Formulary
Sotalol hydrochloride: Indications, Dosing, Side Effects and Interactions
Sotalol hydrochloride clinical drug profile including indications, dosing, side effects, cautions and interactions.
MedNext Academy | 6 min read
Sotalol hydrochloride: Indications, Dosing, Side Effects and Interactions
Sotalol hydrochloride clinical drug profile including indications, dosing, side effects, cautions and interactions.
Indications and dose
**Symptomatic non-sustained ventricular tachyarrhythmias,Prophylaxis of paroxysmal atrial tachycardia or fibrillation, paroxysmal AV re-entrant tachycardias (both nodal and involving accessory pathways), and paroxysmal supraventricular tachycardia after cardiac surgery,Maintenance of sinus rhythm following cardioversion of atrial fibrillation or flutter**
- **Adult** (By Mouth): Initially 80 mg daily in 1-2 divided doses, then increased to 160-320 mg daily in 2 divided doses, dose to be increased gradually at intervals of 2-3 days.
**Life-threatening arrhythmias including ventricular tachyarrhythmias**
- **Adult** (By Mouth): Initially 80 mg daily in 1-2 divided doses, then increased to 160-320 mg daily in 2 divided doses, dose to be increased gradually at intervals of 2-3 days, higher doses of 480-640 mg daily may be required for life-threatening ventricular arrhythmias (under specialist supervision).
**Life-threatening arrhythmias including ventricular tachyarrhythmias for sotalol hydrochloride**
- **Child 12-17 years** (By mouth): Initially 80 mg once daily, alternatively initially 40 mg twice daily, then increased to 80-160 mg twice daily, dose to be increased gradually at intervals of 2-3 days; higher doses of 480-640 mg daily may be required for life-threatening ventricular arrhythmias (under specialist supervision).
**Ventricular arrhythmias, life-threatening ventricular tachyarrhythmia and supraventricular arrhythmias (initiated under specialist supervision) for sotalol hydrochloride**
- **Neonate** (By mouth): Initially 1 mg/kg twice daily, increased if necessary up to 4 mg/kg twice daily, dose to be increased at intervals of 3-4 days.
**Atrial flutter, ventricular arrhythmias, life-threatening ventricular tachyarrhythmia and supraventricular arrhythmias (initiated under specialist supervision) for sotalol hydrochloride**
- **Child 1 month-11 years** (By mouth): Initially 1 mg/kg twice daily, then increased if necessary up to 4 mg/kg twice daily (max. per dose 80 mg twice daily), dose to be increased at intervals of 2-3 days.
- **Child 12-17 years** (By mouth): Initially 80 mg once daily, alternatively initially 40 mg twice daily, increased to 80-160 mg twice daily, dose to be increased gradually at intervals of 2-3 days.
Cautions
For all beta-adrenoceptor blockers (systemic) Diabetes; first-degree AV block; history of obstructive airways disease (introduce cautiously); myasthenia gravis; portal hypertension (risk of deterioration in liver function); psoriasis; symptoms of hypoglycaemia may be masked; symptoms of thyrotoxicosis may be masked Cautions, further information Elderly Screening Tool of Older Persons' potentially inappropriate Prescriptions (STOPP) criteria to aid medication reviews (see Prescribing in the elderly for information). Potentially inappropriate: in combination with verapamil or diltiazem (risk of heart block) with bradycardia (heart rate less than 50 beats per minute), or second- or third-degree AV block (contra-indicated; risk of complete heart block, asystole) in diabetes mellitus patients with frequent hypoglycaemic episodes (risk of suppressing hypoglycaemic symptoms) if prescribed a non-selective beta-blocker (including topical beta-blockers) in a history of asthma requiring treatment (contra-indicated in asthma; risk of increased bronchospasm) Cautions For sotalol hydrochloride Diarrhoea (severe or prolonged)
Contraindications
