Active Ingredient: Zonisamide
Zonisamide is indicated as:
For this indication, competent medicine agencies globally authorize below treatments:
Oral
1 - 8 mg per kg of body weight
From 1 To 8 mg per kg of body weight once every day
Zonisamide must be added to existing therapy for paediatric patients aged 6 years and above. 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.
Physicians should draw the attention of paediatric patients and their parents/carers to the Patient Alert Box (in the package leaflet) on preventing heatstroke.
Table 1. Paediatric population (aged 6 years and above) – recommended dosage escalation and maintenance regimen:
| Treatment Regimen | Titration Phase | Usual Maintenance Dose | ||
|---|---|---|---|---|
| Adjunctive Regimen | ||||
| - with CYP3A4-inducing agents (see section 4.5) | Week 1 | Week 2 to 8 | Patients of weight 20 to 55 kga | Patients of weight >55 kg |
| 1 mg/kg/day (once a day) | Increase at weekly intervals in increments of 1 mg/kg | 6 to 8 mg/kg/day (once a day) | 300–500 mg/day (once a day) | |
| - without CYP3A4-inducing agents | Week 1 + 2 | Weeks ≥3 | 6 to 8 mg/kg/day (once a day) | 300–500 mg/day (once a day) |
Note:
aTo ensure a therapeutic dose is maintained the weight of a child should be monitored and the dose reviewed as weight changes occur up to a weight of 55kg. The dose regime is 6-8 mg/kg/day up to a maximum dose of 500 mg/day.
The safety and efficacy of zonisamide in children aged below 6 years or those below 20 kg have not yet been established.
There are limited data from clinical studies in patients with a body weight of less than 20 kg.
Therefore children aged 6 years and above and with a body weight less than 20 kg should be treated with caution.
It is not always possible to precisely achieve the calculated dose with the commercially available capsule strengths of zonisamide. In these cases it is therefore recommended that the zonisamide total dose should be rounded up or down to the nearest available dose that can be achieved with commercially available capsule strengths of zonisamide (25 mg, 50 mg and 100 mg).
When zonisamide treatment is to be discontinued, it should be withdrawn gradually. In clinical studies of paediatric patients, down-titration was completed by dose reductions at weekly intervals in increments of about 2 mg/kg (i.e. in accordance with the schedule in Table 2).
Table 2. Paediatric population (aged 6 years and above) – recommended down-titration schedule:
| Weight | Decrease at weekly intervals in increments of: |
|---|---|
| 20–28 kg | 25 έως 50 mg/day* |
| 29–41 kg | 50 έως 75 mg/day* |
| 42–55 kg | 100 mg/day* |
| >55 kg | 100 mg/day* |
Note:
* All doses are once daily.
Zonisamide may be taken with or without food.
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