ZONISADE

AbsorptionFollowing a 100 mg ZONISADE dose in normal volunteers, the time to maximum plasma concentrations (T max ) occurred within 0.5–5 hours. Zonisamide pharmacokinetics are dose-proportional in the range of 200 to 400 mg. Once a stable dose is reached, steady state is achieved within 14 days. Effect of Food When ZONISADE is administered with food, the zonisamide T max is delayed, occurring at 3.5–7.5 hours, but food has no effect on the bioavailability of zonisamide.

DistributionThe appare...

The efficacy of ZONISADE is based upon a bioavailability study comparing ZONISADE oral suspension to zonisamide capsules in healthy subjects. The clinical studies information described below pertains to the zonisamide capsule formulation. The effectiveness of zonisamide as adjunctive therapy has been established in three multicenter, placebo-controlled, double blind, 3-month clinical trials (two domestic, one European) in 499 patients with refractory partial-onset seizures with or without secondary generalization. Each patient had a history of at least four partial-onset seizures per month in ...

The following clinically signification adverse reactions are described elsewhere in the labeling:

• Potentially Fatal Reactions to Sulfonamides [see Warnings and Precautions ( 5.1 )]
• Serious Skin Reactions [see Warnings and Precautions ( 5.2 )]
• Serious Hematologic Events [see Warnings and Precautions ( 5.3 )]
• Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multi-Organ Hypersensitivity [see Warnings and Precautions ( 5.4 )]
• Oligohidrosis and Hyperthermia in Pediatric Patient...

ZONISADE is contraindicated in patients who have demonstrated hypersensitivity to sulfonamides or zonisamide. ZONISADE is contraindicated in patients who have demonstrated hypersensitivity to sulfonamides or zonisamide ( 4 ).

• Potentially Fatal Reactions to Sulfonamides: Fatalities have occurred as a result of severe reactions to sulfonamides (zonisamide is a sulfonamide) including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood dyscrasias ( 5.1 ).
• Serious Skin Reactions: Discontinue ZONISADE at the first sign of rash unless clearly not drug related ( 5.2 ).
• Serious Hematologic Events: Aplastic anemia and agranulocytosis have bee...

7 DRUG INTERACTIONS

• ZONISADE should be used with caution if used in combination with alcohol or other CNS depressants ( 7.1 ).
• Concomitant use of ZONISADE with any other carbonic anhydrase inhibitor may increase the severity of metabolic acidosis and may also increase the risk of kidney stone formation ( 7.2 ). 7.1 CNS Depressants Concomitant use of ZONISADE with other CNS depressants, includi...