Betapace: Expert Cardiac Rhythm Control for Atrial Fibrillation
Betapace
| Product dosage: 40mg | |||
|---|---|---|---|
| Package (num) | Per pill | Price | Buy |
| 60 | 1.11 $ | 66.69 $ (0%) | 🛒 Add to cart |
| 90 | 1.00 $ | 100.03 $ 90.09 $ (10%) | 🛒 Add to cart |
| 120 | 0.96 $ | 133.38 $ 114.66 $ (14%) | 🛒 Add to cart |
| 180 | 0.90 $ | 200.07 $ 162.63 $ (19%) | 🛒 Add to cart |
| 270 | 0.87 $ | 300.10 $ 235.17 $ (22%) | 🛒 Add to cart |
| 360 | 0.84 $
Best per pill | 400.14 $ 304.20 $ (24%) | 🛒 Add to cart |
Synonyms | |||
Betapace (sotalol hydrochloride) is a class III antiarrhythmic agent specifically formulated for the maintenance of normal sinus rhythm in patients with symptomatic atrial fibrillation and atrial flutter. It represents a cornerstone in electrophysiological management, offering both beta-blocking and potassium channel blocking properties to effectively suppress and prevent recurrent episodes of these common supraventricular arrhythmias. Its dual mechanism provides a targeted therapeutic approach, making it a vital option in a cardiologist’s arsenal for long-term rhythm control strategies. Prescribed under careful specialist supervision, it is indicated for patients who have been converted to normal sinus rhythm.
Features
- Active Pharmaceutical Ingredient: Sotalol Hydrochloride
- Pharmacological Class: Class III Antiarrhythmic (with non-cardioselective beta-adrenergic blocking properties)
- Available Dosage Strengths: 80 mg, 120 mg, 160 mg, and 240 mg film-coated tablets
- Administration: Oral
- Mechanism of Action: Prolongs action potential duration and effective refractory period in atrial and ventricular tissue through potassium channel blockade; competitively blocks beta-adrenergic receptors
- Bioavailability: Approximately 90-100%
- Elimination Half-life: 12 hours
- Primary Excretion Route: Renal (unchanged)
Benefits
- Provides effective maintenance of normal sinus rhythm, reducing the frequency of symptomatic atrial fibrillation and flutter episodes.
- Offers a dual antiarrhythmic mechanism, combining beta-blockade with potent potassium channel inhibition for comprehensive rhythm control.
- Helps manage ventricular rate during arrhythmia episodes due to its inherent beta-blocking effects.
- Contributes to improved quality of life by decreasing palpitations, dyspnea, and fatigue associated with recurrent arrhythmias.
- Supported by extensive clinical evidence and established guidelines for the management of supraventricular arrhythmias.
- Available in multiple dosage strengths, allowing for precise, individualized titration based on clinical response and renal function.
Common use
Betapace is primarily indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of atrial fibrillation/atrial flutter) in patients with symptomatic atrial fibrillation/atrial flutter who are currently in sinus rhythm. Its use is critical in patients where the recurrence of these arrhythmias causes significant symptoms such as palpitations, reduced exercise tolerance, chest discomfort, or anxiety. It is not indicated for the initial conversion of atrial fibrillation, but rather for maintaining the sinus rhythm achieved through other means (e.g., electrical or pharmacological cardioversion). Treatment is always initiated and titrated in a setting with continuous ECG monitoring and resuscitation capabilities due to the risk of proarrhythmia, particularly Torsade de Pointes.
Dosage and direction
Initial Dosage: The recommended initial dose is 80 mg administered twice daily. Dosage must be individualized based on creatinine clearance, therapeutic response, and QT interval prolongation. Titration: The dose may be increased after a minimum of 3 days (to reach steady-state plasma concentrations) to 120 mg twice daily if the 80 mg dose is tolerated and the QT interval remains <500 ms. Maximum Dosage: The maximum recommended dose is 160 mg twice daily. Some patients with life-threatening refractory ventricular arrhythmias have received doses up to 240-320 mg twice daily, but this is not common for atrial fibrillation and requires extreme caution. Dosage in Renal Impairment: Dosing interval must be extended in patients with renal impairment:
- CrCl > 60 mL/min: Every 12 hours.
- CrCl between 40-60 mL/min: Every 24 hours.
- CrCl between 20-40 mL/min: Dose should be reduced by 50% and administered every 24 hours (or every 36-48 hours with close monitoring).
- CrCl < 20 mL/min: Use is contraindicated. Administration: Tablets should be swallowed whole with a glass of water. It may be taken with or without food, but consistency is advised.
Precautions
- Hospital Initiation: Due to the risk of life-threatening ventricular arrhythmias, particularly in the first few days of therapy, Betapone must be initiated (and any dose increased) in a hospital setting with continuous ECG monitoring for a minimum of 3 days (or until steady-state plasma levels are achieved).
- QT Prolongation: Betapone causes dose-related QT interval prolongation. The QT interval must be monitored prior to and during therapy. If the QT interval prolongs to ≥500 ms, the dose must be reduced or the drug discontinued.
- Renal Function: Renal function (serum creatinine and calculated CrCl) must be assessed prior to and during therapy, as sotalol is primarily excreted by the kidneys. Dosage adjustments are mandatory for any degree of renal impairment.
- Electrolyte Imbalances: Pre-existing hypokalemia or hypomagnesemia must be corrected before initiation and actively avoided during therapy, as these conditions exaggerate QT prolongation and increase the proarrhythmic risk.
