Ethotoin

Ethotoin is a prescription medication indicated for the control of tonic-clonic (grand mal) and complex partial (psychomotor) seizures.

• Ethotoin is available under the following different brand names: Peganone

Common side effects of Ethotoin include:

• headache
• nausea
• vomiting
• diarrhea
• dizziness
• drowsiness
• tiredness
• numbness/tingling
• trouble sleeping (insomnia)
• swelling in the gums
• lack of balance or coordination

Serious side effects of Ethotoin include:

• chest pain
• vision problems
• signs of infection (such as fever, chills, sore throat, flu symptoms, easy bruising or bleeding, mouth sores, unusual weakness)
• stomach pain
• loss of appetite
• dark urine
• clay-colored stools
• yellowing of the skin or eyes (jaundice)
• joint pain or swelling with fever
• swollen glands
• muscle aches
• patchy skin color
• red spots
• butterfly-shaped skin rash over the cheeks and nose (worsens in sunlight)
• worsening of seizures or fever
• sore throat
• headache with a severe blistering
• peeling
• red skin rash

Rare side effects of Ethotoin include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Tonic-Clonic and Complex Partial Seizures

• Adult dosage
  • Initial: Up to 1 g/d orally in 4-6 divided doses
  • Maintenance: 2-3 g/d
• Pediatric dosage
  • Initial: Up to 750 mg/d orally in 4-6 divided doses
  • Maintenance: Usual 500 mg-1 g/d orally; rarely 2 g/d or more

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Ethotoin has severe interactions with the following drug:
  • dofetilide
• Ethotoin has serious interactions with the following drugs:
  • cyclosporine
  • dopamine
  • efavirenz
  • mebendazole
  • mestranol
  • methadone
  • metoclopramide intranasal
  • olopatadine intranasal
  • ropeginterferon alfa 2b
• Ethotoin has moderate interactions with at least 106 other drugs
• Ethotoin has minor interactions with at least 53 other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Hepatic abnormalities
• Blood dyscrasias

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Ethotoin?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Ethotoin?”

Cautions

• Use during pregnancy may result in increased incidence of birth defects in offspring (fetal hydantoin syndrome); do not discontinue in patients with major seizures due to the risk for status epilepticus with hypoxia and risk to mother and fetus
• Possible risk for blood dyscrasias and lymphadenopathy
• May interfere with folic acid metabolism, causing megaloblastic anemia
• Check LFTs if indicated; monitor blood counts and urinalysis at initiation and monthly for several months

Pregnancy and Lactation

• Use in LIFE-THREATENING emergencies when no safer drug is available during pregnancy
• Lactation
  • Enters breast milk/not recommended