Last reviewed · How we verify
Betapace (sotalol)
At a glance
| Generic name | sotalol |
|---|---|
| Sponsor | Bayer |
| Target | Beta-1 adrenergic receptor, Beta-2 adrenergic receptor, Potassium voltage-gated channel subfamily H member 2 |
| Therapeutic area | Cardiovascular |
| Phase | FDA-approved |
Approved indications
- Atrial fibrillation
- Life-Threatening Ventricular Tachycardia
Boxed warnings
- WARNING: LIFE-THREATENING PROARRHYTHMIA To minimize the risk of drug-induced arrhythmia, initiate or reinitiate oral sotalol in a facility that can provide cardiac resuscitation and continuous electrocardiographic monitoring. Sotalol 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. Calculate creatinine clearance to determine appropriate dosing [see Dosage and Administration ( 2.5 )] . WARNING: LIFE-THREATENING PROARRHYTHMIA See full prescribing information for complete boxed warning. Sotalol 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.
Common side effects
- Fatigue
- Bradycardia
- Dizziness
- Dyspnea
- Headache
- Nausea/Vomiting
- Diarrhea
- Weakness
- Hyperhidrosis
- Asthenia
Serious adverse events
- Torsade de Pointes
- Ventricular Tachycardia/Ventricular Fibrillation (VT/VF)
- Proarrhythmia
- QT interval prolongation
- Pulmonary edema
- Thrombocytopenia
- Leukopenia
- Eosinophilia
Key clinical trials
- Medical ANtiarrhythmic Treatment or Radiofrequency Ablation in Ischemic Ventricular Tachyarrhythmias. A Prospective, Randomized Multicentre Study. (Phase 4)
- Efficacy and Safety Evaluation of Azimilide or Sotalol vs Placebo for Treatment of Patients With Atrial Fibrillation. (Phase 3)
- Catheter Ablation Compared With Pharmacological Therapy for Atrial Fibrillation - a Randomized Multicentre Study Comparing Atrial Fibrillation Ablation Strategy With Optimized Conventional Pharmacolog (NA)
- CSP #399 - The Effects of Antiarrhythmic Therapy in Maintaining Stability of Sinus Rhythm in Atrial Fibrillation (Phase 3)
- A Nested Case-control Study of the Association Between Coreg IR and Coreg CR and Hypersensitivity Reactions: Anaphylactic Reaction/Angioedema-Updated Analysis (N/A)
- Initial Management of Patients Receiving a Single Shock (IMPRESS) (NA)
- Cryoballoon Ablation Versus Medical Therapy in Patients With Atrial Fibrillation and Heart Failure With Different Ejection Fraction Categories (N/A)
- N-of-1 Trials for Deprescribing Beta-blockers in HFpEF (Phase 4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Betapace CI brief — competitive landscape report
- Betapace updates RSS · CI watch RSS
- Bayer portfolio CI