Sotalol tablets 160mg, No. 20

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

The method of application and dosage regimen of a particular drug depends on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly observe the compliance of the used dosage form of a particular drug with the indications for use and the dosage regimen.

For oral administration, the initial dose is 40 mg 2-3 times / day. With intravenous administration, a single dose is 20 mg.

Maximum doses: for oral administration - 480 mg / day. If repeated intravenous administration is necessary, the total dose is 1.5 mg / kg.

Active ingredient: sotalol hydrochloride - 160 mg

Excipients : lactose monohydrate (milk sugar) - 157.3 mg, corn starch - 30.4 mg, sodium carboxymethyl starch - 15.2 mg, povidone K25 - 11.4 mg, magnesium stearate - 3.8 mg, colloidal silicon dioxide - 1.9 mg.

Acute heart failure or decompensated chronic heart failure, cardiogenic shock, AV block II or III degree, sinoatrial block, SSS, 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 with myocardial infarction); COPD, bronchial asthma (severe course); peripheral vascular occlusive disease (complicated by gangrene, intermittent claudication or pain at rest), diabetes mellitus with ketoacidosis, metabolic acidosis, concomitant use of MAO inhibitors, lactation period, hypersensitivity to sotalol and sulfonamides.

Description:

Tablets are white or almost white, round, flat-cylindrical, with a score on one side and chamfers on both sides.

Composition:

Active ingredient: sotalol hydrochloride - 80 mg

Excipients: lactose monohydrate (milk sugar) - 78.65 mg, corn starch - 15.2 mg, sodium carboxymethyl starch - 7.6 mg, povidone K25 - 5.7 mg, magnesium stearate - 1.9 mg, colloidal silicon dioxide - 0.95 mg.

Description:

Tablets are white or almost white, round, flat-cylindrical, with a score on one side and chamfers on both sides.

Active ingredient: sotalol hydrochloride - 160 mg

Excipients : lactose monohydrate (milk sugar) - 157.3 mg, corn starch - 30.4 mg, sodium carboxymethyl starch - 15.2 mg, povidone K25 - 11.4 mg, magnesium stearate - 3.8 mg, colloidal silicon dioxide - 1.9 mg.

Clinical and pharmacological group: Beta1-, beta2-blocker

Pharmaco-therapeutic group: Beta-blocker

pharmachologic effect

A nonselective beta-blocker, acts on ?1- and ?2-adrenergic receptors, belongs to class III antiarrhythmic drugs. It has a pronounced antiarrhythmic effect, the mechanism of which is to increase the duration of the action potential and lengthen the absolute refractory period in all parts of the cardiac conduction system. Reduces heart rate and myocardial contractility, slows down AV conduction. Increases the tone of the smooth muscles of the bronchi.

Pharmacokinetics

When taken orally, sotalol is absorbed from the gastrointestinal tract, Cmax in plasma is reached after 2-3 hours. Vd is 2 l / kg. T1 / 2 - about 15 hours. It is excreted mainly by the kidneys.

Indications of the active substances of the drug Sotalol

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

Dosage regimen

The method of application and dosage regimen of a particular drug depends on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly observe the compliance of the used dosage form of a particular drug with the indications for use and the dosage regimen.

For oral administration, the initial dose is 40 mg 2-3 times / day. With intravenous administration, a single dose is 20 mg.

Maximum doses: for oral administration - 480 mg / day. If repeated intravenous administration is necessary, the total dose is 1.5 mg / kg.

Side effect

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

From the side of the cardiovascular system: sinus bradycardia, palpitations, impaired myocardial conduction, AV block (up to the development of complete transverse blockade and cardiac arrest), arrhythmias, weakening of myocardial contractility, development (worsening) of chronic heart failure, lowering blood pressure, orthostatic hypotension , manifestation of angiospasm (increased impairment of peripheral circulation, cooling of the lower extremities, Raynaud's syndrome), chest pain; in rare cases - increased attacks of angina pectoris, ventricular paroxysmal tachycardia of the 'pirouette' type (the risk of development is higher with concomitant use of drugs that prolong the QT interval, or hypokalemia).

From the senses: in some cases - impaired visual acuity, decreased secretion of lacrimal fluid, dry and sore eyes, keratoconjunctivitis.

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

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 adherence to a diet), hypothyroid state.

Allergic reactions : itching, skin rash, urticaria.

Dermatological reactions: increased sweating, skin flushing, exanthema, alopecia, psoriasis-like skin reactions, exacerbation of psoriasis symptoms.

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

Others: back pain, arthralgia, weakening of libido, decreased potency, withdrawal syndrome (increased angina attacks, increased blood pressure).

Contraindications for use

Acute heart failure or decompensated chronic heart failure, cardiogenic shock, AV block II or III degree, sinoatrial block, SSS, 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 with myocardial infarction); COPD, bronchial asthma (severe course); peripheral vascular occlusive disease (complicated by gangrene, intermittent claudication or pain at rest), diabetes mellitus with ketoacidosis, metabolic acidosis, concomitant use of MAO inhibitors, lactation period, hypersensitivity to sotalol and sulfonamides.

Application during pregnancy and lactation

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

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

In the case of sotalol therapy during pregnancy, it should be canceled 48-72 hours before the expected date of delivery (due to the possibility of bradycardia, arterial hypotension, hypokalemia and respiratory depression in the newborn).

The use of sotalol during lactation is contraindicated.

Application for violations of liver function

Use with caution in liver failure.

Application for impaired renal function

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

Application in children

Use with caution in children (efficacy and safety have not been determined).

Use in elderly patients

Use with caution in elderly patients.

special instructions

Use with caution in chronic heart failure, pheochromocytoma, liver failure, chronic renal failure, Raynaud's syndrome, with myasthenia gravis, thyrotoxicosis, depression (including in history), psoriasis, hypokalemia, prolongation of the QT interval, in elderly patients, in children (efficacy and safety not determined).

Use with extreme caution when there is a history of allergic reactions, as well as against the background of desensitizing therapy. sotalol increases sensitivity to allergens.

Treatment is 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 adjustment.

At the end of the course of treatment, the dose of sotalol should be reduced gradually.

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

A few days before the anesthesia, it is necessary to stop taking sotalol or choose an anesthesia drug with a minimal negative inotropic effect.

Influence on the ability to drive vehicles and use mechanisms

During the period of treatment, 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 arrhythmias 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 drugs, 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 suppression of myocardial function and the development of hypotension increases.

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

With the on / in the introduction of sotalol against the background of the use of verapamil and diltiazem, there is a risk of a significant deterioration in myocardial contractility and conductivity. There is an additive depressing effect on the sinus and AV nodes.

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

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

In patients receiving beta-blockers, in the event of a 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, the hypotensive effect of sotalol may be enhanced.

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

With simultaneous use with reserpine, methyldopa, guanfacine, cardiac glycosides, it is possible to develop severe bradycardia and slow conduction.

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 is significantly increased due to the additive action, the risk of developing ventricular arrhythmias (including the 'pirouette' type).

With simultaneous use with erythromycin, the risk of developing ventricular arrhythmias of the 'pirouette' type increases.

Terms and conditions of storage

Store in a place protected from light, out of reach of children, at temperatures up to 25 ? C.

Shelf life is 2 years.

Conditions of dispensing from pharmacies

Dispensed by prescription.