Concise Prescribing Info
Monotherapy for partial seizures w/ or w/o secondary generalisation in adults w/ newly diagnosed epilepsy. Adjunctive therapy for partial seizures in adults w/ epilepsy.
Dosage/Direction for Use
Adult Monotherapy Wk 1+2: 100 mg once daily, wk 3+4: 200 mg once daily, wk 5+6: 300 mg once daily. Usual maintenance dose: 300 mg once daily, may be increased by 100-mg increments at 2-wkly intervals up to max: 500 mg. Adjunctive therapy Initially 100-200 mg once-tds, gradually increased every 1-2 wk up to 200-400 mg daily in 1-3 divided doses. Max: 600 mg daily.
May be taken with or without food.
Hypersensitivity to zonisamide or sulphonamides.
Special Precautions
Unexplained rash including cases of Stevens-Johnson syndrome. Discontinue use if rhabdomyolysis or pancreatitis develops or in case of severe wt loss. Discontinue use or reduce dose if metabolic acidosis occurs. Sulphonamide reactions; acute myopia & secondary angle closure glaucoma, history of eye disorders; patients w/ predisposing risk factors of renal stone formation. Cognitive impairment. Monitor signs of suicidal ideation & behaviours. Monitor pancreatic lipase & amylase levels. Assess serum creatinine phosphokinase & aldolase levels. Ensure adequate hydration. Avoid exposure to excessive temp & strenuous physical exercise. Avoid abrupt w/drawal. Induced skin rashes in patients receiving concomitant antiepileptic agents. Concomitant use w/ carbonic anhydrase inhibitors eg, topiramate or acetazolamide, anticholinergic agents. May affect ability to drive & use machines. Renal & mild to moderate hepatic impairment. Not recommended in severe hepatic impairment. Women of childbearing potential should use effective contraception during treatment & 1 mth after discontinuation. Not to be used during pregnancy. Lactation. Not recommended in underwt childn or have decreased appetite. Elderly.
Adverse Reactions
Anorexia; agitation, irritability, confusional state, depression; ataxia, dizziness, memory impairment, somnolence; diplopia; decreased bicarbonate. Ecchymosis; hypersensitivity; affect lability, anxiety, insomnia, psychotic disorder; bradyphrenia, attention disturbance, nystagmus, paraesthesia, speech disorder, tremor; abdominal pain, constipation, diarrhoea, dyspepsia, nausea; rash, pruritus, alopecia; nephrolithiasis; fatigue, influenza-like illness, pyrexia, peripheral oedema; decreased wt.
Drug Interactions
Possible pharmacodynamic interactions w/ carbonic anhydrase inhibitors eg, topiramate, acetazolamide. Affected pharmacokinetics of P-gp substrates eg, digoxin, quinidine. Enhanced risk of developing kidney stones w/ medicines that may lead to urolithiasis. Pharmacokinetically affected by CYP3A4, N-acetyl transferases & glucuronic acid inducers or inhibitors. Lowered exposure by CYP3A4 inducers eg, phenytoin, carbamazepine, phenobarb.
MIMS Class
ATC Classification
N03AX15 - zonisamide ; Belongs to the class of other antiepileptics.
Zonegran FC tab 100 mg
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