Dosage of cordarone for arrhythmia. Kordaron - instructions for use and composition, form of release, indications, dosage and price. Contraindications to the use of Kordaron

Kordaron has antianginal and antiarrhythmic action. Pharmacologists refer it to the group of drugs with antiarrhythmic effect.

Its active ingredient is amiodarone. It is used to prevent angina pectoris, its attacks, as well as for the treatment and prophylactic methods in violation of the heart rhythm, in the diagnosis of various types of tachycardia, as well as atrial tremors. It is an indispensable drug for ventricular extrasystoles.

On this page you will find all the information about Kordaron: full instructions for use for this drug, average prices in pharmacies, complete and incomplete analogues of the drug, as well as reviews of people who have already used Kordaron. Want to leave your opinion? Please write in the comments.

Clinical and pharmacological group

Antiarrhythmic drug.

Terms of dispensing from pharmacies

Released by prescription.

Prices

How much does Kordaron cost? The average price in pharmacies is at the level of 330 rubles.

Release form and composition

Issue the following dosage forms Cordarona:

Solution for intravenous administration: light yellow transparent (in 3 ml colorless glass ampoules with two marking rings and a break point in the upper part; in plastic blister packs of 6 ampoules; in a carton pack 1 pack).
Tablets: round from white with a creamy tint to white. On one side there is a fault line, on both sides there is a bevel from the edges to the fault line and the engraving “200” under it, a chamfer and a heart-shaped symbol above the fault line (in blisters of 10 pcs; 3 blisters in a carton box).

1 ampoule contains:

Active ingredient: amiodarone hydrochloride - 0.15 g.
Auxiliary components: polysorbate 80 - 0.3 g, water for injection - up to 3 ml, benzyl alcohol - 0.06 g.

The composition of 1 tablet includes:

Active ingredient: amiodarone hydrochloride - 0.2 g.
Auxiliary components: magnesium stearate, anhydrous colloidal silicon dioxide, lactose monohydrate, povidone K90F, corn starch.

Pharmacological effect

Cordarone is an antiarrhythmic drug of the third class. Eliminates angina pectoris and arrhythmia, promotes blocking of adrenergic receptors, slowing down sinoatrial, atrial and nodal conduction, without affecting intraventricular conduction.

Also, the drug reduces myocardial excitability, lengthens the refractory period. Kordaron also has an antianginal effect due to a decrease in myocardial oxygen consumption. This is due to a decrease in heart rate and a decrease in total vascular peripheral resistance. Due to the direct effect on the muscles of the arteries, Kordaron increases coronary blood flow, in addition, the drug maintains cardiac output, reduces myocardial contractility.

According to reviews, Kordaron reaches its maximum activity 15 minutes after intravenous administration, the medicinal effect on the body lasts for four hours. Gradually, the amount of the drug in the blood decreases, but this does not interfere with the saturation of tissues with it. If the patient does not receive repeated injections, the drug is excreted from the body in a few months.

Indications for use

What helps? Kordaron tablets are used to treat the following diseases and pathological conditions:

cardiac arrhythmias in patients with pathology of left ventricular function or coronary heart disease;
supraventricular paroxysmal tachycardia;
atrial fibrillation and atrial flutter;
life-threatening ventricular arrhythmias, in particular, ventricular fibrillation and ventricular.

The use of Kordaron is indicated for the prevention of sudden death in patients at high risk: those with more than 10 ventricular extrasystoles per hour, a reduced left ventricular ejection fraction, in patients after a recent and, as well as in patients with clinical manifestations.

The use of Kordaron in the form of a solution for injection is indicated in the following cases:

for the relief of attacks of ventricular paroxysmal tachycardia, including those characterized by a high frequency of ventricular contractions;
for cardiac resuscitation in cardiac arrest caused by ventricular fibrillation, in case of ineffective defibrillation;
for the relief of seizures and atrial flutter.

During treatment ventricular arrhythmias the use of the drug should be carried out in a hospital and careful cardiomonitoring control.

Contraindications

This medicinal product can be used by patients only on the prescription of a doctor after a thorough examination. Before starting therapy, it is recommended to carefully study the attached instructions for restrictions. Contraindications to the use of Cordaron are:

Age up to 18 years;
Pregnancy and the period of breastfeeding;
Hypokalemia or hypomagnesemia;
sinus bradycardia;
Severe thyroid dysfunction (hyper or hypothyroidism);
interstitial lung disease;
Simultaneous use of drugs that change the parameters of the electrocardiogram and can cause the development of paroxysmal tachycardia;
Congenital lactose intolerance or lactase deficiency;
Individual intolerance to the components of the drug;
Simultaneous use with agents that prolong the QT interval and cause the development of paroxysmal tachycardia, including ventricular "pirouette" tachycardia: class IA antiarrhythmic drugs (hydroquinidine, quinidine, procainamide, disopyramide) and class III (bretylium tosylate, ibutilide, dofetilide), sotalol; other medicines non-antiarrhythmic action: vincamine, bepridil, phenothiazines (fluphenazine, cyamemazine, chlorpromazine, levomepromazine, trifluoperazine, thioridazine), benzamides (sultopride, amisulpride, sulpride, veraliprid, tiapride), pimozide, butyrophenones (haloperidol, droperidol), sertindolic, cisapride, tricyclic antidepressants, azoles, macrolide antibiotics (including spiramycin, erythromycin when administered intravenously), antimalarials (chloroquine, halofantrine, quinine, mefloquine), difemanil methyl sulfate, pentamidine only when administered parenterally, mizolastine, fluoroquinolones, astemizole and terfenadine.

With special care, the drug can be used in patients with chronic heart failure in the stage of decompensation, liver or kidney failure, bronchial asthma, respiratory failure, as well as the elderly (over 65 years).

Additional contraindications to the use of the solution:

Severe arterial hypotension, cardiogenic shock, collapse;
Violations of intraventricular conduction (two- and three-beam blockade) in the absence of a permanent pacemaker;
Heart failure, arterial hypotension, cardiomyopathy or severe respiratory failure - for intravenous jet administration.

All of these contraindications should not be taken into account when performing cardioresuscitation in cardiac arrest against the background of ventricular fibrillation resistant to cardioversion.

Use during pregnancy and lactation

The use of amiodarone in pregnant women is possible with ventricular arrhythmias that pose a threat to the life of the mother, if the expected clinical effect outweighs the potential risk and danger to the fetus.

Cannot be used during lactation.

Instructions for use

The instructions for use indicate that Kordaron tablets are taken orally before meals and washed down with a sufficient amount of water. The drug should be taken only as prescribed by a doctor.

Loading ("saturation") dose: different schemes of saturation can be applied.
In the hospital: the initial dose, divided into several doses, ranges from 600-800 mg (up to a maximum of 1200 mg) / day until a total dose of 10 g is reached (usually within 5-8 days).
Outpatient: the initial dose, divided into several doses, is from 600 to 800 mg per day until a total dose of 10 g is reached (usually within 10-14 days).
Maintenance dose: May vary between patients from 100 to 400 mg/day. The minimum effective dose should be used in accordance with the individual therapeutic effect.

Because Kordaron has a very large T1 / 2, it can be taken every other day or take breaks in taking it 2 days a week.

The average therapeutic single dose is 200 mg.
The average therapeutic daily dose is 400 mg.
The maximum single dose is 400 mg.
The maximum daily dose is 1200 mg.

Side effects

During therapy, the development of disorders from some body systems is possible:

Digestive system: very rarely - nausea;
Endocrine system: with an unknown frequency - hyperthyroidism;
Musculoskeletal system: with an unknown frequency - pain in some parts of the spine (lumbar and lumbosacral);
Immune system: very rarely - anaphylactic shock; with an unknown frequency - angioedema (Quincke's edema);
Nervous system: very rarely - headache, benign intracranial hypertension (pseudotumor of the brain);
Skin and subcutaneous tissues: very rarely - increased sweating, a feeling of heat; with an unknown frequency - urticaria;
Local reactions: often - reactions at the injection site (infection, infiltration, erythema, pain, necrosis, edema, thrombophlebitis, pigmentation, extravasation, induration, inflammation, cellulitis, phlebitis).
Respiratory system: very rarely - cough, interstitial pneumonitis, shortness of breath, apnea and / or bronchospasm (in patients with severe respiratory failure, especially with bronchial asthma), acute respiratory distress syndrome (sometimes fatal);
Biliary tract and liver: very rarely - an isolated increase in the activity of hepatic transaminases in the blood serum (usually moderate, the excess of normal values by 1.5-3 times decreases with dose reduction or even spontaneously), acute liver damage (within 24 hours after administration of Kordaron) with jaundice and / or increased transaminases, including the development of liver failure, sometimes with a fatal outcome;
Cardiovascular system: often - bradycardia (usually a moderate decrease in heart rate), decrease blood pressure, usually transient and moderate (cases of collapse or severe arterial hypotension have been observed with too rapid administration of the drug or overdose); very rarely - an arrhythmogenic effect (the occurrence of new arrhythmias, including ventricular tachycardia "pirouette", or aggravation of existing ones, sometimes with subsequent cardiac arrest. These effects are mainly observed when Kordaron is used together with drugs that prolong the period of repolarization of the ventricles of the heart or with violations of the content in blood electrolytes); severe bradycardia or, in rare cases, sinus node arrest, which requires discontinuation of therapy, especially in patients with sinus node dysfunction and / or elderly patients, flushing of the skin of the face; with an unknown frequency - ventricular tachycardia of the pirouette type.

Overdose

When ingesting large doses of the drug, patients experience signs of an overdose, which are expressed in an increase in the above described side effects, the development of sinus bradycardia, up to cardiac arrest.

With the development of such symptoms or the accidental ingestion of a large dose of the drug, the patient should rinse the stomach as soon as possible, give activated charcoal or other sorbents to drink. Conducted if necessary symptomatic treatment. Hemodialysis is not effective, there is no specific antidote for the drug.

special instructions

Because Side effects of amiodarone are dose-dependent, patients should be treated with the minimum effective dose to minimize the possibility of their occurrence.

Patients should be advised to avoid direct sunlight or take protective measures (eg, sunscreen, appropriate clothing) during treatment.

Treatment monitoring

Before you start taking amiodarone, it is recommended to conduct an ECG study and determine the content of potassium in the blood. Hypokalemia must be corrected before amiodarone is started. During treatment, it is necessary to regularly monitor the ECG (every 3 months) and the activity of transaminases and other indicators of liver function.

In addition, due to the fact that amiodarone can cause hypothyroidism or hyperthyroidism, especially in patients with a history of thyroid disease, before taking amiodarone, a clinical and laboratory (serum TSH concentration determined using an ultrasensitive TSH test) examination should be performed for the subject of detection of dysfunction and diseases of the thyroid gland. During treatment with amiodarone and for several months after its discontinuation, the patient should be regularly examined for clinical or laboratory signs of changes in thyroid function. If thyroid dysfunction is suspected, serum TSH levels should be determined (using an ultrasensitive TSH test).

In patients receiving long-term treatment for arrhythmias, there have been reports of increased frequency of ventricular defibrillation and/or increased response threshold of a pacemaker or implanted defibrillator, which may reduce the effectiveness of these devices. Therefore, before starting or during treatment with amiodarone, they should be regularly checked for correct functioning.

Regardless of the presence or absence of pulmonary symptoms during treatment with amiodarone, it is recommended to conduct an x-ray examination of the lungs and pulmonary function tests every 6 months.

The occurrence of dyspnea or dry cough, either isolated or accompanied by deterioration in general condition (fatigue, weight loss, fever), may indicate pulmonary toxicity, such as interstitial pneumonitis, the suspicion of which requires a chest x-ray and pulmonary function tests. samples

Due to the prolongation of the period of repolarization of the ventricles of the heart, pharmachologic effect Kordaron drug causes certain ECG changes: prolongation of the QT interval, QTc (corrected), U waves may appear. An increase in the QTc interval of no more than 450 ms or no more than 25% of the initial value is acceptable. These changes are not a manifestation of the toxic effect of the drug, however, they require monitoring to adjust the dose and evaluate the possible proarrhythmic effect of Cordaron.

With the development of AV block II and III degree, sinoatrial block or bifascicular intraventricular block, treatment should be discontinued. If AV blockade of the 1st degree occurs, follow-up should be strengthened.

Although the occurrence of arrhythmia or worsening of existing rhythm disturbances, sometimes fatal, has been noted, the proarrhythmic effect of amiodarone is mild (less pronounced than that of most antiarrhythmic drugs) and usually manifests itself in the context of factors prolonging the length of the QT interval, such as interaction with other medicines and / or in violation of the content of electrolytes in the blood. Despite the ability of amiodarone to prolong the QT interval, it showed low activity in provoking ventricular tachycardia of the "pirouette" type.

Blurred vision or decreased visual acuity should promptly conduct an ophthalmological examination, including examination of the fundus. With the development of neuropathy or neuritis optic nerve caused by amiodarone, the drug must be discontinued due to the risk of blindness.

Since Kordaron contains iodine, its intake can disrupt the absorption of radioactive iodine and distort the results of a radioisotope study of the thyroid gland, however, taking the drug does not affect the reliability of determining the content of T3, T4 and TSH in blood plasma. Amiodarone inhibits the peripheral conversion of thyroxine (T4) to triiodothyronine (T3) and can cause isolated biochemical changes (increased serum free T4 concentration, with slightly reduced or even normal serum free T3 concentration) in clinically euthyroid patients, which is not a cause to cancel amiodarone.

The development of hypothyroidism can be suspected when the following clinical signs appear, usually mild: weight gain, cold intolerance, decreased activity, excessive bradycardia.

Before surgery, the anesthesiologist should be informed that the patient is taking Kordaron.

Long-term treatment with Kordaron may increase the hemodynamic risk inherent in local or general anesthesia. This applies in particular to its bradycardic and hypotensive effects, decreased cardiac output, and conduction disturbances.

In addition, in patients taking Kordaron, in rare cases, immediately after surgical intervention noted acute respiratory distress syndrome. With artificial ventilation of the lungs, such patients require careful monitoring.

Careful monitoring of liver function tests (determination of transaminase activity) is recommended before starting Cordaron and regularly during treatment with the drug. When taking Cordaron, acute liver dysfunction (including hepatocellular insufficiency or liver failure, sometimes fatal) and chronic liver damage are possible. Therefore, treatment with amiodarone should be discontinued with an increase in transaminase activity, 3 times the upper limit of the norm.

Clinical and laboratory signs of chronic liver failure when taking amiodarone orally may be minimally pronounced (hepatomegaly, increased transaminase activity, 5 times higher than ULN) and reversible after discontinuation of the drug, however, there have been cases of death due to liver damage.

drug interaction

Only the attending physician can determine the possibility of concomitant therapy, taking into account the condition and clinical indications of the patient.

Compound

Description of the dosage form

Tablets: round, white to off-white in color, with a break line on one side and a chamfer on both sides. There is an engraving: a symbol in the form of a heart above the fault line and 200 below the fault line and a bevel from the edges to the fault line.

Solution: transparent solution of light yellow color.

pharmachologic effect

pharmachologic effect- antiarrhythmic.

Pharmacodynamics

Amiodarone belongs to the III class of antiarrhythmic drugs (a class of repolarization inhibitors) and has a unique mechanism of antiarrhythmic action, tk. in addition to the properties of class III antiarrhythmics (potassium channel blockade), it has the effects of class I antiarrhythmics (sodium channel blockade), class IV antiarrhythmics (calcium channel blockade) and non-competitive beta-adrenergic blocking action.

In addition to antiarrhythmic action, it has antianginal, coronary dilating, alpha and beta adrenoblocking effects.

Antiarrhythmic properties:

An increase in the duration of the 3rd phase of the action potential of cardiomyocytes, mainly due to blocking the ion current in potassium channels (the effect of an antiarrhythmic class III according to the Vaughan-Williams classification);

Decreased automatism of the sinus node, leading to a decrease in heart rate;

Non-competitive blockade of alpha and beta adrenergic receptors;

Deceleration of sinoatrial, atrial and AV conduction, more pronounced with tachycardia;

No changes in ventricular conduction;

An increase in refractory periods and a decrease in the excitability of the myocardium of the atria and ventricles, as well as an increase in the refractory period of the AV node;

Slow conduction and an increase in the duration of the refractory period in additional bundles of atrioventricular conduction.

