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OVERVIEW
Zonegran® (zonisamide) is an anti-epileptic drug (AED) approved in March 2000 by the U.S. Food and Drug Administration (FDA) as adjunctive therapy in the treatment of all partial seizures in adults with epilepsy.
Zonegran is the only once-a-day (qd) newer AED available for adults (16 and older) with epilepsy. The availability of 25 mg, 50 mg and 100 mg strengths allows for flexible dosing as twice daily or once daily. Zonegran has the longest "half-life" of the newer AEDs. Half-life is the time in which the drug concentration in the blood decreases to one-half of its initial or maximum concentration.
Zonegran has a well-established safety profile. Zonegran causes minimal cognitive impairment, minimal drug-to-drug interactions and is not associated with weight gain. Zonegran has been prescribed in more than one million patients worldwide. Zonegran does not require additional blood monitoring.
Please view the sections below to learn more about Zonegran.
SEIZURE CONTROL
Zonegran is clinically proven to provide effective seizure control in patients using at least one other AED. The 63-hour half-life of Zonegran helps to ensure consistent therapeutic levels in the blood.
In pivotal clinical trials, the use of Zonegran as an adjunctive therapy demonstrated a 27 to 40 percent median reduction in all partial seizures verses a -1 to 9 percent median reduction with placebo. Additionally, 28 to 42 percent of patients experienced a 50 percent or higher reduction in their seizure frequency. Zonegran works by multiple potential mechanisms of action that may impact seizure reduction.
COMPLIANCE
Patients can receive maximum benefit from Zonegran when they adhere to treatment as prescribed by a physician. Zonegran offers many attributes that may help people with epilepsy comply with their medication:
- The longer half-life allows Zonegran to be taken once-a-day; research shows compliance can improve with once-daily dosing.
- Zonegran is available in multiple strengths. Flexible dosing options may make it easy for patients to comply with recommended therapies.
- Zonegran is not associated with unwanted weight gain. Weight gain has been a common reason for noncompliance with certain AEDs.
- Zonegran can be taken with or without food, which may make it easy for patients to take.
SAFETY
Zonegran has a well-established safety profile. In clinical trials, the most commonly reported adverse events were somnolence, dizziness, anorexia, headache, nausea and agitation / irritability. Drug interactions are minimal with Zonegran. Zonegran does not influence the metabolism of other commonly prescribed AEDs or oral contraceptives.
Zonegran is a sulfonamide. Hypersensitivity or other serious reactions may occur. Serious skin and hematologic reactions (in the blood or blood-forming organs) have occurred. Physicians should consider discontinuing the drug in patients who develop an otherwise unexplained rash. Oligohidrosis (decreased sweating) has been reported in association with Zonegran therapy in pediatric patients. Zonegran is not approved for pediatric patients under the age of 16. Kidney stones have been reported in patients receiving Zonegran therapy. Patients should take care when driving or if they operate complex machinery until they know how Zonegran may effect their performance.
DOSAGE
Therapy with Zonegran can be initiated up to 100 mg daily. Dosage increments of 100 mg can be made every two weeks as needed to achieve seizure control. Evidence from controlled trials suggests that Zonegran doses of 100 mg to 600 mg/day are effective, but there is no suggestion of increasing response above 400 mg/day.
Click here to view or download full ZONEGRAN prescribing and safety information