The instruction for medical use
of ETATSIZIN® medicine
the Trade name
the International unlicensed
name Etatsizin Lekarstvennaya
the Tablet form, coated, 50 mg
active agent – etatsizin 50 mg,
excipients: potato starch, sugar, methyl cellulose, calcium stearate,
structure of a cover: sugar, polyvinylpirrolidone, dyes quinolinic yellow (E 104) and solar yellow (E 110), calcium carbonate, magnesium carbonate the main, titan dioxide (E 171), silicon dioxide, Carnauba Wax wax.
of the Tablet, coated. On cross section two layers are visible.
The pharmacotherapeutic group
Antiarrhytmic means 1C
of the class Code of Automatic Telephone Exchange C01BC Pharmacological Pharmacokinetics At Properties intake etatsizin is quickly soaked up from digestive tract and is defined in blood in 30-60 minutes. The maximum concentration is reached in 2.5-3 hours. Bioavailability – 40%. Elimination half-life makes 2.5 hours. 90% of active agent contact proteins of blood plasma. Parameters of pharmacokinetics of an etatsizin are subject to considerable individual fluctuations and demand individual study from certain patients for definition of optimum concentration of drug in blood plasma. It is intensively metabolized at the first passing through a liver. Some of the formed metabolites have antiarrhytmic activity.
Out of an organism etatsizin it is brought with urine in the form of metabolites.
Antiarrhytmic means (AAS) of class 1C, possesses intensive and long antiarrhytmic operation. Speed of increase of action potential oppresses, does not change rest potential. Depending on a dose can reduce action potential duration, does not change significantly the effective refractory periods of ventricles and auricles.
Etatsizin slows down carrying out excitement on the carrying-out system of a myocardium. On the electrocardiogram (ECG) there is a lengthening of an interval of PQ (duration of the period of reduction of auricles) and the QRS complex (ventricular complex), ST interval (reflects repolarization of ventricles) tends to shortening.
Etatsizin has moderate antiischemic action. The Aritmogenny effect at use of therapeutic doses develops seldom.
Etatsizin oppresses the fast entering sodium current and, to a lesser extent, the slow entering calcic current. In comparison with Ethmosinum, etatsizin it is characterized more expressed by the oppressing influence on the fast entering current of ions of sodium in a cell of a myocardium and the slow entering calcic current that leads to suppression of spontaneous diastolic depolarization of the ectopic centers of automatism in higher degree, than at Ethmosinum use. Etatsizin exceeds Ethmosinum by 2-3 times on intensity and by 4-5 times on effect duration. Etatsizin raises a threshold of fibrillation of a myocardium and also stops the disturbances of a warm rhythm turning into fibrillation in the conditions of acute ischemia of a myocardium.
Unlike many antiarrhytmic drugs (propranolol, quinidine, novokainamid, Amiodaronum, Rhytmilenum) etatsizin does not cause reliable decrease in frequency of a warm rhythm or lengthening of duration of an interval of QT on the ECG.
The antiarrhytmic effect at intake develops usually on 1-2 day, duration of a course of treatment depends on a form of arrhythmia, efficiency and tolerance of drug.
– ventricular and supraventricular premature ventricular contraction
– ventricular and supraventricular tachycardia (including and paroxysmal)
– paroxysms of a ciliary tachyarrhythmia
– a syndrome of premature excitement of ventricles
to Apply strictly on doctor’s orders in order to avoid complications.
A route of administration and doses
Inside, irrespective of meal time, since 50 mg 3 times a day. At insufficient clinical effect the dose is increased (under control of the ECG) to 50 mg by 4 times a day (200 mg) or 100 mg 3 times a day (300 mg). At achievement of lasting antiarrhytmic effect carry out maintenance therapy in individually picked up minimal effective doses. The antiarrhytmic effect at intake develops usually for 1-2 day, duration of a course of treatment depends on a form of arrhythmia, efficiency and tolerance of drug.
– atrioventricular (AV) blockade
– disturbance of intra ventricular conductivity
– blockade of the right leg of a ventriculonector
– decrease in contractility of a myocardium
– reduction of a coronary blood-groove
– accommodation disturbance
– the increased individual sensitivity to an etatsizin or
– disturbance of conductivity of a myocardium: sinuatrial blockade of the II degree,
atrioventricular (AV) blockade of II and III degree, blockade
of intra ventricular conductivity
– arterial hypotension
– a severe form of heart failure
– disturbance of functions of a liver and kidneys
– a sick sinus syndrome
– combined use of AAS of class 1C (Ethmosinum, an enkainid, a flekainid,
a dorkaimid, a propafenon)
– use of AAS of class 1C in combination with class 1A AAS.
