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Zonegran

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Overview

What is Zonegran?

ZONEGRAN (zonisamide) is an antiseizure drug chemically classified as a sulfonamide and unrelated to other antiseizure agents. The active ingredient is zonisamide, 1,2-benzisoxazole-3-methanesulfonamide. The empirical formula is CHNOS with a molecular weight of 212.23. Zonisamide is a white powder, pKa = 10.2, and is moderately soluble in water (0.80 mg/mL) and 0.1 N HCl (0.50 mg/mL).

The chemical structure is:

ZONEGRAN is supplied for oral administration as capsules containing 25 mg or 100 mg zonisamide.

Each 25 mg capsule contains the labeled amount of zonisamide plus the following inactive ingredients: microcrystalline cellulose, hydrogenated vegetable oil, sodium lauryl sulfate, gelatin, and titanium dioxide.

Each 100 mg capsule contains the labeled amount of zonisamide plus the following inactive ingredients: microcrystalline cellulose, hydrogenated vegetable oil, sodium lauryl sulfate, gelatin, titanium dioxide, FD&C Red No. 40 and FD&C Yellow No. 6.



What does Zonegran look like?



What are the available doses of Zonegran?

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What should I talk to my health care provider before I take Zonegran?

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How should I use Zonegran?

ZONEGRAN is indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy.

ZONEGRAN (zonisamide) is 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. ZONEGRAN should be administered once or twice daily, using 25 mg or 100 mg capsules. ZONEGRAN is given orally and can be taken with or without food. Capsules should be swallowed whole.


What interacts with Zonegran?

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What are the warnings of Zonegran?

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What are the precautions of Zonegran?

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What are the side effects of Zonegran?

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What should I look out for while using Zonegran?

ZONEGRAN is contraindicated in patients who have demonstrated hypersensitivity to sulfonamides or zonisamide.

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.


What might happen if I take too much Zonegran?


How should I store and handle Zonegran?

Store at 20° to 25°C (68° to 77°F).[See USP Controlled Room Temperature]DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.Store at 20° to 25°C (68° to 77°F).[See USP Controlled Room Temperature]DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.Store at 20° to 25°C (68° to 77°F).[See USP Controlled Room Temperature]DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.ZONEGRAN is available as 25 mg and 100 mg two-piece hard gelatin capsules. The capsules are printed in black with “ZONEGRAN 25” or “ZONEGRAN 100,” respectively. ZONEGRAN is available in bottles of 100 with strengths and colors as follows:Store at 25°C (77°F), excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature], in a dry place and protected from light.Manufactured for: Concordia Pharmaceuticals Inc. St. Michael, Barbados BB11005ZONEGRAN® is a registered trademark of Dainippon Pharmaceutical Co., Ltd. and licensed exclusively to Concordia Pharmaceuticals Inc.© 2015 Concordia Pharmaceuticals Inc.Revised: 04/2016ZONEGRAN is available as 25 mg and 100 mg two-piece hard gelatin capsules. The capsules are printed in black with “ZONEGRAN 25” or “ZONEGRAN 100,” respectively. ZONEGRAN is available in bottles of 100 with strengths and colors as follows:Store at 25°C (77°F), excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature], in a dry place and protected from light.Manufactured for: Concordia Pharmaceuticals Inc. St. Michael, Barbados BB11005ZONEGRAN® is a registered trademark of Dainippon Pharmaceutical Co., Ltd. and licensed exclusively to Concordia Pharmaceuticals Inc.© 2015 Concordia Pharmaceuticals Inc.Revised: 04/2016ZONEGRAN is available as 25 mg and 100 mg two-piece hard gelatin capsules. The capsules are printed in black with “ZONEGRAN 25” or “ZONEGRAN 100,” respectively. ZONEGRAN is available in bottles of 100 with strengths and colors as follows:Store at 25°C (77°F), excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature], in a dry place and protected from light.Manufactured for: Concordia Pharmaceuticals Inc. St. Michael, Barbados BB11005ZONEGRAN® is a registered trademark of Dainippon Pharmaceutical Co., Ltd. and licensed exclusively to Concordia Pharmaceuticals Inc.© 2015 Concordia Pharmaceuticals Inc.Revised: 04/2016ZONEGRAN is available as 25 mg and 100 mg two-piece hard gelatin capsules. The capsules are printed in black with “ZONEGRAN 25” or “ZONEGRAN 100,” respectively. ZONEGRAN is available in bottles of 100 with strengths and colors as follows:Store at 25°C (77°F), excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature], in a dry place and protected from light.Manufactured for: Concordia Pharmaceuticals Inc. St. Michael, Barbados BB11005ZONEGRAN® is a registered trademark of Dainippon Pharmaceutical Co., Ltd. and licensed exclusively to Concordia Pharmaceuticals Inc.© 2015 Concordia Pharmaceuticals Inc.Revised: 04/2016ZONEGRAN is available as 25 mg and 100 mg two-piece hard gelatin capsules. The capsules are printed in black with “ZONEGRAN 25” or “ZONEGRAN 100,” respectively. ZONEGRAN is available in bottles of 100 with strengths and colors as follows:Store at 25°C (77°F), excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature], in a dry place and protected from light.Manufactured for: Concordia Pharmaceuticals Inc. St. Michael, Barbados BB11005ZONEGRAN® is a registered trademark of Dainippon Pharmaceutical Co., Ltd. and licensed exclusively to Concordia Pharmaceuticals Inc.© 2015 Concordia Pharmaceuticals Inc.Revised: 04/2016ZONEGRAN is available as 25 mg and 100 mg two-piece hard gelatin capsules. The capsules are printed in black with “ZONEGRAN 25” or “ZONEGRAN 100,” respectively. ZONEGRAN is available in bottles of 100 with strengths and colors as follows:Store at 25°C (77°F), excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature], in a dry place and protected from light.Manufactured for: Concordia Pharmaceuticals Inc. St. Michael, Barbados BB11005ZONEGRAN® is a registered trademark of Dainippon Pharmaceutical Co., Ltd. and licensed exclusively to Concordia Pharmaceuticals Inc.© 2015 Concordia Pharmaceuticals Inc.Revised: 04/2016


