Levetiracetam

May cause CNS depression (impaired coordination, ataxia, abnormal gait, weakness, fatigue, dizziness, and somnolence), which may impair physical or mental abilities. Symptoms occur most commonly during the first month of therapy. Patients must be cautioned about performing tasks that require mental alertness (eg, operating machinery or driving).

Severe reactions, including toxic epidermal necrolysis (TEN) and Stevens-Johnson syndrome (SJS), have been reported in adults and children. Onset is usually within ~2 weeks of treatment initiation, but may be delayed (>4 months); recurrence following rechallenge has been reported. Levetiracetam should be discontinued if there are any signs of a hypersensitivity reaction or unspecified rash; if signs or symptoms suggest SJS or TEN, do not resume therapy and consider alternative treatment.

Decreases in red blood cell counts, hemoglobin, hematocrit, white blood cell counts, and neutrophils and increases in eosinophils have been observed. Cases of, agranulocytosis, pancytopenia, and thrombocytopenia have also been reported.

Potentially life-threatening hypersensitivity reactions, including anaphylaxis, angioedema, hypotension, hives, rash and respiratory distress may occur after the first dose or at any time during treatment. If signs or symptoms of anaphylaxis or angioedema occur, discontinue levetiracetam immediately. If a clear alternative etiology for the symptoms cannot be determined, discontinue permanently.

Isolated elevations in diastolic blood pressure measurements have been reported in children • 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.

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). Monitor all patients for notable changes in behavior that might indicate suicidal thoughts or depression; notify health care provider immediately if symptoms occur. Disease-related concerns:

Use caution with renal impairment; dosage adjustment may be necessary. In patients with ESRD requiring hemodialysis, it is recommended that immediate-release formulations be used instead of ER formulations. Concurrent drug therapy issues:

Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information. Special populations:

Children may have increased incidence of psychiatric symptoms; dose reduction or discontinuation may be required. Other warnings/precautions:

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.