Digoxin

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Digoxin®
Black Box Warning
Adult Indications and Dosage
Pediatric Indications and Dosage
Contraindications
Warnings
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration and Monitoring
IV Compatibility
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient information
Precautions with Alcohol
Brand Names
Look-Alike Drug Names
Drug Shortage Status
Price

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Abdurahman Khalil, M.D. [2]

Synonyms / Brand Names: Digox; Lanoxin

Disclaimer

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Black Box Warning

FDA Package Insert for Digoxin contains no information regarding Black Box Warning.

Overview

Digoxin is a cardiac glycoside drug that is FDA approved for the treatment of atrial fibrillation, atrial flutter, and heart failure. Common adverse reactions include dizziness, headache, mental disorder, nausea, and vomiting.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Heart failure
  • Dosing Information
  • Loading dose: Oral10-15 mcg/kg half of dose administered initially, and the other two quarters are given every 6-8 hours twice.

Intravenous 8-12 mcg/kg half of the dose is given initially, and the other two quarters are given each 6-8 hours in two doses.

  • Maintenance dose: Oral3.4-5.1 mcg/kg/day once daily.

Intravenous 2.4-3.6 mcg/kh/day once daily.

Atrial fibrillation
  • Dosing Information
  • Loading dose: Oral 10-15 mcg/kg PO half of dose administered initially, and the other two quarters are given every 6-8 hours twice.

Intravenous 8-12 mcg/kg half of the dose is given initially, and the other two quarters are given each 6-8 hours in two doses.

  • Maintenance dose: Oral 3.4-5.1 mcg/kg/day PO once daily.

Intravenous 2.4-3.6 mcg/kh/day once daily.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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Non–Guideline-Supported Use

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Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition 1
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Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition 1
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Non–Guideline-Supported Use

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Contraindications

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Warnings

Ventricular Fibrillation in Patients With Accessory AV Pathway (Wolff-Parkinson-White Syndrome)

Patients with Wolff-Parkinson-White syndrome who develop atrial fibrillation are at high risk of ventricular fibrillation. Treatment of these patients with digoxin leads to greater slowing of conduction in the atrioventricular node than in accessory pathways, and the risks of rapid ventricular response leading to ventricular fibrillation are thereby increased.

Sinus Bradycardia and Sino-atrial Block

Digoxin may cause severe sinus bradycardia or sino-atrial block particularly in patients with pre-existing sinus node disease and may cause advanced or complete heart block in patients with pre-existing incomplete AV block. Consider insertion of a pacemaker before treatment with digoxin.

Digoxin Toxicity

Signs and symptoms of digoxin toxicity include anorexia, nausea, vomiting, visual changes and cardiac arrhythmias [first-degree, second-degree (Wenckebach), or third-degree heart block (including asystole); atrial tachycardia with block; AV dissociation; accelerated junctional (nodal) rhythm; unifocal or multiform ventricular premature contractions (especially bigeminy or trigeminy); ventricular tachycardia; and ventricular fibrillation]. Toxicity is usually associated with digoxin levels greater than 2 ng/mL although symptoms may also occur at lower levels. Low body weight, advanced age or impaired renal function, hypokalemia, hypercalcemia, or hypomagnesemia may predispose to digoxin toxicity. Obtain serum digoxin levels in patients with signs or symptoms of digoxin therapy and interrupt or adjust dose if necessary [see Adverse Reactions (6) and Overdosage (10)]. Assess serum electrolytes and renal function periodically. The earliest and most frequent manifestation of digoxin toxicity 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 arrhythmias or alteration in cardiac conduction that develops in a child taking digoxin should initially be assumed to be a consequence of digoxin intoxication.

Misidentification of Digoxin Toxicity

Given that adult patients with heart failure have some symptoms in common with digoxin toxicity, it may be difficult to distinguish digoxin toxicity from heart failure. Misidentification of their etiology might lead the clinician to continue or increase digoxin dosing, when dosing should actually be suspended. When the etiology of these signs and symptoms is not clear, measure serum digoxin levels.

Risk of Ventricular Arrhythmias During Electrical Cardioversion

It may be desirable to reduce the dose of or discontinue digoxin for 1-2 days prior to electrical cardioversion of atrial fibrillation to avoid the induction of ventricular arrhythmias, but physicians must consider the consequences of increasing the ventricular response if digoxin is decreased or withdrawn. If digitalis toxicity is suspected, elective cardioversion should be delayed. If it is not prudent to delay cardioversion, the lowest possible energy level should be selected to avoid provoking ventricular arrhythmias.

Risk of Ischemia in Patients With Acute Myocardial Infarction

Digoxin is not recommended in patients with acute myocardial infarction because digoxin may increase myocardial oxygen demand and lead to ischemia.

Vasoconstriction in Patients With Myocarditis

Digoxin can precipitate vasoconstriction and may promote production of pro-inflammatory cytokines; therefore, avoid use in patients with myocarditis.

Decreased Cardiac Output in Patients With Preserved Left Ventricular Systolic Function

Patients with heart failure associated with preserved left ventricular ejection fraction may experience decreased cardiac output with use of digoxin. 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. Patients with amyloid heart disease may be more susceptible to digoxin toxicity at therapeutic levels because of an increased binding of digoxin to extracellular amyloid fibrils. 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.

Reduced Efficacy in Patients With Hypocalcemia

Hypocalcemia can nullify the effects of digoxin in humans; thus, digoxin may be ineffective until serum calcium is restored to normal. These interactions are related to the fact that digoxin affects contractility and excitability of the heart in a manner similar to that of calcium.

Altered Response in Thyroid Disorders and Hypermetabolic States

Hypothyroidism may reduce the requirements for digoxin. Heart failure and/or atrial arrhythmias resulting from hypermetabolic or hyperdynamic states (e.g., hyperthyroidism, hypoxia, or arteriovenous shunt) are best treated by addressing the underlying condition. Atrial arrhythmias associated with hypermetabolic states are particularly resistant to digoxin treatment. Patients with beri beri heart disease may fail to respond adequately to digoxin if the underlying thiamine deficiency is not treated concomitantly.

Adverse Reactions

Clinical Trials Experience

Condition 1
Central Nervous System
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Cardiovascular
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Respiratory
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Gastrointestinal
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Condition 2
Central Nervous System
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Cardiovascular
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Respiratory
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Postmarketing Experience

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Drug Interactions

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Use in Specific Populations

Pregnancy

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Labor and Delivery

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Nursing Mothers

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Pediatric Use

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Geriatric Use

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Gender

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Race

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Renal Impairment

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Hepatic Impairment

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Carcinogenesis, Mutagenesis, Impairment of Fertility

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Immunocompromised Patients

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Miscellaneous

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Administration and Monitoring

Administration

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Monitoring

Condition 1

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Condition 2

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Condition 3

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IV Compatibility

Solution

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Variable

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Incompatible

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Y-Site

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Variable

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Incompatible

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Admixture

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Incompatible

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Syringe

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TPN/TNA

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Overdosage

Acute Overdose

Signs and Symptoms

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Management

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Chronic Overdose

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Management

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Pharmacology

Digoxin
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Mechanism of Action

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Pharmacodynamics

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Nonclinical Toxicology

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Clinical Studies

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How Supplied

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Images

Drug Images

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Package and Label Display Panel

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Patient Information

Patient Information from FDA

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Patient Information from NLM

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Precautions with Alcohol

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

Brand Names

Brand Names®

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

References