Cordarone side effects with prolonged use. Kordaron: instructions for use and what it is for, price, reviews, analogues

Antiarrhythmic properties:

Extends the 3rd phase of the action potential of heart cells, which is expressed mainly in a decrease in potassium currents (III class according to the classification of Vaughan Williams);

Reduces the automatism of the sinus node to bradycardia, not responding to the effects of atropine.

Non-competitively inhibits alpha and beta adrenergic activity.

Slows down conduction in the sinoatrial node, atria and atrioventricular (AV) node, which is more pronounced with an accelerated rhythm.

Does not change intraventricular conduction.

Increases the refractory period and reduces myocardial excitability at the atrial, AV-nodal and ventricular levels.

Slows down conduction and lengthens the refractory period of accessory atrioventricular pathways.

Anti-ischemic properties

Moderately reduces peripheral vascular resistance and reduces heart rate, which leads to a decrease in oxygen consumption.

It exhibits alpha and beta adrenergic antagonism by a non-competitive mechanism. Increases coronary blood flow due to a direct effect on smooth muscle myocardial arteries.

Maintains cardiac output by reducing intra-arterial pressure and peripheral vascular resistance. Amiodarone does not have a significant negative inotropic effect.

Controlled pediatric studies have not been conducted.

oral intake

Loading dose: 10-20 mg / kg / day. within 7-10 days (or 500 mg / m 2 / day per square meter of body surface)

Maintenance dose: minimum effective dose; depending on the individual response, it can vary from 5 to 10 mg / kg / day. (or 250 mg / m 2 / day per square meter of body surface)

Pharmacokinetics

Suction

The absorption of amiodarone is slow and variable, the drug has a high affinity for tissues.

Distribution

The volume of distribution is very large, but varies individually, since amiodarone actively accumulates in tissues (adipose tissue, liver, lungs, spleen).

Biotransformation

Amiodarone is metabolized primarily by CYP3A4 and also by CYP2C8.

Amiodarone and its metabolite, deethylamiodarone, have the ability to inhibit CYP2C9, CYP2C19, CYP2D6, CYP3A4, CYP2A6, CYP2B6 and 2C8 in vitro. Amiodarone and deethylamiodarone also have the ability to inhibit some transport systems, for example, P-glycoprotein and organic cation transporter (OCT2). (One study reported a 1.1% increase in creatinine (OST 2 substrate)). In vitro data provide information on interactions with substrates CYP3A4, CYP2C9, CYP2D6 and P-glycoprotein.

Bioavailability after oral administration ranges from 30% to 80% (average 50%). The maximum concentration in plasma after taking a single dose is observed after 3-7 hours. The therapeutic effect develops on average within one week (from several days to two weeks).

breeding

Amiodarone has a long half-life, which varies individually (from 20 to 100 days). During the first few days of treatment, amiodarone accumulates in most body tissues, especially adipose tissue. Elimination begins after a few days, and the equilibrium concentration is reached after one or several months, depending on the patient. Due to these properties, to quickly achieve in tissues end traditions necessary for the manifestation therapeutic effect

Relationship between Pharmacokinetics and Pharmacodynamics

A dose of amiodarone 200 mg contains 75 mg of iodine. The iodine group is separated from the molecule and enters the urine in the form of iodides. This corresponds to 6 mg/24 hours. free iodine For daily dose amiodarone 200 mg. Amiodarone is excreted mainly with bile and feces. Renal excretion is negligible, which allows the use standard doses in patients with renal insufficiency. After discontinuation of treatment, the excretion of the drug continues for several months; it should be noted that the pharmacodynamic effect persists for a period of 10 days to one month.

Neither amiodarone nor its metabolites can be removed by dialysis.

Controlled pediatric studies have not been conducted. In the limited published data on pediatric patients, differences from adults have not been noted.

Data from preclinical studies

Preclinical data based on traditional studies pharmacological safety, repeated use toxicity, genotoxicity, carcinogenicity, teratogenicity and toxicity against reproductive function, did not reveal any specific risks to human health, with the exception of the information indicated in the Pregnancy section, breast-feeding and fertility.

Indications for use

Relapse prevention:

life-threatening ventricular tachycardia: treatment should be started in a hospital with close monitoring.

Electrocardiographically confirmed, symptomatic and disabling ventricular tachycardia.

Electrocardiographically confirmed, supraventricular tachycardia with an established need for treatment, if the tachycardia is resistant to other treatments, or there are contraindications to the use of other drugs.

Ventricular fibrillation.

Prevention of rhythm disturbances in Wolff-Parkinson-White syndrome.

Treatment atrial fibrillation: slow heart rate or recovery sinus rhythm with flutter or flicker (fibrillation) of the atria.

Amiodarone may be used if coronary disease heart and / or the presence of left ventricular dysfunction (see Pharmacodynamics).

Prevention of death due to arrhythmias in patients at high risk for symptomatic congestive heart failure or recent myocardial infarction with low ejection fraction or asymptomatic ventricular extrasystoles.

Amiodarone is indicated for the prevention of all-cause mortality, including sudden cardiac death, in high-risk patients with ischemic or non-ischemic congestive heart failure. high risk basically defined as having clinical symptoms severe heart failure or a decrease in ventricular ejection fraction below 40% of normal with or without the presence of: signs of gastric arrhythmia.

