In cases of massive intentional overdosage (2-16 g) of sotalol the following clinical findings were seen: hypotension, bradycardia, prolongation of QT-interval, premature ventricular complexes, ventricular tachycardia, torsades de pointes.If overdosage occurs, therapy with sotalol should be discontinued and the patient observed closely.

Most patients respond to a daily dose of 160 to 320 mg administered in two divided doses at approximately 12 hour intervals. No dosage adjustment is required in hepatically impaired patients. The most significant adverse events were torsade de pointes and other serious new ventricular arrhythmias (see section 4.4), which occurred at the following rates: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. These two trade names have different indications and one product should never be substituted for the other product because of significant differences in labeling (i.e., indications, dosing administration, safety information, and patient package insert information).Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records.

The absorption is reduced by approximately 20% when administered with a standard meal, in comparison to fasting conditions. Although significant beta-blockade may occur at oral doses as low as 25 mg, Class III effects are usually seen at daily doses of greater than 160 mg.Its β-adrenergic blocking activity causes a reduction in heart rate (negative chronotropic effect) and a limited reduction in the force of contraction (negative inotropic effect). The renin-suppressive effect of sotalol is significant both at rest and during exercise. Date of first authorisation/renewal of the authorisationStart typing to retrieve search suggestions. • Raynaud's phenomenon and severe peripheral circulatory disturbances; The half-life of this drug is prolonged (up to 69 hours) in anuric patients.
In this postinfarction study using a fixed dose of 320mg once daily and in a second small randomized trial in high risk postinfarction patients with left ventricular ejection fractions ≤40% treated with high doses (640 mg/day), there were suggestions of an excess of early sudden deaths.Hepatic Impairment: Since Sotalol is not subject to first-pass metabolism, patients with hepatic impairment show no alteration in clearance of Sotalol.Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.Animal studies with sotalol hydrochloride have shown no evidence of teratogenicity or other harmful effects on the foetus. In patients with other, less serious, ventricular arrhythmias and supraventricular arrhythmias, the incidence of torsade de pointes was 1% and 1.4%, respectively.Serious proarrhythmias including torsade de pointes were dose related as indicated below: Percent Incidence of Serious Proarrhythmias * by Dose For Pateints With Sustained VT/VFIn 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. – Treatment of life-threatening ventricular tachyarrhythmias;

In addition, if required, the following therapeutic measures are suggested:Pharmacotherapeutic group: Beta blocking agents, ATC code: C07AA07.D,l-sotalol is a non-selective hydrophilic β-adrenergic receptor blocking agent, devoid of intrinsic sympathomimetic activity or membrane stabilizing activity.Sotalol has both beta-adrenoreceptor blocking (Vaughan Williams Class II) and cardiac action potential duration prolongation (Vaughan Williams Class III) antiarrhythmic properties.

• history of chronic obstructive airway disease or bronchial asthma (a warning will appear on the label);

Distribution occurs to a central (plasma) and a peripheral compartment, with an elimination half-life of 10-20 hours. Age does not significantly alter the pharmacokinetics, although impaired renal function in geriatric patients can decrease the excretion rate, resulting in increased drug accumulation.Do not store above 25°C. Available for Android and iOS devices.

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.Most beta-blockers, particularly lipophilic compounds, will pass into breast milk although to a variable extent.

• hypersensitivity to sotalol, other beta-blockers or any of the excipients in the tablet; The most significant adverse effects, however, are those due to proarrhythmia, including torsades de pointes (see section 4.4).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. Due to the multiple risk factors associated with torsades de pointes, however, caution should be exercised regardless of the QTc-interval.Careful monitoring and dose titration are critical during initiation and followupOf therapy. It allows continued monitoring of the benefit/risk balance of the medicinal product.