Adult Dosing

Absence seizures

• Start 500 mg PO qd
• Increase by 250 mg q4-7 days, until control is achieved with minimal side effects
• Max: 1500 mg/day, in divided dose, should be administered only under supervision of the physician

Pediatric Dosing

• Note: Safety and effectiveness in pediatric patients <3 yrs of age have not been established

Absence seizures

• 3-6 yrs: Start 250 mg PO qd
• >6 yrs: Start 500 mg PO qd
• Increase by 250 mg q4-7 days, until control is achieved with minimal side effects
• Usual dose: 20 mg/kg/day
• Max: 1500 mg/day, in divided doses, should be administered only under supervision of the physician

[Outline]

• Adult Dosing
• Pediatric Dosing

• Control of absence (petit mal) seizures

• Hypersensitivity to any of the ingredients of the product
• History of hypersensitivity to succinimides
• Bone marrow depression

• N/A

Renal dose Adjustment

• Renal impairment: Dose adjustments not defined; use with extreme caution

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined; use with extreme caution

See Supplemental Patient Information

• Blood dyscrasias, including fatal cases, have occurred with use of ethosuximide, observe patients for signs/symptoms of infection, measure blood counts periodically
• Advise patient to perform LFT, urinalysis periodically
• Cases of systemic lupus erythematosus have been reported
• Monitor patients for emergence/worsening of depression or the emergence of suicidality or unusual changes in mood or behavior. Symptoms may develop within 7 days of initiation, and risk may continue up to 24 weeks
• Relative risk for suicidal thoughts or behavior is more for epilepsy as compared to psychiatric conditions, but the absolute risk differences are same for epilepsy and psychiatric indications
• Advise families and caregivers to closely monitor for the emergence or worsening of signs/symptoms of depression, any unusual changes in mood or behavior, emergence of suicidal thoughts, or thoughts about self-harm and report such symptoms immediately to health care providers
• Do not withdraw drug abruptly as this may precipitate absence (petit mal) status; proceed slowly when increasing or decreasing the dose
• When used alone in mixed types of epilepsy, ethosuximide may increase the frequency of grand mal seizures in some patients

Cautions: Use cautiously in

• Renal impairment
• Hepatic impairment
• History of depression
• Bone marrow suppression
• Porphyria

Supplemental Patient Information

• Caution patients not to drive an automobile or operate dangerous machinery that require mental alertness

Pregnancy Category:C

Breastfeeding: Possibly unsafe; ethosuximide is excreted in breastmilk and produce infant plasma levels of 25-30% of maternal levels. Monitor the infant for drowsiness, adequate weight gain, and developmental milestones, especially in younger, exclusively breastfed infants and when using combinations of anticonvulsants. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 18 February 2011). Manufacturer advises caution while administering to nursing mothers.

• GI: Anorexia, vague gastric upset, nausea and vomiting, cramps, epigastric and abdominal pain, weight loss, diarrhea, gum hypertrophy, swelling of the tongue, dyspepsia
• CNS: Drowsiness, headache, dizziness, euphoria, hiccups, irritability, hyperactivity, lethargy, fatigue, ataxia
• PSYCHIATRIC: Sleep disturbances, night terrors, inability to concentrate, aggressiveness, paranoid psychosis, increased libido, suicidal intentions, increased state of depression
• HEMA: Leukopenia, agranulocytosis, pancytopenia, eosinophilia, with or without bone marrow suppression, blood dyscrasias
• DERM: Urticaria, Stevens-Johnson syndrome, systemic lupus erythematosus, pruritic erythematous rashes, hirsutism
• EENT: Myopia
• GU: Vaginal bleeding, microscopic hematuria
• MISC: Allergic reaction

• Anticonvulsant; elevates seizure threshold and suppresses the paroxysmal spike and wave activity associated with lapses of consciousness that is common in absence (petit mal) seizures
• Metabolized by liver
• Renally excreted (<20% unchanged)
• Half-life: 53 hrs

US Trade Name(s)

• Zarontin

US Availability

ethosuximide (generic)

• CAPS: 250 mg
• SYRUP: 250 mg/5 mL

Zarontin

• CAPS: 250 mg
• SYRUP: 250 mg/5 mL

Canadian Trade Name(s)

• Zarontin

Canadian Availability

Zarontin

• CAPS: 250 mg
• SYRUP: 250 mg/5 mL

UK Trade Name(s)

• Emeside
• Zarontin

UK Availability

ethosuximide (generic)

• CAPS: 250 mg

Emeside, Zarontin

• SYRUP: 250 mg/5 mL

Australian Trade Name(s)

• Zarontin

Australian Availability

Zarontin

• CAPS: 250 mg
• SYRUP: 250 mg/5 mL

[Outline]

Neurologic

Anticonvulsants

Succinimides

Pricing data from www.DrugStore.com in U.S.A.

• Zarontin 250 MG CAPS [Bottle] (PFIZER U.S.)
  60 mg = $106.81
  180 mg = $311.71
• Zarontin 250 MG/5ML SOLN [Bottle] (PFIZER U.S.)
  480 5ml = $186.38
  1440 5ml = $540.57
• Ethosuximide 250 MG CAPS [Bottle] (TEVA PHARMACEUTICALS USA)
  30 mg = $38.99
  90 mg = $104.97
• Ethosuximide 250 MG/5ML SOLN [Bottle] (PHARMACEUTICAL ASSOCIATES)
  474 5ml = $58.99
  1422 5ml = $167.97

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

Drug Name: Ethosuximide 250 MG Oral Capsule

Ingredient(s): Ethosuximide

Imprint: PA1000

Color(s): Orange

Shape: Capsule

Size (mm): 9.00

Score: 1

Inactive Ingredient(s): polyethylene glycol / fd&c yellow no. 6 / gelatin / glycerin

Drug Label Author:
Pliva Inc.

DEA Schedule:
Non-Scheduled

Drug Name: Zarontin 250 MG Oral Capsule

Ingredient(s): Ethosuximide

Imprint: P;D;237

Color(s): Orange

Shape: Capsule

Size (mm): 8.00

Score: 1

Inactive Ingredient(s): polyethylene glycol 400 / d&c yellow no. 10 / fd&c red no. 3 / gelatin / glycerin / sorbitol

Drug Label Author:
Parke-Davis Div of Pfizer Inc

DEA Schedule:
Non-Scheduled