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 cardiac electrophysiological stabilization. Proper patient selection and monitored initiation are essential components of its therapeutic application, reflecting its status as a potent intervention in cardiac arrhythmia management.
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-blocking (Class II) and potassium channel blocking (Class III) antiarrhythmic properties
- Demonstrated efficacy in suppressing and preventing recurrent atrial fibrillation/flutter
- Requires hospital initiation with continuous ECG monitoring for dosage titration
- 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 via renal pathway requiring dosage adjustment in renal impairment
Benefits
- Provides dual antiarrhythmic action through combined beta-adrenergic blockade and potassium channel inhibition
- Reduces frequency and duration of atrial fibrillation episodes, improving quality of life
- Lowers ventricular rate during arrhythmic events through AV nodal conduction slowing
- Demonstrates proven efficacy in maintaining sinus rhythm post-cardioversion
- Offers convenient twice-daily dosing regimen for improved adherence
- Provides comprehensive antiarrhythmic coverage for both supraventricular and ventricular arrhythmias
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 have failed first-line antiarrhythmic therapy or those with concomitant conditions requiring beta-blockade. Clinical use typically involves patients with structurally normal hearts or those with mild to moderate structural heart disease, though careful risk-benefit assessment is mandatory given its proarrhythmic potential. The drug is often employed in post-cardioversion management to prevent arrhythmia recurrence and maintain hemodynamic stability.
Dosage and direction
Initial dosage must be initiated in a hospital setting with continuous ECG monitoring and personnel trained in arrhythmia management. 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 necessary. For ventricular arrhythmias: Initial dose is 80 mg twice daily, with gradual escalation to 240-320 mg daily in divided doses based on therapeutic response and tolerance. Dosage adjustments must be made at intervals of at least 3 days to allow adequate assessment of therapeutic effect and QT interval monitoring. Renal function must be assessed prior to initiation, with dosage reduction required in patients with impaired renal function (creatinine clearance <60 mL/min). Administration should occur consistently with regard to meals, preferably at the same times each day to maintain stable plasma concentrations.
Precautions
Betapace carries a black box warning regarding proarrhythmic effects, particularly torsades de pointes, which may occur in 2-4% of patients. Continuous ECG monitoring is mandatory during initiation and dosage adjustments. Renal function must be assessed before and during therapy, with dosage adjustment for creatinine clearance below 60 mL/min. Electrolyte imbalances, particularly hypokalemia and hypomagnesemia, must be corrected before initiation and monitored during therapy. Caution is required in patients with asthma, COPD, or other bronchospastic disorders due to non-selective beta-blockade. Close monitoring is necessary in patients with heart failure, as beta-blockade may precipitate decompensation. Abrupt withdrawal should be avoided due to risk of rebound tachycardia and hypertension. Regular assessment of QT interval is essential throughout therapy.
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 long QT syndrome, cardiogenic shock, uncontrolled heart failure, asthma, severe COPD, and renal failure with creatinine clearance below 40 mL/min. Additional contraindications include hypersensitivity to sotalol or any component of the formulation, severe bradycardia (heart rate below 50 bpm), systolic blood pressure below 90 mmHg, and serum potassium below 4.0 mEq/L. Concomitant use with other QT-prolonging drugs is generally contraindicated unless no therapeutic alternatives exist and careful monitoring can be maintained.
Possible side effect
Common adverse reactions (occurring in >5% of patients) include fatigue (20%), dizziness (20%), dyspnea (16%), bradycardia (16%), chest pain (13%), palpitations (12%), and nausea/vomiting (10%). Cardiovascular effects may include proarrhythmia (4%), heart failure exacerbation (3%), hypotension (8%), and peripheral edema (5%). Respiratory side effects include bronchospasm (10%) in susceptible patients and pulmonary complications (2%). Serious adverse reactions requiring immediate medical attention include torsades de pointes (2-4%), new or worsened ventricular arrhythmias (5%), and heart block (3%). Most side effects are dose-dependent and may diminish with dosage adjustment or continued therapy.
Drug interaction
Betapase exhibits significant interactions with multiple drug classes. Concomitant use with other QT-prolonging agents (antiarrhythmics, antipsychotics, antidepressants, antibiotics) increases proarrhythmic risk. Calcium channel blockers may potentiate bradycardia and AV conduction abnormalities. Insulin and oral hypoglycemics may mask hypoglycemia symptoms. Clonidine withdrawal may produce exaggerated hypertension. Digoxin levels may increase due to reduced renal clearance. Catecholamine-depleting drugs may exaggerate bradycardia and hypotension. NSAIDs may diminish antihypertensive effects. Diuretics may increase risk of hypokalemia and proarrhythmia. Always review complete medication profile before initiation and during therapy.
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. Doubling of doses is strictly contraindicated due to the risk of excessive beta-blockade and QT prolongation. Patients should be instructed to maintain a consistent dosing schedule and use reminder systems if necessary. If multiple doses are missed, medical consultation is recommended before resuming therapy, as dosage re-titration under medical supervision may be necessary.
Overdose
Betapace overdose manifests primarily as excessive beta-blockade and QT prolongation. Symptoms may include severe bradycardia, heart failure, hypotension, bronchospasm, hypoglycemia, and 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 for bronchospasm, vasopressors for hypotension, and magnesium sulfate for torsades de pointes. Hemodialysis may be effective due to the drug’s renal excretion profile. Gastric lavage may be considered if presentation is early after ingestion. Permanent cardiac pacing may be necessary for profound bradycardia or heart block.
Storage
Store 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. Keep in original container with tight closure. Do not store in bathroom or near kitchen sink. Keep out of reach of children and pets. Do not use if tablets show signs of discoloration, cracking, or other physical deterioration. Properly discard any unused medication after expiration date or when no longer needed through medication take-back programs.
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 direct medical supervision. Individual patient response may vary, and therapeutic decisions should be made by qualified healthcare professionals based on comprehensive patient assessment. The manufacturer’s prescribing information should be consulted for complete details regarding use, warnings, and precautions. Patients should not adjust dosage or discontinue therapy without medical consultation.
Reviews
Clinical studies demonstrate Betapase maintains sinus rhythm in 50-60% of atrial fibrillation patients at 6-12 months compared to 30-40% with placebo. The SWORD trial showed mortality benefit in specific ventricular arrhythmia populations when appropriately selected. Cardiologists note its particular value in patients requiring both rhythm and rate control, though emphasize the mandatory monitored initiation period. Patient-reported outcomes indicate improved quality of life measures related to arrhythmia symptom reduction, though side effect profile requires careful management. The drug remains a cornerstone therapy in specialized arrhythmia management despite newer antiarrhythmic options, particularly in patients with concomitant indications for beta-blockade.