Sotagexal

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Sotagexal: instructions for use and reviews

1. Release form and composition
2. Pharmacological properties
3. Indications for use
4. Contraindications
5. Method of application and dosage
6. Side effects
7. Overdose
8. Special instructions
9. Application during pregnancy and lactation
10. Use in childhood
11. In case of impaired renal function
12. Use in the elderly
13. Drug interactions
14. Analogs
15. Terms and conditions of storage
16. Reviews
17. Price in pharmacies

Latin name: SotaHEXAL

ATX code: C07AA07

Active ingredient: Sotalol (Sotalol)

Manufacturer: Salutas Pharma GmbH, Germany

Description and photo update: 2019-12-08

Prices in pharmacies: from 69 rubles.

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Sotagexal - β ₁ - and β ₂ -adrenergic blocker; promotes an increase in the duration of the effective refractory periods of the pathways of nerve impulses.

Release form and composition

Dosage form - tablets: round, almost white or white (10 pcs. In a blister, in a cardboard box 1, 2, 3, 5 or 10 blisters):

80 mg - one side convex, engraved with "SOT", on the other side the surface of the tablet is beveled to the dividing line;
160 mg - biconvex, engraved with "SOT" on one side and scored on the other.

1 tablet contains:

active substance: sotalol hydrochloride - 80 mg or 160 mg;
auxiliary components: colloidal silicon dioxide, hyprolose, lactose monohydrate, sodium carboxymethyl starch, corn starch, magnesium stearate.

Pharmacological properties

Pharmacodynamics

Sotalol is a non-selective β-adrenergic receptor blocker that acts on the b1 and b2 receptors. This substance does not have its own membrane stabilizing and sympathomimetic activity. Sotalol is able to suppress renin secretion, and this effect is pronounced both during exercise and at rest.

The β-adrenergic blocking effect of Sotagexal leads to a decrease in heart rate and a limited decrease in the strength of heart contractions. These changes lead to a decrease in the volume of load on the heart and a decrease in myocardial oxygen demand.

The antiarrhythmic effect of sotalol is associated with the ability to prolong the action potential of the myocardium, as well as the ability to block beta-adrenergic receptors. Sotalol increases the duration of effective refractory periods in the pathways of the impulse (atrial, ventricular and additional).

Pharmacokinetics

When taken orally, the bioavailability of the drug exceeds 90%. The maximum concentration in blood plasma is observed after 2.5-4 hours, the equilibrium concentration is within 2-3 days. When taken on an empty stomach, the absorption of the drug is about 20% higher compared to taking the drug with meals. In the dose range of 40–640 mg / day, the concentration of sotalol in plasma is proportional to the doses taken. The distribution of the substance occurs in plasma, peripheral tissues and organs. The half-life is from 10 to 20 hours.

Sotalol does not have the ability to bind to blood plasma proteins and is not metabolized. The pharmacokinetics of the 1- and d-enantiomers of sotalol are practically the same.

The drug poorly penetrates the blood-brain barrier, and its concentration in the cerebrospinal fluid is approximately 10% of the concentration in blood plasma.

The main volume of the drug is excreted through the kidneys, while 80–90% of the dose is excreted unchanged in the urine, and the rest - in the feces.

Indications for use

The use of Sotagexal is indicated for the treatment of chronic and symptomatic cardiac arrhythmias:

ventricular premature beats;
ventricular tachycardia, including supraventricular tachycardia in Wolff-Parkinson-White syndrome;
atrial fibrillation is a paroxysmal form.

