Label Changes for:
Tracleer (bosentan) 62.5 and 125 mg Tablets
March 2009
Changes have been made to the CONTRAINDICATIONS and PRECAUTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- March 2009
| The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. |
Summary View
Sections Modified
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Sections Modified
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Summary of Changes to Contraindications and Warnings
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CONTRAINDICATIONS
- Lopinavir/ritonavir or other ritonavir-containing HIV regimens
PRECAUTIONS
- Drug Interactions (section reworded)
- Bosentan is metabolized by CYP2C9 and CYP3A4. Inhibition of these enzymes may increase the plasma concentration of bosentan...
- Lopinavir/ritonavir or other ritonavir-containing HIV regimens
- Co-administration of Tracleer in healthy subjects resulted in initial and steady...
MEDICATION GUIDE
- Do not take Tracleer if...
- lopinavir/ritonavir or other ritonavir-containing HIV regimens
- Tell your doctor about all the medicines you use..
- lopinavir/ritonavir or other ritonavir-containing HIV regimens
- What should I avoid..
- Do not take cyclosporine-A...increase your chance of side effects
- Do not take lopinavir/ritonavir or other ritonavir-containing HIV regimens
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CONTRAINDICATIONS
- Lopinavir/ritonavir or other ritonavir-containing HIV regimens
- Co-administration of lopinavir/ritonavir and bosentan resulted in markedly increased plasma concentrations of bosentan.Therefore, concomitant use of Tracleer and lopinavir/ritonavir or other ritonavir-containing HIV regimens is contraindicated...
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