pharmacopeia
GET
/api/v1/drug/ethosuximide
2D structure
3-ethyl-3-methylpyrrolidine-2,5-dione
SMILES CCC1(CC(=O)NC1=O)C
InChIKey HAPOVYFOVVWLRS-UHFFFAOYSA-N

Mechanism of action

Sourced from openFDA

Mechanism-of-action classes: Enzyme Inhibitors; Unknown Cellular or Molecular Interaction.

Enzyme

Indications

Sourced from openFDA
  • Zarontin is indicated for the control of absence (petit mal) epilepsy.ICD-10: G40.909

Contraindications

Sourced from openFDA
  • Ethosuximide should not be used in patients with a history of hypersensitivity to succinimides.contraindicated

Dosage & administration

Sourced from openFDA

Zarontin is administered by the oral route. The initial dose for patients 3 to 6 years of age is one capsule (250 mg) per day; for patients 6 years of age and older, 2 capsules (500 mg) per day. The dose thereafter must be individualized according to the patient's response. Dosage should be increased by small increments. One useful method is to increase the daily dose by 250 mg every four to seven days until control is achieved with minimal side effects. Dosages exceeding 1.5 g daily, in divided doses, should be administered only under the strictest supervision of the physician. The optimal dose for most pediatric patients is 20 mg/kg/day. This dose has given average plasma levels within the accepted therapeutic range of 40 to 100 mcg/mL. Subsequent dose schedules can be based on effectiveness and plasma level determinations. Zarontin may be administered in combination with other anticonvulsants when other forms of epilepsy coexist with absence (petit mal). The optimal dose for most pediatric patients is 20 mg/kg/day.

Warnings & precautions

Sourced from openFDA

Blood Dyscrasias: Blood dyscrasias, including some with fatal outcome, have been reported to be associated with the use of ethosuximide; therefore, periodic blood counts should be performed. Should signs and/or symptoms of infection (e.g., sore throat, fever) develop, blood counts should be considered at that point. Drug-Induced Immune Thrombocytopenia: Drug-induced immune thrombocytopenia (DITP) has been reported with ethosuximide. In the reported cases, the onset of symptoms occurred 1 to 3 weeks after initiation of ethosuximide; one patient had recurrence of symptoms within 1 day of a subsequent re-challenge with the drug. In those cases in which the platelet count was specified, the nadir was 2,000 and 3,000/mm 3 . When DITP is suspected, discontinue Zarontin, monitor serial platelet counts, and treat as appropriate. If possible, assess the presence of drug-dependent antiplatelet antibodies. Avoid future use of Zarontin in patients with history of ethosuximide-induced DITP. Effects on Liver and Kidneys: Ethosuximide is capable of producing morphological and functional changes in the animal liver. In humans, abnormal liver and renal function studies have been reported. Ethosuximide should be administered with extreme caution to patients with known liver or renal disease. Periodic urinalysis and liver function studies are advised for all patients receiving the drug. Systemic Lupus Erythematosus: Cases of systemic lupus erythematosus have been reported with the use of ethosuximide. The physician should be alert to this possibility.

Adverse reactions

Sourced from openFDA

Body As A Whole: Allergic reaction, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). Gastrointestinal System: Gastrointestinal symptoms occur frequently and include anorexia, vague gastric upset, nausea and vomiting, cramps, epigastric and abdominal pain, weight loss, and diarrhea. There have been reports of gum hypertrophy and swelling of the tongue. Hemopoietic System: Hemopoietic complications associated with the administration of ethosuximide have included leukopenia, agranulocytosis, pancytopenia, with or without bone marrow suppression, eosinophilia, and thrombocytopenia (see WARNINGS ). Nervous System: Neurologic and sensory reactions reported during therapy with ethosuximide have included drowsiness, headache, dizziness, euphoria, hiccups, irritability, hyperactivity, lethargy, fatigue, and ataxia. Psychiatric or psychological aberrations associated with ethosuximide administration have included disturbances of sleep, night terrors, inability to concentrate, and aggressiveness. These effects may be noted particularly in patients who have previously exhibited psychological abnormalities. There have been rare reports of paranoid psychosis, increased libido, and increased state of depression with overt suicidal intentions. Integumentary System: Dermatologic manifestations which have occurred with the administration of ethosuximide have included urticaria, pruritic erythematous rashes, Stevens-Johnson syndrome, and hirsutism. Special Senses: Myopia . Genitourinary System: Vaginal bleeding, microscopic hematuria.

