Digoxin

DIGOXIN- digoxin tablet
REMEDYREPACK INC.

1 INDICATIONS AND USAGE

1.1 Heart Failure in Adults

Digoxin tablets are indicated for the treatment of mild to moderate heart failure in adults. Digoxin tablets 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, digoxin tablets should be used in combination with a diuretic and an angiotensin-converting enzyme (ACE) inhibitor.

1.2 Heart Failure in Pediatric Patients

Digoxin tablets increases myocardial contractility in pediatric patients with heart failure.

1.3 Atrial Fibrillation in Adults

Digoxin tablets are 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 digoxin tablets 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 digoxin tablets 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 to 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 Digoxin Tablets Oral Loading Dose

mcg = microgram
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 to 45
Adults and pediatric patients over 10 years	10 to 15

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 Digoxin Tablets Maintenance Dosage in Adults and Pediatric Patients Over 10 Years Old

mcg = microgram
Age	Total Oral Maintenance Dose, mcg/kg/day (given once daily)
Adults and pediatric patients over 10 years	3.4 to 5.1

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 digoxin tablets 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 Digoxin Tablets in Pediatric Patients Over 10 Years Old and Adults by Lean Body Weight and by Renal Function ^a

a Doses are rounded to the nearest dose possible using whole digoxin 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 m 2 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 m 2 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 m 2) = (k x Height)/Scr c If no loading dose administered. d The doses listed assume average body composition.
Corrected Creatinine Clearance b	Lean Body Weight d								Number of Days Before Steady State Achieved c
	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