Other effects:

Absence of negative inotropic action when administered orally and parenterally;

Reducing myocardial oxygen consumption due to a moderate decrease in peripheral resistance and heart rate, as well as myocardial contractility due to beta-blocking action;

An increase in coronary blood flow due to a direct effect on the smooth muscles of the coronary arteries;

Maintenance of cardiac output by reducing pressure in the aorta and reducing peripheral resistance;

Influence on the metabolism of thyroid hormones: inhibition of the conversion of T 3 to T 4 (blockade of thyroxine-5-deiodinase) and blocking the capture of these hormones by cardiocytes and hepatocytes, leading to a weakening of the stimulating effect of thyroid hormones on the myocardium.

Recovery of cardiac activity in cardiac arrest caused by ventricular fibrillation resistant to cardioversion.

Therapeutic effects are observed on average one week after the start of the drug (from several days to two weeks). After stopping its intake, amiodarone is determined in the blood plasma for 9 months. The possibility of maintaining the pharmacodynamic action of amiodarone for 10-30 days after its withdrawal should be taken into account.

Pharmacokinetics

Bioavailability after oral administration in different patients ranges from 30 to 80% (the average value is about 50%). After a single dose of amiodarone, Cmax in plasma is reached after 3-7 hours. However, the therapeutic effect usually develops a week after the start of the drug (from several days to 2 weeks). Amiodarone is a slow-release, high-affinity drug.

Plasma protein binding is 95% (62% with albumin, 33.5% with beta-lipoproteins). Amiodarone has a large volume of distribution. During the first days of treatment, the drug accumulates in almost all tissues, especially in adipose tissue and in addition to it in the liver, lungs, spleen and cornea.

Amiodarone is metabolized in the liver by CYP3A 4 and CYP2C8 isoenzymes. Its main metabolite, deethylamiodarone, is pharmacologically active and may enhance the antiarrhythmic effect of the parent compound. Amiodarone and its active metabolite deethylamiodarone in vitro have the ability to inhibit isoenzymes CYP2C9, CYP2C19, CYP2D6, CYP3A4 , CYP2A6, CYP2B6 and CYP2C8. Amiodarone and deethylamiodarone have also shown the ability to inhibit several transporters such as P-glycoprotein (P-gp) and organic cation transporter (OC2). in vivo interaction of amiodarone with substrates of CYP3A4 isoenzymes was observed, CYP2C9, CYP2D6 and Pgp.

Removal of amiodarone begins after a few days, and the achievement of equilibrium between the intake and excretion of the drug (achievement of an equilibrium state) occurs after one to several months, depending on the individual characteristics of the patient. The main route of excretion of amiodarone is the intestine. Amiodarone and its metabolites are not excreted by hemodialysis. Amiodarone has a long T 1/2 with great individual variability (therefore, when selecting a dose, for example, increasing or decreasing it, it should be remembered that at least 1 month is needed to stabilize the new plasma concentration of amiodarone). Elimination by ingestion proceeds in 2 phases: initial T 1/2 (first phase) - 4-21 hours, T 1/2 in the 2nd phase - 25-110 days (20-100 days). After prolonged oral administration, the average T 1/2 is 40 days. After discontinuation of the drug, the complete elimination of amiodarone from the body can last for several months.

Each dose of amiodarone (200 mg) contains 75 mg of iodine. Part of the iodine is released from the drug and is found in the urine in the form of iodide (6 mg / day at a daily dose of amiodarone 200 mg). Most of the iodine remaining in the composition of the drug is excreted in the feces after passing through the liver, however, with prolonged use of amiodarone, iodine concentrations can reach 60-80% of the concentrations of amiodarone.

The peculiarities of the pharmacokinetics of the drug explain the use of "loading" doses, which is aimed at quickly achieving the required level of tissue saturation, at which its therapeutic effect is manifested.

Pharmacokinetics in renal failure: due to the insignificance of the excretion of the drug by the kidneys in patients with renal insufficiency, dose adjustment of amiodarone is not required.

With the on / in the introduction of Kordaron ®, its activity reaches a maximum after 15 minutes and disappears approximately 4 hours after administration. After the introduction of amiodarone, its concentration in the blood decreases rapidly due to the flow of the drug into the tissues. In the absence of repeated injections, the drug is gradually excreted. With the resumption of its intravenous administration or with the appointment of the drug inside, amiodarone accumulates in the tissues. Amiodarone has a large volume of distribution and can accumulate in almost all tissues, especially in adipose tissue and in addition to it in the liver, lungs, spleen and cornea

Amiodarone and its metabolites are not subject to dialysis.

It is mainly excreted with bile and feces through the intestines. Elimination of amiodarone is very slow. Amiodarone and its metabolites are determined in the blood plasma for 9 months after stopping treatment.

Indications for Kordaron ®

Tablets

Relapse prevention:

life-threatening ventricular arrhythmias, including ventricular tachycardia and ventricular fibrillation (treatment should be started in a hospital with careful cardiac monitoring);

supraventricular paroxysmal tachycardia: documented attacks of recurrent sustained supraventricular paroxysmal tachycardia in patients with organic heart disease; documented attacks of recurrent sustained supraventricular paroxysmal tachycardia in patients without organic heart disease, when antiarrhythmic drugs of other classes are not effective or there are contraindications to their use; documented attacks of recurrent sustained supraventricular paroxysmal tachycardia in patients with Wolff-Parkinson-White syndrome;

atrial fibrillation (atrial fibrillation) and atrial flutter.

prevention of sudden arrhythmic death in high-risk patients: after a recent myocardial infarction with more than 10 ventricular extrasystoles in 1 hour, clinical manifestations chronic heart failure and reduced left ventricular ejection fraction (less than 40%).

treatment of arrhythmias in patients with ischemic heart disease and / or impaired left ventricular function.

Injection form of Kordaron ®

relief of attacks of ventricular paroxysmal tachycardia; supraventricular paroxysmal tachycardia with a high frequency of ventricular contractions, especially against the background of Wolff-Parkinson-White syndrome; relief of paroxysmal and stable forms of atrial fibrillation (atrial fibrillation) and atrial flutter;

cardioresuscitation in cardiac arrest caused by defibrillation-resistant ventricular fibrillation.

Contraindications

Common for both dosage forms

hypersensitivity to iodine, amiodarone or excipients of the drug;

syndrome of weakness of the sinus node (sinus bradycardia, sinoatrial blockade), except in cases of correction by an artificial pacemaker (danger of "stopping" the sinus node).

AV blockade II-III degree, two- and three-beam blockade in the absence of an artificial pacemaker (pacemaker);

hypokalemia, hypomagnesemia;

combination with drugs that can prolong the QT interval and cause the development of paroxysmal tachycardia, including ventricular "pirouette" tachycardia (see "Interaction"):

Antiarrhythmics: class IA (quinidine, hydroquinidine, disopyramide procainamide); class III antiarrhythmic drugs (dofetilide, ibutilide, bretylium tosylate); sotalol;

Other (non-antiarrhythmic) drugs such as bepridil; vincamine; some neuroleptics: phenothiazines (chlorpromazine, cyamemazine, levomepromazine, thioridazine, trifluoperazine, fluphenazine), benzamides (amisulpride, sultopride, sulpride, tiapride, veraliprid), butyrophenones (droperidol, haloperidol), sertindole, pimozide; cisapride; tricyclic antidepressants; macrolide antibiotics (in particular erythromycin when administered intravenously, spiramycin); azoles; antimalarials (quinine, chloroquine, mefloquine, halofantrine); pentamidine when administered parenterally; diphemanil methyl sulfate; mizolastin; astemizole, terfenadine; fluoroquinolones.

congenital or acquired prolongation of the QT interval.

thyroid dysfunction (hypothyroidism, hyperthyroidism).

pregnancy (see "Use during pregnancy and lactation");

lactation period (see "Use during pregnancy and lactation");

age up to 18 years (efficacy and safety have not been established).

For tablets additionally: interstitial lung disease.

For the injection form additionally:

violations of intraventricular conduction (two- and three-beam blockades) in the absence of a permanent artificial pacemaker (pacemaker) - in these cases, intravenous amiodarone can be used in specialized departments under the cover of an artificial pacemaker (pacemaker);

severe arterial hypotension, collapse, cardiogenic shock;

intravenous jet administration is contraindicated in case of arterial hypotension, severe respiratory failure, cardiomyopathy or heart failure (these conditions may be aggravated).

All of the above contraindications do not apply to the use of Kordaron ® during cardioresuscitation in cardiac arrest caused by ventricular fibrillation resistant to cardioversion.

Carefully use for arterial hypotension, decompensated or severe chronic (III-IV FC according to NYHA classification) heart failure, liver failure, bronchial asthma, severe respiratory failure, in elderly patients ( high risk development of severe bradycardia), with AV blockade of the first degree.

Use during pregnancy and lactation

Pregnancy

The currently available clinical information is insufficient to determine whether or not fetal malformations may or may not occur when using amiodarone in the first trimester of pregnancy.

Since the fetal thyroid begins to bind iodine only from the 14th week of pregnancy, it is not expected to be affected by amiodarone if it is used earlier. Excess iodine when using the drug after this period can lead to the appearance of laboratory symptoms of hypothyroidism in the newborn or even to the formation of a clinically significant goiter in him.

Due to the effect of the drug on the thyroid gland of the fetus, amiodarone is contraindicated during pregnancy, except in special cases when the expected benefit outweighs the risk (with life-threatening ventricular arrhythmias).

lactation period

Amiodarone is excreted in breast milk in significant amounts, so it is contraindicated during lactation (therefore, during this period, the drug should be discontinued or breastfeeding should be stopped).

Side effects

The frequency of side effects was defined as follows: very often - ≥10%), often - ≥1%,<10; нечасто — ≥0,1%, <1%; редко — ≥0,01%, <0,1% и очень редко, включая отдельные сообщения — <0,01%, частота не известна (по имеющимся данным частоту определить нельзя).

Tablets.

often - moderate bradycardia, the severity of which depends on the dose of the drug. Infrequently - conduction disturbances (sinoatrial blockade, AV blockade of various degrees); arrhythmogenic effect (there are reports of the occurrence of new arrhythmias or aggravation of existing ones, in some cases with subsequent cardiac arrest). In the light of the available data, it is impossible to determine whether this is a consequence of the use of the drug, or is associated with the severity of cardiac damage, or is a consequence of treatment failure. These effects are observed mainly in cases of application of Cordaron ® together with drugs that prolong the period of repolarization of the ventricles of the heart (QTc interval) or in violation of the electrolyte balance (see "Interaction"). Very rarely - severe bradycardia or, in exceptional cases, stop the sinus node, which were observed in some patients (patients with dysfunction of the sinus node and elderly patients). The frequency is not known - the progression of chronic heart failure (with prolonged use).

very often - nausea, vomiting, loss of appetite, dullness or loss of taste sensations, a feeling of heaviness in the epigastrium, especially at the beginning of treatment; passing after dose reduction; an isolated increase in serum transaminase activity, usually moderate (1.5-3-fold excess of normal values) and decreasing with dose reduction or even spontaneously. Often - acute liver damage with increased transaminases and / or jaundice, including the development of liver failure, sometimes fatal (see "Special Instructions"). Very rarely - chronic liver disease (pseudo-alcoholic hepatitis, cirrhosis), sometimes fatal. Even with a moderate increase in the activity of transaminases in the blood, observed after treatment that lasted more than 6 months, chronic liver damage should be suspected.

often - cases of development of interstitial or alveolar pneumonitis and obliterating bronchiolitis with pneumonia, sometimes ending in death, have been reported. Several cases of pleurisy have been noted. These changes can lead to the development of pulmonary fibrosis, but they are generally reversible with early withdrawal of amiodarone with or without corticosteroids. Clinical manifestations usually disappear within 3-4 weeks. Recovery of the x-ray picture and lung function occurs more slowly (several months). The appearance in a patient receiving amiodarone of severe shortness of breath or dry cough, both accompanied and not accompanied by a deterioration in the general condition (fatigue, weight loss, fever) requires a chest x-ray and, if necessary, discontinuation of the drug. Very rarely - bronchospasm in patients with severe respiratory failure, especially in patients with bronchial asthma; acute respiratory distress syndrome, sometimes fatal and sometimes immediately after surgical interventions (possible interaction with high doses of oxygen) (see "Special Instructions"). The frequency is not known - pulmonary hemorrhage.

From the sense organs: very often - microdeposits in the corneal epithelium, consisting of complex lipids, including lipofuscin, they are usually limited to the pupil area and do not require discontinuation of treatment and disappear after discontinuation of the drug. Sometimes they can cause visual disturbances in the form of the appearance of a colored halo or fuzzy contours in bright light. Very rare - A few cases of optic neuritis/optic neuropathy have been described. Their association with amiodarone has not yet been established. However, since optic neuritis can lead to blindness, if blurred vision or reduced visual acuity occurs while taking Cordarone ® , it is recommended to conduct a complete ophthalmological examination, including fundoscopy, and if optic neuritis is detected, stop taking amiodarone.

Endocrine disorders: often - hypothyroidism with its classic manifestations: weight gain, chilliness, apathy, decreased activity, drowsiness, excessive bradycardia compared to the expected effect of amiodarone. The diagnosis is confirmed by the detection of an elevated serum TSH level. Normalization of thyroid function is usually observed within 1-3 months after discontinuation of treatment. In life-threatening situations, treatment with amiodarone can be continued, with simultaneous additional administration of L-thyroxine under the control of serum TSH levels. Hyperthyroidism, the appearance of which is possible during and after treatment (cases of hyperthyroidism that developed several months after the withdrawal of amiodarone have been described). Hyperthyroidism is more insidious with few symptoms: slight unexplained weight loss, decreased antiarrhythmic and/or antianginal efficacy; mental disorders in elderly patients or even thyrotoxicosis phenomena. The diagnosis is confirmed by the detection of a reduced serum TSH level (supersensitive criterion). If hyperthyroidism is detected, amiodarone should be discontinued. Normalization of thyroid function usually occurs within a few months after discontinuation of the drug. At the same time, clinical symptoms normalize earlier (after 3-4 weeks) than normalization of the level of thyroid hormones occurs. Severe cases can be fatal, so in such cases, urgent medical attention is required. Treatment in each case is selected individually. If the patient's condition worsens, either due to thyrotoxicosis itself or due to a dangerous imbalance between myocardial oxygen demand and its delivery, it is recommended to immediately begin treatment with corticosteroids (1 mg / kg), continuing it for a sufficiently long time (3 months), instead of the use of synthetic antithyroid drugs, which may not always be effective in this case. Very rarely - a syndrome of impaired secretion of antidiuretic hormone.

From the side of the skin: very often - photosensitivity. Often - in the case of prolonged use of the drug in high daily doses, grayish or bluish pigmentation of the skin may be observed; after stopping treatment, this pigmentation slowly disappears. Very rarely - during radiation therapy, there may be cases of erythema, there are reports of skin rash, usually of low specificity, isolated cases of exfoliative dermatitis (the relationship with the drug has not been established); alopecia.

From the side of the central nervous system: often - tremor or other extrapyramidal symptoms; sleep disorders, incl. nightmares. Rarely - sensorimotor, motor and mixed peripheral neuropathies and / or myopathy, usually reversible after discontinuation of the drug. Very rarely - cerebellar ataxia, benign intracranial hypertension (pseudotumor of the brain), headache.

Others: very rarely - vasculitis, epididymitis, several cases of impotence (the relationship with the drug has not been established), thrombocytopenia, hemolytic anemia, aplastic anemia.

Injection

From the side of the cardiovascular system: often - bradycardia (usually a moderate decrease in heart rate); decrease in blood pressure, usually moderate and transient. Cases of severe arterial hypotension or collapse were observed with an overdose or too rapid administration of the drug. Very rarely - a proarrhythmic effect (there are reports of the occurrence of new arrhythmias, including polymorphic ventricular tachycardia of the "pirouette" type, or aggravation of existing ones - in some cases with subsequent cardiac arrest). These effects are observed mainly in cases of application of Kordaron ® in conjunction with drugs that prolong the period of repolarization of the ventricles of the heart (QT interval s) or in violation of the electrolyte balance (see "Interaction"). In the light of the available data, it is impossible to determine whether the occurrence of these arrhythmias is caused by Kordaron ® , or is associated with the severity of cardiac pathology, or is a consequence of treatment failure. Severe bradycardia or, in exceptional cases, sinus arrest, which have been observed in some patients (patients with sinus node dysfunction and elderly patients), flushing of the skin of the face, progression of heart failure (possibly with intravenous jet administration).

