Zonegran

zonisamide

(zoe-niss-a-mide) ,

Zonegran

(trade name)

Classification

Therapeutic: anticonvulsants
Pharmacologic: sulfonamides
Pregnancy Category: C

Indications

Partial seizures in adults.

Action

Raises the threshold for seizures and reduces duration of seizures probably by action on sodium and calcium channels.

Therapeutic effects

Decreased frequency of partial seizures.

Pharmacokinetics

Absorption: Well absorbed following oral administration.
Distribution: Binds extensively to red blood cells.
Protein Binding: 40%.
Metabolism and Excretion: Mostly metabolized by the liver; 35% excreted unchanged in urine. Some metabolism occurs via CYP3A4 enzyme system.
Half-life: 63 hr (plasma).

Time/action profile (blood levels†)

ROUTEONSETPEAKDURATION
POunknown2–6 hr24 hr
†Requires 2 weeks of dosing to achieve steady-state blood levels

Contraindications/Precautions

Contraindicated in: Hypersensitivity to zonisamide or sulfonamides.
Use Cautiously in: All patients (may ↑ risk of suicidal thoughts/behaviors);Hepatic or renal disease (may require slower titration/more frequent monitoring; ↑ risk of metabolic acidosis with renal impairment);Patients with respiratory disorders, diarrhea, or undergoing surgery (↑ risk of metabolic acidosis); Obstetric / Lactation: Use only if potential benefit justifies risk to fetus/infant; Pediatric: Children ≤16 yr (safety not established; ↑ risk of oligohydrosis, hyperthermia, and/or metabolic acidosis).

Adverse Reactions/Side Effects

Central nervous system

  • suicidal thoughts (life-threatening)
  • drowsiness (most frequent)
  • fatigue (most frequent)
  • agitation/irritability
  • depression
  • dizziness
  • psychomotor slowing
  • psychosis
  • weakness

Ear, Eye, Nose, Throat

  • amblyopia
  • tinnitus

Respiratory

  • cough
  • pharyngitis

Gastrointestinal

  • anorexia
  • nausea
  • vomiting

Fluid and Electrolyte

  • metabolic acidosis

Genitourinary

  • kidney stones

Dermatologic

  • stevens-johnson syndrome (life-threatening)
  • oligohydrosis (↑ in children)
  • rash

Metabolic

  • hyperthermia (↑ in children)

Neurologic

  • abnormal gait
  • hyperasthesia
  • incoordination
  • tremor

Interactions

Drug-Drug interaction

Drugs that induce or inhibit CYP3A4 may alter blood levels and effects of zonisamide.Blood levels and effects may be ↓ by phenytoin, carbamazepine, phenobarbital, or valproate.May enhance the adverse/toxic effect of carbonic anhydrase inhibitors, avoid combination.

Route/Dosage

Oral (Adults and Children >16 yr) 100 mg once daily initially for 2 wk, then ↑ to 200 mg daily for 2 wk; with subsequent increments of 100 mg made at 2-wk intervals as required (range 100–600 mg/day). Can be given as a single daily dose or in 2 divided doses.
Oral (Infants and Children) Initial: 1–2 mg/kg/day given in two divided doses/day; increase dose in increments of 0.5–1 mg/kg/day every 2 weeks (maximum dose: 12 mg/kg/day).

Availability (generic available)

Capsules: 25 mg, 50 mg, 100 mg Cost: Generic — 25 mg $54.80 / 100, 50 mg $109.60 / 100, 100 mg $219.20 / 100

Nursing implications

Nursing assessment

  • Monitor closely for notable changes in behavior that could indicate the emergence or worsening of suicidal thoughts or behavior or depression.
  • Monitor frequency, duration, and characteristics of seizures.
  • Monitor patient frequently for development of skin rash. Unexplained rash may require discontinuation of therapy.
  • Assess patient for allergy to sulfa drugs.
  • Lab Test Considerations: Monitor renal function periodically during therapy. May cause ↑ creatinine and BUN.
    • Measure serum bicarbonate before starting and periodically during therapy. Metabolic acidosis may be more frequent and severe in younger patients.
    • May cause ↑ in serum alkaline phosphatase.

