LANOXIN

LANOXIN- digoxin injection, solution
Covis Pharma

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.

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 LANOXIN Injection should be injected into a single site. For pediatric patients, no more than 200 mcg of LANOXIN Injection Pediatric should be injected into a single site.

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

LANOXIN Injection and Injection Pediatric 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.

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

2.2 Loading Dosing Regimen in Adults and Pediatric Patients

Table 1. Recommended LANOXIN 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

Premature

15-25

Full-Term

20-30

1-24 Months

30-50

2-5 Years

25-35

5-10 Years

15-30

Adults and pediatric patients over 10 years

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 doses in adults and pediatric patients over 10 years old with normal renal function are 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 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

2.4-3.6

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 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)/Scrb If no loading dose administeredc The doses listed assume average body composition.

Corrected Creatinine Clearancea

Lean Body Weightc

Number of Days Before Steady State 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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