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  • TDM of Digoxin

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    Mounika16 Pedamallu
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    Digoxin is used to treat congestive heart failure and atrial fibrillation. It has a long half-life of 30-50 hours in patients with normal renal function. Therapeutic drug monitoring is useful to evaluate toxicity, assist in differential diagnosis, and assess medication adherence and drug interactions. Digoxin levels are measured using radioimmunoassay, enzyme immunoassay, or fluorescence polarization immunoassay methods. Interpretation of digoxin levels helps evaluate patient compliance, dosage errors, pharmacokinetics, and response to therapy. Proper sample collection and analysis using a standardized assay procedure is required to accurately interpret digoxin levels.

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    Therapeutic drug monitoring of digoxin- for cardiovascular disease

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    Digoxin is used to treat congestive heart failure and atrial fibrillation. It has a long half-life of 30-50 hours in patients with normal renal function. Therapeutic drug monitoring is useful to evaluate toxicity, assist in differential diagnosis, and assess medication adherence and drug interactions. Digoxin levels are measured using radioimmunoassay, enzyme immunoassay, or fluorescence polarization immunoassay methods. Interpretation of digoxin levels helps evaluate patient compliance, dosage errors, pharmacokinetics, and response to therapy. Proper sample collection and analysis using a standardized assay procedure is required to accurately interpret digoxin levels.

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    32 views13 pages

    TDM of Digoxin

    Uploaded by

    Mounika16 Pedamallu
    Digoxin is used to treat congestive heart failure and atrial fibrillation. It has a long half-life of 30-50 hours in patients with normal renal function. Therapeutic drug monitoring is useful to evaluate toxicity, assist in differential diagnosis, and assess medication adherence and drug interactions. Digoxin levels are measured using radioimmunoassay, enzyme immunoassay, or fluorescence polarization immunoassay methods. Interpretation of digoxin levels helps evaluate patient compliance, dosage errors, pharmacokinetics, and response to therapy. Proper sample collection and analysis using a standardized assay procedure is required to accurately interpret digoxin levels.

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    TDM of Digoxin

    Atiqulla Shariff
    Drug profile

    Indications of drug

     CHF i.e. dilated ventricles with poor ejection fraction

     Atrial fibrillation i.e. Atrial tachyarrhythmia


    Half life
    In patients with normal renal function: 30-50 hrs

    In ESRD patients: 100-200 hrs (50-75% eliminates through renal


    system)

    Time to reach peak serum concentration: 6-8 hrs

    Time to reach steady state concentration: 7-12 days

    VoD: 7.3 L Protein binding: 25%

    Toxic level: ≥ 2.5 ng/mL


    Therapeutic range
    Varies between 0.7 to 2.0 ng/mL

    1. Atrial fibrillation: 1.5- 2.2 ng/mL


    2. CHF: 0.9-1.8 ng/mL

    Dose
    Loading dose is 10-15 mcg/kg/day in 3 divided doses
    Maintenance dose is 0.125- 0.5 mg/day
    • This doses is in normal renal function
    • In renal failure the frequency of administration has to be
    altered and has to be adjusted every 3-5 days.
    Indications for TDM

     To evaluate digoxin toxicity:

     To assist in differential diagnosis:


    To distinguish between drug related adverse effects from
    disease symptoms

     To evaluate suspected drug-drug interaction:


    Quinidine-digoxin interaction resulting in increased plasma
    digoxin concentration

     To assess medication adherence: poor therapeutic response


    Assay method

    Volume of sample: 1-4mL

    Tubing:

     Evacuated tubes are used

     Earlier red stopper tubes were used which contains plasticizer


    interact with drug and inhibits binding of drugs to alpha-
    glycoprotein in serum
    Sampling time:

    Atleast 6-8 hours following an oral dose

    Drug Interactions:

    Drugs INCREASING Drugs DECREASING


    Digoxin levels Digoxin levels
    Amiodarone, Antacids,
    Anticholinergic drugs, Cholestyramine,
    Diltiazem, Domperidone,
    Propafenone, Metoclopramide,
    Quinidine, Sulfasalazine
    Spiranolactone,
    Verapamil
    Radio Immuno Assay:
    Principle:

    Digoxin in serum sample competes with the radio labelled (I-125


    digoxin) derivative for binding sites on the antibody to the
    Digoxin

    The unbound digoxin is then separated from bound form

    One of these is quantitated by radio active counting and the


    concentration of unbound digoxin in the serum is calculated by
    comparison to Digoxin standards

    Advantages: Sensitive, precise and easy to perform


    Disadvantages: Low specificity
    Enzyme immuno assay method:
    Principle:

    Digoxin-enzyme competes with serum digoxin for digoxin


    antibody binding site

    Either free or antibody bound digoxin enzyme is then reacted


    with excess substrate for the enzyme along with cofactors

    The enzyme-reaction produces a chromophore which is measured


    spectrophotometrically or fluorometrically

    Advantages: the precision and sensitivity are similar to RIA


    Fluorescence polarization immuno assay:
    Principle:
    Ability of flurescent labelled digoxin tracer to compete
    with unlabelled serum digoxin for the binding site on
    antibody to digoxin

    Upon excitation by single wavelength polarized light,


    the unbound label and antibody bound florescent
    label exhibit widely different degree of polarisation of
    emission florescence

    Advantage: excellent reproducibility


    Pharmacokinetic evaluation

    If the SDC is lower than anticipated,

     Patient compliance
     Error in dosage regimen
     Poor bioavailability
     Rapid elimination of drug
     Increased VOD
     SSC may not be reached
     Timing of blood sampling
    If the SDC is higher than anticipated
     Patient compliance
     Error in dosage regimen
     Increased bioavailability
     Smaller VOD
     Slow elimination of drug

    If the SDC is proper but patient is not responding to the therapy,


    then it may be due to
     Altered receptor sensitivity
     Possible drug-drug interaction at receptor site
     Look for co-morbid conditions like thyroid disease and
    malabsorption syndrome
    Steps in the analysis
     Define the problem

     Select the correct sample

     Choose the best analytical method

     Standardize the assay

     Process the sample

     Perform the assay competently

     Interpret the results

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