Sotalol Sandoz (sotalol hydrochloride) tablets 160 mg. №50

Description

Sotalol Sandoz (sotalol hydrochloride) tablets 160 mg. №50

Composition

active substance: sotalol;

1 tablet contains sotalol hydrochloride 40 mg or 80 mg or 160 mg;

Excipients: corn starch, lactose monohydrate, sodium starch glycolate (type A), hydroxypropylcellulose, colloidal anhydrous silica, magnesium stearate.

Dosage form

Tablets.

Basic physical and chemical properties:

• 40 mg tablets: white round, biconvex tablets embossed with SOT on one side;
• 80 mg tablets: white round tablets with a dash on one side, convex with embossing “SOT” – on the other;
• 160 mg tablets: white round, biconvex tablets with a dash on one side, embossed “SOT” – on the other.

Pharmacotherapeutic group

Nonselective β-adrenoceptor blockers.
ATX code C07A A07.

Pharmacological properties

Sotalol is a non-selective β-blocker that acts on β1 and β2 adrenoceptors. It has a pronounced antiarrhythmic effect, the mechanism of which is to increase the duration of the action potential and refractory period in all parts of the conduction system of the heart (class III antiarrhythmic drugs). Reduces heart rate and myocardial contractility, reduces the automaticity of the sinus node, slows atrioventricular conduction. By blocking β2-adrenoreceptors, it increases the tone of the smooth muscles of the bronchi and blood vessels.

Indication for use Sotalol Sandoz tablets 

Ventricular arrhythmias:

• prevention of recurrence of life-threatening ventricular tachyarrhythmias;
• treatment of symptomatic unstable ventricular tachyarrhythmia.

Supravitricular arrhythmias:

• prevention of paroxysmal atrial tachycardia, paroxysmal atrial fibrillation, paroxysmal atrioventricular (AV) nodal reciprocal tachycardia, paroxysmal AV-reciprocal tachycardia in the presence of additional conduction pathways, paroxysmal supraventricular tachycardia after surgery;
• maintenance of normal sinus rhythm after conversion of atrial fibrillation or atrial fibrillation.

Contraindication:

• hypersensitivity to sotalol, sulfonamides or to other components of the drug;
• grade IV heart failure according to the NYHA classification (New York Cardiac Association);
• acute and chronic heart failure of II-III degree (in the stage of decompensation);
• acute myocardial infarction;
• sinus node weakness syndrome, including sinoatrial block, if the patient does not have a functioning pacemaker;
• severe sinus node dysfunction;
• Grade II-III blockade (if the patient does not have a functioning pacemaker);
• congenital or acquired syndrome of prolonged QT interval or taking drugs that help prolong QT interval;
• ventricular tachycardia such as torsade de pointes or taking drugs that promote the development of this disease;
• symptomatic sinus bradycardia (≤ 45-50 beats / min);
• uncontrolled congestive heart failure, including right ventricular failure after pulmonary hypertension;
• cardiogenic shock;
• anesthesia with drugs that cause myocardial depression;
• hypokalemia; hypomagnesemia;
• untreated pheochromocytoma;
• arterial hypotension (except that arising from arrhythmia);
• Raynaud’s syndrome and severe peripheral circulatory disorders;
• bronchial asthma and chronic obstructive pulmonary disease;
• metabolic acidosis;
• renal failure (creatinine clearance <10 ml / min).

Use during pregnancy or breastfeeding

As there is insufficient experience with the use of Sotalol Sandoz tablets during pregnancy, the drug can be prescribed only when the expected benefit to the mother outweighs the potential risk to the fetus.

Method of application and dosage

When treating life-threatening ventricular arrhythmias with antiarrhythmic drugs, it is necessary to start therapy and increase the dose in a hospital setting with equipment for monitoring and assessing heart rate variability.

During treatment, follow-up examinations should be performed regularly (for example, using a standard ECG – with an interval of 1 month, a long ECG – every 3 months, as well as, if necessary, ECG during exercise).

Therapy should be reconsidered if individual parameters deteriorate, such as increasing QRS duration or prolonging the QT interval by more than 25%, prolonging the PQ interval by more than 50%, or increasing the frequency and severity of arrhythmias.

