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 antiarrhythmic properties, it offers a dual mechanism of action that distinguishes it from conventional antiarrhythmic therapies. Its carefully calibrated pharmacological profile makes it particularly valuable for patients requiring both rate and rhythm control, though its use demands careful patient selection and monitoring due to its potential proarrhythmic effects. This agent represents a cornerstone therapy in electrophysiology, balancing efficacy with a well-characterized safety profile when administered under appropriate clinical supervision.

Features

• Contains sotalol hydrochloride as active pharmaceutical ingredient
• Available in 80 mg, 120 mg, 160 mg, and 240 mg tablet strengths
• Dual mechanism: beta-adrenergic blockade (Class II) + potassium channel blockade (Class III)
• Bioavailability of approximately 90-100% with minimal first-pass metabolism
• Elimination half-life of approximately 12 hours in patients with normal renal function
• Primarily excreted unchanged in urine with negligible hepatic metabolism
• Linear pharmacokinetics across therapeutic dosing range
• White, round, film-coated tablets with distinct imprints for strength identification

Benefits

• Provides effective conversion and maintenance of sinus rhythm in atrial fibrillation/flutter
• Reduces ventricular rate during arrhythmic episodes through beta-blockade activity
• Demonstrates proven efficacy in suppressing life-threatening ventricular tachyarrhythmias
• Offers convenient twice-daily dosing regimen for improved patient compliance
• Features predictable pharmacokinetics that facilitate dose titration
• Provides comprehensive antiarrhythmic coverage through dual electrophysiological actions

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. It is also approved for the treatment of documented life-threatening ventricular arrhythmias, particularly sustained ventricular tachycardia. The medication finds particular utility in patients who require both rhythm control and ventricular rate reduction, eliminating the need for multiple antiarrhythmic agents. Clinical use typically follows careful risk stratification, with preference for patients without structural heart disease or those with well-compensated cardiac function. Electrophysiologists often employ Betapace after failed treatment with first-line antiarrhythmic agents or in specific patient subsets where its unique pharmacological profile offers distinct advantages.

Dosage and direction

Initial dosing must be initiated in a setting with continuous cardiac monitoring and resuscitation capabilities due to the risk of proarrhythmia. For atrial fibrillation/flutter: The recommended initial dose is 80 mg twice daily, which may be increased after appropriate monitoring to 120 mg twice daily if the 80 mg dose is tolerated but ineffective. The maximum recommended dose is 160 mg twice daily. For ventricular arrhythmias: The usual initial dose is 80 mg twice daily, with gradual upward titration to 240-320 mg daily in divided doses based on therapeutic response and tolerability. Dosage adjustment is required in patients with renal impairment, with dosing intervals extended based on creatinine clearance: CrCl >60 mL/min: every 12 hours; CrCl 30-59 mL/min: every 24 hours; CrCl 10-29 mL/min: every 36-48 hours; CrCl <10 mL/min: individualization required. Tablets should be swallowed whole with a glass of water, with or without food, but consistency in administration relative to meals is recommended.

Precautions

Betapase requires careful clinical supervision due to its potential to cause life-threatening arrhythmias, particularly torsades de pointes. Baseline assessment must include electrolyte status (potassium and magnesium), renal function, ECG, and cardiac evaluation. Hypokalemia and hypomagnesemia must be corrected before initiation and maintained during therapy. Patients should be monitored for QT interval prolongation, with therapy discontinued if QTc exceeds 500 milliseconds. Caution is warranted in patients with compensated heart failure, as beta-blockade may precipitate decompensation. Abrupt withdrawal should be avoided due to potential rebound tachycardia and hypertension. Regular monitoring of renal function is essential, with dose adjustment as needed. Patients should be educated about signs of arrhythmia, heart failure, and bronchospasm. Use with particular caution in elderly patients and those with diabetes, as it may mask hypoglycemia symptoms.

Contraindications

Betapace is contraindicated in patients with baseline QT interval greater than 450 milliseconds, severe sinus node dysfunction, second- or third-degree AV block without a functioning pacemaker, congenital long QT syndrome, cardiogenic shock, uncontrolled heart failure, hypotension, bronchial asthma, severe chronic obstructive pulmonary disease, and severe renal impairment (CrCl <40 mL/min). Additional contraindications include hypersensitivity to sotalol or any component of the formulation, untreated pheochromocytoma, and metabolic acidosis. The medication must not be administered concurrently with other QT-prolonging drugs or within specific washout periods after discontinuing such medications.