– co-administration with monoamine oxidase inhibitors
– during feeding by a breast
the Combination of b-adrenoblockers with AAP of class 1C enhances antiarrhythmic effect, in particular in relation to the arrhythmias provoked by physical activity or a stress. Such combination allows to use small doses of AAP that reduces the frequency of side effects. This combination is shown for treatment and prevention of Bouveret’s diseases, including ventricular.
Clinical practice showed that etatsizin it is possible to combine with Amiodaronum (class AAS Sh). In such cases it is necessary to reduce doses of both drugs. It is possible to apply a combination of an etatsizin to prevention of ventricular fibrillation or a ventricular Bouveret’s disease with meksiletiny and propranolol.
At the combined use of an etatsizin and digoxin the antiarrhytmic effect of drugs amplifies and the sokratitelny ability of a myocardium improves. At their combined use the nausea, a loss of appetite are possible that it is connected with increase in concentration of digoxin in blood. In these cases the reduction of a dose of digoxin is required.
Use of glyutaminovy acid in combination with etatsiziny levels cardiodepressive action of an etatsizin at patients with initial signs of disturbance of blood circulation.
At treatment etatsiziny it is impossible to take alcohol.
of the Precautionary measure
Quite often it is clinically reasonable to start treatment of arrhythmia, having appointed at first Ethmosinum (600-1200 mg/days) – drug, much more rare giving side effects, and only after establishment of a refrakternost of arrhythmia to this drug to pass to reception of more active etatsizin.
Also as well as other antiarrhytmic drugs, etatsizin can work aritmogenno. Therefore when assigning an etatsizin follows:
1) to strictly consider contraindications to drug use,
2) to reveal and eliminate a hypopotassemia in advance,
3) to avoid use of an etatsizin in combination with antiarrhytmic drugs 1A of a class,
4) preferably to begin course treatment in a hospital (especially in the first 3-5 days of administration of drug, taking into account ECG loudspeakers after trial and repeated doses of an etatsizin or data of monitoring of the ECG),
5) immediately to stop treatment at increase of ectopic ventricular complexes, emergence of blockade or bradycardia. Etatsiziny it is necessary to stop treatment also immediately at expansion of ventricular complexes more than for 25%, reduction of their amplitude, duration of a tooth P on the ECG more than 0.12 seconds.
An organic lesion of heart (in particular the postponed myocardial infarction), decrease in fraction of emission, persistent ventricular tachycardia, the maximum doses of drug are considered as risk factors of aritmogenny action of an etatsizin. Besides, it is necessary to be careful at patients with liver diseases as etatsizin can be toxic for hepatocytes.
With extra care appoint etatsizin at AV to blockade of the I degree, incomplete blockade of legs of a ventriculonector, closed-angle glaucoma, prostate adenoma.
In a myocardial infarction drug is appointed on condition of careful medical control of the patient. It is desirable to begin treatment etatsiziny not earlier, than in 3 months after development of a myocardial infarction.
Pregnancy and the period of a lactation
during pregnancy the use of drug is possible when the expected advantage for mother exceeds potential risk for a fruit.
Influence on ability to run the vehicle or potentially dangerous mechanisms
to the Persons testing side effects from central nervous system (for example, dizziness, accommodation disturbances, a diplopia and others), it is impossible to run vehicles or to serve potentially dangerous mechanisms.
Symptoms: strengthening of the oppressing action on the carrying-out system of a myocardium, increase in risk of development of aritmogenny action.
Treatment: gastric lavage, symptomatic therapy.
A form of release and packing
of the Tablet of 50 mg No. 10, coated, in the blister (blister strip packaging) from a film of polyvinylchloride and aluminum foil.
In packing of 50 tablets together with the instruction for use.
To Store storage conditions in the dry, protected from light place, at a temperature from 15 °C to 25 °C.
To store out of children’s reach!
A period of storage
it is impossible to use Drug after the expiry date specified on packing.
According to the prescription
JSC Olaynfarm producer.
Address: Rupnitsu St. 5, Olaine, LV-2114, Latvia.