Physicians should be aware that bupropion is associated with a risk of seizure, which is dose related. The incidence of seizure may be similar to that of the sustained-release formulations of bupropion, since APLENZIN has demonstrated bioequivalence. To reduce the risk of seizures, please see WARNINGS and PRECAUTIONS in the Prescribing Information for patient selection considerations, including concomitant medications and dosing recommendations.
Physicians, families, and caregivers should monitor patients for suicidality as well as anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, and other unusual changes in behavior. All patients should be closely monitored for these symptoms, especially at the beginning of therapy, or with changes in dose and reported immediately to the patient's healthcare provider. Please consult prescribing information for APLENZIN for additional monitoring recommendations. There is concern that such symptoms may be precursors to suicidality, although a causal link has not been proven. If such symptoms occur, prescribers should consider changing or discontinuing treatment. Patients should be screened for bipolar disorder prior to initiating treatment with an antidepressant.
When treating patients with severe hepatic cirrhosis, extreme caution should be exercised, and a reduced dosage and/or frequency is required to avoid accumulation. Increased restlessness, agitation, anxiety, and insomnia, especially shortly after initiation of treatment, have been associated with treatment with bupropion. Neuropsychiatric signs and symptoms, including delusions, hallucinations, psychosis, concentration disturbance, paranoia, and confusion have been reported with bupropion. Anaphylactoid reactions characterized by symptoms such as pruritus, urticaria, angioedema, and dyspnea requiring medical treatment ha
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