Amiocordin 3 ml ampoule number 5

Amount in a package 5
Product form Ampoules
Manufacturer KRKA (Slovenia)
Registration certificate UA/2295/02/01
The main medicament -
morion code 54284

Amiokordin (Amiokordin) instructions for use

Composition

active ingredient: amiodarone hydrochloride 1 ampoule (3 ml) contains 150 mg of amiodarone hydrochloride
auxiliary substances: benzyl alcohol, polysorbate 80, water for injection.

Dosage form

Injection.

Pharmacological group

Antiarrhythmic drugs of the III class. The code of automatic telephone exchange С01В D01.

Indications

Treatment of severe cardiac arrhythmias in cases where oral administration of amiodarone is not advisable, such as:

  • atrial arrhythmia with a high incidence of ventricular contractions;
  • tachycardia associated with the syndrome of premature ventricular arousal (Wolff-Parkinson-White syndrome)
  • Symptomatic ventricular arrhythmias that result in inoperability are documented.

Cardiopulmonary resuscitation in case of cardiac arrest caused by ventricular fibrillation is resistant to external electropulse therapy.

Contraindications

Increased sensitivity of amiodarone or to an auxiliary substance.

Hypersensitivity to iodine.

Sinus bradycardia (heart rate less than 50-55 reductions / min), sinoatrial heart block in the absence of an endocardial pacemaker (artificial pacemaker).

Syndrome of weakness of the sinus node in the absence of a pacemaker (risk of stopping the sinus node).

Violation of AV conduction of a high degree in the absence of a pacemaker (artificial pacemaker).

Bifascicular and trifascicular conduction disorders in the absence of an endocardial pacemaker, which functions continuously.

Vascular insufficiency (vascular collapse).

Severe arterial hypotension.

Thyroid dysfunction.

Pregnancy (except in urgent cases, when the expected effect justifies the possible risk).

The period of breastfeeding.

Simultaneous use with drugs that can cause a paroxysmal ventricular tachycardia of the "torsades de pointes" type:

  • antiarrhythmic drugs Ia class (quinidine, hydroquinidine, disopyramide)
  • antiarrhythmic drugs of the III class (sotalol, dofetilida, ibutilid)

other drugs such as arsenic compounds, for example, bepridil, cisapride, difemanyl, dolasetron (intravenously), erythromycin (intravenously), mizolastine, moxifloxacin, spiramycin (c), vincamine (intravenously), toremifene, some antipsychotics (see "interaction with other drugs and other types of interactions ").

Intravenous injections are contraindicated in severe respiratory failure, uncompensated cardiomyopathy and severe heart failure.

These contraindications do not apply to the use of amiodarone for cardiopulmonary resuscitation in cardiac arrest that has arisen as a result of ventricular fibrillation and which is resistant to external electropulse therapy.

Dosing and Administration

Amiocordin® should be used in a concentration of at least 300 mg (2 ampoules) per 500 ml of 5% glucose solution (glucose). Amiocordin®, injection solution, can be administered only on isotonic (5%) glucose solution (glucose).

Do not dilute the preparation with isotonic sodium chloride solution, since precipitate formation is possible, and not mixed with other drugs in one infusion system!

Amiodarone should be administered through the central veins, except in cases requiring the use of cardiopulmonary resuscitation in cardiac arrest due to ventricular fibrillation, which is resistant to external electropulse therapy. In the event that the introduction through the central veins is not possible, you can enter the drug through the peripheral veins (see section "Features of application").

Dosage

The dose is always selected individually, in accordance with the conditions and needs of each patient.

In severe rhythm disturbances, when oral administration of the drug is not possible, in addition to cardiopulmonary resuscitation in cardiac arrest that occurs as a result of ventricular fibrillation and is resistant to external electropulse therapy, infusion through the central veins.

The shock dose is usually 5 mg / kg of body weight of the patient and is administered only on isotonic (5%) solution of glucose (glucose), preferably with an electric infusion pump for 20 minutes to 2:00. The introduction can be repeated 2-3 times within 24 hours. In connection with the short-term action of the drug, its maintenance infusion is necessary.

A maintenance dose of 10-20 mg / kg per day (an average of 600-800 mg to 1.2 g per day) in 250 ml of a 5% solution of glucose (glucose) for several days. From the first day of the infusion, it is necessary to begin the transition to oral intake of the drug (3 tablets per day). If necessary, the dose can be increased to 4-5 tablets per day.

