Sotalex (Tablets) Instructions for Use

Marketing Authorization Holder

Bristol-Myers Squibb (France)

ATC Code

C07AA07 (Sotalol)

Active Substance

Sotalol (Rec.INN registered by WHO)

Dosage Form

Sotalex

Tablets 160 mg: 30 pcs.

Dosage Form, Packaging, and Composition

10 pcs. – blister packs (3) – cardboard packs.

Clinical-Pharmacological Group

Dietary supplement – additional source of L-carnitine and magnesium

Pharmacotherapeutic Group

Beta-adrenoblocker

Pharmacological Action

Non-selective beta-blocker, acts on β₁– and β₂-adrenergic receptors, belongs to class III antiarrhythmic agents.

It has a pronounced antiarrhythmic effect, the mechanism of which consists in increasing the duration of the action potential and prolonging the absolute refractory period in all parts of the cardiac conduction system.

It reduces heart rate and myocardial contractility, slows AV conduction. Increases the tone of bronchial smooth muscles.

Pharmacokinetics

When taken orally, Sotalol is absorbed from the gastrointestinal tract, C_max in plasma is reached in 2-3 hours.

V_d is 2 L/kg. T_1/2 is about 15 hours. It is excreted mainly by the kidneys.

Indications

Supraventricular tachycardia (including in WPW syndrome), paroxysmal atrial fibrillation, ventricular tachycardia.

ICD codes

Dosage Regimen

Initiate oral therapy at 40 mg administered two to three times daily.

Titrate the dose gradually based on clinical response and patient tolerance.

For intravenous administration, administer a single dose of 20 mg.

Do not exceed the maximum oral daily dose of 480 mg.

If repeated intravenous administration is required, do not exceed a total cumulative dose of 1.5 mg/kg.

Adjust the dosage regimen in patients with renal impairment; reduce frequency or total daily dose.

Monitor heart rate, blood pressure, and ECG (particularly the QT interval) regularly during therapy initiation and titration.

In patients with supraventricular arrhythmias, the usual maintenance dose is 80-160 mg twice daily.

For life-threatening ventricular arrhythmias, doses up to the maximum of 480 mg daily may be required.

Discontinue therapy gradually; do not stop abruptly due to the risk of withdrawal syndrome and rebound hypertension.

Adverse Reactions

From the central and peripheral nervous system increased fatigue, weakness, dizziness, headache, drowsiness or insomnia, nightmares, depression, anxiety, confusion or short-term memory loss, hallucinations, asthenia, myasthenia, paresthesia in the extremities (in patients with intermittent claudication and Raynaud’s syndrome), tremor.

From the cardiovascular system sinus bradycardia, palpitations, impaired myocardial conduction, AV block (up to the development of complete transverse block and cardiac arrest), arrhythmias, decreased myocardial contractility, development (worsening) of chronic heart failure, decreased blood pressure, orthostatic hypotension, manifestation of angiospasm (worsening of peripheral circulation disorders, cold extremities, Raynaud’s syndrome), chest pain; in rare cases – increased angina attacks, ventricular paroxysmal tachycardia of the “torsades de pointes” type (the risk of development is higher with the combined use of drugs that prolong the QT interval, or with hypokalemia).

From the senses in some cases – impaired visual acuity, decreased secretion of tear fluid, dryness and soreness of the eyes, keratoconjunctivitis.

From the digestive system dryness of the oral mucosa, nausea, vomiting, pain in the epigastric region, flatulence, constipation or diarrhea, impaired liver function (dark urine, jaundice of the sclera or skin, cholestasis), taste changes, changes in the activity of liver enzymes, bilirubin concentration.

From the respiratory system nasal congestion, rhinitis, difficulty breathing, laryngo- and bronchospasm.

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

Allergic reactions : itching, skin rash, urticaria.

Dermatological reactions increased sweating, skin hyperemia, exanthema, alopecia, psoriasiform skin reactions, exacerbation of psoriasis symptoms.

