Generic Name and Formulations:
Zonisamide 25mg, 100mg; caps.
Concordia Pharmaceuticals Inc.
Indications for ZONEGRAN:
Adjunct in partial seizures.
Swallow whole. ≥16yrs: initially 100mg once daily; may increase at intervals of at least 2 weeks by 100mg/day in 1 or 2 divided doses. Usual range: 100–400mg/day in 1 or 2 divided doses; usual max 600mg/day.
<16yrs: not recommended.
Discontinue or monitor closely if serious rash occurs. Evaluate immediately if signs/symptoms of DRESS/multi-organ hypersensitivity develop; discontinue if no alternative etiology. Renal failure: not recommended. Renal or hepatic impairment: titrate more slowly and monitor more frequently. Depression. Suicidal tendencies (monitor). Maintain adequate hydration. Exposure to extreme heat; monitor closely for oligohidrosis and hyperthermia (esp. children). Monitor baseline serum bicarbonate and periodically during treatment; consider reducing dose or discontinuing if metabolic acidosis occurs. Avoid abrupt cessation. Women of childbearing potential: use effective contraception. Elderly. Labor & delivery. Newborns. Pregnancy (Cat.C). Nursing mothers: not recommended.
Serum levels may be affected by CYP3A4 inducers or inhibitors. Increased severity of metabolic acidosis and risk of kidney stone formation with concomitant other carbonic anhydrase inhibitors (eg, topiramate, acetazolamide, dichlorphenamide); monitor. Caution with other drugs that interfere with temperature regulation (eg, anticholinergics, carbonic anhydrase inhibitors). Caution with concomitant alcohol or other CNS depressants.
CNS effects (eg, somnolence, anorexia, dizziness, headache, agitation, fatigue, ataxia, confusion, difficulty with memory and/or concentration, depression, insomnia, abnormal vision or speech), GI upset/pain, paresthesia; kidney stones, metabolic acidosis; rarely: Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS, aplastic anemia, agranulocytosis, oligohidrosis, hyperthermia.
To enroll pregnant patients in the North American Antiepileptic Drug Pregnancy Registry, call (888) 233-2334.
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