Index of drugs

Severe, symptomatic ventricular tachycardia. Symptomatic and requiring treatment of cardiac arrhythmia type of supraventricular tachycardia, such as atrio-ventricular tachycardia, supraventricular tachycardia in the WPW syndrome, paroxysmal atrial fibrillation.

1 tabl contains 80 mg of sotalol hydrochloride. The preparation contains lactose.

A class III hydrophilic anti-arrhythmic drug with significant β-adrenergic blocking activity. The effect of class II drugs is caused by the prolongation of the duration of the action potential, without affecting the duration of pulse conduction. The absolute refraction period is extended. This electrophysiological mechanism of action is characteristic of both isomers - right and left-handed - and was found in the vestibule, atrioventricular node, branch of the bundle and chambers. Blocking β-adrenergic receptors (β₁ and β₂) is bound to the levorotatory isomer. Depending on the sympathetic nervous system, the product reduces heart rate and myocardial contractility, atrioventricular conduction time and plasma renin activity. The digestive tract absorbs 75 to 90% of the dose. Absolute bioavailability is 75-90%. The drug does not bind to plasma proteins. No pharmacologically active metabolites were detected. The drug is excreted exclusively through the kidneys. T_0,5 is about 15 hours.

Hypersensitivity to sotalol, sulfonamides or other ingredients of the preparation. Congestive heart failure (NYHA class IV). Shock. Atrio-ventricular block IIst. or IIIst .. Block node and vestibule. Sick node syndrome. Bradycardia (<50 beats per minute). Existing QT prolongation. Hypokalemia. Hypotension. Late stages of obliterative peripheral artery disease. Chronic obstructive pulmonary disease. Metabolic acidosis.

During anti-arrhythmic therapy in patients with previous myocardial infarction or ventricular dysfunction, there is a particular risk of worsening arrhythmia (proarrhythmic effect). The drug may increase the patient's sensitivity to allergens and exacerbate anaphylactic reactions; the risk of serious anaphylactic reactions is greater in patients with a history of severe hypersensitivity reactions and in patients undergoing desensitisation. Sotalol hydrochloride can be given to these patients only when it is absolutely necessary. In patients receiving sotalol hydrochloride (with the exception of intensive care units) intravenous administration of verapamil-type Calcium channel blockers and diltiazem is contraindicated. It should not be given to patients with a pheochromocytoma unless they are receiving treatment blocking alpha-adrenergic receptors at the same time. In the case of renal dysfunction, lower doses of the drug should be administered and patients should be monitored. The possibility of renal dysfunction should be considered in the elderly. The safety and efficacy of the medicine in children has not been established. Due to the lactose content, the drug should not be used in patients with rare hereditary lactose intolerance, Lapp lactase deficiency or malabsorption of glucose-galactose.

The product penetrates the placenta and into breast milk. It can only be used during pregnancy if the benefit to the mother outweighs the possible risk to the fetus. Breastfeeding during the use of the preparation is not recommended.

There may be: inflammation of the cornea and conjunctiva; hypoglycaemia, similar to other beta-blockers, sotalol hydrochloride may cause disturbances in lipid metabolism (increase in total cholesterol and triglycerides, decrease in HDL); confusional states, hallucinations, expressive dreams, sleep disorders, depression; fainting, dizziness, headache, passages; blurred vision reduced volume of tears; increase in symptoms of heart failure, bradycardia and atrioventricular conduction disorders, exacerbation of angina; You may experience a proarrhythmic effect that may lead to heart problems or even cardiac arrest (arrhythmias following administration of sotalol hydrochloride may occur especially in patients with life-threatening arrhythmias and left ventricular dysfunction) due to the prolongation of the QT interval, especially in cases of overdose, bradycardia and ventricular tachyarrhythmias may occur, includingtorsade de pointes; exacerbation of obliterative peripheral arterial disease, cold limbs; dyspnoea in patients with obstructive pulmonary disease; gastrointestinal disorders (e.g., nausea, vomiting, diarrhea), dry mouth; skin reactions; onset or worsening of psoriasis, psoriatic plaque; increased muscle cramps; impotence; tiredness, increased weakness; reduction in blood pressure.

Orally.Severe symptomatic ventricular tachycardia: the starting dose is 80 mg 2 times a day; if necessary, the dose can be increased to 80 mg 3 times a day or 160 mg 2 times a day. In the event of life-threatening arrhythmia and if necessary, the dose may be increased to 480 mg / day in 2 or 3 divided doses. In such cases, the dose can only be increased if the potential benefits outweigh the increased risk of serious side effects (especially proarrhythmic effects).Symptomatic supraventricular tachycardia requiring treatment: the starting dose is 80 mg 2 times a day; if the dose is well tolerated, but it is not effective enough, it can be increased to 80 mg 3 times a day. Patients with paroxysmal atrial fibrillation should not exceed this dose. In patients with persistent atrial fibrillation, the dose may be increased by no more than 160 mg if the initial dose was not sufficiently effective but well tolerated. Do not increase the dose earlier than after 2-3 days of treatment. In the phase of adjusting the dose of sotalol hydrochloride, patients with a history of myocardial infarction or severe heart failure should be closely monitored. In patients with impaired renal function, sotalol hydrochloride may accumulate during repeated administration. Therefore, the dose should be adjusted to the creatinine clearance value while monitoring the heart rate (not less than 50 beats / min) and the clinical response. Patients with severe renal impairment may be given the drug only if ECG and serum concentration are monitored. In patients with a creatinine clearance in the range of 10 to 30 ml / min (serum creatinine 2 to 5 mg / 100 ml), the dose should be halved. Patients with a creatinine clearance below 10 ml / min (serum creatinine> 5 mg / 100 ml) should be administered 1/4 of the usual dose.
The tablets should be swallowed whole. Sotalol hydrochloride should not be taken with meals, as simultaneous consumption of meals (especially milk and milk products) may affect the absorption of the active substance.