To minimize the risk of induced arrhythmia, patients initiated or re-initiated on BETAPACE AF® should be placed for a minimum of three days (on their maintenance dose) in a facility that can provide cardiac resuscitation, continuous electrocardiographic monitoring and calculations of creatinine clearance. For detailed instructions regarding dose selection, and special cautions for people with renal impairment, see DOSAGE AND ADMINISTRATION. Sotalol is also indicated for the treatment of documented life-threatening ventricular arrhythmias and is marketed under the brand name BETAPACE®. BETAPACE® however, should not be substituted for BETAPACE AF® because of significant differences in labeling (i.e. patient package insert, dosing administration and safety information).
BETAPACE AF SUMMARY
BETAPACE AF, (sotalol hydrochloride), is an antiarrhythmic drug with Class II (beta-adrenoreceptor blocking) and Class III (cardiac action potential duration prolongation) properties. It is supplied as a white, capsule-shaped tablet for oral administration.
BETAPACE AF is indicated for the maintenance of normal sinus rhythm [delay in time to recurrence of atrial fibrillation/atrial flutter (AFIB/AFL)] in patients with symptomatic AFIB/AFL who are currently in sinus rhythm. Because BETAPACE AF can cause life-threatening ventricular arrhythmias, it should be reserved for patients in whom AFIB/AFL is highly symptomatic. Patients with paroxysmal AFIB whose AFIB/AFL that is easily reversed (by Valsalva maneuver, for example) should usually not be given BETAPACE AF (see WARNINGS).
In general, antiarrhythmic therapy for AFIB/AFL aims to prolong the time in normal sinus rhythm. Recurrence is expected in some patients (see Clinical Studies).
Sotalol is also indicated for the treatment of documented life-threatening ventricular arrhythmias and is marketed under the brand name BETAPACE (sotalol hydrochloride). BETAPACE, however, must not be substituted for BETAPACE AF because of significant differences in labeling (i.e., patient package insert, dosing administration and safety information).
Published Studies Related to Betapace AF (Sotalol)
The efficacy of sotalol in preventing postoperative atrial fibrillation: a
supraventricular tachyarrhythmias... CONCLUSION: Sotalol is more effective in the prevention of supraventricular
The Drug And Pace Health cliNical Evaluation (DAPHNE) study: a randomized trial comparing sotalol versus beta-blockers to treat symptomatic atrial fibrillation in patients with brady-tachycardia syndrome implanted with an antitachycardia pacemaker. [2008.08]
BACKGROUND: Atrial tachyarrhythmias (ATAs) are mainly treated by pharmacologic therapy for rate control or rhythm control. The aim of our study was to compare sotalol (S) versus beta-blocking agents (BB) in terms of prevention of ATA, cardioversions (CVs), and cardiovascular hospitalizations (H) in patients paced for bradycardia-tachycardia form of sinus node disease (BT-SND)... CONCLUSIONS: In the complex context of "hybrid therapy" in patients with BT-SND implanted with a modern dual chamber rate adaptive pacemaker device delivering atrial antitachycardia pacing, no differences were found between the use of beta-blocker and the use of S, at the relatively low dose achieved after clinical titration, in terms of prevention of cardiovascular H or need for atrial CV.
The clinical noncompliance of oral sotalol/magnesium for prophylactic treatment of atrial fibrillation after coronary artery bypass grafting. [2007.07]
BACKGROUND: Postoperative atrial fibrillation has been refractory to many attempted pharmacologic prevention methods and, when effective, side effects have been described. The present aim was to study the clinical compliance of a suggested prophylactic treatment, oral sotalol, and magnesium... CONCLUSIONS: The tested treatment protocol showed limited compliance among routine cardiac-surgery patients, and further, introduced a biased selection of patients that skewed the results and may have partly explained the treatment effect.
Azimilide vs. placebo and sotalol for persistent atrial fibrillation: the A-COMET-II (Azimilide-CardiOversion MaintEnance Trial-II) trial. [2006.09]
CONCLUSION: This study demonstrates that the anti-arrhythmic efficacy of azimilide is slightly superior to placebo but significantly inferior to sotalol in patients with persistent AF. The modest anti-arrhythmic efficacy and high rate of torsade de pointes and marked QTc prolongation limit azimilide utilization for the treatment of AF.