In the case of cardiopulmonary resuscitation in the case of cardiac arrest that has arisen as a result of ventricular fibrillation and is resistant to external electropulse therapy, it is recommended to use a central venous catheter, provided it is available and ready; otherwise the drug can be injected through the most peripheral vein with the greatest blood flow.

The initial intravenous dose is 300 mg (or 5 mg / kg) dissolved in 20 ml of a 5% solution of glucose (glucose), the injection should be done quickly.

Additional administration of 150 mg of amiodarone (or 2.5 mg / kg) is possible if ventricular fibrillation is not removed.

Do not mix with other drugs in the same syringe.

Elderly patients

Small loading and maintenance doses are recommended.

Patients with impaired renal and hepatic function.

Dosage does not require correction for patients with impaired renal and hepatic function (except for very severe hepatic insufficiency).

Adverse Reactions

From the side of the immune system: anaphylactic shock, urticaria, there are reports of the occurrence of angioedema (Quincke's edema).

From the endocrine system: hypothyroidism.

On the part of the nervous system: benign intracranial hypertension (pseudotumour of the brain), headache.

From the heart: bradycardia (severe or moderate) arrhythmia or worsening of existing arrhythmia, sometimes accompanied by cardiac arrest (pro-arrhythmic effect) sinus pause (amiodarone is needed, especially for patients with conduction impulses and / or elderly patients); paroxysmal ventricular tachycardia of the "torsades de pointes" type.

From the side of the vessels: usually mild and short arterial hypotension expressed arterial hypotension or vascular collapse may occur in case of overdose or after too rapid administration; tides.

From the respiratory, thoracic and mediastinal organs: bronchospasm and / or apnea in patients with severe respiratory failure, especially in patients with bronchial asthma; interstitial pneumopathy; acute respiratory distress syndrome, in some cases with a fatal outcome, sometimes in the early postoperative period (it is possible to interact with high doses of oxygen) (see section "Features of application").

From the liver and biliary tract: chronic liver damage, which requires long-term treatment. Histological changes correspond to the picture of pseudo-alcoholic hepatitis or cirrhosis of the liver. Because clinical and laboratory signs are indistinct (the variability of hepatomegaly, an increase in the level of transaminases in the blood 1.5-5 times normal), regular monitoring of the liver is indicated.

In case of an increase in the level of transaminases in the blood, even mild, occurring after taking the drug for more than 6 months, it is necessary to suspect the development of chronic liver damage. These clinical and biological disorders usually disappear after discontinuation of treatment. Several non-negotiable cases of such changes were reported.

From the gastrointestinal tract: nausea.

From the skin and subcutaneous tissues: excessive sweating.

From the side of the musculoskeletal and connective tissue pain in the back.

General disorders and disorders at the injection site: reactions at the injection site, infusion, including pain, erythema, necrosis, edema, extravasation, infiltrate formation, inflammation, skin induration, thrombophlebitis, phlegmon, infections and pigmentation disorders.

If serious side effects occur, treatment should be discontinued.

Overdose

There is no information about an overdose of amiodarone for intravenous administration.

Very rarely reported on the occurrence of sinus bradycardia, ventricular arrhythmia, especially paroxysmal tachycardia such as "torsades de pointes", cardiac arrest, circulatory disorders and liver function.

Treatment should be symptomatic. Given the kinetic properties of the drug, it is recommended to monitor the function of the heart for a long time. Amiodarone and its metabolites undergo dialysis.

Use during pregnancy and lactation

Pregnancy

Given the influence of amiodarone on the thyroid of the fetus, this drug is contraindicated in pregnancy, except when the use of its destination exceeds the risk associated with it.

Breastfeeding.

Amiodarone and its metabolites, together with iodine, penetrate into breast milk in concentrations higher than their concentrations in the mother's plasma. Because of the risk of developing hypothyroidism in newborn breast-feeding, it is contraindicated in the treatment with amiodarone.

Children

Safety and efficacy of amiodarone for children today have not been evaluated, so the use of this drug for children is not recommended. Amiodarone ampoules for injectable administration contain benzyl alcohol. There are reports of cases of lethal dyspnoea syndrome (gasping syndrome, gasping syndrome) in newborns after the administration of solutions containing this preservative. Symptoms of this complication include sudden onset of shortness of breath, arterial hypotension, bradycardia and the development of cardiovascular collapse.

Application features

Features of the method of application.

Infusion through the central veins is carried out in the case of severe rhythm disturbances, when oral treatment can only use cardiopulmonary resuscitation in cardiac arrest that has arisen as a result of ventricular fibrillation and is resistant to external electropulse therapy.

