LANOXIN (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 doses for pediatric patients are given in Table 4. These recommendations assume the presence of normal renal function.

Table 4. Recommended Starting LANOXIN Injection Maintenance Dosage in Pediatric Patients Less Than 10 Years Old
mcg = microgram

Age

Dose Regimen, mcg/kg/dose (given TWICE daily)

Premature

1.9-3.1

Full-Term

3.0-4.5

1-24 Months

4.5-7.5

2-5 Years

3.8-5.3

5-10 Years

2.3-4.5

Table 5 provides average daily maintenance dose requirements for pediatric patients less than 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 Injection in Pediatric Patients Less Than 10 Years of Agea Based upon Lean Body Weight and Renal Functiona
a Recommended are doses to be given twice daily.b The modified Schwartz equation may be used to estimate creatinine clearance. See footnote a under Table 3.c If no loading dose administered.

Corrected Creatinine Clearanceb

Lean Body Weight

Number of Days Before Steady State Achievedc

kg

5

10

20

30

40

50

60

10 mL/min

8

16

32

48

64

80

96

19

20 mL/min

9

18

36

54

72

90

108

16

30 mL/min

10

20

40

60

80

100

120

14

40 mL/min

11

22

44

66

88

110

132

13

50 mL/min

12

24

48

72

96

120

144

12

60 mL/min

13

26

52

78

104

130

156

11

70 mL/min

14

28

56

84

112

140

168

10

80 mL/min

15

30

60

90

120

150

180

9

90 mL/min

16

32

64

96

128

160

192

8

100 mL/min

17

34

68

102

136

170

204

7

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