Zonegran (zonisamide) is indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy.
Zonegran has a well-established safety profile. Studies demonstrate minimal cognitive impairment*1 and no associated weight gain.2 The incidence of placebo-subtracted cognitive impairment was <5% for all measures.1
Weight gain has been a common reason for non-compliance with certain AEDs.3
Most common treatment-emergent adverse events with Zonegran in combination with other AEDs1
Adverse Event |
Zonegran
(n=269) |
Placebo
(n=230) |
Somnolence |
17% |
7% |
Dizziness |
13% |
7% |
Anorexia |
13% |
6% |
Headache |
10% |
8% |
Nausea |
9% |
6% |
Agitation/irritability |
9% |
4% |
Effect on weight in three clinical trials of Zonegran2
Effect on Weight |
Zonegran
(n=263) |
Placebo
(n=215) |
Maintained |
64.6% |
73.0% |
Lost >5 lbs |
28.9% |
8.4% |
Gained >5 lbs |
6.5% |
18.6% |
*Cognitive impairment is defined as confusion, difficulty concentrating, difficulty with memory, and mental slowing. Mental slowing and difficulty concentrating occurred in the first month of treatment and were associated with doses above 300 mg/day.
Zonegran demonstrates minimal drug-to-drug interactions.1
Zonegran as add-on therapy to these AEDs1
Initial AED |
Effect of Adding Zonegran |
phenytoin |
No interaction |
valproate |
No interaction |
carbamazepine |
No interaction |
lamotrigine2 |
No interaction |
Phenytoin, phenobarbital, and valproate decrease the half-life of Zonegran (range: 27 to 46 hours).1 Zonegran does not inhibit or induce CYP3A41 or commonly used drugs such as oral contraceptives and Digoxin.
Oral contraceptives2 |
No interaction |
Digoxin |
No interaction |
- Zonisamide is a sulfonamide. Hypersensitivity or other serious reactions may occur.
- Serious skin and hematologic reactions have occurred. Consider discontinuing drug in patients who develop an otherwise unexplained rash.
- Oligohidrosis 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 special care when driving or if they operate complex machinery until they know how Zonegran may affect their performance.
Zonegran treatment allows flexible, once-daily dosing. Zonegran may be taken with or without food. It is available in 25 mg and 100 mg capsules.
Dose escalation schedule
Weeks 1 and 2 |
Weeks 3 and 4 |
Weeks 5 and 6 |
Weeks 7 and 8 |
|
100 mg/day
|
200 mg/day
|
300 mg/day
|
400 mg/day
|
Please see Full Prescribing Information.
References:
1. Zonegran Prescribing Information. Eisai Inc.; 2003.
2. Data on file. Eisai Inc.
3. Dichter MA. Integrated use of old and new antiepileptic drugs. Curr Opin Neurol. 1995;8:95-102.
Important Safety Information
Zonegran (zonisamide) capsules is a medicine used to treat partial seizures in adults. It is taken with other seizure medicines to help control your seizures.
Zonegran is not right for everyone. You should not take Zonegran if you are allergic to sulfa drugs. Call your doctor right away if you experience a rash; your seizures worsen; you experience sudden back pain, abdominal pain, or blood in your urine; fever, sore throat, or bruising easily; depression or unusual thoughts; extreme drowsiness, difficulty concentrating, or coordination problems; speech or language problems.
The most common side effects of Zonegran are drowsiness, loss of appetite, dizziness, headache, nausea, and agitation/irritability. These side effects usually occur within the first 4 weeks of therapy.
Zonegran may make you drowsy. Do not drive a car or operate complex machinery until you know how Zonegran may affect you.
Be sure to follow your doctor’s directions on how to take Zonegran. Do not share your Zonegran with others. Do not stop taking Zonegran or any other seizure medication without consulting your doctor first.
Zonegran is available in 25 mg and 100 mg capsules.
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All quotes included on this Web site represent the individual experience of some doctors, some patients, and their caregivers. Individual responses to Zonegran treatment may vary. Actual identities have been changed to protect individual privacy.
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