Non-selective beta blocker with class III antiarrhythmic activity
Brand names: Betapace, Sorine
Updated · Methodology
Second line
Class III antiarrhythmic with β-blocking activity for sinus rhythm maintenance in atrial fibrillation. SEC uses sotalol as an amiodarone alternative in patients without significant structural disease.
Sources
ICD-10: I48 · ICD-11: BC81.3
Second line
Treats symptomatic ventricular arrhythmias and reduces shock frequency in patients with implantable cardioverter-defibrillators.
Sources
ICD-10: I47.2 · ICD-11: BC71.0
Sotalol combines two mechanisms: non-selective beta-adrenergic blockade and IKr potassium channel blockade (class III antiarrhythmic effect). It prolongs the action potential and the QT interval, which is the basis for its use in ventricular and supraventricular tachyarrhythmias. The main risk is torsades de pointes, particularly during initiation and with hypokalaemia. Sotalol undergoes no hepatic metabolism and is renally cleared; dose reduction applies when creatinine clearance falls below 60 mL/min.
AEMPS summary of product characteristics (section 4.6): animal studies with sotalol have shown no teratogenicity or other harm to the fetus, and although there are no adequate well-controlled studies in pregnant women, sotalol crosses the placenta and is found in amniotic fluid. Beta-blockers reduce placental blood flow, which can lead to intrauterine fetal death and immature or preterm births, and the fetus and newborn may have adverse reactions, especially hypoglycaemia and bradycardia; newborns also have a higher risk of cardiac and pulmonary complications after birth. Sotalol should be used in pregnancy only if the potential benefit outweighs the possible risk to the fetus. Treatment is stopped 48–72 hours before the expected delivery date; if that is not possible, the newborn is monitored for the same period after birth for signs of beta-blockade (such as cardiac and pulmonary complications).
Compatible with caution. Hale L3. Transfers into milk at high concentration (RID about 25–30%), the highest among β-blockers. Infant bradycardia and hypoglycaemia are possible; heart rate and glucose monitoring is advised.
Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.
7 pairs found. Sorted from critical to minor.
Mechanism
Both strongly prolong QT (amiodarone 30-50 ms, sotalol 30 ms). Additive prolongation – torsades de pointes.
Symptoms
QTc above 500 ms, syncope, torsades de pointes risk.
Management
Combination contraindicated. Choose one antiarrhythmic.
Sources
Mechanism
Sotalol is a class III antiarrhythmic, and its SmPC contraindicates concomitant QT-prolonging drugs. That list names SSRIs explicitly, citalopram and escitalopram among them. The citalopram SmPC lists ongoing treatment with any drug capable of prolonging the QT interval among its contraindications, with no exceptions.
Symptoms
QTc prolongation on ECG, palpitations, dizziness, syncope. The end point is polymorphic ventricular tachycardia of the torsade type progressing to ventricular fibrillation. The risk is higher with hypokalaemia, hypomagnesaemia, bradycardia, decompensated heart failure and in women.
Management
The pair sits in the citalopram SmPC contraindications, so the question is which drug stays, not how far to cut the dose. A rare case where both labels name each other outright: sotalol lists SSRIs by name, the citalopram label bans class III antiarrhythmics. Sotalol, meanwhile, is prescribed for vital indications more often than the antidepressant is.
Sources
Mechanism
Dual QT prolongation.
Symptoms
QTc above 500 ms, syncope, torsades de pointes risk.
Management
Combination contraindicated.
Mechanism
Dual QT prolongation. Torsades de pointes.
Symptoms
QTc above 500 ms, syncope, torsades de pointes risk.
Management
Combination contraindicated.
Sources
Mechanism
Sotalol is a class III antiarrhythmic: it lengthens ventricular repolarisation and the QT interval, which is both its therapeutic action and its main risk. According to the label (Sotapor, 4.4), the rate of serious proarrhythmia rises with the dose: 0.5% at 81–160 mg/day, 1.8% at 161–320 mg/day, 4.5% at 321–480 mg/day. Pimozide prolongs QT on its own: its label describes QT prolongation, ventricular arrhythmias, torsade de pointes and sudden death even in patients without risk factors (Orap, 4.4). The effects add up, and the pimozide label expects an additive effect on QT with antiarrhythmic agents. The interaction is purely pharmacodynamic; the documents describe no kinetic component.
Symptoms
QT and QTc prolongation on the ECG, flattening or inversion of the T wave, appearance of a U wave (pimozide label), then torsade de pointes, sustained ventricular tachycardia or ventricular fibrillation, sudden death. The patient experiences palpitations, dizziness or syncope. The risk is higher with a pre-treatment QTc above 450 ms, heart rate below 60 beats per minute, hypokalaemia and hypomagnesaemia, in women, with reduced creatinine clearance, heart failure and a history of ventricular arrhythmias (sotalol labels).
