Product InformationZonisamide CapsulesRx Only

DESCRIPTION

Zonisamide capsule 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 C8H8N2O3S 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 HCl (0.50 mg/mL). The chemical structure is:

Zonisamide capsules are supplied for oral administration as capsules containing 25 mg, 50 mg and 100 mg zonisamide. Each capsule contains the labeled amount of zonisamide plus the following inactive ingredients: microcrystalline cellulose, sodium lauryl sulfate, hydrogenated vegetable oil, colloidal silicon dioxide, sodium starch glycolate, talc, gelatin, titanium dioxide. For 100 mg D&C red # 28, D&C yellow # 10, and FD&C # yellow 6 and for 50 mg contains FD&C red # 40, FD&C yellow # 5, and FD&C Blue # 1.

CLINICAL PHARMACOLOGY

Mechanism of Action:

Pharmacokinetics:

Metabolism and Excretion:

Special Populations:

Clinical Studies:

INDICATIONS AND USAGE

CONTRAINDICATIONS

WARNINGS

Serious Skin Reactions:

Serious Hematologic Events:

Oligohidrosis and Hyperthermia in Pediatric Patients:

Suicidal Behavior and Ideation

Metabolic Acidosis:

Seizures on Withdrawal:

Teratogenicity:

Cognitive/ Neuropsychiatric Adverse Events:

PRECAUTIONS

General:

Kidney Stones:

Effect on Renal Function:

Sudden Unexplained Death in Epilepsy:

Status Epilepticus:

Information for Patients:

• Zonisamide capsules may produce drowsiness, especially at higher doses. Patients should be advised not to drive a car or operate other complex machinery until they have gained experience on zonisamide capsules sufficient to determine whether it affects their performance. Because of the potential of zonisamide to cause CNS depression, as well as other cognitive and/or neuropsychiatric adverse events, zonisamide should be used with caution if used in combination with alcohol or other CNS depressants.
• Patients should contact their physician immediately if a skin rash develops or seizures worsen.
• Patients should contact their physician immediately if they develop signs or symptoms, such as sudden back pain, abdominal pain, and/or blood in the urine, that could indicate a kidney stone. Increasing fluid intake and urine output may reduce the risk of stone formation, particularly in those with predisposing risk factors for stones.
• Patients should contact their physician immediately if a child has been taking zonisamide capsules and is not sweating as usual with or without a fever.
• Because zonisamide can cause hematological complications, patients should contact their physician immediately if they develop a fever, sore throat, oral ulcers, or easy bruising.
• Suicidal Thinking and Behavior - Patients, their caregivers, and families should be counseled that AEDs, including zonisamide capsules, may increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Behaviors of concern should be reported     immediately to healthcare providers.
• Patients should contact their physician immediately if they develop fast breathing, fatigue/tiredness, loss of appetite, or irregular heart beat or palpitations (possible manifestations of metabolic acidosis).
• As with other AEDs, patients should contact their physician if they intend to become pregnant or are pregnant during zonisamide capsules therapy. Patients should notify their physician if they intend to breast-feed or are breast-feeding an infant.

Laboratory Tests:

Drug Interactions:

Carcinogenicity, Mutagenesis, Impairment of Fertility:

Pregnancy:

Pediatric Use:

Geriatric Use:

ADVERSE REACTIONS

Adverse Event Incidence in Controlled Clinical Trials:

Other Adverse Events Observed During Clinical Trials:

DRUG ABUSE AND DEPENDENCE

OVERDOSAGE

DOSAGE AND ADMINISTRATION

HOW SUPPLIED

Medication Guide

• a skin rash  
• high fever, recurring fever, or long lasting fever
• less sweat than normal  

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL