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EPIC CODE: LAB567 Amiodarone, Serum

Additional Codes

Sunquest:    AMIODM
Mayo:           AMIO
Previously:   ARUP 0090161

Reporting Name

Amiodarone, S

Useful For

Monitoring amiodarone therapy, especially when amiodarone is coadministered with other drugs that may interact


Evaluating possible amiodarone toxicity


Assessing patient compliance

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Specimen Type

Serum Red

Specimen Required

Collection Container/Tube: Red top (serum gel/SST are not acceptable)

Submission Container/Tube: Plastic vial

Specimen Volume: 1.5 mL

Collection Instructions:

1. Draw blood no sooner than 12 hours (trough value) after last dose or immediately before next scheduled dose.

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
  Frozen  28 days
  Ambient  24 hours

Reference Values


Trough Value

0.5-2.0 mcg/mL: Therapeutic concentration

>2.5 mcg/mL: Toxic concentration



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

Day(s) Performed

Monday through Saturday

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 US Food and Drug Administration.

CPT Code Information


LOINC Code Information

Test ID Test Order Name Order LOINC Value
AMIO Amiodarone, S 55152-3


Result ID Test Result Name Result LOINC Value
9247 Amiodarone, S 3330-8
2485 Desethylamiodarone 6774-4

Clinical Information

Amiodarone is an antiarrhythmic agent used to treat life-threatening arrhythmias; it is typically categorized as a Class III drug (antiarrhythmic agents that are potassium channel blockers) but shows several mechanisms of action. The US Food and Drug Administration approved the use of amiodarone for recurrent ventricular fibrillation and recurrent hemodynamically unstable ventricular tachycardia only after demonstrating lack of response to other antiarrhythmics, but more recent studies have shown amiodarone to be the antiarrhythmic agent of choice for many situations, including atrial fibrillation.(1)


Amiodarone can be administered orally or intravenously for cardiac rhythm control. It is approximately 95% protein bound in blood, with a volume of distribution of 60 L/kg. Amiodarone elimination is quite prolonged, with a half-life of 26-107 days for oral, chronic dosing. Cytochrome P450 (CYP) 3A4 converts amiodarone to its equally active metabolite, N-desethylamiodarone (DEA), which displays very similar pharmacokinetics and serum concentrations compared with the parent drug.(2) Current therapeutic ranges are based solely on amiodarone, but most individuals will have roughly equivalent concentrations of DEA at steady state.(3)


Numerous side effects have been associated with amiodarone. The most common adverse effect is disruption of thyroid function (hypo- or hyperthyroidism) due to amiodarone's structural similarity to thyroid hormones. Neurological and gastrointestinal toxicities are concentration-dependent, whereas thyroid dysfunction, pulmonary fibrosis, and hepatotoxicity are more loosely linked to drug concentration. There is significant potential for drug interactions involving amiodarone, including several other cardioactive drugs (eg, digoxin, verapamil, class I antiarrhythmics [sodium channel blockers]), warfarin, statins, and CYP3A4 substrates.


Clinical effects generally require serum concentrations above 0.5 mcg/mL.


Increased risk of toxicity is associated with amiodarone concentrations above 2.5 mcg/mL.


Although therapeutic and toxic ranges are based only on the parent drug, the active metabolite N-desethylamiodarone should be present in similar concentrations to amiodarone.


Numerous drug interactions have been observed for amiodarone. Clinical follow-up is essential for optimal use of amiodarone. Therapeutic drug monitoring for amiodarone and coadministered medications is highly recommended.


Specimens that are obtained from gel tubes or anticoagulate collections can cause assay interference.

Clinical Reference

1. Goldschlager N, Epstein AE, Naccarelli GV, et al: A practical guide for clinicians who treat patients with amiodarone: 2007. Heart Rhythm. 2007 Sep;4(9):1250-1259

2. Klotz U: Antiarrhythmics: elimination and dosage considerations in hepatic impairment. Clin Pharmacokinet. 2007;46(12):985-996

3. Campbell TJ, Williams KM: Therapeutic drug monitoring: antiarrhythmic drugs. Br J Clin Pharmacol. 2001;52 Suppl1(Suppl 1):21S-34S

4. Rifai N, Horwath AR, Wittwer CT, eds: In: Tietz Textbook of Clinical Chemistry and Molecular Diagnostics. 6th ed. Elsevier; 2018

Method Description

Protein is precipitated from serum and following centrifugation the supernatant is diluted and analyzed by liquid chromatography tandem mass spectrometry.(Unpublished Mayo method)

Report Available

3 to 5 days

Specimen Retention Time

2 weeks

Reject Due To

Gross hemolysis OK
Gross lipemia OK
Gross icterus OK

NY State Approved


Method Name

Liquid Chromatography Mass Spectrometry (LC-MS/MS)

Secondary ID



If not ordering electronically, complete, print, and send a Therapeutics Test Request (T831) with the specimen.