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Test ID: DOXP
Doxepin and Nordoxepin, Serum

NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Useful For Suggests clinical disorders or settings where the test may be helpful

Monitoring therapy

 

Evaluating potential toxicity

 

Evaluating patient compliance

Method Name A short description of the method used to perform the test

High-Performance Liquid Chromatography (HPLC)

Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name

Doxepin and Nordoxepin, S

Aliases Lists additional common names for a test, as an aid in searching

Adapin (Doxepin)
Doxepin (Sinequan)
Nordox (Doxepin)

Specimen Type Describes the specimen type needed for testing

Serum Red

Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.

Container/Tube: Red top

Specimen Volume: 3 mL

Collection Instructions:

1. Draw specimen immediately before next scheduled dose (or at a minimum 12 hours after last dose).

2. Serum must be separated from cells within 2 hours of draw.

Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.

1.1 mL

Reject Due To Identifies specimen types and conditions that may cause the specimen to be rejected

Hemolysis

Mild OK; Gross reject

Lipemia

Mild OK; Gross reject

Icterus

Mild OK; Gross reject

Other

Serum gel tube

Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.

Specimen TypeTemperatureTime
Serum RedRefrigerated (preferred)14 days
 Ambient 14 days
 Frozen 14 days

Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Doxepin is recommended for the treatment of psychoneurotic patients with depression or anxiety, and depression or anxiety associated with alcoholism or organic disease.

 

Nordoxepin (N-desmethyldoxepin) is the major metabolite and is usually present at concentrations equal to doxepin. Optimal efficacy occurs at combined serum concentrations between 50 and 150 ng/mL.

 

Like other tricyclic antidepressants, the major toxicity of doxepin is expressed as cardiac dysrhythmias, which occur at concentrations in excess of 300 ng/mL. Other side effects include nausea, hypotension, and dry mouth.

Reference Values Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

Therapeutic concentration (doxepin + nordoxepin): 50-150 ng/mL

Toxic concentration (doxepin + nordoxepin): > or =300 ng/mL

Interpretation Provides information to assist in interpretation of the test results

Most individuals display optimal response to doxepin when combined serum levels of doxepin and nordoxepin are between 50 and 150 ng/mL. Some individuals may respond well outside of this range, or may display toxicity within the therapeutic range; thus, interpretation should include clinical evaluation. Risk of toxicity is increased with combined levels > or =300 ng/mL.

 

Therapeutic ranges are based on specimens drawn at trough (ie, immediately before the next dose).

Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

Doxepin analytical interferences: sertraline may cause falsely low results, and venlafaxine, diphenhydramine, chlorpromazine, promazine, ethopropazine, or amlodipine may cause false elevations.

 

Nordoxepin analytical interference: sertraline may cause falsely low results.

 

This test cannot be performed on whole blood. Serum must be separated from cells within 2 hours of drawing; if serum is not removed within this time, drug levels may be falsely elevated due to drug release from RBCs.

 

Specimens that are obtained from gel tubes are not acceptable.

Clinical Reference Provides recommendations for further in-depth reading of a clinical nature

1. Wille SM, Cooreman SG, Neels HM, Lambert WE: Relevant issues in the monitoring and the toxicology of antidepressants. Crit Rev Clin Lab Sci 2008;45(1):25-89

2. Thanacoody HK, Thomas SH:  Antidepressant poisoning. Clin Med 2003;3(2):114-118

3. Baumann P, Hiemke C, Ulrich S, et al:  The AGNP-TDM expert group consensus guidelines: therapeutic drug monitoring in psychiatry. Pharmacopsychiatry 2004;37(6):243-265

Method Description Describes how the test is performed and provides a method-specific reference

The tricyclic antidepressants are extracted from serum by liquid-liquid extraction. Analysis is by HPLC.(Unpublished Mayo method)           

 

Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.

Monday through Saturday; Varies

Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.

2 days

Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result

4 days

Specimen Retention Time Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

14 days

Performing Laboratory Location The location of the laboratory that performs the test

Rochester

Test Classification Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) product.

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 Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

80166-Doxepin

80299-Quantitation of drug

LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.

Result IDReporting NameLOINC Code
9301Doxepin3579-0
2464Nordoxepin3862-0
2470Doxepin and Nordoxepin3582-4