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Label Changes for:

Wellbutrin (bupropion hydrochloride) Tablets and Wellbutrin SR (bupropion hydrochloride) Sustained-Release Tablets

March 2013

Changes have been made to the CONTRAINDICATIONS and ADVERSE REACTIONS sections of the safety label.

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

 

March 2013

CONTRAINDICATIONS

  • There is an increased risk of hypertensive reactions when bupropion is used concomitantly with other drugs that inhibit the reuptake of dopamine or norepinephrine or inhibit their metabolism (e.g., MAOIs). The use of WELLBUTRIN within 14 days of stopping treatment with an MAOI is also contraindicated. Starting WELLBUTRIN in a patient treated with reversible MAOIs such as linezolid or intravenous methylene blue is contraindicated.

ADVERSE REACTIONS

Drug Interactions
  • MAO Inhibitors: Concomitant use of MAOIs and bupropion is contraindicated. Bupropion inhibits the reuptake of dopamine and norepinephrine and can increase risk of hypertensive reactions when used concomitantly with drugs that also inhibit the reuptake of dopamine or norepinephrine, including MAOIs. In addition, MAOIs decrease the metabolism of dopamine and norepinephrine. These effects can increase dopaminergic and noradrenergic activity. Studies in animals demonstrate that the acute toxicity of bupropion is enhanced by the MAO inhibitor phenelzine.
Use of WELLBUTRIN With Reversible MAOIs Such as Linezolid or Methylene Blue:
  • Do not start WELLBUTRIN in a patient who is being treated with a reversible MAOI such as linezolid or intravenous methylene blue. Drug interactions can increase the risk of hypertensive reactions. In a patient who requires more urgent treatment of a psychiatric condition, non-pharmacological interventions, including hospitalization, should be considered ...

 

 

July 2011 

PRECAUTIONS

Drug Laboratory Test Interactions
  • new section added.....

MEDICATION GUIDE

  • added content re: false positive test results for amphetamines

 

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