Instructions for use BIOSOTAL


Sotalol Canon, 20 pcs., 80 mg, tablets

Concomitant administration of sotalol with class IA antiarrhythmic drugs (disopyramide, quinidine, procainamide) and class III drugs (for example, amiodarone) may cause prolongation of the QT interval.

The use of potassium-depleting diuretics may lead to hypokalemia or hypomagnesemia, which increases the likelihood of ari.

Sotalol should be used with extreme caution in combination with other drugs that prolong the QT interval, such as class I antiarrhythmics, phenothiazines, tricyclic antidepressants, terfenadine and astemizole, and some quinolone antibiotics.

The simultaneous use of beta-blockers and slow calcium channel blockers can lead to arterial hypotension, bradycardia, conduction disturbances and heart failure. The use of beta-blockers in combination with slow calcium channel blockers that suppress myocardial function (for example, verapamil and diltiazem) should be avoided due to the additive effect of these drugs on AV conduction and ventricular function.

The simultaneous use of catecholamine depleting agents (for example, reserpine and guanitidine) with beta-blockers leads to an excessive decrease in the tone of the sympathetic nervous system at rest. Patients should be carefully monitored due to possible signs of decreased blood pressure and/or severe bradycardia, which can lead to syncope.

When used simultaneously with insulin and oral hypoglycemic agents, hyperglycemia may develop. In this case, it is necessary to adjust the dose of hypoglycemic agents. Sotalol may mask the symptoms of hypoglycemia.

When used concomitantly with sotalol, it may be necessary to prescribe beta2-agonists such as salbutamol, terbutaline and isoprenaline in higher doses.

The use of sotalol does not cause a noticeable effect on the concentration of digoxin in the blood serum. Arrhythmogenic effects were observed more often in patients receiving sotalol simultaneously with digoxin; however, this may be due to chronic heart failure, which is a risk factor for arrhythmogenic effects in patients receiving digoxin.

Beta blockers may potentiate withdrawal hypertension following discontinuation of clonidine. Therefore, beta blockers should be discontinued gradually, several days before tapering off clonidine.

In case of shock or arterial hypotension caused by floctafenine, beta-blockers cause a decrease in compensatory cardiovascular reactions.

The use of inhalation anesthesia, incl. tubocurarine, while taking sotalol increases the risk of suppression of myocardial function and the development of arterial hypotension.

When used simultaneously with amphotericin B and GCS, potassium concentrations must be monitored.

Concomitant use with laxatives is not recommended.

Instructions for use BIOSOTAL

The simultaneous use of sotalol with class IA antiarrhythmic drugs is not recommended, incl. with disopyramide, quinidine, procainamide, amiodarone and bepridil.

When sotalol is used concomitantly with other beta-blockers, an additive effect of class II antiarrhythmic drugs may occur.

Sotalol should be used with extreme caution in combination with other drugs that prolong the QT interval, such as phenothiazines, tricyclic antidepressants, terfenadine, astemizole. Particular caution should also be exercised when concomitantly taking sotalol with drugs that can provoke cardiac dysfunction (IV), halofantrine, pentamidine and quinolone antibiotics.

With the simultaneous use of beta-blockers and calcium channel blockers, arterial hypotension, bradycardia, disturbances in the blood supply to the heart muscle and heart failure may occur. The simultaneous use of beta-blockers and calcium channel blockers that have an inhibitory effect on the activity of the heart muscle, such as verapamil and diltiazem, should be avoided, given their additive effect on vascular tone and myocardial contractility.

With the simultaneous use of diuretics that cause loss of potassium and magnesium, hypokalemia and hypomagnesemia may occur, which can lead to the development of ventricular tachycardia of the “pirouette” type.

Amphotericin B (IV), corticosteroids, and some laxatives can cause hypokalemia. Before prescribing Biosotal, the potassium content in the blood should be determined and electrolyte disturbances caused by previous use of these drugs should be corrected.

If clonidine is suddenly discontinued while taking sotalol, a sharp increase in blood pressure may occur. Therefore, at the end of combination therapy, you should first gradually discontinue sotalol, and after a few days begin a gradual reduction in the dose of clonidine.

Sotalol in a single dose or with repeated doses does not affect the concentration of digoxin in the blood. Proarrhythmic effects were more often observed in patients receiving sotalol and simultaneously digitalis glycosides. However, this was most likely due to the occurrence of congestive heart failure, which is a known risk factor for proarrhythmic effects in patients receiving cardiac glycosides. When taking cardiac glycosides and beta-blockers simultaneously, it is possible to slow down the conduction of excitation in the myocardium.

With the development of shock or arterial hypotension caused by floctafenine, sotalol reduces the compensatory mechanisms of the cardiovascular system.

When used simultaneously with drugs that cause a decrease in catecholamine levels, such as reserpine, guanethidine or α-methyldopa with beta-blockers, an excessive decrease in the tone of the sympathetic nervous system is possible. Patients should be carefully monitored, taking into account the possible occurrence of arterial hypotension and/or severe bradycardia.

