Digoxin
Generic: DIGOXIN
Basic Information
Manufacturer
Hikma Pharmaceuticals USA Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
1b7e5c6e-e052-41b0-a4ce-05dfe62faaaf
Indications & Usage
1 INDICATIONS AND USAGE Digoxin is a cardiac glycoside indicated in adults for the treatment of mild to moderate heart failure and for the control of resting ventricular rate in patients with chronic atrial fibrillation.
( 1.1 , 1.3 ) In pediatric patients with heart failure, digoxin is indicated to increase myocardial contractility.
( 1.2 ) 1.1 Heart Failure in Adults Digoxin Oral Solution is indicated for the treatment of mild to moderate heart failure.
Digoxin increases left ventricular ejection fraction and improves heart failure symptoms as evidenced by increased exercise capacity and decreased heart failure-related hospitalizations and emergency care, while having no effect on mortality.
Where possible, digoxin should be used with a diuretic and an angiotensin-converting enzyme inhibitor, but an optimal order for starting these three drugs cannot be specified.
1.2 Heart Failure in Pediatric Patients Digoxin is indicated to increase myocardial contractility in pediatric patients with heart failure.
1.3 Atrial Fibrillation in Adults Digoxin Oral Solution is indicated for the control of resting ventricular response rate in patients with chronic atrial fibrillation.
Digoxin should not be used for the treatment of multifocal atrial tachycardia.
( 1.1 , 1.3 ) In pediatric patients with heart failure, digoxin is indicated to increase myocardial contractility.
( 1.2 ) 1.1 Heart Failure in Adults Digoxin Oral Solution is indicated for the treatment of mild to moderate heart failure.
Digoxin increases left ventricular ejection fraction and improves heart failure symptoms as evidenced by increased exercise capacity and decreased heart failure-related hospitalizations and emergency care, while having no effect on mortality.
Where possible, digoxin should be used with a diuretic and an angiotensin-converting enzyme inhibitor, but an optimal order for starting these three drugs cannot be specified.
1.2 Heart Failure in Pediatric Patients Digoxin is indicated to increase myocardial contractility in pediatric patients with heart failure.
1.3 Atrial Fibrillation in Adults Digoxin Oral Solution is indicated for the control of resting ventricular response rate in patients with chronic atrial fibrillation.
Digoxin should not be used for the treatment of multifocal atrial tachycardia.
Adverse Reactions
6 ADVERSE REACTIONS The frequency and severity of adverse reactions to digoxin when taken orally depend on the dose and the patient's underlying disease or concomitant therapies [see Warnings and Precautions (5) and Drug Interactions (7) ].
The overall incidence of adverse reactions has been reported as 5% to 20%, with 15% to 20% of them being considered serious (1% to 4% of patients receiving digoxin).
Evidence suggests that the incidence of toxicity has decreased since the introduction of the serum digoxin assay and improved standardization of digoxin tablets.
Cardiac toxicity accounts for about one-half, gastrointestinal disturbances for about one-fourth, and CNS and other toxicity for about one-fourth of these adverse reactions.
Adverse reactions are less common when digoxin is used within the recommended dose range or therapeutic serum concentration range and when there is careful attention to concurrent medications and conditions.
The overall incidence of adverse reactions with digoxin has been reported as 5% to 20%, with 15% to 20% of adverse events considered serious.
Cardiac toxicity accounts for about one-half, gastrointestinal disturbances for about one-fourth, and CNS and other toxicity for about one-fourth of these adverse events.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc.
at 1-800-962-8364 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Cardiac In adults, high doses of digoxin may produce a variety of electrocardiographic changes and rhythm disturbances, such as first-degree, second-degree (Wenckebach), or third-degree heart block (including asystole); atrial tachycardia with block; AV dissociation; accelerated junctional (nodal) rhythm; unifocal or multifocal ventricular premature contractions (especially bigeminy or trigeminy); ventricular tachycardia; and ventricular fibrillation.
Prophylactic use of a cardiac pacemaker may be considered if the risk of heart block is considered unacceptable.
In pediatric patients, the use of digoxin may produce arrhythmias.
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.
6.2 Gastrointestinal Anorexia, nausea, vomiting and diarrhea may be early symptoms of digoxin toxicity.
However, uncontrolled heart failure may also produce such symptoms.
The use of digoxin has been associated with abdominal pain, intestinal ischemia, and hemorrhagic necrosis of the intestines.
6.3 CNS and Special Senses Digoxin can produce visual disturbances (blurred vision, green-yellow color disturbances, halo effect), headache, weakness, dizziness, apathy, confusion, and mental disturbances (such as anxiety, depression, delirium, and hallucination).
6.4 Other Gynecomastia has been reported following the prolonged use of digoxin.
Thrombocytopenia, maculopapular rash and other skin reactions have been observed.
The overall incidence of adverse reactions has been reported as 5% to 20%, with 15% to 20% of them being considered serious (1% to 4% of patients receiving digoxin).
Evidence suggests that the incidence of toxicity has decreased since the introduction of the serum digoxin assay and improved standardization of digoxin tablets.
Cardiac toxicity accounts for about one-half, gastrointestinal disturbances for about one-fourth, and CNS and other toxicity for about one-fourth of these adverse reactions.
Adverse reactions are less common when digoxin is used within the recommended dose range or therapeutic serum concentration range and when there is careful attention to concurrent medications and conditions.
The overall incidence of adverse reactions with digoxin has been reported as 5% to 20%, with 15% to 20% of adverse events considered serious.
Cardiac toxicity accounts for about one-half, gastrointestinal disturbances for about one-fourth, and CNS and other toxicity for about one-fourth of these adverse events.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc.
at 1-800-962-8364 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Cardiac In adults, high doses of digoxin may produce a variety of electrocardiographic changes and rhythm disturbances, such as first-degree, second-degree (Wenckebach), or third-degree heart block (including asystole); atrial tachycardia with block; AV dissociation; accelerated junctional (nodal) rhythm; unifocal or multifocal ventricular premature contractions (especially bigeminy or trigeminy); ventricular tachycardia; and ventricular fibrillation.
Prophylactic use of a cardiac pacemaker may be considered if the risk of heart block is considered unacceptable.
In pediatric patients, the use of digoxin may produce arrhythmias.
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.
6.2 Gastrointestinal Anorexia, nausea, vomiting and diarrhea may be early symptoms of digoxin toxicity.
However, uncontrolled heart failure may also produce such symptoms.
The use of digoxin has been associated with abdominal pain, intestinal ischemia, and hemorrhagic necrosis of the intestines.
6.3 CNS and Special Senses Digoxin can produce visual disturbances (blurred vision, green-yellow color disturbances, halo effect), headache, weakness, dizziness, apathy, confusion, and mental disturbances (such as anxiety, depression, delirium, and hallucination).
6.4 Other Gynecomastia has been reported following the prolonged use of digoxin.
Thrombocytopenia, maculopapular rash and other skin reactions have been observed.