Generic Medicine Info
Indications and Dosage
Life-threatening ventricular arrhythmias
Adult: Initially, 80 mg bid, increased gradually every 3 days to 240-320 mg/day in divided doses if needed. Maintenance: 160-320 mg/day in divided doses. Max: 480-640 mg in divided doses.

Supraventricular arrhythmias, Ventricular arrhythmias
Adult: Initially, 80 mg/day as single or in 2 divided doses, increased gradually every 2-3 days. Usual dose: 160-320 mg/day in 2 divided doses.
Renal Impairment
CrCl (mL/min) Dosage
<10 Not recommended.
10-30 Quarter the usual dose.
30-60 Half the usual dose.
Should be taken on an empty stomach. Take 1-2 hr before meals.
Bronchial asthma or history of COPD, sick sinus syndrome, symptomatic sinus bradycardia, cardiogenic shock. 2nd and 3rd degree AV block, untreated phaeochromocytoma, torsades de pointes, congenital or acquired long QT syndromes, uncontrolled cardiac failure, cardiogenic shock, metabolic acidosis, hypotension, severe peripheral arterial disease, Raynaud's disease, anaesth that causes myocardial depression. Renal impairment (CrCl <10 mL/min). Concomitant use w/ Ca channel blockers (e.g. verapamil and diltiazem).
Special Precautions
Patients w/ well-compensated heart failure, myasthenia gravis, DM, 1st degree AV block. May mask symptoms of hyperthyroidism and hypoglycaemia. May worsen psoriasis. Patients undergoing major surgery requiring general anaesth. Avoid abrupt withdrawal as it may precipitate thyroid storm and exacerbate angina and MI. Renal impairment. Pregnancy and lactation.
Adverse Reactions
Bradycardia, hypotension, chest pain, heart failure, dyspnoea, palpitations, oedema, ECG abnormalities, proarrhythmia, syncope, presyncope, rash, nausea/vomiting, dyspepsia, flatulence, diarrhoea, abdominal pain, cramps, fever, headache, fatigue, lightheadedness, dizziness, asthenia, sleep disturbances, mood changes, depression, paraesthesia, anxiety, sexual dysfunction, visual disturbances, taste abnormalities, hearing disturbances.
Potentially Fatal: Polymorphic ventricular tachycardia (very rare).
IV/Parenteral/PO: B
Monitoring Parameters
Monitor BP, heart rate, serum creatinine; Mg and K levels.
Symptoms: Bradycardia, CHF, hypotension, bronchospasm and hypoglycaemia. Management: Symptomatic and supportive treatment. Admin IV atropine, another anticholinergic drug, a β-adrenergic agonist or use transvenous cardiac pacing for bradycardia; transvenous cardiac pacemaker for heart block; epinephrine for hypotension; aminophylline or aerosol β2-receptor stimulant for bronchospasm; and DC cardioverison, transvenous cardiac pacing, epinephrine, Mg sulfate for torsade de pointes. Removed via haemodialysis.
Drug Interactions
May increase risk of bradycardia w/ digoxin. May increase risk of arrhythmias w/ diuretics. May potentiate rebound HTN w/ clonidine. May prolong refractoriness w/ disopyramide, quinidine, procainamide, amiodarone and bepridil. May prolong QT interval w/ TCAs, phenothiazines, terfenadine and astemizole. Increased risk of torsades de pointes w/ K-depleting diuretics, erythromycin IV, halofantrine, pentamidine, and quinolones. May prolong neuromuscular blockade of tubocurarine. May reduce response to insulin and oral hypoglycaemics.
Potentially Fatal: Additive effect on AV conduction and ventricular function w/ verapamil and diltiazem.
Food Interaction
Absorption may be reduced by food.
Lab Interference
May falsely increase urinary metanephrine levels by photometric methods.
Mechanism of Action: Sotalol is a non-cardioselective β-blocker. It increases sinus cycle length, slows heart rate, decreases AV nodal conduction and increases AV nodal refractoriness. It also prolongs AV monophasic action potentials. However, it lacks intrinsic sympathomimetic and membrane-stabilising properties.
Onset: 1-2 hr (oral); approx 5-10 min (IV).
Duration: 8-16 hr.
Absorption: Almost completely absorbed from the GI tract. Absorption may decrease by 20-30% w/ food. Bioavailability: 90-100% (oral). Time to peak plasma concentration: Approx 2-4 hr.
Distribution: Crosses placenta and blood brain barrier (small amounts); enters breast milk and CSF (small amounts). Plasma protein binding: Low.
Metabolism: Minimal metabolism.
Excretion: Via urine (as unchanged drug). Elimination half-life: 10-20 hr.
Store at 25°C.
MIMS Class
Anon. Sotalol. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. Accessed 29/11/2013.

Betapace AF (Bayer Healthcare Pharmaceuticals). U.S. FDA. Accessed 29/11/2013.

Betapace and Betapace AF. U.S. FDA. Accessed 29/11/2013.

Buckingham R (ed). Sotalol Hydrochloride. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. Accessed 29/11/2013.

Joint Formulary Committee. Sotalol Hydrochloride. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. Accessed 29/11/2013.

McEvoy GK, Snow EK, Miller J et al (eds). Sotalol Hydrochloride. AHFS Drug Information (AHFS DI) [online]. American Society of Health-System Pharmacists (ASHP). Accessed 29/11/2013.

Sotacor Tab (Bristol-Myers Squibb). eMC. Accessed 29/11/2013.

Disclaimer: This information is independently developed by MIMS based on Sotalol from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2024 MIMS. All rights reserved. Powered by
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