Injection amiodarone should be administered through the central veins, because the introduction through the peripheral veins can cause local reactions such as superficial phlebitis. Amiodarone, injectable solution should be administered only as an infusion, since even a very slow injection of the drug may aggravate arterial hypotension, heart failure, or severe respiratory failure (see Section "Adverse Reactions").

The dose is approximately 5 mg / kg of body weight, except for cases of cardiopulmonary resuscitation in case of cardiac arrest that has arisen as a result of ventricular fibrillation and is resistant to external electropulse therapy, amiodarone should be administered for at least 3 minutes. Because of the possible collapse with irreversible consequences, the next intravenous injection can be carried out no earlier than 15 minutes, even if only 1 ampoule was administered.

You can not mix amiodarone with other drugs in one syringe and simultaneously inject other drugs with a single infusion system. If it is necessary to continue treatment with amiodarone, it should be administered by infusion.

In the case of cardiopulmonary resuscitation in cardiac arrest that has arisen as a result of ventricular fibrillation and is resistant to external electropulse therapy, it is usually not recommended to administer the solution through the peripheral veins, since there is a risk of hemodynamic disorders (severe arterial hypotension, vascular insufficiency) through central infusion veins should be carried out whenever possible. It is recommended to use a central venous catheter, provided it is available and ready; otherwise the drug can be injected through the peripheral veins - the most peripheral vein with as much blood flow as possible.

Supervision in the intensive care unit with constant monitoring of blood pressure and ECG is necessary as soon as possible.

If therapy with amiodarone needs to continue, it is administered as an infusion through the central veins with constant monitoring of arterial pressure and ECG.

Cardiac effects associated with the use of amiodarone.

There have been cases of a new or worsening of existing arrhythmia (sometimes with a fatal outcome) that is treatable.

The arrhythmogenic effect of amiodarone is weak, even lower than most antiarrhythmic drugs, and usually occurs under the influence of factors that lead to prolongation of the QT interval, such as interaction with other drugs and / or electrolyte imbalance. In spite of the fact that amiodarone can cause prolongation of the QT interval, its ability to provoke a paroxysmal torsades de pointes tachycardia is weak.

Pulmonary effects associated with the use of amiodarone.

Several cases of interstitial pneumopathy were observed with the use of injectable amiodarone. The appearance of dyspnea or dry cough, either separate or worsening the general condition, indicates the possibility of pulmonary toxicity, for example, interstitial pneumopathy, and requires monitoring of the patient's condition using radiological examination methods.

In addition, there were isolated cases of acute respiratory distress syndrome, sometimes lethal, in patients treated with amiodarone, during the post-surgical period, which may have been caused by interaction with high concentrations of oxygen. Therefore, it is recommended that the condition of such patients be carefully monitored during mechanical ventilation.

Hepatic effects associated with the use of amiodarone.

When using amiodarone, and also within the first 24 hours after the administration of the drug, acute liver disorders (including severe hepatocellular insufficiency or complete failure of liver function) and chronic hepatic disorders can develop. Severe hepatocellular insufficiency, sometimes fatal, can develop within 24 hours after initiation of injection of amiodarone.

Regular monitoring of liver function at the beginning of treatment is recommended and is consistent throughout the course of treatment with amiodarone. It is necessary to reduce the dose of amiodarone or to cancel this drug if the levels of transaminases grow more than 3 times compared with the normal values of these parameters.

Violation of electrolyte balance, especially hypokalemia.

It is important to take into account situations that may be associated with hypokalemia and can trigger the appearance of pro-arrhythmic effects. Hypokalemia should be eliminated to use amiodarone.

With the exception of emergencies, injectable amiodarone should be used only in specialized intensive care units provided constant monitoring (ECG, blood pressure).

Anesthesia.

Before surgery, it is necessary to inform the anesthesiologist that the patient is receiving amiodarone.

Continuous treatment with amiodarone may increase the risk of hemodynamic side effects associated with general or local anesthesia, such as: bradycardia, arterial hypotension, decreased cardiac output, and conduction disorders.

The ability to influence the reaction rate when driving or working with other machinery.

It does not matter.

Interaction with other drugs and other interactions

Antiarrhythmic drugs.

Many antiarrhythmic drugs suppress cardiac automatism, conduction and contractility of the myocardium.

