Digoxin (Page 2 of 8)

2.4 Maintenance Dosing in Pediatric Patients Less Than 10 Years Old

The starting maintenance dose for heart failure in pediatric patients less than 10 years old is based on lean body weight, renal function, age, and concomitant products [see Clinical Pharmacology (12.3)]. The recommended starting maintenance dose for pediatric patients between 5 years and 10 years old is given in Table 4. These recommendations assume the presence of normal renal function.

Table 4. Recommended Starting Digoxin Oral Maintenance Dosage in Pediatric Patients between 5 and 10 Years Old

Age Oral Maintenance Dose, mcg/kg/dose
5 years to 10 years 3.2-6.4 Twice daily

Table 5 provides average daily maintenance dose requirements for pediatric patients between 5 and 10 years old (to be given twice daily) with heart failure based on age, lean body weight, and renal function.

Table 5. Recommended Maintenance Dose (in micrograms given TWICE daily) of Digoxin in Pediatric Patients between 5 and 10 Years of Agea Based upon Lean Body Weight and Renal Functiona,b

Corrected Creatinine Clearance c Lean Body Weight Number of days before SteadyState Achievedd
kg 20 30 40 50 60
10 mL/min 62.5 62.5* 125 125 19
20 mL/min 62.5 62.5 125 125 125 16
30 mL/min 62.5 62.5* 125 125 187.5 14
40 mL/min 62.5 62.5* 125 187.5 187.5 13
50 mL/min 62.5 125 125 187.5 187.5 12
60 mL/min 62.5 125 125 187.5 250 11
70 mL/min 62.5 125 187.5 187.5 250 10
80 mL/min 62.5* 125 187.5 187.5 250 9
90 mL/min 62.5* 125 187.5 250 250 8
100 mL/min 62.5* 125 187.5 250 312.5 7

a. Recommended are doses to be given twice daily.

b. The doses are rounded to the nearest dose possible using whole Digoxin tablets. Recommended doses approximately 30 percent lower than the calculated dose are designated with an *. Monitor digoxin levels in patients receiving these initial doses and increase dose if needed.

c. The modified Schwartz equation may be used to estimate creatinine clearance. See footnote b under Table 3.

d. If no loading dose administered.

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