Sotalol

Pronunciation: Unresolved in the reviewed source..

Generic name
sotalol hydrochloride
Brand names
BETAPACE, BETAPACE AF
Drug class
Class III antiarrhythmic agent with non-selective beta-adrenergic blocking activity
Form
Tablet
Route
Oral
Legal status
FDA-approved medicine; prescription status was not specifically extracted from the reviewed source.

Availability and supply rules vary by country

Trade names by country: United States · Canada

Australia: · Full directory

What sotalol hydrochloride is and how it works

Sotalol hydrochloride is an oral Class III antiarrhythmic medicine with non-selective beta-blocking activity. It can prolong the QT interval and can cause life-threatening ventricular arrhythmias, including Torsade de Pointes-type ventricular tachycardia. (1)

Sotalol treatment must be initiated or re-initiated in a facility able to provide cardiac resuscitation and continuous ECG monitoring. Dosing is individualized according to QTc response and renal function.

Mechanism of action: how sotalol hydrochloride works

Sotalol hydrochloride is a Class III antiarrhythmic agent with non-selective beta-adrenergic blocking activity. (1)

What sotalol hydrochloride is used for

Documented life-threatening ventricular arrhythmias

BETAPACE is approved for treatment of documented, life-threatening ventricular arrhythmias, such as sustained ventricular tachycardia. The label states that sotalol has not been shown to enhance survival in these patients. (1)

Maintenance of normal sinus rhythm in highly symptomatic AFIB/AFL

BETAPACE AF is approved to maintain normal sinus rhythm by delaying recurrence of atrial fibrillation or atrial flutter in patients with highly symptomatic AFIB/AFL who are currently in sinus rhythm. Because of proarrhythmic risk, the label advises against use when AFIB/AFL is likely to be easily reversible or minimally symptomatic. (1)

Before taking sotalol hydrochloride

Do not take / not appropriate for

  • Sotalol is contraindicated in people with sinus bradycardia, second- or third-degree AV block without a functioning pacemaker, sick sinus syndrome, congenital or acquired long QT syndrome, serum potassium below 4 mEq/L, cardiogenic shock, decompensated heart failure, bronchial asthma or other bronchospastic conditions, or known hypersensitivity to sotalol. The prescriber must assess for these conditions before starting treatment. (BETAPACE and BETAPACE AF) (1)
  • For the AFIB/AFL indication, BETAPACE AF is contraindicated when the baseline QT interval is greater than 450 msec; the prescriber must assess QT interval before starting. (BETAPACE AF for AFIB/AFL) (1)

Tell your clinician about

  • Any history of long QT syndrome, slow heart rate, AV block, sick sinus syndrome, fainting, ventricular arrhythmia, heart failure, cardiogenic shock, or coronary artery disease.
  • Kidney impairment or any change in kidney function, because dosing intervals are based on creatinine clearance.
  • Low potassium or magnesium, recent vomiting or diarrhea, or medicines that may affect electrolyte levels.
  • All medicines, including Class I or other Class III antiarrhythmics, digoxin, diltiazem, verapamil, antacids containing aluminum or magnesium, insulin, oral antidiabetic medicines, and beta-2 agonists.
  • Diabetes or fasting, since beta-blockade can mask signs of low blood sugar.
  • Pregnancy, plans for pregnancy, labor or delivery planning, or breastfeeding.
(1)

How to take sotalol hydrochloride

  • Sotalol must be initiated or re-initiated in a facility that can provide cardiac resuscitation and continuous ECG monitoring.
  • The clinician individualizes the dose according to QTc response and renal function. If the QT interval reaches 500 msec or more, the clinician must reduce the dose, lengthen the dosing interval, or discontinue the medicine.
  • Do not change the dose, dosing interval, or treatment plan yourself.
  • Do not abruptly discontinue sotalol. In people with underlying coronary artery disease, abrupt withdrawal of beta-blocker therapy can worsen angina or precipitate myocardial infarction; any discontinuation requires medically supervised gradual tapering over about 1 to 2 weeks.
(1)

Procedures and treatment changes

Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1)

Missed dose

A specific missed-dose protocol was not extracted from the reviewed source. Contact the treating clinician or prescribing service for instructions; do not take an extra dose or alter the dosing schedule without clinician advice.

Overdose

Specific overdose-management steps were not extracted from the reviewed source. For a suspected overdose, contact emergency services or poison control urgently and seek emergency medical assessment. (1)

Side effects

Reported adverse reactions include fatigue, slow heart rate, shortness of breath, proarrhythmia, weakness, and dizziness. Sotalol can also cause serious QT prolongation and life-threatening ventricular arrhythmias.

Fatigue

What to notice: Tiredness or reduced energy. Fatigue occurred in 4% of patients in trials.

What to do: Discuss persistent or troublesome fatigue with the prescribing clinician. (1)

Slow heart rate

What to notice: Bradycardia below 50 beats per minute occurred in 3% of patients in trials.

