Label Changes for:

Halcion (triazolam tablets)

February 2008

Changes have been made to the WARNINGS and PRECAUTIONS sections of the safety label.


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


Summary View

 

Sections Modified Summary of Changes to Contraindications and Warnings

WARNINGS

  • Sleep Disturbances
  • Severe Anaphylactic and Anaphylactoid Reactions

PRECAUTIONS

  • Information for Patients
    • "Sleep-driving" and other Complex Behaviors
    • Drug Interactions
      • Drugs that inhibit triazolam metabolism via cytochrome P450 3A:
      • Ketoconzaole
      • Itraconazole
      • Nefazodone
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