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HelpTest Code SOFT: Z1000 Duloxetine, Serum
Additional Codes
| Ordering Mnemonic | Mayo Test ID |
| EPIC NAME: MISC. LAB TEST | DULOX |
| EPIC CODE: LAB000 |
Reporting Name
Duloxetine, SUseful For
Monitoring duloxetine serum concentration during therapy
Evaluating potential duloxetine toxicity
Evaluating patient compliance
Method Name
Liquid Chromatography Tandem Mass Spectrometry (LC-MS/MS)
Performing Laboratory
Mayo Clinic Laboratories in Rochester
Specimen Type
Serum RedSpecimen Required
Collection Container/Tube: Red top (serum gel/SST are not acceptable)
Submission Container/Tube: Plastic vial
Specimen Volume: 1 mL
Collection Instructions:
1. Draw blood immediately before the next scheduled dose (trough).
2. Centrifuge and aliquot serum into plastic vial within 2 hours of collection.
Specimen Minimum Volume
0.5 mL
Specimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Serum Red | Refrigerated (preferred) | 28 days | |
| Ambient | 28 days | ||
| Frozen | 28 days |
Reject Due To
| Gross hemolysis | OK |
| Gross lipemia | OK |
| Gross icterus | OK |
Reference Values
30-120 ng/mLDay(s) Performed
Wednesday
CPT Code Information
80299
LOINC Code Information
| Test ID | Test Order Name | Order LOINC Value |
|---|---|---|
| DULOX | Duloxetine, S | 46227-5 |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| 89305 | Duloxetine, S | 46227-5 |
Test Classification
This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It has not been cleared or approved by the US Food and Drug Administration.Clinical Information
Duloxetine is an antidepressant of the serotonin-norepinephrine reuptake inhibitor class. It is effective in treating symptoms of depression, including physical pain associated with depression; other uses include therapy of neuropathic pain, fibromyalgia, and urinary stress incontinence. Duloxetine also inhibits serotonin uptake in human platelets and may be associated with potentiation of bleeding.
Duloxetine undergoes extensive hepatic biotransformation to numerous inactive metabolites. The drug is metabolized by cytochrome P450 (CYP) 1A2 and CYP2D6, with moderate potential for drug interactions (duloxetine is both a substrate and a moderate inhibitor of CYP2D6). The mean elimination half-life is 12.5 hours with steady-state concentrations occurring in about 3 days. Specimens for therapeutic monitoring should be collected immediately before the next scheduled dose (ie, trough).
Duloxetine is not recommended for patients with hepatic impairment, substantial alcohol use, or chronic liver disease. Use in patients with kidney disease significantly increases exposure to duloxetine due to decreased elimination. Patients with mild-to-moderate kidney dysfunction should be monitored closely; use of duloxetine is not recommended for patients with kidney failure.
Interpretation
Therapeutic ranges are not well-established, but literature suggests that patients receiving duloxetine monotherapy for depression responded well when trough concentrations were 30 to 120 ng/mL. Higher levels may be tolerated by individual patients. The therapeutic relevance of this concentration range to other uses of duloxetine therapy is currently unknown.
Cautions
Specimens obtained using gel tube or anticoagulant collections cause assay interference.
Clinical Reference
1. Hiemke C, Bergemann N, Clement HW, et al. Consensus guidelines for therapeutic drug monitoring in neuropsychopharmacology: Update 2017. Pharmacopsychiatry. 2018;51(1-02):9-62
2. Westanmo AD, Gayken J, Haight R. Duloxetine: a balanced and selective norepinephrine- and serotonin-reuptake inhibitor. Am J Health-Syst Pharm. 2005;62(23):2481-2490
3. Waldschmitt C, Vogel F, Pfuhlmann B, Hiemke C. Duloxetine serum concentrations and clinical effects. Data from a therapeutic drug monitoring (TDM) survey. Pharmacopsychiatry. 2009;42(5):189-193
4. Feighner JP, Cohn JB. Double-blind comparative trials of fluoxetine and doxepin in geriatric patients with major depressive disorder. J Clin Psychiatry. 1985;46(3 Pt 2):20-25
5. Kelly MW, Perry PJ, Holstad SG, Garvey MJ. Serum fluoxetine and norfluoxetine concentrations and antidepressant response. Ther Drug Monit. 1989;11:165-170
6. Benfield P, Heel RC, Lewis SP. Fluoxetine: a review of its pharmacodynamic and pharmacokinetic properties, and therapeutic efficacy in depressive illness. Drugs. 1986;32(6):481-508
7. Wille SM, Cooreman SG, Neels, et al. Relevant issues in the monitoring and toxicology of antidepressants. Crit Rev Clin Lab Sci. 2008;45(1):25-89
Method Description
Serum samples containing duloxetine are diluted in an aqueous solution containing deuterated internal standard and then injected onto a high-turbulence liquid chromatography system for online extraction. Detection is by tandem mass spectrometry.(Unpublished Mayo method)
Report Available
1 to 8 daysSpecimen Retention Time
14 daysForms
If not ordering electronically, complete, print, and send a Therapeutics Test Request (T831) with the specimen.