Use in specific populations

Sourced from openFDA

Pregnancy: To provide information regarding the effects of in utero exposure to Zarontin, physicians are advised to recommend that pregnant patients taking Zarontin enroll in the NAAED Pregnancy Registry. This can be done by calling the toll free number 1-888-233-2334, and must be done by patients themselves. Information on the registry can also be found at the website: http://www.aedpregnancyregistry.org/ See WARNINGS .

Overdosage

Sourced from openFDA

Acute overdoses may produce nausea, vomiting, and CNS depression including coma with respiratory depression. A relationship between ethosuximide toxicity and its plasma levels has not been established. The therapeutic range of serum levels is 40 mcg/mL to 100 mcg/mL, although levels as high as 150 mcg/mL have been reported without signs of toxicity. Treatment: Treatment should include emesis (unless the patient is or could rapidly become obtunded, comatose, or convulsing) or gastric lavage, activated charcoal, cathartics, and general supportive measures. Hemodialysis may be useful to treat ethosuximide overdose. Forced diuresis and exchange transfusions are ineffective.

Approval history

Sourced from openFDA
  • Nov 2, 1960NDANDA012380Parke Davis
  • Feb 13, 1974ANDAANDA080258Parke-davis
  • Nov 22, 2000ANDAANDA040253Pharm Assoc
  • Oct 28, 2002ANDAANDA040430Bionpharma
  • Dec 22, 2003ANDAANDA040506Chartwell Rx
  • Sep 25, 2012ANDAANDA200892Heritage Pharms Inc
  • Feb 19, 2019ANDAANDA211928Onesource Specialty
  • Mar 16, 2020ANDAANDA210654Puracap Pharm Llc

FAERS reports

View JSON
Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
2,442 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Drug Ineffective50521%
  2. 2Seizure35615%
  3. 3Off Label Use2329.5%
  4. 4Somnolence1546.3%
  5. 5Generalised Tonic-clonic Seizure1415.8%
  6. 6Petit Mal Epilepsy1174.8%
  7. 7Drug Interaction1154.7%
  8. 8Treatment Failure1144.7%
  9. 9Fatigue1104.5%
  10. 10Epilepsy1064.3%
  11. 11Condition Aggravated1044.3%
  12. 12Multiple-drug Resistance1014.1%
  13. 13Status Epilepticus963.9%
  14. 14Vomiting963.9%
  15. 15Decreased Appetite833.4%

Literature

View JSON

Recent PubMed references pinned to Ethosuximide as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

View JSON

The 10 most recently updated of 14 ClinicalTrials.gov registrations naming Ethosuximide as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Ethosuximide work?
Mechanism-of-action classes: Enzyme Inhibitors; Unknown Cellular or Molecular Interaction.
What is Ethosuximide used for?
According to FDA labeling, Ethosuximide carries indications including: Zarontin is indicated for the control of absence (petit mal) epilepsy.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Ethosuximide?
Ethosuximide is classified as Succinimide derivatives, Anti-epileptic Agent, Enzyme Inhibitors, Unknown Cellular or Molecular Interaction, Decreased Central Nervous System Disorganized Electrical Activity, Neurotransmitter & Neuromuscular Transmitter Activity Alteration.
What are the brand names for Ethosuximide?
Ethosuximide is marketed under brand names including Zarontin.
What are the contraindications for Ethosuximide?
Ethosuximide labeling lists contraindications including: Ethosuximide should not be used in patients with a history of hypersensitivity to succinimides.. Always consult the full prescribing information and a clinician.
Note. Data for ethosuximide is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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