Sotalol Sandoz (sotalol hydrochloride) tablets 40 mg. №50


Prevention of relapse of ventricular tachyarrhythmia; ventricular extrasystole; paroxysmal atrial fibrillation; coronary artery disease; maintaining normal sinus rhythm after atrial fibrillation or atrial fibrillation.



Composition and form of release
Active ingredient: sotalol hydrochloride.
Sotalol Sandoz is available in the form of tablets 40 mg, 80 mg or 160 mg.
Pharmacological properties
This is a medicine used for heart rhythm disorders. It is a non-selective beta-adrenergic receptor blocker with a vasodilating effect.
Sotalol Sandoz is used:

  • with ventricular heart rhythm disorders, incl. for their prevention;
  • for the prevention of paroxysms of atrial flutter / atrial fibrillation after restored sinus rhythm;
  • with supraventricular tachyarrhythmia (including nodular / atrioventricular / paroxysmal tachycardia with WPW syndrome, paroxysmal atrial fibrillation);
  • with arrhythmias caused by an excess of catecholamines or hypersensitivity to them.

Sotalol Sandoz should not be used:

  • with sinoatrial blockade;
  • with chronic heart failure at stage IIB – III (uncontrolled);
  • with severe arterial hypotension;
  • with prolongation of the Q – T interval on the ECG;
  • with AV blockade II-III degree (without a pacemaker);
  • with sick sinus syndrome;
  • with cardiogenic shock;
  • with sinus bradycardia;
  • with acute myocardial infarction;
  • with ventricular tachycardia “torsade de pointes”;
  • with hypokalemia / hypomagnesemia;
  • with metabolic acidosis;
  • with swelling of the larynx;
  • with anesthesia that causes myocardial depression;
  • with obliterating vascular diseases;
  • with obstructive respiratory diseases, including bronchial asthma;
  • with CKD at IV – V stage;
  • with Raynaud’s disease;
  • with severe allergic rhinitis;
  • with untreated pheochromocytoma;
  • children;
  • when breastfeeding;
  • with allergy to sulfonamides;
  • with intolerance to the components.

Sotalol Sandoz is prescribed with caution for myasthenia gravis, pregnancy.
Application during pregnancy and lactation
Pregnant women are prescribed with caution, nursing mothers – contraindicated.
Method of administration and dosage
The Sotalol Sandoz tablet is taken orally, without chewing, with water.
Standard dosage for adults:

  • for tachyarrhythmias: the starting dose is 40 mg x2 times / day, the maintenance dose is 160-320 mg / day in 2-3 doses, the maximum is 160 mg x3 times / day;
  • for ventricular rhythm disturbances: standard dose – 80 mg x2–3 times / day, maximum – 240 mg x2 times / day;
  • with atrial fibrillation: the initial dose is 80 mg x2 – 3 times / day, the maximum dose is 160 mg x2 times / day.

The dose is increased at intervals of 2-3 days.
Symptoms: bradycardia (with asystole), cardiogenic / hypovolemic shock, hypoglycemia, mydriasis, generalized myoclonic convulsions, weakness, arterial hypotension, loss of consciousness, bronchospasm, atypical ventricular tachycardia, heart failure.
Treatment: gastric lavage, prescription of sorbents, symptomatic / supportive therapy.
Side effects:

  • Co side of the musculoskeletal system: convulsions, pain in the muscles / joints of myasthenia gravis.
  • From the side of the nervous system: asthenia, dizziness, headache, fatigue, drowsiness, mood changes, paresthesia, sensations of coldness in the extremities, confusion, sleep disturbance, anxiety, depression, hallucinations.
  • From the side of the eyes: impaired visual acuity, decreased tearing, inflammation of the cornea, conjunctiva.
  • Co side of the respiratory system: bronchospasm, allergic bronchitis with fibrosis, dyspnea, chest pain.
  • Co side of the cardiovascular system: proarrhythmic effect, chest pain, bradycardia, arterial hypotension, AV blockade, edema, syncope / presyncopal state, abnormalities on the ECG, increased failure, an increase in the number of angina attacks.
  • Co side of the skin: rash, erythema, psoriasis-like dermatosis, pruritus, exanthema, alopecia, prurigo.
  • On the part of the genitourinary system: edema, decreased libido.
  • From the side of the digestive tract: taste disturbances, nausea, diarrhea, dry mouth, anorexia, flatulence, abdominal pain.
  • Others: fever, temporary hearing impairment, hypoglycemia, increased triglyceride / cholesterol levels.

Storage conditions and periods
Store Sotalol Sandoz for no more than 5 years at room temperature.