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U.S. Department of Health and Human Services

Safety

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Crixivan (indinavir sulfate) Capsules


Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- April 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 Summary of Changes to Contraindications and Warnings

CONTRAINDICATIONS

  • Table 7
    • Oral Midazolam

WARNINGS

  • Drug Interactions
    • Rosuvastatin (added)
    • ...Dosage reduction for midazolam...

PRECAUTIONS

  • Drug Interactions
    • Table 8: Drugs That Should Not Be Coadministered with Crixivan
      • Sedative/hypnotics
        • Oral Midazolam
    • Table 9: Established and Other Potentially Significant Drug Interactions: Alteration in Dose or Regimen May Be Recommended Based on Drug Interaction Studies or Predicted Interaction
      • HMG-CoA Reductase Inhibitors
        • Rosuvastatin
    • Midazolam (parenteral administration)

PATIENT PACKAGE INSERT

  • Can Crixivan be taken with other medications?
    • Medicines you should not take with Crixivan
      • Oral Versed (midazolam)
    • In addition, you should not take Crixivan with the following:
      • Crestor (rosuvastatin)
    • Medicines you can take with Crixivan
      • Intravenous Versed (midazolam) - If you take Crixivan with Intravenous Versed, your doctor may adjust the does of Versed.

CONTRAINDICATIONS

Table 7: Drug Interactions With Crixivan: Contraindicated Drugs

Drug Class: Sedative/hypnotics

Oral midazolam (added as contraindicated drug)

(See highlighted text for labeling revisions.)

WARNINGS

Drug Interactions

Caution should be exercised if HIV protease inhibitors, including Crixivan, are used concurrently with other HMG-CoA reductase inhibitors that are also metabolized by the CYP3A4 pathway (e.g., atorvastatin or rosuvastatin).

...If Crixivan with or without ritonavir is co-administered with parenteral midazolam, it should be done in a setting which ensures close clinical monitoring and appropriate medical management in case of respiratory depression and/or prolonged sedation. Dosage reduction for midazolam should be considered, especially if more than a single dose of midazolam is administered.