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U.S. Department of Health and Human Services

Safety

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Aplenzin (Bupropion Hydrobromide)

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – August 2012

Summary View

 

BOXED WARNING

  • WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS AND NEUROPSYCHIATRIC REACTIONS IN PATIENTS TAKING BUPROPION FOR SMOKING CESSATION…
 

CONTRAINDICATIONS

Aplenzin is contraindicated in patients with the following conditions:
  • Seizure disorder or conditions that increase the risk of seizures (e.g., arteriovenous malformation, severe head injury, CNS tumor or CNS infection, severe stroke, anorexia nervosa or bulimia, or abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs
  • Known hypersensitivity to bupropion. Anaphylactoid/anaphylactic reactions and Stevens-Johnson syndrome have been reported
  • Concurrent use of monoamine oxidase (MAO) inhibitor, because MAOIs have the potential to enhance central nervous (CNS) toxicity. At least 14 days should elapse between
 

WARNINGS AND PRECAUTIONS

Seizure
  • Aplenzin can cause seizure. The risk of seizure is dose-related. The dose should not exceed 522 mg once daily. Increase the dose gradually. Discontinue Aplenzin and do not restart treatment if the patient experiences a seizure