Ethotoin

Trade Names:
Peganone
- Tablets 250 mg

Pharmacology

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May act at motor cortex to inhibit spread of seizure activity. Possibly works by promoting sodium efflux from neurons, thereby stabilizing threshold against hyperexcitability. Also, decreases posttetanic potentiation at synapse.

Pharmacokinetics

Absorption

Fairly rapidly absorbed.

Metabolism

Major metabolites are to N-deethyl and p-hydroxyl-ethotoin.

Elimination

Elimination half-life ranges from 3 to 9 h.

Indications and Usage

Control of tonic-clonic (grand mal) and complex partial (psychomotor) seizures.

Contraindications

Patients with hepatic abnormalities or hematologic disorders.

Dosage and Administration

PO Start with 1 g/day or less (in 4 to 6 divided doses daily), with subsequent gradual dosage increases over a period of several days. Optimum dosage is based on individual response. Usual maintenance dose is 2 to 3 g/day. Doses less than 2 g have not been found to be effective in most adults.

PO Dose depends on age and weight of patient. Do not start with more than 750 mg/day. Usual maintenance dose ranges from 500 mg to 1 g, although occasionally 2 g or, rarely, 3 g may be necessary.

General Advice

• Take after food.
• Separate doses as evenly as practical.

Storage/Stability

Store below 77°F.

Drug Interactions

Anticoagulant effect may be decreased.

Avoid coadministration.

Laboratory Test Interactions

None well documented.

Adverse Reactions

CNS

Ataxia, dizziness, fatigue, headache, insomnia.

Dermatologic

Skin rash, Stevens-Johnson syndrome.

EENT

Diplopia, nystagmus.

GI

Diarrhea, gingival hyperplasia, nausea, vomiting.

Hematologic-Lymphatic

Blood dyscrasias, lymphadenopathy.

Miscellaneous

Chest pain, fever, numbness, systemic lupus erythematosus.

Precautions

Pregnancy

Category D .

Lactation

Excreted in breast milk.

Children

Safety and efficacy in children 1 yr of age and older were established on the basis of open-label, uncontrolled experience in children with various types of seizures.

Elderly

Use with caution, usually starting at the low end of the dosage range, because of the greater frequency of decreased hepatic, renal, or cardiac function, and concomitant diseases or other drug therapy.

Blood dyscrasias

May occur. In addition, there is some evidence that hydantoin-like compounds may interfere with folic acid metabolism, precipitating megaloblastic anemia. Ensure that folic acid levels are periodically evaluated during prolonged therapy. Be prepared to supplement folic acid to prevent megaloblastic anemia.

Fetal harm

May occur.

Hepatic function impairment

Ensure that medication is discontinued in patients who develop hepatic function impairment, marked depression of blood cell count, or lymphadenopathy.

Lymphadenopathy

May occur. Withdrawal of therapy has resulted in remission of clinical and pathological findings. If a lymphoma-like syndrome develops, withdraw therapy and closely observe the patient for regression of signs and symptoms before resuming treatment.

Simultaneous antiepileptic therapy

In patients receiving another antiepileptic drug, it should not be discontinued when starting ethotoin. The dosage of the other drug should be reduced gradually as the dose of ethotoin is increased. Ethotoin may replace the other drug or the optimal dosage of both drugs may be established.

Withdrawal

Do not discontinue treatment in pregnant patients in whom the drug is administered to prevent major seizures because of the possibility of precipitating status epilepticus with hypoxia and risk to both the mother and fetus.

Overdosage

Symptoms

Ataxia, coma, drowsiness, nausea, visual disturbances.

Patient Information

• Instruct patient to continue to take other antiepileptic medications as prescribed by health care provider.
• Advise patient to read the patient information leaflet before starting therapy and with each refill.
• Instruct patient to take exactly as prescribed and to not change the dose or discontinue unless advised by health care provider.
• Advise patient that dose is gradually increased as tolerated until max benefit has been obtained.
• Advise patient that each dose should be taken after food.
• Advise patient that if a dose is missed to take it as soon as remembered, but if several hours have passed, or it is nearing the time for the next scheduled dose, to skip that dose and take the next dose at the regularly scheduled time. Caution patient to never double the dose to catch up.
• Advise patient that if medication needs to be discontinued, it will be slowly withdrawn over a period of several weeks unless safety concerns (eg, rash) require a more rapid withdrawal.
• Caution patient that drug may cause dizziness and to use caution while driving or performing other tasks requiring mental alertness until tolerance is determined.
• Advise women of childbearing potential to use effective contraception during treatment with ethotoin.
• Instruct patients to inform health care provider immediately if easy bruising, epistaxis, fever, malaise, petechiae, skin rash, sore throat or other signs of infection develop.
• Instruct patient to inform health care provider if seizures get worse or if new types of seizures occur.
• Advise patient to carry medical identification (eg, bracelet, card) indicating epilepsy and medication use.

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