Betapace: Advanced Rhythm Control for Atrial Fibrillation
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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 antiarrhythmic therapies. Its clinical utility is particularly notable in patients requiring both rate and rhythm control, providing a comprehensive approach to arrhythmia management. Proper patient selection and monitored initiation are essential components of its therapeutic application, making it a specialized tool in the cardiologist’s arsenal.
Features
- Contains sotalol hydrochloride as the active pharmaceutical ingredient
- Available in 80 mg, 120 mg, 160 mg, and 240 mg tablet strengths
- Exhibits both beta-blocking (Class II) and potassium channel blocking (Class III) antiarrhythmic properties
- Demonstrated efficacy in suppressing and preventing atrial and ventricular arrhythmias
- Requires hospital initiation with continuous ECG monitoring for dosage titration
- FDA-approved for life-threatening ventricular arrhythmias and maintenance of sinus rhythm in AF/AFL
Benefits
- Provides dual antiarrhythmic action through combined beta-blockade and potassium channel inhibition
- Reduces frequency of symptomatic atrial fibrillation episodes and associated hospitalizations
- Lowers risk of sudden cardiac death in high-risk ventricular arrhythmia patients
- Offers convenient twice-daily dosing regimen for improved adherence
- Eliminates need for multiple medications through combined rhythm and rate control properties
- Maintains hemodynamic stability through balanced electrophysiological effects
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 with coexisting hypertension or coronary artery disease where beta-blockade provides additional therapeutic benefits. Clinical use requires careful patient selection, with emphasis on preserved renal function and absence of structural heart disease contraindications. It is typically prescribed after failure of or intolerance to first-line antiarrhythmic agents.
Dosage and direction
Initial dosage must be initiated in a hospital setting with continuous ECG monitoring and renal function assessment. For atrial fibrillation/flutter: Starting dose is 80 mg twice daily, which may be increased to 120 mg twice daily after 3 days if the 80 mg dose is tolerated and QTc remains <500 ms. For ventricular arrhythmias: Begin with 80 mg twice daily, increasing gradually to 240-320 mg daily based on therapeutic response and tolerance. Dosage adjustment is required in renal impairment: CrCl >60 mL/min: normal dosing; CrCl 30-59 mL/min: administer every 24 hours; CrCl 10-29 mL/min: administer every 36-48 hours; CrCl <10 mL/min: use is not recommended. Tablets should be swallowed whole with water, preferably at the same times each day.
Precautions
Betapace requires careful cardiac monitoring due to its potential to cause life-threatening proarrhythmia, particularly torsades de pointes. Baseline assessment must include electrolyte levels (potassium, magnesium), renal function, and thorough cardiac evaluation. Patients should be educated about signs of excessive bradycardia (fatigue, dizziness, syncope) and instructed to maintain adequate hydration. Regular ECG monitoring is mandatory during dosage adjustments and periodically during maintenance therapy. Use with extreme caution in patients with asthma, COPD, or other bronchospastic disorders due to beta-blocking properties. Diabetic patients require glucose monitoring as beta-blockade may mask hypoglycemia symptoms.
Contraindications
Betapace is contraindicated in patients with baseline QTc interval greater than 450 msec, severe sinus node dysfunction, second or third-degree AV block without a functioning pacemaker, cardiogenic shock, uncontrolled heart failure, hypokalemia (<4 mEq/L), hypomagnesemia, severe renal impairment (CrCl <40 mL/min for AF/AFL, <50 mL/min for VT), bronchial asthma, and known hypersensitivity to sotalol. Concomitant use with other QT-prolonging medications is generally contraindicated unless no therapeutic alternatives exist and careful monitoring can be maintained.
Possible side effect
Common adverse reactions include fatigue (10-20%), dizziness (10-15%), bradycardia (10-13%), dyspnea (10-12%), and proarrhythmia (4-5%). Serious side effects include torsades de pointes (2-4%), new or worsened heart failure (3-5%), and heart block (2-3%). Other reported effects include chest pain (5-8%), palpitations (5-7%), nausea (4-6%), and sleep disturbances. Most side effects are dose-dependent and often diminish with continued therapy or dosage adjustment. Pulmonary effects including bronchospasm may occur in susceptible individuals due to beta-blocking properties.
Drug interaction
Betapace exhibits significant interactions with multiple medication classes. Concomitant use with other QT-prolonging agents (antiarrhythmics, antipsychotics, antibiotics) increases proarrhythmia risk. Calcium channel blockers and digoxin may potentiate bradycardia and AV conduction abnormalities. Insulin and oral hypoglycemics require dosage adjustment due to masked hypoglycemia symptoms. Diuretics may exacerbate electrolyte abnormalities. CYP450 interactions are minimal due to renal excretion, but drugs affecting renal function may alter sotalol clearance. Always review complete medication profile before initiation.
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, skip the missed dose and resume the regular dosing schedule. Do not double the dose to make up for a missed administration. Patients should be instructed to maintain consistent timing of doses to ensure stable antiarrhythmic effect. If multiple doses are missed, medical consultation is recommended before resuming therapy, as dosage re-titration may be necessary.
Overdose
Sotalol overdose manifests as excessive beta-blockade (severe bradycardia, hypotension, bronchospasm) and QT prolongation with risk of torsades de pointes. Management includes gastric lavage if presented early, activated charcoal, and continuous cardiac monitoring with readiness for defibrillation. Bradycardia may respond to atropine, isoproterenol, or cardiac pacing. Hypotension may require vasopressors. Torsades de pointes should be treated with magnesium sulfate, pacing, or isoproterenol. Hemodialysis may be effective due to sotalol’s low protein binding and renal excretion.
Storage
Store at controlled room temperature (20-25°C or 68-77°F) in the original container with tight closure. Protect from light and moisture. Keep out of reach of children and pets. Do not use after the expiration date printed on the packaging. Do not transfer tablets to other containers as this may affect stability. Discard any medication that shows signs of discoloration or physical deterioration.
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 provider familiar with antiarrhythmic therapy. Individual patient response may vary, and therapeutic decisions should be based on comprehensive clinical evaluation. The manufacturer’s prescribing information should be consulted for complete details regarding use, warnings, and precautions.
Reviews
Clinical studies demonstrate Betapace’s efficacy in maintaining sinus rhythm in 50-60% of atrial fibrillation patients at 6-12 months compared to 30-40% with placebo. The SWORD trial highlighted importance of appropriate patient selection, showing increased mortality in post-MI patients with left ventricular dysfunction. More recent studies confirm its value in specific patient populations when initiated properly. Cardiologists note its particular effectiveness in young, otherwise healthy AF patients without structural heart disease. Patient-reported outcomes indicate improved quality of life scores related to reduced arrhythmia burden, though side effects remain a consideration in long-term management.