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Lanoxin
Generic Name: Digoxin
Drug Category: Cardiac Glycoside
Litigation Alert Level: High
This drug has been approved for use by males and females over the age of 0 year old for a maximum duration of 3 years.
| Approved Uses |
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Indicated for: Heart Failure in Adults: • Treatment of mild to moderate heart failure in adults. Where possible, LANOXIN should be used in combination with a diuretic and an angiotensin-converting enzyme (ACE) inhibitor. Heart Failure in Pediatric Patients: • Increasing myocardial contractility in pediatric patients with heart failure. Atrial Fibrillation in Adults: • The control of ventricular response rate in adult patients with chronic atrial fibrillation. LANOXIN is contraindicated in patients with ventricular fibrillation. Consider interruption or reduction in LANOXIN dose prior to electrical cardioversion. LANOXIN is not recommended in patients with acute myocardial infarction because digoxin may increase myocardial oxygen demand and lead to ischemia. LANOXIN can precipitate vasoconstriction and may promote production of pro-inflammatory cytokines; therefore, avoid use in patients with myocarditis. Patients with heart failure associated with preserved left ventricular ejection fraction may experience decreased cardiac output with use of LANOXIN. LANOXIN should generally be avoided in these patients, although it has been used for ventricular rate control in the subgroup of patients with atrial fibrillation. The safety and effectiveness of LANOXIN in the control of ventricular rate in children with atrial fibrillation have not been established. The safety and effectiveness of LANOXIN in the treatment of heart failure in children have not been established in adequate and well-controlled studies. 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. LANOXIN may cause severe sinus bradycardia or sinoatrial 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. 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. Hypothyroidism may reduce the requirements for digoxin. Patients with beriberi heart disease may fail to respond adequately to digoxin if the underlying thiamine deficiency is not treated concomitantly. Hypocalcemia can nullify the effects of digoxin in humans; thus, digoxin may be ineffective until serum calcium is restored to normal. Digoxin concentrations increased when used with quinidine or ritonavir. Concomitant administration with dofetilide was associated with a higher rate of torsades de pointes. Concomitant administration with sotalol associated with proarrhythmic events. Concomitant administration with dronedarone associated with sudden death. Concomitant administration with teriparatide associated with increased serum calcium and possible digitalis toxicity. Concomitant administration with thyroid supplement may increase the dose requirements of digoxin. Concomitant administration with epinephrine, norepinephrine, and dopamine can increase the risk of cardiac arrhythmias. Concomitant administration with succinylcholine may cause sudden extrusion of potassium from muscle cells, causing arrhythmias in patients taking digoxin. Calcium If administered rapidly by intravenous route, can produce serious arrhythmias in digitalized patients. Concomitant administration with beta-adrenergic blockers and calcium channel blockers have additive effects on AV node conduction that can result in bradycardia and advanced or complete heart block. Use with ivabradine can increase the risk of bradycardia. It is also not known whether digoxin can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Animal reproduction studies have not been conducted with digoxin. Digoxin has been shown to cross the placenta and is found in amniotic fluid. Monitor neonates for signs and symptoms of digoxin toxicity, including vomiting, and cardiac arrhythmias. Studies have shown that digoxin distributes into breast milk and that the milk-to serum concentration ratio is approximately 0.6-0.9. |
| Off-label Uses |
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• Improve renal function. GoToSource • Intervention in preterm pregnancies complicated by pre-eclampsia or eclampsia. GoToSource |
| Adverse Events |
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Increased risk of death in dialysis patients. GoToSource Increase in deaths among heart failure patients treated with digoxin compared to patients not treated with the drug. GoToSource Cardiac arrhythmias. GoToSource Intestinal necrosis. GoToSource Ocular toxicity. GoToSource Increased risk of uterus cancer. GoToSource Increased risk of breast cancer. GoToSource Sexual dysfunction, decreased serum testosterone and serum luteinizing hormone. GoToSource Gynecomastia (enlarged male breast tissue). GoToSource Thrombocytopenia (low blood platelet count). GoToSource Exacerbation of psoriasis. GoToSource |
| Litigation |
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Lawsuits filed for deaths and cardiac injuries. |
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