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Test ID ITCON Itraconazole, Serum

Useful For

Verifying systemic absorption of orally administered itraconazole

 

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.

Method Name

Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS)

Reporting Name

Itraconazole, S

Specimen Type

Serum Red

Collection Container/Tube: Red top

Submission Container/Tube: Plastic vial

Specimen Volume: 1 mL

Specimen Minimum Volume

0.18 mL

Specimen Stability Information

Specimen Type Temperature Time
Serum Red Refrigerated (preferred) 14 days
  Ambient  14 days
  Frozen  14 days

Clinical Information

Itraconazole is a synthetic triazole antifungal drug approved for treatment and prophylaxis of a variety of fungal infections. Its activity results from inhibition of fungal synthesis of ergosterol, an integral component of fungal cell membranes.

 

Concerns about adequate absorption and drug interactions are some of the major indications for therapeutic drug monitoring. Mean oral bioavailability approximates 55% but is highly variable; absorption can be enhanced by food or acidic drinks. Hepatic enzyme inducers can cause low serum itraconazole levels, and coadministration of these drugs has been associated with itraconazole therapeutic failure.

 

Itraconazole therapeutic efficacy is greatest when serum concentrations exceed 0.5 mcg/mL for localized infections, or 1.0 mcg/mL for systemic infections. An active metabolite, hydroxyitraconazole, is present in serum at roughly twice the level of the parent drug. These concentrations refer to analysis by HPLC; quantitation by bioassay results in considerably higher apparent drug measurements, due to reactivity with the active metabolite.

Reference Values

ITRACONAZOLE (TROUGH)

>0.5 mcg/mL (localized infection)

>1 mcg/mL (systemic infection)

 

HYDROXYITRACONAZOLE

No therapeutic range established; activity and serum concentration are similar to parent drug.

Cautions

Enteropathy, H2-histamine receptor blockers, hepatic enzyme inducers, and other variables can result in low to nondetectable serum levels with concomitant high risk of therapeutic failure.

 

AIDS patients and organ transplant patients receiving immunosuppressive therapy tend to have lower serum itraconazole levels on standard doses and are thus at high risk of therapeutic failure.

Day(s) Performed

Tuesday through Saturday; 8 a.m.

Report Available

Same day/1 day

Performing Laboratory

Mayo Medical Laboratories in Rochester

Test Classification

This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the U.S. Food and Drug Administration.

CPT Code Information

80299

NY State Approved

Yes