Loading…
SOTALOL is a brand name for Sotalol. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Sotalol 80 mg Tablets are indicated for: Ventricular arrhythmias: Treatment of life-threatening ventricular tachyarrhythmias. Treatment of symptomatic non-sustained ventricular tachyarrhythmias. Supraventricular arrhythmias: Prophylaxis of paroxysmal atrial tachycardia, paroxysmal atrial fibrillation, paroxysmal A-V…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Adults The recommended initial dose is 40 mg either as a single dose or in two divided doses taken at 12 hour intervals. The dosage of Sotalol 40 mg Tablets should be gradually increased according to the patient’s response.
Adjustments to dosage should be made after steady-state has been attained, usually after 2-3 days, and to allow monitoring of QT intervals. Proarrhythmias can occur at initiation and at each upward adjustment of dosage. Most patients respond to a daily dose of 160 to 320 mg, administered in two divided doses at approximately 12 hour intervals.
4). Paediatric population Sotalol is not intended for administration to children.
Dosage in Renally Impaired Patients:
Because Sotalol is excreted mainly in urine, patients with a creatinine clearance of less than 60 ml/min should be prescribed with a reduced dose according to the following: Creatinine clearance: >60 ml/min: Recommended dose.
Creatinine clearance: 30-60 ml/min:
Half recommended dose.
Creatinine clearance: 10-30 ml/min:
Quarter recommended dose.
Creatinine clearance: <10 ml/min:
Not recommended. 4 μmol/l).
Dosage in Hepatically Impaired Patients:
No dosage adjustment is necessary in patients with impaired hepatic function. Method of administration Sotalol 80 mg Tablets are for oral administration in adults. 4). As with other antiarrhythmic agents, it is recommended that Sotalol be initiated and doses increased in a facility capable of monitoring and assessing cardiac rhythm.
The dosage must be individualized and based on the patient's response. Proarrhythmic events can occur not only at initiation of therapy, but also with each upward dosage adjustment. 4).
The most common adverse effects are due to the beta-blockade properties of Sotalol. These effects do not usually necessitate interruption or withdrawal of treatment and normally disappear when dosage is reduced. 4). Patients with a history of anaphylactic reactions may be more prone to severe adverse reactions.
The following are adverse events considered related to therapy, occurring in 1% or more of patients treated with Sotalol.
Side-effects include:
Blood and the lymphatic system disorders Purpura, thrombocytopenia Psychiatric disorders Sleep disturbances, depression, mood changes, anxiety, psychoses Nervous system disorders Dizziness, light-headedness, headache, paraesthesia, taste abnormalities Eye disorders Visual disturbances Ear and labyrinth disorders Hearing disturbances, vertigo Cardiac disorders Bradycardia, palpitations, ECG abnormalities, proarrhythmia- including torsades de pointes, heart failure Vascular disorders Hypotension, syncope, presyncope Respiratory, thoracic and mediastinal disorders Dyspnoea Sotalol should be used with caution in patients with a history of wheezing or asthma, as there is a risk of bronchospasm with beta-blockade Gastrointestinal disorders Nausea, vomiting, diarrhoea, dyspepsia, abdominal pain, flatulence Skin and subcutaneous tissue disorders Rash, exacerbation of the symptoms of psoriasis vulgaris, alopecia Musculoskeletal, connective tissue and bone disorders Muscle cramp Reproductive system and breast disorders Sexual dysfunction General disorders and administration site conditions Chest pain, oedema, fatigue, asthenia, fever In trials of patients with cardiac arrhythmia, the most common adverse events leading to discontinuation of Sotalol were fatigue 4%, bradycardia (<50 bpm) 3%, dyspnoae 3%, proarrhythmia 2%, asthenia 2%, and dizziness 2%.
Cold and cyanotic extremities, Raynaud's phenomenon, increase in existing intermittent claudication and dry eyes have been seen in association with other beta- blockers. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
Abrupt Withdrawal Patients should be carefully monitored when discontinuing chronic Sotalol administration, particularly those with ischaemic heart disease. Dosage should be gradually reduced over a period of 1 to 2 weeks and if necessary at the same time initiating replacement therapy.
Hypersensitivity to catecholamines is observed in patients withdrawn from beta-blocker therapy. Occasional cases of exacerbation of angina pectoris, arrhythmias, and in some cases, myocardial infarction have been reported after abrupt discontinuation of therapy.
Abrupt discontinuation may unmask latent coronary insufficiency. In addition hypertension may develop. Pro-arrhythmias Sotalol may aggravate pre-existing arrhythmias or provoke new arrhythmias. Sotalol should be used with caution in patients with Raynauld’s phenomenon.
