Label Changes for:
Aplenzin (bupropion hydrobromide) Extended-Release Tablets
April 2011
Changes have been made to the BOXED WARNING, WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – April 2011
BOXED WARNING
- Use in Smoking Cessation Treatment... added
5 WARNINGS AND PRECAUTIONS
5.2 Neuropsychiatric Symptoms and Suicide Risk in Smoking Cessation Treatment
- new section added
6 ADVERSE REACTIONS
6.2 Other Events
Nervous System
- agitation... completed suicide...
17 PATIENT COUNSELING INFORMATION
17.1 Counseling Information
- New section added... Neuropsychiatric Symptoms and Suicide Risk in Smoking Cessation
MEDICATION GUIDE
- multiple and extensive changes. See document for details
