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.|
|Sections Modified||Summary of Changes to Contraindications and Warnings|
PATIENT PACKAGE INSERT
Table 7: Drug Interactions With Crixivan: Contraindicated Drugs
Drug Class: Sedative/hypnotics
Oral midazolam (added as contraindicated drug)
(See highlighted text for labeling revisions.)
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.