Label Changes for:
Zyban (bupropion hydrochloride) Sustained-Release Tablets
Changes have been made to the PRECAUTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
- Drug-Laboratory Test Interactions: False-positive urine immunoassay screening tests for amphetamines have been reported.....
- 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.
- Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088