Zonisamide 25 mg/1
Zonisamide · CAPSULE · Exelan Pharmaceuticals, Inc.
Zonisamide is a capsule containing zonisamide at 25 mg/1, taken oral. Manufactured by Exelan Pharmaceuticals, Inc..
Key Facts
- Brand Name
- Zonisamide
- Generic Name
- Zonisamide
- NDC Code (Product)
76282-226- Manufacturer
- Exelan Pharmaceuticals, Inc.
- Strength
- 25 mg/1
- Dosage Form
- CAPSULE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA077869
- Drug Class
- Anti-epileptic Agent [EPC]
- Marketing Start
- 03/15/2021
Recall History
American Health Packaging
CGMP Deviations: Firm did not adequately investigate customer complaints.
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations
Glenmark Pharmaceuticals Inc., USA
cGMP deviations
Direct Rx
CGMP Deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
Glenmark Pharmaceuticals Inc., USA
cGMP deviations
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations
Wockhardt Usa Inc.
CGMP Deviations: Firm did not adequately investigate customer complaints.
Direct Rx
CGMP deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
Glenmark Pharmaceuticals Inc., USA
cGMP deviations
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Zonisamide capsules are indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy.
Dosage & Administration
DOSAGE AND ADMINISTRATION Zonisamide capsules are recommended as adjunctive therapy for the treatment of partial seizures in adults. Safety and efficacy in pediatric patients below the age of 16 have not been established. Zonisamide capsules should be administered once or twice daily, using 25 mg, 50 mg or 100 mg capsules. Zonisamide capsules are given orally and can be taken with or without food. Capsules should be swallowed whole. Adults over Age 16 The prescriber should be aware that, because of the long half-life of zonisamide, up to two weeks may be required to achieve steady state levels upon reaching a stable dose or following dosage adjustment. Although the regimen described below is one that has been shown to be tolerated, the prescriber may wish to prolong the duration of treatment at the lower doses in order to fully assess the effects of zonisamide at steady state, noting that many of the side effects of zonisamide are more frequent at doses of 300 mg per day and above. Although there is some evidence of greater response at doses above 100-200 mg/day, the increase appears small and formal dose-response studies have not been conducted. The initial dose of zonisamide shou…
Warnings
WARNINGS Potentially Fatal Reactions to Sulfonamides: Fatalities have occurred, although rarely, as a result of severe reactions to sulfonamides (zonisamide is a sulfonamide) including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood dyscrasias. Such reactions may occur when a sulfonamide is readministered irrespective of the route of administration. If signs of hypersensitivity or other serious reactions occur, discontinue zonisamide immediately. Specific experience with sulfonamide-type adverse reaction to zonisamide is described below. Serious Skin Reactions Consideration should be given to discontinuing zonisamide in patients who develop an otherwise unexplained rash. If the drug is not discontinued, patients should be observed frequently. Seven deaths from severe rash [i.e., Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN)] were reported in the first 11 years of marketing in Japan. All of the patients were receiving other drugs in addition to zonisamide. In post-marketing experience from Japan, a total of 49 cases of SJS or TEN have been reported, a reporting rate of 46 per mi…
Contraindications
CONTRAINDICATIONS Zonisamide capsules are contraindicated in patients who have demonstrated hypersensitivity to sulfonamides or zonisamide.
Drug Interactions
Drug Interactions Drug Interactions with CNS Depressants: Concomitant administration of zonisamide and alcohol or other CNS depressant drugs has not been evaluated in clinical studies. Because of the potential of zonisamide to cause CNS depression, as well as other cognitive and/or neuropsychiatric adverse events, zonisamide should be used with caution if used in combination with alcohol or other CNS depressants. Other Carbonic Anhydrase Inhibitors: Concomitant use of zonisamide, a carbonic anhydrase inhibitor, with any other carbonic anhydrase inhibitor (e.g., topiramate, acetazolamide or dichlorphenamide), may increase the severity of metabolic acidosis and may also increase the risk of kidney stone formation or the risk of hyperammonemia. Therefore, if zonisamide is given concomitantly with another carbonic anhydrase inhibitor, the patient should be monitored for the appearance or worsening of metabolic acidosis (see CLINICAL PHARMACOLOGY, Interactions of Zonisamide with Other Carbonic Anhydrase Inhibitors subsection and WARNINGS, Metabolic Acidosis subsection and Hyperammonemia and Encephalopathy subsection).
Adverse Reactions
ADVERSE REACTIONS The most common adverse reactions with zonisamide (an incidence at least 4% greater than placebo) in controlled clinical trials and shown in descending order of frequency were somnolence, anorexia, dizziness, ataxia, agitation/irritability, and difficulty with memory and/or concentration. In controlled clinical trials, 12% of patients receiving zonisamide as adjunctive therapy discontinued due to an adverse reaction compared to 6% receiving placebo. Approximately 21% of the 1,336 patients with epilepsy who received zonisamide in clinical studies discontinued treatment because of an adverse reaction. The most common adverse reactions leading to discontinuation were somnolence, fatigue and/or ataxia (6%), anorexia (3%), difficulty concentrating (2%), difficulty with memory, mental slowing, nausea/vomiting (2%), and weight loss (1%). Many of these adverse reactions were dose-related (see WARNINGS and PRECAUTIONS ) . Adverse Reaction Incidence in Controlled Clinical Trials Table 4 lists adverse reactions that occurred in at least 2% of patients treated with zonisamide in controlled clinical trials that were numerically more common in the zonisamide group. In these stu…
Frequently Asked Questions
What is Zonisamide used for?
Zonisamide contains Zonisamide. It is a capsule taken oral. Consult your doctor for specific uses.
Is Zonisamide a controlled substance?
Zonisamide is not classified as a controlled substance by the DEA.
What is the generic name for Zonisamide?
The generic name for Zonisamide is Zonisamide. There are 2 other brand versions of Zonisamide.
What is the NDC code for Zonisamide 25 mg/1?
The NDC (National Drug Code) for Zonisamide 25 mg/1 is 76282-226, listed by Exelan Pharmaceuticals, Inc..