Rufinamide (Oral Route)

Rufinamide is taken together with other drugs to manage seizures in people with Lennox-Gastaut syndrome. It works by decreasing unusual excitement in one’s brain.

Overview

Rufinamide is used together with other seizure drugs to help manage seizures related to Lennox-Gastaut syndrome in both adults and kids aged four and over. Lennox-Gastaut syndrome refers to a seizure condition where one experiences different kinds of seizures and frequent seizures. Rufinamide isn’t used for treating other seizure disorders.

Your doctor can suggest this drug for other conditions not mentioned in this article. If you haven’t discussed this with your healthcare provider or are unsure why you’re using Rufinamide, speak to him or her. Don’t stop using Rufinamide without first consulting your doctor.

Don’t let anyone else use your Rufinamide medication, even if they show symptoms like yours. It may be dangerous for anyone to take Rufinamide if it has not been prescribed to them.

Rufinamide is available as a tablet and a liquid (oral suspension) under the brand name Banzel. The tablet comes in three sizes: 100 mg, 200mg, and 400 mg.

Conditions Treated

  • Epilepsy associated with Lennox-Gastaut Syndrome
  • Petit Mal Epilepsy and Multiple Seizure types
  • Seizure without normal strength or tone
  • Seizures with spells of unconsciousness and other symptoms

Type of Medicine

  • Anti-seizure

Side Effects

Just like many medications, Rufinamide may cause a number of side effects, which may be severe or mild, temporary or long-lasting. A side effect refers to an undesirable reaction to a medicine when it’s used in regular doses.

The Rufinamide side effects itemized below aren’t felt by everybody who uses this medicine. If you’re bothered about the side effects, please discuss this medication’s benefits and risks with your doctor.

At least 1% of people using Rufinamide reported the following effects. Many of them can be controlled, and some may eventually vanish on their own.

Call up your physician if you feel the following effects and they’re bothersome or very serious (severe). Your pharmacist can give you advice on how to manage them:

  • Nausea
  • Vomiting
  • Diarrhea
  • Decreased appetite
  • Acne
  • Dizziness
  • Dry skin
  • Dry eyes
  • Fatigue
  • Flu-like symptoms (sore throat, cough, fever, sudden loss of energy)
  • Muscle aches
  • Headache
  • Sleepiness
  • Nose bleeds
  • Tiredness
  • Stuffy/runny nose

While the majority of the effects mentioned below happen less often, they might result in serious issues if you don’t get medical attention.

See your healthcare specialist promptly if you’ve got any of these effects:

  • Disorientation
  • Balance problems
  • Changes in menstrual cycle
  • Fever
  • Difficulty with speaking
  • Difficulty with walking
  • Loss of appetite
  • Inability to focus or concentrate
  • Mood changes
  • Ringing in ears
  • Sensation of spinning
  • Involuntary eye movement
  • Reduced coordination
  • Rapid/irregular heartbeat
  • Signs of anemia (fewer red blood cells, pale skin, unusual weakness/tiredness)
  • Signs of eye infection (for example painful, irritated, red eyes)
  • Signs of depression (for example poor concentration, reduced interest in activities, changes in sleep, changes in weight, thoughts of suicide)
  • Signs of infection (for example fever or chills, shortness of breath, severe diarrhea, prolonged dizziness, stiffness, headache, listlessness, or weight loss)
  • Vision changes (for example blurred vision or double vision)
  • Tremor
  • Signs of liver disease (for example diarrhea, nausea, vomiting, weight loss, loss of appetite, pale stools, dark urine, yellowing of whites of eyes or skin)

Stop taking Rufinamide and seek urgent medical treatment if you develop any of the following symptoms:

  • Severe skin rash (for example loosening, peeling, or blistering of mucus membranes and the skin)
  • Thoughts of harming yourself or committing suicide
  • Signs of an abnormal heartbeat (for example dizziness, loss of consciousness or fainting, palpitations [racing or pounding heartbeat])
  • Signs of an allergy (for example rash, fever, swollen lymph nodes, facial swelling)

Some people may feel other side effects not mentioned above. Consult with your healthcare professional if you have any symptom that bothers you while you’re using Rufinamide.

Dosage

Take Rufinamide exactly as directed by your healthcare provider. Don’t take Rufinamide for longer than prescribed or in smaller or larger doses. Follow the instructions you see on the prescription label.

Your doctor can occasionally change your Rufinamide dose to ensure you achieve the best possible results.

Take this medicine with food.

You can swallow the Rufinamide tablet whole, cut it in half, or crush it.

Shake the liquid version of Rufinamide (oral suspension) well before you measure your dose. To measure the oral suspension, use the dosing syringe you’re given, or use a special medicine cup or dose-measuring spoon. Don’t measure the suspension with a standard tablespoon. If you don’t have a dose-measuring tool or dosing syringe, ask for one from your pharmacist.

