Digoxin

Generic name
Digoxin
Brand name
ATC Code
C01AA05
Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

Narrow therapeutic range. Given the long half-life, a loading dose is needed for a rapid effect. The steady state is achieved without a loading dose after approximately 10 days.
Bioavailability after oral administration is approximately 67%.

The following values have been found for the clearance:
- Children 1 week: 32 ± 7 ml/min/1.73m²
- Children 3 months: 65.6 ± 30 ml/min/1.73m²
- Children 12 months: 88 ± 43 ml/min/1.73m²

dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

Available formulations

No information is present at this moment.

Dosages

Supraventricular arrhythmias and congestive heart failure
  • Oral
    • Premature infants < 1.5 kg
      [1]

      • Initial dose: 25 mcg/kg/24 hours in divided doses of 50%-25%-25% with pauses of 4-8 hours in between
        Maintenance dose: 5 mcg/kg/day in 1-2 doses

         

      • DIGOXIN IS VERY TOXIC TO NEW-BORNS

        The dosage should be adjusted to the individual based on the clinical response and the concentrations determined

    • Premature infants 1.5 up to 2.5 kg
      [1]

      • Initial dose: 30 mcg/kg/24 hours in divided doses of 50%-25%-25% with pauses of 4-8 hours in between
        Maintenance dose: 6 mcg/kg/day in 1-2 doses

      • DIGOXIN IS VERY TOXIC TO NEW-BORNS

        The dosage should be adjusted to the individual based on the clinical response and the concentrations determined

    • Full-term neonate 0 years up to 2 years
      [1]

      • Initial dose: 45 mcg/kg/24 hours in divided doses of 50%-25%-25% with pauses of 4-8 hours in between
        Maintenance dose: 11.25 mcg/kg/day in 1-2 doses

      • DIGOXIN IS VERY TOXIC TO NEW-BORNS

        The dosage should be adjusted to the individual based on the clinical response and the concentrations determined

    • 2 years up to 5 years
      [1]

      • Initial dose: 35 mcg/kg/24 hours in divided doses of 50%-25%-25% with pauses of 4-8 hours in between
        Maintenance dose: 8.75 mcg/kg/day in 1-2 doses

      • The dosage should be adjusted to the individual based on the clinical response and the concentrations determined

    • 5 years up to 10 years
      [1]

      • Initial dose: 25 mcg/kg/24 hours in divided doses of 50%-25%-25% with pauses of 4-8 hours in between
        Maintenance dose: 6.25 mcg/kg/day in 1-2 doses

      • The dosage should be adjusted to the individual based on the clinical response and the concentrations determined

    • 10 years up to 18 years
      [1]

      • Slow onset of action

        Initial dose: 0.25-0.75 mg/day for 1 week
        Maintenance dose: 0.125-0.5 mg/day in 1-2 doses

        Rapid onset of action:

        Initial dose: 0.75-1.5 mg as a one-time dose
        Maintenance dose: 0.125-0.5 mg/day in 1-2 doses

        • If there is an elevated risk of toxicity, reduce the loading dose by max. 50% and distribute over multiple administrations with pauses in between of 6 hours, followed after 24 hours by a single maintenance dose
        • The dosages above should be adjusted to the individual based on the clinical response and the concentrations determined
  • Intravenous
    • Premature infants < 1.5 kg
      [1]

      • Initial dose: 20 mcg/kg/24 hours in divided doses of 50%-25%-25% with pauses of 4-8 hours in between
        Maintenance dose: 4 mcg/kg/day in 1-2 doses

      • DIGOXIN IS VERY TOXIC TO NEW-BORNS

        The dosage should be adjusted to the individual based on the clinical response and the concentrations should be determined.

