Sotalol

Registered South African indications:

• Cardiac arrhythmias
• Angina pectoris  
• Hypertension  

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Severe renal impairment
• Sick sinus syndrome
• Second and third degree AV heart block unless a functioning pacemaker is present
• Congenital or acquired long QT syndromes
• Torsades de pointes
• Symptomatic sinus bradycardia
• Uncontrolled congestive heart failure
• Cardiogenic shock
• Untreated phaeochromocytoma
• Hypotension (except due to arrhythmia)
• Raynaud's phenomenon and severe peripheral circulatory disturbances
• Chronic obstructive airway disease or bronchial asthma  
• Metabolic acidosis
• Anaesthesia that produces myocardial depression
• Coadministration with class Ia antiarrhythmics
• Coadministration with class II antiarrhythmics such as amiodarone, dofetilide, ibutilide
• Coadministration with neuroleptics such as trimipramine, phenobarbitone, chlorpromazine
• Coadministration with IV erythromycin
• Coadministration with moxifloxacin

Cautions

• Pregnancy
• Breastfeeding
• Moderate renal impairment
• Abrupt withdrawal
• Sustained ventricular tachycardia
• Hypokalaemia
• Hypomagnesaemia
• History of congestive heart failure 
• QT prolongation
• Bradycardia
• Cardiomegaly
• Left ventricular dysfunction controlled on therapy 
• Recent myocardial infarction with impaired left ventricular function
• Left ventricular ejection fractions ≤40% 
• History of severe anaphylaxis to allergens
• Diabetes mellitus 
• Thyroid disease 
• Psoriasis
• Myasthenia gravis
• History of psychiatric disease

Forms avail. in SA and covered in this monograph: tab

Atrial fibrillarion - maintenance of sinus rhythm
Atrial flutter - maintenance of sinus rhythm

• Oral (tab): Initial: 80mg/day in 1-2 divided doses; Titrate at intervals of  2-3 days; Maintenance: 160-320mg/day in 2 divided doses; Max: 320mg/24hrs

Ventricular arrhythmias 

• Oral (tab): Initial: 80mg/day in 1-2 divided doses; Titrate at intervals of  2-3 days; Maintenance: 160-320mg/day in 2 divided doses

Life-threatening refractory ventricular arrhythmias may require doses as high as 480-640mg, but should only be given when potential benefit outweigh risk

Sotalol can cause life threatening ventricular tachycardia associated with QT interval prolongation. Initiatiation and dose increases to be done in a facility capable of monitoring and assessing cardiac rhythm

The dosage must be individualised and based on the patient's response

Discontinue treatment gradually over a  period of 1 - 2 weeks

Not established for use in South Africa for children

Pregnancy

• Caution; no evidence of risk in studies
• Animal studies with sotalol hydrochloride have shown no evidence of teratogenicity or other harmful effects on the foetus. Although there are no adequate and well-controlled studies in pregnant women, sotalol hydrochloride has been shown to cross the placenta and is found in amniotic fluid
• Beta-blockers reduce placental perfusion, which may result in intrauterine foetal death, immature and premature deliveries. In addition, adverse effects (especially hypoglycaemia and bradycardia) may occur in foetus and neonate. There is an increased risk of cardiac and pulmonary complications in the neonate in the postnatal period. Therefore, sotalol should be used in pregnancy only if the potential benefits outweigh the possible risk to the foetus
• The neonate should be monitored very carefully for 48 - 72 hours after delivery if it was not possible to interrupt maternal therapy with sotalol 2-3 days before the birthdate

Breastfeeding

• Caution; not recommended
• Most beta-blockers, particularly lipophilic compounds, will pass into breast milk although to a variable extent. Breastfeeding is therefore not recommended during administration of these compounds

Renal Impairment 

• Mild: No dose adjustment recommended
• Moderate: Caution; dose adjustment recommended
• Severe: Contraindicated

Hepatic Impairment

• No dose adjustment recommended

Elderly

• No dose adjustment recommended 

Porphyria Information

• Not porphyrinogenic (NP)

Drugs in Sport

• Prohibited - In certain sports

Prohibited - In  and out of competition:
Archery (WA)
Shooting (ISSF) (IPC)

Prohibited - In competition:
Automobile (FIA)
Billiards (all disciplines) (WCBS)
Darts (WDF)
Golf (IGF)
Skiing / Snowboarding (FIS) in ski jumping, freestyle aerials/halfpipe and snowboard halfpipe/big air
Underwater sports (CMAS) in constant-weight apnoea with or without fins, dynamic apnoea with and without fins, free immersion apnoea, Jump Blue apnoea, spearfishing, static apnoea, target shooting and variable weight apnoea

Coentral Nervous System Disorders

• Fatigue
• Dizziness
• Lightheadedness
• Headache
• Sleep disturbances
• Depression
• Paraesthesia
• Mood changes
• Anxiety
• Sensation of cold
• Impaired consciousness  

Cardiovascular Disorders

• Bradycardia
• Chest pain
• Palpitations
• Oedema
• ECG abnormalities
• Hypotension
• Proarrhythmias
• Syncope
• Heart failure
• Presyncope
• Congestive heart failure
• Torsades de pointes
• Peripheral vascular disorder
• Angina pectoris
• Worsened ventricular tachycardia
• Cerebrovascular accident
• Hypertension
• Vasodilation
• Q-T prolongation

Respiratory Disorders

• Dyspnoea
• Upper respiratory symptoms
• Pulmonary disease
• Tracheobronchitis
• Asthma

Gastrointestinal Disorders

• Nausea and vomiting
• Diarrhoea
• Dyspepsia
• Abdominal pain
• Flatulence
• Changes in appetite

Genitourinary Disorders

• Sexual dysfunction

Endocrine and Metabolic Disorders

• Weight changes

Musculoskeletal Disorders

• Cramps
• Weakness

Skin and Subcutaneous Tissue Disorders

• Rash
• Hyperhidrosis
• Diaphoresis

Immune, Blood and Lymphatic System Disorders

• Haemorrhage
• Infection
• Influenza
• Fever

Sensory Disorders

• Visual disturbances
• Taste abnormalities
• Hearing disturbances

• Anaesthetic agents
• Class Ia antiarrhythmic drugs
• Class II antiarrhythmic
• Amiodarone
• Dofetilide
• Ibutilide
• Neuroleptics
• Trimipramine
• Phenobarbitone
• Chlorpromazine
• Erythromycin
• Moxifloxacin
• QT prolonging agents
• Agents known to increase risk for torsades de pointes  
• Floctafenine
• Calcium channel blockers
• Agents that decrease serum potassium
• Clonidine
• Cardiac glycosides
• Catecholamine-depleting agents
• Insulin
• Antidiabetic agents
• Neuromuscular blocking agents  
• Beta-2 agonists

• ECG
• Renal function
• Electrolytes
• Heart rate
• Blood pressure

Sotalol has both beta-adrenoreceptor-blocking and cardiac action potential duration prolongation properties. It uniformly prolongs the action potential duration in cardiac tissues by delaying the repolarisation phase. Its major effects are prolongation of the atrial, ventricular and accessory pathway effective refractory periods.

Tablet 80mg

• Sotahexal (Sandoz)

Tablet 160mg 

• Sotahexal (Sandoz)