Betapace: Advanced Rhythm Control for Atrial Fibrillation
Betapace
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Synonyms | |||
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 potassium channel blocking properties, it offers a dual mechanism of action that sets it apart from conventional antiarrhythmics. Its clinical utility is well-established in cardiology practice, particularly for patients requiring both rate and rhythm control. Proper patient selection and monitored initiation are essential components of its therapeutic application, reflecting its specialized role in cardiac electrophysiology.
Features
- Contains sotalol hydrochloride as active pharmaceutical ingredient
- Available in 80 mg, 120 mg, 160 mg, and 240 mg tablet strengths
- Dual electrophysiological properties: beta-adrenergic blockade and class III antiarrhythmic action
- Demonstrated efficacy in suppressing ventricular tachycardia and maintaining sinus rhythm
- Requires hospital initiation with continuous ECG monitoring for most patients
- Generic formulations available alongside brand-name product
- Renal elimination pathway with dosage adjustment required for impaired kidney function
Benefits
- Provides comprehensive antiarrhythmic coverage through dual mechanism of action
- Reduces frequency of symptomatic atrial fibrillation episodes
- Lowers risk of sudden cardiac death in high-risk ventricular arrhythmia patients
- Offers predictable pharmacokinetics with twice-daily dosing convenience
- Eliminates need for multiple medications through combined beta-blockade and antiarrhythmic effects
- Supported by extensive clinical evidence across various cardiac arrhythmia subtypes
Common use
Betapace is primarily indicated for the treatment of documented life-threatening ventricular arrhythmias, particularly sustained ventricular tachycardia. Additionally, it is approved for the maintenance of normal sinus rhythm in patients with symptomatic atrial fibrillation or atrial flutter who are currently in sinus rhythm. The medication finds particular utility in patients who require both rhythm control and heart rate reduction, eliminating the need for separate beta-blocker therapy. Cardiologists often prescribe Betapace after other antiarrhythmic agents have proven ineffective or unsuitable, making it a second-line but valuable option in arrhythmia management. Its use requires careful patient selection considering the potential for proarrhythmic effects.
Dosage and direction
Initial dosing must be initiated in a hospital setting with continuous ECG monitoring for a minimum of three days or until steady-state drug levels are achieved. The recommended initial dose for ventricular arrhythmias is 80 mg twice daily, which may be increased gradually to 240-320 mg daily based on therapeutic response and QT interval monitoring. For atrial fibrillation/flutter, the starting dose is typically 80 mg twice daily, with upward titration to 120 mg twice daily if necessary. Dosage must be adjusted based on creatinine clearance: for CrCl 30-60 mL/min, administer every 24 hours; for CrCl 10-30 mL/min, every 36-48 hours; and for CrCl <10 mL/min, individualize dosing based on close monitoring. Administration should occur consistently with regard to meals, and tablets should be swallowed whole without crushing or chewing.
Precautions
Betapace carries a black box warning regarding the risk of life-threatening ventricular arrhythmias, particularly torsades de pointes, which necessitates careful patient selection and monitored initiation. Electrolyte imbalances, particularly hypokalemia and hypomagnesemia, must be corrected before initiation and monitored throughout therapy. Renal function must be assessed before treatment and periodically thereafter, with appropriate dosage adjustments implemented. Patients should be advised about the potential for excessive bradycardia and instructed to monitor their pulse rate regularly. Concomitant use with other QT-prolonging drugs requires extreme caution and enhanced monitoring. The medication should be used with particular care in patients with asthma or other bronchospastic conditions due to its non-selective beta-blocking properties.
Contraindications
Betapace is contraindicated in patients with baseline QT interval greater than 450 msec, severe sinus node dysfunction, second- or third-degree AV block without a functioning pacemaker, congenital or acquired long QT syndromes, cardiogenic shock, uncontrolled heart failure, hypotension, bronchial asthma, and severe chronic obstructive pulmonary disease. Additional contraindications include severe renal impairment (CrCl <40 mL/min), hypersensitivity to sotalol or any component of the formulation, and metabolic acidosis. The medication should not be used in combination with other drugs known to prolong the QT interval without exceptional clinical justification and intensive monitoring.
