Label Changes for:

Lanoxin (digoxin) pediatric injection and tablets

February 2010

Changes have been made to the WARNINGS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – February 2010

WARNINGS

Use in Patients with Preserved Left Ventricular Systolic Function
  • Digoxin should generally be avoided in these patients, although it has been used for ventricular rate control in the subgroup of patients with chronic atrial fibrillation.
Use in Patients with Beri Beri Heart Disease
  • Patients with beri beri heart disease may fail to respond adequately to digoxin if the underlying thiamine deficiency is not treated concomitantly
Drug Interactions, Succinylcholine (revised)
  • Succinylcholine may cause a sudden extrusion of potassium from muscle cells, and may thereby cause arrhythmias in digitalized patients. Although calcium channel blockers and digoxin may be useful in combination to control atrial fibrillation, their additive effects on AV node conduction can result in advanced or complete heart block. Both digitalis glycosides and beta-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia. Digoxin concentrations are increased by about 15% when digoxin and carvedilol are administered concomitantly. Therefore, increased monitoring of digoxin is recommended when initiating, adjusting, or discontinuing carvedilol
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