- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
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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
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dose recommendation of formulary compared to licensed use (on-label versus off-label)
No information is present at this moment.
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Available formulations
No information is present at this moment.
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Dosages
| Supraventricular arrhythmias and congestive heart failure |
|---|
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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.
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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
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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.
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Interactions
The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here
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Reference
- Aspen Pharma Trading Limited, SPC Lanoxin (RVG 01363) 10-02-2017, www.geneesmiddeleninformatiebank.nl
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Changes
Changes