The combined use of sotalol and hypoglycemic drugs, especially during physical activity, can lead to the development of symptoms of hypoglycemia. In this case, the dose of insulin or oral hypoglycemic drugs should be adjusted. It should be borne in mind that beta-blockers can mask the manifestations of hypoglycemia (for example, tachycardia).

The use of sotalol is not recommended in patients receiving beta2-blockers. If simultaneous use is necessary, the dose of beta2-blockers should be increased.

The presence of sotalol in urine may lead to a false increase in the concentration of metanephrine in the urine determined by the photometric method. In patients with suspected pheochromocytoma taking sotalol, metanephrine should be determined using liquid chromatography.

Sotalol

Drug interactions

When used simultaneously with class I antiarrhythmic drugs, a pronounced expansion of the QRS complex is possible. The risk of developing ventricular arrhythmia increases.

When used simultaneously with class III antiarrhythmic drugs, a pronounced increase in the duration of the QT interval is possible.

When used simultaneously with calcium channel blockers and antihypertensive drugs, tranquilizers, hypnotics, tricyclic antidepressants, barbiturates, phenothiazines, opioid analgesics, diuretics, vasodilators, a significant decrease in blood pressure is possible.

When used simultaneously with drugs for inhalation anesthesia, the risk of suppression of myocardial function and the development of hypotension increases.

When used simultaneously with amiodarone, arterial hypotension, bradycardia, ventricular fibrillation, and asystole are possible.

With intravenous administration of sotalol while using verapamil and diltiazem, there is a risk of significant deterioration in myocardial contractility and conductivity. An additive inhibitory effect on the sinus and AV nodes is noted.

When used simultaneously with insulins and oral hypoglycemic drugs, especially with increased physical activity, a decrease in blood glucose levels or increased symptoms of hypoglycemia may occur.

When used simultaneously with clonidine, cases of paradoxical arterial hypertension have been described.

In patients receiving beta-blockers, severe arterial hypertension may develop if clonidine is suddenly discontinued. 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 effect.

When used simultaneously with nifedipine, antidepressants, barbiturates, and antihypertensive drugs, the hypotensive effect of sotalol may be enhanced.

When used simultaneously with norepinephrine and MAO inhibitors, severe arterial hypertension is possible.

When used simultaneously with reserpine, methyldopa, guanfacine, cardiac glycosides, severe bradycardia and conduction slowdown may develop.

When used simultaneously with furosemide, indapamide, prenylamine, procainamide, an additive increase in the QT interval is possible.

When used simultaneously with cisapride, the QT interval significantly increases due to an additive effect and the risk of developing ventricular arrhythmia (including pirouette type).

When used simultaneously with erythromycin, the risk of developing ventricular ari increases.

Sotahexal

When taking slow calcium channel blockers such as verapamil and diltiazem simultaneously, a decrease in blood pressure may occur as a result of worsening contractility. IV administration of these drugs should be avoided while using sotalol (except in cases of emergency medicine).

The combined use of class IA antiarrhythmic drugs (especially quinidine type: disopyramide, quinidine, procainamide) or class III (for example, amiodarone) can cause a pronounced prolongation of the QT interval. Drugs that prolong the QT interval should be used with caution with drugs that prolong the QT interval, such as class I antiarrhythmics, phenothiazines, tricyclic antidepressants, terfenadine and astemizole, and some quinolone antibiotics.

When taking nifedipine and other 1,4-dihydropyridine derivatives simultaneously, a decrease in blood pressure is possible.

The simultaneous administration of norepinephrine or MAO inhibitors, as well as abrupt withdrawal of clonidine, can cause arterial hypertension. In this case, withdrawal of clonidine should be carried out gradually and only a few days after stopping Sotahexal.

Tricyclic antidepressants, barbiturates, phenothiazines, opioids, antihypertensives, diuretics, and vasodilators can cause a sharp decrease in blood pressure.

The use of inhalation anesthesia, incl. tubocurarine while taking Sotahexal increases the risk of suppression of myocardial function and the development of arterial hypotension.

With the simultaneous use of Sotahexal with reserpine, clonidine, alpha-methyldopa, guanfacine and cardiac glycosides, severe bradycardia and a slowdown in the conduction of excitation in the heart may develop.

Beta blockers may potentiate withdrawal hypertension following discontinuation of clonidine, so beta blockers should be discontinued gradually, several days before tapering clonidine.

Prescribing insulin or other oral hypoglycemic agents, especially during physical activity, can lead to increased hypoglycemia and the manifestation of its symptoms (increased sweating, rapid pulse, tremor). In case of diabetes mellitus, dose adjustment of insulin and/or hypoglycemic drugs is necessary.

Potassium-sparing diuretics (for example, furosemide, hydrochlorothiazide) can provoke arrhythmias caused by hypokalemia.

When used concomitantly with Sotahexal, the use of higher doses of beta-agonists such as salbutamol, terbutaline and isoprenaline may be required.

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