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Zonimid (ZONISAMIDE)

brandsClassZonimid commonly prescribed forHow Zonimid worksHow long until Zonimid worksNotable Side EffectsLife Threatening Side Effectsweight gainsedationWhat to do about Zonimid side effectsusual dosage rangeDosage Formslong term usehabit formingRenal ImpairmentHepatic ImpairmentCardiac ImpairmentElderlyChildren and AdolescentsPregnancyBreast Feeding

Marketer: Intas Pharmaceuticals Limited

THERAPEUTICS

brands

  • Zonegran
  • Excegran
  • Zonimid

Class

  • Anticonvulsant, voltage-sensitive sodium channel modulator; T-type calcium channel modulator; structurally a sulfonamide

Zonimid commonly prescribed for

(Bold for FDA approved)

• Adjunct therapy for partial seizures in adults with epilepsy
• Bipolar disorder
• Chronic neuropathic pain
• Migraine
• Parkinson’s disease
• Psychotropic drug-induced weight gain
• Binge eating disorder

How Zonimid works

• Unknown

• Modulates voltage-sensitive sodium channels by an unknown mechanism

• Also modulates T-type calcium channels

• Facilitates dopamine and serotonin release

• Inhibits carbonic anhydrase

How long until Zonimid works

• Should reduce seizures by 2 weeks

• Onset of action as well as convincing therapeutic efficacy have not been demonstrated for uses other than adjunctive treatment of partial seizures

SIDE EFFECTS

Notable Side Effects

• Sedation, depression, difficulty concentrating, agitation, irritability, psychomotor slowing, dizziness, ataxia

• Headache

• Nausea, anorexia, abdominal pain, vomiting

• Kidney stones

• Elevated serum creatinine and blood urea nitrogen

Life Threatening Side Effects

• Rare serious rash (Stevens–Johnson syndrome, toxic epidermal necrolysis) (sulfonamide)

• Rare oligohidrosis and hyperthermia (pediatric patients)

• Rare blood dyscrasias (aplastic anemia; agranulocytosis)

• Sudden hepatic necrosis

• Sudden unexplained deaths have occurred (unknown if related to zonisamide use)

• Rare activation of suicidal ideation and behavior (suicidality)

weight gain

unusual

unusual

sedation

common

common

What to do about Zonimid side effects

• Wait

• Wait

• Wait

• Take more of the dose at night to reduce daytime sedation

• Lower the dose

• Switch to another agent

DOSING AND USE

usual dosage range

• 100–600 mg/day in 1–2 doses

Dosage Forms

• Capsule 25 mg, 50 mg, 100 mg

long term use

• Safe

• Consider periodic monitoring of blood urea nitrogen and creatinine

habit forming

• No

SPECIAL POPULATIONS

Renal Impairment

• Zonisamide is primarily renally excreted

• Use with caution

• May require slower titration

Hepatic Impairment

• Use with caution

• May require slower titration

Cardiac Impairment

• No specific recommendations

Elderly

• Some patients may tolerate lower doses better

• Elderly patients may be more susceptible to adverse effects

Children and Adolescents

• Cases of oligohidrosis and hyperthermia have been reported

• Not approved for use in children under age 16

• Use in children for the expert only, with close monitoring, after other options have failed

Pregnancy

• Effective June 30, 2015, the FDA requires changes to the content and format of pregnancy and lactation information in prescription drug labels, including the elimination of the pregnancy letter categories; the Pregnancy and Lactation Labeling Rule (PLLR or final rule) applies only to prescription drugs and will be phased in gradually for drugs approved on or after June 30, 2001

• Controlled studies have not been conducted in pregnant women

• Use in women of childbearing potential requires weighing potential benefits to the mother against the risks to the fetus

• Antiepileptic Drug Pregnancy Registry: 1-888-233-2334, www.aedpregnancyregistry.org

• Taper drug if discontinuing

• Seizures, even mild seizures, may cause harm to the embryo/fetus

• Lack of convincing efficacy for treatment of conditions other than epilepsy suggests risk/benefit ratio is in favor of discontinuing zonisamide during pregnancy for these indications

Breast Feeding

• Unknown if zonisamide is secreted in human breast milk, but all psychotropics are assumed to be secreted in breast milk

• Recommended either to discontinue drug or bottle feed

• If drug is continued while breast feeding, infant should be monitored for possible adverse effects

• If child becomes irritable or sedated, breast feeding or drug may need to be discontinued

Based on data Published online by Cambridge University Press

Compiled by Dr. Jash Ajmera