Universal reference book for medicines
Product name: TENSOL (TENSOL)

Active substance: sotalol

Type: Beta 1 -, beta 2 -adrenergic blocker

Manufacturer: КАНОНФАРМА ПРОДАКШН (Russia)
Description of the active substance:
This information is a reference and it is not enough that the drug has been prescribed by a doctor ..

A non-selective beta-blocker, acts on?
1 - and? 2- adrenoreceptors, refers to antiarrhythmic drugs of class III. Has a pronounced antiarrhythmic effect, the mechanism of which is to increase the duration of the action potential and the lengthening of the absolute refractory period in all parts of the conduction system of the heart. Reduces heart rate and contractility of the myocardium, slows AV-conduction. Increases the tone of the smooth muscles of the bronchi.
When administered orally, sotalol is absorbed from the gastrointestinal tract, C max in plasma is reached after 2-3 hours. V d is 2 l / kg.
T 1/2 - about 15 hours. It is excreted mainly by the kidneys.
Nadzheludochkovaya tachycardia (including with WPW syndrome), paroxysmal form of atrial fibrillation, ventricular tachycardia.

When administered orally, the initial dose is 40 mg 2-3 times / day.
With iv introduction, a single dose of 20 mg.
The maximum dose: when ingested - 480 mg / day.
If necessary, repeated IV introduction, the total dose is 1.5 mg / kg.
From the central nervous system and peripheral nervous system: fatigue, weakness, dizziness, headache, drowsiness or insomnia, nightmares, depression, anxiety, confusion or short-term memory loss, hallucinations, asthenia, myasthenia gravis, paresthesia in the extremities (in patients with the syndrome intermittent claudication and Raynaud's syndrome), tremor.

Cardiovascular system: sinus bradycardia, palpitations, conduction disturbance of the myocardium, AV blockade (up to the development of complete transverse blockade and cardiac arrest), arrhythmias, weakening of myocardial contractility, development of chronic heart failure, lowering of blood pressure, orthostatic hypotension , manifestation of angiospasm (increased peripheral circulatory disturbance, lower extremities cooling, Raynaud's syndrome), chest pain;
in rare cases - increased attacks of angina pectoris, ventricular paroxysmal tachycardia such as "pirouette" (the risk of developing higher with a combination of medications, prolonging the QT interval, or hypokalemia).
From the sense organs: in some cases - a violation of visual acuity, a decrease in the secretion of tear fluid, dryness and soreness of the eyes, keratoconjunctivitis.

On the part of the digestive system: dryness of the oral mucosa, nausea, vomiting, epigastric pain, flatulence, constipation or diarrhea, impaired liver function (dark urine, icteric sclera or skin, cholestasis), changes in taste, changes in hepatic enzyme activity, concentration bilirubin.

On the part of the respiratory system: nasal congestion, rhinitis, difficulty breathing, laryngo- and bronchospasm.

From the endocrine system: hyperglycemia (in patients with insulin-dependent diabetes mellitus), hypoglycemia (in patients receiving insulin, or with strict adherence to diet), a hypothyroid condition.

Allergic reactions : itching, skin rash, hives.

Dermatological reactions: increased sweating, skin hyperemia, exanthema, alopecia, psoriasis-like skin reactions, exacerbation of psoriasis symptoms.

From the hemopoietic system: thrombocytopenia (unusual bleeding and hemorrhage), agranulocytosis, leukopenia.

Other: back pain, arthralgia, weakening of libido, decreased potency, withdrawal syndrome (increased angina attacks, increased blood pressure).

Acute heart failure or decompensated chronic heart failure, cardiogenic shock, AV blockade of II or III degree, sinoatrial blockade, SSSU, sinus bradycardia (heart rate less than 55 bpm), prinzmetal angina, cardiomegaly (no signs of heart failure), arterial hypotension (systolic blood pressure less than 90 mm Hg, especially with myocardial infarction);
COPD, bronchial asthma (severe course); Occlusal diseases of peripheral vessels (complicated by gangrene, intermittent claudication or pain at rest), diabetes mellitus with ketoacidosis, metabolic acidosis, simultaneous administration of MAO inhibitors, lactation period, hypersensitivity to sotalol and sulfonamides.
Application in pregnancy, especially in the first trimester, is only possible on strict indications, after a thorough assessment of the relationship between the intended benefit for the mother and the potential risk to the fetus.

