Clozapine and Metabolites Quantitative


Sunquest Code:CLOZPM  
Epic Code:LAB6979Epic Name:Clozapine and Metabolites Quantitative
Synonyms:Clozaril
Methodology:Liquid chromatography/Tandem mass spectrometry
Turnaround Time:Specimens are sent to reference laboratory Mon-Sat; results are reported within 1-3 days.
Compliance:

This test was developed and its performance characteristics determined by ARUP Laboratories. The U.S. Food and Drug Administration has not approved or cleared this test; however, FDA clearance or approval is not currently required for clinical use. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions.



Collection Instructions

Specimen:Blood
Optimal Volume:2 mL
Minimum\Peds Volume:1.2 mL
Container:Red (no gel) (Purple (EDTA))
Collection Instructions:Usual sampling time is immediately prior to next dose (trough).
Causes for Rejection:Whole blood. Gel separator tubes. Light blue (citrate) or yellow (SPS or ACD solution).


Processing and Shipping

Specimen Processing:Within 2 hours of collection, centrifuge and aliquot 1 mL, 0.5 mL minimum. Store refrigerated.
Shipping Instructions:Ship refrigerated.
Stability:After separation from cells: 5 weeks at room temperature; 2 months refrigerated (preferred), or frozen.
Test Performed at or Referral Lab Lab Sendouts  (ARUP)
Referral Lab number:2013433


Interpretive

Therapeutic Range:Therapeutic ranges are not well established. Clozapine is metabolized to norclozapine and clozapine-N-oxide. Clozapine concentrations between 100 and 700 ng/mL may correlate more with a clinical response; however, non-responsiveness may also occur within this range. For refractory schizophrenia, clozapine concentrations greater than 350 ng/mL are suggested to achieve a therapeutic response. Toxicity: Toxic ranges are not well established. Serum/plasma concentrations greater than or equal to 1500 ng/mL (clozapine, norclozapine and clozapine-N-oxide combined) may cause drug-induced agranulocytosis. Stevens-Johnson syndrome, seizures, hypotension, cardiovascular abnormalities, drowsiness and death.


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