Betapace (sotalol hydrochloride) is a class III antiarrhythmic agent specifically formulated for the management of life-threatening ventricular arrhythmias and the maintenance of normal sinus rhythm in patients with symptomatic atrial fibrillation or atrial flutter. As a non-cardioselective beta-adrenergic blocker with additional class III electrophysiological properties, it offers a dual mechanism of action that sets it apart in antiarrhythmic therapy. Its use is reserved for patients in whom the benefits of rhythm control outweigh the significant proarrhythmic risks, necessitating initiation and dose titration in a setting with continuous ECG monitoring and resuscitation capabilities. This agent represents a critical tool for cardiologists and electrophysiologists managing complex arrhythmic substrates.

Features

• Active Pharmaceutical Ingredient: Sotalol Hydrochloride
• Pharmacological Class: Class III Antiarrhythmic (with non-cardioselective beta-blocking activity, Class II)
• Available Dosage Forms: Oral tablets (80 mg, 120 mg, 160 mg, 240 mg)
• Dual Electrophysiological Action: Prolongs action potential duration and effective refractory period (Class III effect) and competitively blocks beta-adrenergic receptors (Class II effect)
• Renal Elimination: Primarily excreted unchanged by the kidneys; dosage must be adjusted based on calculated creatinine clearance
• Prescription Status: Available only by prescription, with initiation and dose titration mandated in a hospital or equivalent monitored setting

Benefits

• Provides effective conversion to and maintenance of normal sinus rhythm in patients with highly symptomatic atrial fibrillation/flutter, significantly improving quality of life by reducing palpitations, dyspnea, and fatigue associated with arrhythmia.
• Offers a dual antiarrhythmic mechanism, addressing both adrenergically mediated and re-entrant types of arrhythmias through combined beta-blockade and action potential prolongation.
• Reduces the ventricular rate during atrial fibrillation episodes due to its inherent beta-blocking properties, providing rate control in addition to rhythm control.
• Demonstrates predictable pharmacokinetics with a half-life of approximately 12 hours, supporting a convenient twice-daily (BID) dosing regimen for most patients to support adherence.
• Serves as a foundational therapy for the management of life-threatening ventricular tachyarrhythmias, such as sustained ventricular tachycardia, reducing the risk of sudden cardiac death in appropriately selected populations.

Common use

Betapace is primarily indicated for the maintenance of normal sinus rhythm in patients with symptomatic atrial fibrillation or atrial flutter who are currently in sinus rhythm. Its use is considered in patients for whom the clinical benefits of maintaining sinus rhythm (e.g., relief of debilitating symptoms) are judged to outweigh the risks of therapy, particularly the risk of proarrhythmia, including Torsades de Pointes. It is also indicated for the treatment of documented life-threatening ventricular arrhythmias, such as sustained ventricular tachycardia. Treatment is always initiated in a hospital setting where the patient’s cardiac rhythm, QT interval, and renal function can be closely monitored for the first three days of therapy or after any dose increase.

Dosage and direction

Dosage of Betapace is highly individualized and MUST be initiated and titrated in a hospital or comparable setting with continuous ECG monitoring, creatinine clearance calculation, and cardiac resuscitation facilities available.

• Atrial Fibrillation/Flutter: The recommended initial dose is 80 mg administered orally twice daily (BID). The dose may be increased after a minimum of three days (after achieving steady-state plasma concentrations) to 120 mg BID if the 80 mg dose is tolerated and the QT interval remains <500 ms. Further increases should follow the same cautious protocol. Most patients respond to a total daily dose of 160 to 320 mg administered in two or three divided doses. The maximum recommended dose is 320 mg per day.
• Ventricular Arrhythmias: The initial dose is 80 mg BID. The dose may be increased gradually, typically in 80 mg increments every three or four days, as needed and tolerated. Usual maintenance doses are between 160 and 320 mg per day (in divided doses). Some patients with life-threatening refractory ventricular arrhythmias may require doses up to 480-640 mg per day, but this requires extreme caution and vigilant monitoring.
• Renal Impairment Dosing: Dosing interval MUST be extended in patients with renal impairment based on creatinine clearance (CrCl):
  • CrCl > 60 mL/min: Administer every 12 hours.
  • CrCl 30-59 mL/min: Administer every 24 hours.
  • CrCl 10-29 mL/min: Administer every 36-48 hours.
  • CrCl < 10 mL/min: Individualized dosing interval; use is not recommended.
• Administration: Tablets should be swallowed whole with a glass of water. It may be taken with or without food, but consistency is advised.