- Heart Failure: Can cause or exacerbate heart failure due to its negative inotropic (beta-blocking) effects. Use with caution in patients with compensated heart failure; contraindicated in those with uncompensated cardiac failure.
- Abrupt Withdrawal: Abrupt discontinuation can exacerbate angina pectoris or precipitate myocardial infarction in patients with coronary artery disease. Dose should be tapered gradually over 1-2 weeks.
- Conduction Disorders: Can cause symptomatic bradycardia and sinus node dysfunction. Use is contraindicated in patients with sinus bradycardia, sick sinus syndrome, and 2nd or 3rd degree AV block (without a permanent pacemaker).
Contraindications
- Baseline QT interval prolongation (QTc >450 msec)
- Sinus bradycardia (heart rate <50 bpm)
- Sick sinus syndrome
- Second- or third-degree AV block (unless a functioning pacemaker is present)
- Cardiogenic shock or uncompensated cardiac failure
- Hypersensitivity to sotalol or any component of the formulation
- Bronchial asthma or related bronchospastic conditions
- Severe renal impairment (CrCl <20 mL/min)
- Serum potassium <4 mEq/L
- Congenital or acquired long QT syndromes
Possible side effect
- Common (>10%): Fatigue, dizziness, lightheadedness, weakness, dyspnea, bradycardia.
- Less Common (1-10%): Chest pain, palpitations, headache, sleep disturbances (insomnia/nightmares), nausea/vomiting, diarrhea, dyspepsia, edema, hypotension.
- Serious (<1% but require immediate medical attention):
- Proarrhythmia: New or worsened ventricular arrhythmias, including Torsade de Pointes (polymorphic ventricular tachycardia).
- Heart Failure: New onset or exacerbation of pre-existing heart failure.
- Severe Bradycardia: Profound slowing of the heart rate.
- Heart Block: Worsening of conduction defects.
- Bronchospasm: In susceptible patients.
- Hypotension: Significant drops in blood pressure.
Drug interaction
- Other QT-Prolonging Agents: Concomitant use is contraindicated (e.g., quinidine, procainamide, amiodarone, ibutilide, phenothiazines, tricyclic antidepressants, certain macrolide/fluoroquinolone antibiotics, methadone).
- Calcium Channel Blockers (Verapamil, Diltiazem): Increased risk of bradycardia, systolic impairment, and AV block. Avoid concurrent use.
- Digoxin: May increase the risk of bradycardia. Monitor digoxin levels.
- Insulin and Oral Hypoglycemics: Beta-blockers can mask signs of hypoglycemia (tachycardia) and potentiate hypoglycemia.
- Catecholamine-Depleting Agents (e.g., Reserpine, Guanethidine): Additive effects, may produce excessive bradycardia and hypotension.
- Beta-2 Agonists (e.g., Albuterol): Betapone may block the bronchodilator effects.
- Clonidine: Beta-blockers may potentiate the rebound hypertension effect after clonidine withdrawal.
Missed dose
If a dose is missed, it should be taken as soon as it is remembered. However, if it is almost time for the next scheduled dose, the missed dose should be skipped. The patient should never take a double dose to make up for a missed one. Maintaining a consistent dosing schedule is crucial for stable therapeutic effects.
Overdose
Symptoms: Overdose is primarily characterized by exacerbation of its pharmacological effects: severe bradycardia, congestive heart failure, hypotension, bronchospasm, hypoglycemia, and particularly, QT prolongation leading to Torsade de Pointes and cardiac arrest. Management: There is no specific antidote for sotalol overdose. Treatment is supportive and symptomatic, based on continuous ECG and hemodynamic monitoring.
- Bradycardia/AV Block: Administer atropine, isoproterenol, or consider cardiac pacing.
- Heart Failure: Conventional therapy with diuretics, digoxin (with caution), and inotropic agents.
- Hypotension: Use vasopressors (e.g., epinephrine, dopamine, dobutamine) with extreme caution due to risk of exacerbating arrhythmias.
- Torsade de Pointes: Immediate cardiac pacing or electrical cardioversion/defibrillation. Administer magnesium sulfate, even if serum magnesium is normal.
- Hemodialysis: Can be effective in removing sotalol from the plasma and is recommended in severe overdose, especially with renal impairment.
Storage
Store at room temperature between 20°C to 25°C (68°F to 77°F). Excursions are permitted between 15°C and 30°C (59°F and 86°F). Keep the bottle tightly closed to protect from light and moisture. Keep out of reach of children and pets. Do not use after the expiration date printed on the bottle.
Disclaimer
This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or before starting or altering any treatment regimen. Never disregard professional medical advice or delay in seeking it because of something you have read here. The content has been compiled from various pharmacological references but may not be exhaustive or fully updated.
Reviews
“Betapone has been a game-changer for my patients with persistent AFib. The hospital initiation protocol is a necessary hurdle, but the long-term rhythm control it provides, especially with its dual mechanism, is often superior to other options. Meticulous attention to renal function and QT interval is non-negotiable.” – Cardiologist, 15 years experience
“As an electrophysiology nurse, I manage many patients on Betapone. The transition from in-patient initiation to home management requires thorough patient education on signs of bradycardia and the critical importance of not missing doses. When managed correctly, patients report a significant improvement in symptoms and quality of life.” – EP Nurse Practitioner
“After struggling with frequent episodes of atrial flutter, my cardiologist started me on Betapone. The first few days were in the hospital, which was reassuring. I’ve been on it for two years now with only one minor recurrence. I experience some tiredness, but it’s a fair trade-off for the stability it provides.” – Patient, 68