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Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Adverse reactions that are clearly related to sotalol are those which are typical of its Class II (beta-blocking) and Class III (cardiac action potential duration prolongation) effects and are dose related.
Serious Adverse Reactions
In patients with a history of sustained ventricular tachycardia, the incidence of Torsade de Pointes during oral sotalol treatment was 4% and worsened VT was about 1%; in patients with other less serious ventricular arrhythmias the incidence of Torsade de Pointes was 1% and new or worsened VT was about 0.7%. Incidence of Torsade de Pointes arrhythmias in patients with VT/VF are shown in Table 3 below.
Table 3: Percent Incidence of Torsade de Pointes and
Mean QTc Interval by Dose For Patients With Sustained VT/VF
|Daily Dose (mg)||Torsade de Pointes Incidence||Mean QTc * (msec)|
|80||0 (69)||463 (17)|
|160||0.5 (832)||467 (181)|
|320||1.6 (835)||473 (344)|
|480||4.4 (459)||483 (234)|
|> 640||5.8 (103)||512 (62)|
|( ) Number of patients assessed
*highest on-therapy value
Table 4 below relates the incidence of Torsade de Pointes to on-therapy QTc and change in QTc from baseline in patients with ventricular arrhythmias. It should be noted, however, that the highest on-therapy QTc was in many cases the one obtained at the time of the Torsade de Pointes event, so that the table overstates the predictive value of a high QTc.
Table 4: Relationship
Between QTc Interval Prolongation and Torsade de Pointes
|On-Therapy QTc Interval (msec)||Incidence of Torsade de Pointes||Change from Baseline in QTc (msec)||Incidence of Torsade de Pointes|
|< 500||1.3% (1787)||< 65||1.6% (1516)|
|500-525||3.4% (236)||65-80||3.2% (158)|
|525-550||5.6% (125)||80-100||4.1% (146)|
|> 550||10.8% (157)||100-130||5.2% (115)|
|> 130||7.1% (99)|
|( ) Number of patients assessed|
Table 5: Incidence (%) of
Common Adverse Reactions ( ≥ 2% in
the Placebo group and less frequent than in the Betapace groups) in a
Placebo-controlled Parallel-group Comparison Study of Patients with Ventricular
|Body System/ Adverse Reaction (Preferred Term)||Placebo
N = 37 (%)
|Betapace Total Daily Dose|
N = 38 (%)
N = 39 (%)
|Upper Respiratory Tract Problem||2.7||2.6||12.8|
The most common adverse reactions leading to discontinuation of Betapace in trials of patients with ventricular arrhythmias are: fatigue 4%, bradycardia (less than 50 bpm) 3%, dyspnea 3%, proarrhythmia 3%, asthenia 2%, and dizziness 2%. Incidence of discontinuation for these adverse reactions was dose related.
One case of peripheral neuropathy that resolved on discontinuation of Betapace and recurred when the patient was rechallenged with the drug was reported in an early dose tolerance study.
In an unblinded multicenter trial of 25 pediatric patients with SVT and/or VT receiving daily doses of 30, 90 and 210 mg/m² with dosing every 8 hours for a total of 9 doses, no Torsade de Pointes or other serious new arrhythmias were observed. One (1) patient, receiving 30 mg/m² daily, was discontinued because of increased frequency of sinus pauses/bradycardia. Additional cardiovascular AEs were seen at the 90 and 210 mg/m² daily dose levels. They included QT prolongation (2 patients), sinus pauses/bradycardia (1 patient), increased severity of atrial flutter and reported chest pain (1 patient). Values for QTc ≥ 525 msec were seen in 2 patients at the 210 mg/m² daily dose level. Serious adverse events including death, Torsade de Pointes, other proarrhythmias, high-degree A-V blocks, and bradycardia have been reported in infants and/or children.
Atrial Fibrillation/Atrial Flutter
Placebo-controlled Clinical Trials
In a pooled clinical trial population consisting of 4 placebo-controlled studies with 275 patients with atrial fibrillation (AFIB)/atrial flutter (AFL) treated with 160 to 320 mg doses of Betapace AF, the following adverse reactions presented in Table 6 occurred in at least 2% of placebo-treated patients and at a lesser rate than Betapace-treated patients. The data are presented by incidence of reactions in the Betapace AF and placebo groups by body system and daily dose.
Table 6: Incidence (%) of Common Adverse Reactions ( ≥
2% in the Placebo group and less frequent than in the Betapace AF groups) in
Four Placebo-controlled Studies of Patients with AFIB/AFL
|Body System/ Adverse Reaction (Preferred Term)||Placebo
N = 282 (%)
|Betapace AF Total Daily Dose|
N = 153 (%)
| > 240-320 mg
N = 122 (%)
Overall, discontinuation because of unacceptable adverse events was necessary in 17% of the patients, and occurred in 10% of patients less than two weeks after starting treatment. The most common adverse reactions leading to discontinuation of Betapace AF were: fatigue 4.6%, bradycardia 2.4%, proarrhythmia 2.2%, dyspnea 2%, and QT interval prolongation 1.4%.
The following adverse drug reactions have been identified during post-approval use of sotalol. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Voluntary reports since introduction include reports (less than one report per 10,000 patients) of: emotional lability, slightly clouded sensorium, incoordination, vertigo, paralysis, thrombocytopenia, eosinophilia, leukopenia, photosensitivity reaction, fever, pulmonary edema, hyperlipidemia, myalgia, pruritis, alopecia.
Read the Betapace (sotalol) Side Effects Center for a complete guide to possible side effects
Antiarrhythmics And Other QT Prolonging Drugs
Sotalol has not been studied with other drugs that prolong the QT interval such as antiarrhythmics, some phenothiazines, tricyclic antidepressants, certain oral macrolides and certain quinolone antibiotics. Discontinue Class I or Class III antiarrhythmic agents for at least three half-lives prior to dosing with sotalol. Class Ia antiarrhythmic drugs, such as disopyramide, quinidine and procainamide and other Class III drugs (for example, amiodarone) are not recommended as concomitant therapy with Betapace/Betapace AF, because of their potential to prolong refractoriness [see WARNINGS AND PRECAUTIONS]. There is only limited experience with the concomitant use of Class Ib or Ic antiarrhythmics. Additive Class II effects would also be anticipated with the use of other beta-blocking agents concomitantly with Betapace/Betapace AF.
Proarrhythmic events were more common in sotalol treated patients also receiving digoxin; it is not clear whether this represents an interaction or is related to the presence of CHF, a known risk factor for proarrhythmia, in the patients receiving digoxin. Both digitalis glycosides and beta-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia.
Calcium-Channel Blocking Drugs
Sotalol and calcium-blocking drugs can be expected to have additive effects on atrioventricular conduction or ventricular function. Monitor such patients for evidence of bradycardia and hypotension.
Concomitant use of catecholamine-depleting drugs, such as reserpine and guanethidine, with a beta-blocker may produce an excessive reduction of resting sympathetic nervous tone. Monitor such patients for evidence of hypotension and/or marked bradycardia which may produce syncope.
Insulin And Oral Antidiabetics
Concomitant use with sotalol increases the risk of bradycardia. Because beta-blockers may potentiate the rebound hypertension sometimes observed after clonidine discontinuation, withdraw sotalol several days before the gradual withdrawal of clonidine to reduce the risk of rebound hypertension.
Avoid administration of oral sotalol within 2 hours of antacids containing aluminum oxide and magnesium hydroxide.
Read the Betapace Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 5/23/2016
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