Schedule H

Oral, Intravenous (IV)

• Tablets: 40 mg, 80 mg

• Injection: 150 mg/10 mL (15 mg/mL) vial

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Ventricular Arrhythmias (Ventricular Tachycardia — Sustained or Non-sustained)

Parameter Recommendation

Starting dose 80 mg PO twice daily

Titration Increase by 80 mg/day every 2–3 days based on response and QTc

Usual maintenance dose 160–320 mg/day in two divided doses

Maximum dose 480 mg/day (exceptional cases under specialist supervision)

IV dosing 1.5 mg/kg over 5 minutes; hospital setting with continuous cardiac monitoring only

Clinical notes: ECG and QTc monitoring essential before initiation, during titration, and at maintenance. Do not initiate if baseline QTc >450 ms.

1. Supraventricular Tachycardias (AVNRT, Atrial Flutter)

Parameter Recommendation

Starting dose 80 mg PO twice daily

Titration Increase by 40–80 mg/day at intervals of ≥3 days

Usual maintenance dose 160 mg/day in two divided doses

Maximum dose 320 mg/day

Clinical notes: Obtain baseline ECG and serum electrolytes. Avoid if QTc >450 ms. Correct hypokalaemia and hypomagnesaemia prior to initiation.

1. Atrial Fibrillation (Maintenance of Sinus Rhythm Post-Cardioversion)

Parameter Recommendation

Starting dose 80 mg PO twice daily

Titration Adjust every 3 days based on QTc response

Usual maintenance dose 160–240 mg/day in divided doses

Maximum dose 320 mg/day

Clinical notes: Use only for rhythm control in patients with stable sinus rhythm after cardioversion. Not indicated for rate control. Ideally initiate in hospital or monitored setting.

Secondary Indications — Adults (Off-label)

Indication Dose Duration Notes

Prevention of postoperative atrial fibrillation (post-cardiac surgery) 80 mg PO BD, starting 1–3 days preoperatively Continue 5–10 days postoperatively Specialist only; requires QTc and renal monitoring

Evidence basis: Supported by RCTs; used in Indian cardiothoracic surgical protocols (AIIMS, tertiary centres)

OFF-LABEL

PAEDIATRIC DOSING (Specialist Only)

Primary Indications

1. Supraventricular arrhythmia

1. Ventricular arrhythmia

Weight-Based Dosing (Oral)

Parameter Recommendation

Starting dose 1–2 mg/kg/dose twice daily

Titration Increase every 3 days with ECG and QTc monitoring

Usual maintenance dose 2–3 mg/kg/dose twice daily

Maximum dose 4 mg/kg/dose (not exceeding 160 mg/day total)

IV Dosing

• 1 mg/kg over 5 minutes under continuous cardiac monitoring

• Reserved for PICU settings only

Safety Parameters

Parameter Requirement

Minimum age Generally avoided below 2 years unless life-threatening arrhythmia with no alternative

Monitoring Continuous ECG on initiation/titration, serum K⁺, Mg²⁺, renal function

Precautions Avoid if baseline QTc >450 ms, hypokalaemia, hypomagnesaemia, or structural heart disease

Secondary Indications — Paediatrics (Off-label)

Indication Dose Duration Notes

Prophylaxis of paroxysmal SVT 2 mg/kg/day divided BD Individualised; typically months Specialist only

Evidence basis: Based on tertiary centre practice (AIIMS, IAP subspecialty guidance)

OFF-LABEL

Required — Sotalol is renally excreted unchanged; accumulation increases QT prolongation risk

60 No adjustment required

30–60 Reduce dose or frequency by 50%; monitor QTc closely

10–30 Use with extreme caution; start at 40 mg/day, titrate slowly with strict QT monitoring

<10 or ESRD on dialysis Not recommended; if essential, dose post-dialysis with ECG monitoring

• Baseline QTc >450 ms

• Sinus bradycardia (<50 bpm) without pacemaker

• Second- or third-degree AV block without pacemaker

• Decompensated heart failure

• Cardiogenic shock

• Bronchial asthma or severe COPD

• Creatinine clearance <10 mL/min

• Uncorrected hypokalaemia or hypomagnesaemia

• Known hypersensitivity to sotalol or other beta-blockers

• Concomitant use with Class Ia antiarrhythmics (quinidine, procainamide)

• Elderly patients — increased risk of QT prolongation and reduced renal clearance

• Diabetes mellitus — may mask hypoglycaemia symptoms (tremor, tachycardia)

• Impaired renal function — requires dose adjustment and closer monitoring

• Electrolyte imbalance — correct K⁺ and Mg²⁺ before and during therapy

• Concomitant use of other QT-prolonging drugs — additive proarrhythmic risk

• Structural heart disease — increases proarrhythmic risk

• Peripheral vascular disease — may worsen symptoms

Parameter Recommendation

Risk category Avoid unless clearly indicated (limited human safety data)

