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ZONAS

ZONISAMIDE · by ARAF

ANTIEPILEPTICS Benzisoxazole derivative ARAF

Composition

Tab 100 mg: Zonisamide 100

Indications & Dosage

Monotherapy for treatment of focal seizures with or without secondary generalisation in adults with newly diagnosed epilepsy: Adult: Initially 100 mg once daily for 2 weeks, then increased in steps of 100 mg every 2 weeks, usual maintenance dose 300mg once daily; max. 500 mg per day. Adjunctive treatment for refractory focal seizures with or without secondary generalization: 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, maintenance 300-500mg daily in 1-2 divided doses Children 6-17 yrs: Initially 1 mg/kg once daily for 7 days, then increased in steps of 1 mg/kg every 7 days, usual maintenance 300-500mg once daily.

Precautions

Low body-weight or poor appetite; monitor weight throughout treatment, 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, elderly. Dose should 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. Avoid overheating and ensure adequate hydration especially in children, during strenuous activity or if in warm environment; risk of fatal heat stroke in children.

Interactions

Anticholinergics, glucoronic acid, digoxin, carbonic anhydrase inhibitor, inducer of urolithiasis, inducers and inhibitors of CYP3A4, St. Johns wort, clarithromycin, erythromycin, diltiazem, rotinavir

Pregnancy

Caution advised

Lactation

Avoid

Side Effects

Agitation, alopecia, , ataxia, fatigue, confusion, constipation, diarrhoea, nausea, diplopia, dizziness, drowsiness, depression, ecchymosis, impaired attention, impaired memory, insomnia, irritability, nystagmus, paraesthesia, peripheral oedema, pruritus, psychosis, pyrexia, rash, speech disorder, tremor, weight loss, vomiting. Rare: Amnesia, suicidal ideation, urinary calculus, blood disorders, coma, dyspnoea, hallucinations, heat stroke, hydronephrosis, metabolic acidosis, myasthenic syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis