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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 molecular formula is C8H8N2O3S with a molecular weight of 212.23. Zonisamide is a white powder, pKa = 10.2, and is moderately soluble in water (0.8 mg/mL) and 0.1 N HCl (0.5 mg/mL).
The chemical structure is:
Zonisamide is supplied for oral administration as capsules containing 25 mg, 50 mg or 100 mg zonisamide, USP. Each capsule contains the labeled amount of zonisamide plus the following inactive ingredients: microcrystalline cellulose, hydrogenated vegetable oil, gelatin, and titanium dioxide.
In addition, individual empty hard gelatin capsule shell contains:
50 mg : Black iron oxide.
100 mg : FD&C Blue #1 and FD&C Red #40.
The imprinting ink contains black iron oxide, shellac glaze, propylene glycol and also contains either FD & C Blue No. 2, FD & C Red No. 40, FD & C Blue No. 1 and D & C Yellow No.10 or strong ammonia solution and potassium hydroxide.
Zonisamide is indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy.
Zonisamide is contraindicated in patients who have demonstrated hypersensitivity to sulfonamides or zonisamide.
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, zonisamide did not demonstrate abuse liability and dependence potential. Monkeys did not self-administer zonisamide in a standard reinforcing paradigm. Rats exposed to zonisamide did not exhibit signs of physical dependence of the CNS-depressant type. Rats did not generalize the effects of diazepam to zonisamide in a standard discrimination paradigm after training, suggesting that zonisamide does not have abuse potential of the benzodiazepine-CNS depressant type.
Product Information Zonisamide Capsules Rx Only
Zonisamide Capsules USP 8423065/0618 Rx only
The purpose of this study is to evaluate the relative bioavailability (rate and extent of absorption) of a test formulation of zonisamide capsules compared to the reference formulation, Zo...
The purpose of this study is to determine which of seven combinations of Zonisamide CR and Bupropion SR gives the best weight loss and is safe and well tolerated for the treatment of obesi...
The purpose of this study is to evaluate and compare the relative bioavailability of a test formulation of zonisamide capsules to an equivalent dose of a reference formulation, Zonegran® ...
Zonisamide is already marketed for the treatment of partial seizures in epilepsy. This study is intended to provide evidence that zonisamide is safe and effective in the treatment of myocl...
The purpose of this study is to compare the efficacy and safety of zonisamide with carbamazepine and to determine the optimum dose of zonisamide in patients with epilepsy.
To evaluate the efficacy and safety of zonisamide as an add-on therapy in structural focal epilepsy in children with cerebral palsy (CP).
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