"The U.S. Food and Drug Administration today approved Entresto (sacubitril/valsartan) tablets for the treatment of heart failure. The drug has been shown to reduce the rate of cardiovascular death and hospitalization related to heart failure."...
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.
Heart Failure in Pediatric Patients
LANOXIN increases myocardial contractility in pediatric patients with heart failure.
Atrial Fibrillation in Adults
DOSAGE AND ADMINISTRATION
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.
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.
Loading Dosing Regimen in Adults and Pediatric Patients
Table 1: Recommended LANOXIN Injection Loading Dose
|Age||Total IV Loading Dose (mcg/kg) Administer half the total loading dose initially, then 1/4 the loading dose every 6-8 hours twice|
|Adults and pediatric patients over 10 years||8-12|
|mcg = microgram|
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].
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
|Age||Total Intravenous Maintenance Dose, mcg/kg/day (given once daily)|
|Adults and pediatric patients over 10 years||2.4-3.6|
|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)
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
|Corrected Creatinine Clearancea||Lean Body Weightc||Number of Days Before Steady State Achievedb|
|aFor 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
bIf no loading dose administered
cThe doses listed assume average body composition.
Maintenance Dosing in Pediatric Patients Less Than 10 Years Old
The starting maintenance dose for heart failure in pediatric patients less than 10 years old is based on lean body weight, renal function, age, and concomitant products [see CLINICAL PHARMACOLOGY]. The recommended starting maintenance doses for pediatric patients are given in Table 4. These recommendations assume the presence of normal renal function.
Table 4: Recommended Starting LANOXIN Injection
Maintenance Dosage in Pediatric Patients Less Than 10 Years Old
|Age||Dose Regimen, mcg/kg/dose (given TWICE daily)|
|mcg = microgram|
Table 5 provides average daily maintenance dose requirements for pediatric patients less than 10 years old (to be given twice daily) with heart failure based on age, lean body weight, and renal function.
Table 5: Recommended
Maintenance Dose (in micrograms given TWICE daily) of LANOXIN Injection in
Pediatric Patients Less Than 10 Years of Agea Based upon Lean Body
Weight and Renal Functiona
|Corrected Creatinine Clearanceb||Lean Body Weight||Number of Days Before Steady State Achievedc|
|a Recommended are doses to be given twice daily.
b The modified Schwartz equation may be used to estimate creatinine clearance. See footnote a under Table 3.
c If no loading dose administered.
Monitoring to Assess Safety, Efficacy, and Therapeutic Blood Levels
Monitor for signs and symptoms of digoxin toxicity and clinical response. Adjust dose based on toxicity, efficacy, and blood levels.
Serum digoxin levels less than 0.5 ng/mL have been associated with diminished efficacy, while levels above 2 ng/mL have been associated with increased toxicity without increased benefit.
Interpret the serum digoxin concentration in the overall clinical context, and do not use an isolated measurement of serum digoxin concentration as the basis for increasing or decreasing the LANOXIN dose. Serum digoxin concentrations may be falsely elevated by endogenous digoxin-like substances [see DRUG INTERACTIONS]. If the assay is sensitive to these substances, consider obtaining a baseline digoxin level before starting LANOXIN and correct post-treatment values by the reported baseline level.
Obtain serum digoxin concentrations just before the next scheduled LANOXIN dose or at least 6 hours after the last dose. The digoxin concentration is likely to be 10-25% lower when sampled right before the next dose (24 hours after dosing) compared to sampling 8 hours after dosing (using once-daily dosing). However, there will be only minor differences in digoxin concentrations using twice daily dosing whether sampling is done at 8 or 12 hours after a dose.
Switching from Intravenous Digoxin to Oral Digoxin
When switching from intravenous to oral digoxin formulations, make allowances for differences in bioavailability when calculating maintenance dosages (see Table 6).
Table 6: Comparison of the Systemic Availability and
Equivalent Doses of Oral and Intravenous LANOXIN
|Absolute Bioavailability||Equivalent Doses (mcg)|
|LANOXIN Intravenous Injection||100%||50||100||200||400|
Dosage Forms And Strengths
LANOXIN Injection: Ampules of 500 mcg (0.5 mg) in 2 mL (250 mcg [0.25 mg] per 1 mL).
LANOXIN Injection Pediatric: Ampules of 100 mcg (0.1 mg) in 1 mL.
Storage And Handling
LANOXIN (digoxin) Injection, 500 mcg (0.5 mg) in 2 mL (250 mcg [0.25 mg] per mL); box of 10 ampules (NDC 24987 260 10)
LANOXIN (digoxin) Injection Pediatric, 100 mcg (0.1 mg) in 1 mL; box of 10 ampules (NDC 24987 262 10)
Store at 25 °C (77 °F); excursions permitted to 15 °C to 30 °C (59 °F to 86 °F) [see USP Controlled Room Temperature] and protect from light.
LANOXIN Injection manufactured by Jubilant Hollister. Kirkland, Canada H9H 4J4. LANOXIN Injection Pediatric manufactured by DSM Pharmaceuticals, Inc. Greenville, NC 27834. Distributed by Covis Pharmaceuticals, Inc. Cary, NC 27511This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 6/17/2013
Additional Lanoxin Injection Information
- Lanoxin Injection Drug Interactions Center: digoxin inj
- Lanoxin Injection Side Effects Center
- Lanoxin Injection FDA Approved Prescribing Information including Dosage
Report Problems to the Food and Drug Administration
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