SOTALOL HYDROCHLORIDE

Posology Paediatric population The safety and effectiveness of Sotalol in children under 18 has not been established. There is no relevant use of Sotalol in the paediatric population. The initiation of treatment or changes in dosage with sotalol should follow an appropriate medical evaluation including ECG control with measurement of the corrected QT interval, and assessment of renal function, electrolyte balance and concomitant medications (see Section

). 8 Undesirable effects Sotalol is well tolerated in the majority of patients, with the most frequent adverse effects arising from its betablockade 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.

The following are adverse events considered related to therapy with Sotalol:

System Organ Class Common Unknown Cardiac disorders Bradycardia Dyspnoea Chest pain Palpitations Oedema Electrocardiogram abnormal Hypotension Arrhythmia Syncope Presyncope Cardiac failure Skin and subcutaneous tissue disorder Rash Alopecia Hyperhidrosis Gastrointestinal disorder Nausea Vomiting Diarrhoea Dyspepsia Abdominal pain Flatulence Musculoskeletal, connective tissue and bone disorders Muscle spasms Nervous system disorders Headache Dizziness Fatigue Asthenia Lightheadedness Paraesthesia Dysgeusia Psychiatric disorders Sleep disorder Mood altered Depression Anxiety Reproductive system and breast disorders Sexual dysfunction Eye disorders Visual disturbance Ear and labyrinth disorders Hearing disturbances General disorders and administration site conditions Pyrexia Blood and lymphatic system disorders Thrombocytopenia 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 two weeks.

3% VT = ventricular tachycardia; VF = ventricular fibrillation; NSVT = nonsustained ventricular tachycardia; PVC = premature ventricular contraction; SVA = supraventricular arrhythmia. Overall, discontinuation because of unacceptable adverse events was necessary in 18% of all patients in cardiac arrhythmia trials.

The most common adverse events leading to discontinuation of Sotacor 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 betablockers.

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 on Google Paly or Apple App store.

4 Special warnings and special precautions for use). 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 Special warnings and special precautions for use).

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 Special warnings and special precautions for use). 4 μmol/l). Dosage in hepatically impaired patients Since Sotalol is not subject to firstpass metabolism, patients with hepatic impairment show no alteration in clearance of Sotalol.

No dosage adjustment is required in hepatically impaired patients. 3 Contraindications 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 (a warning will appear on the label); • hypersensitivity to sotalol, other beta-blockers or any of the excipients in the tablet; • metabolic acidosis; • renal failure (creatinine clearance < 10 ml/min).

4 Special warnings and precautions for use 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, if necessary at the same time initiating replacement therapy.

Abrupt discontinuation 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.

Experience to date indicates that the risk of torsades de pointes is associated with the prolongation of the QT-interval, reduction of the heart rate, reduction in serum potassium and magnesium, high plasma sotalol concentrations and with the concomitant use of sotalol and other medications which have been associated with torsades de pointes (see Section

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 (a warning will appear on the label); • hypersensitivity to sotalol, other beta-blockers or any of the excipients in the tablet; • metabolic acidosis; • renal failure (creatinine clearance < 10 ml/min).