Itraconazole and Hydroxyitraconazole

Abbrev Code:ITRCZ   
Order Code:LAB8151Order Name:Itraconazole and Metabolite
Methodology:Liquid chromatograph/Tandem mass spectrometry
CPT Codes: 80189 x1, 80299 x1
Test Includes:Itraconazole and Hydroxyitraconazole
Turnaround Time:Performed Tuesday and Thursday; results are reported the same day. The cutoff time for same day reporting is 9:30 am on Tuesday, and 11:00 am on Thursday..

Collection Instructions

Optimal Volume:2 mL
Minimum\Peds Volume:0.6 mL
Container:Purple (EDTA)
Alternate Containers: Green (lithium heparin, no gel), Green (sodium heparin, no gel), Red (no gel)
Causes for Rejection:Collected in a gel tube.

Processing and Shipping

Specimen Processing:Within 2 hours of collection, centrifuge and aliquot 1 mL, 0.2 mL minimum. Freeze immediately.
Shipping Instructions:Ship on dry ice.
Stability:2 hours at room temperature; 1 week refrigerated; 2 weeks frozen.
Test Performed at or Referral Lab UM Special Drug/BGEN (Azole Z) 


Critical Range:Itraconazole and Hydroxyitraconazole combined that is 10 μg/mL or greater
Reference Range:
Itraconazole 0.5-5.0 μg/mL
Hydroxyitraconazole No therapeutic range established

No therapeutic range is established for Hydroxyitraconazole. Hydroxyitraconazole is an active metabolite that has comparable activity to the parent drug itraconazole. The clinical practice guidelines for the management of blastomycosis by the Infectious Diseases Society of America recommends that combined itraconazole and hydroxyitraconazole concentrations should not exceed 10 µg/mL due to potential toxicity.

Itraconazole therapeutic efficacy is greatest when serum concentrations exceed 0.5 µg/mL for localized infections, or 1.0 µg/mL for systemic infections. An active metabolite, hydroxyitraconazole, is present in serum at roughly twice the level of the parent drug.
Use:The test is indicated in patients with life-threatening fungal infections and in patients considered at risk for poor absorption or rapid clearance of itraconazole.

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