Simultaneous use of antiarrhythmic drugs belonging to different classes can ensure the achievement of a favorable therapeutic effect, but more often this combination requires careful clinical monitoring and ECG monitoring. The simultaneous use of antiarrhythmic drugs that can cause paroxysmal tachycardia such as "torsades de pointes" (amiodarone, disopyramide, quinidine compound, sotalol, bepridil and others) is contraindicated.

Simultaneous use of antiarrhythmic drugs of one class is not recommended, except for some cases, since such treatment increases the risk of cardiac side effects.

Simultaneous use with drugs that have a negative isotropic effect, slow heart rate and / or slow AV conduction, requires careful clinical monitoring and monitoring of the ECG.

Medicines that can cause a paroxysmal tachycardia of the "torsades de pointes" type.

This serious type of arrhythmia may be caused by drugs irrespective of whether they are anti-arrhythmic drugs. Favorable factors for its occurrence is a hypokalemia, bradycardia, or congenital or acquired lengthening the interval QT.

Medicaments which may lead to the use of paroxysmal tachycardia type «torsade de pointes»: Class Ia antiarrhythmics (quinidine, gidrohinidin, disopyramide), class III antiarrhythmics (sotalol, dofetilide, ibutilide), some antipsychotics. For erythromycin, spiramycin and vincamine this interaction is activated only when used intravenous forms.

The simultaneous use of drugs, each of which contributes to the occurrence of ventricular tachycardia type «torsade de pointes», contraindicated except methadone and certain subgroups of drugs that are exceptions to the rule:

protiparazitni drugs (halofantrine, lumefantrine, pentamidine) is not only recommended for use with drugs that induce paroxysmal tachycardia type «torsades de pointes»;

neuroleptics, which can lead to paroxysmal tachycardia type «torsades de pointes», is also not recommended for use in conjunction with other drugs, contributing to the emergence of ventricular tachycardia type «torsades de pointes», but this combination is not contraindicated.

Means for causing bradycardia.

Most drugs can cause bradycardia. This applies antiarrhythmics of class Ia, beta-blockers, certain antiarrhythmic agents of Class III, some calcium channel blockers, digitalis drugs, pilocarpine and anticholinesterase agents.

The risk of bradycardia (additive effect).

Contraindicated combination.

  • Medicines that may cause paroxysmal ventricular tachycardia type «torsades de pointes»:
  • Class Ia antiarrhythmics (quinidine, gidrohinidin, disopyramide)
  • antiarrhythmics of class III (dofetilide, ibutilide, sotalol)
  • Other drugs, such as arsenic, bepridil, cisapride, difemanil, dolasetron for intravenous use, erythromycin for intravenous use, mizolastine, vincamine for intravenous use, moxifloxacin, spiramycin for intravenous administration, toremifene.

High risk of ventricular arrhythmias, especially paroxysmal ventricular tachycardia type «torsades de pointes».

These contraindications do not apply to the use of amiodarone during cardiopulmonary resuscitation in cardiac arrest related to ventricular fibrillation, the ineffectiveness of the use of external cardioversion.

Combinations which are not recommended.

Cyclosporine.

Increasing the level of cyclosporine in the blood due to lower its metabolism in the liver is the risk of nephrotoxicity.

It should conduct definition of cyclosporin blood levels, monitoring of renal function and dose adjustment during and after cessation of treatment with amiodarone.

Fluoroquinolone.

During treatment with amiodarone should be avoided use of fluoroquinolones.

Diltiazem, injectable form.

The risk of bradycardia and AV block. If you can not avoid this combination, it is necessary to establish the clinical supervision and continuous monitoring of the ECG.

Verapamil, injectable form.

The risk of bradycardia and AV block. If you can not avoid this combination, it is necessary to establish the clinical supervision and continuous monitoring of the ECG.

Antiparasitic drugs that can cause paroxysmal ventricular tachycardia type «torsades de pointes» (halofantrine, lumefantrine, pentamidine).

Increased risk of ventricular arrhythmia, in particular the type of pirouette «torsades de pointes». If possible - to cancel the antifungal azole group means. If you can not avoid this combination, you must first assess the duration of the QT interval and to make an electrocardiogram.

Antipsychotics, which may cause paroxysmal ventricular tachycardia type «torsades de pointes»: chlorpromazine, tsiamemazin, levopromazin, thioridazine, trifluoperazine, amisulpride, sulprid, tiaprid, veraliprid, droperidol, fluphenazine, haloperidol, pimozide, pipamperone, pipotiazine, sertindole, sultopride, zuclopenthixol , there is an increased risk of ventricular arrhythmias, in particular the type of pirouette «torsades de pointes».

Methadone.

