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Adverse reactions associated with PEGANONE, in decreasing order of severity, are:
Isolated cases of lymphadenopathy and systemic lupus erythematosus have been reported in patients taking hydantoin compounds, and lymphadenopathy has occurred with PEGANONE. Withdrawal of therapy has resulted in remission of the clinical and pathological findings. Therefore, if a lymphoma-like syndrome develops, the drug should be withdrawn and the patient should be closely observed for regression of signs and symptoms before treatment is resumed.
Ataxia and gum hypertrophy have occurred only rarely—usually only in patients receiving an additional hydantoin derivative. It is of interest to note that ataxia and gum hypertrophy have subsided in patients receiving other hydantoins when PEGANONE (ethotoin tablets, USP) was given as a substitute antiepileptic.
Occasionally, vomiting or nausea after ingestion of PEGANONE has been reported, but if the drug is administered after meals, the incidence of gastric distress is reduced. Other side effects have included chest pain, nystagmus, diplopia, fever, dizziness, diarrhea, headache, insomnia, fatigue, numbness, skin rash, and Stevens-Johnson syndrome.
To report SUSPECTED ADVERSE REACTIONS, contact Recordati Rare
Diseases Inc. at 1-888-575-8344 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Read the Peganone (ethotoin) Side Effects Center for a complete guide to possible side effects
PEGANONE used in combination with other drugs known to adversely affect the hematopoietic system should be avoided if possible.
A two-way interaction between the hydantoin antiepileptic, phenytoin, and the coumarin anticoagulants has been suggested. Presumably, phenytoin acts as a stimulator of coumarin metabolism and has been reported to cause decreased serum levels of the coumarin anticoagulants and increased prothrombin-proconvertin concentrations. Conversely, the coumarin anticoagulants have been reported to increase the serum levels and prolong the serum half-life of phenytoin by inhibiting its metabolism. Although there is no documentation of such, a similar interaction between ethotoin and the coumarin anticoagulants may occur. Caution is therefore advised when administering PEGANONE to patients receiving coumarin anticoagulants.
Read the Peganone Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 9/19/2013
This monograph has been modified to include the generic and brand name in many instances.
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