Label: ZONISAMIDE capsule

  • NDC Code(s): 62756-258-01, 62756-258-02, 62756-258-03, 62756-258-04, view more
  • Packager: Sun Pharmaceutical Industries, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated June 24, 2020

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  • DESCRIPTION
    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 ...
  • CLINICAL PHARMACOLOGY
    Mechanism of Action: The precise mechanism(s) by which zonisamide exerts its antiseizure effect is unknown. Zonisamide demonstrated anticonvulsant activity in several experimental models. In ...
  • INDICATIONS AND USAGE
    Zonisamide is indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy.
  • CONTRAINDICATIONS
    Zonisamide is contraindicated in patients who have demonstrated hypersensitivity to sulfonamides or zonisamide.
  • WARNINGS
    Potentially Fatal Reactions to Sulfonamides: Fatalities have occurred, although rarely, as a result of severe reactions to sulfonamides (zonisamide is a sulfonamide) including Stevens-Johnson ...
  • PRECAUTIONS
    General: Somnolence is commonly reported, especially at higher doses of zonisamide (see WARNINGS: Cognitive/Neuropsychiatric Adverse Events subsection). Zonisamide is metabolized by the liver ...
  • ADVERSE REACTIONS
    The most common adverse reactions with zonisamide (an incidence at least 4% greater than placebo) in controlled clinical trials and shown in descending order of frequency were somnolence ...
  • DRUG ABUSE AND DEPENDENCE
    The abuse and dependence potential of zonisamide has not been evaluated in human studies (see WARNINGS, Cognitive/Neuropsychiatric Adverse Events subsection). In a series of animal studies ...
  • OVERDOSAGE
    Human Experience: Experience with zonisamide daily doses over 800 mg/day is limited. During zonisamide clinical development, three patients ingested unknown amounts of zonisamide as suicide ...
  • DOSAGE AND ADMINISTRATION
    Zonisamide capsules are 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 ...
  • HOW SUPPLIED
    Zonisamide capsules are available as 25 mg, 50 mg and 100 mg two-piece hard gelatin capsules. The capsules are printed in black with product code on cap and body “258”, “259” and “260” ...
  • Medication Guide
    Zonisamide (zoe nis’ a mide) Capsules - What is the most important information I should know about Zonisamide Capsules?   Zonisamide capsules may cause serious ...
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL-50mg
    NDC 62756-259-01 - Zonisamide Capsules - 50 mg - Rx only - 30 Capsules - SUN PHARMA - PHARMACIST: Please dispense with Medication Guide provided separately to each patient.
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL-25mg
    NDC 62756-258-01 - Zonisamide Capsules - 25 mg - Rx only - 30 Capsules - SUN PHARMA - PHARMACIST: Please dispense with Medication Guide provided separately to each patient.
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL-100mg
    NDC 62756-260-01 - Zonisamide Capsules - 100 mg - Rx only - 30 Capsules - SUN PHARMA - PHARMACIST: Please dispense with Medication Guide provided separately to each patient.
  • INGREDIENTS AND APPEARANCE
    Product Information