Indication
Aplenzin? (bupropion hydrobromide extended-release tablets) is indicated for the treatment of major depressive disorder.
IMPORTANT SAFETY INFORMATION
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Aplenzin or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24 there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Aplenzin is not approved for use in pediatric patients.
Aplenzin is contraindicated in patients who have a seizure disorder, patients being treated with Zyban? (bupropion HCl) Sustained-Release Tablets, Wellbutrin? (bupropion HCl), Wellbutrin SR? (bupropion HCl) Sustained-Release Tablets, or any other medications that contain bupropion, patients who have or had bulimia or anorexia nervosa, patients undergoing abrupt discontinuation of alcohol or sedatives (including benzodiazepines), patients who have shown an allergic response to bupropion, and patients taking MAO inhibitors. At least 14 days should elapse between discontinuation of an MAO inhibitor and initiation of Aplenzin.
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 have been reported in clinical trials with bupropion. There have been reports of hypertension, in some cases severe, in patients receiving bupropion alone and in combination with nicotine replacement therapy.
The most common adverse reactions reported are dry mouth, nausea, insomnia, dizziness, pharyngitis, abdominal pain, agitation, anxiety, tremor, palpitation, sweating, tinnitus, myalgia, anorexia, urinary frequency, and rash.