What to do: Contact the prescribing clinician promptly for assessment, particularly if associated with dizziness, faintness, or other new symptoms. (1)

Shortness of breath, weakness, or dizziness

What to notice: Dyspnea occurred in 3%, asthenia or weakness in 2%, and dizziness in 2% of patients in trials.

What to do: Discuss these symptoms with the prescribing clinician, especially if they are new, worsening, or persistent. (1)

New or worsening heart failure

What to notice: New or worsening symptoms of heart failure during initiation or dose titration.

What to do: Contact the prescribing clinician promptly for assessment. (1)

Possible hypoglycemia with reduced warning signs

What to notice: Beta-blockade can mask warning signs of low blood sugar, such as tachycardia. This is a particular consideration for people with diabetes and people who are fasting.

What to do: Contact the clinician managing diabetes and the sotalol prescriber promptly if low blood sugar is suspected or glucose control changes. (1)

Serious warnings

QT prolongation and proarrhythmia, including Torsade de Pointes-type ventricular tachycardia — emergency

Symptoms: Life-threatening ventricular arrhythmias may occur. Risk is increased by reduced renal clearance, female sex, higher doses, bradycardia, and a history of heart failure. Low potassium or magnesium and concurrent QT-prolonging medicines increase concern.

Action: Seek emergency medical care for suspected serious rhythm symptoms. Sotalol initiation and re-initiation require facility-based continuous ECG monitoring and cardiac-resuscitation capability; QT- and dose-related decisions must be made by the treating clinician. (1)

Bradycardia — urgent

Symptoms: Sotalol can cause bradycardia, which can itself increase the risk of Torsade de Pointes.

Action: Seek prompt medical assessment for symptoms that may indicate clinically important slow heart rate. The clinician should direct any treatment change. (1)

Bronchospasm — urgent

Symptoms: Sotalol is a non-selective beta-blocker; bronchial asthma and other bronchospastic conditions are a contraindication, and any new or worsening breathing symptoms during treatment need assessment.

Action: Seek urgent medical assessment for breathing symptoms. The prescriber, not the patient, determines whether sotalol is suitable and manages dosing. (1)

Interactions

Medicine or testEffectAction
Class I or other Class III antiarrhythmicsConcurrent use increases proarrhythmic risk and is not recommended. These medicines should generally be discontinued for at least three half-lives before sotalol is started.The prescriber must coordinate any antiarrhythmic transition and monitoring plan. (1)
Digoxin, diltiazem, and verapamilConcomitant use can increase the risk of bradycardia and hypotension.Give the prescriber and pharmacist a complete medicine list so they can assess heart-rate and blood-pressure risks. (1)
Aluminum- or magnesium-containing antacidsThese antacids can reduce sotalol absorption by about 20% to 26%.Separate sotalol and these antacids by at least 2 hours as directed by the clinician or pharmacist. (1)
Insulin and oral antidiabetic medicinesBeta-blockade can affect glucose counter-regulation and awareness of hypoglycemia; antidiabetic-medicine dose adjustment may be needed.The clinicians managing sotalol and diabetes should review glucose monitoring and any medicine adjustments. (1)
Beta-2 agonistsHigher beta-2 agonist doses may be needed to overcome sotalol's non-selective beta-blockade.A clinician should review respiratory medicines and any required dose changes. (1)

Pregnancy, breastfeeding, kidney/liver function, age

Children

Pediatric dosing is based on weight and body-surface area and must be individualized by a specialist. Children younger than 2 years require age-adjusted lower dosing because clearance variability is faster; this is not a self-directed dose. (1)

Kidney impairment

Sotalol dosing intervals require adjustment according to creatinine clearance. Reduced renal clearance also increases the risk of QT prolongation and proarrhythmia. (1)

Pregnancy

Sotalol crosses the placenta. Potential fetal risks include growth restriction, bradycardia, hypoglycemia, and reports of intrauterine death. If used in pregnancy, continuous fetal and neonatal monitoring is recommended around labor and delivery. (1)

Breastfeeding

The reviewed label advises against breastfeeding during sotalol treatment. Breast-milk concentrations are high, with estimated infant exposure about 22% to 25.5% of the maternal weight-adjusted dose, comparable to neonatal therapeutic doses. (1)

Monitoring

Before starting

  • Confirm the exact indication and assess contraindications.
  • Measure QT or QTc interval and assess creatinine clearance for dose-interval selection.
  • Correct hypokalemia and hypomagnesemia before therapy.
  • Review medicines for QT-prolonging medicines, antiarrhythmics, negative chronotropes or AV-nodal blockers, antacids, diabetes medicines, and beta-2 agonists.
  • Arrange facility-based initiation or re-initiation with continuous ECG monitoring and cardiac-resuscitation capability.

During treatment

  • Monitor QTc response and renal function to individualize dosing.
  • If the QT interval prolongs to 500 msec or more, the treating clinician must reduce the dose, lengthen the dosing interval, or discontinue the medicine.
  • Monitor for proarrhythmia, bradycardia, hypotension, new-onset or worsening heart failure, and bronchospasm.
  • Assess potassium and magnesium and correct low values through clinician-directed care.
  • Monitor glucose-related concerns in people with diabetes or those who are fasting, recognizing that beta-blockade can mask tachycardia as a hypoglycemia warning sign.
(1)

Storage

Storage instructions were not extracted from the reviewed source and remain unresolved. Follow the dispensing label and pharmacist's instructions for the exact product.

