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TDM of Digoxin

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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Mounika16 Pedamallu
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180 views

TDM of Digoxin

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.

Uploaded by

Mounika16 Pedamallu
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PDF, TXT or read online on Scribd
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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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