Possible side effect
The most serious adverse reaction is proarrhythmia, occurring in approximately 4% of patients, primarily manifesting as torsades de pointes. Common side effects include fatigue (20%), dizziness (20%), dyspnea (16%), bradycardia (16%), chest pain (13%), and palpitations (10%). Gastrointestinal disturbances such as nausea (10%), vomiting (8%), and diarrhea (7%) may occur. Other reported effects include headache (9%), sleep disturbances (7%), and peripheral edema (5%). Less frequently, patients may experience depression (4%), visual disturbances (3%), and sexual dysfunction (2%). Most side effects are dose-dependent and may diminish with continued therapy or dosage adjustment.
Drug interaction
Betapace exhibits significant interactions with multiple medication classes. Concomitant use with other QT-prolonging agents (antiarrhythmics, antipsychotics, antidepressants, antibiotics) dramatically increases arrhythmia risk. Calcium channel blockers, particularly verapamil and diltiazem, may potentiate bradycardia and AV conduction abnormalities. Insulin and oral hypoglycemics may mask hypoglycemia symptoms while potentiating hypoglycemic effects. Diuretics may increase the risk of hypokalemia and subsequent arrhythmias. Digoxin levels may increase when co-administered with Betapace. Antacids containing aluminum or magnesium may reduce sotalol absorption. Clonidine withdrawal may be exacerbated by beta-blockade. Close monitoring and dosage adjustments are essential when these combinations cannot be avoided.
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 of doses is important for maintaining stable drug levels and optimal antiarrhythmic effect. If multiple doses are missed, patients should contact their healthcare provider for guidance, as re-titration or additional monitoring may be necessary. Documentation of missed doses should be maintained and discussed during follow-up visits to assess adherence patterns.
Overdose
Sotalol overdose primarily manifests as excessive beta-blockade and QT prolongation, potentially leading to severe bradycardia, hypotension, heart failure, bronchospasm, hypoglycemia, and life-threatening ventricular arrhythmias. Management requires immediate medical attention with continuous cardiac monitoring in an intensive care setting. Treatment is supportive and symptomatic: atropine for bradycardia, beta-agonists or glucagon for hypotension, and appropriate antiarrhythmic measures for ventricular tachyarrhythmias. Hemodialysis may be effective due to sotalol’s low protein binding and renal elimination. Gastric lavage may be considered if presentation is early after ingestion. The QT interval may remain prolonged for several days after overdose due to the drug’s elimination half-life.
Storage
Store Betapace tablets at controlled room temperature between 20°C to 25°C (68°F to 77°F), with excursions permitted between 15°C to 30°C (59°F to 86°F). Protect from light and moisture by keeping the container tightly closed. Keep out of reach of children and pets. Do not use after the expiration date printed on the packaging. Proper disposal of unused medication should follow FDA-recommended guidelines, typically through medication take-back programs or by mixing with undesirable substance and placing in sealed container in household trash. Do not flush medications down the toilet unless specifically instructed to do so.
Disclaimer
This information is provided for educational purposes only and does not constitute medical advice. Betapace is a prescription medication that should be used only under the supervision of a qualified healthcare professional familiar with antiarrhythmic therapy. Individual patient responses may vary, and therapeutic decisions should be based on comprehensive clinical evaluation. The prescribing physician should be consulted for specific dosage recommendations and monitoring requirements. Never initiate, adjust, or discontinue Betapase without medical supervision due to the risk of serious cardiovascular events.
Reviews
Clinical studies demonstrate that Betapace maintains sinus rhythm in 50-60% of atrial fibrillation patients at six months compared to 30-35% with placebo. In ventricular arrhythmia management, it shows 60-70% efficacy in suppressing inducible ventricular tachycardia during electrophysiological testing. Cardiologists note its particular value in patients requiring both rhythm and rate control, though many emphasize the necessity of careful patient selection and monitored initiation. Patients report improved quality of life with reduced arrhythmia frequency, though some describe dose-limiting fatigue or dizziness. The requirement for hospital initiation remains a significant consideration in treatment decisions, but most specialists consider this a necessary precaution given the medication’s proarrhythmic potential.