Instruction for use: SotaHEXAL

Active substance: Sotalol

ATX Code C07AA07 Sotalol

Pharmacotherapeutic group:

Beta-blockers

The nosological classification (ICD-10)

I47.1 Supraventricular tachycardia

Supraventricular paroxysmal tachycardia; supraventricular tachyarrhythmia; supraventricular tachycardia; Supraventricular arrhythmias; Supraventricular paroxysmal tachycardia; supraventricular tachyarrhythmias; supraventricular tachycardia; Neurogenic sinus tachycardia; orthodromic tachycardia; Paroxysmal supraventricular tachycardia; Paroxysm of supraventricular tachycardia; Paroxysm of supraventricular tachycardia with WPW-syndrome; Paroxysm of atrial tachycardia; Paroxysmal supraventricular tachyarrhythmia; Paroxysmal supraventricular tachycardia; Politopnye atrial tachycardia; Atrial fibrillation; Atrial tachycardia is true; Atrial tachycardia; Atrial tachycardia with AV block; reperfusion arrhythmias; Reflex Bertsolda-Jarisch; Recurrent sustained supraventricular paroxysmal tachycardia; Symptomatic ventricular tachycardia; Sinus tachycardia; Supraventricular paroxysmal tachycardia; supraventricular tachyarrhythmia; supraventricular tachycardia; supraventricular arrhythmia; supraventricular arrhythmias; Tachycardia of AV connections; supraventricular tachycardia; Tachycardia orthodromic; sinus tachycardia; The nodal tachycardia; Chaotic atrial tachycardia politopnye; Wolff-Parkinson-White

I47.2 Ventricular tachycardia

Torsades de pointes (torsade de pointes), Symptomatic ventricular tachycardia, Torsades de pointes in myocardial infarction, Ventricular fibrillation, Ventricular tachycardia , Ventricular tachyarrhythmias, Life-threatening ventricular arrhythmias, Sustained ventricular tachycardia, Sustained monomorphic ventricular tachycardia, Paroxysmal ventricular tachycardia torsades, Paroxysmal ventricular tachycardia

I49.9 Irregular heartbeat, unspecified

Paroxysmal supraventricular tachycardia; extrasystole arrhythmia; Atrial fibrillation tachysystolic; supraventricular tachyarrhythmia; supraventricular arrhythmias; AV reciprocating tachycardia; AV-nodal reciprocating tachycardia; ventricular fibrillation; Irregular heartbeat; Antidromic reciprocating tachycardia; Cardiac arrhythmias; Arrhythmias; Arrhythmia; Heart arythmy; Arrhythmia due to hypokalemia; ventricular tachyarrhythmias; The high frequency of ventricular contraction; Cardiac arrhythmias; Paroxysmal supraventricular arrhythmia; Paroxysmal supraventricular arrhythmia; Paroxysmal dysrhythmia; Paroxysmal atrial-ventricular rhythm; cardiac arrhythmias; supraventricular tachycardia; tachyarrhythmia; Precordial abnormal pulsation

Structure and Composition

Tablets 1 tab.

sotalol hydrochloride 80 mg/ 160 mg

Excipients: corn starch; lactose; hydroxypropylcellulose; sodium starch glycolate; silicon dioxide; magnesium stearate

in blisters of 10 pcs .; a stack of cardboard 2, 5 or 10 packages.

Pharmacological Properties
Pharmachologic effect

antiarrhythmic.

Blocks beta1- and beta2-adrenergic receptors. It reduces heart rate, myocardial contractility, slows AV conduction. It increases the tone of smooth muscles of the bronchi.

Indications

Supraventricular tachyarrhythmias: nodal tachycardia, tachycardia with WPW-syndrome, paroxysmal atrial fibrillation; ventricular tachycardia, ventricular arrythmia.

Contraindications

Hypersensitivity (including to sulfonamides), chronic heart failure IIb-III stage, shock, AV block II-III degree sinoatrial block, sick sinus syndrome, bradycardia, prolongation of the interval QT, hypokalemia, hypotension, severe peripheral circulatory disorders , obstructive airway disease (including asthma), metabolic acidosis, laryngeal edema, myasthenia gravis, severe allergic rhinitis.

Pregnancy and breast-feeding

In the I trimester of pregnancy is possible under strict medical indications, a careful analysis of all risk factors. At the time of treatment should stop breastfeeding.

Side effects

From the nervous system and sensory organs: dizziness, headache, fatigue, sleep disturbances, confusion, paraesthesia, depression. Inflammation of the cornea and conjunctiva (to consider when wearing contact lenses), blurred vision (rare), a decrease in lacrimation.

Cardio-vascular system and blood (blood, hemostasis): heart failure, bradycardia, AV block, angina (in rare cases), hypotension.

From the respiratory system: bronchospasm.

From the digestive tract: nausea, diarrhea, constipation, dry mouth.

From a metabolism: hypoglycaemia (more common in patients with diabetes mellitus or with strict adherence to the diet).

With the genitourinary system: loss of potency.

From the musculoskeletal system: the feeling of cooling in the extremities, muscle weakness or cramps.

For the skin: skin rash, itching (rare); redness, psoriazoformny dermatosis, alopecia.

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Interaction

In a joint application with the IA antiarrhythmic drugs (especially quinidine type) and Class III increases the risk of ventricular arrhythmias and prolongation of QT interval; tricyclic antidepressants, barbiturates, phenothiazines, calcium antagonists and drugs, antihypertensives, diuretics and vasodilating agents - threatening hypotension and sick sinus; with norepinephrine blockers or MAO - hypertension; with reserpine, clonidine, alpha-methyldopa, guanfacine and cardiac glycosides - bradycardia or AV block, with kaliyvyvodyaschimi diuretics - arrhythmia caused by hypokalemia. Enhances hypoglycemic effect of insulin and oral hypoglycemic agents.

Dosing and Administration

Inside, the food, without chewing, drinking plenty of fluids, at 80-120 mg / day. 2-3 reception. With the lack of efficiency - up to 160-240-320 mg / day. 2-3 reception. In severe arrhythmias - up to 480 mg / day. 2-3 reception. Increasing doses should be performed at intervals of 2-3 days.

Overdose

Symptoms: hypotension, bradycardia, loss of consciousness, generalized seizures, ventricular tachycardia; in severe cases - symptoms of cardiogenic shock, asystole.

Treatment: atropine purpose - 1-2 times / jet, glucagon - first - short / in infusion at a dose of 0.2 mg / kg body weight, and then - in a dose of 0.5 mg / kg body weight per 12 hours dopamine, dobutamine, epinephrine isoprenaline or - depending on the weight and therapeutic effect.

Displayed by hemodialysis.

Precautionary measures

Continuous monitoring of heart rate, blood pressure, ECG. Be wary appoint diabetes, pheochromocytoma, renal failure, in the elderly, psoriasis (including history, including family), allergic reactions, as well as on the background of desensitizing therapy, diet, in II-III trimester of pregnancy ( only on strict conditions, reception is stopped for 48-72 hours before delivery). It is necessary to eliminate the use of alcohol. Avoid the simultaneous on / in the calcium channel blocker (verapamil, diltiazem). Be wary of during the drivers of vehicles and people skills relate to the high concentration of attention.

In the case of withdrawal of the drug dose should be reduced gradually.

Storage conditions

The temperature is not above 25 ° C.

Keep out of the reach of children.

shelf life

5 years.

Do not use beyond the expiration date printed on the package.