Rufinamide

Generic Name: Rufinamide (roo-FIN-a-mide)Brand Name: Banzel

Rufinamide is used for:

Treating seizures in certain patients with Lennox-Gastaut syndrome.

Rufinamide is an anticonvulsant. Exactly how it works is not known, but it may work by slowing abnormal nerve impulses in the brain.

Do NOT use Rufinamide if:

  • you are allergic to any ingredient in Rufinamide
  • you or a family member has a history of certain heart problems (eg, short QT syndrome)
  • you have severe liver problems

Contact your doctor or health care provider right away if any of these apply to you.

Before using Rufinamide :

Some medical conditions may interact with Rufinamide . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a history of heart problems or if you take a medicine that affects your heart rate
  • if you have a history of mental or mood problems (eg, depression) or suicidal thoughts or actions
  • if you are on dialysis
  • if you have liver problems

Some MEDICINES MAY INTERACT with Rufinamide . Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Valproic acid because the risk of its side effects may be increased by Rufinamide
  • Carbamazepine, phenobarbital, phenytoin, or primidone because they may decrease Rufinamide 's effectiveness
  • Phenobarbital or phenytoin because the risk of their side effects may be increased by Rufinamide
  • Carbamazepine, lamotrigine, oral contraceptives (eg, birth control pills), or triazolam because their effectiveness may decreased by Rufinamide

This may not be a complete list of all interactions that may occur. Ask your health care provider if Rufinamide may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Rufinamide :

Use Rufinamide as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Rufinamide comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Rufinamide refilled.
  • Take Rufinamide by mouth with food.
  • Do not suddenly stop taking Rufinamide or your other seizure medicines. You may have an increased risk of side effects (eg, seizures). If you need to stop Rufinamide or add a new medicine, your doctor will gradually lower your dose.
  • Taking Rufinamide at the same time each day will help you remember to take it.
  • Take Rufinamide on a regular schedule to get the most benefit from it.
  • Continue to take Rufinamide even if you feel well. Do not miss any doses.
  • If you miss a dose of Rufinamide , take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Rufinamide .

Important safety information:

  • Rufinamide may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Rufinamide with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Rufinamide ; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
  • Do NOT take more than the recommended dose without checking with your doctor.
  • Rufinamide may increase the risk for suicidal thoughts or actions in some patients. Watch patients who take Rufinamide closely. Contact the doctor at once if new, worsened, or sudden symptoms such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual change in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.
  • Contact your health care provider if your seizures become worse, if you have a new type of seizure, or if you develop a rash associated with a fever.
  • Tell your doctor or dentist that you take Rufinamide before you receive any medical or dental care, emergency care, or surgery.
  • Hormonal birth control (eg, birth control pills) may not work as well while you are using Rufinamide . To prevent pregnancy, use an extra form of birth control (eg, condoms).
  • Lab tests, including complete blood cell counts and liver function tests, may be performed while you use Rufinamide . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use Rufinamide with caution in the ELDERLY; they may be more sensitive to its effects.
  • Rufinamide should be used with extreme caution in CHILDREN younger than 4 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Rufinamide while you are pregnant. Rufinamide is found in breast milk. Do not breast-feed while taking Rufinamide .

Possible side effects of Rufinamide :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; drowsiness; headache; nausea; tiredness; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); appetite changes; behavioral, mental, or mood changes (eg, aggression, agitation, anger, anxiety, depression, mania); blood in the urine; changes in the amount of urine produced; blurred vision or other vision changes; decreased coordination or trouble walking; fever; irregular heartbeat; new or worsening seizures; severe or persistent dizziness, drowsiness, tiredness, or weakness; sore throat; suicidal thoughts or attempts; tremor; trouble sleeping.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately.

Proper storage of Rufinamide :

Store Rufinamide at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Rufinamide out of the reach of children and away from pets.

General information:

  • If you have any questions about Rufinamide , please talk with your doctor, pharmacist, or other health care provider.
  • Rufinamide is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor. This information is a summary only. It does not contain all information about Rufinamide .

If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

  • Rufinamide Professional Patient Advice (Wolters Kluwer)
  • rufinamide Advanced Consumer (Micromedex) - Includes Dosage Information
  • Banzel Prescribing Information (FDA)
  • Banzel Consumer Overview