Etacizin coated pills 50mg N50
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Active ingredients
Diethylaminopropion-ethoxycarbonylamino-phenothiazine
Release form
Pills
Composition
Diethylaminopropionethoxycarbonylaminophenothiazine hydrochloride 50 mg adjuvants: potato starch — 9.57 mg, sucrose — 19.3 mg, methylcellulose — 0.33 mg, calcium stearate — 0.8 mg. , sunsets sunset yellow (e110) - 0.003 mg, calcium carbonate - 6.308 mg, magnesium hydroxycarbonate basic - 3.678 mg, titanium dioxide (e171) - 0.665 mg, silicon dioxide - 0.827 mg, carnauba wax - 0.046 mg.
Pharmacological effect
Antiarrhythmic drug class IC. Has a long antiarrhythmic effect. Inhibits the rate of rise of the front of the action potential (V max), does not change the resting potential. Depending on the dose, it can reduce the duration of the action potential. Significantly does not change the effective refractory periods of the ventricles and atria. Inhibits the fast incoming sodium current and, to a lesser extent, the slow incoming calcium current. Ethazisin slows down the conduction of excitation along the myocardial conduction system. Prolongation of the PR interval and the QRS complex appears on the ECG; ST interval, reflecting repolarization of the ventricles, tends to shorten. Ethazisin has a moderate anti-ischemic effect. An arrhythmogenic effect when used in therapeutic doses rarely develops. Ethacizin raises the threshold for myocardial fibrillation and also suppresses cardiac rhythm changes that become fibrillation under conditions of acute myocardial ischemia. Unlike many antiarrhythmic drugs (including propranolol, quinidine, novacinamide, amiodarone, rhythmylen) Ethicizin does not cause a significant decrease in heart rate or prolong the QT interval on the ECG. The antiarrhythmic effect on ingestion usually develops for 1-2 days, the duration of the course of treatment It depends on the form of arrhythmia, the effectiveness and tolerability.
Pharmacokinetics
Absorption When ingested, the drug is rapidly absorbed from the gastrointestinal tract and is determined in the blood after 30-60 minutes. C max in plasma is reached in 2.5-3 hours. Bioavailability is 40%. DistributionBinding to plasma proteins is about 90%. Etacizin crosses the placental barrier. It is excreted in breast milk. MetabolismIntensively metabolized during the first passage through the liver. Some of the resulting metabolites have antiarrhythmic activity.Withdrawal Of the organism, the active substance is excreted in the urine as metabolites. T1 / 2 is 2.5 hours. Pharmacokinetics in special clinical situations. The Etacizin pharmacokinetic parameters are subject to significant individual variations and require individual study in individual patients to determine the optimal plasma concentration of the drug.
Indications
Supraventricular and ventricular premature beats. Paroxysms of atrial fibrillation and flutter. Paroxysmal supraventricular tachycardia (including with WPW syndrome). Paroxysmal ventricular tachycardia (in the absence of organic lesions of the heart).
Contraindications
Severe conduction disorders (including sinoatrial block, AV block II and III degree in the absence of an artificial pacemaker, violation of intraventricular conduction). Ventricular rhythm disturbances of the heart in combination with the blockades of the His system - Purkinje fibers. Severe left myocardial hypertrophy ventricle. The presence of post-infarction cardiosclerosis. Cardiogenic shock. Severe arterial hypotension. Chronic heart failure II and III stages. Severe abnormalities of the liver and / or kidneys. nny reception of MAO inhibitors. Pregnancy. Lactation period (breastfeeding). Hypersensitivity to the drug.
