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 

Summary View 

 

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
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