Potential Nursing Diagnoses

Risk for injury (Adverse Reactions)

Implementation

  • Oral: May be administered with or without meals. Capsules should be swallowed whole.

Patient/Family Teaching

  • Instruct patient to take zonisamide as directed, even if feeling well. Consult health care professional if a dose is missed. Do not discontinue abruptly without consulting health care professional; may cause seizures. Instruct patient to read the Medication Guide before starting and with each Rx refill, changes may occur.
  • Instruct patient to contact health care professional immediately if skin rash occurs or seizures worsen. Patient should also contact health care professional if a child taking zonisamide is not sweating as usual, with or without a fever, or if they develop fever, sore throat, oral ulcers, easy bruising, depression, unusual thoughts, speech or language problems.
  • May cause drowsiness. Caution patient to avoid driving or other activities requiring alertness until cleared by health care professional and effects of medication is known.
  • Advise patient to increase fluid intake to at least 6–8 glasses of water/day to minimize risk of kidney stones. Instruct patient to contact health care professional if symptoms of kidney stones (sudden back pain, abdominal pain, blood in urine) occur.
  • Advise patient and family to notify health care professional if thoughts about suicide or dying, attempts to commit suicide; new or worse depression; new or worse anxiety; feeling very agitated or restless; panic attacks; trouble sleeping; new or worse irritability; acting aggressive; being angry or violent; acting on dangerous impulses; an extreme increase in activity and talking, other unusual changes in behavior or mood occur.
  • Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
  • May have teratogenic effects. Advise women of childbearing age to use effective contraception throughout therapy. Instruct patient to notify health care professional if pregnancy is planned or suspected or if planning to breast feed.

Evaluation/Desired Outcomes

  • Decrease in frequency and duration of partial seizures.

Zonegran®

Zonisamide Neurology An agent used to manage partial seizures in adults with epilepsy. See Seizures.
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References in periodicals archive ?
M2 EQUITYBITES-June 23, 2017-Eisai partners with Ewopharma for commercialising Halaven, Targretin and Zonegran in Central Eastern Europe
Amitriptyline* Elavil Bupropion * Wellbutrin, Zyban Clomipramine* Anafranil Desipramine* Norpramin Exenatide* Byetta, Bydureon Imipramine* Tofranil Levomilnacipran * Fetzima Liraglutide * Victoza, Saxenda Lorcaserin * Belviq Metformin * Glucophage Methylphenidate * Ritalin, Methylin Mirtazapine* Remeron Naltrexone/bupropion * Contrave Nefazodone * Serzone Nortriptyline* Pamelor Olanzapine* Zyprexa Orlistat* Xenical Paroxetine * Paxil Phentermine/topiramate * Qsymia Pramlintide* Symlin Protriptyline* Vivactil Quetiapine* Seroquel Trazodone * Desyrel, Oleptro Vilazodone* Viibryd Vortioxetine * Trintellix Zonisamide * Zonegran
Eisai defines epilepsy as a therapeutic area of focus and in the United States markets Zonegran (under license from the originator Dainippon Sumitomo Pharma Co.
Eisai, a Japan-based pharmaceutical company, has received approval for the license extension application for the use of antiepileptic agent, Zonegran, from the European Commission, for the treatment of paediatric patients, it was reported yesterday.
Dep't of Justice, Elan Pharmaceuticals Pleads Guilty, Sentenced for Off-Label Marketing of Zonegran (Feb.
said it has obtained approval for sale of its epilepsy treatment Zonegran, its first drug set to be sold there, from the country's regulatory authorities.
Zonisamide, which is marketed as Zonegran by Eisai Inc.
plans to promote products in the field of neurology, including Eisai's proprietary antiepileptic agents Zonegran and Inovelon.
The dispute, which will be played out in a US court, is over the epilepsy drug Zonegran.
0 percent from the previous year to 520 billion yen on further sales growth for Aricept and Pariet/Aciphex as well as the addition of Zonegran, a new epilepsy drug.
regarding the use of antiepileptic agent Zonegran (zonisamide) in the treatment of pediatric patients.