7 year old woman has been a
bition to eart but now complains of nausea
and reduced mobility Her current dose of digoxin is
1875 micrograms orally dally Her digoxin level is 3.0
mol/l (therapeutic range 1.0-2.6 nmol/L). Which of the
following is the most appropriate course of action? ( 1
Reduce the dose
Stop the digoxin and restart at a lower
dose once the level is therapeutic
Continue the current dose
Prescribe digoxin-specific antibody
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Answers
Answer:
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Digoxin Tablets BP 62.5 micrograms
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Accord-UK Ltd
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Active ingredient
digoxin
Legal Category
POM: Prescription only medicine
SmPC
Patient Leaflet
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This information is intended for use by health professionals
1. Name of the medicinal product
DIGOXIN TABLETS BP 62.5 micrograms
2. Qualitative and quantitative composition
Each tablet contains 62.5 micrograms Digoxin PhEur.
3. Pharmaceutical form
Blue uncoated tablets.
Blue, circular, flat bevelled edge, uncoated tablets impressed “C” on one face and the identifying letters “DD” on the reverse
4. Clinical particulars
4.1 Therapeutic indications
• Digoxin is indicated for the treatment of congestive cardiac failure.
• Digoxin may be used for certain supraventricular dysrhythmias, particularly atrial fibrillation.
4.2 Posology and method of administration
The following schedules are intended as an initial guide but each patient has to be tailored individually according to age, lean body weight and renal function for his/her needs:
Suggested doses are intended only as an initial guide.
In cases where cardiac glycosides have been taken in the preceding two weeks the recommendations for initial dosing of a patient should be reconsidered and a reduced dose is advised.
The difference in bioavailability between injectable digoxin and oral formulations must be considered when changing from one dosage form to another. For example if patients are switched from oral to the I.V. formulation the dosage should be reduced by approximately 33%.
Adults and children over 10 years:
Rapid oral loading:
750-1500micrograms (0.75mg-1.5mg) as a single dose. If a greater risk or less urgency eg the elderly, the oral loading dose should be given in divided doses 6 hours apart, assessing clinical response, before giving each additional dose.
Slow oral loading:
250-750micrograms (0.25mg-0.75mg) should be given daily for 1 week, followed by appropriate maintenance dose. A clinical response should be seen within one week.
NB
The clinical state of the patient and the urgency of the condition will depend on the choice between slow or rapid oral loading
The maintenance dosage should be based upon the percentage of the peak body stores lost each day through elimination. The following formula has had wide clinical use:
Maintenance dose:
is peak body stores x (% daily loss ÷ 100)
Where: peak body stores = loading dose; % daily loss = 14 + creatinine clearance (Ccr)/5.
Ccr is creatinine clearance corrected to 70kg body weight or 1.73m2 body surface area. If only serum creatinine (Scr) concentrations are available, a Ccr (corrected to 70kg body weight) may be estimated in men as:
NB:
Serum creatinine values are in micromol/l, these can be converted to mg/100ml (mg/%) as follows:
Where: 113.12 is the molecular weight of creatinine.
For Women: Multiply the result by 0.85.
NB
This formulae cannot be used for creatinine clearance in children.
In practice, this will mean that most patients will be maintained on 0.125 to 0.25mg digoxin daily, however, in those who show increased sensitivity to the adverse effects of digoxin, a dosage of 62.5microgram (0.0625mg) daily or less may suffice. Conversely, some patients may require a higher dose.
Children up to 10 years:
In the newborn, particularly in the premature infant, renal clearance of digoxin is diminished and suitable dose reductions must be observed, over and above general dosage instructions.
Beyond the immediate newborn period, children generally require proportionally larger doses than adults on the basis of body weight or body surface area, as indicated in the schedule below. Children over ten years of age require adult dosages in proportion to their body weight.
Oral loading dose: This should be administered in accordance with the following schedule: pre-term neonates less than 1.5kg (25 micrograms/kg body weight over 24 hours); pre-term neonates 1.5-2.5kg (30 micrograms/kg body weight over 24 hours); term neonates to 2 years (45 micrograms/kg body weight over 24 hours); 2-5 years (35 micrograms/kg body weight over 24 hours); 5-10 years (25 micrograms/kg body weight over 24 hours).
The loading dose should be administered in divided doses with approximately half the total dose given as the first dose, and further fractions of the total dose given at intervals of 4-8 hours, assessing clinical response before giving each additional dose.
Maintenance: The maintenance dose should be administered in accordance with the following schedule: pre-term neonates (daily dose is 20% of 24 hour loading dose); term neonates and children up to 10 years (daily dose is 25% of 24 hour loading dose).