Effect of amiodarone and sotalol on ventricular defibrillation threshold: the optimal pharmacological therapy in cardioverter defibrillator patients (OPTIC) trial. [2006.07.11]
CONCLUSIONS: Although amiodarone increased DFT, the effect size with modern ICD systems is very small. Therefore, DFT reassessment after the institution of antiarrhythmic drug therapy with amiodarone or sotalol is not routinely required.
Clinical Trials Related to Betapace AF (Sotalol)
Genetic Sources of Variability of the Adaptation of the Ventricular Repolarisation [Recruiting]
The main objective is to research for genetic factors involved in the extreme modifications
of the QT interval of the electrocardiogram in answer to a pharmacological stimulation
(sotalol) and physiological stimulation in the apparently normal general population.
The phenotypic characterization, based on the ventricular repolarisation dynamics will be
used aiming at term of the predictive genetic factors of the acquired long QT syndrome
Efficacy and Safety Evaluation of Azimilide or Sotalol vs Placebo for Treatment of Patients With Atrial Fibrillation. [Completed]
Atrial fibrillation (abnormal rhythm in the upper chamber of the heart) is a common
supraventricular arrhythmia (a type of abnormal heart rhythm) for which antiarrhythmic
therapy is often prescribed. The primary goals of therapy are to maintain sinus rhythm
(normal heart rhythm) and to reduce the occurrence of episodes of atrial fibrillation.
The double-blind, placebo-controlled phase of this study is designed to evaluate the efficacy
and safety of oral azimilide compared with placebo and with sotalol, an antiarrhythmic drug,
in maintaining sinus rhythm in patients who require cardioversion (electric shock to correct
heart rhythm) to correct atrial fibrillation. Once this phase of the study is completed, a
second phase with a different study design will be conducted. The second phase is an
open-label, follow-up phase to the first study. The follow-up phase will continue to evaluate
the long-term safety of a daily oral dose of azimilide in patients who complete the
double-blind, placebo-controlled phase of this study.
Comparing the Effects of Amiodarone, Sotalol, and Placebo in Maintaining Sinus Rhythm in Patients With Atrial Fibrillation Converted to Sinus Rhythm [Completed]
Atrial fibrillation is the most frequently occurring cardiac arrhythmia, with 1. 0-1. 5 million
cases annually. It is a risk factor for congestive heart failure, and stroke, 75,000 cases of
the latter occurring annually in patients with atrial fibrillation. The safety of the most
widely used antiarrhythmic agent for this group of patients, quinidine, has been called into
question. This study seeks to determine whether two other agents, amiodarone and sotalol, are
safe and effective treatments for patients with atrial fibrillation.
Pilot Study of Catheter Ablation for Ventricular Tachycardia in Patients With an Implantable Cardioverter Defibrillator [Recruiting]
The purpose of this pilot trial is to determine the feasibility of a large, multi-center
randomized clinical trial aimed to test whether a treatment strategy of percutaneous
catheter ablation of ventricular tachycardia (VT) is superior to state-of-the-art
pharmacologic therapy at reducing all-cause mortality in patients with an implantable
cardioverter defibrillator (ICD) who receive therapy for VT in the absence of any reversible
Kansai Plus Atrial Fibrillation Trial [Recruiting]
This is a 2x2 factorial randomized controlled trial (KPAF Trial), evaluating two different
pharmacological approaches to improve long-term outcome of catheter ablation for atrial
fibrillation (AF). The study is composed of UNmasking Dormant Electrical Reconduction by
Adenosine TriPhosphate (UNDER-ATP) Trial and Efficacy of Antiarrhythmic Drugs Short-Term Use
after Catheter Ablation for Atrial Fibrillation (EAST-AF) Trial. Patients with paroxysmal or
persistent AF will be randomized to ATP guide ablation or control group in a 1: 1 ratio
before the procedure (UNDER-ATP Trial). Excluding those with severe procedural complications
or substantial bradycardia identified first after ablation for persistent AF, patients will
be randomized in a 1: 1 ratio to antiarrhythmic-drug (AAD) or control group after the
procedure (EAST-AF Trial).
Reports of Suspected Betapace AF (Sotalol) Side Effects
Blood Creatinine Increased (2),
NO Adverse Event (2),
Drug Ineffective (1),
Muscle Spasms (1),
Atrial Flutter (1),
Atrial Fibrillation (1),
Muscular Weakness (1), more >>
Page last updated: 2013-02-10