Expiration date: 01/2025
Composition and form of issue:
Tablets, 1 tablet contains:
of sotalol hydrochloride 80 mg
160 mg.
excipients: corn starch, lactose, hydroxypropyl cellulose glycolate sodium starch silicon dioxide magnesium stearate
in a contour acheikova packing 10 PCs per cartons 2, 5 or 10 packs.
Pharmacological action:
Blocks beta1-and beta2-adrenergic receptors. Reduces heart rate, myocardial contractility, slows down AV conduction. It increases the tone of the smooth muscles of the bronchi.
Indications:
Supraventricular tachyarrhythmia: nodal tachycardia, tachycardia in WPW-syndrome, paroxysmal atrial fibrillation ventricular tachycardia, ventricular extrasystole.
Contraindications:
Hypersensitivity (including sulfonamides), chronic heart failure stage II-III, shock, AV block II-III degree, sinoatrial blockade, sinus node weakness syndrome, bradycardia, QT interval extension, hypokalemia, hypotension, severe peripheral blood circulation disorders, obstructive respiratory diseases (including bronchial asthma), metabolic acidosis, laryngeal edema, myasthenia gravis, severe allergic rhinitis.
Use during pregnancy and breast-feeding:
In the first trimester of pregnancy is possible for strict medical reasons, with a thorough analysis of all risk factors. At the time of treatment should stop breastfeeding.
Side effect:
From the nervous system and sensory organs: dizziness, headache, feeling tired, sleep disturbance, confusion, paresthesia, depression. Inflammation of the cornea and conjunctiva (should be considered when wearing contact lenses), vision impairment (extremely rare), reduction of tear.
From the cardiovascular system and blood (hematopoiesis, hemostasis): heart failure, bradycardia, AV blockade, angina (in rare cases), hypotension.
From the respiratory system: bronchospasm.
From the digestive tract: nausea, diarrhea, constipation, dry mouth.
From the metabolism: hypoglycemia (more often in patients with diabetes mellitus or with strict observance of the diet).
From the urogenital system: reduced potency.
From the musculoskeletal system: feeling cold in the limbs, muscle weakness or cramps.
From the skin: skin rash, itching (rarely) redness, psoriasis-shaped dermatosis, alopecia.
Drug interaction:
When combined with antiarrhythmics IA (especially quinidine type) and class III increases the risk of ventricular arrhythmias and prolongation of the QT interval with tricyclic antidepressants, barbiturates, phenothiazines, calcium antagonists and narcotic, antihypertensive, diuretic and vasodilating agents-dangerous hypotension and weakness of the sinus node with noradrenaline or MAO — hypertension blockers with reserpine — clonidine, alpha-methyldopa, guanphacin and cardiac glycosides-bradycardia or AV blockade, with potassium-excreting diuretics — arrhythmia caused by hypokalemia. Enhances the hypoglycemic effect of insulin and oral hypoglycemic agents.
Dosage and administration:
Inside, before eating, without chewing, drinking enough liquid, 80-120 mg / day. in 2-3 reception. With insufficient efficiency - up to 160-240-320 mg / day. in 2-3 reception. In severe arrhythmias - up to 480 mg / day. in 2-3 reception. Increasing the dose should be carried out 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-1-2 times / in struino, glucagon-first-short-term / in infusion at a dose of 0, 2 mg/kg body weight, then — at a dose of 0, 5 mg / kg body weight for 12 hours of dopamine, dobutamine, isoprenaline or adrenaline — depending on body weight and therapeutic effect.
It is excreted by hemodialysis.
Precautionary measures:
Requires constant monitoring of heart rate, blood PRESSURE, ECG. Caution is prescribed for diabetes, pheochromocytoma, renal failure, in the elderly, psoriasis (including history, including family), allergic reactions, as well as against the background of desensitizing therapy, diet, in the II–III trimester of pregnancy (only for strict indications, reception is discontinued for 48-72 hours before birth). Alcohol intake should be excluded. Avoid the simultaneous I/V administration of calcium channel blockers (verapamil, diltiazem). Be wary of during the drivers of vehicles and people skills relate to the high concentration of attention.
In the case of drug withdrawal dose should be reduced gradually.
