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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 is indicated in adults for prophylaxis of: - life-threatening ventricular tachycardias; - documented symptomatic and disabling ventricular tachycardias in the absence of uncontrolled heart failure; - documented supraventricular tachycardias in the absence of uncontrolled heart failure when the need for…
Verbatim from this product's MHRA label. Tap a section to expand.
5). As with other antiarrhythmic substances, it is recommended that Sotalol is initiated and doses increased under ECG control, because proarrhythmic events can occur not only at the initiation of therapy but also with every upward dosage adjustment.
The treatment of life-threatening ventricular tachycardias must be initiated under monitoring in a hospital environment. The initial dose is 80 mg administered either as a single or as two divided doses administered at 12 hours interval.
Dosing increments should be separated by an interval of 2 or 3 days in order to attain a steady state and allow monitoring of QT intervals. g. g. 3x 80 mg) divided doses per day. Some patients who have life-threatening arrhythmias may require doses as high as 480 mg or 640 mg/day; however, these doses should be used under specialist supervision and only be prescribed when the potential benefit outweighs the increased risk of adverse events, in particular proarrhythmia.
Renal impairment The dosage should be adjusted according to the creatinine clearance, because sotalol is excreted mainly in urine. The heart rate (should not fall below 50 beats per minute) and the clinical effect should also be considered.
85. 4 μmol/l). Hepatic impairment Since Sotalol is not subject to first pass metabolism, patient with hepatic impairment show no alteration in clearance of Sotalol. No dosage adjustment is required in hepatically impaired patients. Elderly Age in itself is not a reason to adapt the initial dosage.
Reduction in renal function due to old age may necessitate dose adaptation (see also ’Renal impairment’). Paediatric population Due to lack of data, sotalol is not intended for use in children. g. a glass of water) and swallowed whole.
Clinical The most frequent undesirable effects of sotalol arise from its beta-blockade properties. They are usually transient in nature, and rarely require discontinuation of the treatment. They usually disappear when the dosage is reduced.
4). 4), exanthema, rash, pruritus, photosensitivity, diaphoresis, alopecia, hyperhidrosis; - Musculoskeletal and connective tissue disorders: cramps, arthralgia, myalgia; - Reproductive system and breast disorders: disorders of sexual function; - General disorders and administration site conditions: fever.
- Ear and labyrinth disorders: hearing disturbances. Investigations In rare cases, formation of anti-nuclear anti-bodies has been reported, only exceptionally accompanied by clinical manifestations of lupus-like syndrome which disappear when the treatment is discontinued.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product 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.
Warnings Never withdraw the treatment abruptly in patients with angina pectoris: this could cause severe arrhythmias, myocardial infarction and sudden death. Because coronary artery disease is common and maybe unrecognised in patients receiving Sotalol, abrupt discontinuation in patients with arrhythmias may unmask latent coronary insufficiency.
In addition, hypertension may develop. It is recommended to monitor patients, especially those suffering from ischaemic heart disease, and to decrease the dose gradually over 1-2 weeks. The most dangerous undesirable effect of antiarrhythmic active substances is the aggravation of pre-existing arrhythmias or the provocation of new arrhythmias.
Active substances that prolong the QT interval, including sotalol, may cause torsades de pointes. 5) - severe ventricular arrhythmias - females may be at an increased risk of developing torsades de pointes. The incidence of torsades de pointes is dose-dependent.
Proarrhythmic events occur more often within the first week of treatment initiation or dose escalation. However, they may occur after a longer period of treatment even without any dose change. They may be symptomatic (syncopes), they may discontinue spontaneously or more rarely progress to ventricular fibrillation.
In clinical trials of patients with ventricular arrhythmias carrying a life-threatening risk (sustained ventricular tachycardias or ventricular fibrillation), the incidence of severe proarrhythmias (torsades de pointes or new ventricular tachycardias or ventricular fibrillation) was less than 2 % at doses up to 320 mg.
The incidence is more than doubled for higher doses. The highest risk of developing severe proarrhythmic events with sotalol (7%) occurs in patients with sustained ventricular tachycardia and heart failure. The risk of proarrhythmic events may be reduced by initiating therapy with 80 mg, with gradual upward dose titration thereafter.
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Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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During therapy, medical monitoring and ECG controls should be performed at regular intervals. g. 25% or greater prolongation of the QRS or QT interval, 50% or greater prolongation of the PQ interval or if the QTc interval exceeds 480 ms) or if the frequency and severity of arrhythmias increase, a re- evaluation of the benefit/risk ratio should be considered.
Precautions for use - Bradycardia If heart rate drops to below 50-55 beats per minute at rest and the patient shows symptoms associated with bradycardia, the posology must be reduced. Bradycardia increases the risk of torsades de pointes.
- First degree atrioventricular heart block Given its negative dromotropic effect, sotalol should be administered with caution to patients with first degree atrioventricular heart block. ). Due to its beta-blockade properties, sotalol can further depress myocardial contractility and precipitate sudden decompensation of severe cardiac failure.
- Recent myocardial infarction The benefit/risk ratio of sotalol administration should be evaluated in post-infarction patients, with impaired left ventricular function. If this treatment is deemed necessary, its initiation and any subsequent changes in posology must be carefully monitored.
e. apparent increase in mortality) suggests that Sotalol should be avoided in patients with left ventricular ejection fraction ≤40% without serious ventricular arrhythmia. - Electrolytic disturbances Sotalol should not be used in patients with hypokalaemia or hypomagnesaemia prior to correction of the imbalance; these conditions can exaggerate the degree of QT prolongation, and increase the potential for torsades de pointes.
The electrolytic and acid-base balance must be closely monitored in patients with severe or prolonged diarrhoea or patients receiving concomitant magnesium- and/or potassium-depleting medicinal products. 5) or iodised contrast media or occur during desensitisation therapy.
, tachycardia) as well as cardiovascular signs of thyrotoxicosis. 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.
- Psoriasis As exacerbation of this illness has been reported with beta-blockers, the indication needs to be weighed up. - Elderly The contraindications must imperatively be respected. Effort should be made to initiate treatment with a low dose and to ensure strict follow-up.
2). - Diabetes mellitus Inform the patient and reinforce glycaemic self-monitoring at the initiation of treatment. The precursor signs of hypoglycaemia may be masked, in particular tachycardia, palpitations and sweating. - […]