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Zonegran Generic Name & Formulations
Legal Class
Rx
General Description
Zonisamide 25mg, 100mg; caps.
Pharmacological Class
Carbonic anhydrase inhibitor (sulfonamide).
How Supplied
Caps—100
Manufacturer
Zonegran Indications
Indications
Adjunct in partial seizures.
Zonegran Dosage and Administration
Adult
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.
Children
<16yrs: not established.
Zonegran Contraindications
Not Applicable
Zonegran Boxed Warnings
Not Applicable
Zonegran Warnings/Precautions
Warnings/Precautions
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. Acute myopia. Secondary angle closure glaucoma. Depression. Suicidal tendencies (monitor). Maintain adequate hydration. Exposure to extreme heat; monitor closely for oligohidrosis and hyperthermia (esp. children). Measure baseline serum bicarbonate and periodically during treatment; consider reducing dose or discontinuing if metabolic acidosis occurs. Avoid abrupt cessation. Advise women of childbearing potential to use effective contraception. Elderly. Labor & delivery. Newborns. Pregnancy. Nursing mothers: not recommended.
Zonegran Pharmacokinetics
See Literature
Zonegran Interactions
Interactions
Antagonized by CYP3A4 inducers (eg, phenytoin, carbamazepine, phenobarbital); may need to adjust zonisamide dose. Increased severity of metabolic acidosis, risk of kidney stone formation or hyperammonemia 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, other CNS depressants, or P-gp substrates (eg, digoxin, quinidine).
Zonegran Adverse Reactions
Adverse Reactions
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, hyperammonemia, encephalopathy; rarely: Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS, aplastic anemia, agranulocytosis, oligohidrosis, hyperthermia.
Zonegran Clinical Trials
See Literature
Zonegran Note
Notes
To enroll pregnant patients in the North American Antiepileptic Drug Pregnancy Registry, call (888) 233-2334.
Zonegran Patient Counseling
See Literature
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