Oral bioavailability is almost complete . The maximum andriol concentration in plasma is achieved through 2.5-4 hours after oral administration and the equilibrium concentration within 2-3 days. Drug absorption is reduced by about 20% during a meal compared to fasted. In the dose range from 40 to 640 mg / day sotalol concentration in plasma is proportional to the dose received. Distribution occurs in the plasma and in peripheral organs and tissues, and the half-life of 10-20 hours. Sotalol is not bound to plasma proteins and is metabolized. From of the administered dose is excreted unchanged in the urine, and the remainder in the faeces. Patients with renal impairment function should be prescribed lower doses of the drug. With age, the pharmacokinetics does not change significantly, although impaired renal function in elderly patients reduces the rate of excretion, which leads to increased accumulation of the drug in the body.
• the prevention of relapse life-threatening ventricular tachyarrhythmias;
• the treatment of symptomatic unstable ventricular tachyarrhythmia. Supraventricular arrhythmia: • the prevention of paroxysmal atrial tachycardia, paroxysmal atrial fibrillation, paroxysmal atrioventricular nodal reciprocating tachycardia type «re-entru” paroxysmal atrioventricular reciprocating tachycardia involving accessory pathways, and paroxysmal supraventricular tachycardia after surgery; • the maintenance of normal sinus rhythm after conversion of atrial fibrillation or atrial flutter.
• Hypersensitivity to sotalol, other components of the drug, and sulfonamides;
• signs syndrome sick sinus, including sinus block, unless there is a functioning artificial heart rate of the driver;
• atrioventricular block II and III degree;
• congenital or acquired elongated interval or the use of drugs that can prolong the QT-interval (see section “Interactions”.);
• torsades ventricular tachycardia or the use of drugs associated with the violation (see “Interactions” section.);
• symptomatic sinus bradycardia (rate heart rate <45 – 50 beats / min);.
• uncontrolled congestive heart failure andriol, including congestive heart failure of the right ventricle due to pulmonary hypertension;
• cardiogenic shock;
• anesthesia, causing suppression of myocardial function;
• hypotension, except in cases caused by arrhythmia ;
• Raynaud’s phenomenon and severe peripheral circulatory disorders;
• bronchial asthma or chronic obstructive pulmonary disease in history;
• metabolic acidosis,
• renal insufficiency (creatinine clearance <10 mL / min);
• pheochromocytoma without simultaneous use of alpha-blockers;
• the age of 18 years (effectiveness and safety have been established).
Application of pregnancy and during breastfeeding
Use of the drug andriolduring pregnancy, especially during the first trimester, is possible only for health reasons, and in a careful ratio of all risk factors. In animal studies, the use of sotatola did not cause teratogenic or other deleterious effects on the fetus. Controlled trials of sotalol in pregnant women have been conducted. Sotalol penetrates through the blood-barrier. Beta-blockers reduce placental blood flow, which can cause fetal death, premature birth, birth immature fruit. In the case of treatment during pregnancy, use of the drug should be discontinued for 48-72 hours prior to the expected delivery date because of the possibility of hypoglycemia, bradycardia, hypotension, hypokalemia, and respiratory depression in the newborn.
Sotalol passes into breast milk and there reaches effective concentrations.
If necessary, use during lactation, breast-feeding should be discontinued.
Dosing and Administration
The drug is taken orally for 1-2 hours before a meal without chewing, drinking plenty of fluids.
Simultaneous food intake (especially milk and milk products) reduces the absorption of the drug.
Dose picked individually, depending on the severity of the disease and the patient’s response to treatment.
With the lack of expression andriol of therapeutic effect dose can be gradually increased up to 240-320 mg per day, divided into 2-3 doses. In most patients, a therapeutic effect is achieved at a total daily dose of 160-320 mg, divided into 2 doses.
Some patients with life-threatening refractory ventricular arrhythmias may increase the dose to a maximum of 6-8 tablets Sotageksal drug (480-640 mg sotalol), divided into 2 or 3 separate reception.However, only in those cases it is possible to apply such a dose, where the potential benefits outweigh the risk of side effects, especially pro-arrhythmogenic action.