Digoxin

DIGOXIN- digoxin injection
Hikma Pharmaceuticals USA Inc.

1 INDICATIONS AND USAGE

1.1 Heart Failure in Adults

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

1.2 Atrial Fibrillation in Adults

Digoxin 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 digoxin 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.

Parenteral administration of digoxin should be used only when the need for rapid digitalization is urgent or when the drug cannot be taken orally. Intramuscular injection can lead to severe pain at the injection site, thus intravenous administration is preferred. If the drug must be administered by the intramuscular route, it should be injected deep into the muscle followed by massage. For adults, no more than 500 mcg of Digoxin Injection should be injected into a single site. For pediatric patients, see the full prescribing information for pediatric digoxin injection (not available from West-Ward) for specific recommendations.

Administer the dose over a period of 5 minutes or longer and avoid bolus administration to prevent systemic and coronary vasoconstriction. Mixing of Digoxin Injection with other drugs in the same container or simultaneous administration in the same intravenous line is not recommended.

Digoxin Injection can be administered undiluted or diluted with a 4-fold or greater volume of Sterile Water for Injection, 0.9% Sodium Chloride Injection, or 5% Dextrose Injection. The use of less than a 4-fold volume of diluent could lead to precipitation of the digoxin. Immediate use of the diluted product is recommended.

If tuberculin syringes are used to measure very small doses do not flush with the parenteral solution after its contents are expelled into an indwelling vascular catheter to avoid overadministration of digoxin.

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

2.2 Loading Dosing Regimen in Adults and Pediatric Patients Over 10 Years Old

Table 1. Recommended Digoxin Injection Loading Dose
mcg = microgram
Age Total IV Loading Dose (mcg/kg) Administer half the total loading dose initially, then ¼ the loading dose every 6-8 hours twice
Adults and pediatric patients over 10 years old 8-12

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 Injection Maintenance Dosage in Adults and Pediatric Patients Over 10 Years Old
mcg = microgram
Age Total Intravenous Maintenance Dose, mcg/kg/day(given once daily)
Adults and pediatric patients over 10 years old 2.4-3.6

Table 3 provides the recommended (once daily) maintenance dose for adults and pediatric patients over 10 years old 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 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 Injection in Pediatric Patients Over 10 Years Old and Adults by Lean Body Weight and by Renal Function

a 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

b If no loading dose administered

c The doses listed assume average body composition.

Corrected Creatinine Clearancea Lean Body Weightc Number of Days Before SteadyState Achievedb
kg 40 50 60 70 80 90 100
10 mL/min 64 80 96 112 128 144 160 19
20 mL/min 72 90 108 126 144 162 180 16
30 mL/min 80 100 120 140 160 180 200 14
40 mL/min 88 110 132 154 176 198 220 13
50 mL/min 96 120 144 168 192 216 240 12
60 mL/min 104 130 156 182 208 234 260 11
70 mL/min 112 140 168 196 224 252 280 10
80 mL/min 120 150 180 210 240 270 300 9
90 mL/min 128 160 192 224 256 288 320 8
100 mL/min 136 170 204 238 272 306 340 7

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