Sotalol

Brand Canonpharma

In stock 1024 Items

Available since: 2019-09-19

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Clinical Pharmacology

Beta₁-, beta₂- blocker. Sotalol is a non-selective β-adrenoreceptor blocker that acts as a β₁- and β₂receptors without their own sympathomimetic and membrane stabilizing activity.

Like other beta-blockers, sotalol inhibits renin secretion, and this effect is pronounced both at rest and during exercise. Beta-adrenoceptor blocking effect of the drug causes a decrease in heart rate (negative chronotropic effect) and a limited decrease in the strength of heart contractions (negative inotropic effect). These changes in heart function reduce the oxygen demand of the myocardium and the load on the heart.

The antiarrhythmic properties of sotalol are associated with both the blockade of β-adrenergic receptors and the ability to prolong the action potential of the myocardium. The main effect of sotalol is to increase the duration of effective refractory periods in the atrial, ventricular, and additional ways of conducting an impulse. On an ECG taken in standard leads, properties corresponding to Class II and III of antiarrhythmic agents may be reflected in the form of prolonged PR, QT and QT intervals._c (QT with correction for heart rate) in the absence of noticeable changes in the duration of the QRS complex.

Indications

prevention of paroxysmal atrial tachycardia, paroxysmal atrial fibrillation, paroxysmal atycopharyngeal recurrent tachycardia of the re-enter type, paroxysmal atrioventricular recurrent tachycardia based on additional pathways and paroxysmal atraoventricular tachycardia after-tachycardia after-tachycardia based on additional pathways and paroxysmal atrao-ventricular recurrent tachycardia based on additional pathways
maintaining normal sinus rhythm after relief of atrial fibrillation or atrial flutter;
treatment of symptomatic unstable ventricular tachyarrhythmias and symptomatic premature contractions of the ventricles;
treatment of arrhythmias due to elevated levels of catecholamines circulating in the blood or hypersensitivity to catecholamines.

Composition

1 tablet contains:

Active substance: Sotalol hydrochloride - 80 mg

Excipients: calcium hydrophosphate dihydrate - 118 mg, colloidal silicon dioxide (Aerosil) - 1 mg, croscarmellose sodium - 12 mg, mannitol - 56.8 mg, povidone - 8.6 mg, magnesium stearate - 3.6 mg.

Sotalol is marketed under different brands and generic names, and comes in different dosage forms:

Brand name	Manufacturer	Country	Dosage form
Sotalol canon	Canonpharma	Russia	pills
SotaHexal®	Sandoz	Switzerland	pills

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Dosage and Administration

The drug is taken orally for 1-2 hours before meals.

At the beginning of treatment, it is recommended to prescribe 160 mg / day in 2 doses (after about 12 hours). If necessary, this dose can be increased after appropriate clinical assessment of the patient’s condition to 240 or 320 mg / day. In most patients, a therapeutic response is achieved when using the drug in a total daily dose of 160-320 mg, divided into 2 doses.

Some patients withlife-threatening refractory ventricular arrhythmia may require up to 480-640 mg / day; However, such doses can be prescribed only in cases where the potential benefit exceeds the risk of side effects, especially proarrhythmic action.

In patients with cardiomyopathy, chronic heart failure, with angina, arterial hypertension, conditions after myocardial infarction, it is recommended to begin treatment in a hospital. The initial dose is 160 mg / day in 1 or 2 doses. After a week, the dose can, if necessary, be increased by 80 mg / day (1 tab. 80 mg or 1/2 tablet. 160 mg) at weekly intervals. The rate of dose increase depends on the tolerability of the drug in patients, which, in particular, is assessed according to the degree of induced bradycardia and the clinical response. Thanks to the relatively long T_1/2 in most patients, sotalol is effective when taken 1 time / day. Dose interval: 160-320 mg / day.

Patients with impaired renal function

Since sotalol is excreted mainly in the urine, T_1/2 increases in the presence of renal insufficiency, the dose should be reduced when serum creatinine level is more than 120 mcmol / l in accordance with the following recommendations:

Serum creatinine		Recommended dose
mcmol / l	mg / dL	Recommended dose
less than 120	Usual dose
120-200	1.20-3 / 4 usual dose
200-300	2.3-1 / 2 usual doses
300-500	3.4-1 / 4 usual doses

Adverse reactions

Sotalol is usually well tolerated. Side effects are transient and in rare cases require interruption or discontinuation of treatment.

From the nervous system:dizziness, headache, sleep disturbance (drowsiness or insomnia), depression, paresthesia in the limbs, anxiety, emotional lability, depression, tremor.

On the part of the organ of vision:visual impairment.

From the organ of hearing:hearing impairment.

Since the cardiovascular system:bradycardia, retrosternal pain, shortness of breath, ECG changes, palpitations, hypotension, arrhythmogenic effect, heart failure, peripheral edema, fainting.

From the digestive system: nausea, vomiting, dyspepsia, diarrhea, abdominal pain, flatulence, disturbed taste sensations.

From the genital and breast organs:decrease in potency.

From the musculoskeletal system:convulsions.

Allergic reactions:urticaria, skin rash.

Common disorders:fever, tired feeling, asthenia.

From the laboratory and instrumental data:overestimated results may be observed with photometric analysis of urine for metanephrine (O-methyladrenaline).

If pheochromocytoma is suspected, the urine of patients should be investigated using high performance liquid chromatography with solid phase extraction.

