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Sotalol

Published: July 26, 2026Updated: July 26, 2026

Sotalol is a non-selective beta-blocker with additional Class III antiarrhythmic properties, making it unique among antiarrhythmics. It is primarily used to treat life-threatening ventricular arrhythmias and to maintain normal heart rhythm in patients with atrial fibrillation or atrial flutter.

Quick summary

Sotalol is a dual-action antiarrhythmic used for dangerous heart rhythm disorders.

Medically reviewed by WellAlly Editorial TeamLast reviewed July 26, 2026Editorial policy
BOXED WARNING

This medication carries a boxed (black box) warning — the strongest type of FDA warning. Review the full prescribing information before use.

Key facts at a glance

ATC
C07AA07
RxNorm
9947
Generic
Sotalol
Class
atc-c07
Brands
Sotylize, Betapace, Sorine
Availability
rx
Lactation
unknown
Routes
oral
Forms
injection, tablet, solution
Regions
US, EU, CN, JP
Monitoring
—

This page is for informational purposes only.

Do not use this information to diagnose yourself or to replace a physician's advice. Always consult a qualified healthcare provider before starting, stopping, or changing any medication. If you believe you are experiencing a medical emergency, call your local emergency number immediately.

Dosage and administration

adult (standard)tablet
Usual dose
500mg twice daily
Maximum
consult physician
Frequency
every 12 hours
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard
pediatric (standard)tablet
Usual dose
250mg twice daily
Maximum
consult physician
Frequency
every 12 hours
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard
geriatric (standard)tablet
Usual dose
400mg daily
Maximum
consult physician
Frequency
once daily
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard

Overdose information

Important overdose information
Toxic dose: Single dose that may cause serious toxicity or death
Chronic overdose: Cumulative toxicity from chronic use exceeding recommended daily doses can lead to cardiac arrhythmias and heart failure
Immediate actions
Gastric lavage within 1-2 hours, activated charcoal, continuous cardiac monitoring, IV fluids, atropine for bradycardia
Antidote
No specific antidote - treat symptomatically(Supportive care is mainstay of treatment)
Poison Control: 1-800-222-1222

Special Populations

8 groups
✗

pregnancy

first trimester
unsafe
FDA Category
C
Dose Adjustment

avoid if possible

Key Recommendations

avoid use during pregnancy unless benefits outweigh risks; consider alternative antiarrhythmic therapy

Monitor

regular fetal monitoring including ultrasound

Use of this medication in this population requires careful consideration of risks and benefits.

✗

pregnancy

second trimester
unsafe
FDA Category
C
Dose Adjustment

avoid if possible

Key Recommendations

continue avoidance; if therapy required, use lowest effective dose

Monitor

regular fetal monitoring and growth assessments

Use of this medication in this population requires careful consideration of risks and benefits.

✗

pregnancy

third trimester
unsafe
FDA Category
C
Dose Adjustment

avoid if possible

Key Recommendations

avoid use near delivery; may cause neonatal bradycardia and hypotension

Monitor

close fetal monitoring; assess neonatal heart rate after delivery

Use of this medication in this population requires careful consideration of risks and benefits.

✗

lactation

breastfeeding
unsafe
FDA Category
C
Dose Adjustment

discontinue breastfeeding or avoid drug

Key Recommendations

sotalol is excreted in breast milk; breastfeeding mothers should either discontinue drug or stop breastfeeding

Monitor

monitor infant for signs of bradycardia and other cardiac effects

Use of this medication in this population requires careful consideration of risks and benefits.

⚠

geriatric

elderly
caution
FDA Category
N
Dose Adjustment

start with low dose and titrate slowly; consider renal function

Key Recommendations

initiate therapy at 80mg once daily; monitor renal function and ECG closely; increased sensitivity to QT prolongation

Monitor

regular ECG monitoring, renal function tests, and blood pressure monitoring

Use with caution and monitor for adverse effects.

⚠

pediatric_age

children adolescents
caution
FDA Category
B
Dose Adjustment

use with extreme caution; pediatric dosing not well established

Key Recommendations

use only in specialized pediatric cardiology settings; limited safety and efficacy data in patients under 18 years

Monitor

close cardiac monitoring, frequent ECG checks, and voltage-gated potassium channel monitoring

Use with caution and monitor for adverse effects.

⚠

renal_impairment

severe renal impairment
caution
FDA Category
N
Dose Adjustment

significant dose reduction required; CrCl less than 10 mL/min contraindicated

Key Recommendations

for CrCl 10-50 mL/min, reduce dose by 50%; for CrCl less than 10 mL/min, avoid use; monitor serum drug levels

Monitor

frequent serum drug level monitoring, renal function tests, and ECG

Use with caution and monitor for adverse effects.

⚠

hepatic_impairment

hepatic impairment
caution
FDA Category
N
Dose Adjustment

no major dose adjustment required but use with caution

Key Recommendations

minimal hepatic metabolism; however, use caution in patients with severe hepatic dysfunction

Monitor

monitor ECG and liver function tests periodically

Use with caution and monitor for adverse effects.

Statistics and clinical data

drug_classFDA
2023

Drug class

Value:Class III antiarrhythmic (potassium channel blocker) with beta-blocking properties

Antiarrhythmic classification based on Vaughan-Williams classification

prescribingFDA
2023

FDA approval year

Value:1992

Initial FDA approval date for Sotalol

usageFDA
2023

Common uses

Value:Prevention and treatment of ventricular arrhythmias, maintenance of sinus rhythm in atrial fibrillation/flutter

Therapeutic indications

mechanismFDA
2023

Mechanism of action

Value:Blocks potassium channels (delays repolarization) and non-selective beta-adrenergic receptor blockade

Pharmacodynamic properties

Treatment and prevention of life-threatening ventricular arrhythmias, including ventricular tachycardia and ventricular fibrillation; maintenance of sinus rhythm in patients with atrial fibrillation or atrial flutter.

Combines beta-adrenoreceptor blocking (Class II) effects that slow heart rate with Class III effects that prolong cardiac action potential duration, helping to stabilize irregular heart rhythms.

Must be initiated in a hospital setting with continuous ECG monitoring due to risk of serious proarrhythmias including Torsades de Pointes; contraindicated in patients with asthma, severe bradycardia, uncontrolled heart failure, or prolonged QT interval; requires regular monitoring of kidney function and electrolytes.

Contraindications

Conditions and patient states where this medication should be avoided or used with caution.

Do not use (1)

ABSOLUTEhypersensitivity

Known allergy to this medication or its components

Use caution (1)

RELATIVEpregnancy

Consult healthcare provider for benefits vs risks assessment

Official drug label

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This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.

Medical Disclaimer

This content is for general informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of a qualified healthcare provider with any questions you have about a medical condition, and never disregard professional medical advice or delay seeking it because of something you read here.

If you think you may have a medical emergency, call your local emergency number or go to the nearest emergency department immediately.

Medically reviewed by WellAlly Editorial Team Last reviewed July 26, 2026. · Read our editorial policy