From the respiratory system: very rarely - cough, shortness of breath, interstitial pneumonitis; bronchospasm and / or apnea in patients with severe respiratory failure, especially in patients with bronchial asthma; acute respiratory distress syndrome, sometimes fatal and sometimes immediately after surgical interventions (possible interaction with high oxygen concentrations) (see "Special Instructions").

From the digestive system: very often - nausea. Very rarely - an isolated increase in the activity of hepatic transaminases in the blood serum, usually moderate (1.5-3-fold excess of normal values) and decreasing with dose reduction or even spontaneously. Acute liver damage (within 24 hours after the administration of amiodarone) with an increase in transaminases and / or jaundice, including the development of liver failure, sometimes fatal (see "Special Instructions").

From the side of the skin: very rarely - a feeling of heat, increased sweating.

From the side of the central nervous system: very rarely - benign intracranial hypertension (pseudotumor of the brain), headache.

Immune system disorders: very rarely - anaphylactic shock. Unknown frequency - angioedema.

Reactions at the injection site: often - inflammatory reactions, such as superficial phlebitis, when injected directly into a peripheral vein. Injection site reactions such as: pain, erythema, edema, necrosis, extravasation, infiltration, inflammation, induration, thrombophlebitis, phlebitis, cellulitis, infection, pigmentation.

Interaction

Drugs that can cause torsades de pointes or prolong the QT interval

Drugs that can cause ventricular "pirouette" tachycardia. Combination therapy with drugs that can cause ventricular "pirouette" tachycardia is contraindicated, as it increases the risk of potentially fatal ventricular "pirouette" tachycardia.

Antiarrhythmic drugs: Class IA (quinidine, hydroquinidine, disopyramide, procainamide), sotalol, bepridil.

Other (non-antiarrhythmic) drugs: vincamine; some antipsychotics - phenothiazines (chlorpromazine, cyamemazine, levomepromazine, thioridazine, trifluoperazine, fluphenazine), benzamides (amisulpride, sultopride, sulpride, tiapride, veraliprid), butyrophenones (droperidol, haloperidol), sertindole, pimozide; tricyclic antidepressants; cisapride; macrolide antibiotics (erythromycin with intravenous administration, spiramycin); azoles; antimalarials (quinine, chloroquine, mefloquine, halofantrine, lumefantrine); pentamidine when administered parenterally; diphemanil methyl sulfate; mizolastin; astemizole; terfenadine.

Drugs capable of prolonging the QT interval. Co-administration of amiodarone with drugs that can prolong the QT interval should be based on a careful assessment for each patient of the ratio of expected benefit and potential risk (the possibility of an increased risk of developing ventricular torsades de pointes). When using such combinations, constant monitoring of the ECG (to detect prolongation of the QT interval), the content of potassium and magnesium in the blood is necessary.

In patients taking amiodarone, the use of fluoroquinolones, including moxifloxacin, should be avoided.

Drugs that decrease heart rate or cause disturbances in automatism or conduction

Combination therapy with these drugs is not recommended.

Beta-blockers, CCBs that reduce heart rate (verapamil, diltiazem) can cause disturbances in automatism (development of excessive bradycardia) and conduction.

Drugs that can cause hypokalemia

Not recommended combinations. With laxatives that stimulate intestinal motility, capable of causing hypokalemia, which increases the risk of developing ventricular "pirouette" tachycardia. When combined with amiodarone, laxatives of other groups should be used.

Combinations requiring caution when using. With diuretics that cause hypokalemia (in monotherapy or in combination with other drugs); systemic corticosteroids (GCS, mineralocorticosteroids), tetracosactide; amphotericin B (in / in the introduction).

It is necessary to prevent the development of hypoglycemia, and in case of its occurrence, restore the potassium content in the blood to a normal level, monitor the concentration of electrolytes in the blood and ECG (for possible prolongation of the QT interval), in case of ventricular "pirouette" tachycardia, antiarrhythmic drugs should not be used (should ventricular pacing should be started; possibly intravenous administration of magnesium salts).

Preparations for inhalation anesthesia

It was reported about the possibility of developing the following severe complications in patients receiving amiodarone, when they received general anesthesia: bradycardia (resistant to the administration of atropine), arterial hypotension, conduction disturbance, decreased cardiac output.

Very rare cases of severe complications from the respiratory system, sometimes fatal, have been observed - acute respiratory distress syndrome in adults, which developed immediately after surgery, the occurrence of which is associated with high oxygen concentrations.

Drugs that slow down the heart rate

Clonidine, guanfacine, cholinesterase inhibitors (donepezil, galantamine, rivastigmine, tacrine, ambenonium chloride, pyridostigmine bromide, neostigmine bromide), pilocarpine - risk of developing excessive bradycardia (cumulative effects).

Dosage and administration

Tablets.

inside before meals with plenty of water. The drug should be taken only as prescribed by a doctor!

Loading ("saturating") dose: various saturation schemes can be used.

In the hospital: the initial dose, divided into several doses, ranges from 600-800 mg (up to a maximum of 1200 mg) per day until a total dose of 10 g is reached (usually within 5-8 days).

Outpatient: the initial dose, divided into several doses, ranges from 600 to 800 mg per day until a total dose of 10 g is reached (usually within 10-14 days).

Maintenance dose: may vary in different patients from 100 to 400 mg / day. The minimum effective dose should be used according to the individual therapeutic outcome.

Since Kordaron ® has a very long half-life, it can be taken every other day or take breaks in taking it 2 days a week.

The average therapeutic single dose is 200 mg. The average therapeutic daily dose is 400 mg. The maximum single dose is 400 mg. The maximum daily dose is 1200 mg.

Injection.

In / in the introduction: Kordaron ® (injection form) is intended for use in cases where a rapid achievement of an antiarrhythmic effect is required, or if the drug cannot be taken orally.

With the exception of urgent clinical situations, the drug should only be used in a hospital in an intensive care unit under constant monitoring of ECG and blood pressure!

When administered intravenously, Kordaron ® should not be mixed with other drugs. Do not inject other drugs into the same line of the infusion system as Kordaron ®. Use diluted only. To dilute the drug Kordaron ®, only 5% dextrose (glucose) solution should be used. Due to the peculiarities of the dosage form of the drug, it is not recommended to use the concentration of the infusion solution less than that obtained by diluting 2 ampoules in 500 ml of 5% dextrose (glucose).

Amiodarone should be administered via a central venous catheter to avoid injection site reactions, except in cases of cardioversion-resistant ventricular fibrillation, when, in the absence of central venous access, peripheral veins (the largest peripheral vein with maximum blood flow) can be used to administer the drug. ) (see "Special Instructions").

Severe cardiac arrhythmias, in cases where it is impossible to take the drug orally (with the exception of cases of cardioresuscitation during cardiac arrest caused by ventricular fibrillation resistant to cardioversion).

Intravenous drip through a central venous catheter

The usual loading dose is 5 mg/kg in 250 ml of 5% dextrose (glucose) solution, administered using an electronic pump, if possible, over 20-120 minutes. It can be re-introduced 2-3 times within 24 hours. The rate of administration of the drug is adjusted depending on the clinical effect. The therapeutic effect appears during the first minutes of administration and gradually decreases after the cessation of the infusion, therefore, if it is necessary to continue treatment with injectable Kordaron ®, it is recommended to switch to continuous intravenous drip administration of the drug.

maintenance doses: 10-20 mg / kg / day (usually 600-800 mg, but can be increased to 1200 mg / day) in 250 ml of 5% dextrose (glucose) solution and for several days. From the first day of infusion, a gradual transition to taking Kordaron ® inside (3 tablets, 200 mg per day) should begin. The dose can be increased to 4 or even 5 tablets. 200 mg per day.

Cardiac resuscitation in cardiac arrest caused by ventricular fibrillation resistant to cardioversion

Intravenous jet administration (see "Special Instructions")

The first dose is 300 mg (or 5 mg / kg) cordarone, after dilution in 20 ml of a 5% dextrose (glucose) solution and is administered intravenously (stream).

If fibrillation is not stopped, then additional intravenous jet administration of Cordarone ® at a dose of 150 mg (or 2.5 mg/kg) is possible.

Overdose

Symptoms: Very high oral doses have reported several cases of sinus bradycardia, cardiac arrest, ventricular tachycardia, torsades de pointes, and liver injury. It is possible to slow down the atrioventricular conduction, increase the already existing heart failure.

Treatment: symptomatic (gastric lavage, administration of activated charcoal (if the drug has been taken recently), in other cases, symptomatic therapy is carried out: for bradycardia - beta-adrenergic stimulators or the installation of a pacemaker, for pirouette-type tachycardia - intravenous administration of magnesium salts or cardiac stimulation. Neither amiodarone nor its metabolites are removed by hemodialysis.There is no specific antidote.

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

special instructions

Tablets

Since the side effects of amiodarone are dose-dependent, patients should be treated with the minimum effective dose to minimize the possibility of their occurrence.

Patients should be warned to avoid direct sunlight during treatment or to take protective measures (eg, use of sunscreen, wearing appropriate clothing).

Treatment monitoring

Before you start taking amiodarone, it is recommended to conduct an ECG study and determine the level of potassium in the blood. Hypokalemia must be corrected before amiodarone is started. During treatment, it is necessary to regularly monitor the ECG (every 3 months), the level of transaminases and other indicators of liver function.

In addition, due to the fact that amiodarone can cause hypothyroidism or hyperthyroidism, especially in patients with a history of thyroid disease, before taking amiodarone, a clinical and laboratory (TSH) examination should be performed to detect dysfunction and diseases of the thyroid gland. During treatment with amiodarone and for several months after its discontinuation, the patient should be regularly examined for clinical or laboratory signs of changes in thyroid function. If you suspect a violation of the thyroid gland, it is necessary to determine the level of TSH in the blood serum.

In patients receiving long-term treatment for arrhythmias, cases of an increase in the frequency of ventricular fibrillation and / or an increase in the response threshold of a pacemaker or implanted defibrillator have been reported, which may reduce their effectiveness. Therefore, before starting or during treatment with amiodarone, the correct functioning of these devices should be checked regularly.

The appearance of dyspnea or dry cough, either isolated or accompanied by a deterioration in the general condition, should indicate the possibility of pulmonary toxicity, such as interstitial pneumopathy, the suspicion of which requires an x-ray examination of the lungs and pulmonary function tests.

Due to the prolongation of the period of repolarization of the ventricles of the heart, the pharmacological action of Kordaron ® causes certain changes in the ECG: prolongation of the QT interval, QT c (corrected), U waves may appear. An increase in the QT c interval of no more than 450 ms or no more than 25% of the initial value is acceptable . These changes are not a manifestation of the toxic effect of the drug, but require monitoring for dose adjustment and evaluation of the possible proarrhythmic effect of Kordaron ® .

With the development of AV block II and III degree, sinoatrial block or bifascicular intraventricular block, treatment should be discontinued. If AV blockade of the first degree occurs, follow-up should be strengthened.

Although the occurrence of arrhythmia or worsening of existing rhythm disturbances has been noted, it should be noted that the proarrhythmic effect of amiodarone is weak and usually manifests itself in combination with certain drugs or in electrolyte imbalance.

If vision is blurred or visual acuity is reduced, an ophthalmological examination, including an examination of the fundus, should be performed. With the development of neuropathy or optic neuritis caused by amiodarone, the drug must be discontinued due to the risk of blindness.

Since Kordaron ® contains iodine, its administration may distort the results of a radioisotope study of the thyroid gland, but does not affect the reliability of determining the content of T 3 , T 4 and TSH in blood plasma.

Before surgery, the anesthesiologist should be informed that the patient is receiving Kordaron ® .

Prolonged treatment with Kordaron ® may increase the hemodynamic risk inherent in local or general anesthesia. This applies in particular to its bradycardic and hypotensive effects, decreased cardiac output, and conduction disturbances.

In addition, acute respiratory distress syndrome was noted in patients receiving Kordaron ® in rare cases immediately after surgery. With artificial ventilation of the lungs, such patients require careful monitoring.

Injection

In / in the jet injection should be carried out only in urgent cases with the ineffectiveness of other types of treatment and only in the intensive care unit under constant monitoring of ECG, blood pressure. The dose is 5 mg/kg. Except in cases of cardioresuscitation in defibrillation-resistant ventricular fibrillation, intravenous bolus administration of amiodarone should be carried out for at least 3 minutes. Repeated administration of amiodarone should not be carried out earlier than 15 minutes after the first injection, even if the contents of only one ampoule were administered during the first injection (the possibility of irreversible collapse).

If there is a need to continue the administration of amiodarone, it should be administered as an infusion.

In order to avoid the occurrence of reactions at the injection site (see "Side Effects"), it is recommended to administer the injection form of Cordarone ® through a central venous catheter. Only in the case of cardioresuscitation during cardiac arrest caused by ventricular fibrillation resistant to cardioversion, in the absence of central venous access (absence of an installed central venous catheter), the injection form of Kordaron ® can be injected into a large peripheral vein with maximum blood flow.

If, after cardioresuscitation, treatment with Kordaron ® should continue, then the drug should be administered intravenously through a central venous catheter under constant monitoring of blood pressure and ECG.

Kordaron ® must not be mixed in the same syringe or dropper with other drugs .

In connection with the possibility of developing interstitial pneumonitis, when severe shortness of breath or dry cough appears after the administration of Kordaron ®, both accompanied and not accompanied by a deterioration in the general condition (fatigue, fever), it is required to conduct a chest x-ray and, if necessary, cancel the drug, t .to. interstitial pneumonitis can lead to the development of pulmonary fibrosis. However, these effects are generally reversible with early withdrawal of amiodarone with or without corticosteroids. Clinical manifestations usually disappear within 3-4 weeks. Recovery of the x-ray picture and lung function occurs more slowly (several months).

After artificial ventilation of the lungs (for example, when bringing surgical interventions) in patients who were administered Kordaron ®, there were rare cases of the development of acute respiratory distress syndrome, sometimes fatal (possible interaction with high doses of oxygen) (see "Side effect"). Therefore, it is recommended to exercise strict monitoring of the condition of such patients.

During the first days after the start of the use of the injectable form of Kordaron ®, severe acute liver damage may develop with the development of liver failure, sometimes with a fatal outcome. Regular monitoring of liver function is recommended during treatment with Kordaron ® .

General anesthesia

Before surgery, the anesthesiologist should be informed that the patient is receiving Kordaron ® . Treatment with Kordaron ® may increase the hemodynamic risk inherent in local or general anesthesia. This applies in particular to its bradycardic and hypotensive effects, decreased cardiac output, and conduction disturbances.

Combinations with beta-blockers other than sotalol (a contraindicated combination) and esmolol (a combination requiring special care when using), verapamil and diltiazem should only be considered in the context of the prevention of life-threatening ventricular arrhythmias and in the event of cardiac recovery in cardiac arrest caused by fibrillation ventricles resistant to cardioversion.

Electrolyte disorders, especially hypokalemia: it is important to take into account situations that may be accompanied by hypokalemia as predisposing to proarrhythmic phenomena. Hypokalemia must be corrected prior to the start of Kordaron ® .

Side effects of the drug (see "Side Effects") usually depend on the dose; therefore, care should be taken when determining the minimum effective maintenance dose in order to avoid or minimize the occurrence of undesirable effects.

Amiodarone may cause thyroid dysfunction, especially in patients with thyroid dysfunction in their own or family history. Therefore, in the case of switching to taking Kordaron ® orally, during treatment and several months after the end of treatment, careful clinical and laboratory monitoring should be carried out. If thyroid dysfunction is suspected, serum TSH levels should be determined.

The safety and efficacy of amiodarone have not been studied in children. Ampoules of injectable Kordaron ® contain benzyl alcohol. Acute choking with fatal outcome has been reported in neonates following intravenous administration of solutions containing benzyl alcohol.

Influence on the ability to drive a car and other mechanisms. During the period of treatment with Kordaron ®, one should refrain from driving a car and engaging in potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions.

Release form

Tablets, 200 mg. In a blister 10 pcs.; in a pack of cardboard 3 blisters.

