TOPIRAMA

*Monotherapy of Generalized tonic-clonic seizures or focal seizures with or without secondary generalization:* Adult: Initially 25 mg once daily at night, for 1 week, then increased in steps of 25-50 mg every 1-2 weeks; usual dose 100-200 mg daily in 2 divided doses, adjusted according to response, max. 500 mg per day; doses of 1 g daily have been used in refractory epilepsy Children 6-17 yrs: Initially 0.5-1 mg/kg once daily at night, (max. per dose 25 mg) for 1 week, then increased in steps of 250-500 mcg/kg twice daily, at intervals of 1-2 weeks; usual dose 50 mg twice daily (max. per dose 7.5 mg/kg twice daily), if child cannot tolerate titration then smaller steps or longer interval between steps may be used; max. 500 mg per day. *Adjunctive treatment of Generalized tonic-clonic seizures or focal seizures with or without secondary generalization, Adjunctive treatment for seizures associated with Lennox-Gastaut syndrome:* Adult: Initially 25-50 mg once daily at night, for 1 week, then increased in steps of 25-50 mg every 1-2 weeks; usual dose 200-400 mg daily in 2 divided doses; max. 400 mg per day. Children 2-17 yrs: Initially 1-3 mg/kg once daily at night, (max. per dose 25 mg) for 1 week, then increased in steps of 0.5-1.5 mg/kg twice daily, dose to be increased by a max. of 25 mg twice daily at intervals of 1-2 weeks; usual dose 2.5-4.5 mg/kg twice daily (max. per dose 7.5 mg/kg twice daily), if child cannot tolerate then smaller steps or longer interval between steps may be used; max. 400 mg per day. *Migraine prophylaxis:* Adult: Initially 25 mg once daily at night, for 1 week, then increased in steps of 25 mg every week; usual dose 50-100 mg daily in 2 divided doses; max. 200 mg per day.

Renal and hepatic impairment. Avoid in acute porphyrias, risk of metabolic acidosis, risk of nephrolithiasis; ensure adequate hydration (especially in strenuous activity or warm environment). Withdraw gradually.

Phenytoin, carbamazepine, digoxin, oral contra-ceptives, agents causing nephrolithiasis.

Abdominal pain, aggression, agitation, alopecia, anaemia, anxiety, appetite changes, arthralgia, cognitive impairment, confusion, constipation, depression, diarrhoea, dizziness, drowsiness, dry mouth, dyspepsia, dyspnea, epistaxis, gastritis, impaired attention and coordination, irritability, malaise, movement disorders, muscle spasm, muscular weakness, myalgia, nausea, nephrolithiasis, nystagmus, paraesthesia, pruritus, rash, seizures, sleep disturbance, speech disorder, taste disturbance, tinnitus, tremor, urinary disorders, visual disturbances, vomiting