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Sotalol

Sotahexal, Sotastad · ATC code C07AA07

Brand names: Sotahexal, Sotastad, Darob Mite, Sotalex, Darob, Talozin, Betapace, Betapace AF, Sotylize

Key facts
Active substance
Sotalol
Drug class
Beta blocker
ATC code
C07AA07
Authorisation
authorised nationally; no central EU authorisation
Information as of
2026-10-29

Boxed warning

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.

If the QT interval prolongs to 500 msec or greater, reduce the dose, lengthen the dosing interval, or discontinue the drug.

Calculate creatinine clearance to determine appropriate dosing [see Dosage and Administration (2.5)] .

Key facts

Sotalol is an antiarrhythmic with beta-blocking (Class II) and Class III properties. Per the US prescribing information, it is used for life-threatening ventricular arrhythmias and to maintain sinus rhythm in highly symptomatic atrial fibrillation/flutter.

What it is used for

  • Documented, life-threatening ventricular arrhythmias such as sustained ventricular tachycardia (no proven survival benefit)
  • Maintenance of normal sinus rhythm in patients with highly symptomatic atrial fibrillation/atrial flutter who are in sinus rhythm

Dosing

  • Start or restart in hospital for at least 3 days with continuous ECG monitoring; withdraw other antiarrhythmics first; correct potassium and magnesium; check QTc 2 to 4 hours after each dose increase
  • Initially 80 mg twice daily; may be increased by 80 mg per day every 3 days if QTc <500 msec
  • Ventricular arrhythmias: usually 160 to 320 mg/day in two or three divided doses; AFIB/AFL: most patients respond to 120 mg twice daily
  • Renal impairment: dosing interval by creatinine clearance – 12 hours if > 60 mL/min, 24 hours if 30–59 mL/min, 36–48 hours if 10–29 mL/min; individualize if < 10 mL/min
  • Children: dosing by body surface area – see the full text; a missed dose should not be doubled

Contraindications

  • Sinus bradycardia, sick sinus syndrome, second and third degree AV block without a functioning pacemaker
  • Congenital or acquired long QT syndromes; baseline QT >450 msec for AFIB/AFL
  • Cardiogenic shock or decompensated heart failure
  • Serum potassium <4 mEq/L; bronchial asthma or bronchospastic conditions; hypersensitivity to sotalol

Important warnings

  • Boxed warning: can cause life-threatening ventricular tachycardia with QT prolongation; initiate in a facility with resuscitation and ECG monitoring; reduce dose or stop if QT reaches 500 msec or more; dose by creatinine clearance
  • Torsade de Pointes: higher risk with reduced creatinine clearance, female sex, higher doses, slow heart rate, heart failure
  • Bradycardia (13% in trials), heart block, hypotension, heart failure
  • Cardiac ischemia after abrupt discontinuation; bronchospasm
  • May mask hypoglycemia and hyperthyroidism; anaphylaxis

Side effects

  • In AFIB/AFL trials: fatigue (up to 20%), dizziness, bradycardia (up to 13%), headache, dyspnea, nausea/vomiting, diarrhea, hyperhidrosis, weakness
  • Serious: ventricular arrhythmias including Torsade de Pointes

Interactions

  • Class I or III antiarrhythmics: stop at least three half-lives before; disopyramide, quinidine, procainamide and amiodarone are not recommended; avoid other QT-prolonging drugs
  • Digitalis, diltiazem, verapamil, beta-blockers: increased risk of bradycardia or hypotension
  • Catecholamine-depleting agents: see the full text
  • Antacids with aluminum oxide and magnesium hydroxide: not within 2 hours

Pregnancy and breastfeeding

  • Both the untreated condition and sotalol use can cause adverse outcomes for mother and fetus; see the full text

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Patient information (US)

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

Austria

  • SotahexalHexal Pharma Gmbh · 1 register entry
  • SotastadStada Arzneimittel Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Germany

  • Darob MiteViatris Healthcare Gmbh · 1 register entry
  • SotahexalHexal Ag · 1 register entry
  • SotalexCheplapharm Arzneimittel Gmbh · 2 register entries
  • Sotalol1 A Pharma Gmbh, Ratiopharm Gmbh, Umip Limited, Abz-Pharma Gmbh · 4 register entries

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Turkey

  • DarobABBOTT LABORATUARLARI İTHALAT İHRACAT VE TİC. LTD. ŞTİ. · 1 register entry
  • TalozinADEKA İLAÇ SAN. VE TİC. A.Ş. · 3 register entries

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

USA

  • BetapaceLegacy Pharma USA, Inc. · 1 register entry
  • Betapace AFLegacy Pharma USA, Inc. · 1 register entry
  • SotylizeAzurity Pharmaceuticals, Inc. · 1 register entry

Source: U.S. FDA – Drug labels (openFDA/DailyMed), as of 2026-10-29

Brand names in 25 more European countries
Belgium
Sotalex, Sotalol Sandoz, Sotalol Viatris
Bulgaria
Дароб, Сотагамма Sotagamma, Сотахексал
Croatia
Darob Mite
Cyprus
Sotalol Mc, Sotax
Czechia
Sotahexal
Denmark
Sotalol Viatris
Estonia
Sotahexal
Finland
Sotacor, Sotalol Viatris
France
Sotalex, Sotalol Arrow Lab, Sotalol Biogaran, Sotalol Cristers, Sotalol Eg, Sotalol Sandoz, Sotalol Teva, Sotalol Viatris, Sotalol Zentiva
Greece
Sotalol Mylan
Hungary
Sotalex Mite
Iceland
Sotalol Viatris
Ireland
Sotoger
Italy
Rytmobeta, Sotalex, Sotalolo Hexal, Sotalolo Mylan Generics, Sotalolo Teva
Latvia
Sotagamma
Luxembourg
Sotalex
Malta
Sotalol Hydrochloride Accord Healthcare
Netherlands
Sotalol Hcl Focus, Sotalol Hcl Hyloris, Sotalol Hcl Sandoz, Sotalol Hcl Viatris, Sotalol Hydrochloride Aurobindo
Norway
Sotalol Mylan
Poland
Biosotal, Sotahexal, Sotalol Aurovitas
Portugal
Darob, Sotalol Aurobindo, Sotalol Sandoz
Romania
Darob, Sotagamma, Sotalol Al
Slovenia
Darob Mite
Spain
Sotalol Sandoz, Sotapor
Sweden
Sotacor, Sotalol Viatris

EMA – Article 57 product data (EU/EEA), 2026-10-29

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

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Sources

  1. U.S. Food and Drug Administration. Sotalol Hydrochloride (Oxford Pharmaceuticals, LLC) – Prescribing Information, 2023-11-02. DailyMed (NLM), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c8ac6351-b1e9-4dd2-82f2-5980814fda15
  2. EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  3. EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  4. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  5. U.S. FDA – Drug labels (openFDA/DailyMed), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/
  6. Wikidata (CC0): ATC C07AA.

Editorial: Medelix editorial team · last updated 2026-10-29 · How these pages are made · Report an error

Source: U.S. Food and Drug Administration (FDA), prescribing information, via DailyMed (NLM); public domain. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.