Possible side effect

Common adverse reactions (≥5%) include fatigue (10-20%), dizziness (10-15%), bradycardia (10-15%), dyspnea (10-12%), proarrhythmia (4-8%), QT prolongation (5%), chest pain (5-7%), and nausea/vomiting (5-6%). Serious side effects requiring immediate medical attention include torsades de pointes (1-4%), new or worsened ventricular arrhythmias (3-7%), heart failure exacerbation (3-5%), significant bradycardia (5-10%), and heart block (2-3%). Other reported effects include sleep disturbances, depression, Raynaud’s phenomenon, and impotence. Most side effects are dose-dependent and often manageable through careful dose titration and monitoring.

Drug interaction

Betapace exhibits significant interactions with multiple medication classes. Concomitant use with other QT-prolonging agents (antiarrhythmics, antipsychotics, antidepressants, antibiotics) increases torsadogenic risk. Calcium channel blockers and digoxin may potentiate bradycardia and AV conduction abnormalities. Insulin and oral hypoglycemics require adjustment due to masked hypoglycemia symptoms. Catecholamine-depleting agents may cause excessive bradycardia and hypotension. Non-dihydropyridine calcium channel blockers should generally be avoided. Drugs that affect renal function may alter sotalol clearance. Antacids containing aluminum or magnesium may reduce absorption. Close monitoring is essential when initiating or discontinuing concomitant medications.

Missed dose

If a dose is missed, it should be taken as soon as remembered unless it is nearly time for the next scheduled dose. In that case, the missed dose should be skipped, and the regular dosing schedule resumed. Patients should never double the dose to make up for a missed administration. Consistent timing is important for maintaining therapeutic antiarrhythmic effects. If multiple doses are missed, medical consultation is recommended before resuming therapy, as dose retitration may be necessary. Patients should be specifically educated about this aspect due to the potential for rebound arrhythmias with irregular dosing.

Overdose

Sotalol overdose manifests primarily as excessive beta-blockade and QT prolongation, leading to bradycardia, hypotension, heart failure, bronchospasm, hypoglycemia, and life-threatening torsades de pointes. Management requires immediate medical attention with continuous ECG monitoring in an intensive care setting. Treatment is supportive and symptomatic: atropine for bradycardia, beta-agonists or pacing for heart block, vasopressors for hypotension, magnesium sulfate for torsades, and potassium supplementation as needed. Hemodialysis may be effective due to sotalol’s low protein binding and renal excretion. Gastric lavage may be considered if presentation is early after ingestion. The prolonged elimination half-life in overdose situations necessitates extended monitoring.

Storage

Store at controlled room temperature (20-25°C or 68-77°F) with excursions permitted between 15-30°C (59-86°F). Protect from light and moisture. Keep in the original container with the lid tightly closed. Do not store in bathroom or kitchen where humidity and temperature variations may occur. Keep out of reach of children and pets. Do not use if tablets show signs of discoloration, cracking, or if the expiration date has passed. Proper disposal of unused medication is essential to prevent accidental ingestion or environmental contamination.

Disclaimer

This information is provided for educational purposes only and does not constitute medical advice. Betapase is a prescription medication that must be used under the supervision of a qualified healthcare professional familiar with antiarrhythmic therapy. Individual patient response may vary, and therapeutic decisions should be based on comprehensive clinical assessment. The prescribing physician should be consulted for specific dosing, monitoring, and management recommendations. Never initiate, adjust, or discontinue Betapase without medical supervision. Report any adverse effects to your healthcare provider promptly.

Reviews

Clinical studies demonstrate Betapase effectively maintains sinus rhythm in 50-60% of atrial fibrillation patients at 6-12 months, compared to 30-40% with placebo. In ventricular arrhythmia trials, it shows 60-70% suppression of inducible VT. Electrophysiologists appreciate its dual mechanism but emphasize the necessity for inpatient initiation and careful follow-up. Patient reviews frequently mention improved quality of life with rhythm control but note fatigue and dizziness as challenging side effects. The requirement for frequent monitoring and dose adjustments is consistently noted in both clinical feedback and published literature. Overall, it remains a valuable option in the antiarrhythmic arsenal when used appropriately in selected patients.