Solution for intravenous administration. In ampoules of 3 ml; in a box of 6 pcs.

Manufacturer

Sanofi Winthrop Industria, 1, rue de la Vierge, Ambarès e Lagrave, 33565 Carbon Blanc, France.

HINOIN Plant of Pharmaceutical and Chemical Products CJSC st. Levai, 5, 2112, Veresgyhaz, Hungary.

Terms of dispensing from pharmacies

On prescription.

Storage conditions of the drug Kordaron ®

At a temperature not higher than 30 °C.

Keep out of the reach of children.

Shelf life of Cordaron ®

solution for intravenous administration 50 mg / ml - 2 years.

200 mg tablets - 3 years.

Do not use after the expiry date stated on the packaging.

Synonyms of nosological groups

Category ICD-10	Synonyms of diseases according to ICD-10
I47.1 Supraventricular tachycardia	Supraventricular paroxysmal tachycardia
	Supraventricular tachyarrhythmia
	Supraventricular tachycardia
	Supraventricular arrhythmias
	Supraventricular paroxysmal tachycardia
	Supraventricular tachyarrhythmias
	Supraventricular tachycardia
	Neurogenic sinus tachycardia
	orthodromic tachycardias
	Paroxysmal supraventricular tachycardia
	Paroxysm of supraventricular tachycardia
	Paroxysm of supraventricular tachycardia in WPW syndrome
	Paroxysm of atrial tachycardia
	Paroxysmal supraventricular tachyarrhythmia
	Paroxysmal supraventricular tachycardia
	Polytopic atrial tachycardia
	Atrial arrhythmia
	Atrial true tachycardia
	Atrial tachycardia
	Atrial tachycardia with AV block
	Reperfusion arrhythmia
	Berzold-Yarish reflex
	Recurrent sustained supraventricular paroxysmal tachycardia
	Symptomatic ventricular tachycardias
	Wolff-Parkinson-White Syndrome
	Sinus tachycardia
	Supraventricular paroxysmal tachycardia
	Supraventricular tachyarrhythmia
	Supraventricular tachycardia
	Supraventricular extrasystole
	Supraventricular arrhythmias
	Tachycardia from the AV junction
	Supraventricular tachycardia
	Tachycardia orthodromic
	Sinus tachycardia
	Nodal tachycardia
	Chaotic polytopic atrial tachycardia
I47.2 Ventricular tachycardia	Ventricular arrhythmia
	Ventricular paroxysmal tachycardia
	Ventricular tachyarrhythmia
	Ventricular tachycardia
	Paroxysmal bidirectional fusiform ventricular tachycardia
	Paroxysmal ventricular tachycardia
	Pirouette tachycardia (torsade de pointes)
	Pirouette tachycardia in myocardial infarction
	Symptomatic ventricular tachycardia
	Ventricular tachycardia
	Life-threatening ventricular arrhythmia
	Sustained ventricular tachycardia
	Sustained monomorphic ventricular tachycardia
I48 Atrial fibrillation and flutter	Relief of a frequent ventricular rhythm with atrial fibrillation or flutter
	Atrial fibrillation
	supraventricular arrhythmia
	Paroxysm of atrial fibrillation and flutter
	Paroxysm of atrial fibrillation
	Paroxysmal form of atrial fibrillation and flutter
	Paroxysmal atrial fibrillation and flutter
	Paroxysmal atrial fibrillation
	Permanent form of atrial tachyarrhythmia
	Atrial extrasystole
	Atrial extrasystoles
	Tachyarrhythmic form of atrial fibrillation
	Tachysystolic form of atrial fibrillation
	atrial flutter

	Atrial fibrillation
	Chronic atrial fibrillation
I49.0 Ventricular fibrillation and flutter	Ventricular fibrillation

	ventricular flutter
	Life-threatening ventricular fibrillation
	ventricular fibrillation
I49.3 Premature ventricular depolarization	Arrhythmia ventricular
	Asynergy of the ventricles of the heart
	Asynergy of the left ventricle
	Severe ventricular extrasystoles
	Ventricular arrhythmia
	Ventricular extrasystole
	Ventricular extrasystole
	Ventricular arrhythmias
	Ventricular extrasystoles
	Paroxysmal ventricular extrasystole
	Recurrent ventricular arrhythmias
	Extrasystole ventricular
I49.8 Other specified cardiac arrhythmias	Arrhythmia atrial
	Arrhythmia atrial fibrillation paroxysmal
	Atrial fibrillation tachysystolic
	Sinus arrhythmia
	Asynergy of the ventricles of the heart
	Asynergy of the left ventricle
	bigeminia
	Corrigan's pulse
	Atrial fibrillation
	Atrial tachyarrhythmia
	Migration of the supraventricular pacemaker
	Orthostatic heart rate changes
	Sinoatrial node failure
	Paradoxical pulse
	Paroxysm of atrial fibrillation
	Paroxysmal atrial fibrillation
	Paroxysmal arrhythmia
	Paroxysmal atrioventricular rhythm
	Romano-Ward syndrome
	trigeminy
I51.9 Heart disease, unspecified	Heart diseases
	Cardiac decompensation
	heart disease
	Non-atherosclerotic coronary artery disease
	Fainting in heart disease
	organic heart disease
	Acute decompensated heart failure
	Acquired heart disease
	Heart attack
	chronic heart disease

Cordarone is an antiarrhythmic drug.

Release form and composition

Dosage forms:

Tablets are divisible: from white with a creamy tint to white, round in shape with a chamfer on both sides, a bevel from the edges to the fault line on one of the sides and engraving: above the separating risk - a symbol in the form of a heart, under the risk - the number 200 (10 pieces in blisters, in a cardboard bundle 3 blisters);
Solution for intravenous (in / in) administration: a clear liquid of light yellow color (3 ml in ampoules, 6 pcs in a box).

The active substance is amiodarone hydrochloride:

1 tablet - 200 mg;
1 ml of solution - 50 mg.

Auxiliary components:

Tablets: corn starch, lactose monohydrate, magnesium stearate, anhydrous colloidal silicon dioxide, povidone K90F;
Solution: benzyl alcohol, polysorbate 80, water for injection.

Indications for use

The use of Kordaron in the form of tablets is indicated for the prevention of relapses:

Supraventricular paroxysmal tachycardia: attacks of recurrent sustained supraventricular paroxysmal tachycardia, fixed in patients with organic heart disease; attacks of recurrent sustained supraventricular paroxysmal tachycardia, fixed in patients without organic heart disease (with the ineffectiveness of antiarrhythmic drugs of other classes or contraindications to their use); attacks of recurrent sustained supraventricular paroxysmal tachycardia, fixed in patients with Wolff-Parkinson-White syndrome;
Ventricular arrhythmias that pose a threat to the life of the patient, including ventricular tachycardia and ventricular fibrillation (during inpatient treatment with careful cardiac monitoring);
Atrial fibrillation (atrial fibrillation) and atrial flutter.

In addition, tablets are prescribed for the treatment of patients with arrhythmias against the background of impaired left ventricular function and / or coronary heart disease (CHD).

Tablets are taken to prevent sudden arrhythmic death in patients who have recently had a myocardial infarction, who have clinical manifestations of chronic heart failure or more than 10 ventricular extrasystoles in 1 hour and a reduced left ventricular ejection fraction (less than 40%).

The use of the drug in the form of a solution is indicated for the relief of attacks of ventricular paroxysmal tachycardia, supraventricular paroxysmal tachycardia with a high frequency of ventricular contractions (especially in Wolff-Parkinson-White syndrome), a stable and paroxysmal form of atrial fibrillation (atrial fibrillation) and atrial flutter.

Cordarone injections are also used for cardiac resuscitation during cardiac arrest, against the background of defibrillation-resistant ventricular fibrillation.

Contraindications

Contraindications to the use of tablets and solution:

Age up to 18 years;
Atrioventricular (AV) blockade II and III degree, two- and three-beam blockade in patients without a pacemaker;
Sinus node weakness syndrome (sinoatrial blockade, sinus bradycardia), except in cases of correction by an artificial pacemaker (pacemaker);
Simultaneous use with agents that prolong the QT interval and cause the development of paroxysmal tachycardia, including ventricular "pirouette" tachycardia: class IA antiarrhythmic drugs (hydroquinidine, quinidine, procainamide, disopyramide) and class III (bretylium tosylate, ibutilide, dofetilide), sotalol; other non-antiarrhythmic drugs: vincamine, bepridil, phenothiazines (fluphenazine, cyamemazine, chlorpromazine, levomepromazine, trifluoperazine, thioridazine), benzamides (sultopride, amisulpride, sulpride, veraliprid, tiapride), pimozide, butyrophenones (haloperidol, droperidol), sertindole, cisapride, tricyclic antidepressants, azoles, macrolide antibiotics (including spiramycin, erythromycin when administered intravenously), antimalarials (chloroquine, halofantrine, quinine, mefloquine), diphemanil methyl sulfate, pentamidine only when administered parenterally, mizolastine, fluoroquinolones, astemizole and terfenadine;
Hypomagnesemia, hypokalemia;
Prolongation of the QT interval, including congenital;
The period of pregnancy and breastfeeding;
Thyroid dysfunction (hyperthyroidism, hypothyroidism);
Hypersensitivity to the components of the drug and to iodine.

Cordarone should be administered with caution to patients with AV blockade of the 1st degree, arterial hypotension, severe chronic (III-IV functional class according to the NYHA classification) or decompensated heart failure, liver failure, bronchial asthma, severe respiratory failure and elderly patients.

Tablets should not be taken with interstitial lung disease.

Additional contraindications to the use of the solution:

Severe arterial hypotension, cardiogenic shock, collapse;
Violations of intraventricular conduction (two- and three-beam blockade) in the absence of a permanent pacemaker;
Heart failure, arterial hypotension, cardiomyopathy or severe respiratory failure - for intravenous jet administration.

All of these contraindications should not be taken into account when performing cardioresuscitation in cardiac arrest against the background of ventricular fibrillation resistant to cardioversion.

Method of application and dosage

Tablets: orally, before meals, with a small amount of water. Dosing is prescribed by the doctor based on clinical indications and the patient's condition. The loading dose in a hospital is increased, starting with a daily dose of 0.6-0.8 g (up to 1.2 g) divided into several doses, until a total dose of 10 g is reached after 5-8 days of admission; outpatient saturation up to 10 g is performed within 10-14 days at a daily dose of 0.6-0.8 g. The maintenance dose should be the minimum effective, selected individually, can range from 0.1 to 0.4 g per day. The average therapeutic single dose is 0.2 g, the daily dose is 0.4 g. The maximum single dose is 0.4 g, the daily dose is 1.2 g. Tablets can be taken every other day or with a break in taking 2 days a week;
Solution for injection: intended for intravenous administration to achieve a rapid antiarrhythmic effect or when it is impossible to take the drug orally. In addition to special emergency clinical situations, the solution should be used only in intensive care hospital under constant monitoring of blood pressure and electrocardiogram (ECG). Do not mix the solution with other agents, enter into the same line of the infusion system or use undiluted. For dilution, it is necessary to use only 5% dextrose (glucose) solution, the concentration of the resulting solution should not be less than when diluting 6 ml of the drug in 500 ml of 5% dextrose (glucose). The introduction should always be made through a central venous catheter, the introduction through the peripheral veins is allowed for cardioresuscitation in ventricular fibrillation resistant to cardioversion, in the absence of a central venous access. In case of severe cardiac arrhythmias, if it is impossible to take the drug orally, intravenous drip through a central venous catheter is recommended at the usual loading dose at the rate of 0.005 g per 1 kg of the patient's weight in 250 ml of 5% dextrose (glucose) solution. It should be administered within 20-120 minutes, preferably with an electronic pump. It can be administered within 24 hours 2-3 times, the correction of the rate of administration depends on the clinical effect. The maintenance daily dose of amiodarone is usually prescribed in the amount of 0.6-0.8 g, it is allowed to increase to 1.2 g in 250 ml of a 5% dextrose (glucose) solution. Within 2-3 days of intravenous administration, you should gradually switch to taking the drug orally. Intravenous jet administration during cardiac resuscitation during cardiac arrest against the background of ventricular fibrillation resistant to cardioversion is recommended at a dose of 0.3 g of the drug diluted in 20 ml of 5% dextrose (glucose) solution. In the absence of a clinical effect, additional administration of 0.15 g of amiodarone is possible.

Side effects

The use of Kordaron can cause common side effects for each of the forms:

From the respiratory system: very rarely - bronchospasm and / or apnea against the background of severe respiratory failure, especially bronchial asthma; acute respiratory distress syndrome (sometimes immediately after surgery, sometimes fatal);
From the side of the cardiovascular system: often - moderate (dose-dependent) bradycardia; very rarely - severe bradycardia or sinus node arrest (in exceptional cases), more often in patients with sinus node dysfunction and elderly patients;
From the nervous system: very rarely - headache, benign intracranial hypertension.

The use of tablets can cause the following side effects:

From the side of the cardiovascular system: infrequently - AV blockade of various degrees, sinoatrial blockade (conduction disturbance), the occurrence of new or aggravation of existing arrhythmias; the frequency is unknown - the progression of chronic heart failure (against the background of long-term therapy);
From the respiratory system: often - cases of development of alveolar or interstitial pneumonitis, bronchiolitis obliterans with pneumonia (sometimes fatal), pleurisy, pulmonary fibrosis, severe shortness of breath or dry cough with symptoms of deterioration in general condition (fatigue, weight loss, fever ) or without it; frequency unknown - pulmonary bleeding;
On the part of the digestive system: very often - nausea, vomiting, loss of appetite, decrease in taste sensations or their loss, a feeling of heaviness in the epigastrium (especially at the beginning of use, disappears after a dose reduction), an isolated abrupt violation of the activity of liver enzymes in the blood serum; often - jaundice, acute liver damage, liver failure (sometimes fatal); very rarely - chronic liver diseases such as cirrhosis, pseudo-alcoholic hepatitis (sometimes fatal);
From the sensory organs: very often - a transient visual impairment (blurring of contours in bright light), caused by the deposition of complex lipids in the corneal epithelium; very rarely - optic neuritis or optic neuropathy;
From the side of the skin: very often - photosensitivity; often - transient skin pigmentation (with long-term therapy); very rarely - erythema, skin rash, alopecia, exfoliative dermatitis (the relationship with the drug has not been confirmed);
From the nervous system: often - extrapyramidal symptoms (tremor), sleep disturbances, nightmares; rarely - myopathy and / or peripheral neuropathies (sensory-motor, mixed, motor); very rarely - cerebellar ataxia;
Endocrine disorders: often - hypothyroidism (with a high level of thyroid-stimulating hormone (TSH) in the blood serum, the drug must be discontinued), hyperthyroidism; very rarely - a syndrome of impaired secretion of antidiuretic hormone;
Others: very rarely - epididymitis, vasculitis, impotence (no connection with amiodarone has been confirmed), hemolytic anemia, thrombocytopenia, aplastic anemia.

The use of Kordaron in the form of a solution causes undesirable effects:

From the side of the cardiovascular system: often - a moderate and transient decrease in blood pressure (BP); very rarely - proarrhythmic effect, progression of heart failure, flushing of blood to the skin of the face (with intravenous jet administration);
Immune system disorders: very rarely - anaphylactic shock; frequency unknown - angioedema;
From the respiratory system: very rarely - shortness of breath, cough, interstitial pneumonitis;
On the part of the skin: very rarely - increased sweating, a feeling of heat;
From the digestive system: very often - nausea; very rarely - an increase or decrease in the activity of liver enzymes in the blood (isolated), acute liver damage (sometimes fatal);
Reactions at the injection site: often - pain, swelling, induration, erythema, necrosis, infiltration, extravasation, inflammation, phlebitis (including superficial), thrombophlebitis, cellulitis, pigmentation, infection.

special instructions

The drug should be taken only as prescribed by a doctor!

Side effects of Kordaron are dose-dependent, therefore, treatment should be carried out with the minimum effective doses.

During the period of use of the drug, patients should avoid exposure to direct sunlight.

The purpose of the drug should be made taking into account the data of the study of the ECG and blood to determine the content of potassium. Hypokalemia should be corrected before starting treatment. Treatment should be accompanied by regular monitoring of ECG (1 every 3 months) and liver function tests.