Increased risk of ventricular arrhythmias, particularly type «torsades de pointes». Necessary to monitor the ECG and clinical monitoring.

Combinations that require the application of measures.

With oral anticoagulants.

Strengthening the action of anticoagulants and risk of bleeding due to rising levels of anticoagulants in blood plasma. Requires frequent monitoring of prothrombin in the blood and control MOE. It should adjust anticoagulant dosage for both oral use in the treatment of amiodarone and for 8 days after preparation.

With beta-blockers other than sotalol (contraindicated combination) and esmolol (combination that requires precautions for use).

Violations of cardiac contractility, automatism and conduction (suppression of sympathetic compensatory mechanisms). Necessary to monitor the ECG and clinical monitoring.

With beta-blockers in heart failure (bisoprolol, carvedilol, metoprolol, nebivolol).

Violation of automaticity and conduction of the heart (synergy effects) with the risk of bradycardia.

Increased risk of ventricular arrhythmia, in particular the type of «torsades de pointes». Requires regular monitoring of ECG and clinical monitoring.

With dabigatran.

Increased dabigatran plasma concentrations with an increased risk of bleeding. Clinical monitoring and dose adjustment of dabigatran if necessary, but no higher than 150 mg / day.

Because amiodarone has a long half-life, the occurrence of interactions can be observed for several months after stopping treatment with amiodarone.

Substrates of P-glycoprotein.

Amiodarone is an inhibitor of P-glycoprotein. It is expected that while the use of P-glycoprotein substrates will increase their concentration in the blood.

With digitalis drugs.

Deterioration of automatism (severe bradycardia) and the disturbance of atrioventricular conduction. If used digoxin, there is an increase in the blood level followed by a decrease in clearance of digoxin. Necessary to monitor the ECG and clinical monitoring, monitoring of digoxin levels in blood and, if necessary - adjustment of doses of digoxin.

With diltiazem for oral administration.

The risk of bradycardia or AV-blockade, especially in elderly patients. Necessary to monitor the ECG and clinical monitoring.

With some macrolides (azithromycin, clarithromycin, roxithromycin).

Increased risk of ventricular arrhythmia, in particular the type of «torsades de pointes». Requires regular monitoring of ECG and clinical monitoring.

With verapamil for oral administration.

The risk of bradycardia or AV-blockade, especially in elderly patients. Necessary to monitor the ECG and clinical monitoring.

With esmolol.

Motility disorders, automatism and conduction (suppression of sympathetic compensatory mechanisms). Necessary to monitor the ECG and clinical monitoring.

With means that can cause hypokalaemia:

diuretics (which cause hypokalemia by themselves or in combination with other drugs), laxatives, stimulating action, amphotericin B (for intravenous use), glucocorticoids (for regular use), tetrakosaktid (there is an increased risk of ventricular arrhythmia, in particular the type of «torsades de pointes », hypokalemia is favorable). It is necessary to prevent the occurrence of hypokalemia and conduct correction hypokalemia. It is necessary to carefully control the duration of the QT interval. In case of ventricular arrhythmia, in particular the type of «torsades de pointes» should not be used antiarrhythmic drugs and start a ventricular pacing; possible introduction of magnesium preparations. Requires monitoring ECG monitoring laboratory values and clinical monitoring.

With lidocaine.

The risk of raising of lidocaine in blood plasma, which can cause neurological and cardiac side effects, amiodarone inhibition of its metabolism in the liver. Requires clinical monitoring and ECG monitoring, if necessary - control of lidocaine plasma levels of lidocaine and dose adjustment during treatment with amiodarone and after its cancellation.

Since orlistat.

The risk reduction of amiodarone and its active metabolites in plasma. Clinical monitoring is required and, if necessary, - monitoring the ECG.

Since phenytoin (cover fosphenytoin).

Enhancement of phenytoin in blood plasma simultaneously with signs of overdose, particularly neurological manifestations (phenytoin decrease the metabolism in the liver).

Requires clinical monitoring, monitoring of phenytoin plasma levels and possible dose adjustment.

Since simvastatin.

The increased risk of side effects depending on the concentration, such as rhabdomyolysis (depression simvastatin metabolism in the liver). Exceed the dose of simvastatin 20 mg / day or assign another statin, which does not have this type of interaction.

Since tacrolimus.

Elevated levels of tacrolimus in the blood due to the suppression of its metabolism by amiodarone.

It is necessary to determine the level of tacrolimus in the blood monitoring of renal function and tacrolimus dose adjustment for simultaneous use with amiodarone and after withdrawal of amiodarone.

