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Label Changes for:

Kaletra (lopinavir and ritonavir) Solution for Oral Use

October 2008

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) -- October 2008


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. Read about the new physician labeling format.

Summary View


Sections Modified


  • Established and Other Potentially Significant Drug Interactions
    • Table 9: Established and Other Potentially Significant Drug Interactions
      • Non-nucleoside Reverse Transcriptase Inhibitors
        • Efavirenz
      • HIV CCR5 – antagonist
        • Maraviroc
      • Anticancer Agents
        • Vincristine
        • Vinblastine
      • Anticonvulsants
        • Phenytoin
      • Antidepressant
        • Bupropion
      • Antifungals
        • Voriconazole