Management
The combination is contraindicated from both sides. The AEMPS sotalol label (Sotapor, 4.3) bars sotalol with QT-prolonging drugs and names pimozide; the AEMPS pimozide label (Orap, 4.3 and 4.5) bars pimozide with such drugs and names sotalol. The pimozide label contraindicates use with any drug that prolongs the QT interval and names sotalol in Drug Interactions. The FDA sotalol label (Betapace, 5.1) says to avoid the combination. If a patient is on both, the torsade-inducing drug is withdrawn. If the combination cannot be avoided, QT is measured before starting and the ECG is monitored (sotalol label, 4.5). Sotalol is started in hospital with continuous ECG monitoring for at least 3 days, after a baseline ECG, normalised potassium and magnesium and a creatinine clearance to set the dosing interval; QTc is checked 2–4 hours after each dose increase (Betapace, 2.1). Sotalol is contraindicated at serum potassium below 4 mEq/L (Betapace, 4). Starting at 80 mg with gradual titration lowers the proarrhythmia risk; at QTc above 480 ms on treatment, benefit and risk are reassessed and dose reduction or withdrawal is seriously considered (Sotapor, 4.4). Pimozide needs an ECG before the start and periodically during treatment, and is stopped at QT or QTc above 500 ms (Orap, 4.4). The FDA label rules out further dose increases at QTc above 0.52 s in adults (0.47 s in children) or more than 25% above baseline. Potassium is corrected before pimozide and kept normal (FDA pimozide label); potassium-wasting diuretics are avoided with pimozide (Orap, 4.5).
Sources
Mechanism
Additive QT prolongation (sotalol extends 30 ms, quinidine 20–40 ms). Torsades de pointes.
Symptoms
Syncope, torsades de pointes.
Management
Combination contraindicated.
Sources
Mechanism
Dual QT prolongation, torsades risk.
Symptoms
QTc above 500 ms, syncope, torsades de pointes risk.
Management
Combination contraindicated.
Sources
Verbatim lines from the interaction sections, in the language of the label
«Antiarrítmicos: Sotalol no debe combinarse con antiarrítmicos de clase Ia, como disopiramida, quinidina, procainamida y flecainida, ni con otros medicamentos antiarrítmicos de clase III como…»AEMPS, section 4.5 · Open on CIMA
«Antiarrítmicos: Sotalol no debe combinarse con antiarrítmicos de clase Ia, como disopiramida, quinidina, procainamida y flecainida, ni con otros medicamentos antiarrítmicos de clase III como…»AEMPS, section 4.5 · Open on CIMA
«Antiarrítmicos: Sotalol no debe combinarse con antiarrítmicos de clase Ia, como disopiramida, quinidina, procainamida y flecainida, ni con otros medicamentos antiarrítmicos de clase III como…»AEMPS, section 4.5 · Open on CIMA
«Antiarrítmicos: Sotalol no debe combinarse con antiarrítmicos de clase Ia, como disopiramida, quinidina, procainamida y flecainida, ni con otros medicamentos antiarrítmicos de clase III como…»AEMPS, section 4.5 · Open on CIMA
«Antiarrhythmics and Other QT Prolonging Drugs: Discontinue Class I or Class III antiarrhythmic agents for at least three half-lives prior to dosing with sotalol. Class Ia antiarrhythmic drugs, such…»FDA, section 7 · Open on DailyMed
«Antacids: Avoid administration of oral sotalol within 2 hours of antacids containing aluminum oxide and magnesium hydroxide.»FDA, section 7 · Open on DailyMed
«Bloqueantes de canales de calcio: El uso concomitante de betabloqueantes y bloqueantes de canales de calcio produce hipotensión, bradicardia, trastornos de la conducción e insuficiencia cardiaca…»AEMPS, section 4.5 · Open on CIMA
«DRUG INTERACTIONS: Class I or III Antiarrhythmics or other drugs that prolong the QT interval: Avoid concomitant use (7.1)»FDA, section 7 · Open on DailyMed
«Antiarrítmicos: Sotalol no debe combinarse con antiarrítmicos de clase Ia, como disopiramida, quinidina, procainamida y flecainida, ni con otros medicamentos antiarrítmicos de clase III como…»AEMPS, section 4.5 · Open on CIMA
«Bloqueantes de canales de calcio: El uso concomitante de betabloqueantes y bloqueantes de canales de calcio produce hipotensión, bradicardia, trastornos de la conducción e insuficiencia cardiaca…»AEMPS, section 4.5 · Open on CIMA
