Safety

Zyban (bupropion hydrochloride) sustained-release tablet

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

June 2016

Summary View

ADVERSE REACTIONS

Postmarketing Experience

Nervous System

  • (recategorizing some adverse effects under a single term) Abnormal electroencephalogram (EEG), aggression, akinesia, aphasia, coma, completed suicide, delirium, delusions, dysarthria, euphoria, extrapyramidal syndrome (dyskinesia, dystonia, hypokinesia, parkinsonism), hallucinations, increased libido, manic reaction, neuralgia, neuropathy, paranoid ideation, restlessness, suicide attempt, and unmasking tardive dyskinesia.

 

August 2014

Summary View

WARNINGS AND PRECAUTIONS

  • * include a new warning on the risk of angle-closure glaucoma.*

ADVERSE REACTIONS

  • * include a new warning on the risk of angle-closure glaucoma.*

PATIENT COUNSELLING INFORMATION

  • * include a new warning on the risk of angle-closure glaucoma.*

MEDICATION GUIDE

Visual problems
  • …changes in vision…

 

January 2012

Summary View

PRECAUTIONS

Drug Interactions 
  • Drug-Laboratory Test Interactions: False-positive urine immunoassay screening tests for amphetamines have been reported..... 

 

September 2010

Summary View

PRECAUTIONS

Drug Interactions
  • In a series of studies in healthy volunteers, ritonavir (100 mg twice daily or 600 mg twice daily) or ritonavir 100 mg plus lopinavir 400 mg (KALETRA) twice daily reduced the exposure of bupropion and its major metabolites in a dose dependent manner by approximately 20% to 80%. This effect is thought to be due to the induction of bupropion metabolism. Patients receiving ritonavir may need increased doses of bupropion, but the maximum recommended dose of bupropion should not be exceeded
  • Therefore, the potential exists for a drug interaction between Zyban and drugs that are substrates of or inhibitors/inducers of the CYP2B6 isoenzyme (e.g.,...ticlopidine, and clopidogrel).
  • Drugs Metabolized by Cytochrome P450IID6 (CYP2D6): Although citalopram is not primarily metabolized by CYP2D6, in one study bupropion increased the Cmax and AUC of citalopram by 30% and 40%, respectively. Citalopram did not affect the pharmacokinetics of bupropion and its three metabolites.

MEDICATION GUIDE

  • Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

 

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