Preferred alternatives Beta-1 selective blockers (metoprolol, labetalol) preferred for rate control in pregnancy

When may be used Life-threatening ventricular arrhythmias where benefit outweighs risk; specialist supervision essential

Monitoring Maternal QTc monitoring, foetal heart rate, growth scans if prolonged use

Parameter Recommendation

Compatibility Not routinely recommended

Level in milk Moderate to high

Preferred alternatives Metoprolol considered safer if beta-blocker required during breastfeeding

Infant monitoring Observe for bradycardia, poor feeding, excessive sleepiness

If used Administer immediately after breastfeeding; monitor infant closely

Parameter Recommendation

Starting dose 40 mg BD; may start at 40 mg OD in frail elderly

Titration Slower titration with ECG review every 2–3 days

Special risks Reduced renal clearance, increased QT prolongation risk, falls due to bradycardia/hypotension

Precautions Avoid polypharmacy with other QT-prolonging drugs; monitor electrolytes frequently

Interacting Drug/Class Effect Recommendation

QT-prolonging agents (amiodarone, azithromycin, haloperidol, ondansetron) Additive QT prolongation → increased torsades de pointes risk Avoid combination or use with extreme caution and ECG monitoring

Class Ia antiarrhythmics (quinidine, procainamide, disopyramide) Synergistic QT prolongation Contraindicated

Verapamil, Diltiazem Additive bradycardia, AV block, hypotension Avoid combination

Hypokalaemia-inducing agents (furosemide, thiazides, amphotericin B) Increased torsades risk Monitor and correct electrolytes frequently

Clonidine Risk of rebound hypertension on clonidine withdrawal Discontinue beta-blocker several days before clonidine withdrawal

Interacting Drug/Class Effect Recommendation

Insulin / Oral hypoglycaemics Masked hypoglycaemia symptoms Monitor blood glucose more frequently

Beta-agonists (salbutamol, terbutaline) Bronchodilator effect antagonised May require higher doses of beta-agonist

Digoxin Enhanced bradycardia and AV block risk Monitor heart rate and rhythm

Antacids (aluminium/magnesium) Reduced oral absorption of sotalol Separate administration by at least 2 hours

Fluoroquinolones (levofloxacin, moxifloxacin) Additive QT prolongation Use with caution; monitor QTc

NSAIDs May reduce antihypertensive effect Monitor blood pressure

• Fatigue

• Dizziness / Lightheadedness

• Bradycardia

• Dyspnoea

• Cold extremities

• Nausea, diarrhoea

• Headache

• Sleep disturbances

Adverse Effect Action Required

Torsades de pointes Immediate discontinuation; emergency cardiac intervention

Significant QT prolongation (QTc >500 ms) Discontinue; correct electrolytes; cardiac monitoring

Severe bradycardia or high-degree AV block Discontinue; consider atropine or temporary pacing

Exacerbation of heart failure Reduce dose or discontinue; supportive care

Bronchospasm Discontinue; avoid in asthma/severe COPD

Syncope Evaluate for arrhythmia; consider dose reduction or discontinuation

Long-term Periodic ECG every 1–3 months; electrolytes monthly in high-risk patients (diuretic users, elderly); renal function every 3 months

• Sotacor

• Sotalar

• Betacord

• Sotalex

(Check regional availability; IV formulations limited outside tertiary centres)

Note: Not under NPPA price control; not included in NLEM 2022

• Always assess baseline QTc and renal function before starting; do not initiate if QTc >450 ms

• Sotalol is not interchangeable with other beta-blockers — it has a distinct Class III antiarrhythmic role

• Ideally initiate therapy in a hospital or monitored setting; outpatient initiation only in low-risk patients with close follow-up

• Torsades de pointes risk increases sharply with electrolyte derangement — always correct K⁺ and Mg²⁺ before and during therapy

• Use small dose increments with ECG monitoring to prevent QTc >500 ms

• Antacid interaction is often overlooked — counsel patients to space doses by at least 2 hours

antiarrhythmic; sotalol; class III; QT prolongation; torsades de pointes; ventricular tachycardia; supraventricular tachycardia; atrial fibrillation; renal-adjusted; cardiology; India

RxIndia v1.0 — 02 Apr 2025

• CDSCO-approved product labels

• Indian Pharmacopoeia / National Formulary of India 2021

• NLEM 2022 (Sotalol not included)

• API Textbook of Medicine

• AIIMS Cardiology protocols

• Indian Heart Rhythm Society guidance

• RCT/meta-analysis (for off-label postoperative AF prophylaxis — marked)