Drug Name:
Digoxin Oral Solution Rx

Generic Name and Formulations:
Digoxin 0.05mg; per mL; lime-flavored; contains alcohol 10%.
Company:
Roxane Laboratories, Inc.
Therapeutic Use:
Indications for Digoxin Oral Solution:
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.
Adult:
Individualize: see full labeling. Initially 0.003mg/kg per day. Monitor digoxin levels.
Children:
Individualize: see full labeling. >2yrs: initially 0.01mg/kg per day. Monitor digoxin levels.
Contraindications:
Ventricular fibrillation.
Warnings/Precautions:
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, hypertrophic cardiomyopathy). Electrical cardioversion. Acute MI. Avoid in myocarditis. Toxicity risk increased by hypokalemia, hypomagnesemia, hypercalcemia, diabetes. Hypocalcemia may nullify effects. Thyroid disease. Hypermetabolic states. Monitor digoxin levels, electrolytes, renal function. Elderly. Children. Infants. Pregnancy (Cat.C). Nursing mothers.
Pharmacological Class:
Cardiac glycoside.
Interactions:
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.
Adverse Reactions:
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).
How Supplied:
Soln—60mL
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