Adult Dosing
Partial seizures
- 100-600 mg/day PO divided bid
- Initial dose: 100 mg/day PO x2wks; then titrate the dose by 100 mg/day q2 wks. Max: 600 mg/day
Pediatric Dosing
Partial seizures
- >16 yrs
- 100-600 mg/day PO divided bid
- Initial dose: 100 mg/day PO x2wks; then titrate the dose by 100 mg/day q2 wk. Max: 600 mg/day
Note: Safety and effectiveness in pediatric patients of age <16 yrs of age have not been established
[Outline]
Renal Dose Adjustment (Based on CrCl)
- 50-80 mL/min: Caution advised; titrate slowly, dose adjustments not defined
- <50 mL/min: Contraindicated
Hepatic Dose Adjustment
- Hepatic impairment: Caution advised; titrate slowly, dose adjustments not defined
See Supplemental Patient Information
- Severe hypersensitivity reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood dyscrasias can occur with sulfonamides therapy, discontinue the drug immediately on occurrence of any of these symptoms
- Oligohidrosis resulting in heat stroke and hospitalization has been observed with zonisamide especially in pediatric patients. Monitor the patients closely for evidence of decreased sweating and increased body temperature, especially in warm or hot weather
- Antiepileptic drugs including zonisamide increases the risk of suicidal thoughts or behavior, hence monitor the patient for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior
- Zonisamide can cause hyperchloremic, non-anion gap, metabolic acidosis, manifested as hyperventilation, fatigue and anorexia, or more severe sequelae including cardiac arrhythmias or stupor. Renal disease, severe respiratory disorders, status epilepticus, diarrhea, ketogenic diet, or specific drugs additive to the bicarbonate lowering effects of zonisamide are the predisposing factors
- Chronic, untreated metabolic acidosis can result in osteomalacia or osteoporosis with an increased risk for fracture, also increases the risk of nephrolithiasis or nephrocalcinosis and reduce growth rates in pediatric patients
- Monitor serum bicarbonate at base line and periodically during the treatment and if metabolic acidosis develops and persists consider reducing the dose or discontinuation of therapy and if zonisamide is continued, consider alkali treatment
- Abrupt withdrawal of zonisamide in epileptic patient can precipitate, increased seizure frequency or status epilepticus. Hence gradually discontinue the drug by reducing the dose
- Zonisamide can cause fetal abnormalities, including cardiovascular defects, and embryo-fetal deaths. Advise women of child bearing potential receiving zonisamide to use effective contraception
- Central nervous system-related adverse events such as depression and psychosis, difficulty with concentration, and speech or language problems and somnolence or fatigue have been reported with zonisamide therapy
- Increase in baseline serum creatinine, blood urea nitrogen (BUN) and creatine phosphokinase has been observed with zonisamide therapy. Discontinue the drug if acute renal failure develops or clinically significant increase in creatinine/BUN concentration is observed
- Sudden unexplained death has been reported in epileptic patient receiving zonisamide
Cautions: Use cautiously in
- Renal impairment
- Hepatic impairment
- Alcohol abuse
- Concomitant CNS depressant
- High environmental temperature
- Severe respiratory disorders
- Status epilepticus
- Diarrhea
- Ketogenic diet
- Pediatric patients
- Nephrolithiasis
Supplemental Patient Information
- Patients should read the Medication Guide prior to taking the therapy. Take zonisamide only as prescribed
- Therapy may produce drowsiness, especially at higher doses. Therefore do not drive a car or operate other complex machinery
- Use with caution if used in combination with alcohol or other CNS depressants because of the potential of zonisamide to cause CNS depression, as well as other cognitive and/or neuropsychiatric adverse events
- Contact physician immediately if a skin rash develops or seizures worsen or if a child has been taking therapy and is not sweating as usual with or without a fever
- Therapy may increase the risk of suicidal thoughts and behavior
Pregnancy Category:C
Breastfeeding: Safety unknown. Limited information indicates that maternal doses of zonisamide up to 400 mg daily produce relatively high levels in milk, but serum levels in neonates decrease during the first month of life while nursing. This information is based upon LactMed database http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 18 April 2011). Due to the potential for serious adverse reactions in nursing infants, manufacturer recommends discontinuation of nursing or discontinuation of drug, taking into account the importance of the drug to the mother.
Pricing data from www.DrugStore.com in U.S.A.
- Zonisamide 100 MG CAPS [Bottle] (GLENMARK PHARMACEUTICALS)
30 mg = $59.99
90 mg = $169.97 - Zonegran 100 MG CAPS [Bottle] (EISAI)
30 mg = $131.99
90 mg = $380.98 - Zonisamide 50 MG CAPS [Bottle] (GLENMARK PHARMACEUTICALS)
100 mg = $91.99
300 mg = $259.98 - Zonegran 25 MG CAPS [Bottle] (EISAI)
30 mg = $42.99
90 mg = $106.97 - Zonisamide 25 MG CAPS [Bottle] (GLENMARK PHARMACEUTICALS)
100 mg = $50.99
300 mg = $141.97
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.