The following dosing regimen is recommended: the initial dose is 80 mg per day as a single dose or in 2 doses (40 mg) with an interval of 12 hours.

If the effectiveness of therapy is insufficient, the daily dose can be gradually increased at intervals of at least 3 days to achieve steady-state plasma concentrations of sotalol and monitor the duration of QT intervals by ECG.

For some patients, a daily dose of 160-320 mg divided into 2 doses may be required.

To prevent supraventricular arrhythmias, it is recommended to use a dose of 320 mg / day in 2 doses with an interval of 12 hours. To prevent supraventricular arrhythmia after heart surgery, the daily dose should be 240 mg in 2 doses.

Some patients with life-threatening persistent ventricular arrhythmia may be prescribed 480-640 mg of sotalol per day. However, prescribing such a dose requires careful evaluation of the potential benefit-risk balance of severe adverse reactions (especially proarrhythmogenic effects).

Application method

The Sotalol Sandoz tablets should be taken without chewing, drinking plenty of fluids (eg 1 glass of water) before meals. The drug should not be taken with food, as the absorption of sotalol hydrochloride from the digestive tract may be reduced (particularly for milk and dairy products).

The duration of treatment is determined by the doctor.

Patients who have suffered a myocardial infarction or have severe cardiac abnormalities require constant close medical supervision when adjusting the dose of antiarrhythmic drugs.

Patients with coronary heart disease and / or arrhythmia, as well as in the case of long-term use of the drug, therapy should be discontinued gradually, as abrupt withdrawal may lead to worsening of the clinical condition.

Children

Do not use the drug Sotalol Sandoz tablets in children.

Overdose

Symptoms of overdose depend on the general state of the patient’s heart activity (left ventricular function, cardiac arrhythmia). In the case of severe heart failure, even in the case of the use of the drug in the lowest doses, there may be deterioration of cardiac function.

According to clinical data, depending on the degree of intoxication, the following symptoms of overdose: dizziness, fainting, weakness, asystole, symptoms of cardiogenic or hypovolemic shock, heart failure, arthrioventricular block, arrhythmia, cyanosis of the nails or palms, convulsions, convulsions, hypochondria fatigue, loss of consciousness, mydriasis, sometimes generalized seizures, hypotension, hypoglycaemia, severe bradycardia up to cardiac arrest (replacement rhythm often on the ECG), prolongation of the QT interval, atypical ventricular tachycardia (torsade de pointes). Overdose of sotalol hydrochloride in isolated cases has been fatal.

Side effects:

• From the immune system: hypersensitivity reactions;
• Metabolic and nutritional disorders: hypoglycaemia (signs of low blood sugar (particularly tachycardia) may be masked by drug therapy should be considered in patients with prolonged fasting, diabetes mellitus, and patients with a history of spontaneous hypoglycaemia);
• From the psyche: anxiety, restlessness, confusion, mood swings, hallucinations, irritability, depression;
• From the nervous system: dizziness, drowsiness, headache, dysomnia, paresthesia, cold sensation in the extremities, weakness, convulsions, tremor;
• From the eyes: visual impairment;
• From the hearing organs: hearing impairment;
• From the cardiovascular system: chest pain, orthostatic and arterial hypotension, dyspnea, edema, increased symptoms of heart failure (swelling of the ankles, feet, shortness of breath), arrhythmia, bradycardia, palpitations, ECG abnormalities, myocardial conduction disorders, atriovenous , syncopal or presyncopal states;
• From the respiratory system: rhinitis, shortness of breath, bronchospasm, laryngospasm; infrequently – dyspnea: may occur in patients with obstructive pulmonary disorders;
• From the digestive tract: taste disturbance, abdominal pain, nausea, vomiting, diarrhea, dyspepsia, flatulence, xerostomia;
• On the skin: erythema, skin rash, urticaria, itching, exanthema;
• From the musculoskeletal system: muscle spasm or myasthenia gravis, back pain, arthralgia, muscle pain.
• From the reproductive system: erectile dysfunction;
• General disorders: fever, fatigue, cyanosis of the extremities, asthenia, withdrawal syndrome.