Betapace (Sotalol HCI)
Betapace AF (sotalol HCI) Patient Pack

Warning: Life-Threatening Proarrhythmia

See full prescribing information for complete boxed warning.

  • Betapace/Betapace AF can cause life-threatening ventricular tachycardia associated with QT interval prolongation.
  • If the QT interval prolongs to 500 msec or greater, reduce the dose, lengthen the dosing interval, or discontinue the drug.
  • Initiate or reinitiate in a facility that can provide cardiac resuscitation and continuous electrocardiographic monitoring.
  • Adjust the dosing interval based on creatinine clearance.

Warnings and Precautions

  • QT prolongation, bradycardia, AV block, hypotension, worsening heart failure: Reduce dose or discontinue
  • Acute exacerbation of coronary artery disease upon cessation of therapy: Do not abruptly discontinue
  • Correct any electrolyte disturbances
  • May mask symptoms of hypoglycemia or worsen hyperglycemia in diabetic patients; monitor

Drug Interactions

  • Class I or III Antiarrhythmics or other drugs that prolong the QT interval: Avoid concomitant use
  • Digoxin, calcium channel blocker: increased risk of bradycardia, hypotension, heart failure
  • Dosage of insulin or antidiabetic drugs may need adjustment
  • Aluminum or magnesium based antacids reduce sotalol exposure
  • Adverse Events

  • The most common adverse reactions (≥2%) for Betapace are: fatigue 4%, bradycardia (less than 50 beats per minute) 3%, dyspnea 3%, proarrhythmia 3%, asthenia 2%, and dizziness 2%.
  • Use In Specific Populations

  • Lactation: Do not breastfeed

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