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 antiarrhythmics. Its efficacy is supported by decades of clinical use and rigorous studies, making it a cornerstone therapy in cardiac electrophysiology. Proper patient selection and monitored initiation are critical to maximizing therapeutic outcomes while minimizing risks.
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
- Oral administration with bioavailability of approximately 90–100%
- Elimination half-life of 12 hours in patients with normal renal function
- Primarily excreted unchanged via the kidneys requiring dosage adjustment in renal impairment
- Manufactured under current Good Manufacturing Practices (cGMP) standards
Benefits
- Effectively suppresses and prevents recurrence of atrial fibrillation and atrial flutter
- Reduces ventricular rate during arrhythmic episodes through beta-blockade activity
- Demonstrates proven efficacy in managing life-threatening ventricular tachyarrhythmias
- Offers convenient twice-daily dosing regimen for improved patient compliance
- Provides predictable pharmacokinetics with linear dose-response relationship
- Serves as an alternative for patients intolerant to other antiarrhythmic therapies
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 who require combined beta-blockade and antiarrhythmic effects. Cardiology specialists often prescribe Betapace after careful risk-benefit assessment, especially considering its potential proarrhythmic effects. The drug is typically used in patients with structurally normal hearts or those with controlled heart failure, as determined by comprehensive cardiac evaluation.
Dosage and direction
Initial dosing must be initiated in a setting with continuous cardiac monitoring and resuscitation capabilities due to the risk of proarrhythmic events. For atrial fibrillation/atrial flutter, the recommended initial dose is 80 mg twice daily, which may be increased after appropriate assessment to 120 mg twice daily if necessary. For ventricular arrhythmias, dosing typically begins at 80 mg twice daily, with gradual upward titration to 240–320 mg daily based on therapeutic response and tolerance. Dosage adjustment is mandatory in patients with renal impairment, with recommended intervals between doses extended according to creatinine clearance: every 12 hours for CrCl >60 mL/min, every 24 hours for CrCl 30–60 mL/min, and every 36–48 hours for CrCl 10–30 mL/min. Not recommended when CrCl <10 mL/min. Tablets should be swallowed whole with water, with or without food, but consistency in administration relative to meals is advised.
Precautions
Betapace requires careful patient selection and monitoring due to its potential to cause life-threatening arrhythmias, particularly torsades de pointes. Baseline assessment should include electrolyte levels (potassium and magnesium), renal function, ECG, and cardiac status. Hypokalemia and hypomagnesemia must be corrected before initiation and maintained during therapy. Patients should be monitored for QT interval prolongation, with dosage reduction or discontinuation if QTc exceeds 500 milliseconds. Caution is warranted in patients with asthma, chronic obstructive pulmonary disease, diabetes, thyroid disorders, or electrolyte imbalances. Abrupt withdrawal should be avoided due to potential rebound hypertension or angina exacerbation. Regular follow-up including ECG monitoring is essential, particularly during dosage adjustments.
Contraindications
Betapace is contraindicated in patients with baseline QT interval prolongation (QTc >450 msec), sinus bradycardia (heart rate <50 bpm), second- or third-degree AV block without a functioning pacemaker, cardiogenic shock, uncontrolled heart failure, asthma, bronchospasm, severe chronic obstructive pulmonary disease, serum potassium <4 mEq/L, creatinine clearance <40 mL/min, and known hypersensitivity to sotalol or any component of the formulation. 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 include fatigue (10–20%), dizziness (10–15%), bradycardia (10–15%), dyspnea (10–12%), and proarrhythmia (4–5%). Serious side effects include torsades de pointes (2–4%), new or worsened heart failure (3–5%), heart block (2–3%), and bronchospasm (1–2%). Other reported effects include nausea (8–10%), headache (6–8%), chest pain (4–6%), edema (3–5%), and sleep disturbances (2–4%). Most side effects are dose-dependent and may diminish with continued therapy or dosage adjustment. Patients should be advised to report any symptoms of dizziness, palpitations, shortness of breath, or syncope immediately.
Drug interaction
Betapace has significant interactions with multiple drug classes. Concomitant use with other QT-prolonging agents (antiarrhythmics, antipsychotics, antidepressants, antibiotics) increases arrhythmia risk. Calcium channel blockers and digoxin may potentiate bradycardia and AV conduction abnormalities. Insulin and oral hypoglycemics may mask hypoglycemia symptoms. Beta-agonists may have reduced efficacy. Diuretics may increase the risk of electrolyte disturbances. Drugs that inhibit renal secretion may increase sotalol concentrations. CYP450 interactions are minimal due to renal excretion, but caution is advised with drugs affecting renal function.
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 one. Consistent timing is important for maintaining therapeutic drug levels, particularly given the medication’s effect on cardiac rhythm. Patients should be advised to maintain a regular dosing schedule and consider using pill organizers or reminder systems to improve adherence.
Overdose
Sotalol overdose can be life-threatening, manifesting as excessive bradycardia, heart failure, hypotension, bronchospasm, hypoglycemia, and particularly torsades de pointes. Management requires immediate medical attention with continuous cardiac monitoring. Treatment is supportive and symptomatic, including gastric lavage if presentation is early. Bradycardia may respond to atropine, isoproterenol, or cardiac pacing. Hypotension may require fluids, vasopressors, or glucagon. Torsades de pointes should be managed with magnesium sulfate, cardiac 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 (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 appear discolored, damaged, or beyond the expiration date printed on the packaging. Proper disposal of unused medication is recommended through take-back programs.
Disclaimer
This information is for educational purposes only and does not constitute medical advice. Betapace is a prescription medication that should only be used under the supervision of a qualified healthcare professional. The prescribing physician should be consulted for complete information regarding indications, contraindications, warnings, precautions, and adverse effects. Individual patient response may vary, and therapeutic decisions should be based on professional judgment and patient-specific factors. Never initiate, adjust, or discontinue medication without medical supervision.
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. In ventricular arrhythmia management, it shows 60–70% suppression of inducible tachycardia during electrophysiology study. Cardiologists note its particular value in patients requiring both rate and rhythm control, though emphasize the necessity of monitored initiation. Patient-reported outcomes indicate improved quality of life with rhythm control, though some report tolerance issues with fatigue and dizziness. The risk of proarrhythmia remains a significant consideration in clinical decision-making, with most experts reserving Betapace for patients without structural heart disease or with carefully managed structural issues.