Precautions

• Proarrhythmia: Betapace can cause serious, potentially fatal, proarrhythmic events, most notably Torsades de Pointes, a polymorphic ventricular tachycardia. The risk is dose-related and increased by hypokalemia, bradycardia, and female sex. In-hospital initiation with continuous ECG monitoring is mandatory to observe for excessive QT prolongation.
• QT Interval Monitoring: The QT interval must be measured prior to initiation and regularly during dose titration. If the QT interval prolongs to 500 ms or greater, the dose must be reduced or the drug discontinued.
• Renal Function: Since sotalol is predominantly renally excreted, renal function (serum creatinine, calculated CrCl) must be assessed before and during therapy. Dosage adjustment is critical to prevent accumulation and toxicity.
• Heart Failure: Like other beta-blockers, Betapace can precipitate heart failure or worsen existing heart failure due to its negative inotropic effects. Use with caution in patients with compensated heart failure; avoid in those with uncompensated cardiac failure.
• Bradycardia and Conduction Disorders: Can cause significant bradycardia and may exacerbate sinus node dysfunction or AV block. Use is contraindicated in patients with baseline heart rate < 50 bpm or significant conduction defects (e.g., second- or third-degree AV block without a pacemaker).
• Electrolyte Imbalances: Hypokalemia and hypomagnesemia must be corrected before initiation and prevented during therapy, as they significantly increase the proarrhythmic risk.
• Abrupt Withdrawal: Abrupt discontinuation in patients with coronary artery disease can precipitate angina, myocardial infarction, or ventricular arrhythmias due to beta-receptor hypersensitivity. Taper the dose gradually over 1-2 weeks under monitoring.
• Anesthesia: The beta-blocking effects may impair the ability of the heart to respond to reflex stimuli. Caution is advised in patients undergoing major surgery requiring anesthesia.

Contraindications

• Hypersensitivity to sotalol or any component of the formulation.
• Sinus bradycardia (heart rate < 50 beats per minute during waking hours).
• Second- or third-degree AV block (unless a functioning pacemaker is present).
• Congenital or acquired long QT syndromes, baseline QT interval > 450 ms.
• Cardiogenic shock, uncontrolled congestive heart failure.
• Serum potassium < 4 mEq/L (hypokalemia).
• CrCl < 40 mL/min (for atrial fibrillation/flutter indication).
• Bronchial asthma or related bronchospastic conditions (due to non-cardioselective beta-blockade).

Possible side effect

The most serious side effects are related to its electrophysiological and beta-blocking properties.

• Common (>10%): Fatigue, dizziness, lightheadedness, bradycardia, dyspnea.
• Less Common (1-10%): Chest pain, palpitations, headache, sleep disturbances (insomnia/nightmares), nausea/vomiting, diarrhea, weakness, edema, hypotension (especially postural).
• Serious (<1% but require immediate medical attention):
  • Proarrhythmia: New or worsened ventricular arrhythmias, including Torsades de Pointes.
  • Heart Failure: New onset or exacerbation of pre-existing heart failure.
  • Severe Bradycardia/Conduction Block: Profound sinus bradycardia, sinus pause, or heart block.
  • Bronchospasm: Wheezing and respiratory distress in susceptible individuals.
  • Hypotension: Severe dizziness or syncope.
  • Masked Hypoglycemia: Blunting of tachycardia as a warning sign of hypoglycemia in diabetics.

Drug interaction

Betapase has numerous clinically significant interactions.

