Betapace (sotalol hydrochloride) is a potent antiarrhythmic agent specifically formulated for the management of life-threatening ventricular arrhythmias and the maintenance of normal sinus rhythm in patients with highly symptomatic atrial fibrillation or flutter. As a class III antiarrhythmic drug with additional beta-blocking properties, it offers a dual mechanism of action that effectively prolongs the cardiac action potential duration and refractory period, thereby stabilizing erratic electrical activity within the heart. Its use is reserved for patients in whom the benefits outweigh the significant risks, necessitating initiation and dose titration within a setting equipped for cardiac monitoring due to the proarrhythmic potential, particularly torsades de pointes. Proper patient selection, adherence to dosing protocols, and continuous evaluation are paramount to achieving optimal therapeutic outcomes while minimizing adverse events.

Features

• Contains sotalol hydrochloride as the active pharmaceutical ingredient
• Available in tablet formulations of 80 mg, 120 mg, 160 mg, and 240 mg strengths
• Exhibits both beta-adrenergic blocking (Class II) and action potential prolongation (Class III) antiarrhythmic effects
• Oral administration with bioavailability of approximately 90–100%
• Not subject to significant first-pass metabolism; primarily excreted unchanged by the kidneys
• Demonstrated efficacy in suppressing and preventing recurrence of ventricular tachycardia and fibrillation
• Effective in converting atrial fibrillation/flutter to sinus rhythm and maintaining sinus rhythm post-cardioversion
• Requires hospital-based initiation with continuous ECG monitoring for a minimum of 3 days or until steady-state dosing is achieved

Benefits

• Reduces the frequency and severity of symptomatic atrial and ventricular arrhythmias, decreasing emergency department visits and hospitalizations.
• Lowers the risk of sudden cardiac death in high-risk patient populations by preventing life-threatening tachyarrhythmias.
• Provides a dual antiarrhythmic mechanism, offering comprehensive electrical stabilization for complex arrhythmia substrates.
• Helps maintain sinus rhythm, improving overall cardiac efficiency, exercise tolerance, and quality of life.
• Supports long-term rhythm control strategies with a well-established efficacy and safety profile when used appropriately.
• Allows for dose customization based on renal function, clinical response, and QT interval, facilitating personalized treatment.

Common use

Betapace is primarily indicated for the treatment of documented life-threatening ventricular arrhythmias, such as sustained ventricular tachycardia. It is also used to maintain normal sinus rhythm in patients with symptomatic atrial fibrillation or atrial flutter who are currently in sinus rhythm. Its use is generally considered after other antiarrhythmic agents have failed or are contraindicated, given its specific risk profile. It is not intended for use in patients with less severe arrhythmias or as a first-line treatment option without thorough cardiovascular evaluation.

Dosage and direction

Dosage must be individualized based on renal function, clinical response, and QT interval monitoring. The usual initial dose for ventricular arrhythmias is 80 mg twice daily, which may be increased gradually to 240–320 mg per day divided into two or three doses. For atrial fibrillation/flutter, the starting dose is typically 80 mg twice daily, with upward titration to 120 mg twice daily if necessary. Doses must be adjusted in patients with renal impairment. All patients should be initiated on Betapace in a hospital setting with continuous ECG monitoring for at least 3 days. Administration should occur at the same times each day, with or without food.

Precautions

Betapace should be used with extreme caution due to its potential to cause life-threatening proarrhythmias, including torsades de pointes. Renal function must be assessed prior to and during therapy. Electrolyte imbalances, particularly hypokalemia and hypomagnesemia, should be corrected before initiation. Use is not recommended in patients with baseline QT prolongation, sinus bradycardia, second- or third-degree AV block (unless a functioning pacemaker is present), cardiogenic shock, uncontrolled heart failure, or asthma. Periodic monitoring of ECG, heart rate, blood pressure, and renal function is essential throughout treatment.

Contraindications

Betapace is contraindicated in patients with:

• Sinus bradycardia (heart rate < 50 bpm)
• Second- or third-degree AV block without a pacemaker
• Congenital or acquired long QT syndromes
• Cardiogenic shock or uncompensated heart failure
• Severe renal impairment (CrCl < 40 mL/min)
• Bronchial asthma or related bronchospastic conditions
• Hypersensitivity to sotalol or any component of the formulation
• Concomitant use with other QT-prolonging drugs

Possible side effect

Common side effects may include fatigue, dizziness, bradycardia, dyspnea, chest pain, palpitations, and lightheadedness. Serious adverse reactions include proarrhythmia (torsades de pointes), heart failure exacerbation, severe bradycardia, hypotension, and bronchospasm. Other potential effects include nausea, vomiting, diarrhea, sleep disturbances, depression, and visual changes. Any symptoms suggestive of arrhythmia or heart failure should prompt immediate medical evaluation.

Drug interaction

Betapase has significant interactions with:

• Other QT-prolonging drugs (e.g., antiarrhythmics, antipsychotics, antibiotics) – increased risk of torsades de pointes
• Calcium channel blockers and beta-blockers – additive effects on heart rate and contractility
• Digoxin – may potentiate bradycardia
• Insulin and oral hypoglycemics – masking of hypoglycemia symptoms
• Catecholamine-depleting agents (e.g., reserpine) – risk of excessive bradycardia and hypotension
• Diuretics – may exacerbate electrolyte disturbances

Missed dose

If a dose is missed, it should be taken as soon as remembered unless it is nearly time for the next dose. In that case, the missed dose should be skipped, and the regular dosing schedule resumed. Doubling the dose to make up for a missed one is not recommended.

Overdose

Overdose may lead to severe bradycardia, hypotension, heart failure, bronchospasm, hypoglycemia, and life-threatening arrhythmias. Management includes gastric lavage if ingestion was recent, along with supportive measures such as atropine for bradycardia, beta-agonists for bronchospasm, vasopressors for hypotension, and transvenous pacing if necessary. Hemodialysis may be effective due to Betapace’s renal excretion.

Storage

Store at room temperature (20–25°C or 68–77°F), in a tightly closed container, away from light, moisture, and heat. Keep out of reach of children and pets. Do not use after the expiration date printed on the packaging.

Disclaimer

This information is intended for educational purposes and does not replace professional medical advice, diagnosis, or treatment. Always consult a qualified healthcare provider before starting, changing, or discontinuing any medication or treatment plan. Individual patient needs and responses may vary.

Reviews

Clinical studies and post-marketing surveillance have demonstrated Betapace’s efficacy in managing serious cardiac arrhythmias, though its use requires careful patient selection and monitoring. Many cardiologists regard it as a valuable option for rhythm control in appropriately screened individuals. Patient experiences often reflect improved symptom control and quality of life when treatment is successfully managed, though side effects—particularly fatigue and dizziness—are frequently reported. Long-term adherence is supported by regular follow-up and dose adjustments based on tolerance and therapeutic response.