Zonegran

Zonisamide

Monotherapy in the treatment of partial seizures, w/ or w/o secondary generalization, in adults w/ newly diagnosed epilepsy. Adjunctive therapy in the treatment of partial seizures, w/ or w/o secondary generalisation, in adults, adolescents & childn ≥6 yr.

Adult Monotherapy Newly diagnosed patients Titration phase: Wk 1 + 2: 100 mg/day. Wk 3 + 4: 200 mg/day. Wk 5 + 6: 300 mg/day. Maintenance dose: 300 mg/day. If a higher dose is required, increase at 2 wkly intervals, at increments of 100 mg. Max: 500 mg. Adjunctive therapy w/ CYP3A4-inducing agents Titration phase: Wk 1: 50 mg/day in 2 divided doses. Wk 2: 100 mg/day in 2 divided doses. Wk 3-5: Increase at wkly intervals in increments of 100 mg. Maintenance dose: 300-500 mg once daily or in 2 divided doses. Adjunctive therapy w/o CYP3A4-inducing agents, or w/ renal or hepatic impairment Titration phase: Wk 1 + 2: 50 mg/day in 2 divided doses. Wk 3 + 4: 100 mg/day in 2 divided doses. Wk 5-10: Increase at 2 wkly intervals in increments of up to 100 mg. Maintenance dose: 300-500 mg once a day or 2 divided doses. Childn ≥6 yr Adjunctive therapy w/ CYP3A4-inducing agents Titration phase: Wk 1: 1 mg/kg/day. Wk 2-8: Increase at wkly intervals in increments of 1 mg/kg. Maintenance dose: Patients weighing 20-55 kg 6-8 mg/kg/day, >55 kg 300-500 mg/day. Adjunctive therapy w/o CYP3A4-inducing agents Titration phase: Wk 1 + 2: 1 mg/kg/day. Wk ≥3: Increase at 2 wkly intervals in increments of 1 mg/kg. Maintenance dose: Childn weighing 20-55 kg 6-8 mg/kg/day, >55 kg 300-500 mg/day. If treatment is to be discontinued, gradually w/draw at wkly interval in increments of: Weighing >55 kg 100 mg once daily, 42-55 kg 100 mg once daily, 29-41 kg 50-75 mg once daily, 20-28 kg 25-50 mg once daily.

May be taken with or without food.

Hypersensitivity to zonisamide or sulphonamides.

Closely supervise patients who develop a rash during treatment especially those receiving concomitant antiepileptic agents. Gradually w/draw treatment. Serious immune based reactions eg, rash, allergic reaction & major haematological disturbances. Monitor for signs of suicidal ideation & behaviours; pancreatic lipase & amylase levels. Patients w/ a predisposition to nephrolithiasis may be at increased risk for renal stone formation, & associated signs & symptoms eg, renal colic, renal pain or flank pain; acidosis eg, renal disease, severe resp disorders, status epilepticus, diarrhea, surgery, ketogenic diet or medicinal products. Evaluate & monitor serum bicarbonate levels. Adult patients treated concomitantly w/ carbonic anhydrase inhibitors eg, topiramate or acetazolamide. Decreased sweating & elevated body temp especially in paed patients. Adults using drugs predisposing to heat-related disorders eg, carbonic anhydrase inhibitors & anticholinergics. Discontinue use if pancreatitis develops. Assess markers of muscle damage including serum creatinine phosphokinase & aldolase levels if severe muscle pain &/or weakness develop either in the presence or absence of fever; discontinue treatment if elevated in the absence of another cause eg, trauma or grand mal seizures. Wt loss especially in childn. Not recommended in underwt childn. Hepatic dysfunction. May affect the ability to drive & use machines. Women of childbearing potential must use adequate contraception during treatment & 1 mth after discontinuation. Pregnancy & lactation. Childn <6 yr & 20 kg.

Anorexia; agitation, irritability, confusional state, depression; ataxia, dizziness, memory impairment, somnolence; diplopia; decreased bicarbonate. Ecchymosis; hypersensitivity, affect lability, anxiety, insomnia, psychotic disorder; bradyphrenia, disturbance in attention, nystagmus, paraesthesia, speech disorder, tremor; abdominal pain, constipation, diarrhea, dyspepsia, nausea; rash, pruritis, alopecia; nephrolithiasis; fatigue, flu-like illness, pyrexia, peripheral oedema, decreased wt.

Carbonic anhydrase inhibitors eg, topiramate & acetazolamide. P-gp substrates eg, digoxin, quinidine. Drugs that may cause urolithiasis. Changes in conc may occur w/ rifampicin.

Anticonvulsants

N03AX15 - zonisamide ; Belongs to the class of other antiepileptics.

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