Sotalol is an antiarrhythmic indicated for the treatment of life-threatening ventricular arrhythmias the maintenance of normal sinus rhythm in patients with atrial fibrillation or flutter (AFIB/AFL), among other approved uses. MedsAcross supplies Sotalol for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
Betapace/Betapace AF is an antiarrhythmic indicated for: the treatment of life-threatening ventricular arrhythmias the maintenance of normal sinus rhythm in patients with atrial fibrillation or flutter (AFIB/AFL). Limitations of Use Betapace has not been shown to enhance survival in patients with life threatening ventricular arrhythmias. Avoid use in patients with minimally symptomatic or easily reversible AFIB/AFL
Source: US FDA prescribing information
Sotalol has both beta-adrenoreceptor blocking (Vaughan Williams Class II) and cardiac action potential duration prolongation (Vaughan Williams Class III) antiarrhythmic properties. The two isomers of sotalol have similar Class III antiarrhythmic effects, while the l-isomer is responsible for virtually all of the beta-blocking activity. The beta-blocking effect of sotalol is non-cardioselective, half maximal at about 80 mg/day and maximal at doses between 320 and 640 mg/day. Sotalol does not have partial agonist or membrane stabilizing activity. Although significant beta-blockade occurs at oral doses as low as 25 mg, significant Class III effects are seen only at daily doses of 160 mg and above. In children, a Class III electrophysiologic effect can be seen at daily doses of 210 mg/m 2 body surface area (BSA).
Source: US FDA prescribing information
Betapace/Betapace AF: Initial dosage in adults is 80 mg twice daily. Increase the dose as needed in increments of 80 mg/day, every 3 days to a maximum 320 mg total daily dose. Pediatrics: Dosage depends on age
Source: US FDA prescribing information
Betapace/Betapace AF is contraindicated in patients with: Sinus bradycardia, sick sinus syndrome, second and third degree AV block, unless a functioning pacemaker is present Congenital or acquired long QT syndromes Cardiogenic shock or decompensated heart failure Serum potassium <4 mEq/L Bronchial asthma or related bronchospastic conditions Hypersensitivity to sotalol For the treatment of AFIB/AFL, Betapace/Betapace AF is also contraindicated in patients with: Baseline QT interval >450 msec For the treatment of AFIB/AFL or ventricular arrhythmias Sinus bradycardia, 2 nd or 3 rd degree AV block, sick sinus syndrome. Congenital or acquired long QT syndrome. Serum potassium <4 mEq/L.
Source: US FDA prescribing information
Boxed warning (life-threatening proarrhythmia): To minimize the risk of drug-induced arrhythmia, initiate or reinitiate oral sotalol in a facility that can provide cardiac resuscitation and continuous electrocardiographic monitoring. Sotalol can cause life-threatening ventricular tachycardia associated with QT interval prolongation. QT prolongation, bradycardia, AV block, hypotension, worsening heart failure: Reduce dose or discontinue. Correct any electrolyte disturbances. Acute exacerbation of coronary artery disease upon cessation of therapy: Do not abruptly discontinue. Diabetes: May mask symptoms of hypoglycemia and alter glucose levels, monitor
Source: US FDA prescribing information
The most common adverse reactions (≥2%) for Betapace are: fatigue 4%, bradycardia (less than 50 bpm) 3%, dyspnea 3%, proarrhythmia 3%, asthenia 2%, and dizziness 2%.
Source: US FDA prescribing information
Class I or III Antiarrhythmics or other drugs that prolong the QT interval: Avoid concomitant use. Digoxin, calcium channel blocker: increased risk of bradycardia, hypotension, heart failure. Dosage of insulin or antidiabetic drugs may need adjustment. Aluminum- or magnesium-based antacids reduce sotalol exposure
Source: US FDA prescribing information
Store at 25°C (77°F), excursions permitted to 15 to 30°C (59 to 86°F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
12 presentations of Sotalol, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Sotalol 80 mg tabletOralGeneric name | — | US FDA | Available on request |
| Sotalol 120 mg tabletOralGeneric name | — | US FDA | Available on request |
| Sotalol 160 mg tabletOralGeneric name | — | US FDA | Available on request |
| Sotalol 240 mg tabletOralGeneric name | — | US FDA | Available on request |
| Sotylize 5 mg/mL oral solutionOral | Azurity Pharmaceuticals | US FDA | Available on request |
| Betapace 120 mg tabletOral | Legacy Pharma | US FDA | Available on request |
| Betapace 160 mg tabletOral | Legacy Pharma | US FDA | Available on request |
| Betapace 80 mg tabletOral | Legacy Pharma | US FDA | Available on request |
| Betapace Af 120 mg tabletOral | Legacy Pharma | US FDA | Available on request |
| Betapace Af 160 mg tabletOral | Legacy Pharma | US FDA | Available on request |
| Betapace Af 80 mg tabletOral | Legacy Pharma | US FDA | Available on request |
| Sotalol 150 mg/10 mL injectionIntravenousGeneric name | — | US FDA | Available on request |
3 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 30 October 1992 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Conditions linked to Sotalol in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 12 presentations of Sotalol and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 3 brand names for Sotalol, including Betapace, Betapace Af, Sotylize.
Yes. The US FDA first approved Sotalol on 30 October 1992, according to Drugs@FDA.
No listed presentation of Sotalol is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Sotalol is classified under ATC code C07AA07 (Sotalol).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.