Trade Names:Peganone- Tablets 250 mg
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.
Fairly rapidly absorbed.
Major metabolites are to N-deethyl and p-hydroxyl-ethotoin.
Elimination half-life ranges from 3 to 9 h.
Control of tonic-clonic (grand mal) and complex partial (psychomotor) seizures.
Patients with hepatic abnormalities or hematologic disorders.
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.Children
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.
Store below 77°F.
Anticoagulant effect may be decreased.Drugs known to adversely affect the hematopoietic system
None well documented.
Ataxia, dizziness, fatigue, headache, insomnia.
Skin rash, Stevens-Johnson syndrome.
Diarrhea, gingival hyperplasia, nausea, vomiting.
Blood dyscrasias, lymphadenopathy.
Chest pain, fever, numbness, systemic lupus erythematosus.
Monitor LFTs if clinical evidence suggests the possibility of hepatic function impairment.Infection
Monitor patient for skin rash, fever, or other signs of infection; sores in the mouth; unusual bruising or bleeding; and petechiae.Urinalysis/CBC
Ensure that urinalysis and CBC with differential are performed before starting therapy and at monthly intervals for several months during therapy.Response to treatment
Frequently assess patient for response to treatment.Review therapy
Ensure that therapy is periodically reviewed to determine if it needs to be continued without change or if a dose change (eg, increase, decrease, discontinuation) is indicated.
Category D .
Excreted in breast milk.
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.
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.
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.
Ensure that medication is discontinued in patients who develop hepatic function impairment, marked depression of blood cell count, or 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.
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.
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.
Ataxia, coma, drowsiness, nausea, visual disturbances.
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