Zonegran

Zonegran

zonisamide

Manufacturer:

Sumitomo Pharma

Distributor:

Zuellig
/
HI-Eisai

Marketer:

Eisai
Concise Prescribing Info
Contents
Zonisamide
Indications/Uses
Partial seizures: Simple partial seizures (focal seizure eg, Jacksonian type, autonomic seizures, psychomotor seizure); complex partial seizures (eg, psychomotor seizure, focal seizure); secondary generalized tonic-clonic seizures (eg, grand mal). Generalized seizures: Tonic-clonic seizures (eg, generalized convulsion, grand mal); tonic seizures (eg, generalized convulsion); atypical absence (eg, petit mal variant). Combined seizures.
Dosage/Direction for Use
Adult 1-2 tab/day in 1-3 divided doses, gradually increased every 1-2 wk up to 2-4 tab/day in 1-3 divided doses. Max: 600 mg/day. Childn >6 yr 2-4 mg/kg/day in 1-3 divided doses, gradually increased every 1-2 wk up to 4-8 mg/kg/day in 1-3 divided doses. Max: 12 mg/kg/day.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity to zonisamide or to sulfonamides.
Special Precautions
Severe hepatic dysfunction or measure serum bicarbonate if signs & symptoms of those w/ anamnesis. Abrupt discontinuance of the administration may cause status epilepticus. Elderly & debilitated. Perform hepatic & renal function tests & blood exam regularly. Increased body temp particularly in ped patients. Suicidal ideation & behavior. Keep patient hydrated & out of high temp environment. Measure serum bicarbonate if signs or symptoms of metabolic acidosis occurs. Consider reducing or discontinuing treatment if metabolic acidosis develops & persists. Discontinue treatment if unexplained rash develops. Patients w/ risk factors of nephrolithiasis. Assess markers of muscle damage including serum creatine phosphokinase & aldolase levels. Monitor pancreatic lipase & amylase levels. Abnormality of Ig eg, IgA & IgG may occur. May impair ability to drive or operate machinery. Pregnancy & lactation. Childn. Elderly.
Adverse Reactions
Anorexia, dizziness, somnolence, decreased bicarbonate. Ecchymosis; affect lability, agitation, anxiety, depression, insomnia, irritability; psychotic disorder; ataxia, bradyphrenia, confusion, convulsion, disturbance, inattention, memory impairment, nystagmus, paresthesia, speech disorder, tremor; abdominal pain, constipation, diarrhea, dyspepsia, nausea; rash; diplopia; nephrolithiasis; fatigue, flu-like illness; wt decreased.
Drug Interactions
Decreased blood conc w/ anti-epileptic drugs eg, carbamazepine, Na valproate. Increased blood conc w/ phenytoin. Concomitant use w/ P-gp substrates eg, digoxin, quinidine.
MIMS Class
Anticonvulsants
ATC Classification
N03AX15 - zonisamide ; Belongs to the class of other antiepileptics.
Presentation/Packing
Form
Zonegran FC tab 100 mg
Packing/Price
100's
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