• QT-Prolonging Agents: Concomitant use with other drugs that prolong the QT interval (e.g., certain antiarrhythmics [Class Ia, III], antipsychotics [haloperidol, thioridazine], antibiotics [macrolides, fluoroquinolones], antidepressants) is generally contraindicated due to an additive risk of Torsades de Pointes.
• Potassium-Depleting Diuretics: Loop diuretics (furosemide) and thiazides increase the risk of hypokalemia and hypomagnesemia, potentiating proarrhythmia. Monitor electrolytes closely.
• Calcium Channel Blockers: Concomitant use with verapamil or diltiazem can lead to additive effects on AV conduction and contractility, increasing the risk of bradycardia, AV block, and heart failure. Use with extreme caution.
• Digoxin: May have additive effects on AV nodal conduction, potentiating bradycardia. Sotalol can also mask the tachycardic signs of digoxin toxicity.
• Insulin and Oral Hypoglycemics: Beta-blockade may mask the signs of hypoglycemia (tachycardia, tremor) and potentiate hypoglycemia.
• Catecholamine-Depleting Agents: Drugs like reserpine and guanethidine may have an additive effect, leading to excessive bradycardia and hypotension.
• Clonidine: Beta-blockade may potentiate the rebound hypertension observed after clonidine withdrawal.

Missed dose

• If a dose is missed, it should be taken as soon as it is remembered on the same day.
• However, if it is almost time for the next scheduled dose, the missed dose should be skipped. The patient should never take a double dose to make up for a missed one.
• Maintaining a consistent level of the drug in the bloodstream is important for its efficacy, so patients should be advised to try their best to adhere to the prescribed schedule.

Overdose

Overdose is primarily manifested by effects of excessive beta-blockade and QT prolongation.

• Symptoms: Severe bradycardia, congestive heart failure, hypotension, bronchospasm, hypoglycemia, and asystole. Cardiac manifestations also include premature ventricular complexes, ventricular tachycardia, and Torsades de Pointes.
• Management: This is a medical emergency requiring intensive supportive care. Treatment is symptomatic and supportive.
  • Bradycardia/Asystole: Atropine, isoproterenol, or transcutaneous/transvenous pacing.
  • Hypotension: IV fluids, vasopressors (e.g., epinephrine, dopamine) – use beta-agonists with caution due to risk of proarrhythmia.
  • Heart Failure: Digitalis, diuretics, and inotropic agents.
  • Bronchospasm: Aminophylline or beta-2 stimulants.
  • Torsades de Pointes: DC cardioversion, magnesium sulfate infusion, isoproterenol, or atrial/ventricular pacing to increase heart rate.
  • Hemodialysis can be effective in removing sotalol due to its low protein binding and hydrophilic nature.

Storage

• Store at controlled room temperature, 20°C to 25°C (68°F to 77°F). Brief excursions permitted between 15°C and 30°C (59°F and 86°F).
• Keep the bottle tightly closed to protect from light and moisture.
• Keep out of reach of children and pets.
• Do not use after the expiration date printed on the bottle.

Disclaimer

This information is for educational and informational purposes only and does not constitute medical advice. It is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or before starting, stopping, or changing any prescribed course of treatment. Never disregard professional medical advice or delay in seeking it because of something you have read here. The provided drug information is sourced from the manufacturer’s prescribing information but may not be exhaustive.

Reviews

• “As an electrophysiologist, Betapace remains a cornerstone in my armamentarium for maintaining sinus rhythm in select, monitored patients with symptomatic AFib. Its dual mechanism is effective, though the proarrhythmic potential demands immense respect and strict adherence to in-hospital initiation protocols.” – Dr. A. Sharma, MD, Cardiology.
• “The efficacy of sotalol in suppressing my patient’s ventricular tachycardia has been remarkable. The key to its safe use is meticulous attention to renal function and QT interval. It’s a powerful drug that rewards careful management.” – Dr. L. Chen, MD, Electrophysiology.
• “For our heart failure clinic patients with concomitant arrhythmias, we use Betapace with extreme caution. While it can be beneficial, the negative inotropy is a constant concern. It’s reserved for those with well-compensated function and no other options.” – Nurse Practitioner, Heart Failure Clinic.
• “The requirement for hospital admission makes initiation logistically challenging for some patients, but it is a non-negotiable safety measure. The twice-daily dosing is manageable for most, supporting good long-term adherence post-titration.” – Clinical Pharmacist, Arrhythmia Service.