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
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

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.

2.5 Monitoring to Assess Safety, Efficacy, and Therapeutic Blood Levels

Monitor for signs and symptoms of digoxin toxicity and clinical response. Adjust dose based on toxicity, efficacy, and blood levels.

Serum digoxin levels less than 0.5 ng/mL have been associated with diminished efficacy, while levels above 2 ng/mL have been associated with increased toxicity without increased benefit.

Interpret the serum digoxin concentration in the overall clinical context, and do not use an isolated measurement of serum digoxin concentration as the basis for increasing or decreasing the LANOXIN dose. Serum digoxin concentrations may be falsely elevated by endogenous digoxin-like substances [see Drug Interactions (7.4)]. If the assay is sensitive to these substances, consider obtaining a baseline digoxin level before starting LANOXIN and correct post-treatment values by the reported baseline level.

Obtain serum digoxin concentrations just before the next scheduled LANOXIN dose or at least 6 hours after the last dose. The digoxin concentration is likely to be 10-25% lower when sampled right before the next dose (24 hours after dosing) compared to sampling 8 hours after dosing (using once-daily dosing). However, there will be only minor differences in digoxin concentrations using twice daily dosing whether sampling is done at 8 or 12 hours after a dose.

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