Steady‐State Pharmacokinetics of Zonisamide, an Antiepileptic Agent for Treatment of Refractory Complex Partial Seizures

Kochak, Gregory M.; Page, John G.; Buchanan, R. A.; Peters, R.K.; Padgett, Claire

doi:10.1002/j.1552-4604.1998.tb04406.x

Cited by 55 publications

(56 citation statements)

References 5 publications

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“…[124,125,168] In comparison with both phenytoin administration (27%) in healthy patients. [184] Zonisamide is primaand carbamazepine, oxcarbazepine has equal efficacy and better rily eliminated in the urine. Although therapeutic serum levels of tolerability.…”

Section: Dosage and Administrationmentioning

confidence: 99%

Use of Second-Generation Antiepileptic Drugs in the Pediatric Population

Chung

Eiland

2008

Pediatric Drugs

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Epilepsy is common in the pediatric population. Nine second-generation antiepileptic drugs have been approved in the US for use in epilepsy over the past 15 years: felbamate, gabapentin, lamotrigine, topiramate, tiagabine, levetiracetam, oxcarbazepine, zonisamide, and pregabalin. Their use in pediatric patients is fairly widespread, despite most of these agents not having US FDA indications for use. Felbamate and gabapentin were the first two second-generation antiepileptic drugs to be approved in the US. Felbamate use has been limited because of the occurrence of hepatotoxicity and aplastic anemia. Although gabapentin is a fairly well tolerated antiepileptic drug, its use has also been limited as a result of inconsistent efficacy and concern about seizure exacerbation. Lamotrigine and topiramate are broad-spectrum antiepileptic drugs with efficacy in a wide variety of seizure types. Both agents have some tolerability concerns: rash with lamotrigine and neuropsychiatric events with topiramate. There are very little data on tiagabine use in children, but this agent appears to be effective and to have a good tolerability profile. Levetiracetam is a second-generation antiepileptic agent that is available intravenously. Considering its good efficacy, fast onset of action, and low incidence of serious adverse effects, its use in the acute setting could potentially increase. Oxcarbazepine and zonisamide have been relatively well studied in pediatric seizure patients, including use as monotherapy. Both agents have demonstrated good efficacy and tolerability for patients as young as 1 month old. Vigabatrin and rufinamide are currently not available in the US, but have been shown to have some success in other countries. Pregabalin is the newest antiepileptic agent, but lacks pediatric data currently.

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Section: Dosage and Administrationmentioning

confidence: 99%

Use of Second-Generation Antiepileptic Drugs in the Pediatric Population

Chung

Eiland

2008

Pediatric Drugs

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“…Food reduces the rate but not extent of absorption, increasing the time to maximum plasma concentration to 4–6 hours 1,9. Zonisamide displays dose-dependent pharmacokinetics, with maximum plasma concentrations and the area under the time-plasma concentration curve reaching linearity after single doses of 100–800 mg and after multiple doses of 100–400 mg daily 1,10. It has a rather long half-life of 60 hours, allowing for once-daily dosing 1,9.…”

Section: Pharmacokinetic and Pharmacodynamic Propertiesmentioning

confidence: 99%

Update on once-daily zonisamide monotherapy in partial seizures

Afra¹,

Adamolekun²

2014

NDT

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Zonisamide is an antiepileptic drug that is structurally different from other antiepileptic agents. Its long half-life, once-daily dosing, lack of induction of hepatic enzymes, and broad spectrum of action makes it a suitable candidate for monotherapy. It has been approved as monotherapy for partial onset epilepsy in Japan and South Korea for more than a decade, and was recently approved as monotherapy in Europe. In the USA, it is only approved by the US Food and Drug Administration for adjunctive treatment of partial onset epilepsy. In this paper, we briefly review the literature on zonisamide monotherapy in partial onset epilepsy with regard to its efficacy, safety, tolerability, and long-term side effects, including a recent noninferiority trial in comparison with extended-release carbamazepine. While European regulatory agencies use noninferiority trials for approval of monotherapy, such a trial design does not meet the current regulatory requirements for approval as monotherapy in the USA.

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“…Population PK parameters were used for determining dose regimens in epileptic patients (Peters and Sorkin 1993; Hashimoto et al 1994; Kochak et al 1998). A favorable linear PK profile has been reported for zonisamide, and the zonisamide parameters are summarized in Table 2.…”

Section: Pharmacokinetics (Pk)mentioning

confidence: 99%

Zonisamide ? a review of experience and use in partial seizures

Wilfong

Willmore²

2006

Neuropsychiatric Disease and Treatment

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Zonisamide is a modern antiepileptic drug (AED) that is distinguished from other AEDs by its unique structure and broad mechanistic profi le. Preclinical studies have reported a range of potential mechanisms of action for zonisamide, such as blocking voltage-gated sodium channels, reduction of T-type calcium channel currents, and enhancement of gammaaminobutyric acid (GABA)-mediated inhibition, which are indicative of its broad antiseizure effects. Zonisamide has a favorable linear pharmacokinetic profi le, a long half-life, and a low incidence of protein-binding interactions with other AEDs. Hepatically metabolized through the cytochrome P450 pathway, zonisamide does not induce its own metabolism or liver enzymes. For more than 2 decades, zonisamide has been extensively used as monotherapy and adjunctive therapy for the treatment of partial and generalized seizures in pediatric and adult patients in Japan. Zonisamide was approved in the USA in 2000 as adjunctive therapy for partial seizures in adults. With over 2 million patient-years of exposure internationally, zonisamide has demonstrated safety and effi cacy against a multitude of epilepsy and seizure types, including both partial and generalized seizures. This review focuses on the experience and use of zonisamide in partial seizures, as well as possible new uses for zonisamide.

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Steady‐State Pharmacokinetics of Zonisamide, an Antiepileptic Agent for Treatment of Refractory Complex Partial Seizures

Cited by 55 publications

References 5 publications

Use of Second-Generation Antiepileptic Drugs in the Pediatric Population

Use of Second-Generation Antiepileptic Drugs in the Pediatric Population

Update on once-daily zonisamide monotherapy in partial seizures

Zonisamide ? a review of experience and use in partial seizures

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