«Antiarrhythmics and Other QT Prolonging Drugs: Discontinue Class I or Class III antiarrhythmic agents for at least three half-lives prior to dosing with sotalol. Class Ia antiarrhythmic drugs, such…»FDA, section 7 · Open on DailyMed
«Antacids: Avoid administration of oral sotalol within 2 hours of antacids containing aluminum oxide and magnesium hydroxide.»FDA, section 7 · Open on DailyMed
«Antiarrhythmics and Other QT Prolonging Drugs: Discontinue Class I or Class III antiarrhythmic agents for at least three half-lives prior to dosing with sotalol. Class Ia antiarrhythmic drugs, such…»FDA, section 7 · Open on DailyMed
«Bloqueantes de canales de calcio: El uso concomitante de betabloqueantes y bloqueantes de canales de calcio produce hipotensión, bradicardia, trastornos de la conducción e insuficiencia cardiaca…»AEMPS, section 4.5 · Open on CIMA
«Anfotericina B (i.v.), corticosteroides (sistémicos) y algunos laxantes se asocian también a la hipopotasemia; en caso de administración concomitante con sotalol, deben controlarse los niveles de…»AEMPS, section 4.5 · Open on CIMA
«Deben extremarse las precauciones en la administración concomitante de sotalol con otros medicamentos con un efecto conocido de prolongación del intervalo QT, como fenotiazinas, antidepresivos…»AEMPS, section 4.5 · Open on CIMA
«Insulina e hipoglucemiantes orales: Puede desarrollarse hiperglucemia, y puede ser necesario ajustar la dosis de los antidiabéticos orales. Los betabloqueantes pueden enmascarar síntomas de…»AEMPS, section 4.5 · Open on CIMA
«Insulina e hipoglucemiantes orales: Puede desarrollarse hiperglucemia, y puede ser necesario ajustar la dosis de los antidiabéticos orales. Los betabloqueantes pueden enmascarar síntomas de…»AEMPS, section 4.5 · Open on CIMA
«DRUG INTERACTIONS: Dosage of insulin or antidiabetic drugs may need adjustment (7.4)»FDA, section 7 · Open on DailyMed
«Clonidina: Los betabloqueantes pueden potenciar la hipertensión de rebote que se produce en ocasiones tras abandonar el tratamiento con clonidina; por consiguiente, la administración del…»AEMPS, section 4.5 · Open on CIMA
«Anfotericina B (i.v.), corticosteroides (sistémicos) y algunos laxantes se asocian también a la hipopotasemia; en caso de administración concomitante con sotalol, deben controlarse los niveles de…»AEMPS, section 4.5 · Open on CIMA
«Diuréticos eliminadores de potasio: Puede desarrollarse hipopotasemia o hipomagnesemia, con el consiguiente aumento del riesgo de «torsade de pointes» (ver también la sección 4.4).»AEMPS, section 4.5 · Open on CIMA
«Deben extremarse las precauciones en la administración concomitante de sotalol con otros medicamentos con un efecto conocido de prolongación del intervalo QT, como fenotiazinas, antidepresivos…»AEMPS, section 4.5 · Open on CIMA
«La administración conjunta de hidroxizina con fármacos que se sabe que prolongan el intervalo QT y/AEMPS, section 4.5 · Open on CIMA
«Interacciones con otros medicamentos: antiarrítmicos de la clase clase III (p. ej., amiodarona, sotalol, dofetilida, ibutilida),»AEMPS, section 4.5 · Open on CIMA
«Está contraindicado el uso concomitante de pimozida con fármacos de los que se conoce su efecto de prolongar el intervalo QT (ver sección 4.3 Contraindicaciones), incluyendo ciertos antiarrítmicos…»AEMPS, section 4.5 · Open on CIMA
«DRUG INTERACTIONS: Because pimozide prolongs the QT interval of the electrocardiogram, an additive effect on QT interval would be anticipated if administered with other drugs, such as phenothiazines…»FDA, section 7 · Open on DailyMed
«Administración concomitante de antiarrítmicos de clase Ia (p.ej. quinidina) o clase III (p.ej. dofetilida, sotalol) distintos de la amiodarona.»AEMPS, section 4.3 · Open on CIMA
«CONTRAINDICATIONS: dofetilide, sotalol, quinidine, other Class Ia and III anti-arrhythmics, mesoridazine, thioridazine, chlorpromazine, droperidol, pimozide, sparfloxacin, gatifloxacin, moxifloxacin…»FDA, section 4 · Open on DailyMed
«Los fármacos que prolongan el intervalo QT , incluidos antiarritímicos como la quinidina, los antihistamínicos astemizol y terfenadina, algunos antipsicóticos (particularmente la pimozida y el…»AEMPS, section 4.5 · Open on CIMA
