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Lanoxin Tablets (Digoxin Tablets)

SKU: N/A

Synonyms: Acid Phenylethylbarbituric, Gardenal, Hysteps, Luminal, Monosodium Salt Phenobarbital, Phenemal, Phenobarbital, Phenobarbital Sodium, Phenobarbital Monosodium Salt, Phenobarbitone, Phenylbarbital, Phenylethylbarbituric Acid, Sodium Phenobarbital,

CAS#: 20830-75-5

Molecular Mass: 780.949 g/mol

Molecular Formula:  C41H64O14

Form: Tablets

Administration: Oral

Storage: Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended that the product be stored at 20-25°C (68-77°F), however, brief excursions are permitted between 15-30°C (59-86°F).


Each tablet contains 125 or 250 mcg of Digoxin as active ingredient.

Digoxin, sold under the brand name Lanoxin among others, is a medication used to treat various heart conditions.

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Description

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What is Lanoxin (Digoxin)?

LANOXIN (digoxin) is a cardiac glycoside, a closely related group of drugs having in common specific effects on the myocardium. These drugs are found in a number of plants. Digoxin is extracted from the leaves of Digitalis lanata.

LANOXIN is supplied as 125 mcg (0.125-mg) or 250 mcg (0.25-mg) tablets for oral administration. Each tablet contains the labeled amount of digoxin USP and the following inactive ingredients: corn and potato starches, lactose, and magnesium stearate. In addition, the dyes used in the 125 mcg (0.125 mg) tablets are D&C Yellow No. 10 and FD&C Yellow No. 6.

Indications and Dosage

Indications

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

LANOXIN is indicated for the control of ventricular response rate in adult patients with chronic atrial fibrillation.

Dosage and Administration

Important Dosing 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.

Consider interruption or reduction in digoxin dose prior to electrical cardioversion.

Use digoxin solution to obtain the appropriate dose in infants, young pediatric patients, or patients with very low body weight.

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 4 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 LANOXIN Oral Loading Dose

 

AgeOral Loading Dose, mcg/kg
5 to 10 years20 -45
Adults and pediatric patients over 10 years10-15
mcg = micrograms

 

Maintenance Dosing in Adults and Pediatric Patients Over 10 Years Old

The maintenance dose is based on the lean body weight, renal function, age, and concomitant products.

The recommended starting maintenance dosage in adults and pediatric patients over 10 years old is displayed in Table 2. Doses may be increased every 2 weeks according to clinical response, serum drug levels, and toxicity.

Table 2: Recommended Starting LANOXIN Maintenance Dosage in Adults and Pediatric Patients Over 10 Years Old

 

AgeOral Maintenance Dose, mcg/kg/day (given once daily)
Adults and pediatric patients over 10 years3.4 – 5.1
mcg = micrograms

 

Table 3 displays the recommended (once daily) maintenance dose of LANOXIN in pediatric patients over 10 years old and adult patients 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 in Pediatric Patients Over 10 Years Old and Adults by Lean Body Weight and by Renal Functiona

 

Corrected Creatinine ClearancebLean Body WeightdNumber of Days Before Steady State Achievedc
kg405060708090100
lb88110132154176198220
10 mL/min62.5*125125187.5187.5187.525019
20 mL/min125125125187.5187.525025016
30 mL/min125125187.5187.5250250312.514
40 mL/min125187.5187.5250250312.5312.513
50 mL/min125187.5187.5250250312.5312.512
60 mL/min125187.5250250312.5312.537511
70 mL/min187.5187.5250250312.537537510
80 mL/min187.5187.5250312.5312.5375437.59
90 mL/min187.5250250312.5375437.5437.58
100 mL/min187.5250312.5312.5375437.55007
aDoses are rounded to the nearest dose possible using whole and/or half LANOXIN 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. .

bFor 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

cIf no loading dose administered.

dThe 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 the lean body weight, renal function, age, and concomitant products.

The recommended starting maintenance dose for pediatric patients between 5 and 10 years old with normal renal function is displayed in Table 4.

Table 4: Recommended Starting LANOXIN Maintenance Dosage in Pediatric Patients Between 5 and 10 Years Old

 

AgeDaily Oral Maintenance Dose, mcg/kg/dayDose Regimen, mcg/kg/dose
5 to 10 years6.4 – 12.93.2 – 6.4 Twice daily

 

The recommended maintenance dose (to be given twice daily) is presented in Table 5.

Table 5: Recommended Maintenance Dose (in micrograms given twice daily) of LANOXIN in Pediatric Patients < 10 Years of Age Based upon Lean Body Weight and Renal Function,b

 

Corrected Creatinine ClearancecLean Body WeightNumber of Days Before Steady State Achievedd
kg2030405060
lb446688110132
10 mL/min62.562.5*12512519
20 mL/min62.562.512512512516
30 mL/min62.562.5*125125187.514
40 mL/min62.562.5*125187.5187.513
50 mL/min62.5125125187.5187.512
60 mL/min62.5125125187.525011
70 mL/min62.5125187.5187.525010
80 mL/min62.5*125187.5187.52509
90 mL/min62.5*125187.52502508
100 mL/min62.5*125187.5250312.57
aRecommended are doses to be given twice daily.

bThe doses are rounded to the nearest dose possible using whole and/or half LANOXIN 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

c The modified Schwartz equation may be used to estimate creatinine clearance. See footnote b under Table 2.

d If no loading dose administered.

 

 

Monitor for signs and symptoms of digoxin toxicity and clinical response. Adjust dose based on toxicity, efficacy, and blood levels.

Serum digoxin levels < 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.

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% to 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 BioavailabilityEquivalent Doses (in micrograms)
LANOXIN Tablets60 -80%62.5125250500
LANOXIN Intravenous Injection100%50100200400

 

HOW SUPPLIED

Dosage Forms And Strengths

Tablets: 125 micrograms are yellow, round, scored tablets with “Y3B” imprinted on one side. Tablets: 250 micrograms are white, round, scored tablets with “X3A” imprinted on one side.

Storage And Handling

LANOXIN (digoxin) Tablets, Scored 125 mcg (0.125 mg): Bottles of 100 with child-resistant cap (NDC 0173-0242-55) and 1,000 (NDC 0173-0242-75); unit dose pack of 100 (NDC 01730242-56). Imprinted with LANOXIN and Y3B (yellow).

LANOXIN (digoxin) Tablets, Scored 250 mcg (0.25 mg): Bottles of 100 with child-resistant cap (NDC0173-0249-55), 1,000 (NDC 0173-0249-75), and 5,000 (NDC 0173-0249-80); unit dose pack of 100 (NDC 0173-0249-5656). Imprinted with LANOXIN and X3A (white).

Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) in a dry place and protect from light. Keep out of reach of children.

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