Zonisamidum [Latin]

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http://www.rxlist.com/cgi/generic3/zonisamide.htm

Zonisamidum_[Latin] FDA

Zonisamidum_[Latin] MSDS

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212.227 g/mol

161-163 ^oC

0.8 mg/mL

Solid

0.87

Capsule (100 mg); Tablet

For use as adjunctive treatment of partial seizures in adults with epilepsy.

Zonisamide is an antiseizure drug chemically classified as a sulfonamide and unrelated to other antiseizure agents. The precise mechanism by which zonisamide exerts its antiseizure effect is unknown, although it is believed that the drug blocks sodium channels which leads to the suppression of neuronal hypersynchronization (i.e. convulsions). Likewise zonisamide has also been found not to potentiate syanptic activity by GABA (gamma amino butyric acid).

Variable, yet relatively rapid rate of absorption with a time to peak concentration of 2.8-3.9 hours. Food has no effect on the bioavailability of zonisamide.

Symptoms of overdose include diminished breathing, loss of consciousness, low blood pressure, and slow heartbeat.

LEAFLET

Questions and Answers about ZONEGRAN^® (zonisamide) capsules

What is the most important information I should know about ZONEGRAN?

Some people taking ZONEGRAN (ZON-uh-gran) can get serious reactions. If you get any of the following symptoms, call your doctor right away:

* Rash (may be a sign of a dangerous condition)

* Fever, sore throat, sores in your mouth, or bruising easily (may be signs of a blood problem)

* Sudden back pain, abdominal (stomach area) pain, pain when urinating, bloody or dark urine (may be signs of a kidney stone)

* Decreased sweating or a rise in body temperature (especially in patients under 17 years old)

* Depression

* Thoughts that are unusual for you

* Speech or language problems

* Severe muscle pain and/or weakness

ZONEGRAN can cause drowsiness and coordination problems.

Do not drive or operate dangerous machinery until you know how ZONEGRAN affects you.

What Is ZONEGRAN?

ZONEGRAN is a medicine to treat partial seizures in adults. It is taken with other seizure medicines to help control your seizures.

Who should not take ZONEGRAN?

Talk to your doctor first before stopping ZONEGRAN.

Tell your doctor if you are allergic to sulfa drugs. Do not take ZONEGRAN if you are allergic to any sulfa drugs (for example, Bactrim^TM or Septra^®) or ZONEGRAN.

How should I take ZONEGRAN?

Be sure to follow your doctorís directions. Starting a new medicine can be confusing. If you have any questions, call your doctor.

Start with one ZONEGRAN capsule each day (100 mg). Swallow the capsule whole. Do not bite into or break the capsule. You may take this medicine with or without food.

After a week or so, your doctor may increase your dose of ZONEGRAN. This may occur more than once. It is done to get the best control for your seizures. Take only the number of ZONEGRAN capsules you were told to take.

Talk to your doctor about what to do if you miss a dose.

If you think you have overdosed on your medicine, call your local poison control center or emergency room right away.

Drink 6-8 glasses of water a day. This may help prevent kidney stones.

Talk to your doctor before stopping ZONEGRAN or any other seizure medicine. Stopping a seizure medicine all at once can cause status epilepticus, a serious problem.

What shoud I avoid while taking ZONEGRAN?

ZONEGRAN may make you drowsy. Do not drive a car or operate complex machinery until you know how ZONEGRAN may affect you.

Tell your doctor about any other medicines you may be taking, including non-prescription medicines.

Tell your doctor right away if you are pregnant or plan to become pregnant. You and your doctor can decide if the benefits of taking ZONEGRAN outweigh the risks. ZONEGRAN may cause birth defects.

It is not known whether ZONEGRAN is passed through breast milk to the baby. Before taking ZONEGRAN, tell your doctor if you are nursing or planning to nurse your baby.

What are the possible or reasonably likely side effects of ZONEGRAN?

The most common side effects are drowsiness, loss of appetite, dizziness, headache, nausea, agitation, and irritability. These side effects could occur at any time, but most often occur in the first 4 weeks.

Contact your doctor right away if:

* you develop skin rash

* your seizures worsen

* you develop signs of kidney stones (sudden back pain, abdominal pain, blood in your urine)

* you develop signs of a blood problem (fever, sore throat, sores in your mouth, or bruising easily)

* you get depressed

* you start having thoughts that are unusual for you

* you are very drowsy, have difficulty concentrating, or have coordination problems

* you develop speech or language problems

Other information about ZONEGRAN:

Medicines are sometimes prescribed for purposes other than those listed in a patient leaflet. Use ZONEGRAN only for the reason your doctor told you. Do not use it for another reason. Do not share your ZONEGRAN with others.

This is a summary of information about ZONEGRAN. Call your healthcare professional with any questions. Your doctor or pharmacist can give you the complete information about ZONEGRAN that is written for health professionals. You can also get information about ZONEGRAN at www.elan.com. You can get information and help from the Epilepsy Foundation at 800-EFA-1000 or www.efa.org.

Distributed by: Elan Biopharmaceuticals, a business unit of Elan Pharmaceuticals, Inc.

San Diego, CA 92121, ZONEGRAN is a trademark licensed exclusively to Elan Pharmaceuticals, Inc., All other product names may be trademarks of the respective companies with which they are associated., © 2000 Elan Pharmaceuticals, Inc.

Humans and other mammals