Drugs that prolong the QT interval may cause torsades de pointes, a polymorphic ventricular tachycardia associated with prolongation of the QT-interval. 5). Females may be at increased risk of developing torsades de pointes. The incidence of torsades de pointes is dose dependent and usually occurs within 7 days of initiation of treatment or after increasing the dose, and can progress to ventricular fibrillation.
In clinical trials of patients with sustained VT/VF the incidence of severe proarrhythmia (torsades de pointes or new sustained VT/VF) was <2% at doses up to 320 mg. The incidence more than doubled at higher doses. Other risk factors for torsades de pointes were excessive prolongation of the QTc and history of cardiomegaly or congestive heart failure.
Patients with sustained ventricular tachycardia and a history of congestive heart failure have the highest risk of serious proarrhythmia. Proarrhythmic events must be anticipated not only on initiating therapy but with every upward dose adjustment.
Initiating therapy at 80 mg with gradual upward dose titration thereafter reduces the risk of proarrhythmia. Caution is advised if the QTc exceeds 500 msec whilst on therapy. When the QTc-interval exceeds 550 msec dosage should be reduced or therapy with Sotalol discontinued.
Cardiovascular Sotalol is contra-indicated in patients with the following conditions. Sick sinus syndrome, second or third degree AV heart block unless fitted with a functional pacemaker, congenital or acquired long QT syndromes, torsades de pointes, symptomatic sinus bradycardia, uncontrolled congestive heart failure, cardiogenic shock, anaesthesia that produces myocardial depression, hypotension (except due to arrhythmia), severe peripheral circulatory disturbances including those associated with Raynaud’s phenomenon.
Respiratory History of chronic obstructive airway disease, bronchial asthma or bronchospasm Hypersensitivity Hypersensitivity to any of the ingredients of the tablet Untreated phaeochromocytoma, metabolic acidosis, renal failure (creatinine clearance < 10 ml/min)
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Sotalol in United Kingdom.
Know a brand we are missing in United Kingdom? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard.
Due to the multiple risk factors associated with torsades de pointes, however, caution should be exercised regardless of the QTc-interval. Electrolyte Disturbances Sotalol should not be used in patients with hypokalaemia or hypomagnesaemia prior to correction of the imbalance as this can exaggerate the degree of QT prolongation, and increase the potential for torsades de pointes.
Special care should be given to electrolyte and acid-base balance in patients with severe or persistent diarrhoea and in patients receiving concomitant drugs that are likely to reduce serum potassium and/or magnesium levels. Congestive Heart Failure Beta blockade may further depress myocardial contractility and precipitate more severe heart failure.
e. ); a low initial dose and careful dose titration is appropriate. Recent Myocardial Infarction In post-infarction patients with impaired left ventricular function, the risk versus benefit of Sotalol administration must be considered.
Careful monitoring and dose titration are critical at all stages of therapy. Sotalol should not be used in patients with left ventricular ejection fractions ≤ 40% without serious ventricular arrhythmias. Electrocardiographic Changes Excessive prolongation of the QT-interval, >500 msec, can be a sign of toxicity, and should be avoided.
Sinus bradycardia has been observed very commonly in arrhythmia patients receiving Sotalol in clinical trials. Bradycardia increases the risk of torsades de pointes. Sinus pause, sinus arrest and sinus node dysfunction occur in less than 1% of patients.
The incidence of 2nd- or 3rd-degree AV block is approximately 1%. Anaphylaxis Patients with a history of anaphylactic reaction to a variety of allergens may have a more severe reaction on repeated challenge while taking beta-blockers.
Such patients may be unresponsive to the usual doses of adrenaline used to treat the allergic reaction. Anaesthesia As with other beta-blocking agents, Sotalol should be used with caution in patients undergoing surgery and in association with anaesthetics that cause myocardial depression, such as cyclopropane or trichloroethylene.
Diabetes Mellitus Caution should be exercised when administering Sotalol tablets to patients with diabetes (especially labile diabetes) or a history of spontaneous hypoglycaemia as beta-blockade may mask some important signs of acute hypoglycaemia such as tachycardia.
g. tachycardia). Sotalol should not be withdrawn abruptly from patients suspected of developing thyrotoxicosis, as this may exacerbate the symptoms of hyperthyroidism, including thyroid storm. 2). Psoriasis Beta-blocking drugs have been reported rarely to exacerbate the symptoms of psoriasis vulgaris.