LANOXIN
LANOXIN- digoxin injection, solution
Covis Pharma US, 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.
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
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.
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.
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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