Rufinamide

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

Rufinamide is used for:

Treating seizures in certain patients with Lennox-Gastaut syndrome. It should be used along with other medicine(s).

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 have 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.

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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
  • if you have a history of mental or mood problems (eg, depression), suicidal thoughts or actions, or alcohol abuse or dependence
  • 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:

  • Divalproex or valproic acid because they may increase the risk of rufinamide's side effects
  • 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 be decreased by rufinamide
  • Medicines that may cause a certain type of irregular heartbeat (shortened QT interval). Ask your doctor if you are unsure if any of your medicines might shorten the QT interval

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 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, dizziness, or blurred vision. 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.
  • Check with your doctor before you drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are taking 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 of 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.
  • A serious and sometimes fatal reaction has been reported in patients taking medicines for seizures, including rufinamide. Contact your doctor right away if you develop swollen lymph nodes, fever, rash, blood in the urine, chest pain, symptoms of kidney problems (eg, decreased urination), or symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, stomach pain, yellowing of the skin or eyes).
  • Contact your health care provider if your seizures become worse or if you have a new type of seizure.
  • 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 taking rufinamide. To prevent pregnancy, use an extra form of birth control (eg, condoms).
  • Lab tests, including complete blood cell counts and liver function, 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.
  • 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 taking 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 or swallowing; tightness in the chest; swelling of the mouth, face, lips, or tongue); appetite changes; decreased coordination or trouble walking; fever, chills, or sore throat; irregular heartbeat; new or worsening behavior, or mental or mood changes (eg, aggression, agitation, anger, anxiety, depression, irritability, mania, panic attacks, restlessness); severe muscle pain; severe or persistent dizziness, drowsiness, tiredness, or weakness; suicidal thoughts or attempts; tremor; trouble sleeping; unusual bruising or bleeding; vision changes (eg, blurred vision, double vision).

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, 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.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take rufinamide or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about rufinamide. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to rufinamide. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using rufinamide.

Issue Date: December 3, 2014
Database Edition 14.4.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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