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Betapace ISI

Betapace®/Betapace AF® (sotalol hydrochloride) Tablets Important Safety Information

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.

Indication and Dosing

Betapace/Betapace AF is an antiarrhythmic indicated for:

  • the treatment of life-threatening ventricular arrhythmias
  • the maintenance of normal sinus rhythm in patients with atrial fibrillation or flutter (AFIB/AFL)

Limitations of Use

  • Betapace has not been shown to enhance survival in patients with life threatening ventricular arrhythmias
  • Avoid use in patients with minimally symptomatic or easily reversible AFIB/AFL

Contraindications

For the treatment of AFIB/AFL or ventricular arrhythmias:

  • Sinus bradycardia, 2ndor 3rd degree atrioventricular (AV) block, sick sinus syndrome
  • Congenital or acquired long QT syndrome
  • Serum potassium <4 mEq/L
  • Cardiogenic shock, decompensated heart failure
  • Bronchial asthma or related bronchospastic conditions
  • Hypersensitivity to sotalol

For the treatment of AFIB/AFL also contraindicated for:

  • QT interval >450 msec

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

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%.

To report SUSPECTED ADVERSE REACTIONS, contact Covis Pharma at 1-866-488-4423 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

 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

Use In Specific Populations

  • Lactation: Do not breastfeed

Please see Full Prescribing Information, including Boxed Warning, for Betapace/Betapace AF.

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