Patients with and without thyroid disease should undergo laboratory and clinical examination of the thyroid before starting amiodarone therapy, during treatment, and for several months after discontinuation of the drug.

In case of suspected functional disorders, it is necessary to determine the level of TSH in the blood serum.

During the period of use of the drug, patients should undergo x-ray examination of the lungs and functional pulmonary tests every 6 months.

With long-term therapy of patients with a pacemaker or an implanted defibrillator, it is necessary to regularly monitor the correct functioning of them.

With the appearance of AV blockade of the first degree, it is necessary to strengthen the observation. Treatment should be discontinued if sinoatrial block, II or III degree AV block, or bifascicular intraventricular block develop.

An ophthalmological examination should be performed with an examination of the fundus with a decrease in visual acuity and the appearance of blurred vision. Patients with optic neuritis or neuropathy that developed while taking amiodarone, further use of the drug should be discontinued.

Before the operation, it is necessary to inform the anesthesiologist about the drug intake.

Long-term therapy with Cordaron may increase the hemodynamic risk associated with anesthesia.

In addition, in rare cases, acute respiratory distress syndrome may occur in patients immediately after surgery, requiring careful monitoring during mechanical ventilation.

In / in the jet injection should be carried out for at least 3 minutes, re-introduction is possible only 15 minutes after the first.

Against the background of the administration of the drug, the development of interstitial pneumonitis is possible, therefore, in the event of severe shortness of breath or dry cough, with or without deterioration in the general condition (fatigue, fever) or without it, the patient should undergo a chest x-ray. In case of violation of the x-ray picture, the drug must be discontinued, since the disease can develop pulmonary fibrosis.

It is possible to develop severe acute liver damage with the development of liver failure (sometimes fatal) during the first day of injection use, it is necessary to regularly monitor liver function during therapy.

Simultaneous use with verapamil, diltiazem and beta-blockers, except for esmolol and sotalol, is possible only for the prevention of life-threatening ventricular arrhythmias and the restoration of cardiac activity after cardiac arrest caused by ventricular fibrillation resistant to cardioversion.

drug interaction

Only the attending physician can determine the possibility of concomitant therapy, taking into account the condition and clinical indications of the patient.

Analogues

Kordaron's analogs are: Amiocordin, Amiodaron, Amiodaron-SZ, Vero-Amiodaron, Cardiodaron, Ritmorest, Aritmil, Rotaritmil.

Terms and conditions of storage

Keep out of the reach of children at temperatures up to 30 °C.

Shelf life - 3 years.

Terms of dispensing from pharmacies

Released by prescription.

www.neboleem.net

Kordaron

Compound

1 tablet contains 200 mg of the active ingredient amiodarone hydrochloride. Additional components are: povidone, starch, silicon dioxide, lactose monohydrate, magnesium stearate.

1 ml of the solution contains 50 mg of the active ingredient amiodarone hydrochloride. Additional components are: polysorbate, injection water, benzyl alcohol.

Release form

Available in tablet form, as a solution.

pharmachologic effect

Antiarrhythmic agent, inhibitor of repolarization.

Pharmacodynamics and pharmacokinetics

The main substance is amiodarone. It has coronary dilating, antianginal, hypotensive, alpha-adrenergic blocking, beta-adrenergic blocking effects. Under the action of the drug, the oxygen demand of the heart muscle decreases, which explains the antianginal effect. Kordaron inhibits the work of alpha-, beta-adrenergic receptors of the cardiovascular system without blocking them.

Amiodarone reduces the sensitivity of the sympathetic nervous system to hyperstimulation, reduces the tone of the coronary arteries, improves blood flow, lowers the pulse, increases myocardial energy reserves, and lowers blood pressure.

The antiarrhythmic effect is achieved by influencing the course of electrophysiological processes in the myocardium, lengthening the action potential of myocardiocytes, increasing the refractory, effective period of the atria, the His bundle, the AV node, and the ventricles.

Cordarone is able to inhibit diastolic, slow depolarization of the sinus node cell membrane, inhibit atrioventricular conduction, and cause bradycardia. The structure of the main component of the drug is similar to thyroid hormone.

Indications for Kordaron's use

The drug is prescribed for paroxysmal arrhythmias (treatment, prevention). Indications for the use of Kordaron are: ventricular fibrillation, fatal ventricular arrhythmias, supraventricular arrhythmias, atrial flutter, atrial paroxysm, angina pectoris, ventricular arrhythmia in patients with Chagas myocarditis, arrhythmias in coronary insufficiency, parasystole.

Contraindications

Cordarone is not prescribed for sinus bradycardia, iodine intolerance, amiodarone, cardiogenic shock, collapse, hypokalemia, hypothyroidism, arterial hypotension, breastfeeding, interstitial lung disease, pregnancy, taking MAO inhibitors, hypokalemia, atrioventricular blockade 2-3 degrees.

Elderly people, with liver pathology, heart failure, patients under 18 years of age, with pathology of the hepatic system are prescribed with caution.

Side effects

Nervous system: sleep disorders, memory disorders, peripheral neuropathy, paresthesia, auditory hallucinations, fatigue, depression, dizziness, weakness, headaches, optic neuritis, intracranial hypertension, ataxia, extrapyramidal manifestations.

Sense organs: micro detachment of the retina, deposition of lipofuscin in the corneal epithelium, uveitis.

Cardiovascular system: drop in blood pressure, tachycardia, progression of CHF, atrioventricular block, sinus bradycardia. Metabolism: thyrotoxicosis, hypothyroidism, elevated T4 levels.

Respiratory system: apnea, bronchospasm, pleurisy, pulmonary fibrosis, alveolitis, anterstitial pneumonia, shortness of breath, cough.

Digestive system: cirrhosis of the liver, jaundice, cholestasis, toxic hepatitis, increased levels of liver enzymes, loss, dulling of taste perception, decreased appetite, vomiting, nausea.

Long-term use causes aplastic anemia, hemolytic anemia, thrombocytopenia, allergic reactions, dermatitis. With parenteral administration, phlebitis develops.

Kordaron can cause the following side effects: alopecia, decreased potency, myopathy, vasculitis, epididymitis, photosensitivity, pigmentation of the skin, increased sweating.

Application instruction of Kordaron (Way and dosage)

Kordaron solution, instructions for use

The solution is administered intravenously according to the scheme of 5 mg/kg for the relief of acute rhythm disturbances, patients with CHF are calculated according to the scheme of 2.5 mg/kg. Infusions are carried out within 10-20 minutes.

Kordaron tablets, instructions for use

Tablets are taken before meals: 0.6-0.8 grams for 2-3 doses; the dosage is reduced after 5-15 days to 0.3-0.4 grams per day, after which they switch to maintenance therapy of 0.2 grams per day for 1-2 doses.

To prevent cumulation, the drug is taken for 5 days, after which they take a break for 2 days.

Overdose

It is characterized by a drop in blood pressure, atrioventricular blockade, bradycardia.

Requires the appointment of cholestyramine, gastric lavage, the installation of a pacemaker. Hemodialysis was found to be ineffective.

Interaction

Kordaron causes an increase in the level of procainamide, phenytoin, quinidine, digoxin, cyclosporine, flecainide in the blood plasma.

The drug causes an increase in the effects of indirect anticoagulants (acenocoumarol and warfarin).

When prescribing warfarin, its dosage is reduced to 66%, when prescribing acenocoumarol - by 50%, control of prothrombin time is mandatory.

Loop diuretics, astemizole, tricyclic antidepressants, phenothiazines, terfenadine, thiazides, sotalol, glucocorticosteroids, laxatives, pentamidine, tetracosactide, first-class antiarrhythmics, amphotericin B can provoke an arrhythmogenic effect.

Cardiac glycosides, Verapamil, beta-blockers increase the likelihood of inhibition of atrioventricular conduction, the development of bradycardia.

Drugs that cause photosensitivity may cause an additive photosensitizing effect.

Arterial hypotension, bradycardia, conduction disturbances can develop during oxygen therapy, during general anesthesia using drugs for inhalation anesthesia.

Cordarone is able to suppress the absorption of sodium pertechnett, sodium iodide by the thyroid gland.

With the simultaneous use of lithium preparations, the risk of developing hypothyroidism increases. Cimetidine increases the half-life of the main component, and cholestyramine reduces its absorption in the blood plasma.

Terms of sale

Requires a prescription.

Storage conditions

In a place inaccessible to children at a temperature not exceeding 25 degrees Celsius.

Best before date

No more than two years.

special instructions

On the eve of the appointment of antiarrhythmic therapy, an examination of the hepatic system is carried out, the work of the thyroid gland is evaluated, an X-ray examination of the pulmonary system is performed, and the level of electrolytes in the plasma is determined.

During treatment, be sure to monitor the level of liver enzymes, ECG. The function of external respiration is examined every six months, X-ray examination of the lungs is carried out once a year, the level of thyroid hormones is determined once every 6 months. In the absence of a clinical picture of thyroid dysfunction, antiarrhythmic treatment is continued.

It is recommended to use special sunscreens, avoid direct sunlight to prevent the development of photosensitivity. Periodic observation by an ophthalmologist is required to diagnose deposits in the cornea.

Withdrawal of the drug may cause a relapse of the rhythm disorder.

Parenteral administration of the drug Kordaron is possible only in a hospital under the control of blood pressure, pulse, ECG.

Appointment during breastfeeding and pregnancy is possible only in cases that threaten the life of a woman.

After stopping treatment, the pharmacodynamic effect persists for 10-30 days.

Cordarone contains iodine in its composition, which can provoke false-positive tests for the determination of radioactive iodine in the thyroid gland.

During surgical interventions, the team should be informed about the use of the drug due to the possibility of developing an acute form of distress syndrome.

Amiodarone affects driving, attention.

INN: Amiodarone.

How long can the medicine be taken?

After saturation with the drug (usually within a week), they switch to maintenance therapy, which can last quite a long time. Therapy should be carried out under the supervision of the attending physician.

Cordarone and alcohol

The drug is incompatible with alcohol.

Kordaron's analogs

Coincidence in the ATX code of the 4th level:

What can replace the remedy? Analogues can be called drugs: Amiodarone, Amiocordin, Aritmil, Cardiodaron, Rotaritmil.

Reviews about Cordarone

There are a large number of opinions that the drug is effective in atrial fibrillation, really relieves symptoms and alleviates the general condition.

However, there are many reviews about Cordarone on the forums, which indicate that the drug does not help at all or helps only slightly.

Kordaron price, where to buy

The price of Kordaron in tablets of 200 mg is 320 rubles per pack of 30 pieces.

Internet pharmacies in RussiaRussia
Internet pharmacies of UkraineUkraine
Internet pharmacies of KazakhstanKazakhstan

WER.RU

Kordaron tablets 200 mg 30 pcs Sanofi-Vintrop Industry
Cordarone solution 50 mg/ml 3 ml 6 pcs Sanofi Avents [Sanofi-Aventis]

ZdravZone

Kordaron solution for injections 150mg/3ml №6 amp.
Cordarone 200mg №30 tabletsChinoin Pharmaceutical and Chemical Work

Pharmacy IFK

KordaronSanofi/ Chinoin, Hungary
KordaronSanofi-Winthrop, France

Pharmacy24

Kordaron solution for in. 150mg amp. 3ml №6 ActionSanofi (France)
KordaronSanofi Winthrop Industrie (France)

PaniApteka

Kordaron rr d / in. 150mg amp. 3ml №6

BIOSPHERE

Cordarone 200 mg No. 30 tab. del. Sanofi-Winthrop Industrie (France)

NOTE! Information about medicines on the site is a general reference, collected from publicly available sources and cannot serve as a basis for making a decision on the use of medicines in the course of treatment. Before medicine use Kordaron surely consult with the attending physician.

medicalmed.ru

Kordaron

Kordaron is a drug with antiarrhythmic action.

Release form and composition

Cordarone is produced in the following dosage forms:

Tablets: round, off-white to white, with a break line on one side, chamfered and beveled from the edges to the break line on both sides, with a heart symbol above the break line and the number "200" below the line break (10 pieces in blisters, 3 blisters in a cardboard box);
Solution for intravenous administration: light yellow, transparent (in colorless glass ampoules of 3 ml, 6 ampoules in plastic blister packs, 1 pack in a carton box).

The composition of 1 tablet includes:

Active substance: amiodarone hydrochloride - 200 mg;
Auxiliary components: corn starch, lactose monohydrate, magnesium stearate, povidone K90F, anhydrous colloidal silicon dioxide.

The composition of 1 ampoule includes:

Active substance: amiodarone hydrochloride - 150 mg;
Auxiliary components: polysorbate 80 - 300 mg; benzyl alcohol - 60 mg; water for injection - up to 3 ml.

Indications for use

Cordarone in the form of tablets:

Prevention of recurrence of life-threatening ventricular arrhythmias, including ventricular fibrillation and ventricular tachycardia (therapy should be started in a hospital with careful cardiac monitoring);
Prevention of recurrence of supraventricular paroxysmal tachycardia, including documented attacks of recurrent sustained paroxysmal supraventricular tachycardia in patients with organic heart disease; documented attacks of recurrent sustained supraventricular paroxysmal tachycardia in patients without organic heart disease in cases where antiarrhythmic drugs of other classes are ineffective or there are contraindications to their use; documented attacks of recurrent sustained supraventricular paroxysmal tachycardia in patients with Wolff-Parkinson-White syndrome;
Prevention of recurrence of atrial flutter and atrial fibrillation (atrial fibrillation);
Prevention of sudden arrhythmic death in patients at high risk (after a recent myocardial infarction, with clinical manifestations of chronic heart failure and reduced left ventricular ejection fraction, as well as patients with more than 10 ventricular extrasystoles in 1 hour);
Treatment of arrhythmias in patients with ischemic heart disease and/or left ventricular dysfunction.

Cordarone in the form of a solution for intravenous administration:

Relief of attacks of paroxysmal tachycardia, including relief of attacks of supraventricular paroxysmal tachycardia with a high frequency of ventricular contractions, especially in Wolff-Parkinson-White syndrome; relief of attacks of ventricular paroxysmal tachycardia; relief of a stable and paroxysmal form of atrial fibrillation (atrial fibrillation) and atrial flutter;
Cardiac resuscitation in cardiac arrest caused by defibrillation-resistant ventricular fibrillation.

Contraindications

Sinus node weakness syndrome (sinoatrial blockade, sinus bradycardia) in the absence of a pacemaker - an artificial pacemaker (due to the danger of "stopping" the sinus node);
AV block II-III degree in the absence of a permanent pacemaker;
Intraventricular conduction disorders (two- and three-beam blocks) in the absence of a permanent pacemaker. With such conduction disturbances, intravenous use of Kordaron is possible only in specialized departments under the cover of a temporary pacemaker;
Hypomagnesemia, hypokalemia;
Cardiogenic shock, collapse, severe arterial hypotension;
Functional disorders of the thyroid gland (hyperthyroidism, hypothyroidism);
Prolongation of the QT interval (acquired or congenital);
Simultaneous use with drugs that can prolong the QT interval and lead to the development of paroxysmal tachycardia, including ventricular torsades de pointes: sotalol; class I A antiarrhythmic drugs (hydroquinidine, quinidine, procainamide, disopyramide); class III antiarrhythmics (ibutilide, dofetilide, bretylium tosylate); other (non-antiarrhythmic) drugs (eg, bepridil); tricyclic antidepressants; vincamine; cisapride; azoles; some antipsychotics phenothiazines (cyamemazine, chlorpromazine, fluphenazine, levomepromazine, trifluoperazine, thioridazine), benzamides (veralipride, sulpiride, amisulpride, tiapride, sultopride), butyrophenones (haloperidol, droperidol), sertindole, pimozide; antibiotics of the macrolide group (in particular, spiramycin, erythromycin when administered intravenously); pentamidine when administered parenterally; antimalarial drugs (chloroquine, quinine, halofantrine, mefloquine); mizolastin; diphemanil methyl sulfate; fluoroquinolones; terfenadine, astemizole;
Pregnancy and the period of breastfeeding (lactation);
Age up to 18 years (safety and efficacy for this age group of patients have not been established);
Hypersensitivity to the components of the drug.

Intravenous jet administration of Cordarone is contraindicated in severe respiratory failure, arterial hypotension, heart failure or cardiomyopathy (due to the possible aggravation of these conditions).

