Zonegran Dosage/Direction for Use

Posology - Adults: Dosage escalation and maintenance: Zonegran 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 2. Some patients, especially those not taking CYP3A4-inducing agents, may respond to lower doses.
Withdrawal: When Zonegran treatment is to be discontinued, it should be withdrawn gradually (see Precautions). 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). (See Table 2.)

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General dosing recommendations for Zonegran in special patient populations: Paediatric population (aged 6 years and above): Dosage escalation and maintenance: Zonegran 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 3. 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 heat stroke (see Precautions). (See Table 3.)

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The safety and efficacy of Zonegran 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.
Withdrawal: When Zonegran treatment is to be discontinued, it should be withdrawn gradually (see Precautions). 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 4). (See Table 4.)

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Elderly: Caution should be exercised at initiation of treatment in elderly patients as there is limited information on the use of Zonegran in these patients. Prescribers should also take account of the safety profile of Zonegran (see Adverse Reactions).
Patients with renal impairment: Caution must be exercised in treating patients with renal impairment, as there is limited information on use in such patients and a slower titration of Zonegran might be required. Since zonisamide and its metabolites are excreted renally, it should be discontinued in patients who develop acute renal failure or where a clinically significant sustained increase in serum creatinine is observed.
In subjects with renal impairment, renal clearance of single doses of zonisamide was positively correlated with creatinine clearance. The plasma AUC of zonisamide was increased by 35% in subjects with creatinine clearance < 20 ml/min.
Patients with hepatic impairment: Use in patients with hepatic impairment has not been studied. Therefore use in patients with severe hepatic impairment is not recommended. Caution must be exercised in treating patients with mild to moderate hepatic impairment, and a slower titration of Zonegran may be required.
Method of administration: Zonegran Tablets 100 mg is for oral use.
Effect of food: Zonegran may be taken with or without food (see Pharmacology: Pharmacokinetics under Actions).