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
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
- 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.
- 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.