Zonisamide 100mg Cap, 100ct Bottle

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Description

What is Zonisamide and how is it used?

Zonisamide is a prescription medicine that is used with other medicines to treat partial seizures in adults.

It is not known if Zonisamide is safe or effective in children under 16 years of age.

What are the possible side effects of Zonisamide?

Zonisamide may cause serious side effects, including:

  1. Serious skin rash that can cause death.
  2. Serious allergic reactions that may affect different parts of the body.
  3. Less sweating and increase in your body temperature (fever).
  4. Serious eye problems
  5. Suicidal thoughts or actions in some people.
  6. Increased level of acid in your blood (metabolic acidosis).
  7. Problems with your concentration, attention, memory, thinking, speech, or language.
  8. Blood cell changes such as reduced red and white blood cell counts.

These serious side effects are described below.

Call your health care provider right away if you have:

These eye problems can lead to permanent loss of vision if not treated.

Call your healthcare provider right away if you have any new eye symptoms, including any eye pain or redness or any new problems with your vision.

Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:

Other serious side effects include:

The most common side effects of Zonisamide include:

Side effects can happen at any time, but are more likely to happen during the first several weeks after starting Zonisamide.

These are not all of the possible side effects of Zonisamide. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

iNDICATIONS

ZONISAMIDE is indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy.

DOSAGE AND ADMINISTRATION

ZONISAMIDE (zonisamide) is recommended as adjunctive therapy for the treatment of partial seizures in adults. Safety and efficacy in pediatric patients below the age of 16 have not been established. ZONISAMIDE should be administered once or twice daily, using 25 mg or 100 mg capsules. ZONISAMIDE is given orally and can be taken with or without food. Capsules should be swallowed whole.

Adults Over Age 16

The prescriber should be aware that, because of the long half-life of zonisamide, up to two weeks may be required to achieve steady state levels upon reaching a stable dose or following dosage adjustment. Although the regimen described below is one that has been shown to be tolerated, the prescriber may wish to prolong the duration of treatment at the lower doses in order to fully assess the effects of zonisamide at steady state, noting that many of the side effects of zonisamide are more frequent at doses of 300 mg per day and above. Although there is some evidence of greater response at doses above 100–200 mg/day, the increase appears small and formal dose-response studies have not been conducted.

The initial dose of ZONISAMIDE should be 100 mg daily. After two weeks, the dose may be increased to 200 mg/day for at least two weeks. It can be increased to 300 mg/day and 400 mg/day, with the dose stable for at least two weeks to achieve steady state at each level.

Evidence from controlled trials suggests that ZONISAMIDE doses of 100–600 mg/day are effective, but there is no suggestion of increasing response above 400 mg/day (see CLINICAL PHARMACOLOGY, Clinical Studies subsection). There is little experience with doses greater than 600 mg/day.

Patients With Renal Or Hepatic Disease

Because zonisamide is metabolized in the liver and excreted by the kidneys, patients with renal or hepatic disease should be treated with caution, and might require slower titration and more frequent monitoring (see CLINICAL PHARMACOLOGY and PRECAUTIONS).

Storage

Store at 25°C (77°F), excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature], in a dry place and protected from light.