Active Ingredient: Zonisamide
Zonisamide is indicated as:
For this indication, competent medicine agencies globally authorize below treatments:
Oral
50 - 500 mg
From 50 To 500 mg once every day
Zonisamide may be taken as monotherapy or added to existing therapy in adults. The dose should be titrated on the basis of clinical effect. Recommended escalation and maintenance doses are given in Table 1. Some patients, especially those not taking CYP3A4-inducing agents, may respond to lower doses.
When zonisamide treatment is to be discontinued, it should be withdrawn gradually. In clinical studies of adult patients, dose reductions of 100 mg at weekly intervals have been used with concurrent adjustment of other antiepileptic medicine doses (where necessary).
Table 1. Adults – recommended dosage escalation and maintenance regimen:
| Treatment Regimen | Titration Phase | Usual Maintenance Dose | ||
|---|---|---|---|---|
| Monotherapy | ||||
| Newly diagnosed adult patients | Week 1 + 2 | Week 3 + 4 | Week 5 + 6 | 300 mg per day (once a day). If a higher dose is required: increase at two-weekly intervals in increments of 100 mg up to a maximum of 500 mg. |
| 100 mg/day (once a day) | 200 mg/day (once a day) | 300 mg/day (once a day) | ||
| Adjunctive therapy | ||||
| - with CYP3A4-inducing agents (see section 4.5) | Week 1 | Week 2 | Week 3 έως 5 | 300 to 500 mg per day (once a day or two divided doses). |
| 50 mg/day (in two divided doses) | 100 mg/day (in two divided doses) | Increase at weekly intervals in increments of 100 mg | ||
| - without CYP3A4-inducing agents; or with renal or hepatic impairment | Week 1 + 2 | Week 3 + 4 | Week 5 to 10 | 300 to 500 mg per day (once a day or two divided doses). Some patients may respond to lower doses. |
Zonisamide may be taken with or without food.
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