Lanoxin tablet
For information about (Generic Name), click here.

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# Black Box Warning

# Overview
Lanoxin tablet is a _______ drug that is FDA approved for the treatment of _______. There is a Black Box Warning for this drug as shown here. Common adverse reactions include _______.

# Adult Indications and Dosage

## FDA-Labeled Indications and Dosage (Adult)

### Heart failure
- Dosing Information

### Atrial fibrillation
- Dosing Information

## Off-Label Use and Dosage (Adult)

### Guideline-Supported Use
- Developed by: (Organisation)
- Class of Recommendation: (Class) (Link)
- Strength of Evidence: (Category A/B/C) (Link)
- Dosing Information
- Developed by: (Organisation)
- Class of Recommendation: (Class) (Link)
- Strength of Evidence: (Category A/B/C) (Link)
- Dosing Information

### NonGuideline-Supported Use
- Dosing Information
- Dosing Information
- Dosing Information

# Pediatric Indications and Dosage

## FDA-Labeled Indications and Dosage (Pediatric)
- Dosing Information
- Loading dose
- 5-10 years old: 20-45 mcg/kg Administer half the total loading dose initially, then 14 the loading dose every 6 to 8 hours twice.
- >10 year old: 10-15 mcg/kg Administer half the total loading dose initially, then 14 the loading dose every 6 to 8 hours twice.
- Maintenence dose:
- 2-5 years: 10-15 mcg/kg/day.
- 5-10 years: 7-10 mcg/kg/day.
- More than 10 years: 3-5 mcg/kg/day.
- Dosing Information

## Off-Label Use and Dosage (Pediatric)

### Guideline-Supported Use
- Developed by: (Organisation)
- Class of Recommendation: (Class) (Link)
- Strength of Evidence: (Category A/B/C) (Link)
- Dosing Information
- Developed by: (Organisation)
- Class of Recommendation: (Class) (Link)
- Strength of Evidence: (Category A/B/C) (Link)
- Dosing Information

### NonGuideline-Supported Use
0.01 mg/kg orally 3 times daily for the first 2 doses, then 0.0035 mg/kg 3 times daily
Maternal 0.25 to 0.375 mg PO daily alone or with verapamil.
- Dosing Information
- Dosing Information
- Dosing Information

# Contraindications
- Ventricular fibrillation
- Hypersensitivity to digoxin

# Warnings
Because digoxin slows sinoatrial and AV conduction, the drug commonly prolongs the PR interval. The drug may cause severe sinus bradycardia or sinoatrial block in patients with pre-existing sinus node disease and may cause advanced or complete heart block in patients with pre-existing incomplete AV block. In such patients consideration should be given to the insertion of a pacemaker before treatment with digoxin.
After intravenous digoxin therapy, some patients with paroxysmal atrial fibrillation or flutter and a coexisting accessory AV pathway have developed increased antegrade conduction across the accessory pathway bypassing the AV node, leading to a very rapid ventricular response or ventricular fibrillation. Unless conduction down the accessory pathway has been blocked (either pharmacologically or by surgery), digoxin should not be used in such patients. The treatment of paroxysmal supraventricular tachycardia in such patients is usually direct-current cardioversion.
Patients with certain disorders involving heart failure associated with preserved left ventricular ejection fraction may be particularly susceptible to toxicity of the drug. Such disorders include restrictive cardiomyopathy, constrictive pericarditis, amyloid heart disease, and acute cor pulmonale. Patients with idiopathic hypertrophic subaortic stenosis may have worsening of the outflow obstruction due to the inotropic effects of digoxin. Digoxin should generally be avoided in these patients, although it has been used for ventricular rate control in the subgroup of patients with atrial fibrillation.

# Adverse Reactions

## Clinical Trials Experience

### Infant and Children
The side effects of digoxin in infants and children differ from those seen in adults in several respects. Although digoxin may produce anorexia, nausea, vomiting, diarrhea, and CNS disturbances in young patients, these are rarely the initial symptoms of overdosage. Rather, the earliest and most frequent manifestation of excessive dosing with digoxin in infants and children is the appearance of cardiac arrhythmias, including sinus bradycardia. In children, the use of digoxin may produce any arrhythmia. The most common are conduction disturbances or supraventricular tachyarrhythmias, such as atrial tachycardia (with or without block) and junctional (nodal) tachycardia. Ventricular arrhythmias are less common. Sinus bradycardia may be a sign of impending digoxin intoxication, especially in infants, even in the absence of first-degree heart block. Any arrhythmia or alteration in cardiac conduction that develops in a child taking digoxin should be assumed to be caused by digoxin, until further evaluation proves otherwise.

## Postmarketing Experience
FDA Package Insert for digoxin tablet contains no information regarding 'Postmarketing Experience'.