The above contraindications to the use of Kordaron during cardiac resuscitation in case of cardiac arrest caused by defibrillation-resistant ventricular fibrillation do not apply.

Kordaron should be used with caution in elderly patients (due to the high risk of developing severe bradycardia), as well as in the following diseases / conditions:

arterial hypotension;
Bronchial asthma;
Decompensated or severe heart failure (III-IV functional classes according to the NYHA classification);
Liver failure;
severe respiratory failure;
AV block I degree.

Method of application and dosage

Kordaron in the form of tablets should be taken before meals inside, drinking plenty of water. The drug is used only as directed by a doctor.

Loading ("saturating") dose: it is possible to use various schemes of saturation.

Inpatient treatment: the initial daily dose may vary from 600-800 mg to a maximum of 1200 mg. The daily dose should be divided into several doses. The drug is taken until a total dose of 10 g is reached (usually 5-8 days).

Outpatient treatment: the initial daily dose is usually 600-800 mg. The daily dose should be divided into several doses. The drug is taken until a total dose of 10 g is reached (usually 10-14 days).

Maintenance dose: in different patients can vary from 100 to 400 mg per day. It is necessary to apply the smallest effective dose, determined by the individual therapeutic effect.

Since Kordaron has a very long half-life, it can be used every other day or with two days off per week.

Average therapeutic dose: single - 200 mg, daily - 400 mg.

Maximum dose: single - 400 mg; daily - 1200 mg.

Intravenously Kordaron is used in cases where it is necessary to achieve a rapid antiarrhythmic effect or when it is impossible to take the drug orally.

In addition to emergency clinical situations, Kordaron should be used only in the intensive care unit in a hospital under constant monitoring of blood pressure and electrocardiogram (ECG).

Kordaron when administered intravenously can not be mixed with other drugs. Do not simultaneously inject other drugs into the same line of the infusion system.

The solution for injection is used only diluted. To dilute Kordaron, only 5% glucose (dextrose) solution can be used. Due to the peculiarities of the dosage form, it is not recommended to use the concentration of the infusion solution less than that obtained by diluting 2 ampoules in 0.5 l of 5% glucose (dextrose) solution.

To avoid the development of reactions at the injection site, Kordaron should be administered through a central venous catheter, except in cases of cardioresuscitation with ventricular fibrillation that is resistant to defibrillation. In this case, in the absence of a central venous access for the introduction of Kordaron, it is possible to use peripheral veins (the largest peripheral vein with maximum blood flow).

In severe cardiac arrhythmias when it is impossible to take the drug orally (except in cases of cardiac resuscitation during cardiac arrest caused by ventricular fibrillation resistant to defibrillation), Kordaron can be administered intravenously by drip through a central venous catheter or intravenously by jet.

When administered intravenously through a central venous catheter, the loading dose is usually 5 mg/kg of body weight in 250 ml of 5% glucose (dextrose) solution. The drug, if possible, is administered using an electronic pump for 20-120 minutes. Within 24 hours, the procedure can be repeated up to 3 times. Depending on the clinical effect, the rate of administration of Cordarone can be adjusted. Due to the fact that the therapeutic effect of the drug gradually decreases after the infusion is stopped, if it is necessary to continue therapy with an injection solution, it is recommended to switch to continuous intravenous drip administration of Kordaron.

Maintenance doses: 10-20 mg/kg per day (usually 600-800 mg, but if necessary, it can be increased to 1200 mg over 24 hours) in 250 ml of 5% glucose (dextrose) solution for several days. From the first day of therapy, it is recommended to start gradually switching to taking Cordarone orally (3 tablets of 200 mg per day, if necessary, the dose can be increased to 4-5 tablets).

Intravenous jet administration can be carried out only in urgent cases with the ineffectiveness of other types of therapy and only in intensive care units under constant monitoring of blood pressure and ECG. Such an introduction is usually not recommended due to the high hemodynamic risk (collapse and a sharp decrease in blood pressure).

The dose is usually 5 mg/kg body weight. Intravenous jet administration of Kordaron should be carried out for at least 3 minutes (except in cases of cardioresuscitation in case of ventricular fibrillation resistant to defibrillation). Re-introduction of the drug should not be carried out earlier than 15 minutes after the first injection, even if the contents of only one ampoule were used during the first injection of the solution (due to the possibility of irreversible collapse). If further use of the drug is necessary, it should be administered as an infusion.

In the course of cardiac resuscitation during cardiac arrest caused by ventricular fibrillation, showing resistance to defibrillation, intravenous bolus administration is indicated at a dose of 300 mg (5 mg / kg), diluted in 20 ml of 5% glucose solution (dextrose). If fibrillation could not be stopped, Kordaron can be additionally injected intravenously in a dose of 150 mg (2.5 mg / kg).

Side effects

During therapy, the development of disorders from some body systems is possible:

Respiratory system: very rarely - cough, interstitial pneumonitis, shortness of breath, apnea and / or bronchospasm (in patients with severe respiratory failure, especially with bronchial asthma), acute respiratory distress syndrome (sometimes fatal);
Cardiovascular system: often - bradycardia (usually a moderate decrease in heart rate), lowering blood pressure, usually transient and moderate (cases of collapse or severe arterial hypotension were observed when the drug was administered too quickly or overdose); very rarely - an arrhythmogenic effect (the occurrence of new arrhythmias, including ventricular tachycardia "pirouette", or aggravation of existing ones, sometimes with subsequent cardiac arrest. These effects are mainly observed when Kordaron is used together with drugs that prolong the period of repolarization of the ventricles of the heart or with violations of the content in blood electrolytes); severe bradycardia or, in rare cases, sinus node arrest, which requires discontinuation of therapy, especially in patients with sinus node dysfunction and / or elderly patients, flushing of the skin of the face; with an unknown frequency - ventricular tachycardia of the "pirouette" type;
Musculoskeletal system: with an unknown frequency - pain in some parts of the spine (lumbar and lumbosacral);
Immune system: very rarely - anaphylactic shock; with an unknown frequency - angioedema (Quincke's edema);
Digestive system: very rarely - nausea;
Endocrine system: with an unknown frequency - hyperthyroidism;
Nervous system: very rarely - headache, benign intracranial hypertension (pseudotumor of the brain);
Skin and subcutaneous tissues: very rarely - increased sweating, a feeling of heat; with an unknown frequency - urticaria;
Biliary tract and liver: very rarely - an isolated increase in the activity of hepatic transaminases in the blood serum (usually moderate, the excess of normal values by 1.5-3 times decreases with dose reduction or even spontaneously), acute liver damage (within 24 hours after administration of Kordaron) with jaundice and / or increased transaminases, including the development of liver failure, sometimes with a fatal outcome;
Local reactions: often - reactions at the injection site (infection, infiltration, erythema, pain, necrosis, edema, thrombophlebitis, pigmentation, extravasation, induration, inflammation, cellulitis, phlebitis).

special instructions

Since the severity of side effects depends on the doses taken, therapy should be carried out at the lowest effective doses.

During the treatment period, exposure to direct sunlight should be avoided or necessary protective measures should be taken (wear appropriate clothing and apply sunscreen).

Before starting therapy, you need to conduct an ECG study and determine the content of potassium in the blood. Hypokalemia should be corrected before Cordaron is started.

Due to the fact that amiodarone can lead to the development of hypothyroidism or hyperthyroidism, especially in patients with a history of thyroid disease, laboratory and clinical examinations should be carried out before taking Cordarone to detect thyroid dysfunction.

The appearance of a dry cough or shortness of breath may indicate pulmonary toxicity, which requires pulmonary function tests and chest x-ray.

With the development of sinoatrial blockade, AV block II and III degree or bifascicular intraventricular block, therapy should be interrupted. With AV blockade of the 1st degree, it is necessary to strengthen the observation of the patient.

With a decrease in visual acuity or blurry vision, an ophthalmological examination should be urgently performed. With the development of neuritis or neuropathy of the optic nerve, Kordaron should be canceled because of the risk of developing blindness.

Before performing a surgical intervention, the anesthesiologist must be informed about the therapy being carried out.

Laboratory and clinical signs of chronic liver failure when Cordarone is taken orally may be minimally pronounced and reversible after discontinuation of the drug, however, there are reports of cases of death due to liver damage.

Except in emergency cases, intravenous administration of Kordaron should be carried out only in the intensive care unit with constant ECG monitoring.

It must be remembered that even a slow intravenous stream administration of the drug can cause the development of an excessive decrease in blood pressure and circulatory collapse.

During the first days after the start of the use of Kordaron in the form of a solution for injection, severe acute liver damage may occur with the development of liver failure (in some cases with a fatal outcome).

Patients with paroxysms of severe arrhythmias during the period of therapy, it is desirable to refrain from activities that require the speed of psychomotor reactions and increased concentration of attention (driving vehicles and potentially dangerous activities).

drug interaction

Since the simultaneous use of Kordaron with certain drugs can lead to the development of undesirable consequences (cause bidirectional ventricular tachycardia of the "pirouette" type, hypokalemia, increase the duration of the QT interval, etc.), during the period of therapy, the use of other drugs should be agreed with the doctor.

Terms and conditions of storage

Keep out of the reach of children.

Best before date:

Tablets - 3 years at temperatures up to 30 ° C;
Solution for intravenous administration - 2 years at temperatures up to 25 ° C.

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Kordaron instructions for use, contraindications, side effects, reviews

Class III antiarrhythmic drug Drug: CORDARON

Active substance of the drug: amiodarone ATC code: C01BD01 CFG: Antiarrhythmic drug Registration number: P No. 014833/01-2003 Registration date: 03/12/03

The owner of the reg. Award: SANOFI WINTHROP INDUSTRIE (France)

Release form Kordaron, drug packaging and composition.

Tablets are round, divided, white or white with a creamy tint, engraved with a symbol in the form of a middle and the number "200" on one side; tablets can be easily separated along the break line under normal conditions of use. 1 tab. amiodarone hydrochloride 200 mg Excipients: lactose monohydrate, corn starch, polyvidone K90F, anhydrous colloidal silicon dioxide, magnesium stearate. 10 pieces. - blisters (3) - packs of cardboard. The solution for intravenous administration is clear, pale yellow. 1 amp. amiodarone hydrochloride 150 mg Excipients: benzyl alcohol, polysorbate 80, water for injection, nitrogen.

3 ml - colorless glass ampoules (6) - contour packaging (1) - cardboard boxes.

The description of the drug is based on the officially approved instructions for use.

Pharmacological action Kordaron

Class III antiarrhythmic drug. It has antiarrhythmic and antianginal effects. The antiarrhythmic effect is due to an increase in the 3rd phase of the action potential, mainly due to a decrease in the potassium current through the channels of the cell membranes of cardiomyocytes and a decrease in the automatism of the sinus node. The drug noncompetitively blocks - and -adrenergic receptors. Slows down sinoatrial, atrial and nodal conduction without affecting intraventricular conduction. Kordaron increases the refractory period and reduces myocardial excitability. Slows down the conduction of excitation and lengthens the refractory period of additional atrioventricular pathways. The antianginal effect of Kordaron is due to a decrease in myocardial oxygen consumption (due to a decrease in heart rate and a decrease in OPSS), non-competitive blockade of - and -adrenergic receptors, an increase in coronary blood flow by direct action on the smooth muscles of the arteries, maintaining cardiac output by reducing pressure in the aorta and a decrease in peripheral resistance. Kordaron does not have a significant negative inotropic effect, reduces myocardial contractility mainly after intravenous administration. It affects the metabolism of thyroid hormones, inhibits the conversion of T3 to T4 (thyroxine-5-deiodinase blockade) and blocks the uptake of these hormones by cardiocytes and hepatocytes, which leads to a weakening of the stimulating effect of thyroid hormones on the myocardium. It is determined in the blood plasma for 9 months after stopping its intake. Therapeutic effects are observed after 1 week (from several days to 2 weeks) after the start of oral administration of the drug.

With the on / in the introduction of Kordaron, its activity reaches a maximum after 15 minutes and disappears approximately 4 hours after administration. Despite the fact that the amount of Cordarone administered in the blood rapidly decreases, tissue saturation with the drug is achieved. In the absence of repeated injections, the drug is gradually eliminated. When resuming its administration or when prescribing the drug for oral administration, its tissue reserve is formed.

Pharmacokinetics of the drug.

Absorption After oral administration, amiodarone is absorbed slowly (absorption is 30-50%), the absorption rate is subject to significant fluctuations. Bioavailability after oral administration ranges from 30 to 80% in different patients (on average, about 50%). After a single dose of the drug inside, Cmax in the blood plasma is reached after 3-7 hours. The distribution of Amiodarone has a large Vd. Amiodarone accumulates most in adipose tissue, liver, lungs, spleen and cornea. After a few days, amiodarone is excreted from the body. Css is achieved within 1 to several months, depending on the individual characteristics of the patient. Plasma protein binding - 95% (62% - with albumin, 33.5% - with beta-lipoproteins). Metabolism Metabolized in the liver. The main metabolite, deethylamiodarone, is pharmacologically active and may enhance the antiarrhythmic effect of the main compound. Each dose of Kordaron (200 mg) contains 75 mg of iodine; 6 mg of these were determined to be released as free iodine. With prolonged treatment, its concentrations can reach 60-80% of the concentrations of amiodarone. Withdrawal Excretion when taken orally proceeds in 2 phases: T1 / 2 in the -phase - 4-21 hours, T1 / 2 in the -phase - 25-110 days. After prolonged oral administration, the average T1 / 2 is 40 days (this is important when choosing a dose, because it takes at least 1 month to stabilize plasma concentrations, and complete elimination can last more than 4 months).

After discontinuation of the drug, its complete elimination from the body continues for several months. The presence of pharmacodynamic effects of Kordaron should be taken into account for 10 days and up to 1 month after its cancellation. Amiodarone is excreted in bile and feces. Renal excretion is negligible.

Pharmacokinetics of the drug.

in special clinical situations Insignificant excretion of the drug in the urine allows you to prescribe the drug in renal failure in medium doses. Amiodarone and its metabolites are not subject to dialysis.

Indications for use:

Relief of attacks of ventricular paroxysmal tachycardia; - relief of attacks of supraventricular paroxysmal tachycardia with a high frequency of ventricular contractions (especially against the background of WPW syndrome); - relief of paroxysmal and stable forms of atrial fibrillation (atrial fibrillation) and atrial flutter. Prevention of relapse - life-threatening ventricular arrhythmias and ventricular fibrillation of the heart (treatment should be started in a hospital with careful cardiac monitoring); - supraventricular paroxysmal tachycardias, incl. documented attacks of recurrent sustained supraventricular paroxysmal tachycardia in patients with organic heart disease; documented attacks of recurrent sustained supraventricular paroxysmal tachycardia in patients without organic heart disease, when antiarrhythmic drugs of other classes are not effective or there are contraindications to their use; documented attacks of recurrent sustained supraventricular paroxysmal tachycardia in patients with WPW syndrome; - atrial fibrillation (atrial fibrillation) and atrial flutter. - prevention of sudden arrhythmic death in patients at high risk after a recent myocardial infarction, with more than 10 ventricular extrasystoles per hour, clinical manifestations of chronic heart failure and a reduced left ventricular ejection fraction (

Kordaron refers to cardiovascular drugs. Released only by prescription.

Pharmacological action of Kordaron

Also, the drug reduces myocardial excitability, lengthens the refractory period. Kordaron also has an antianginal effect due to a decrease in myocardial oxygen consumption. This is due to a decrease in heart rate and a decrease in total vascular peripheral resistance. Due to the direct effect on the muscles of the arteries, Kordaron increases coronary blood flow, in addition, the drug maintains cardiac output, reduces myocardial contractility.

Release form

Kordaron is issued in the form of solution and tablets.

Indications for Kordaron's use

Kordaron is used to stop attacks of paroxysmal tachycardia, stop paroxysmal ventricular and supraventricular tachycardia, accompanied by a high frequency of ventricular contractions, to remove paroxysmal and stable forms of atrial fibrillation, as well as atrial flutter.

According to reviews of Cordarone, the drug is effective in the treatment of patients suffering from heart diseases of organic origin (including coronary heart disease), which are accompanied by a change in the function of the left ventricle.

Application instruction of Kordaron

According to the instructions Kordaron tablets are taken according to several schemes.

