Monotherapy for treatment of focal seizures with or
without secondary generalisation in adults with newly
diagnosed epilepsy
▶BY MOUTH
▶Adult: Initially 100 mg once daily for 2 weeks, then
increased in steps of 100 mg every 2 weeks, usual
maintenance dose 300 mg once daily; maximum
500 mg per day
Adjunctive treatment for refractory focal seizures with or
without secondary generalisation
▶BY MOUTH
▶Child 6–17 years (body-weight 20–54 kg): Initially 1 mg/kg
once daily for 7 days, then increased in steps of
1 mg/kg every 7 days, usual maintenance 6–8 mg/kg
once daily (max. per dose 500 mg once daily), dose to
be increased at 2-week intervals in patients who are
not receiving concomitant carbamazepine, phenytoin,
phenobarbital or other potent inducers of cytochrome
P450 enzyme CYP3A4
▶Child 6–17 years (body-weight 55 kg and above): Initially
1 mg/kg once daily for 7 days, then increased in steps
of 1 mg/kg every 7 days, usual maintenance
300–500 mg once daily, dose to be increased at 2-week
intervals in patients who are not receiving
concomitant carbamazepine, phenytoin, phenobarbital
or other potent inducers of cytochrome P450 enzyme
CYP3A4
▶Adult: Initially 50 mg daily in 2 divided doses for
7 days, then increased to 100 mg daily in 2 divided
doses, then increased in steps of 100 mg every 7 days,
usual maintenance 300–500 mg daily in 1–2 divided
doses, dose to be increased at 2-week intervals in
patients who are not receiving concomitant
carbamazepine, phenytoin, phenobarbital or other
potent inducers of cytochrome P450 enzyme CYP3A4
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Elderly. low body-weight or poor appetite—
monitor weight throughout treatment (fatal cases of
weight loss reported in children). metabolic acidosis—
monitor serum bicarbonate concentration in children and
those with other risk factors (consider dose reduction or
discontinuation if metabolic acidosis develops). risk
factors for renal stone formation (particularly
predisposition to nephrolithiasis)
CAUTIONS, FURTHER INFORMATION Avoid overheating and
ensure adequate hydration especially in children, during
strenuous activity or if in warm environment (fatal cases of
heat stroke reported in children).
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Contra-indicated in
sulfonamide hypersensitivity.
Antiepileptic hypersensitivity syndrome theoretically
associated with zonisamide. See under Epilepsy p. 321 for
more information.
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Switching between formulations Care should be taken when
switching between oral formulations. The need for
continued supply of a particular manufacturer’s product
should be based on clinical judgement and consultation
with the patient or their carer, taking into account factors
such as seizure frequency and treatment history.
Patients may need to be maintained on a specific
manufacturer’s branded or generic zonisamide product.
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Scottish Medicines Consortium (SMC) decisions
SMC No. 949/14
The Scottish Medicines Consortium has advised (March
2014) that zonisamide (Zonegran ®) is accepted for
restricted use within NHS Scotland as adjunctive
treatment of focal seizures, with or without secondary
generalisation, in adolescents and children aged 6 years
and above. It is restricted to use on advice from specialists
in paediatric neurology or epilepsy.
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