Label Changes for:

Reyataz (atazanavir sulfate) Capsules

August 2008

Changes have been made to the CONTRAINDICATIONS, PRECAUTIONS and PATIENT PACKAGE INSERT sections of the safety label.


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

CONTRAINDICATIONS

  • Table 3: Drugs That Are Contraindicated with Reyataz
    • Benzodiazepines

DRUG INTERACTIONS

  • Potential for Reyataz to Affect Other Drugs
  • Established and Other Potentially Significant Drug Interactions
    • Table 10
      • HIV Antiviral Agents
      • Other Agents
  • Drugs with No Observed or Predicted Interactions with Reyataz

PATIENT PACKAGE INSERT

  • What important information should I know about taking Reytataz with other medicines?
    • Midazolam, also known as Versed (used for sedation), when taken by mouth.
  • Do not take the following medicines with Reyataz because they may lower the amount of Reyataz in your blood...
    • Viramune (nevirapine, used for HIV infection).
  • Talk to your healthcare provider about choosing an effective method of contraception...

CONTRAINDICATIONS

See Table 3: Drugs That Are Contraindicated with Reyataz:

Triazolam and orally administered midazolam are extensively metabolized by CYP3A4. Coadministration of triazolam or orally administered midazolam with Reyataz may cause large increases in the concentration of these benzodiazepines...

Hide
(web4)