Recommended Assessments for Safety

To assess for metabolic acidosis, obtain baseline serum bicarbonate prior to initiating ZONISADE, and obtain periodic serum bicarbonate during treatment [see Warnings and Precautions (5.8)].

Recommended Dosage

Administer ZONISADE once or twice daily with or without food.

The recommended initial dosage of ZONISADE is 100 mg daily. The dosage may be increased by 100 mg daily every two weeks, based on clinical response and tolerability, to 400 mg daily. Patients who are tolerating ZONISADE at 400 mg daily and require further reduction of seizures may be increased up to a maximum dosage of 600 mg daily. However, evidence from controlled trials shows no suggestion of increasing response above 400 mg/day [see Clinical Studies (14)].

Important Administration Information

Shake well before every administration. To administer ZONISADE directly into the mouth, it is important that ZONISADE be measured with an accurate measuring device [see Overdosage (10)]. A household teaspoon is not an accurate measuring device. A pharmacist will provide an appropriate device and instructions for measuring the correct dose.

Administer ZONISADE orally with or without food.

Discard unused portion of ZONISADE 30 days after first opening the bottle.

Discontinuation of ZONISADE

When discontinuing ZONISADE, the dose should be decreased gradually. As with most antiepileptic drugs, avoid abrupt discontinuation, when possible, to minimize the risk of increased seizure frequency and status epilepticus [see Warnings and Precautions (5.9)].