Outpatient treatment begins with taking from 600 to 800 milligrams of the drug per day, divided into several times. After a period of 10 to 14 days, when the total amount of the drug taken reaches 10 grams, the patient is recommended to take a maintenance dose, which is prescribed at the rate of 3 milligrams per kilogram of weight (on average, from 100 to 400 milligrams per day).

During inpatient treatment, the patient is first prescribed the drug from 600 to 800 grams per day (a maximum dose of 1200 milligrams is acceptable). Within 5-8 days, bring up to 10 grams.

Since Kordaron has a long half-life, the daily intake of the drug can be in the amount of 100 milligrams and every other day - in the amount of 200 milligrams. Breaks in taking the drug are allowed two days a week.

Kordaron's solution is used for intravenous injections and infusions. When conducting an infusion, the loading dose for an adult is 5 milligrams per kilogram of body weight. Cordarone is dissolved in 250 milliliters of 5% glucose. Infusion is carried out from 20 minutes to 2 hours. During the day, the introduction is repeated 2-3 times.

Over time, the effect of the drug gradually decreases, therefore, a maintenance infusion is recommended, for which adults are prescribed the drug at the rate of 10 to 20 milligrams per 1 kilogram of weight (on average, from 600 to 800 milligrams per day, the maximum dose is not more than 1200 milligrams) . This dose is also diluted in 250 milliliters of 5% glucose before administration.

The recommended dose for adult patients is 5 mg per 1 kg of body weight. The procedure is carried out within three minutes, the next injection - no earlier than 15 minutes after the previous one. If it is necessary to continue treatment, it is recommended to switch to infusion administration.

Kordaron can also be used in children after they reach the age of three. Dosage - 5 milligrams per 1 kilogram of weight. The syringe should not contain any other drug other than Kordaron, its mixing with other drugs is not allowed.

With an overdose of the drug, it is possible: sinus bradycardia, paroxysmal ventricular tachycardia, cardiac arrest, ventricular tachycardia of the "pirouette" type, impaired liver function and blood circulation, lowering blood pressure.

To eliminate the symptoms of an overdose, symptomatic treatment is prescribed, including gastric lavage, taking cholestyramine, with tachycardia of the "pirouette" type - intravenous administration of magnesium salts, as well as slowing pacing, with bradycardia, beta-stimulators or the installation of a pacemaker are prescribed.

Side effects of Kordaron

The use of the drug can lead to: deposition of lipofuscin in the corneal epithelium, photosensitivity, hypothyroidism, hyperthyroidism, bradycardia, hypotension, decreased AV conduction, alveolitis, nausea, liver dysfunction, epigastric heaviness.

There are reviews of Cordarone as a drug that provokes the occurrence of tremor and the development of peripheral neuropathy.

With parenteral administration, fever, sweating, apnea, bronchospasm, phlebitis, and increased intracranial pressure may occur.

Contraindications to the use of Kordaron

According to the instructions, Kordaron tablets are not recommended for use in case of intolerance to amiodarone or iodine, with weakness of the sinus node, changes in intraventricular and atrioventricular conduction, thyroid dysfunction, hypokalemia, heart failure, interstitial lung disease.

In addition, the drug in tablets is contraindicated in children under the age of 18, as well as lactating and pregnant women.

It is not allowed to administer Kordaron intravenously to children under the age of three years and to lactating women. Pregnant women are prescribed only in exceptional cases.

The simultaneous use of Kordaron with antiarrhythmic drugs, as well as with sultopride, vincamine, pentamidine for parenteral administration, erythromycin for intravenous administration, is not recommended, since the development of ventricular tachycardia of the "pirouette" type is possible.

It is forbidden to carry out combination therapy with beta-blockers, as well as individual calcium channel blockers (these include: verapamil, diltiazem). The consequences of the simultaneous administration of Kordaron with these drugs may be a violation of automatism (in the form of bradycardia) and conduction.

It is forbidden to take Kordaron together with laxative drugs, drugs that provoke the occurrence of hypokalemia, with anticoagulants, with cardiac glycosides, with cyclosporine, phenytoin, flecainide, simvastatin. In addition, according to the instructions, Kordaron is not recommended for patients who have undergone general anesthesia.

Terms and conditions of storage

The drug in the form of tablets is recommended to be stored in a dark place at a positive temperature not exceeding 30 ° C. Shelf life - three years. Cordarone solution for intravenous administration is stored in a dry place where the temperature does not exceed 25°C. Shelf life is two years.

Antiarrhythmic drug

Active substance

Release form, composition and packaging

Tablets white to creamy white, round, with a breakline on one side, beveled from the edges to the breakline and chamfered on both sides, engraved with a heart symbol above the breakline and the number "200" below the breakline.

Excipients: lactose monohydrate, corn starch, magnesium stearate, K90F, anhydrous colloidal silicon dioxide.

10 pieces. - blisters (3) - packs of cardboard.

pharmachologic effect

Antiarrhythmic drug. Amiodarone belongs to class III (a class of repolarization inhibitors) and has a unique mechanism of antiarrhythmic action, tk. in addition to the properties of class III antiarrhythmics (potassium channel blockade), it has the effects of class I antiarrhythmics (sodium channel blockade), class IV antiarrhythmics (calcium channel blockade) and a non-competitive beta-adrenergic blocking effect.

In addition to the antiarrhythmic action, the drug has antianginal, coronary dilating, alpha and beta adrenoblocking effects.

Antiarrhythmic action:

- an increase in the duration of the 3rd phase of the action potential of cardiomyocytes, mainly due to blocking the ion current in potassium channels (the effect of class III antiarrhythmics according to the Williams classification);

- a decrease in the automatism of the sinus node, leading to a decrease in heart rate;

- non-competitive blockade of α- and β-adrenergic receptors;

- slowing of sinoatrial, atrial and AV conduction, more pronounced with tachycardia;

- no changes in ventricular conduction;

- an increase in refractory periods and a decrease in the excitability of the myocardium of the atria and ventricles, as well as an increase in the refractory period of the AV node;

- slowing down conduction and an increase in the duration of the refractory period in additional bundles of AV conduction.

Other effects:

- the absence of a negative inotropic effect when taken orally;

— decrease in oxygen consumption by the myocardium due to a moderate decrease in peripheral vascular resistance and heart rate;

- an increase in coronary blood flow due to a direct effect on the smooth muscles of the coronary arteries;

- maintaining the ejection by reducing the pressure in the aorta and reducing the peripheral vascular resistance;

- influence on the metabolism of thyroid hormones: inhibition of the conversion of T3 to T4 (thyroxine-5-deiodinase blockade) and blocking the capture of these hormones by cardiocytes and hepatocytes, leading to a weakening of the stimulating effect of thyroid hormones on the myocardium.

After the start of taking the drug inside, therapeutic effects develop on average after a week (from several days to 2 weeks). After stopping its use, amiodarone is determined in the blood within 9 months. The possibility of maintaining the pharmacodynamic action of amiodarone for 10-30 days after its withdrawal should be taken into account.

Pharmacokinetics

Suction

Bioavailability after oral administration in different patients ranges from 30% to 80% (average value is about 50%). After a single dose of amiodarone orally, Cmax in plasma is reached after 3-7 hours. However, the therapeutic effect usually develops a week after the start of the drug (from several days to 2 weeks).

Distribution

Plasma protein binding is 95% (62% - with, 33.5% - with beta-lipoproteins). Amiodarone has a large V d . Amiodarone is characterized by slow tissue penetration and high affinity for them. During the first days of treatment, the drug accumulates in almost all tissues, especially in adipose tissue and in addition to it in the liver, lungs, spleen and cornea.

Metabolism

Amiodarone is metabolized in the liver by CYP3A4 and CYP2C8 isoenzymes. Its main metabolite, deethylamiodarone, is pharmacologically active and may enhance the antiarrhythmic effect of the parent compound. Amiodarone and its active metabolite deethylamiodarone in vitro have the ability to inhibit CYP1A1, CYP1A2, CYP2C9, CYP2C19, CYP2D6, CYP3A4, CYP2A6, CYP2B6 and CYP2C8 isoenzymes. Amiodarone and deethylamiodarone have also been shown to inhibit several transporters such as P-glycoprotein (P-gp) and organic cation transporter (OC2). In vivo, the interaction of amiodarone with substrates of CYP3A4, CYP2C9, CYP2D6 and P-gp isoenzymes was observed.

breeding

Removal of amiodarone begins after a few days, and the achievement of equilibrium between the intake and excretion of the drug (reaching C ss) occurs after one to several months, depending on the individual characteristics of the patient. The main route of excretion of amiodarone is the intestine. Amiodarone and its metabolites are not excreted by hemodialysis. Amiodarone has a long T 1/2 with great individual variability (therefore, when selecting a dose, for example, increasing or decreasing it, it should be remembered that at least 1 month is needed to stabilize the new plasma concentration of amiodarone).

Elimination by ingestion proceeds in 2 phases: initial T 1/2 (first phase) - 4-21 hours, T 1/2 in the 2nd phase - 25-110 days. After prolonged oral administration, the average T 1/2 is 40 days. After discontinuation of the drug, the complete elimination of amiodarone from the body can last for several months.

Each dose of amiodarone (200 mg) contains 75 mg. Part of the iodine is released from the drug and is found in the urine in the form of iodide (6 mg in 24 hours at a daily dose of amiodarone 200 mg). Most of the iodine remaining in the drug is excreted through the intestines after passing through the liver, however, with prolonged use of amiodarone, iodine concentrations in the blood can reach 60-80% of the concentrations of amiodarone in the blood.

The peculiarities of the pharmacokinetics of the drug explain the use of loading doses, which is aimed at the rapid accumulation of amiodarone in the tissues, in which its therapeutic effect is manifested.

Pharmacokinetics in special clinical situations

Due to the insignificance of excretion of the drug by the kidneys in patients with renal insufficiency, dose adjustment of amiodarone is not required.

Indications

Prevention of relapses

- life-threatening ventricular arrhythmias, including ventricular tachycardia and ventricular fibrillation (treatment should be started in a hospital with careful cardiac monitoring).

- supraventricular paroxysmal tachycardia:

- documented attacks of recurrent sustained supraventricular paroxysmal tachycardia in patients with organic heart disease;

- documented attacks of recurrent sustained supraventricular paroxysmal tachycardia in patients without organic heart disease, when antiarrhythmic drugs of other classes are not effective or there are contraindications to their use;

- documented attacks of recurrent sustained supraventricular paroxysmal tachycardia in patients with Wolff-Parkinson-White syndrome.

- atrial fibrillation (atrial fibrillation) and atrial flutter.

Prevention of sudden arrhythmic death in high-risk patients

- patients after a recent myocardial infarction with more than 10 ventricular extrasystoles per hour, clinical manifestations of chronic heart failure and a reduced left ventricular ejection fraction (less than 40%).

Kordaron can be used in the treatment of arrhythmias in patients with coronary artery disease and / or impaired left ventricular function.

Contraindications

- SSSU (sinus bradycardia, sinoatrial blockade), except for cases of their correction by an artificial pacemaker (danger of "stopping" the sinus node);

- AV block II and III degree in the absence of an artificial pacemaker (pacemaker);

- hypokalemia, hypomagnesemia;

- interstitial lung disease;

- thyroid dysfunction (hypothyroidism, hyperthyroidism);

- congenital or acquired prolongation of the QT interval;

- combination with drugs that can prolong the QT interval and cause the development of paroxysmal tachycardias, including ventricular tachycardia of the "pirouette" type (torsade de pointes): class I A antiarrhythmic drugs (quinidine, hydroquinidine, disopyramide, procainamide); class III antiarrhythmic drugs (dofetilide, ibutilide, bretylium tosylate); sotalol; other (non-antiarrhythmic) drugs such as bepridil; vincamine; some antipsychotics phenothiazines (chlorpromazine, cyamemazine, levomepromazine, thioridazine, trifluoperazine, fluphenazine), benzamides (amisulpride, sultopride, sulpiride, tiapride, veraliprid), butyrophenones (droperidol, haloperidol), sertindole, pimozide; cisapride; tricyclic antidepressants; antibiotics of the macrolide group (in particular, erythromycin with intravenous administration, spiramycin); azoles; antimalarial drugs (quinine, chloroquine, mefloquine, halofantrine); pentamidine when administered parenterally; diphemanil methyl sulfate; mizolastin; astemizole, terfenadine; fluoroquinolones;

- age up to 18 years (efficacy and safety have not been established);

- pregnancy;

- lactation period;

- lactose intolerance (lactase deficiency), glucose-galactose malabsorption syndrome (the drug contains lactose);

- hypersensitivity to iodine, amiodarone or excipients of the drug.

FROM caution should be used in decompensated or severe chronic (III-IV functional class according to the NYHA classification) heart failure, liver failure, bronchial asthma, severe respiratory failure, in elderly patients (high risk of developing severe bradycardia), with AV blockade I degree.

Dosage

The drug should be taken only as prescribed by a doctor.

Kordaron tablets are taken orally before meals and washed down with a sufficient amount of water.

Loading ("saturating") dose: various saturation schemes can be applied.

In the hospital: the initial dose, divided into several doses, ranges from 600-800 mg (up to a maximum of 1200 mg) / day until a total dose of 10 g is reached (usually within 5-8 days).

Outpatient: the initial dose, divided into several doses, ranges from 600 to 800 mg per day until a total dose of 10 g is reached (usually within 10-14 days).

Maintenance dose: may vary in different patients from 100 to 400 mg / day. The minimum effective dose should be used in accordance with the individual therapeutic effect.

Because Kordaron has a very large T 1/2, it can be taken every other day or take breaks in taking it 2 days a week.

The average therapeutic single dose is 200 mg.

The average therapeutic daily dose is 400 mg.

The maximum single dose is 400 mg.

The maximum daily dose is 1200 mg.

Side effects

The frequency of side effects was determined in accordance with the WHO classification: very often (≥10%); often (≥1%,<10); нечасто (≥0.1%, <1%); редко (≥0.01%, <0.1%); очень редко, включая отдельные сообщения (<0.01%); частота неизвестна (по имеющимся данным частоту определить нельзя).

From the side of the cardiovascular system: often - bradycardia, usually moderate, the severity of which depends on the dose of the drug; infrequently - conduction disturbance (sinoatrial blockade, AV blockade of various degrees), arrhythmogenic effect (there are reports of the occurrence of new arrhythmias or aggravation of existing ones, in some cases with subsequent cardiac arrest); based on the available data, it is impossible to determine whether the occurrence of these rhythm disturbances is caused by the action of the Cordaron drug, the severity of the cardiovascular pathology, or is a consequence of treatment failure. These effects are observed mainly in cases of the use of the drug Kordaron in conjunction with drugs that prolong the period of repolarization of the ventricles of the heart (QT interval s) or in violation of electrolytes in the blood.

Very rarely - severe bradycardia or, in exceptional cases, stop of the sinus node, which were observed in some patients (patients with dysfunction of the sinus node and elderly patients), vasculitis; the frequency is unknown - the progression of chronic heart failure (with prolonged use), ventricular tachycardia of the "pirouette" type.

From the digestive system: very often - nausea, vomiting, dysgeusia (dullness or loss of taste), usually occurring when taking a loading dose and passing after its reduction.

From the side of the liver and biliary tract: very often - an isolated increase in serum transaminase activity, usually moderate (1.5-3 times higher than normal values; decreases with dose reduction or spontaneously); often - acute liver damage with increased activity of transaminases and / or jaundice, including the development of liver failure, sometimes fatal; very rarely - chronic liver disease (pseudo-alcoholic hepatitis, cirrhosis), sometimes fatal. Even with a moderate increase in the activity of transaminases in the blood, observed after treatment that lasted more than 6 months, chronic liver damage should be suspected.

From the respiratory system: often - pulmonary toxicity, sometimes fatal (alveolar / interstitial pneumonitis or fibrosis, pleurisy, bronchiolitis obliterans with pneumonia). Although these changes may lead to the development of pulmonary fibrosis, they are generally reversible with early withdrawal of amiodarone and with or without corticosteroids. Clinical manifestations usually disappear within 3-4 weeks. Recovery of the x-ray picture and lung function occurs more slowly (several months). The appearance in a patient taking amiodarone, severe shortness of breath or dry cough, both accompanied and not accompanied by a deterioration in the general condition (fatigue, weight loss, fever) requires a chest x-ray and, if necessary, discontinuation of the drug.

