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Label Changes for:

Betapace (sotalol hydrochloride) and Betapace AF (sotalol hydrochloride) Tablets

February 2011

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

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – February 2011



Drug Interactions
  • Digoxin: ...Both digitalis glycosides and beta-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia.