Bupropion Hydrochloride Oral tablet, 12 hour [Depression/Mood Disorders]

Clinical Worsening and Suicide Risk in Treating Psychiatric Disorders
• Antidepressants may increase risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (18–24 years of age) with major depressive disorder and other psychiatric disorders; balance this risk with clinical need. Bupropion is not approved for use in pediatric patients. (See Pediatric Use under Cautions.)
• In pooled data analyses, risk of suicidality was not increased in adults >24 years of age and apparently was reduced in adults ≥65 years of age with antidepressant therapy compared with placebo.
• Depression and certain other psychiatric disorders are themselves associated with an increased risk of suicide.
• Appropriately monitor and closely observe all patients who are started on bupropion therapy for clinical worsening, suicidality, or unusual changes in behavior; involve family members and/or caregivers in this process. (See Clinical Worsening and Suicide Risk in Treating Psychiatric Disorders under Cautions.)

Neuropsychiatric Symptoms and Suicide Risk in Smoking Cessation Treatment
• Serious neuropsychiatric symptoms (e.g., depression, suicidal ideation, suicide attempt, completed suicide) have been reported in patients receiving bupropion for smoking cessation. (See Neuropsychiatric Symptoms and Suicide Risk in Smoking Cessation Treatment under Cautions.)
• Symptoms have occurred in patients with and without preexisting psychiatric disease; some patients experienced worsening of their psychiatric illness.
• Depressed mood may be a symptom of nicotine withdrawal; however, some symptoms occurred in bupropion-treated patients who continued to smoke.
• Most symptoms occurred during bupropion therapy, but some were reported following discontinuance of drug.
• Monitor all patients receiving bupropion for smoking cessation for neuropsychiatric symptoms, including changes in behavior, hostility, agitation, depressed mood, and suicide-related events (including ideation, behavior, and attempted suicide).
• Patients should discontinue bupropion and immediately contact their clinician if agitation, hostility, depressed mood, or changes in thinking or behavior not typical for the patient occur, or if patient develops suicidal ideation or behavior.
• Symptoms resolved upon drug discontinuance in many cases, but persisted in a few cases. Provide ongoing monitoring and supportive care until symptoms resolve.
• Weigh risks of bupropion for smoking cessation against benefits. Bupropion shown to increase likelihood of abstinence from smoking for up to 6 months compared with placebo. Health benefits of quitting smoking are immediate and substantial.

REMS:

FDA approved a REMS for bupropion to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of bupropion and consists of the following: medication guide. See the FDA REMS page ([Web]) or the ASHP REMS Resource Center ([Web]).