Since flecainide.

Amiodarone increases the plasma concentrations of flecainide by inhibiting cytochrome SYP 2D6. Therefore, the dose of flecainide is necessary to correct.

Substrates cytochrome P450 ZA4.

Assignment of these drugs against application amiodarone, which is an inhibitor of cytochrome SYP ZA4, may cause higher plasma concentrations of these drugs and, consequently, a possible increase in their toxicity.

Cyclosporine.

The combination with amiodarone may increase cyclosporine levels in the blood plasma, so the dose should be adjusted.

Fentanyl.

The combination with amiodarone may lead to enhanced pharmacological effects of fentanyl and increase the risk of symptoms of toxicity.

Statins.

There is a risk of toxicity with respect to the muscles is increased under conditions of co-administration of amiodarone with statins metabolized SYP ZA4, such as simvastatin, atorvastatin and lovastatin.

If necessary, the simultaneous use of statins with amiodarone is recommended to use statins not metabolized SYP ZA4.

Other drugs metabolized by the action SYP ZA4: lidocaine, tacrolimus, sildenafil, triazolam, dihydroergotamine, ergotamine, colchicine.

Means that cause bradycardia.

Increased risk of ventricular arrhythmia, in particular the type of «torsades de pointes»; necessary to conduct clinical monitoring and ECG monitoring.

Substrates SYP 2C9.

Amiodarone increases the concentration of substances that are substrates SYP 2S9, such as warfarin and phenytoin, by inhibiting cytochrome P450 2C9.

Combinations that require special attention.

With pilocarpine.

The risk of excessive bradycardia (additive effects of the drugs that cause bradycardia).

During treatment with amiodarone it is recommended to avoid use SYP ZA4 inhibitors (e.g. grapefruit juice and certain drugs).

Pharmacological properties

Pharmacodynamics.

Amiodarone has antiarrhythmic and antianginal action and a class III antiarrhythmic drug of Vaughan-Williams classification.

Antiarrhythmic properties.

Increasing the third phase of the action potential without affecting the level or lifting frequency.

Isolated increase in the third phase of the action potential occurs by reducing potassium passage through potassium channel, with no change in the sodium and calcium channel.

Bradikarditichna effect by reducing the sinus node automaticity. Atropine is not acting antagonist of this action.

Noncompetitive blocks alpha- and beta-adrenergic receptors.

Sinotrialnu slows, and atrial nodal conduction that is more intense in the presence of a high heart rate.

It does not affect ventricular conduction.

Increases the refractory period and reduces myocardial excitability on an atrial, nodal and ventricular level.

It slows conductivity refractory period and continues additional atrioventricular pathways.

No negative inotropic effect.

Pharmacokinetics.

The bioavailability of 30-60%. The rapid decrease in concentration in the blood is mainly due to the distribution in the peripheral tissues. The distribution ranges from 40 to 130 l / kg. In cardiac muscle, the maximum concentration is achieved after a few minutes following injection. amiodarone levels in cardiac muscle than in plasma. Metabolism of amiodarone is the same as after oral administration. The half-life after a single injection of amiodarone averages 3,2-20,7 hours and after administration of extending the half-life of amiodarone is very long, namely 13-103 days (average 53 ± 24 days).

Amiodarone is metabolized in the liver with the formation of the major metabolite - dezetilamiodarona which has similar pharmacodynamic and pharmacokinetic properties, in part - in the intestine. Amiodarone is excreted in bile and urine. Because it is almost completely metabolized, it is fixed in the feces and urine in very small amounts.

During the first few days of treatment with amiodarone accumulates in the body. The process of withdrawal begins in just a few days. Plasma concentration at steady state is achieved gradually, over weeks or months. After cessation of treatment withdrawal of amiodarone continues for another few months. Through the above-mentioned characteristics of amiodarone treatment should be started with a large (drums) doses with the aim to achieve as quickly as possible in the tissue concentrations required for therapeutic effect.

Basic physical and chemical properties

clear, slightly yellowish solution with no visible impurities.

Incompatibility

Do not dilute the formulation isotonic sodium chloride solution as the formation of precipitate. Do not mix with other drugs other than those specified in the "Method of use and dosage."

Shelf life

2 years.

Storage conditions

Store at a temperature not higher than 25 ° C in original package to protect from the action sveta.Hranit the reach of children.

Packaging

3 ml of solution for injection in ampoules 5 ampoules per carton.

Category of leave

On prescription.

 

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