Zonegran

DRUG DESCRIPTION

ZONEGRAN® (zonisamide) is an antiseizure drug chemically classified as a sulfonamide and unrelated to other antiseizure agents. The active ingredient is zonisamide, 1,2-benzisoxazole-3-methanesulfonamide. The empirical formula is C8H8N2O3 with a molecular weight of 212.23. Zonisamide is a white powder, pKa = 10.2, and is moderately soluble in water (0.80 mg/mL) and 0.1 N HC1 (0.50 mg/mL).

The chemical structure is:

ZONEGRAN®
  (zonisamide) Structural Formula Illustration

ZONEGRAN is supplied for oral administration as capsules containing 25 mg or 100 mg zonisamide. Each capsule contains the labeled amount of zonisamide plus the following inactive ingredients: microcrystalline cellulose, hydrogenated vegetable oil, sodium lauryl sulfate, gelatin, and colorants.

What are the possible side effects of zonisamide (Zonegran)?

Get emergency medical help if you have any of these signs of an allergic reaction: any form of skin rash; hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have any of these serious side effects:

  • fever, sore throat, and...

Read All Potential Side Effects and See Pictures of Zonegran »

What are the precautions when taking zonisamide (Zonegran)?

Before taking zonisamide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease (such as kidney stones), lung/breathing problems, long-term diarrhea, metabolic imbalance (metabolic acidosis), a special diet (ketogenic diet), mental/mood problems (such as depression, psychosis).

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic...

Read All Potential Precautions of Zonegran »


Zonegran Consumer (continued)

SIDE EFFECTS: Dizziness, drowsiness, trouble sleeping, lack of coordination, loss of appetite, diarrhea, and double vision may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any unlikely but serious side effects, including: easy bruising/bleeding, signs of infection (such as fever, persistent sore throat), mental/mood problems (such as confusion, difficulty concentrating, memory problems, agitation, irritability), speech problems, decreased sweating, sudden back/side/abdominal pain, painful urination, pink/bloody urine.

A small number of people who take anticonvulsants for any condition (such as seizure, bipolar disorder, pain) may experience depression, suicidal thoughts/attempts, or other mental/mood problems. Tell your doctor right away if you or your family/caregiver notice any unusual/sudden changes in your mood, thoughts, or behavior including signs of depression, suicidal thoughts/attempts, thoughts about harming yourself.

This medication may cause a serious metabolic problem (metabolic acidosis). Get medical help right away if you have any of the following symptoms: bone pain/breakage, rapid breathing, fast/irregular heartbeat, sudden/unexplained tiredness, severe drowsiness/difficulty staying awake.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking zonisamide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease (such as kidney stones), lung/breathing problems, long-term diarrhea, metabolic imbalance (metabolic acidosis), a special diet (ketogenic diet), mental/mood problems (such as depression, psychosis).

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication may decrease your ability to sweat, making you more likely to get heat stroke. Avoid activities that may cause you to overheat (such as doing strenuous work/exercise in hot weather, using hot tubs). When the weather is hot, drink plenty of fluids and dress lightly. If you become overheated, promptly seek cooler shelter and stop exercising. Get medical help right away if you develop a fever, mental/mood changes, headache, or dizziness.

Children may be more sensitive to the side effects of the drug, especially decreased sweating, heat stroke, or metabolic imbalance.

During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. However, since untreated seizures are a serious condition that can harm both a pregnant woman and her unborn baby, do not stop taking this medication unless directed by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, immediately talk to your doctor about the benefits and risks of using this medication during pregnancy.

This medication passes into breast milk. Consult your doctor before breast-feeding.


Zonegran Patient Information Including Side Effects

Brand Names: Zonegran

Generic Name: zonisamide (Pronunciation: zoe NIS a mide)

  • What is zonisamide (Zonegran)?
  • What are the possible side effects of zonisamide (Zonegran)?
  • What is the most important information I should know about zonisamide (Zonegran)?
  • What should I discuss with my healthcare provider before taking zonisamide (Zonegran)?
  • How should I take zonisamide (Zonegran)?
  • What happens if I miss a dose (Zonegran)?
  • What happens if I overdose (Zonegran)?
  • What should I avoid while taking zonisamide (Zonegran)?
  • What other drugs will affect zonisamide (Zonegran)?
  • Where can I get more information?

What is zonisamide (Zonegran)?

Zonisamide is a sulfa drug with anti-convulsant effects.

Zonisamide is used together with other anti-convulsant medications to treat partial seizures in adults with epilepsy.

Zonisamide may also be used for other purposes not listed in this medication guide.

What are the possible side effects of zonisamide (Zonegran)?

Get emergency medical help if you have any of these signs of an allergic reaction: any form of skin rash; hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have any of these serious side effects:

  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
  • the first sign of any skin rash, no matter how mild;
  • increased or worsening seizures;
  • rapid breathing or feeling short of breath with dry mouth, confusion, dizziness or weakness, numbness or tingling, chest pain;;
  • fast, pounding, or uneven heartbeats;
  • pale skin, easy bruising or bleeding, unusual weakness;
  • fever, chills, body aches, flu symptoms, white patches or sores inside your mouth or on your lips;
  • problems with thinking or speech, trouble concentrating;
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • dizziness or weakness and hot, dry skin without sweating;
  • urinating less than usual or not at all; or
  • sudden back pain, stomach or side pain, pain or bleeding when urinating, bloody or dark urine.

Less serious side effects may include:

  • drowsiness, dizziness, headache, tired feeling;
  • mild loss of appetite, weight loss;
  • loss of balance or coordination;
  • sore throat, cough; or
  • blurred vision, ringing in your ears.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about zonisamide (Zonegran)?

Do not use this medication if you are allergic to zonisamide, or to other sulfa drugs such as sulfamethoxazole (Gantanol), sulfisoxazole (Gantrisin), or sulfamethoxazole-trimethoprim (Bactrim, Septra, Cotrim, and others). A sulfa drug allergic reaction can be fatal.

You may have thoughts about suicide while taking this medication. Your doctor will need to check you at regular visits. Do not miss any scheduled appointments.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

Zonisamide can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Do not stop taking zonisamide without first talking to your doctor, even if you feel fine. Stopping zonisamide suddenly may cause you to have seizures. You may need to use less and less before you stop the medication completely.

If you need to have any type of surgery, tell the surgeon ahead of time that you are taking zonisamide.

Carry an ID card or wear a medical alert bracelet stating that you are taking zonisamide, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you are taking a seizure medication.

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