Epitam 500 Special Precautions

Psychiatric symptoms: Psychosis, paranoia, hallucinations and behavioral symptoms (including aggression, agitation, anger, anxiety, apathy, confusion, depersonalization, depression, emotional lability, hostility, hyperkinesias, irritability, nervousness, neurosis, and personality disorder) may occur; dose reduction or discontinuation may be required.
Suicidal ideation: Pooled analysis of trials involving various antiepileptics (regardless of indication) showed an increased risk of suicidal thoughts/behavior (incidence rate: 0.43% treated patients compared to 0.24% of patients receiving placebo); risk observed as early as 1 week after initiation and continued through duration of trials (most trials 24 weeks or less). Monitor all patients for notable changes in behavior that might indicate suicidal thoughts or depression; notify health care provider immediately if symptoms occur.
Withdrawal: Anticonvulsants should not be discontinued abruptly because of the possibility of increasing seizure frequency; therapy should be withdrawn gradually to minimize the potential of increased seizure frequency, unless safety concerns require a more rapid withdrawal.
Renal function impairment: Use caution with renal impairment; dosage adjustment may be necessary. In patients with end-stage renal disease requiring hemodialysis, it is recommended that immediate-release formulations be used instead of extended-release formulations.
Hematologic effects: Decreases in red blood cell counts, hemoglobin, hematocrit, white blood cell counts and neutrophils have been observed. Case of eosinophilia, agranulocytosis, and lymphocytosis have also been reported.