    • Premature infants 1.5 up to 2.5 kg
      [1]

      • Initial dose: 30 mcg/kg/24 hours in divided doses of 50%-25%-25% with pauses of 4-8 hours in between
        Maintenance dose: 6 mcg/kg/day in 1-2 doses

      • DIGOXIN IS VERY TOXIC TO NEW-BORNS

        The dosage should be adjusted to the individual based on the clinical response and the concentrations determined

    • Full-term neonate 0 years up to 2 years
      [1]

      • Initial dose: 35 mcg/kg/24 hours in divided doses of 50%-25%-25% with pauses of 4-8 hours in between
        Maintenance dose: 8.75 mcg/kg/day in 1-2 doses

      • DIGOXIN IS VERY TOXIC TO NEW-BORNS

        The dosage should be adjusted to the individual based on the clinical response and the concentrations determined

    • 2 years up to 5 years
      [1]

      • Initial dose: 35 mcg/kg/24 hours in divided doses of 50%-25%-25% with pauses of 4-8 hours in between
        Maintenance dose: 8.75 mcg/kg/day in 1-2 doses

      • The dosage should be adjusted to the individual based on the clinical response and the concentrations determined

    • 5 years up to 10 years
      [1]

      • Initial dose: 25 mcg/kg/24 hours in divided doses of 50%-25%-25% with pauses of 4-8 hours in between
        Maintenance dose: 6.25 mcg/kg/day in 1-2 doses

      • The dosage should be adjusted to the individual based on the clinical response and the concentrations should be determined.

    • 10 years up to 18 years
      [1]

      • Initial dose: 0.5-1 mg/24 hours in divided doses of 50%-25%-25% with pauses of 4-8 hours in between
        Maintenance dose:   ORAL: 0.125-0.5 mg/day in 1-2 doses

Renal impaiment in children > 3 months

Digoxin in children aged < 10 years
GFR 10-50 ml/min/1.73m²:
- give a normal loading dose
- initial maintenance dose after the loading dose: 100% of the standard maintenance dose and interval between two doses: 24 hours
- then adjust the dose depending on the clinical picture and digoxin level
GFR < 10 ml/min/1.73m²:
- no general recommendations are given
Note: The half-life is extended in reduced renal function; it takes longer for the steady state to be reached. Determine the digoxin concentration weekly until a steady state is achieved.

Digoxin in children aged ≥ 10 years
GFR 10-50 ml/min/1.73m²:
- give a normal loading dose
- initial maintenance dose after the loading dose: 0.125 mg/day
- then adjust the dose depending on the clinical picture and the digoxin level
GFR < 10 ml/min/1.73m²:
- no general recommendations are given
Note: The half-life is extended in reduced renal function; it takes longer for the steady state to be reached. Determine the digoxin concentration weekly until a steady state is achieved.

Clinical consequences

Information
In cases of reduced renal function, the renal excretion of digoxin decreases and the digoxin level can rise to toxic levels as a result.

The therapeutic serum concentration of digoxin is ideally between 0.8 mcg/l and 2.0 mcg/l. The risk of side effects of digoxin increases rapidly at serum concentrations above 3.0 mcg/l. Symptoms of this are gastrointestinal complaints (nausea, anorexia, vomiting), impairments of the central nervous system (confusion, hallucination, dizziness, change in colour vision, blurred vision) and arrhythmia.

The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

The therapeutic bandwidth of digoxin is narrow. Side effects that occur are generally a sign of overdosing. The effects can be subdivided into:

  • Gastrointestinal impairments: anorexia, nausea, vomiting.
  • Neurological symptoms: tiredness, nightmares, headache, disorientation.
  • Cardiac symptoms: arrhythmia

The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications

No information available on specific contra indications in children.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions in children

The toxicity is exacerbated by hypokalaemia; caution is needed when combined with diuretics. Particularly in neonates (both premature and full-term), accumulation is possible due to delayed excretion of digoxin because the renal function is not yet properly developed.
Narrow therapeutic bandwidth: the levels must be determined. Blood samples that are taken within 8 hours of administration cannot be interpreted.

 

Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

CARDIAC GLYCOSIDES

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

Reference

  1. Aspen Pharma Trading Limited, SPC Lanoxin (RVG 01363) 10-02-2017, www.geneesmiddeleninformatiebank.nl

Changes

Therapeutic Drug Monitoring


Overdose