appetite
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Works well to lessen the number of seizures in a month if you have Lennox–Gastaut syndrome
Can give to children 1 year of age and older
Comes as an orange-flavored suspension if you have trouble swallowing pills
Not a controlled substance, so it doesn't have strict regulations from the government
Must take with other anti-seizure medications (not by itself)
Only used for seizures from Lennox-Gastaut syndrome; not for other seizure conditions
Must take with food to help the body fully absorb the medication
Can cause drowsiness
You'll first start taking rufinamide (Banzel) at a low dose. Your prescriber might have a dosing schedule for you to follow so that you take a slightly higher dose every other day until you get to the dose that's right for you. Follow up with your prescriber about how often you're having seizures and what side effects you have to help with dose adjustments.
Always take rufinamide (Banzel) with food so that your body absorbs it fully. If you take it on an empty stomach, you might not get the full effect of the medication.
If you or your child has difficulty swallowing pills, you can cut the tablets in half with a pill splitter or crush them. You can also ask the prescriber for the liquid form of rufinamide (Banzel).
Rufinamide (Banzel) can make you feel drowsy or dizzy. It can also affect your motor skills. Avoid activities that require you to be alert and coordinated, like riding a bike, driving a car, or operating machinery, until you know how this medication affects you. In particular, be aware of the effects of rufinamide (Banzel) when you first start taking it and after you switch to a higher dose.
Avoid drinking alcohol with rufinamide (Banzel). Also avoid taking other medications can make you tired while you're taking rufinamide (Banzel). It can make side effects like drowsiness and tiredness more intense.
Let your healthcare team know what other antiepileptic medications you're taking especially carbamazepine (Tegretol), phenytoin (Dilantin), phenobarbital, or valproate. Taking certain antiepileptic medications with rufinamide (Banzel) can affect the levels of the medications in the body. This can either cause more side effects or make them work less well. Make sure to tell your prescriber every time you start, stop, or change doses of your seizure medications.
Rufinamide (Banzel) can make hormonal birth control work less well. If you're sexually active and you can become pregnant, use additional nonhormonal birth control (like condoms) while you're taking rufinamide (Banzel). This will help make sure your birth control works well to prevent unplanned pregnancies. Talk to your prescriber about which nonhormonal birth control options are best for you.
More tips for the liquid form of rufinamide (Banzel):
Make sure to store the suspension liquid of rufinamide (Banzel) at room temperature (don't refrigerate). Throw out any unused medication 3 months after you open the original bottle.
Shake the rufinamide (Banzel) bottle well each time before you measure out your dose.
Use the adapter and oral syringe that comes in the rufinamide (Banzel) box. This makes sure that you draw up the right dose of the liquid medication. Talk to your pharmacist if you're not sure about how to use these supplies. It's important that you don't use household kitchen or measuring spoons for measuring your medication out since they might not be accurate.
Rufinamide (Banzel) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Antiepileptic (anti-seizure) medications like rufinamide (Banzel) can raise your risk of thoughts of suicide or suicidal behavior. Watch for new or worsening signs of depression and any unusual changes in mood or behavior, especially during the first few months of taking this medication and when your dose changes. Report anything concerning to your prescriber. Call 911 or get medical help right away if you have thoughts of hurting yourself.
Rufinamide (Banzel) can cause drowsiness, tiredness, or weakness. It can also cause dizziness and problems with movement or coordination. These side effects usually happen when you first start the medication or when you switch to a higher dose. Avoid activities that require you to be alert, such as riding a bike, driving, or operating machinery, until you know how rufinamide (Banzel) affects you.
Risk factors: Familial short QT syndrome | Taking other medications that can also shorten the QT interval (a specific change in the electrical activity of your heart)
Rufinamide (Banzel) can cause changes to the electrical activity of your heart. It makes the heart muscle recharge faster than usual between beats. This is known as QT shortening, which can lead to dizziness, fainting, and abnormal heart rhythms.
Tell your prescriber if you've had any heart rhythm problems. You can't take rufinamide (Banzel) if you have a genetic heart condition called familial short QT syndrome. This is because you're at higher risk for potentially life-threatening irregular heart rhythm.
Also make sure your healthcare team knows about all the medications you take. They can help you watch out for possibly dangerous drug interactions with rufinamide (Banzel). For example, certain medications, such as primidone (Mysoline), lamotrigine (Lamictal), and phenytoin (Dilantin), can raise your risk for QT shortening because they cause similar changes to the electrical activity of the heart as rufinamide (Banzel).
Some people who've taken rufinamide (Banzel) have had a severe allergic reaction called drug reaction with eosinophilia and systemic symptoms (DRESS). This allergic reaction cause symptoms like fever, rash, swollen lymph nodes, or swelling of the face or mouth. It can also lead to low blood cell counts and damage to important organs, such as the liver, kidneys, and heart. Stop taking rufinamide (Banzel) and Gget medical attention as soon as possible if you notice any signs of a serious allergic reaction.
Don't stop taking rufinamide (Banzel) without talking to your prescriber first. You shouldn't stop taking antiepileptic (anti-seizure) medications like rufinamide (Banzel) too suddenly. It can lead to seizures due to medication withdrawal. Speak with your prescriber if you'd like to stop taking rufinamide (Banzel) or if it's necessary to stop taking it. Your prescriber will instruct you on how to lower your dose slowly over time.
In clinical studies, a few people who took rufinamide (Banzel) experienced status epilepticus, which is a seizure attack that lasts a long time and is life-threatening. In general, it's a good idea to have a plan with family and friends about how to help (and when to call 911) during a seizure attack if you or your child has epilepsy or a seizure condition.
Rufinamide (Banzel) can lower your white blood cell counts. This can make it harder for your body to fight off infections. Let your prescriber know if you're getting sick more than usual or if any infections last longer than normal.
Age 1 year to younger than 17 years: The dose depends on your child's weight. The typical starting dose is 5 mg/kg of body weight by mouth twice a day. The prescriber will raise the dose every other day up to the maximum dose of 22.5 mg/kg twice daily (or a maximum of 3,200 mg per day).
Age 17 years and older: The typical starting dose is 200 mg to 400 mg by mouth twice a day. The prescriber will raise the dose every other day up to the maximum dose of 1,600 mg twice a day (total maximum of 3,200 mg per day).
Your dose might differ if you're on dialysis or if you're also taking valproate.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Familial short QT syndrome (a genetic heart rhythm condition)
Seizures related to Lennox-Gastaut syndrome (LGS) - add-on treatment
Partial seizures in adults with epilepsy
Seizures linked to Lennox-Gastaut syndrome (LGS) in children - add-on treatment
Treatment of seizures from Lennox-Gastaut syndrome in people ages 2 years and older (as an add-on to other anti-seizure medications)
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