Zonegran

Pronunciation

Generic Name: zonisamide (zoe-NIS-a-mide)
Brand Name: Zonegran

Zonegran is used for:

Treating certain types of seizures (partial seizures) in patients with epilepsy. It is used along with other medicines. It may also be used for other conditions as determined by your doctor.

Zonegran is an anticonvulsant. Exactly how Zonegran works is not known.

Do NOT use Zonegran if:

  • you are allergic to any ingredient in Zonegran or to a sulfonamide medicine (eg, sulfamethoxazole)
  • you have kidney failure

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

Slideshow: Flashback: FDA Drug Approvals 2013

Before using Zonegran:

Some medical conditions may interact with Zonegran. 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 (including tartrazine)
  • if you are allergic to aspirin
  • if you have a history of status epilepticus (eg, long periods of continuous seizure activity or a series of seizures without a full return to consciousness)
  • if you have a history of liver or kidney problems, kidney stones, lung or breathing problems, high blood acid levels (metabolic acidosis), mental or mood problems (eg, depression), or suicidal thoughts or actions
  • if you have diarrhea, will be having surgery, or are on a diet high in fat called a ketogenic diet

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

  • Carbonic anhydrase inhibitors (eg, acetazolamide, dichlorphenamide, topiramate) because the risk of high blood acid levels and kidney stones may be increased
  • Anticholinergics (eg, benztropine) because the risk of heatstroke or high blood acid levels may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Zonegran 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 Zonegran:

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

  • Zonegran comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Zonegran refilled.
  • Take Zonegran by mouth with or without food.
  • Swallow Zonegran whole. Do not break, crush, or chew before swallowing.
  • Drink plenty of liquids (6 to 8 glasses of water per day) while taking Zonegran to help prevent kidney stones.
  • Do not suddenly stop taking Zonegran. Suddenly stopping Zonegran may cause serious problems (eg, seizures to occur more often, seizures that will not stop). If you need to stop Zonegran, your doctor will gradually lower your dose.
  • If you miss a dose of Zonegran, 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 Zonegran.

Important safety information:

  • Zonegran may cause dizziness, drowsiness, or vision changes. These effects may be worse if you take it with alcohol or certain medicines. Use Zonegran 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 using Zonegran; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
  • Zonegran is a sulfonamide (sulfa) medicine. Some patients have experienced severe and rarely fatal reactions to sulfonamide medicines. This includes serious and sometimes fatal skin reactions (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis). These skin reactions are more likely to happen within the first 4 months of treatment but may happen at any time. Contact your doctor right away if you develop fever, chills, cough, or sore throat; a rash; red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; sores in the mouth, throat, nose, or eyes; symptoms of liver damage (eg, yellowing of the eyes or skin, pale stools, dark urine, severe stomach pain, loss of appetite); unusual bruising or bleeding; unusual tiredness of weakness; or unusually pale skin.
  • Reduced sweating has been seen with Zonegran, especially in children. Sometimes, this has led to heat stroke and hospital stays. The risk of heat stroke is greater in hot weather and/or during vigorous exercise. Drink plenty of fluids. Dress lightly while in hot climates or when exercising. Check carefully for signs of decreased sweating. If this occurs, promptly seek cooler or air-conditioned shelter and/or stop exercising. Seek medical attention right away if you have a high fever, fever that goes away and comes back, long-lasting fever, less sweating than normal, mental or mood changes, headache, or dizziness.
  • Zonegran may cause high blood acid levels (metabolic acidosis). The risk may be greater in children and in patients with kidney problems, status epilepticus, severe breathing problems, or diarrhea. It may also be greater in patients who are taking certain other medicines (eg, acetazolamide), will be having surgery, or are on a ketogenic diet. Over a period of time, metabolic acidosis may cause kidney problems, bone problems, or decreased growth in children. Contact your doctor immediately if you experience fast breathing; unusual weakness or fatigue; sluggishness; fainting; persistent loss of appetite; or fast, slow, or irregular heartbeat.
  • Patients who take Zonegran may be at increased risk of suicidal thoughts or actions. The risk may be greater in patients who have had suicidal thoughts or actions in the past. Watch patients who take Zonegran 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.
  • Tell your doctor or dentist that you take Zonegran before you receive any medical or dental care, emergency care, or surgery.
  • This product may contain tartrazine dye (FD&C Yellow No. 5). This may cause an allergic reaction in some patients. If you have ever had an allergic reaction to tartrazine, ask your pharmacist if your product has tartrazine in it.
  • Lab tests, including kidney function or blood bicarbonate levels, may be performed while you use Zonegran. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Zonegran is not approved for use in CHILDREN younger than 16 years old; safety and effectiveness in these children have not been confirmed. CHILDREN may be at a higher risk of heatstroke, kidney stones, decreased growth, and metabolic acidosis.
  • If you may become pregnant, you should use an effective form of birth control while you take Zonegran. If you have questions about effective birth control, talk with your doctor.
  • PREGNANCY AND BREAST-FEEDING: Zonegran may cause harm to the fetus. If you think you may be pregnant, contact your doctor right away. You and your doctor will need to decide if you will continue to take Zonegran while you are pregnant. Zonegran is found in breast milk. Do not breast-feed while taking Zonegran.

Possible side effects of Zonegran:

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:

Diarrhea; dizziness; drowsiness; headache; loss of appetite; nausea; tiredness; trouble sleeping.

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); bone pain; a burning, numbness, or tingling feeling that is not normal; change in the amount of urine produced; confusion; decreased coordination; decreased sweating; double vision or other vision problems; memory problems; new or worsening seizures; severe muscle pain or weakness; severe or persistent drowsiness; swelling of the hands, ankles, or feet; symptoms of kidney stones (eg, dark or bloody urine, painful urination, stomach or back pain); tremor; trouble moving around; trouble speaking or other speech problems; trouble thinking or concentrating; unusual eye movements; unusual or disturbing thoughts.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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 Zonegran:

Store Zonegran at room temperature between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Zonegran out of the reach of children and away from pets.

General information:

  • If you have any questions about Zonegran, please talk with your doctor, pharmacist, or other health care provider.
  • Zonegran 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 Zonegran 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 Zonegran. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Zonegran. 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 Zonegran.

Issue Date: November 5, 2014
Database Edition 14.4.1.002
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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