BLACK BOX WARNING
- QT prolongation and serious ventricular arrhythmias
sotalol
Brand: Betapace, Sorine
⚠ BBW Prototype: amiodarone
Drug Class: antiarrhythmic (Class III/II)
Drug Family: antiarrhythmic
Subclass: non-selective beta-blocker + potassium channel blocker
Organ Systems: cardiovascular
Mechanism of Action
Non-selective beta-blocker with Class III potassium channel blockade; prolongs QT interval; racemic mixture (L-enantiomer is beta-blocker, D-enantiomer is Class III).
beta-1/beta-2 adrenergic receptorsIKr potassium channel
Indications
- ventricular arrhythmias (VT/VF)
- atrial fibrillation (maintenance of sinus rhythm)
Contraindications
- QT prolongation >450ms
- hypokalemia
- CrCl <40 (accumulates)
- cardiogenic shock
- 2nd/3rd degree AV block
Adverse Effects
Common
- bradycardia
- dizziness
- fatigue
- QT prolongation
Serious
- torsades de pointes (dose-dependent)
- severe bradycardia
- proarrhythmia
Pharmacokinetics (ADME)
| Absorption | ~100% oral bioavailability |
| Distribution | low (hydrophilic) |
| Metabolism | not metabolized — excreted unchanged |
| Excretion | renal |
| Half-life | 12 hours |
| Onset | 2-3 hours |
| Peak | 2.5-4 hours |
| Duration | 24 hours |
| Protein Binding | 0% |
| Vd | 1.2-2.4 L/kg |
Drug Interactions
| Drug / Agent | Mechanism | Severity |
|---|---|---|
| QT-prolonging drugs | additive QT prolongation/TdP | major |
| diuretics (causing hypokalemia) | hypokalemia amplifies TdP risk | major |
Nursing Considerations
- QTc monitoring: obtain ECG before each dose increase — hold if QTc >500ms
- Requires in-hospital ECG monitoring for first 3 days (REMS program)
- Renally cleared — dose interval adjustment in renal impairment
- Correct hypokalemia and hypomagnesemia before initiation
Clinical Pearls
- Hydrophilic: no hepatic metabolism, renally cleared; dose interval extends as CrCl falls
- Proarrhythmia risk (TdP) highest at low heart rates (reverse use-dependence) and hypokalemia
Safety Profile
Pregnancy avoid
Lactation avoid
Renal Adjustment Required
Hepatic Adjustment Not required
TDM Not required
Concordance Terms
Cross-referenced clinical concepts — click any term to see all content where it appears.