Don’t stop taking Rufinamide without first consulting your healthcare specialist, even if you’re getting better. If you suddenly stop using Rufinamide, you may experience increased seizures. You may have to reduce your dosage before you stop using the medication altogether.

Have an ID card with you indicating that you use Rufinamide or put on a health alert tag. Any healthcare professional who treats you must know that you use seizure medication.

To get maximum benefit from Rufinamide, use it regularly. Have your medication refilled before it runs out completely. Give your doctor a call if your seizures become more frequent while taking Rufinamide or they become worse.

If you use too much Rufinamide, you may suffer symptoms of overdose. You can seek emergency treatment, or call your poison control center or healthcare provider right away.

If Rufinamide is given to you by a healthcare specialist in a medical environment, an overdose is unlikely to occur. However, if you think an overdose has occurred, get emergency medical attention.

Drinking alcohol may increase certain Rufinamide side effects.

This medicine may impair your reactions or thinking and cause blurred vision. Be cautious while driving or doing any activity that requires clear vision and alertness.

Interactions

Rufinamide may interact with any of these medications:

  • Alcohol
  • Birth control pills
  • Baclofen
  • Carbamazepine
  • Divalproex
  • Chloral hydrate
  • Benzodiazepines (for example lorazepam, diazepam, clonazepam)
  • Barbiturates (for example phenobarbital, butalbital)
  • Methadone
  • Gabapentine
  • Lamotrigine
  • Entacapone
  • Phenytoin
  • Primidone
  • Pregabalin
  • Scopolamine
  • Topiramate
  • Tramadol
  • Valproic acid
  • Tolcapone
  • Tricyclic antidepressants (for example: despiramine, amitriptylline, nortriptylline)
  • Narcotic pain relievers (for example codeine, morphine, oxycodone, fentanyl)
  • Muscle relaxants (for example orphenadrine, methocarbamol, cyclobenzaprine)
  • Antipsychotics (for example clozapine, chlorpromazine, olanzepine, haloperidol, risperidone, quetiapine)
  • Antihistamines (for example cetirizine, loratadine, doxylamine, hydroxyzine, diphenhydramine)

If you’re using any of the above medicines, speak to your pharmacist as well as your doctor. Based on your specific case, your doctor may direct you to:

  • Stop using one of those medicines
  • Change from one medication to another
  • Change your way of using both or one of the medicines
  • Not change anything

Drug interactions don’t always mean you must discontinue one of two drugs. Speak to your healthcare professional to know how any medication interactions should be controlled or how they’re being controlled.

Other medications not listed above might interact with Rufinamide. Please tell your prescriber or healthcare professional about all sorts of medications you’re taking (e.g. over-the-counter, prescription, and herbal medications). Also report any supplements you’re taking, as well as alcohol, caffeine, cigarettes, or street drugs. Since these substances can affect how medications work, please let your pharmacist and doctor know if you take them.

Warnings

Make sure to report any allergies or medical conditions you have to your doctor before you begin taking any medication. Also report any drugs you’re using, whether you’re pregnant or nursing an infant and any other crucial details about your health. The following factors can affect how you ought to use Rufinamide.

Birth control

Just like other anti-seizure drugs, Rufinamide can reduce the efficacy of contraceptives taken orally or other hormone treatments for women (e.g. birth control pills, implants, patches, rings, and injections). It’s advisable to make use of a non-hormonal birth control method while you’re using Rufinamide. Be sure to contact your doctor right away if you notice changes in your monthly periods like breakthrough bleeding while using Rufinamide.

Abnormal heart rhythms

This medication can change the regular rhythm of the heart, such as an irregular heartbeat known as QT shortening. This is a serious disorder that may cause fainting and potentially fatal heart rhythm problems.

If you’re susceptible to heart rhythm issues or are using medicines that bring about QT shortening (such as phenytoin, mexiletine, magnesium sulfate, digoxin), discuss with your healthcare specialist how Rufinamide may affect your condition, how your condition can affect the dosage and effectiveness of Rufinamide, and whether you need any special monitoring. People who had or have short QT syndrome or have a history of the condition in their family should not use this medication.

Drowsiness/reduced alertness

If you have uncontrolled epilepsy, you shouldn’t handle potentially hazardous machinery or drive a car. Some common Rufinamide side effects include dizziness, drowsiness, blurred vision, double vision, and difficulties with muscle condition. Do not carry out activities that require physical coordination or mental alertness until you establish how this medication affects you.

Hypersensitivity/allergic reactions

In rare cases, Rufinamide can bring on potentially deadly severe allergic reactions. These reactions can involve a number of organs. If you notice any lymph nodes around your neck, swelling of your face, or rash, be sure to give your doctor a call.

