Generic Name and Formulations:
Ethotoin 250mg; tabs.
Recordati Rare Diseases, Inc.
Indications for PEGANONE:
For the control of tonic-clonic (grand mal) and complex partial (psychomotor) seizures.
Take after food. Individualize. Give in 4 to 6 divided doses daily. Initially 1g or less daily, with subsequent gradual dose increases over a period of several days. Usual maintenance: 2–3g daily.
<1yr: not recommended. ≥1yr: Take after food. Individualize. Give in 4 to 6 divided doses daily. Initial max 750mg daily. Usual maintenance: 500mg–1g daily, although occasionally 2g or (rarely) 3g daily may be necessary. Concomitant other antiepileptic: reduce dose while increasing Peganone dose.
Hepatic abnormalities. Hematologic disorders.
Monitor for emergence of depression, suicidal thoughts/behavior, and/or unusual changes in mood/behavior. Hepatic dysfunction: perform LFTs; discontinue if liver damage occurs. Monitor blood counts, urinalysis when therapy is begun and at monthly intervals for several months thereafter. Pregnancy (Cat. D; avoid). Nursing mothers: not recommended.
Caution with coumarin anticoagulants; monitor.
GI upset, chest pain, nystagmus, diplopia, fever, dizziness, headache, insomnia, fatigue, numbness, rash, Stevens-Johnson syndrome, blood dyscrasias, ataxia, gum hypertrophy, lymphadenopathy (withdraw if occurs), systemic lupus erythematosus.
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