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.

Table 4. Recommended Starting LANOXIN 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 LANOXIN in Pediatric Patients between 5 and 10 Years of Agea Based upon Lean Body Weight and Renal Functiona,b
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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