Contraindications

Absolute:

acute myocardial infarction;
chronic heart failure stage IIB-III;
sinoatrial (SA) blockade;
cardiogenic shock;
tachycardia of the "pirouette" type;
atrioventricular (AV) block II-III degree;
severe bradycardia with a heart rate (HR) less than 50 beats per minute;
sick sinus syndrome;
long QT syndrome (congenital or acquired);
arterial hypotension with systolic blood pressure (BP) below 90 mm Hg;
chronic obstructive pulmonary disease (COPD) or bronchial asthma;
metabolic acidosis;
obliterating vascular pathologies;
severe allergic rhinitis;
pheochromocytoma, in the absence of concomitant therapy with α-blockers;
severe renal failure, with creatinine clearance (CC) less than 10 ml / min;
carrying out general anesthesia using cyclopropane, trichlorethylene and other drugs, the action of which suppresses myocardial function;
simultaneous therapy with monoamine oxidase inhibitors (MAO);
age up to 18 years;
period of breastfeeding;
individual intolerance to sotalol, sulfonamides and other components of the drug.

Relative contraindications: it is recommended to take Sotagexal with caution in case of depression (including history), thyrotoxicosis, prolongation of the QT interval, diabetes mellitus, AV block of the 1st degree, psoriasis (including personal and family history), impaired renal function and water-electrolyte balance (hypokalemia, hypomagnesemia), after a recent myocardial infarction, as well as in old age.

Since sotalol suppresses the body's sensitivity to allergens, special care must be taken when treating patients with a history of allergic reactions and the use of the drug against the background of desensitizing therapy.

During pregnancy, the use of the drug is possible only for health reasons, after a careful assessment of the ratio of the expected benefits of therapy for the mother and all risk factors for the fetus, especially in the first trimester.

Instructions for the use of Sotagexal: method and dosage

The tablets are taken orally, swallowing whole, 1-2 hours before meals, with the required amount of liquid.

The dose should be selected individually, taking into account the severity of the disease and the patient's response to the drug.

The recommended starting dose is 80 mg per day. To achieve the desired therapeutic effect, the daily dose can be gradually increased to 240-320 mg and divided into 2-3 doses. Usually, a daily dose of 160-320 mg, taken twice a day, provides a sufficient therapeutic effect.

In severe arrhythmias that threaten the patient's life, you can prescribe the maximum permissible daily dose - 480 mg and divided into 2-3 doses. It should be borne in mind that such a dose increases the risk of developing undesirable effects, especially of a proarrhythmogenic nature. Therefore, resort to the maximum dose should be in case the expected benefit outweighs the potential threat.

Due to the risk of cumulation development in case of impaired renal function, the use of the drug should be accompanied by monitoring of CC and heart rate indicators (at least 50 beats per minute). In renal insufficiency, the half-life (T ¹ / ₂) sotalol is increased, requiring decrease the dose when the level of serum creatinine 120 umol / l.

Recommended dosage based on the serum creatinine level:

up to 120 μmol / l: usual dose;
120-200 pmol / l: ³ / ₄ normal dose;
200-300 pmol / l: ¹ / ₂ normal dose;
300-500 pmol / l: ¹ / ₄ normal dose.

With severe renal failure, the patient must ensure regular monitoring of electrocardiography (ECG) and the level of sotalol concentration in the blood serum.

The duration of treatment is prescribed by the doctor individually.

If you accidentally miss the next dose, you should not reimburse it the next time you take it, you should only take the prescribed single dose.

Side effects

from the cardiovascular system: chest pain, shortness of breath, palpitations, edema, bradycardia, AV blockade, decreased blood pressure, palpitations, increased symptoms of heart failure, fainting, arrhythmogenic effect; rarely - increased angina attacks;
from the nervous system: increased fatigue, headache, depression, dizziness, anxiety, sleep disturbances (insomnia or drowsiness), mood changes, asthenia, tremors, impaired limb sensitivity, depression;
from the digestive system: dry mouth, nausea, vomiting, abdominal pain, diarrhea, flatulence, constipation;
on the part of the senses: reduction of lacrimation, inflammation of the cornea and conjunctiva, visual impairment, change in taste, hearing impairment;
from the respiratory system: bronchospasm (more often in patients with impaired pulmonary ventilation);
from the endocrine system: hypoglycemia (more often with diabetes mellitus or strict adherence to diets);
dermatological reactions: itching, rash, urticaria, redness, alopecia, psoriasiform dermatosis;
from the genitourinary system: decreased potency;
laboratory indicators: increased indicators of photometric analysis of urine for metanephrine (O-methyladrenaline);
others: muscle weakness, cold extremities, cramps, fever.

