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22232 Amiodarone (AMIO)

Amiodarone (AMIO)
Test Code: AMIOSO
Synonyms/Keywords

Cordarone​, Desethylamiodarone, Pacerone (Amiodarone Hydrochloride)

Useful For

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

Evaluation of possible amiodarone toxicity

Assessment of patient compliance​

Specimen Requirements
Fasting Required Specimen Type Preferred Container/Tube Acceptable Container/Tube Specimen Volume Specimen Minimum Volume
(allows for 1 repeat)
Pediatric Minimum Volume
(no repeat)
No​ Serum​Red Top Tube (RTT)​1.5 mL​0.5 mL​
Collection Processing Instructions
Draw blood no sooner than 12 hours (trough value) after last dose or immediately before next scheduled dose.  Centrifuge within 2 hours of draw and aliquot to remove serum from spun RBCs. 
Specimen Stability Information
Specimen Type Temperature Time
Serum ​​ ​ Refrigerated (preferred) 28 days​
Frozen 28 days
Ambient ​24 hours
Rejection Criteria
​Serum separator tube (SST)
Interference

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.

Performing Laboratory Information
Performing Location Day(s) Test Performed Report Available Methodology/Instrumentation
Mayo Clinic Laboratories Monday through Saturday 2 to 5 days Liquid Chromatography Mass Spectrometry (LC-MS/MS)
Reference Lab
Test 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.

Reference Range Information
Performing Location Reference Range
Mayo Clinic Laboratories

Amiodarone:

Trough Value

Therapeutic concentration: 0.5-2.0 mcg/mL​

Toxic concentration: >2.5 mcg/mL

Desethylamiodarone:

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

Interpretation

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.

Outreach CPTs
CPT Modifier
(if needed)
Quantity Description Comments
80151 ​1
Synonyms/Keywords

Cordarone​, Desethylamiodarone, Pacerone (Amiodarone Hydrochloride)

Ordering Applications
Ordering Application Description
COM Amiodarone, Serum (AMIO)
​Cerner ​Amiodarone, Serum (AMIO)
If the ordering application you are looking for is not listed, contact your local laboratory for assistance.
Specimen Requirements
Fasting Required Specimen Type Preferred Container/Tube Acceptable Container/Tube Specimen Volume Specimen Minimum Volume
(allows for 1 repeat)
Pediatric Minimum Volume
(no repeat)
No​ Serum​Red Top Tube (RTT)​1.5 mL​0.5 mL​
Collection Processing
Draw blood no sooner than 12 hours (trough value) after last dose or immediately before next scheduled dose.  Centrifuge within 2 hours of draw and aliquot to remove serum from spun RBCs. 
Specimen Stability Information
Specimen Type Temperature Time
Serum ​​ ​ Refrigerated (preferred) 28 days​
Frozen 28 days
Ambient ​24 hours
Rejection Criteria
​Serum separator tube (SST)
Interference

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.

Useful For

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

Evaluation of possible amiodarone toxicity

Assessment of patient compliance​

Reference Range Information
Performing Location Reference Range
Mayo Clinic Laboratories

Amiodarone:

Trough Value

Therapeutic concentration: 0.5-2.0 mcg/mL​

Toxic concentration: >2.5 mcg/mL

Desethylamiodarone:

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

Interpretation

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.

For more information visit:
Performing Laboratory Information
Performing Location Day(s) Test Performed Report Available Methodology/Instrumentation
Mayo Clinic Laboratories Monday through Saturday 2 to 5 days Liquid Chromatography Mass Spectrometry (LC-MS/MS)
Reference Lab
For billing questions, see Contacts
Outreach CPTs
CPT Modifier
(if needed)
Quantity Description Comments
80151 ​1
For most current information refer to the Marshfield Laboratory online reference manual.