Etacizin (etacizin) coated tablets 50 mg. №50

Description

Etacizin Storage
active substance: etatsizin;

1 film-coated tablet contains etatsizin 50 mg;

excipients: potato starch, methylcellulose, sucrose, calcium stearate; shell: sucrose, povidone, calcium carbonate, magnesium carbonate light, colloidal anhydrous silica, carnauba wax, dyes: quinoline yellow (E 104), yellow FCF (E 110), titanium dioxide (E 171).

Etacizin Dosage form
Coated tablets.

Main physical and chemical properties: round biconvex tablets, coated with yellow. In cross section, the shell and core are almost white.

Pharmacotherapeutic group
Antiarrhythmic drugs, class IP. ATX code C01BC09.

Pharmacological properties

Pharmacodynamics.

Etatsizin is an antiarrhythmic drug of IC class. Has a pronounced and long-lasting antiarrhythmic effect. Inhibits the rate of increase of the action potential front, does not change the resting potential. Affects mainly sodium channels (both on the outer and inner surface of the cell membrane), reduces the amplitude and slows down the processes of inactivation and reactivation of fast sodium current. Blocks the entry of calcium ions through the slow channels of the membrane. Prolongs the duration of refractory periods of the atria and arthrioventricular node. Slows down the rate of increase of the action potential in the atrial and ventricular fibers of Purkinje and additional pathways of excitation through the atrioventricular (AV) node and the Kent bundle. Inhibits sinoatrial conduction, especially in the syndrome of sinus node weakness, spreads the QRS complex on the electrocardiogram (approximately 25%), as it slows the conduction of the ventricles (in the His-Purkinje system). Has a negative isotropic effect, shows local anesthetic and antispasmodic activity.

Etatsizin does not change the heart rate with short-term use and reduces with long-term use.

Etacizin Pharmacokinetics.

When taken orally, etatsizin is rapidly absorbed from the gastrointestinal tract and is detected in the blood in 30-60 minutes. The maximum concentration of etatsizin in blood plasma is registered in 2,5–3 hours. Bioavailability – 40%. 90% is bound to blood proteins. The half-life averages 2.5 hours. All these pharmacokinetic parameters are subject to significant individual fluctuations. Etatsizin is intensively metabolized during the first passage through the liver. Some of the metabolites formed have antiarrhythmic activity.

It is excreted in the urine as metabolites.

Indication
Ventricular and supraventricular extrasystole; paroxysms of atrial fibrillation and flutter; ventricular and supraventricular tachycardia, including in the syndrome of premature ventricular excitation.

Contraindication
Hypersensitivity to etatsizin or to the excipients of the drug;
severe conduction disorders (including sinoatrial block, atrioventricular block of II-III degree in the absence of an artificial pacemaker), disorders of intraventricular conduction;
severe left ventricular myocardial hypertrophy;
the presence of postinfarction cardiosclerosis;
cardiogenic shock;
acute coronary syndrome;
acute myocardial infarction and a period of three months after acute myocardial infarction;
pronounced dilation of the heart cavity;
reduction of the left ventricular ejection fraction (echocardiography data), sinus node arrest;
severe hypotension;
chronic heart failure of III and IV class;
severe liver and / or kidney dysfunction;
electrolyte imbalance (hypokalemia, hyperkalemia, hypomagnesemia);
concomitant use of monoamine oxidase inhibitors (MAOIs);
simultaneous use of antiarrhythmic drugs IP (moracizin (etmosin), propafenone, alapinin) and class IA (quinidine, procainamide, disopyramide, aimalin);
cardiac arrhythmias in combination with blockades of the His system – Purkinje fibers;
pregnancy and breastfeeding;
the patient’s age is up to 18 years.