Sotalol can have a negative effect on the fetus: intrauterine growth retardation, hypoglycemia, bradycardia.

In the case of sotalol therapy during pregnancy, it should be discontinued 48-72 hours before the expected term of labor (due to the possibility of bradycardia, arterial hypotension, hypokalemia and respiratory depression in the newborn).

The use of sotalol during the lactation period is contraindicated.

C use caution in chronic renal failure.
Patients with renal failure require a correction of the dosing regimen.
C use with caution in liver failure.

C use caution in children (efficacy and safety are not defined).

C use caution in elderly patients.

They are used with caution for chronic heart failure, pheochromocytoma, hepatic insufficiency, chronic renal failure, Reynaud's syndrome, myasthenia gravis, thyrotoxicosis, depression (including history), psoriasis, hypokalemia, QT interval prolongation, in elderly patients, children (efficacy and safety not identified).

With extreme caution apply at the instructions in the anamnesis for allergic reactions, and also against desensitizing therapy.
Sotalol increases sensitivity to allergens.
The treatment is performed under the control of heart rate, blood pressure, ECG.
With a marked decrease in blood pressure or a decrease in heart rate, the daily dose should be reduced. Patients with renal failure require a correction of the dosing regimen.
At the conclusion of the course of treatment, the dose of sotalol should be reduced gradually.

With a sudden withdrawal of clonidine against the background of sotalol, a sharp increase in blood pressure is possible.

A few days before the anesthesia should stop taking sotalol or pick up an agent for anesthesia with a minimal negative inotropic effect.

Impact on the ability to drive vehicles and manage mechanisms

During the treatment period, one should refrain from engaging in potentially dangerous activities requiring increased attention and speed of psychomotor reactions.

With simultaneous use with antiarrhythmic drugs of Class I, a possible expansion of the QRS complex is possible.
The risk of ventricular arrhythmia increases.
With simultaneous use with antiarrhythmic drugs of III class, a marked increase in the duration of the QT interval is possible.

With the simultaneous use of calcium channel blockers and antihypertensive drugs, tranquilizers, hypnotics, tricyclic antidepressants, barbiturates, phenothiazines, opioid analgesics, diuretics, vasodilators, a significant reduction in blood pressure is possible.

With simultaneous use with funds for inhalation anesthesia, the risk of oppression of myocardial function and development of hypotension increases.

With simultaneous use with amiodarone possible arterial hypotension, bradycardia, ventricular fibrillation, asystole.

With intravenous administration of sotalol against the background of verapamil and diltiazem, there is a risk of a significant deterioration in myocardial contractility and conduction.
There is an additive inhibitory effect on the sinus and AV-nodes.
With simultaneous use with insulin, oral hypoglycemic drugs, especially with increased physical exertion, it is possible to lower blood glucose levels or increase symptoms of hypoglycemia.

With simultaneous use with clonidine, there are cases of paradoxical arterial hypertension.

In patients receiving beta-adrenoblockers, in the event of a sudden withdrawal of clonidine, the development of severe arterial hypertension is possible.
It is believed that this is due to an increase in the content of catecholamines in the circulating blood and an increase in their vasoconstrictor action.
With simultaneous use with nifedipine, antidepressants, barbiturates, antihypertensive drugs may increase the hypotensive effect of sotalol.

With simultaneous use with noradrenaline, MAO inhibitors, severe arterial hypertension is possible.

When used simultaneously with reserpine, methyldopa, guanfacin, cardiac glycosides, it is possible to develop a pronounced bradycardia and a decrease in conduction.

With simultaneous application with furosemide, indapamide, prenylamine, procainamide, an additive increase in the QT interval is possible.

With simultaneous application with cisapride, the QT interval is significantly increased due to additive action, the risk of ventricular arrhythmia (including pirouette).

With the simultaneous use of erythromycin, the risk of ventricular arrhythmia such as pirouette increases.

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