Clinical and pharmacological group: & nbsp

Beta-blockers

Included in the formulation
  • SOTAHEXAL
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    HEXAL AG     Germany
  • Sotalex®
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  • Sotalol
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  • Sotalol
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    ATOLL, LLC     Russia
  • Sotalol Canon
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  • Included in the list (Order of the Government of the Russian Federation No. 2782-r of 30.12.2014):

    VED

    ONLS

    АТХ:

    C.07.A.A   Non-selective beta-blockers

    C.07.A.A.07   Sotalol

    Pharmacodynamics:

    The drug is a mixed type of action (II / III classes). Non-selective β-blocker is a racemic mixture of two stereoisomers (L and D), blocking the potassium channels, slowing down repolarization of the cell membrane and time-extending action potential, which prolongs the refractory period in all parts of the heart. The indiscriminate blockade of β-adrenergic receptors leads to inhibition of automatism of the sinoatrial node, decrease of automatism and conduction in the atrioventricular node and other parts of the conduction system of the heart.

    Pharmacokinetics:

    After oral administration, an empty stomach is absorbed up to 90-100% in the gastrointestinal tract. The maximum concentration in the blood plasma is reached after 2-4 hours. It does not bind to blood plasma proteins. Poorly passes through the blood-brain barrier, but penetrates the placental barrier and enters the breast milk. Removed during hemodialysis.

    The therapeutic effect develops 1 hour after ingestion.The duration of action is 24 hours. With intravenous administration - after 5 minutes. The duration of action is 90-120 minutes.

    The elimination half-life is 7-12 hours. Elimination by the kidneys is unchanged.

    Indications:

    Ventricular arrhythmias: fibrillation, refractory forms, tachycardia (persistent and paroxysmal forms, with the programmed electrical stimulation of the heart); AV reciprocal tachycardia in anomalies of the conduction system of the heart (WPW syndrome, AV node dissociation); supraventricular arrhythmias (including prevention); tachycardia with thyrotoxicosis; angina pectoris, especially when combined with tachyarrhythmias; arterial hypertension; hypertrophic cardiomyopathy, mitral valve prolapse, prevention and treatment of myocardial infarction (with stable patient condition)

    IX.I30-I52.I45.6   Syndrome of premature agitation

    IX.I30-I52.I47.1   Nadzheludochkovaya tachycardia

    IX.I30-I52.I47.2   Ventricular tachycardia

    IX.I30-I52.I48   Atrial fibrillation and flutter

    Contraindications:

    Cardiogenic shock, atrioventricular blockade of II-III degree, bradycardia, chronic heart failure - resistant to the action of cardiac glycosides,cardiomegaly, arterial hypotension, stenocardia Prinzmetal, bronchial asthma, renal and hepatic insufficiency, diabetes mellitus with ketoacidosis, metabolic acidosis.

    Individual intolerance.

    Carefully:

    Chronic renal failure, myasthenia gravis, Raynaud's syndrome, depression, thyrotoxicosis, psoriasis, advanced age.

    Pregnancy and lactation:Recommendations for FDA - Category B. It is used during pregnancy according to vital indications. With sotalol therapy during pregnancy, the drug should be discontinued 48-72 hours before the expected delivery. Contraindicated during lactation.
    Dosing and Administration:

    Use in children

    Newborns: 1 mg / kg 2 times / day, if necessary, the dose rises every 3-4 days to 4 mg / kg 2 times / day;

    1 month - 12 years: 1 mg / kg with a possible increase in dose every 2-3 days to a maximum of 80 mg / day;

    12-18 years: 80 mg / day in 1-2 divided doses, with a gradual increase to the maximum - 480-640 mg / day.

    Adults

    Inside for 80-160 mg / day.

    Intravenous by 1.5 mg / kg for arresting paroxysmal supraventricular tachycardia, with the goal of prevention - in a dose of 80 mg.

    The highest daily dose: 480 mg orally, if necessary, repeated intravenous administration, the total dose is 1.5 mg / kg.

    The highest single dose: 160 mg orally, with intravenous administration - 20 mg.

    Side effects:

    Central nervous system: dizziness, insomnia, asthenia.

    Respiratory system: dyspnea, rarely - bronchospasm

    Cardiovascular system: bradycardia, atrioventricular block, cold extremities.

    System of blood: neutropenia, thrombocytopenia.

    Sense organs: "dry eye syndrome", transient visual impairment.

    Gastrointestinal tract: indigestion, diarrhea or constipation.

    Reproductive system: decreased potency.

    Endocrine system: hypoglycemia in patients with insulin-dependent diabetes, hyperglycemia in patients receiving insulin preparations; hypothyroid condition.

    Skin: Hyperhidrosis.

    Allergic reactions.

    Overdose:

    Pronounced bradycardia, arterial hypotension.

    Treatment. Intravenous 1-2 mg atropine, 2.5 μg / kg dobutamine, intravenously strontaneously 10 mg glucagon, intravenously drip 10-20 μg isoprenaline at a rate of not more than 5 μg / min.

    Interaction:

    Increases the concentration of ethanol in the blood and lengthens its excretion.

    Potentiates the effect of lidocaine in systemic application.

    Negative dromo-, foreign, chromotropic influences are intensified with simultaneous admission with amiodarone, anesthetics, antiarrhythmics, digoxin, diltiazem, verapamil.

    Increases the bioavailability of sotalol combined with cimetidine.

    Special instructions:

    Discontinue taking the drug gradually (for 8-10 days).

    Before an operative intervention it is necessary to inform the anesthesiologist about taking the drug by the patient.

    The use of sotalol in psoriasis can provoke an exacerbation of the disease or worsening of its course.

    During treatment, patients should refrain from driving the car and controlling moving mechanisms.

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