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Clinical Information

Chemical Structure

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Clinical Pharmacology

The precise mechanism(s) by which zonisamide exerts its antiseizure effect is unknown. Zonisamide demonstrated anticonvulsant activity in several experimental models. In animals, zonisamide was effective against tonic extension seizures induced by maximal electroshock but ineffective against clonic seizures induced by subcutaneous pentylenetetrazol. Zonisamide raised the threshold for generalized seizures in the kindled rat model and reduced the duration of cortical focal seizures induced by electrical stimulation of the visual cortex in cats. Furthermore, zonisamide suppressed both interictal spikes and the secondarily generalized seizures produced by cortical application of tungstic acid gel in rats or by cortical freezing in cats. The relevance of these models to human epilepsy is unknown.

Zonisamide may produce these effects through action at sodium and calcium channels. In vitro pharmacological studies suggest that zonisamide blocks sodium channels and reduces voltage-dependent, transient inward currents (T-type Ca currents), consequently stabilizing neuronal membranes and suppressing neuronal hypersynchronization. In vitro binding studies have demonstrated that zonisamide binds to the GABA/benzodiazepine receptor ionophore complex in an allosteric fashion which does not produce changes in chloride flux. Other in vitro studies have demonstrated that zonisamide (10–30 µg/mL) suppresses synaptically-driven electrical activity without affecting postsynaptic GABA or glutamate responses (cultured mouse spinal cord neurons) or neuronal or glial uptake of [H]-GABA (rat hippocampal slices). Thus, zonisamide does not appear to potentiate the synaptic activity of GABA. In vivo microdialysis studies demonstrated that zonisamide facilitates both dopaminergic and serotonergic neurotransmission.

Zonisamide is a carbonic anhydrase inhibitor. The contribution of this pharmacological action to the therapeutic effects of zonisamide is unknown. However, as a carbonic anhydrase inhibitor, zonisamide may cause metabolic acidosis (see subsection).

Non-Clinical Toxicology
ZONEGRAN is contraindicated in patients who have demonstrated hypersensitivity to sulfonamides or zonisamide.

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.

Drug Interactions with CNS Depressants:





Somnolence is commonly reported, especially at higher doses of ZONEGRAN (see subsection). Zonisamide is metabolized by the liver and eliminated by the kidneys; caution should therefore be exercised when administering ZONEGRAN to patients with hepatic and renal dysfunction (see subsection).

The most common adverse reactions with ZONEGRAN (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 ZONEGRAN 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 ZONEGRAN 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 and ).

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Tips

Tips

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Interactions

Interactions

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