Sulfonamide

Epilepsy, partial (treatment) - Zonisamide is indicated for adjunctive therapeutic use in the treatment of partial seizures in adults with epilepsy.

FDA Pregnancy Category C

Swallowing whole, not chewing or breaking capsule proper dosing

Missed dose: taking as soon as possible; not taking if almost time for next scheduled dose; not doubling doses

Importance of regular visits to physician to check progress of therapy.

Discussing alcohol use or use of other CNS depressants use with physician

Possible blurred or doubled vision, dizziness, drowsiness, or light headedness; caution when driving, using machinery, or doing other jobs that require alertness.

Caution during exercise or hot weather; overheating may result in heat stroke.

Checking with physician if condition does not improve within a few weeks or if it becomes worse.

Contacting physician immediately if skin rash develops, if experiencing fever, sore thorat, oral ulcers, easy bruising, or worsening of seizures.

Checking with physician immediately if a child taking zonisamide is not sweating as usual.

Using effective contraception.

Not discontinuing zonisamide abruptly; cheking with physician about gradually redusing dosage before stopping completely.

Importance of adequate fluid intake during therapy to help prevent kidney stone formation.

Contraindication:

This medication should not be used when the following medical problems exist:

Previous hypersensitivity reaction to zonisamide or any other sulfonamide.

Renal failure (glomerular filtration rate < 50 ml/min)

Risk-Benefit should be considered: when the following medical problems exist:

Hepatic dysfunction, Renal dysfunction.

Drug interactions:

Anticholinergics, Carbonic anhydrase inhibitors,CNS depressions-producing medications

Anticovulsants including: Carbamazepine, Phenobarbital, Phenytoin, Valproate (anti epileptic agents that are cytochrome P450 inducers have caused decreasd serum concentration of zonisamide. Oligohidrosis, heat stroke with symptoms of decreased sweating, Fatalities have occurred rarely as a result of serve reactions to sulfonamides including, Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood dyscrasis as.

Usual adult and adolescent dose:

Anticonvulsant -

Patients 16 years of age and olderinital - Oral 100mg a day, the dosage being increased by 100mg a day increments at intervals of at least two weeks to allow for attainment of steady state plasma levels, up to 400mg a day, since many side effects are more frequent at doses of 300mg and above, it is suggested that treatment may be prolonged at lower dosing levels in order to more accurately assess all effects of zonisamide at steady state.

Maintenance oral, 200 to 400 mg a day, in one single, or two equally-divided doses.

Anticonvulsant -

Safety and efficacy have not been established for children younger than 16 years of age.

Those indicating need for medical attention

Incidence more frequent:

Ataxia,confusion,depression

Incidence less frequent:

Ecchymosis,rash;schizophrenic or schizopherniform behavior

Those indicating need for medical attention only if they continue

Incidence more frequent:

Abdominal pain; anorexia, agitation or irritability; difficulty in concentrating; difficulty with memory; diplopia; dizziness; fatigue; headache; insomnia; nausea; somnolence; tiredness.

Incidence less frequent:

Anxiety; constipation; diarrhea; difficulty in verbal expression; dry mouth; dyspepsia; flu syndrome; mental slowing; nervousness; nystagmus; pareshtesia; rhinitis; speech abnormalities; taste perversion; weight loss.

Store below 25˚ C (77˚ F) between 15˚ and 30˚ C (59˚ and 86˚ F). Protect from light and moisture.

Boxes of 48 ZONISAMIDE 100 mg, 50 mg and 25 mg capsules.