Very rarely - bronchospasm (in patients with severe respiratory failure, especially in patients with bronchial asthma), acute respiratory distress syndrome (sometimes fatal and sometimes immediately after surgery; the possibility of interaction with high oxygen concentrations is expected).

Frequency unknown - pulmonary hemorrhage.

From the side of the organ of vision: very often - micro-deposits in the corneal epithelium, consisting of complex lipids, including lipofuscin, they are usually limited to the pupil area and do not require discontinuation of treatment and disappear after discontinuation of the drug, sometimes they can cause visual impairment in the form of a colored halo or fuzzy contours in bright light; very rarely - optic neuritis / optic neuropathy (the relationship with amiodarone has not yet been established; however, since optic neuritis can lead to blindness, if vision is blurred or visual acuity decreases while taking Kordaron, it is recommended to conduct a complete ophthalmological examination, including fundoscopy, and if optic neuritis is detected, stop taking the drug).

From the endocrine system: often - hypothyroidism (weight gain, chilliness, apathy, reduced activity, drowsiness, excessive, compared with the expected effect of amiodarone, bradycardia). The diagnosis is confirmed by the detection of an elevated serum TSH level (using an ultrasensitive TSH test); normalization of thyroid function is usually observed within 1-3 months after discontinuation of treatment; in life-threatening situations, treatment with amiodarone can be continued with simultaneous additional administration of L-thyroxine under the control of serum TSH levels.

Also, hyperthyroidism often occurs, sometimes fatal, the appearance of which is possible during and after treatment (cases of hyperthyroidism that developed several months after the withdrawal of amiodarone have been described). Hyperthyroidism is more insidious with few symptoms: slight unexplained weight loss, decreased antiarrhythmic and/or antianginal efficacy; mental disorders in elderly patients or even thyrotoxicosis phenomena. The diagnosis is confirmed by detecting a reduced serum TSH level (using an ultrasensitive TSH test). If hyperthyroidism is detected, amiodarone should be discontinued. Normalization of thyroid function usually occurs within a few months after discontinuation of the drug. In this case, the clinical symptoms normalize earlier (after 3-4 weeks) than the normalization of the level of thyroid hormones occurs. Severe cases can be fatal, so in such cases, urgent medical attention is required. Treatment in each case is selected individually. If the patient's condition worsens both due to thyrotoxicosis itself, and due to a dangerous imbalance between myocardial oxygen demand and its delivery, it is recommended to immediately begin treatment: the use of antithyroid drugs (which may not always be effective in this case), treatment with corticosteroids ( 1 mg / kg), which lasts for a long time (3 months), beta-blockers.

Very rarely - a syndrome of impaired secretion of ADH.

From the skin and subcutaneous tissues: very often - photosensitivity; often (in the case of prolonged use of the drug in high daily doses) - grayish or bluish pigmentation of the skin (after stopping treatment, this pigmentation slowly disappears); very rarely - erythema (during radiation therapy), skin rash (usually low specific), alopecia, exfoliative dermatitis, alopecia; frequency unknown - urticaria.

From the nervous system: often - tremor or other extrapyramidal symptoms, sleep disturbances, nightmares; infrequently - sensorimotor peripheral neuropathies and / or myopathy (usually reversible within a few months after discontinuation of the drug, but sometimes not completely); very rarely - cerebellar ataxia, benign intracranial hypertension (pseudotumor of the brain), headache.

From the genitals and mammary gland: very rarely - epididymitis, impotence.

From the hematopoietic system: very rarely - thrombocytopenia, hemolytic anemia, aplastic anemia.

Allergic reactions: the frequency is unknown - angioedema (Quincke's edema).

Laboratory and instrumental data: very rarely - an increase in the concentration of creatinine in the blood serum.

General disorders: the frequency is unknown - the formation of granulomas, including bone marrow granuloma.

Overdose

Symptoms: at ingestion of very large doses, several cases of sinus bradycardia, cardiac arrest, attacks of ventricular tachycardia, paroxysmal ventricular tachycardia of the "pirouette" type and liver damage have been described. It is possible to slow down AV conduction, increase the already existing heart failure.

Treatment: gastric lavage, the use of activated charcoal, if the drug has been taken recently, in other cases, symptomatic therapy is carried out: for bradycardia - beta-adrenostimulators or the installation of a pacemaker, for ventricular tachycardia of the "pirouette" type - intravenous administration of magnesium salts or cardiac stimulation.

Neither amiodarone nor its metabolites are removed by hemodialysis. There is no specific antidote.

drug interaction

Drugs capable of causing torsades de pointes or prolonging the QT interval

Drugs capable of causing ventricular tachycardia of the "pirouette" type

Combination therapy with drugs that can cause ventricular tachycardia of the "pirouette" type is contraindicated, because. the risk of developing potentially fatal ventricular tachycardia of the "pirouette" type increases. These include:

- antiarrhythmic drugs: class IA (quinidine, hydroquinidine, disopyramide, procainamide), sotalol, bepridil;

- other (non-antiarrhythmic) drugs, such as vincamine; some neuroleptics: phenothiazines (chlorpromazine, cyamemazine, levomepromazine, thioridazine, trifluoperazine, fluphenazine), benzamides (amisulpride, sultopride, sulpride, tiapride, veraliprid), butyrophenones (droperidol, haloperidol), sertindole, pimozide; tricyclic antidepressants; cisapride; macrolide antibiotics (erythromycin with intravenous administration, spiramycin); azoles; antimalarial drugs (quinine, chloroquine, mefloquine, halofantrine, lumefantrine); pentamidine when administered parenterally; diphemanil methyl sulfate; mizolastin; astemizole; terfenadine.

Drugs capable of prolonging the QT interval

Co-administration of amiodarone with drugs that can prolong the QT interval should be based on a careful assessment for each patient of the ratio of expected benefit and potential risk (the possibility of an increased risk of developing ventricular tachycardia of the "pirouette" type), when using such combinations, it is necessary to constantly monitor the ECG of patients (for detection of prolongation of the QT interval), the content of potassium and magnesium in the blood.

In patients taking amiodarone, the use of fluoroquinolones, including moxifloxacin, should be avoided.

Drugs that slow the heart rate or cause disturbances in automatism or conduction

Combination therapy with these drugs is not recommended.

Beta-blockers, blockers of slow calcium channels that reduce heart rate (verapamil, diltiazem), can cause disturbances in automatism (development of excessive bradycardia) and conduction.

Drugs that can cause hypokalemia

- with laxatives that stimulate intestinal motility, which can cause hypokalemia, which increases the risk of developing ventricular tachycardia of the "pirouette" type. When combined with amiodarone, laxatives of other groups should be used.

Combinations requiring caution when using

- with diuretics that cause hypokalemia (in monotherapy or in combination with other drugs);

- with systemic corticosteroids (glucocorticoids, mineralocorticoids), tetracosactide;

- with amphotericin B (in / in the introduction).

It is necessary to prevent the development of hypoglycemia, and in case of its occurrence, restore the content of potassium in the blood to a normal level, monitor the concentration of electrolytes in the blood and ECG (for a possible lengthening of the QT interval), and in case of ventricular tachycardia of the "pirouette" type, antiarrhythmic drugs should not be used (Ventricular pacing should be started; IV administration of magnesium salts is possible).

Preparations for inhalation anesthesia

The possibility of developing the following severe complications in patients taking amiodarone during general anesthesia has been reported: bradycardia (resistant to the administration of atropine), lowering blood pressure, conduction disturbances, and reduced cardiac output.

Very rare cases of severe complications from the respiratory system, sometimes fatal (acute adult respiratory distress syndrome, which developed immediately after surgery, and the occurrence of which is associated with high oxygen concentrations), have been observed.

Heart rate slowing drugs (clonidine, guanfacine, cholinesterase inhibitors (donepezil, galantamine, rivastigmine, tacrine, ambenonium chloride, neostigmine bromide), pilocarpine

Risk of developing excessive bradycardia (cumulative effects).

Effect of amiodarone on other medicinal products

Amiodarone and/or its metabolite deethylamiodarone inhibit CYP1A1, CYP1A2, CYP3A4, CYP2C9, CYP2D6 and P-glycoprotein isoenzymes and may increase the systemic exposure of drugs that are their substrates. Due to the long T 1/2 of amiodarone, this interaction can be observed even several months after stopping its administration.

Drugs that are P-gp substrates

Amiodarone is a P-gp inhibitor. It is expected that its co-administration with drugs that are P-gp substrates will lead to an increase in the systemic exposure of the latter.

Cardiac glycosides (digitalis preparations)

The possibility of violations of automatism (pronounced bradycardia) and atrioventricular conduction. In addition, the combination of digoxin with amiodarone may increase the concentration of digoxin in the blood plasma (due to a decrease in its clearance). Therefore, when combining digoxin with amiodarone, it is necessary to determine the concentration of digoxin in the blood and monitor possible clinical and electrocardiographic manifestations of digitalis intoxication. Doses of digoxin may need to be reduced.

Dabigatran

Caution should be exercised when co-administering amiodarone with dabigatran due to the risk of bleeding. The dose of dabigatran may need to be adjusted as directed in its prescribing information.

Drugs that are substrates of the CYP2C9 isoenzyme

Amiodarone increases the blood concentration of drugs that are substrates of the CYP2C9 isoenzyme, such as warfarin or phenytoin, by inhibiting cytochrome P450 2C9.

warfarin

When warfarin is combined with amiodarone, it is possible to enhance the effects of an indirect anticoagulant, which increases the risk of bleeding. Prothrombin time should be monitored more frequently (by determining the INR) and dose adjustments of the anticoagulant should be made, both during treatment with amiodarone and after its discontinuation.

Phenytoin

When phenytoin is combined with amiodarone, an overdose of phenytoin may develop, which can lead to neurological symptoms; clinical monitoring and dose reduction of phenytoin at the first signs of overdose are necessary, it is desirable to determine the concentration of phenytoin in the blood plasma.

Drugs that are substrates of the CYP2D6 isoenzyme

Flecainide

Amiodarone increases the plasma concentration of flecainide by inhibiting the CYP2D6 isoenzyme, and therefore requires dose adjustment of flecainide.

Drugs that are substrates of the CYP3A4 isoenzyme

When combined with amiodarone, an inhibitor of the CYP3A4 isoenzyme, with these drugs, their plasma concentrations may increase, which may lead to an increase in their toxicity and / or an increase in pharmacodynamic effects and may require a reduction in their doses. These medicines are listed below.

Cyclosporine

The combination of cyclosporine with amiodarone may increase plasma concentrations of cyclosporine and dose adjustment is necessary.

Fentanyl

Combination with amiodarone may increase the pharmacodynamic effects of fentanyl and increase the risk of its toxic effects.

HMG-CoA reductase inhibitors (statins) (simvastatin, atorvastatin and lovastatin)

Increased risk of muscle toxicity of statins when used concomitantly with amiodarone. The use of statins that are not metabolized by CYP3A4 is recommended.

Other drugs metabolized by CYP3A4 isoenzyme: lidocaine(risk of developing sinus bradycardia and neurological symptoms), tacrolimus(risk of nephrotoxicity), sildenafil(risk of increasing its side effects), midazolam(risk of developing psychomotor effects), triazolam, dihydroergotamine, ergotamine, colchicine.

A drug that is a substrate of CYP2D6 and CYP3A4 isoenzymes - dextromethorphan

Amiodarone inhibits CYP2D6 and CYP3A4 isoenzymes and may theoretically increase the plasma concentration of dextromethorphan.

Clopidogrel

Clopidogrel is an inactive thienopyrimidine drug metabolized in the liver to active metabolites. An interaction between clopidogrel and amiodarone is possible, which may lead to a decrease in the effectiveness of clopidogrel.

Effects of other medicinal products on amiodarone

CYP3A4 and CYP2C8 isoenzyme inhibitors may have the potential to inhibit the metabolism of amiodarone and increase its concentration in the blood and, accordingly, its pharmacodynamic and side effects.

It is recommended to avoid taking CYP3A4 inhibitors (for example, grapefruit juice and certain drugs, such as cimetidine, and HIV protease inhibitors (including indinavir) during amiodarone therapy. HIV protease inhibitors, when used simultaneously with amiodarone, may increase the concentration of amiodarone in blood.

CYP3A4 isoenzyme inducers

Rifampicin

Rifampicin is a potent inducer of the CYP3A4 isoenzyme; when used together with amiodarone, it can reduce plasma concentrations of amiodarone and deethylamiodarone.

Hypericum perforatum preparations

St. John's wort is a powerful inducer of the CYP3A4 isoenzyme. In this regard, it is theoretically possible to reduce the plasma concentration of amiodarone and reduce its effect (clinical data are not available).

special instructions

Because Side effects of amiodarone are dose-dependent, patients should be treated with the minimum effective dose to minimize the possibility of their occurrence.

Patients should be advised to avoid direct sunlight or take protective measures (eg, sunscreen, appropriate clothing) during treatment.

Treatment monitoring

Due to the prolongation of the period of repolarization of the ventricles of the heart, the pharmacological action of the drug Kordaron causes certain changes in the ECG: prolongation of the QT interval, QT c (corrected), U waves may appear. An increase in the QT interval c no more than 450 ms or no more than 25% of the initial value is acceptable . These changes are not a manifestation of the toxic effect of the drug, however, they require monitoring to adjust the dose and evaluate the possible proarrhythmic effect of Cordaron.

Although arrhythmia or worsening of existing arrhythmias, sometimes fatal, has been noted, the proarrhythmic effect of amiodarone is mild (less pronounced than most antiarrhythmic drugs) and usually occurs in the context of factors prolonging the QT interval, such as interactions with other drugs and / or with violations of the content of electrolytes in the blood. Despite the ability of amiodarone to prolong the QT interval, it showed low activity in inducing torsades de pointes.

Blurred vision or decreased visual acuity should promptly conduct an ophthalmological examination, including examination of the fundus. With the development of neuropathy or optic neuritis caused by amiodarone, the drug must be discontinued due to the risk of blindness.

The development of hypothyroidism can be suspected when the following clinical signs appear, usually mild: weight gain, cold intolerance, decreased activity, excessive bradycardia.

Before surgery, the anesthesiologist should be informed that the patient is taking Kordaron.

In addition, in patients taking Kordaron, in rare cases, acute respiratory distress syndrome was noted immediately after surgery. With artificial ventilation of the lungs, such patients require careful monitoring.

Influence on the ability to drive vehicles and control mechanisms

Based on safety data, there is no evidence that amiodarone interferes with the ability to drive vehicles or engage in other potentially hazardous activities. However, as a precautionary measure, it is advisable for patients with paroxysms of severe arrhythmias during the period of treatment with Kordaron to refrain from driving and engaging in potentially hazardous activities that require increased concentration and psychomotor speed.

Pregnancy and lactation

Pregnancy

Currently available clinical information is insufficient to determine the possibility or impossibility of malformations in the embryo when using amiodarone in the first trimester of pregnancy.

Since the thyroid gland of the fetus begins to bind iodine only from the 14th week of pregnancy (amenorrhea), it is not expected to be affected by amiodarone if it is used earlier. Excess iodine when using the drug after this period can lead to the appearance of laboratory symptoms of hypothyroidism in the newborn or even to the formation of a clinically significant goiter in him.

Due to the effect of the drug on the thyroid gland of the fetus, amiodarone is contraindicated during pregnancy, except in special cases when the expected benefits outweigh the risks (with life-threatening ventricular arrhythmias).

breastfeeding period

Amiodarone is excreted in breast milk in significant quantities, so it is contraindicated during lactation (during this period, the drug should be discontinued or breastfeeding should be stopped).

Application in childhood

Contraindication: children and adolescents under 18 years of age (efficacy and safety have not been established).

For impaired renal function

Insignificant excretion of the drug in the urine allows you to prescribe the drug for renal failure in medium doses. Amiodarone and its metabolites are not subject to dialysis.

For impaired liver function

Use with caution in liver failure.

Use in the elderly

FROM caution should be used in elderly patients (high risk of severe bradycardia).

Terms of dispensing from pharmacies

The drug is dispensed by prescription.

Terms and conditions of storage

The drug should be stored out of the reach of children at a temperature not exceeding 30°C. Shelf life - 3 years.