Ethotoin (Peganone) is an antiepileptic drug that belongs to the class of drugs called hydantoins (like phenytoin). It is used in the treatment of patients with seizures.

Ethotoin (Peganone) Uses:

• Seizures:

  • It is used in the management of generalized tonic-clonic or grand mal and complex-partial or psychomotor seizures.

Ethotoin (Peganone) Dose in Adults

Ethotoin (Peganone) Dose for Seizures:

• Oral: Initial:
  • ≤1 g/day, in four or six divided doses;
  • The dose may be increased over a period of several days to the usual maintenance dose of 2 to 3 g/day.

Ethotoin (Peganone) Dose in Children

Ethotoin (Peganone) for Seizures:

• Children ≥1 year and Adolescents:

  • Oral: Initial:
    • ≤750 mg/day, in four or six divided doses;
    • The usual maintenance dose is 0.5 to 1 g/day
    • The maximum daily dose is 3 g/day.

Pregnancy Risk Category: D

• After maternal drug use, adverse drug reactions may occur in the fetus.
• Consuming antiepileptic drugs may lead to neonatal bleeding defects or bleeding within 24 hours after birth.
• Other hydantoins have been used in conjunction with in utero exposure to ethotoin.

Use of Ethotoin while breastfeeding

• Breast milk contains the drug.
• The manufacturer suggests that you stop breastfeeding because of possible adverse reactions in your infant.

Ethotoin (Peganone) Dose in Kidney Disease:

No dosage adjustment has been provided in the manufacturer’s labeling.

Ethotoin (Peganone) Dose in Liver disease:

It is contraindicated in patients with liver disease.

Side effects of Ethotoin (Peganone):

• Cardiovascular:

  • Chest Pain

• Central Nervous System:

  • Ataxia
  • Dizziness
  • Fatigue
  • Headache
  • Insomnia
  • Numbness

• Dermatologic:

  • Skin Rash
  • Stevens-Johnson Syndrome

• Gastrointestinal:

  • Diarrhea
  • Gingival Hyperplasia
  • Nausea
  • Vomiting

• Hematologic & Oncologic:

  • Hematologic Disease
  • Lymphadenopathy

• Neuromuscular & Skeletal:

  • Lupus-Like Syndrome

• Ophthalmic:

  • Diplopia
  • Nystagmus

• Miscellaneous:

  • Fever

Contraindications to Ethotoin (Peganone):

• Hepatic impairment
• Blood disorders
• Hypersensitivity reactions to any component of the drug or the drug itself.

Warnings and precautions

• Blood dyscrasias

  • It is possible for patients to develop blood dyscrasias and cytopenias after the drug's use. 
  • Patients who have an underlying hematological condition or suffer from cytopenias may be at greater risk.
  • Patients should be monitored for blood-related side effects. Patients might be warned to report fever, sore throats, infections, easybruising, and skin rash (petechiae, purpuric)
  • If the patient develops cytopenias, treatment can be stopped.
  • Megaloblastic anemia is also possible in individuals who have impaired folic acid metabolism due to the drug.
  • Patients with preexisting hematological conditions such as severe anemia and cytopenia should avoid it.

• Suicidal thoughts:

  • Antiepileptics have been shown to increase suicidal thoughts/ideas and suicidal behavior.
  • Suicidal ideation can be detected as soon as treatment begins. It is also possible during drug intake.
  • Patients must be closely monitored for any changes in behavior, especially if they are displaying suicidal thoughts. 
  • These patients should be immediately reported to their healthcare providers.

Ethotoin: Drug Interaction

Note: Drug Interaction Categories:

• Risk Factor C: Monitor When Using Combination
• Risk Factor D: Consider Treatment Modification
• Risk Factor X: Avoid Concomitant Use

Monitoring parameters:

• Monitor CBC and urinalysis before treatment initiation and every month thereafter for several months.
• Monitor liver function tests especially if there are clinical signs of hepatic dysfunction;
• Observe for suicidal behavior such as suicidal thoughts, depression, and behavioral changes.

How to administer Ethotoin (Peganone)?

It may be administered after meals to reduce the gastrointestinal side effects.

Mechanism of action of Ethotoin (Peganone):

It stops seizure activity from spreading and progressing by stabilizing the neuronal membrane (stabilizing seizure threshold).

Absorption:

• Rapid

Metabolism:

• It is metabolized in the liver to its metabolites. The enzymes are saturable therefore the relationship between the dose and concentration of the metabolites is not linear.

Half-life elimination:

• 3 to 9 hours

Excretion:

• Urine.

International Brand Names of Ethotoin:

• Peganone

Ethotoin Brand Names in Pakistan:

No Brands Available in Pakistan.