Liver function

If you’ve got liver disease or decreased liver function, talk to your healthcare provider about how Rufinamide can affect your condition, how your condition can affect the efficacy and dosage of Rufinamide, and whether you need any special monitoring. People with very serious liver impairment should not take this drug.

Red blood cells

This medication can cause low red blood cell levels. If you have symptoms of anemia (decrease in red blood cells) such as feeling unusually tired, pale skin, or shortness of breath, get in touch with your doctor promptly.

Stopping the medication

You shouldn’t suddenly stop taking any antiepileptic medicine as this can cause rebound seizures. Generally, you should stop the medication gradually, according to your doctor’s advice, to reduce this risk. Before you stop taking Rufinamide, seek guidance from your doctor.

Suicidal behavior or thoughts and depression

As with other antiepileptic medicines, Rufinamide may trigger thoughts of self-harming or suicide. People with epilepsy can also suffer from depression.

If you have symptoms like agitation, anxiety, restlessness, irritability, aggressiveness, not feeling okay, unusual changes in mood or behavior, or wanting to hurt others or yourself, call your physician at once. If one of your family members has these side effects and is taking Rufinamide, call their doctor straight away.

Vision problems

Rufinamide can cause vision problems or changes, such as seeing double, blurred vision, eye infections, and dry eyes. Report any vision changes to your physician right away.

Pregnancy

It’s not known how Rufinamide can affect an unborn child when used during pregnancy. Unless the benefits are more than the risks, this medicine shouldn’t be taken during pregnancy. If you fall pregnant while taking Rufinamide, report it to your doctor immediately.

Don’t stop taking Rufinamide until you’ve spoken to your doctor, as doing so may bring about rebound seizures that could be harmful to you as well as the unborn baby.

Breastfeeding

This medicine can get into breast milk. So if you’re taking Rufinamide and breastfeeding at the same time, this could harm your baby. Consult your physician about whether it’s advisable to continue breastfeeding while taking Rufinamide.

Children

The efficacy and safety of Rufinamide use in children under the age of 4 have not been determined. Therefore, make sure to consult your doctor before you give your baby this medicine.

The elderly

The use of this drug by people above the age of 65 hasn’t been well researched. Older adults are at a higher risk of the effects of many medicines and a reduced dose of Rufinamide might be appropriate.

Storage

  • Keep Rufinamide oral suspension and tablets at 15 to 30 degrees Celsius.
  • Keep Rufinamide tablets somewhere dry.
  • Securely replace the cap of the oral suspension after opening.
  • Keep the oral suspension of Rufinamide in a vertical position.
  • Make sure to use the oral suspension of Rufinamide within 90 days after opening the bottle.
  • Keep all medicines including Rufinamide far away from children.

Summary

If you’re allergic to Rufinamide, don’t use it. Also, don’t take the medicine if you have a hereditary heart rhythm disorder known as short QT syndrome.

Do not use Rufinamide if you’re allergic to any azole antifungal medication, such as ketoconazole and fluconazole.

This medication should not be given to kids younger than 4.

Before using Rufinamide, inform your healthcare giver if you have any of these medical disorders: liver disease, heart disease, kidney disease, a history of mental illness or depression, or suicidal actions or thoughts.

It is not yet known whether this medication will affect an unborn child, but suffering a seizure when pregnant may put you and your baby at risk. Tell your doctor straight away if you fall pregnant while using Rufinamide to treat seizures. Consult your doctor first before you stop or start using Rufinamide during pregnancy.

You may have suicidal thoughts or actions while using Rufinamide. Make sure you’re checked by your doctor at regular intervals. Don’t skip any scheduled appointments.

Tell your physician about any worsening or new symptoms, such as depression, mood/behavior changes, panic attacks, anxiety, and trouble with sleeping. Also inform him/her if you feel agitated, impulsive, hostile, restless, aggressive, irritable, talkative, hyperactive, or are thinking about harming yourself or committing suicide.

Before using Rufinamide, inform your physician if you usually take other medications that cause sleepiness (such as narcotic medicine, allergy or cold medicine, sedatives, muscle relaxers, sleeping pills, and depression or anxiety medicine. They can increase sleepiness brought on by Rufinamide.

Report all other seizure medicines you use, especially Carbamazepine (Tegretol, Equetro, Carbatrol), Primidone (Mysoline), Phenytoin (Dilantin), Phenobarbital (Solfoton, Luminal), or Valproic acid (Stavzor, Depakene).

Don’t stop taking Rufinamide without talking to your physician first, even if you’re feeling okay. Don’t stop taking Rufinamide suddenly or you may experience increased seizures. Before you completely stop using Rufinamide, you may have to take less and less of it.

Contact your healthcare provider if your seizures worsen or they become more frequent while using Rufinamide.

For more details about Rufinamide, be sure to consult your pharmacist.

Resources
Last Reviewed:
January 31, 2018
Last Updated:
February 10, 2018