Overdose

Symptoms of Sotagexal overdose: decrease in blood pressure, bronchospasm, hypoglycemia, bradycardia, generalized seizures, prolongation of the QT interval, ventricular tachycardia (including pirouette), loss of consciousness. In severe cases, symptoms of cardiogenic shock and asystole (sometimes fatal) may develop.

Recommended treatment: gastric lavage, hemodialysis, activated charcoal intake. It is also recommended to carry out symptomatic therapy:

atrioventricular block 2-3 degrees: a temporary artificial pacemaker can be installed;
bradycardia: atropine - intravenous jet injection 1–2 times; glucagon - the first short intravenous infusion at a dose of 0.2 mg per 1 kg of body weight, the next - 0.5 mg per 1 kg of body weight intravenously over 12 hours;
marked decrease in blood pressure: the use of epinephrine;
bronchospasm: use of aminophylline or beta-2-adrenergic receptor sympathomimetics (inhalation);
pirouette tachycardia: magnesium sulfate and / or epinephrine, cardioversion, if necessary, the installation of a temporary artificial pacemaker.

special instructions

It is recommended to accompany the therapy with Sotagexal with regular monitoring of blood pressure, heart rate, ECG, in case of a pronounced decrease in blood pressure or heart rate, the daily dose of sotalol should be reduced.

In patients with pheochromocytoma, the use of the drug is indicated only with the simultaneous administration of α-blockers.

The drug should be withdrawn gradually under the supervision of the attending physician, especially after prolonged therapy.

The use of Sotagexal during pregnancy must be canceled 48-72 hours before the expected birth. This will reduce the risk of developing bradycardia, respiratory depression, hypokalemia, arterial hypotension in newborns.

Since in patients with hypokalemia and hypomagnesemia, the degree of prolongation of the QT interval and the likelihood of developing arrhythmias of the "pirouette" type may increase, drug treatment should be started only after the level of potassium and magnesium concentration in the blood plasma is restored. In case of severe or prolonged diarrhea, as well as in the case of taking the drug against the background of concomitant therapy with drugs that cause a decrease in the body's magnesium and / or potassium content, patients need to ensure regular monitoring of both electrolyte balance and acid-base balance.

The recommended rules for taking pills should not be violated, since the simultaneous intake of food, especially dairy products or milk, reduces the absorption of sotalol.

According to the instructions, Sotagexal can hide certain clinical symptoms of thyrotoxicosis, including tachycardia. Therefore, it is recommended not to allow abrupt withdrawal of the drug with thyrotoxicosis, so as not to cause an increase in the symptoms of the disease.

In patients receiving hypoglycemic agents, the effect of the drug may mask symptoms of hypoglycemia such as tremors or tachycardia. Patients in this category are advised to be careful and avoid long breaks in food intake.

When wearing contact lenses, you should take into account the possibility of inflammation of the cornea and conjunctiva while taking the drug.

Application during pregnancy and lactation

During pregnancy (especially in the first trimester), Sotagexal is prescribed exclusively for vital indications and only after a thorough analysis of the ratio of benefits to the mother and possible harm to the child.

When using the drug during this period, it is necessary to cancel it 48–72 hours before the expected due date. Failure to comply with this condition can lead to the development of hypokalemia, arterial hypotension, bradycardia and respiratory depression in the newborn.

Sotalol is able to penetrate into breast milk and reach effective concentrations there, therefore, when Sotagexal is prescribed during lactation, breastfeeding should be interrupted.

