ADMINISTRATION ROUTES:
PO, IV
ALTERNATIVE NAMES:
Sotalol, Sotacor
ICU INDICATIONS:
- Acute treatment and prevention of supraventricular tachycardia
PRESENTATION AND ADMINISTRATION:
IV:
Injection vial (40 mg/4 mL solution)
Add required dose to an appropriate volume of compatible IV fluid to prepare a solution with a concentration of 0.1 - 2 mg/mL (see examples in table below). Infuse over 10 minutes.
| Sotalol volume (mL) | Diluent volume (mL) | Total volume (mL) | Sotalol concentration (mg/mL) |
|---|---|---|---|
| 4 | 16 | 20 | 2 |
| 4 | 36 | 40 | 1 |
| 4 | 46 | 50 | 0.8 |
| 4 | 96 | 100 | 0.4 |
| 8 | 32 | 40 | 2 |
| 8 | 72 | 80 | 1 |
Compatible with the following IV fluids: 0.9% sodium chloride, 5% glucose
Store at room temperature; if storage is necessary after dilution, refrigerate for no more than 24 hours.
PO:
Tablets:
Sotalol 80 mg tablets (white), Sotalol 160 mg (white)
DOSAGE:
IV:
0.5 to 1.5 mg/kg (20 – 120 mg)
Repeat 6 hourly if necessary. Max daily dose 320 mg
PO:
80 mg BD
Gradually increase to 240 - 320 mg/day
DOSAGE IN RENAL FAILURE AND RENAL REPLACEMENT THERAPY:
Dose in renal impairment
| GFR (ml/min) | DOSE |
|---|---|
| <10 | Avoid or use with caution |
| 10-20 | 25% of normal dose |
| >20-50 | 50% of normal dose |
Dose in renal replacement therapy
| MODALITY | DOSE |
|---|---|
| CAPD | Do not use |
| HD | Do not use |
| CVVHDF | 25% of normal dose |
DOSAGE IN PAEDIATRICS:
IV:
0.5 - 2 mg/kg over 10 mins QID
PO:
1 - 4 mg/kg BD or TDS
CLINICAL PHARMACOLOGY:
Sotalol hydrochloride is an antiarrhythmic drug with Class II (beta-adrenoreceptor blocking) and Class III (cardiac action potential duration prolongation) properties. It has no intrinsic sympathomimetic or membrane stabilising activity and low lipid solubility. It decreases both heart rate and force of contraction, so reducing cardiac work and myocardial oxygen demand. It does not decrease blood pressure in normotensive patients. AV conduction time is increased. Sotalol inhibits renin release. it is well absorbed enterally (75 - 90%) with no first pass effect. Peak plasma concentrations are achieved 2 - 3 hours after dosage. Sotalol is not metabolised & is exclusively renally excreted.
CONTRAINDICATIONS:
- Sinus bradycardia
- Heart block greater than first degree
- Sick sinus syndrome
- Cardiogenic shock
- Overt cardiac failure
- Right ventricular failure secondary to pulmonary hypertension
- Congenital or acquired QT prolongation
- Asthma
- Severe renal impairment
- Hypokalaemia
- Hypomagnesaemia
- Untreated phaeochromocytoma (unless co-administered with alpha-blockade)
WARNINGS:
Proarrhythmia:
Like other antiarrhythmic agents, sotalol can provoke new or worsened ventricular arrhythmias in some patients, including sustained ventricular tachycardia or ventricular fibrillation, with potentially fatal consequences.
Cardiac Failure
Sympathetic stimulation is necessary in supporting circulatory function in congestive heart failure, and beta blockade carries the potential hazard of further depressing myocardial contractility and precipitating more severe failure.
Discontinuation of therapy
Discontinuation of therapy in a patient with coronary artery disease may lead to rebound angina, arrhythmia or myocardial infarction.
Diabetes and Hypoglycaemia
Beta blockers may mask tachycardia occurring with hypoglycaemia.
Thyrotoxicosis
Beta-adrenergic blockade may mask certain clinical signs (e.g. tachycardia) of hyperthyroidism. Abrupt withdrawal of beta blockade might precipitate a thyroid storm.
PRECAUTIONS:
Sotalol may aggravate peripheral circulatory disorders
Laboratory Tests:
No tests are required in addition to routine ICU tests
Drug/Laboratory Test Interactions:
The presence of sotalol in the urine may result in falsely elevated levels of urinary metanephrine when measured by fluorimetric or photometric methods.
IMPORTANT DRUG INTERACTIONS IN ICU:
Class Ia antiarrhythmic drugs, such as disopyramide, quinidine and procainamide and other Class III drugs (e.g. amiodarone) are not recommended as concomitant therapy with sotalol, because of their potential to prolong refractoriness leading to ventricular arrhythmia. Additive Class II effects would also be anticipated with the use of other beta-blocking agents concomitantly with sotalol.
Sotalol should be administered with caution in conjunction with calcium blocking drugs because of possible additive effects on atrioventricular conduction or ventricular function. Additionally, concomitant use of these drugs may have additive effects on blood pressure, possibly leading to hypotension.
Beta blockers may exacerbate the rebound hypertension which can follow the withdrawal of clonidine.
ADVERSE REACTIONS:
General:
Tiredness, fatigue
Cardiovascular:
Bradycardia, ventricular tachycardia, cold extremities, hypotension, leg pain
Respiratory:
Wheeze, dyspnoea
Gastrointestinal:
Diarrhoea, nausea
Neurological:
Dizziness, vertigo, light-headedness