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SOTALOL is a brand name for Sotalol. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Sotalol 160mg 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…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Paediatric population There is no relevant use of Sotalol in the paediatric population. 4). As with other antiarrhythmic agents, it is recommended that Sotalol 40mg Tablets 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).
Method of administration The following dosing schedule can be recommended:
The initial dose is 80 mg, administered either singly or as two divided doses. Oral dosage of sotalol should be adjusted gradually allowing 2-3 days between dosing increments in order to attain steady-state, and to allow monitoring of QT intervals.
Most patients respond to a daily dose of 160 to 320 mg administered in two divided doses at approximately 12 hour intervals. Some patients with life-threatening refractory ventricular arrhythmias may require doses as high as 480 - 640 mg/day.
4). 4 μmol/l). Dosage in hepatically impaired patients Since Sotalol is not subject to first-pass metabolism, patients with hepatic impairment show no alteration in clearance of Sotalol. No dosage adjustment is required in hepatically impaired patients.
). 8 Undesirable effects Sotalol is well tolerated in the majority of patients, with the most frequent adverse effects arising from its beta-blockade properties. Adverse effects are usually transient in nature and rarely necessitate interruption of, or withdrawal from treatment.
These include dyspnoea, fatigue, dizziness, headache, fever, excessive bradycardia and/or hypotension. If they do occur, they usually disappear when the dosage is reduced. 4). Frequency is defined using the following convention: very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000); very rare (<1/10,000) including isolated reports, not known (cannot be estimated from the available data) The following are adverse events considered related to therapy: Cardiac disorders Common: Bradycardia, dyspnoea, chest pain, palpitations, oedema, ECG abnormalities, hypotension, arrhythmia, syncope, cardiacfailure, presyncope Skin and subcutaneous tissue disorders Common: Rash Unknown: Alopecia, Hyperhidrosis Blood and lymphatic system disorders Unknown: Thrombocytopenia Gastro-intestinal disorders Common: Nausea, vomiting, diarrhoea, dyspepsia, abdominal pain, flatulence Musculoskeletal, connective tissue and bone disorders Common: Muscle spasms Nervous system disorders Common: Fatigue, dizziness, asthenia, light-headedness, headache, paraesthesia, dysgeusia Psychiatric disorders Common: Sleep disorder, mood altered, depression, anxiety Reproductive system and breast disorders Common: Sexual dysfunction Eye disorders Common: Visual disturbances Ear and labyrinth disorders Common: Hearing disturbances General disorders and administration site conditions Common: Pyrexia In clinical trials, 3256 patients with cardiac arrhythmias (1363 with sustained ventricular tachycardia) received oral Sotalol, of whom 2451 received the drug for at least 2 weeks.
3% VT = ventricular tachycardia; VF = ventricular fibrillation; NSVT = nonsustained ventricular tachycardia; PVC = premature ventricular contractions; SVA = supraventricular arrhythmia. Overall, discontinuation because of unacceptable adverse events was necessary in 18% of all patients in cardiac arrhythmia trials.
Abrupt Withdrawal 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.
Patients should be carefully monitored when discontinuing chronically administered sotalol, particularly those with ischaemic heart disease. If possible the dosage should be gradually reduced over a period of one to two weeks. Because coronary artery disease is common and may be unrecognised in patients receiving Sotalol, abrupt discontinuation in patients with arrhythmias may unmask latent coronary insufficiency.
In addition, hypertension may develop. Proarrhythmias The most dangerous adverse effect of Class I and Class III antiarrhythmic drugs (such as sotalol) is the aggravation of pre-existing arrhythmias or the provocation of new arrhythmias.
Drugs that prolong the QT-interval may cause torsades de pointes, a polymorphic ventricular tachycardia associated with prolongation of the QT-interval. 5: Interactions). Females may be at increased risk of developing torsades de pointes.
Other risk factors for torsades de pointes were excessive prolongation of the QTc and history of cardiomegaly or congestive heart failure. The incidence of torsades de pointes is dose dependent. Torsades de pointes usually occurs within 7 days of initiating therapy or escalation of 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. Patients with sustained ventricular tachycardia and a history of congestive heart failure have the highest risk of serious proarrhythmia (7%).
Sotalol should not be used where there is evidence of: • 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 • anaesthesia that produces myocardial depression • untreated phaeochromocytoma • hypotension (except due to arrhythmia) • Raynaud's phenomenon and severe peripheral circulatory disturbances • history of chronic obstructive airway disease or bronchial asthma • hypersensitivity to sotalol, other betablockers or any of the excipients in the formulation.
• metabolic acidosis • renal failure (creatinine clearance < 10 ml/min).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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The most common adverse events leading to discontinuation of Sotalol are listed in the table below: Fatigue 4% Bradycardia (<50 bpm) 3% Dyspnoea 3% Proarrythmia 2% Asthenia 2% 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 products is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
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. In patients already receiving sotalol caution should be used if the QTc exceeds 500msec whilst on therapy, and serious consideration should be given to reducing the dose or discontinuing therapy when the QTc-interval exceeds 550 msec.
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 imbalance; these conditions can exaggerate the degree of QT prolongation, and increase the potential for torsades de pointes.
Special attention should be given to electrolyte and acid-base balance in patients experiencing severe or prolonged diarrhoea or patients receiving concomitant magnesium- and/or potassium-depleting drugs. Congestive Heart Failure Beta-blockade may further depress myocardial contractility and precipitate more severe heart failure.
e. ACE Inhibitors, diuretics, digitalis, etc); a low initial dose and careful dose titration is appropriate. Recent MI 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 during initiation and follow-up of therapy. e. apparent increase in mortality) suggest that Sotalol should be avoided 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 (see Proarrhythmias above). 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 40mg Tablets should be used with caution in patients undergoing surgery and in association with anaesthetics that cause myocardial depression, such as cyclopropane or trichloroethylene.
g. tachycardia. , tachycardia). Patients suspected of developing thyrotoxicosis should be managed carefully to avoid abrupt withdrawal of beta-blockade which might be followed by an exacerbation of symptoms of hyperthyroidism, including thyroid storm.
2). Psoriasis Beta-blocking drugs have been reported rarely to exacerbate the symptoms of psoriasis vulgaris. This medicine contains less than 1mmol […]