Zonisamide is an anti-epileptic agent sold in the U.S. under 2 brand and generic names, for partial epilepsies. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Zonisade (application NDA214273). Other zonisamide products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
The recommended initial dosage of ZONISADE is 100 mg daily. The dosage may be increased by 100 mg daily every two weeks, based on clinical response and tolerability, to 400 mg daily. Patients who are tolerating ZONISADE at 400 mg daily and require further reduction of seizures may be increased up to a maximum dosage of 600 mg daily ( 2.2 ). • ZONISADE is given orally and can be taken with or without food ( 2.2 ). 2.1 Recommended Assessments for Safety To assess for metabolic acidosis, obtain baseline serum bicarbonate prior to initiating ZONISADE, and obtain periodic serum bicarbonate during treatment [see Warnings and Precautions ( 5.8 )]. 2.2 Recommended Dosage Administer ZONISADE once or twice daily with or without food. The recommended initial dosage of ZONISADE is 100 mg daily. The dosage may be increased by 100 mg daily every two weeks, based on clinical response and tolerability, to 400 mg daily. Patients who are tolerating ZONISADE at 400 mg daily and require further reduction of seizures may be increased up to a maximum dosage of 600 mg daily. However, evidence from controlled trials shows no suggestion of increasing response above 400 mg/day [see Clinical Studies ( 14 )] . 2.3 Important Administration Information Shake well before every administration. To administer ZONISADE directly into the mouth, it is important that ZONISADE be…
The following clinically signification adverse reactions are described elsewhere in the labeling: • Potentially Fatal Reactions to Sulfonamides [see Warnings and Precautions ( 5.1 )] • Serious Skin Reactions [see Warnings and Precautions ( 5.2 )] • Serious Hematologic Events [see Warnings and Precautions ( 5.3 )] • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multi-Organ Hypersensitivity [see Warnings and Precautions ( 5.4 )] • Oligohidrosis and Hyperthermia in Pediatric Patients [see Warnings and Precautions ( 5.5 )] • Acute Myopia and Secondary Angle Closure Glaucoma [see Warnings and Precautions ( 5.6 )] • Suicidal Behavior and Ideation [see Warnings and Precautions ( 5.7 )] • Metabolic Acidosis [see Warnings and Precautions ( 5.8 )] • Seizures on Withdrawal of Antiepileptic Drugs [see Warnings and Precautions ( 5.9 )] • Teratogenicity [see Warnings and Precautions ( 5.10 )] • Cognitive/Neuropsychiatric Adverse Reactions [see Warnings and Precautions ( 5.11 )] • Hyperammonemia and Encephalopathy [see Warnings and Precautions ( 5.12 )] • Kidney Stones [see Warnings and Precautions ( 5.13 )] • Effect on Renal Function [see Warnings and Precautions ( 5.14 )] • Status Epilepticus [see Warnings and Precautions ( 5.15 )] The most common adverse reactions with ZONISADE (an incidence at least 4% greater than placebo) in controlled clinical trials and shown in…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | 72/100 | Prescription | Suspension | Generic | $3 | View → | |
| 2 | Not yet rated | Prescription | Capsule | Generic | $3 |
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| 258;258 | 25 mg | white, white | capsule | — |
| 259;259 | 50 mg | white, gray | capsule | — |
| 260;260 | 100 mg | white, orange | capsule | — |
| G24;25 | 25 mg | blue, white | capsule | — |
| ZNS;100 | 100 mg | pink, white | capsule | — |
| G24;25 | 25 mg |
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
ZONISADE is contraindicated in patients who have demonstrated hypersensitivity to sulfonamides or zonisamide. ZONISADE is contraindicated in patients who have demonstrated hypersensitivity to sulfonamides or zonisamide ( 4 ).
ZONISADE should be used with caution if used in combination with alcohol or other CNS depressants ( 7.1 ). • Concomitant use of ZONISADE with any other carbonic anhydrase inhibitor may increase the severity of metabolic acidosis and may also increase the risk of kidney stone formation ( 7.2 ). 7.1 CNS Depressants Concomitant use of ZONISADE with other CNS depressants, including alcohol, may increase the risk of CNS depression, as well as other cognitive and/or neuropsychiatric adverse events [see Warnings and Precautions ( 5.11 )] . 7.2 Other Carbonic Anhydrase Inhibitors Concomitant use of ZONISADE, a carbonic anhydrase inhibitor, with any other carbonic anhydrase inhibitor, may increase the severity of metabolic acidosis and may also increase the risk of kidney stone formation [see Warnings and Precautions ( 5.8 , 5.15 )] . Therefore, if ZONISADE is given concomitantly with another carbonic anhydrase inhibitor, monitor the patient for the appearance or worsening of metabolic acidosis [see Clinical Pharmacology ( 12.1 , 12.3 )] . 7.3 CYP3A4 Inducers If co-administration with a potent CYP3A4 inducer is necessary, the patient should be closely monitored and the dose of ZONISAMIDE and other drugs that CYP3A4 substrates may need to be adjusted [see Clinical Pharmacology ( 12.3 )] .
| blue, white |
| capsule |
| — |
| G24;50 | 50 mg | yellow, white | capsule | — |
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| G24;100 | 100 mg | green, white | capsule | — |
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| ZNS;25 | 25 mg | white | capsule | — |
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| ZNS;50 | 50 mg | white | capsule | — |
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| ZNS;100 | 100 mg | pink, white | capsule | — |
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