# Drug Interactions
Potassium-depleting diuretics are a major contributing factor to digitalis toxicity.
Calcium, particularly if administered rapidly by the intravenous route, may produce serious arrhythmias in digitalized patients.
Quinidine, verapamil, amiodarone, propafenone, indomethacin, itraconazole, alprazolam, and spironolactone raise the serum digoxin concentration due to a reduction in clearance and/or in volume of distribution of the drug, with the implication that digitalis intoxication may result.
Erythromycin and clarithromycin (and possibly othermacrolide antibiotics) and tetracycline may increase digoxin absorption in patients who inactivate digoxin by bacterial metabolism in the lower intestine, so that digitalis intoxication may result (see Pharmacology).
Decrease gut motility, which may increase digoxin absorption.
May interfere with intestinal digoxin absorption, resulting in unexpectedly low serum concentrations.
May decrease serum digoxin concentration, especially in patients with renal dysfunction, by increasing the non-renal clearance of digoxin.
Thyroid administration to a digitalized, hypothyroid patient may increase the dose requirement of digoxin.
Concomitant use of digoxin and sympathomimetics increases the risk of cardiac arrhythmias.
Succinylcholine may cause a sudden extrusion of potassium from muscle cells, and may thereby cause arrhythmias in digitalized patients.
Use with digoxin may be useful in combination to control atrial fibrillation, their additive effects on AV node conduction can result in advanced or complete heart block.
Both digitalis glycosides and beta-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia. Digoxin concentrations are increased by about 15% when digoxin and carvedilol are administered concomitantly. Therefore, increased monitoring of digoxin is recommended when initiating, adjusting, or discontinuing carvedilol.

# Use in Specific Populations

### Pregnancy
Animal reproduction studies have not been conducted with digoxin. It is also not known whether digoxin can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Digoxin should be given to a pregnant woman only if clearly needed.

### Labor and Delivery
(Description)

### Nursing Mothers
Studies have shown that digoxin concentrations in the mothers serum and milk are similar. However, the estimated exposure of a nursing infant to digoxin via breastfeeding will be far below the usual infant maintenance dose. Therefore, this amount should have no pharmacologic effect upon the infant. Nevertheless, caution should be exercised when digoxin is administered to a nursing woman.

### Pediatric Use
Newborn infants display considerable variability in their tolerance to digoxin. Premature and immature infants are particularly sensitive to the effects of digoxin, and the dosage of the drug must not only be reduced but must be individualized according to their degree of maturity. Digitalis glycosides can cause poisoning in children due to accidental ingestion.

### Geriatric Use
The majority of clinical experience gained with digoxin has been in the elderly population. This experience has not identified differences in response or adverse effects between the elderly and younger patients. However, this drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, which should be based on renal function, and it may be useful to monitor renal function (see DOSAGE AND ADMINISTRATION).

### Gender
(Description)

### Race
(Description)

### Renal Impairment
(Description)

### Hepatic Impairment
(Description)

### Females of Reproductive Potential and Males
(Description)

### Immunocompromised Patients
(Description)

# Administration and Monitoring

### Administration
(Oral/Intravenous/etc)

### Monitoring
(Description regarding monitoring, from Warnings section)
(Description regarding monitoring, from Warnings section)
(Description regarding monitoring, from Warnings section)

# IV Compatibility

## Solution

### Compatible
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### Not Tested
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### Variable
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### Incompatible
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## Y-Site

### Compatible
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### Not Tested
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### Variable
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### Incompatible
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## Admixture

### Compatible
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### Not Tested
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### Variable
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### Incompatible
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## Syringe

### Compatible
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### Not Tested
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### Variable
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### Incompatible
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## TPN/TNA

### Compatible
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### Not Tested
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### Variable
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### Incompatible
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# Overdosage

## Acute Overdose

### Signs and Symptoms
(Description)

### Management
(Description)

## Chronic Overdose

### Signs and Symptoms
(Description)

### Management
(Description)

# Pharmacology

## Mechanism of Action
(Description)

## Structure
(Description with picture)

## Pharmacodynamics
(Description)

## Pharmacokinetics
(Description)

## Nonclinical Toxicology
(Description)

# Clinical Studies
(Description)
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# How Supplied
(Description)
- National Drug Code (NDC):
- Storage:
- Manufactured by:
- Distributed by:

# Images

## Drug Images
(PillBox Images)

## Package and Label Display Panel
(Package Images)
(Display Panel Images)

# Patient Information

## Patient Information from FDA
(Patient Counseling Information)

## Patient Information from NLM
(Link to patient information page)

# Precautions with Alcohol
Alcohol-Lanoxin tablet interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

# Look-Alike Drug Names
- (Paired Confused Name 1a)  (Paired Confused Name 1b)
- (Paired Confused Name 2a)  (Paired Confused Name 2b)
- (Paired Confused Name 3a)  (Paired Confused Name 3b)

# Drug Shortage Status

# Price