Generic Medicine Info
May be taken with or without food.
History of hypersensitivity to sulfonamides.
Special Precautions
Patient with decreased hepatic mitochondrial activity or inborn errors of metabolism; risk factors for nephrolithiasis (e.g. family history, previous stone formation, hypercalciuria), predisposition to acidosis (e.g. severe respiratory disease, status epilepticus, diarrhoea, surgery, ketogenic diet, other drugs); history of eye disorders. Avoid abrupt withdrawal. Not recommended in renal (GFR <50 mL/min) and severe hepatic impairment; in children who are underweight and have decreased appetite. Concomitant use with carbonic anhydrase inhibitors and drugs with anticholinergic activity in adults; avoid concomitant use in children. Renal and mild to moderate hepatic impairment. Children and elderly. Pregnancy and lactation. Patient Counselling This drug may cause drowsiness, sedation, and difficulty with concentration; if affected, do not drive or operate machinery. Ensure adequate hydration or fluid intake, particularly in children. Avoid exposure to excessive temperatures and strenuous physical activity. Monitoring Parameters Monitor serum bicarbonate levels before initiation and periodically during treatment; metabolic profile (particularly BUN and serum creatinine); ammonia levels (if signs or symptoms of encephalopathy occur); pancreatic lipase and amylase levels (in patients who develop pancreatitis); serum creatine phosphokinase and aldolase levels (in those who experience severe muscle pain or weakness with or without fever). Assess for signs and symptoms of emergence or worsening of suicidal thoughts or behaviour, depression and/or unusual changes in behaviour; decreased sweating and increased body temperature specifically during hot or warm weather (particularly in children).
Adverse Reactions
Significant: Suicidal ideation and behaviour, CNS effects (e.g. fatigue, sedation, somnolence, depression, psychosis, speech or language problems, difficulty with concentration), acute myopia, secondary angle-closure glaucoma, rash; hyperammonaemia with or without encephalopathy; hyperchloraemic, non-anion gap, metabolic acidosis (dose-dependent); elevated serum creatinine and BUN, nephrolithiasis, pancreatitis, rhabdomyolysis; decreased sweating, increased body temperature and levels of AST, ALT, gamma-glutamyltransferase (GGT) and bilirubin (particularly in children). Blood and lymphatic system disorders: Ecchymosis. Eye disorders: Diplopia, nystagmus. Gastrointestinal disorders: Nausea, dyspepsia, diarrhoea, abdominal pain, constipation, vomiting. General disorders and administration site conditions: Flu-like illness, pyrexia, peripheral oedema. Immune system disorders: Hypersensitivity. Investigations: Decreased bicarbonate levels and weight; increase blood creatine phosphokinase. Metabolism and nutrition disorders: Anorexia, decreased appetite. Nervous system disorders: Dizziness, ataxia, paraesthesia, tremor, bradyphrenia, memory impairment, attention disturbance. Psychiatric disorders: Agitation, anxiety, irritability, confusional state, mood swings, insomnia, affect lability. Skin and subcutaneous tissue disorders: Pruritus, alopecia.
Potentially Fatal: Drug reaction with eosinophilia and systemic symptoms (DRESS) or multiorgan hypersensitivity reaction; heatstroke requiring hospitalisation, weight loss which may lead to deterioration of general condition (particularly in children). Rarely, serious skin reactions (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme), haematologic disturbances (e.g. agranulocytosis, aplastic anaemia), fulminant hepatic necrosis.
Drug Interactions
May increase the risk of metabolic acidosis, hyperammonaemia, and kidney stone formation with other carbonic anhydrase inhibitors (e.g. topiramate, acetazolamide). Risk of heat-related disorders may be increased with carbonic anhydrase inhibitors and drugs with anticholinergic activity (e.g. haloperidol, diphenhydramine, clomipramine, oxybutynin), especially in children. May decrease exposure and serum concentration with CYP3A4 inducers (e.g. phenytoin, carbamazepine, phenobarbital, rifampicin). May cause additive CNS effects (e.g. fatigue, somnolence) with other CNS depressants.
CIMS Class
ATC Classification
N03AX15 - zonisamide ; Belongs to the class of other antiepileptics.
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