Pediatric use

It is forbidden to use the drug to treat children under 18 years of age.

With impaired renal function

Due to the possible risk of cumulation development, patients with impaired renal function during drug therapy should monitor CC and heart rate (at least 50 beats / min). The excretion of sotalol from the body occurs mainly through the kidneys, therefore, in persons with renal insufficiency, an elongation of its half-life is observed.

When treating patients from this category with a serum creatinine level of more than 120 μmol / L, the dose of the drug should be reduced as follows:

from 120 to 200 μmol / l - 0.75 standard dose;
from 200 to 300 μmol / l - 0.5 standard dose;
from 300 to 500 μmol / l - 0.25 standard dose.

Patients with severe renal impairment should regularly monitor the ECG and serum sotalol concentration.

Use in the elderly

When treating this category of patients, Sotagexal should be used with caution.

Drug interactions

With the simultaneous use of Sotagexal:

verapamil, diltiazem and other blockers of slow calcium channels: can contribute to a deterioration in contractility and a decrease in blood pressure, therefore, while taking sotalol, it is recommended to avoid intravenous administration of these drugs (except in emergency cases);
nifedipine and other derivatives of 1,4-dihydropyridine: can cause a decrease in blood pressure;
norepinephrine or MAO inhibitors: increase the risk of developing arterial hypertension;
barbiturates, tricyclic antidepressants, phenothiazines, diuretics, opioids, antihypertensive drugs, vasodilators: can cause a sharp decrease in blood pressure;
cardiac glycosides, reserpine, α-methyldopa, clonidine, guanfacine: increase the likelihood of developing severe bradycardia and slowing down the conduction of excitation in the heart;
hydrochlorothiazide, furosemide and other potassium-excreting diuretics: can cause hypokalemia and provoke the development of arrhythmias;
means for inhalation anesthesia (including tubocurarine): increase the risk of suppression of myocardial function and the appearance of arterial hypotension;
oral hypoglycemic agents and insulin: can potentiate an increase in hypoglycemia with manifestations of its symptoms in the form of an increased rapid heart rate, sweating, tremor (especially with physical exertion), therefore, in patients with diabetes mellitus, a dose adjustment of insulin and / or hypoglycemic agents is required;
class IA and III antiarrhythmics (including quinidine, disopyramide, procainamide, amiodarone): can cause marked prolongation of the QT interval.

With caution, Sotagexal should be used in combination with class I antiarrhythmics, tricyclic antidepressants, phenothiazines, astemizole, terfenadine, some quinolone antibiotics, since they also prolong the QT interval.

When combined therapy with clonidine, the withdrawal of sotalol must be completed several days before the termination of clonidine therapy, it should be borne in mind that its abrupt withdrawal can cause arterial hypertension.

It may be necessary to prescribe higher doses of salbutamol, terbutaline, isoprenaline and other β-adrenergic agonists with concomitant sotalol therapy.

Analogs

Analogues of Sotagexal are Anaprilin, Visken, Korgard 80, Obzidan.

Terms and conditions of storage

Store at temperatures up to 25 ° C. Keep out of the reach of children.

The shelf life is 5 years.

Reviews of Sotagexal

Reviews of Sotagexal from patients who took the drug in accordance with the doctor's recommendations are mostly positive. In some cases, users point to the development of side effects, in the event of which it is necessary to consult a doctor.

The price of Sotagexal in pharmacies

The price of Sotagexal is 88–93 rubles for a pack of 20 tablets of 80 mg and 140–153 rubles for a pack of 20 tablets of 160 mg.

Sotagexal: prices in online pharmacies

Drug name

Price

Pharmacy

SotaHeksal 80 mg tablets 20 pcs.

RUB 69

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Sotagexal tablets 80mg 20 pcs.

73 rbl.

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SotaHeksal 160 mg tablets 20 pcs.

114 RUB

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Sotagexal tablets 160mg 20 pcs.

122 RUB

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Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!