LANOXIN

LANOXIN — digoxin tablet
Concordia Pharmaceuticals Inc.

1 INDICATIONS AND USAGE

1.1 Heart Failure in Adults

LANOXIN is indicated for the treatment of mild to moderate heart failure in adults. LANOXIN increases left ventricular ejection fraction and improves heart failure symptoms as evidenced by improved exercise capacity and decreased heart failure-related hospitalizations and emergency care, while having no effect on mortality. Where possible, LANOXIN should be used in combination with a diuretic and an angiotensin-converting enzyme (ACE) inhibitor.

1.2 Heart Failure in Pediatric Patients

LANOXIN increases myocardial contractility in pediatric patients with heart failure.

1.3 Atrial Fibrillation in Adults

LANOXIN is indicated for the control of ventricular response rate in adult patients with chronic atrial fibrillation.

2 DOSAGE AND ADMINISTRATION

2.1 Important Dosing and Administration Information

In selecting a LANOXIN dosing regimen, it is important to consider factors that affect digoxin blood levels (e.g., body weight, age, renal function, concomitant drugs) since toxic levels of digoxin are only slightly higher than therapeutic levels. Dosing can be either initiated with a loading dose followed by maintenance dosing if rapid titration is desired or initiated with maintenance dosing without a loading dose.

Consider interruption or reduction in LANOXIN dose prior to electrical cardioversion [see Warnings and Precautions ( 5.4)].

Use digoxin solution to obtain the appropriate dose in infants, young pediatric patients, or patients with very low body weight.

2.2 Loading Dosing Regimen in Adults and Pediatric Patients

For adults and pediatric patients if a loading dosage is to be given, administer half the total loading dose initially, then ¼ the loading dose every 6-8 hours twice, with careful assessment of clinical response and toxicity before each dose. The recommended loading dose is displayed in Table 1.

Table 1. Recommended LANOXIN Oral Loading Dose
Age Total Oral Loading Dose (mcg/kg) Administer half the total loading dose initially, then ¼ the loading dose every 6 to 8 hours twice
5 to 10 years 20-45
Adults and pediatric patients over 10 years 10-15

mcg = microgram

2.3 Maintenance Dosing in Adults and Pediatric Patients Over 10 Years Old

The maintenance dose is based on lean body weight, renal function, age, and concomitant products [see Clinical Pharmacology (12.3)].

The recommended starting maintenance dose in adults and pediatric patients over 10 years old with normal renal function is given in Table 2. Doses may be increased every 2 weeks according to clinical response, serum drug levels, and toxicity.

Table 2. Recommended Starting LANOXIN Maintenance Dosage in Adults and Pediatric Patients Over 10 Years Old
Age Total Oral Maintenance Dose, mcg/kg/day (given once daily)
Adults and pediatric patients over 10 years 3.4-5.1

mcg = microgram

Table 3 provides the recommended (once daily) maintenance dose for adults and pediatric patients over 10 years old (to be given once daily) according to lean body weight and renal function. The doses are based on studies in adult patients with heart failure. Alternatively, the maintenance dose may be estimated by the following formula (peak body stores lost each day through elimination):

Total Maintenance Dose = Loading Dose (i.e., Peak Body Stores) x % Daily Loss/100(% Daily Loss = 14 + Creatinine clearance/5)

Reduce the dose of LANOXIN in patients whose lean weight is an abnormally small fraction of their total body mass because of obesity or edema.

Table 3. Recommended Maintenance Dose (in micrograms given once daily) of LANOXIN in Pediatric Patients Over 10 Years Old and Adults by Lean Body Weight and by Renal Functiona
Corrected Creatinine Clearanceb Lean Body Weightd Number of Days Before Steady State Achievedc
kg 40 50 60 70 80 90 100
10 mL/min 62.5* 125 125 187.5 187.5 187.5 250 19
20 mL/min 125 125 125 187.5 187.5 250 250 16
30 mL/min 125 125 187.5 187.5 250 250 312.5 14
40 mL/min 125 187.5 187.5 250 250 312.5 312.5 13
50 mL/min 125 187.5 187.5 250 250 312.5 312.5 12
60 mL/min 125 187.5 250 250 312.5 312.5 375 11
70 mL/min 187.5 187.5 250 250 312.5 375 375 10
80 mL/min 187.5 187.5 250 312.5 312.5 375 437.5 9
90 mL/min 187.5 250 250 312.5 375 437.5 437.5 8
100 mL/min 187.5 250 312.5 312.5 375 437.5 500 7

a 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.
b For adults , creatinine clearance was corrected to 70-kg body weight or 1.73 m2 body surface area. If only serum creatinine concentrations (Scr) are available, a corrected Ccr may be estimated in men as (140 – Age)/Scr. For women, this result should be multiplied by 0.85.
For pediatric patients, the modified Schwartz equation may be used. The formula is based on height in cm and Scr in mg/dL where k is a constant. Ccr is corrected to 1.73 m2 body surface area. During the first year of life, the value of k is 0.33 for pre-term babies and 0.45 for term infants. The k is 0.55 for pediatric patients and adolescent girls and 0.7 for adolescent boys.
GFR (mL/min/1.73 m2) = (k x Height)/Scr
c If no loading dose administered.d The doses listed assume average body composition.

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