Betapace: Advanced Rhythm Control for Atrial Fibrillation
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Synonyms | |||
Betapace (sotalol hydrochloride) is a class III antiarrhythmic agent indicated for the treatment of documented 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 effectively prolongs the action potential duration and refractory period in cardiac tissue. Its use requires careful patient selection, initiation in a monitored setting due to proarrhythmic risks, and ongoing evaluation of renal function and QT interval. Betapace represents a cornerstone therapy for appropriate patients requiring rhythm control strategies.
Features
- Active ingredient: Sotalol hydrochloride
- Available in 80 mg, 120 mg, 160 mg, and 240 mg tablet strengths
- Dual electrophysiological properties: beta-adrenergic blockade (Class II) and action potential prolongation (Class III)
- Renal elimination with half-life of approximately 12 hours in normal renal function
- Requires hospital initiation with continuous ECG monitoring for at least 3 days
- Bioavailability of approximately 90-100% with no first-pass metabolism
- Linear pharmacokinetics with dose-proportional increases in plasma concentrations
Benefits
- Effectively converts atrial fibrillation to normal sinus rhythm and prevents recurrence
- Reduces ventricular rate during arrhythmia episodes through beta-blocking activity
- Provides predictable pharmacokinetics with twice-daily dosing in patients with adequate renal function
- Offers comprehensive antiarrhythmic coverage through dual mechanism of action
- Demonstrated efficacy in reducing symptomatic arrhythmia burden and improving quality of life
- Available in multiple strengths allowing for precise dose titration based on clinical response
Common use
Betapace is primarily prescribed 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 indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that in the judgment of the physician are life-threatening. The medication is typically reserved for patients who have not responded adequately to or cannot tolerate other antiarrhythmic therapies. Clinical use requires careful consideration of the risk-benefit ratio due to the potential for proarrhythmic effects, particularly torsades de pointes. Patients selected for therapy generally have structurally normal hearts or minimal structural heart disease, as the risk of proarrhythmia may be increased in those with significant cardiac impairment.
Dosage and direction
Initial dosing must be initiated in a hospital setting with continuous ECG monitoring and renal function assessment. The recommended initial dose for atrial fibrillation/atrial flutter is 80 mg twice daily, which may be increased after at least 3 days to 120 mg twice daily if the 80 mg dose is tolerated but inadequate. The maximum recommended dose is 160 mg twice daily. Dosage must be individualized based on creatinine clearance: for CrCl >60 mL/min, administer every 12 hours; for CrCl 30-60 mL/min, administer every 24 hours; for CrCl 10-30 mL/min, administer every 36-48 hours; and for CrCl <10 mL/min, use is not recommended. Tablets should be swallowed whole with a glass of water, preferably at the same times each day. Dose adjustments should not be made more frequently than every 3 days due to the long elimination half-life.
Precautions
Betapace requires extreme caution in patients with renal impairment, as decreased clearance may lead to toxic accumulation. Regular monitoring of QT interval is mandatory, with therapy discontinuation if QTc exceeds 500 ms. Electrolyte imbalances, particularly hypokalemia and hypomagnesemia, must be corrected before initiation and prevented during therapy. Use with caution in patients with asthma, COPD, or other bronchospastic diseases due to beta-blocking effects. Caution is warranted in diabetic patients as beta-blockade may mask hypoglycemia symptoms. Hepatic impairment requires careful monitoring as sotalol is primarily renally eliminated but hepatic metabolism may contribute. Elderly patients often require dose adjustments due to age-related decreases in renal function. Periodic monitoring of renal function is essential during long-term 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, cardiogenic shock, uncontrolled heart failure, hypokalemia (<4 mEq/L), hypomagnesemia, severe renal impairment (CrCl <40 mL/min for AFib indication), bronchial asthma, and known hypersensitivity to sotalol. Concomitant use with other QT-prolonging drugs is generally contraindicated. The medication is also contraindicated in patients with congenital long QT syndrome and those with severe bradycardia (heart rate <50 bpm).
Possible side effect
The most serious adverse effect is proarrhythmia, particularly torsades de pointes, which occurs in approximately 2-4% of patients. Common side effects include fatigue (10-20%), dizziness (10-15%), dyspnea (10-15%), bradycardia (10-15%), and chest pain (5-10%). Gastrointestinal effects such as nausea (5-10%) and diarrhea (5-8%) may occur. Other potential effects include headache (5-8%), sleep disturbances (5-7%), and peripheral edema (5-7%). Less common but serious side effects include heart failure exacerbation, bronchospasm, and masking of hypoglycemia symptoms. Most side effects are dose-dependent and may diminish with time or dose reduction.
Drug interaction
Betapace has significant interactions with numerous medication classes. Concomitant use with other QT-prolonging drugs (antiarrhythmics, antipsychotics, antidepressants, antibiotics) increases torsades de pointes risk. Calcium channel blockers and digoxin may potentiate bradycardia and AV conduction abnormalities. Insulin and oral hypoglycemics may have masked hypoglycemia symptoms. Diuretics may exacerbate electrolyte imbalances. CYP450 interactions are minimal due to lack of significant metabolism. NSAIDs may reduce antihypertensive effects. Clonidine withdrawal may be exacerbated. 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 almost time for the next scheduled dose. In that case, the missed dose should be skipped and the regular dosing schedule resumed. Patients should never take a double dose to make up for a missed one. Consistent timing is important to maintain stable drug levels, particularly given the medication’s effect on cardiac rhythm. Patients should be instructed to maintain a regular dosing schedule and consider using reminder systems if adherence is challenging.
Overdose
Sotalol overdose may manifest as excessive bradycardia, hypotension, heart failure, bronchospasm, hypoglycemia, and particularly torsades de pointes. QT prolongation is dose-dependent and may lead to life-threatening ventricular arrhythmias. Management includes immediate discontinuation, gastric lavage if recent ingestion, and supportive care with continuous ECG monitoring. Bradycardia may respond to atropine, isoproterenol, or cardiac pacing. Hypotension may require fluids and vasopressors. Torsades de pointes should be treated with magnesium sulfate, cardiac pacing, or isoproterenol. Hemodialysis may be effective due to sotalol’s low protein binding and renal elimination.
Storage
Store at controlled room temperature between 20°C to 25°C (68°F to 77°F). Keep in the original container with the lid tightly closed to protect from moisture and light. Do not store in bathroom or kitchen where humidity and temperature fluctuations may occur. 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 local regulations, typically through medication take-back programs.
Disclaimer
This information is for educational purposes only and does not constitute medical advice. Betapace is a prescription medication that must be used 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 prescribing physician should be thoroughly familiar with the risks and benefits of antiarrhythmic therapy, particularly the proarrhythmic potential of Betapace. Always consult with a healthcare professional before making any changes to medication regimen.
Reviews
Clinical studies demonstrate Betapace’s efficacy in maintaining sinus rhythm in 50-60% of patients with atrial fibrillation at 6-12 months, compared to 30-40% with placebo. The medication shows particular effectiveness in patients with minimal structural heart disease. Most clinical trials report satisfactory tolerance when appropriate patient selection and monitoring protocols are followed. Many electrophysiologists consider Betapace a valuable option for rhythm control in appropriately selected patients, though most emphasize the critical importance of careful initiation and ongoing monitoring. Patient-reported outcomes generally indicate improved quality of life with reduced arrhythmia burden, though some report bothersome side effects particularly at higher doses.