Study the drug class: Beta blockers · Class III antiarrhythmics

Professional information

Clinician-facing context only. Use the current full local product information, ECG/QTc monitoring requirements, creatinine-clearance assessment, electrolyte management, and facility-based initiation or re-initiation protocol.

United States

Indication: Adult BETAPACE or BETAPACE AF use

Dose summary: Adult therapy is initiated at 80 mg twice daily. It may be titrated upward by 80 mg/day approximately every 3 days to a usual effective range of 160 to 320 mg/day, with a maximum of 320 mg/day, provided QTc remains below 500 msec. Initiation or re-initiation must occur in a facility with cardiac-resuscitation capability and continuous ECG monitoring.

Renal context: Creatinine clearance greater than 60 mL/min: usual 12-hour dosing interval; 30 to 59 mL/min: every 24 hours; 10 to 29 mL/min: every 36 to 48 hours; less than 10 mL/min: individualized dosing. No hepatic-impairment-specific dosing guidance was identified in the reviewed source. (1)

United States

Indication: Pediatric sotalol use

Dose summary: Specialist-directed, weight- and body-surface-area-based dosing starts around 1.2 mg/kg three times daily and may be titrated to a maximum around 2.4 mg/kg three times daily. Children younger than 2 years require individualized, age-adjusted lower dosing.

Renal context: Pediatric renal-impairment dosing details were not extracted from the reviewed source and remain unresolved for this draft. (1)

Mechanism of action

Hepatic guidance

No hepatic-impairment-specific dosing guidance was identified in the reviewed source.

Overdose note

A specific overdose-management protocol, including antidotes or treatment steps, was not extracted from the reviewed source. Route suspected overdose to emergency services or poison control. (1)

Frequently asked questions

Why must sotalol be started or restarted in a monitored facility?

Sotalol can prolong the QT interval and cause life-threatening ventricular arrhythmias, including Torsade de Pointes-type ventricular tachycardia. The label requires initiation or re-initiation in a facility with continuous ECG monitoring and cardiac-resuscitation capability. (1)

Can I change my sotalol dose or schedule myself?

No. Dose and dosing interval are individualized using QTc response and kidney function. A QT interval of 500 msec or more requires clinician-directed action. (1)

Can I abruptly discontinue sotalol?

No. Abrupt withdrawal of beta-blocker therapy can worsen angina or precipitate myocardial infarction in people with underlying coronary artery disease. A clinician should direct any gradual tapering plan. (1)

What should I do if I miss a dose?

The reviewed source did not provide a specific missed-dose protocol. Contact the treating clinician or prescribing service for instructions rather than changing the schedule or taking an extra dose. (1)

What is the mechanism of action of sotalol hydrochloride?

Sotalol hydrochloride is a Class III antiarrhythmic agent with non-selective beta-adrenergic blocking activity. (1)

What is the generic name of Sotalol?

The generic name is sotalol hydrochloride. It is sold under brand names including BETAPACE, BETAPACE AF. (1)

What class of drug is sotalol hydrochloride?

Sotalol is classed as: Class III antiarrhythmic agent with non-selective beta-adrenergic blocking activity. (1)

References

  1. BETAPACE (sotalol hydrochloride) / BETAPACE AF (sotalol hydrochloride) tablets, full prescribing informationU.S. Food and Drug Administration (DailyMed) · United States · accessed 2026-08-05 · source 1
  2. SOTALOL HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK] — US prescribing information (DailyMed SPL)U.S. National Library of Medicine (DailyMed) · US · accessed 2026-08-14 · source 2
  3. Sotalol — patient drug information (MedlinePlus)U.S. National Library of Medicine (MedlinePlus) · US · accessed 2026-08-14 · source 3
  4. Sotalol Hydrochloride — FDA approval record (Drugs@FDA ANDA075563)U.S. Food and Drug Administration · US · accessed 2026-08-14 · source 4
  5. sotalol — RxNorm normalized drug concept (RXCUI 7008)U.S. National Library of Medicine (RxNorm) · US · accessed 2026-08-14 · source 5

Brand names by country

Single-ingredient sotalol hydrochloride names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.

Priority countries

United States

  • Sotalol Hydrochloride AF120 mg, 160 mg, 80 mg · unichem pharmaceuticals (usa), inc.
  • BETAPACE80 mg, 160 mg, 120 mg · legacy pharma usa, inc.
  • BETAPACE AF80 mg, 120 mg, 160 mg · legacy pharma usa, inc.
  • SOTYLIZE5 mg/mL · azurity pharmaceuticals, inc.

Canada

  • CO SOTALOL
View brands in additional countries.

This page provides general medicine information, not a diagnosis, prescription, dosing plan, ECG-monitoring plan, emergency plan, or substitute for the treating clinician and current local product information.

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