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

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

Contraindications

Acute heart failure or decompensated chronic heart failure, cardiogenic shock, AV block II or III degree, sinoatrial block, sick sinus syndrome, sinus bradycardia (heart rate less than 55 beats/min), Prinzmetal’s angina, cardiomegaly (without signs of heart failure), arterial hypotension (systolic blood pressure less than 90 mm Hg, especially in myocardial infarction); COPD, bronchial asthma (severe course); occlusive peripheral vascular diseases (complicated by gangrene, intermittent claudication or pain at rest), diabetes mellitus with ketoacidosis, metabolic acidosis, simultaneous use of MAO inhibitors, lactation period, hypersensitivity to sotalol and sulfonamides.

Use in Pregnancy and Lactation

Use during pregnancy, especially in the first trimester, is possible only for strict indications, after careful assessment of the ratio of the expected benefit for the mother and the potential risk to the fetus.

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

If sotalol therapy is carried out during pregnancy, it should be discontinued 48-72 hours before the expected date of birth (due to the possibility of developing bradycardia, arterial hypotension, hypokalemia and respiratory depression in the newborn).

The use of sotalol during lactation is contraindicated.

Use in Hepatic Impairment

Use with caution in hepatic insufficiency.

Use in Renal Impairment

Use with caution in chronic renal failure. Patients with renal insufficiency require dosage regimen adjustment.

Pediatric Use

Use with caution in children (efficacy and safety not established).

Geriatric Use

Use with caution in elderly patients.

Special Precautions

Use with caution in chronic heart failure, pheochromocytoma, hepatic insufficiency, chronic renal failure, Raynaud’s syndrome, with myasthenia, thyrotoxicosis, depression (including in history), psoriasis, hypokalemia, QT interval prolongation, in elderly patients, in children (efficacy and safety not established).

Use with particular caution in case of history of allergic reactions, as well as during desensitizing therapy, because Sotalol increases sensitivity to allergens.

Treatment should be carried out under the control of heart rate, blood pressure, ECG. With a pronounced decrease in blood pressure or a decrease in heart rate, the daily dose should be reduced. Patients with renal insufficiency require dosage regimen adjustment.

When completing the course of treatment, the dose of sotalol should be reduced gradually.

With sudden withdrawal of clonidine while taking sotalol, a sharp increase in blood pressure is possible.

Several days before anesthesia, it is necessary to stop taking sotalol or select an anesthetic agent with minimal negative inotropic effect.

Effect on ability to drive vehicles and mechanisms

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

Drug Interactions

With simultaneous use with class I antiarrhythmic drugs, a pronounced expansion of the QRS complex is possible. The risk of developing ventricular arrhythmia increases.

With simultaneous use with class III antiarrhythmic drugs, a pronounced increase in the duration of the QT interval is possible.

With simultaneous use with calcium channel blockers and antihypertensive agents, tranquilizers, hypnotics, tricyclic antidepressants, barbiturates, phenothiazines, opioid analgesics, diuretics, vasodilators, a significant decrease in blood pressure is possible.

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

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

With intravenous administration of sotalol against the background of verapamil and diltiazem use, there is a risk of significant deterioration of myocardial contractility and conduction. An additive depressant effect on the sinus and AV nodes is noted.

With simultaneous use with insulins, oral hypoglycemic drugs, especially with increased physical activity, a decrease in blood glucose levels or an increase in hypoglycemia symptoms is possible.

With simultaneous use with clonidine, cases of paradoxical arterial hypertension have been described.

In patients receiving beta-blockers, in case of sudden withdrawal of clonidine, severe arterial hypertension may develop. 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, an increase in the hypotensive effect of sotalol is possible.

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

With simultaneous use with reserpine, methyldopa, guanfacine, cardiac glycosides, the development of severe bradycardia and conduction slowing is possible.

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

With simultaneous use with cisapride, the QT interval significantly increases due to an additive effect, the risk of developing ventricular arrhythmia (including “torsades de pointes” type).

With simultaneous use with erythromycin, the risk of developing ventricular arrhythmia of the “torsades de pointes” type increases.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.