LANOXIN (Page 2 of 9)
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.
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.
a Recommended are doses to be given twice daily.b The doses are rounded to the nearest dose possible using whole LANOXIN 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. | |||||||||
CorrectedCreatinineClearancec | Lean Body Weight | Number of DaysBefore 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 |
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