Sotalol Sandoz (sotalol hydrochloride) tablets 160 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;
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.