What is the difference between Betapace and Betapace AF?
Betapace and Betapace AF are two prescription medications that contain the same active ingredient called sotalol hydrochloride. Sotalol is a beta blocker used in the treatment and prevention of irregular heartbeats or arrhythmias.
Betapace and Betapace AF are essentially the same but they differ in their appearance - Betapace is a light-blue tablet and Betapace AF is a white tablet - and their approved uses.
Betapace was approved by the US Food and Drug Administration (FDA) in 1992. This approval allowed for Betapace to be used in the treatment of life-threatening ventricular arrhythmias, such as sustained ventricular tachycardia. A ventricular arrhythmia is an abnormal heartbeat affecting the lower chambers of the heart called the ventricles. It can cause the heart to beat too fast (tachycardia) and can limit or prevent your heart from pumping blood around your body. This type of arrhythmia can cause fainting, cardiac arrest and death.
In 2000, the FDA approved Betapace AF. Betapace AF, however, wasn’t approved to treat ventricular arrhythmias, but was instead approved for the maintenance of normal sinus rhythm (delay in time to recurrence of atrial fibrillation/atrial flutter (AFIB/AFL)) in patients with symptomatic AFIB/AFL who are currently in sinus rhythm. Normal sinus rhythm is a regular and healthy heartbeat that originates for the sinus node or natural pacemaker of the heart. AFIB/AFL is not usually considered life-threatening.
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When Betapace AF was first approved by the FDA, the prescribing information documents for both Betapace and Betapace AF contained a warning stating that the two products should not be substituted for one another because they were approved for different uses and had significant differences in their product labels, including the patient package insert, dosing administration and safety information.
However, in 2015, Covis Pharma acquired US marketing rights for the products and moved to providing only one lot of prescribing information covering both products, at which point the warnings about substitutions were dropped.
How do Betapace and Betapace AF compare?
| Betapace | Betapace AF | |
| FDA approval | 1992 | 2000 |
| Uses | Treatment of life-threatening ventricular arrhythmias | Maintenance of normal sinus rhythm in patients with AFIB/AFL |
| Dosage form and strength | 80 mg, 120 mg and 160 mg oral tablets | 80 mg, 120 mg and 160 mg oral tablets |
| Tablet appearance | Light-blue capsule-shaped scored tablet | White capsule-shaped scored tablet |
| Ingredients |
Active ingredient: sotalol
Inactive ingredients: microcrystalline cellulose, lactose, starch, stearic acid, magnesium stearate, colloidal silicon dioxide, and FD&C blue color #2 (aluminum lake, conc.). |
Active ingredient: sotalol
Inactive ingredients: microcrystalline cellulose, lactose, starch, stearic acid, magnesium stearate, and colloidal silicon dioxide. |
References
- Covis Pharma. Historic Milestones. [Accessed October 21, 2022]. Available from: https://covispharma.com/index.php/timeline/.
- Food and Drug Administration (FDA). Betapace and Betapace AF Product Label. June 2021. [Accessed October 21, 2022]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019865s022lbl.pdf.
- Food and Drug Administration (FDA). Betapace Product Label. August 2011. [Accessed October 21, 2022]. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019865s020lbl.pdf.
- Food and Drug Administration (FDA). Betapace AF Product Label. August 2011. [Accessed October 21, 2022]. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021151s010lbl.pdf.
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