For all beta-adrenoceptor blockers (systemic) Asthma; cardiogenic shock; hypotension; marked bradycardia; metabolic acidosis; phaeochromocytoma (apart from specific use with alpha-blockers); Prinzmetal's angina; second-degree AV block; severe peripheral arterial disease; sick sinus syndrome; third-degree AV block; uncontrolled heart failure Contra-indications, further information Bronchospasm Beta-blockers, including those considered to be cardioselective, should usually be avoided in patients with a history of asthma, bronchospasm or a history of obstructive airways disease. However, when there is no alternative, a cardioselective beta-blocker can be given to these patients with caution and under specialist supervision. In such cases the risk of inducing bronchospasm should be appreciated and appropriate precautions taken. Contra-indications For sotalol hydrochloride Long QT syndrome (congenital or acquired); torsade de pointes
Side effects
For all beta-adrenoceptor blockers (systemic) Common or very common Abdominal discomfort; bradycardia; confusion; depression; diarrhoea; dizziness; dry eye (reversible on discontinuation); dyspnoea; erectile dysfunction; fatigue; headache; heart failure; nausea; paraesthesia; peripheral coldness; rash (reversible on discontinuation); Raynaud's phenomenon; sleep disorders; syncope; visual impairment; vomiting Uncommon Alopecia; atrioventricular block; bronchospasm Rare or very rare Hallucination; psoriasis exacerbated Side-effects, further information With administration by intravenous injection, excessive bradycardia can occur and may be countered with intravenous injection of atropine sulfate. Overdose Therapeutic overdosages with beta-blockers may cause lightheadedness, dizziness, and possibly syncope as a result of bradycardia and hypotension; heart failure may be precipitated or exacerbated. With administration by intravenous injection, excessive bradycardia can occur and may be countered with intravenous injection of atropine sulfate. For details on the management of poisoning, see Beta-blockers, under Emergency treatment of poisoning . Side-effects For sotalol hydrochloride Common or very common Anxiety; arrhythmia; chest pain; dyspepsia; fever; flatulence; hearing impairment; mood altered; muscle spasms; oedema; palpitations; sexual dysfunction; taste altered; torsade de pointes (increased risk in females)
Interactions
**Severe interactions:**
- Digitalis glycosides Single and multiple doses of sotalol do not significantly affect serum digoxin levels.
**Other interactions (12):**
- Antiarrhythmics Class 1a antiarrhythmic drugs, such as disopyramide, quinidine and procainamide and other Class III antiarrhythmic drugs such as amiodarone and bepridil are not recommended as...
- Other drugs prolonging the QT-interval Sotalol 40mg Tablets should be given with extreme caution in conjunction with other drugs known to prolong the QT-interval such as phenothiazines, tricyclic...
- Other drugs that have been associated with an increased risk for torsades de pointes include erythromycin IV, halofantrine, pentamidine, and quinolone antibiotics.
- Floctafenine Beta-adrenergic blocking agents may impede the compensatory cardiovascular reactions associated with hypotension or shock that may be induced by Floctafenine.
- Calcium channel blocking drugs Concurrent administration of beta-blocking agents and calcium channel blockers has resulted in hypotension, bradycardia, conduction defects, and cardiac failure.
- Beta-blockers should be avoided in combination with cardiodepressant calcium-channel blockers such as verapamil and diltiazem because of the additive effects on atrioventricular conduction, and...
Pregnancy
For all beta-adrenoceptor blockers (systemic) Beta-blockers may cause intra-uterine growth restriction, neonatal hypoglycaemia, and bradycardia; the risk is greater in severe hypertension.
Breast feeding
For all beta-adrenoceptor blockers (systemic) With systemic use in the mother, infants should be monitored as there is a risk of possible toxicity due to beta-blockade. However, the amount of most beta-blockers present in milk is too small to affect infants. Breast feeding For sotalol hydrochloride Water soluble beta-blockers such as sotalol are present in breast milk in greater amounts than other beta blockers.
Renal impairment
Manufacturer advises avoid if creatinine clearance less than 10 mL/minute. Dose adjustments See Prescribing in renal impairment . Manufacturer advises use half normal dose if creatinine clearance 30-60 mL/minute; use one-quarter normal dose if creatinine clearance 10-30 mL/minute.
Medicinal forms
Solution
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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