Precautionary measures
Patients with SSSU, especially during the initial administration of the drug, must have an ECG monitor (QRS complex) 2-3 days after prescribing Etacizin. Appointment Etacizin to patients with ventricular arrhythmias in combination with blockades of the His system - Purkinje fibers is contraindicated. Just like and other antiarrhythmic drugs, Etacizin can act arrhythmogenically. Risk factors of arrhythmogenic action EtatsizinOrganic damage to the heart (especially myocardial infarction). Reduced ejection fraction. Resistant eludochkovaya tachycardia. Maximum doses of the drug. Liver disease. Therefore, when prescribing Etacizin, you should: Strictly take into account contraindications to the use of the drug. Identify and eliminate hypokalemia beforehand. Avoid using Ethatsizin in combination with class I antiarrhythmic drugs. It is preferable to start treatment in the hospital (especially in the first 3-5 days of taking the drug, taking into account the dynamics ECG after trial and repeated doses of Etizizin or ECG monitoring data). Immediately stop treatment if there is an increase in ectopic ventricular complexes,blockade or bradycardia. Immediately stop treatment if the ventricular complexes are expanded by more than 25%, their amplitude decreases, the duration of the P wave on the ECG is more than 0.12 sec. When treating Etacizin, you should not drink alcohol. During therapy, you must carefully monitor the patient’s condition and cardiac function. vascular system (BP, ECG, EchoCG). Use in pediatrics The efficacy and safety of using the drug in children and adolescents under the age of 18 years have not been established. Use for violations of the liver, the use of the drug in case of marked disorders of the liver. Use for violations of renal function. The drug is contraindicated for marked disorders of the kidneys. Impact on the ability to drive motor vehicles and control mechanisms. It is not recommended to drive vehicles or maintain complex mechanisms that require increased attention, ability to concentrate.
Use during pregnancy and lactation
The use of the drug is contraindicated in pregnancy and lactation (breastfeeding). Ethazine penetrates the placental barrier. It is excreted in breast milk.
Side effects
On the part of the cardiovascular system, AV blockade, a violation of intraventricular conduction, reduced myocardial contractility, reduced coronary blood flow, ECG changes (prolongation of the PQ interval, expansion of the P wave and QRS complex); rarely - arrhythmogenic effect. On the part of the central nervous system, dizziness of accommodation. On the part of the digestive system Nausea. In clinical studies, side effects after Etacizin have been reported, on average, in 44% of patients. In half of the cases, they were of the same type and felt subjectively: headache, dizziness, staggering when walking or turning the head, general weakness, slight drowsiness, and in some cases diplopia was observed. For most patients, the side effect was usually early: on the second or third day of treatment initial dose of 100-150 mg / day. With long-term treatment with Etacizin, the side effects did not increase, and when they stopped taking the drug, they quickly disappeared. Other side effects of Etacizin are associated with inhibition of myocardial conductivity (28.6%).
Overdose
Symptoms: increased inhibitory effect on the myocardial conduction system, increased risk of arrhythmogenic action. Treatment: Gastric lavage, symptomatic therapy. Patients with electromechanical dissociation resulting from Etzizin's side effect (or its relative overdose) should be urgently and continuously resuscitated: external massage cardiac administration of adrenomimetic agents, calcium salts, dopamine, reopolyglukine. Patients with ventricular tachycardia caused This Ethizisin should be given electropulse therapy (EIT) or IV injection of lidocaine or trimecaine, against the background of which the effectiveness of EIT may increase. Contraindicated for stopping ventricular tachycardia caused by Etacizin, the use of class IA antiarrhythmic drugs (including novainamide, rhythmylen, aymalin). Hemodialysis is ineffective.
Interaction with other drugs
The use of Etacizin, as well as other class IC antiarrhythmic drugs (encainide, flecainide, lorkinaid, propafenone), is contraindicated in combination with class I antiarrhythmic drugs. Etacizin should not be administered concurrently with MAO inhibitors. , especially in relation to arrhythmias provoked by exercise or stress. This combination allows the use of small doses of antiarrhythmic drugs, which reduces the incidence of side effects. This combination is indicated for the treatment and prevention of paroxysmal tachycardias, including ventricular ones. With the combined use of Etacizin and digoxin, the antiarrhythmic effect of the drugs is enhanced and the myocardial contractility is improved. With their combined use, nausea, loss of appetite are possible, which is associated with an increase in the concentration of digoxin in the blood. In these cases, a reduction in the dose of digoxin is required. The use of glutamic acid in combination with Etacizin levels the cardiodepressive effect of Etacizin in patients with initial signs of circulatory disorders.