Contraindications

Carefully the drug should be prescribed to patients who have recently had a myocardial infarction, in diabetes mellitus, psoriasis, patients with impaired renal function, with AV-blockade of I degree, impaired water-electrolyte balance (hypomagnesaemia, hypokalemia), thyrotoxicosis, depression (including history), pheochromocytoma (while taking with alpha-blockers), burdened with an allergic history, elderly patients.

Drug interactions

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

The use of diuretics that reduce the content of potassium, can lead to hypokalemia or hypomagnesemia, which increases the likelihood of arrhythmias such as "pirouette."

Sotalol should be used with extreme caution in combination with other QT agents, such as class I antiarrhythmic drugs, phenothiazines, tricyclic antidepressants, terfenadine and astemizole, as well as 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-adrenergic blockers in combination with blockers of slow calcium channels that suppress myocardial function (for example, verapamil and diltiazem) should be avoided due to the additive effect of these agents on AV conduction and ventricular function.

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

When used concomitantly with insulin and hypoglycemic agents for oral administration, 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 simultaneously with sotalol, beta administration may be required.₂- adrenomimetics, 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 serum. Arrhythmogenic effect was observed more frequently in patients who received sotalol concurrently with digoxin; however, it may be associated with chronic heart failure, which is a risk factor for arrhythmogenic effects in patients receiving digoxin.

Beta-blockers can potentiate arterial hypertension withdrawal after discontinuing clonidine. Therefore, beta-blockers should be abolished gradually, a few days before the gradual cessation of clonidine.

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

Use of agents for inhalation anesthesia, incl. tubocurarine, while taking sotalol increases the risk of inhibition of myocardial function and the development of arterial hypotension.

With simultaneous use with amphotericin B and GCS it is necessary to control the concentration of potassium.

Not recommended simultaneous use with laxatives.

Pregnancy and Lactation

The use of the drug Sotalol Canon during pregnancy, especially in the first 3 months, is possible only for vital reasons after a careful assessment of the ratio of all risk factors.

In the case of therapy during pregnancy, the drug should be discontinued 48-72 hours before the expected term of childbirth because of the possibility of developing bradycardia, hypotension, hypokalemia and respiratory depression in the newborn.

Sotalol penetrates into breast milk and reaches effective concentrations there. If necessary, the appointment of the drug during lactation, breastfeeding should be discontinued.

Special instructions

Treatment with Sotalol Canon is carried out under the control of heart rate, blood pressure, ECG. In case of drug withdrawal, the dose should be reduced gradually. You can not abruptly interrupt treatment because of the risk of severe arrhythmias and myocardial infarction. Cancellation is carried out gradually.

In thyrotoxicosis, the drug Sotalol Canon can mask certain clinical signs of thyrotoxicosis (for example, tachycardia). Abrupt cancellation in patients with thyrotoxicosis is contraindicated because it can enhance the symptoms of the disease.

When prescribing the drug Sotalol Canon, patients with pheochromocytoma should simultaneously prescribe alpha-blockers.

When prescribing beta-adrenergic blockers to patients receiving hypoglycemic drugs, care should be taken, because during prolonged interruptions in food intake hypoglycemia may develop. Moreover, symptoms such as tachycardia or tremor, will be masked by the action of the drug.

The drug Sotalol Canon should not be used in patients with hypokalemia or hypomagnesemia before correcting existing disorders. These conditions can increase the degree of prolongation of the QT interval and increase the likelihood of arrhythmias such as "pirouette". The electrolyte balance and acid-base state should be especially carefully monitored in patients with severe or prolonged diarrhea and in patients receiving drugs that cause a decrease in the content of magnesium and / or potassium in the body.

The patient should be trained in the method of calculating heart rate and instructed on the need for medical consultation with heart rate less than 50 beats / min.

In smoking patients, the effectiveness of beta-blockers is lower.

Patients using contact lenses should take into account that a decrease in the production of tear fluid is possible during treatment.

Perhaps an increase in the severity of hypersensitivity reactions and the lack of effect from the usual doses of epinephrine on the background of aggravated allergic history.

In the case of elderly patients, increasing bradycardia (less than 50 beats / min), arterial hypotension (systolic blood pressure below 100 mm Hg), AV blockade, bronchospasm, ventricular arrhythmias, severe liver dysfunction and kidney should be reduced or stop treatment.

It is recommended to stop therapy in the development of depression caused by taking beta-blockers.

At the time of treatment it is necessary to exclude the use of alcohol.

It is necessary to discontinue the drug before the study in the blood and urine of catecholamines, normetanephrine and vanillimindal acid, titers of antinuclear antibodies.

Influence on ability to drive motor transport and control mechanisms

During the period of treatment, headache and feeling of fatigue may occur, so care must be taken when driving vehicles and engaging in other potentially dangerous activities that require increased concentration of attention and quickness of psychomotor reactions.

Overdosage

Symptoms: bradycardia, chronic heart failure, exacerbation of chronic heart failure, excessive reduction of blood pressure, bronchospasm, hypoglycemia.

Treatment: gastric lavage, the appointment of activated carbon; if AV conduction is impaired, 1-2 mg of atropine is introduced into the IV, with a low efficiency, a temporary pacemaker is installed; with bronchospasm - inhaled or parenterally beta-adrenergic; with a decrease in blood pressure, epinephrine is effective; hemodialysis.