Generic Name and Formulations:
Digoxin 0.0625mg, 0.125mg+, 0.25mg+; (+) scored tabs.
Concordia Pharmaceuticals Inc.
Indications for LANOXIN:
Mild-to-moderate heart failure (with a diuretic and an ACE inhibitor when possible). Increase myocardial contractility in pediatrics with heart failure. Control of ventricular response rate in chronic atrial fibrillation.
Adults and Children:
Individualize: see full labeling. Reduce dose in premature and immature infants. Children usually need proportionally larger doses (based on body weight or surface area) than adults. Use divided doses for children <10yrs. Retitrate when changing formulations (esp. oral tabs to or from other dose forms).
Renal dysfunction: reduce dose. Sinus node disease. Incomplete AV block. Accessory AV pathway (Wolff-Parkinson-White syndrome). Heart failure with preserved LV ejection fraction (eg, restrictive cardiomyopathy, constrictive pericarditis, amyloid heart disease, acute cor pulmonale, idiopathic hypertrophic subaortic stenosis). Electrical cardioversion. Acute MI. Avoid in myocarditis. Toxicity risk increased by hypokalemia, hypomagnesemia, hypercalcemia. Hypocalcemia may nullify effects. Thyroid disease. Hypermetabolic states. Monitor digoxin levels, electrolytes, renal function. Premature infants. Neonates. Labor & Delivery. Pregnancy; monitor. Nursing mothers.
Toxicity risk increased by potassium-depleting drugs (eg, diuretics, amphotericin B, corticosteroids). Digoxin levels increased by antibiotics (eg, macrolides, tetracyclines), amiodarone, dronedarone, propafenone, quinidine, quinine, ritonavir, verapamil, indomethacin, itraconazole, lapatinib, mirabegron, spironolactone, telaprevir, drugs that reduce GI motility (eg, propantheline, diphenoxylate), thyroid antagonists, drugs that reduce renal function, others. Digoxin levels decreased by thyroid hormones, antacids, kaolin-pectin, cholestyramine, neomycin, penicillamine, rifampin, sulfasalazine, drugs that increase GI motility (eg, metoclopramide), certain antineoplastics, others. Digoxin levels possibly affected by alprazolam, cyclosporine, diclofenac, others. Arrhythmias with sympathomimetics, succinylcholine, or rapid calcium infusion. Heart block with drugs that affect cardiac conduction (eg, calcium channel blockers, β-blockers). Increased risk of bradycardia with ivabradine.
GI upset, anorexia, CNS effects (eg, blurred or yellow vision, or mental disturbances, confusion, headache, weakness, dizziness, apathy), gynecomastia, rash, heart block, arrhythmias (esp. children).
Tabs—100, 1000; Inj 0.25mg/mL (2mL amps)—10; Inj Pediatric (1mL amp)—10