«DRUG INTERACTIONS: Disopyramide Quinidine Dofetilide Amiodarone Sotalol Procainamide Not Recommended Disopyramide, Quinidine: There have been postmarketing reports of torsades de pointes occurring…»FDA, section 7 · Open on DailyMed
«bepridil, sotalol, ibutilida, amiodarona).»AEMPS, section 4.5 · Open on CIMA
«Efectos en el intervalo QTc: Se desconoce la relevancia clínica de este hallazgo y no puede generalizarse a todo tipo de pacientes en cualquier circunstancia, ya que dependerá de los factores de…»AEMPS, section 4.4 · Open on CIMA
«Uso con medicamentos que prolongan el intervalo QT: Debido a que el tratamiento de deprivación de andrógenos puede prolongar el intervalo QT, se recomienda precaución cuando se administre abiraterona…»AEMPS, section 4.5 · Open on CIMA
«Cuando se prescribe amisulprida con medicamentos que prolongan el intervalo QT por ejemplo antiarritmicos de la clase IA (por ejemplo, quinidina, disopiramida) y antiarritmicos de la clase III (por…»AEMPS, section 4.5 · Open on CIMA
«Medicamentos asociados con prolongación del intervalo QT: Azitromicina se debe usar con precaución en pacientes que reciben medicamentos que se sabe que prolongan el intervalo QT (ver sección 4.4)…»AEMPS, section 4.5 · Open on CIMA
«Antiarrítmicos inductores de torsades de pointes (amiodarona, bretilio, disopiramida, quinidínicos, sotalol).»AEMPS, section 4.5 · Open on CIMA
«Sustancias que pueden desencadenar torsades de pointes: - antiarrítmicos de clase III (por ejemplo, amiodarona, sotalol)»AEMPS, section 4.5 · Open on CIMA
«Potential for Other Drugs to Affect Clozapine: Use caution when administering concomitant medications that prolong the QT interval or inhibit the metabolism of clozapine. Drugs that cause QT…»FDA, section 7 · Open on DailyMed
«Drugs that Prolong the QT Interval: Do not use fluoxetine in combination with thioridazine or pimozide. Use fluoxetine with caution in combination with other drugs that cause QT prolongation. These…»FDA, section 7 · Open on DailyMed
Showing 40 of 69, heaviest first
Opens the checker prefilled with this drug. Pick the second one from your regimen.
Summary of a multi-drug list →
Medicine list: everything you take in one place →
Sotalol is evaluated for the following indications with varying evidence strength: Atrial fibrillation (evidence tier B), Ventricular tachycardia (evidence tier B). See the full indication matrix with dosing and citations above on this page.
Common side effects of Sotalol (≥ 1 in 100): Bradycardia, Fatigue, Dyspnoea, Dizziness, Cold extremities. See the Safety section for uncommon and serious reactions.
AEMPS summary of product characteristics (section 4.6): animal studies with sotalol have shown no teratogenicity or other harm to the fetus, and although there are no adequate well-controlled studies in pregnant women, sotalol crosses the placenta and is found in amniotic fluid. Beta-blockers reduce placental blood flow, which can lead to intrauterine fetal death and immature or preterm births, and the fetus and newborn may have adverse reactions, especially hypoglycaemia and bradycardia; newborns also have a higher risk of cardiac and pulmonary complications after birth. Sotalol should be used in pregnancy only if the potential benefit outweighs the possible risk to the fetus. Treatment is stopped 48–72 hours before the expected delivery date; if that is not possible, the newborn is monitored for the same period after birth for signs of beta-blockade (such as cardiac and pulmonary complications).
Compatible with caution. Hale L3. Transfers into milk at high concentration (RID about 25–30%), the highest among β-blockers. Infant bradycardia and hypoglycaemia are possible; heart rate and glucose monitoring is advised.
Sotalol is contraindicated in: Hypersensitivity to sotalol; Sinus bradycardia below 50 bpm; 2nd–3rd degree AV block without pacemaker; QT prolongation (>450 ms men, >470 ms women); Bronchial asthma. Full list in the Safety section.
Direct links to regulator labels. Open in a new tab.
Atenolol, Bisoprolol, Carvedilol, Labetalol, Metoprolol, Nebivolol, Propranolol