Contraindications

Hypersensitivity to amiodarone or any of the excipients, or iodine.

Sinus bradycardia and sinoatrial heart block, unless the condition is corrected by an artificial pacemaker.

Syndrome of weakness of the sinus node, with the exception of cases of correction of the condition by an artificial pacemaker (danger of stopping the sinus node).

Severe conduction disturbances, in the absence of correction of the condition by an artificial pacemaker.

Hyperthyroidism, due to the possible aggravation of the condition by amiodarone.

Pregnancy

Breast-feeding.

Combination with drugs that can cause tachycardia type "pirouette" (torsades de pointes):

Class 1a antiarrhythmic drugs (quinidine, hydroquinidine, disopyramide),

class III antiarrhythmic drugs (sotalol, dofetilide, ibutilide), sultopride,

Other drugs such as bepridil, cisapride, diphemanil, intravenous erythromycin, mizolastine, moxifloxacin, intravenous vincamine

Pregnancy and lactation

In animal studies, the drug had a fetotoxic effect in some species. Taking amiodarone in the 2nd and 3rd trimester of pregnancy and especially before childbirth is associated with risk; the drug can cause bradycardia and prolongation of the QT interval in newborns and impair the function thyroid gland at the fetus. In this regard, amiodarone therapy during pregnancy is contraindicated, except in cases (when the benefit outweighs the risk).

Breast-feeding

Amiodarone in significant quantities goes to breast milk, and therefore the use of the drug during breastfeeding is contraindicated.

Dosage and administration

The doses shown are for adults only.

Initial treatment

The initial dosage regimen (loading dose) is the appointment of 3 tablets (600 mg) per day for 8-10 days. In some cases, higher doses (4 or 5 tablets per day) may be used at the beginning of treatment, but only for a short time and under electrocardiographic control. The result of therapeutic saturation are characteristic changes on the ECG: prolongation of the QT interval (due to the prolongation of the repolarization period) with possible appearance U waves (see special instructions).

Supportive care

The minimum effective dose should be chosen, which, in accordance with the individual response of the patient, can be in the range from 1/g tablet per day (or one tablet every other day) to 2 tablets every day. During treatment, regular ECG monitoring is necessary.

Special patient groups

kidney failure

In patients with renal insufficiency, dose adjustment is not required (see Pharmacodynamics. Relationship between pharmacokinetics and pharmacodynamics), however clinical experience absent.

Liver failure

There is no clinical experience in patients with hepatic impairment.

Elderly patients

There are no sufficient clinical data on the use in elderly patients. Amiodarone should be used in elderly patients with extreme caution.

Pediatric Patients

The safety and efficacy of amiodarone in children has not been established. Currently available data are described in the Pharmacodynamics and Pharmacokinetics sections).

Mode of application Reception inside.

Side effect

Side effects were classified by organs and systems, as well as by the frequency of manifestation as follows:

Very often (> 1/10); often (>1/100 to 1/1000 to 1/10000 to

If you experience symptoms similar to those described below (especially those in bold italics), please contact your doctor immediately!

Violations of the organ of vision:

Very common Corneal micro-deposits, almost always present in adults, are usually limited to the area under the pupil and do not require discontinuation of treatment. They rarely lead to visual impairment in the form of a colored halo in bright light or a foggy feeling. Microdeposits on the cornea are composed of complex lipid x components and are always completely reversible after discontinuation of the drug.

Very rare: Several cases of optic neuropathy/neuritis with blurred vision, decreased visual acuity, and fundus edema have been described. This can lead to a more or less severe reduction in visual acuity. The relationship of this phenomenon with amiodarone has not yet been established, however, in the absence of other obvious reasons, drug treatment should be suspended.

Skin disorders:

Very common Photosensitivity: Patients should be warned to avoid sunlight(And ultraviolet rays at all).

Often, grayish or bluish skin pigmentation; after cessation of treatment, this pigmentation slowly (within 10-24 months) disappears.

Very rarely:

Erythema may occur during radiotherapy

There are reports about skin rash, usually non-specific

Isolated cases of exfoliative dermatitis; however, the relationship with the drug has not been established.

Hair loss.

Frequency unknown:

Hives

Endocrine disorders

Application Precautions)

hypothyroidism,

Hyperthyroidism, sometimes with lethal outcome

Syndrome of inappropriate secretion of antidiuretic hormone (SIAH)

Respiratory disorders:

Often Cases of pulmonary toxicity (alveolar / interstitial pneumonitis and bronchiolitis obliterans with pneumonia) are described, sometimes with a fatal outcome. In patients with developing dyspnea or unproductive cough both independent symptoms and worsening general condition(fatigue, weight loss, fever) X-ray should be taken chest and, if necessary, stop the drug. These types of pneumopathy can lead to fibrosis of the lung however, they are mostly reversible with early withdrawal of amiodarone with or without corticosteroids. Clinical symptoms usually disappear within 3-4 weeks, and then there is a slower recovery of the radiological picture and lung function (several months).

There have been cases of pleurisy associated with interstitial pneumopathies.

There are also cases of pulmonary hemorrhage (occurrence unknown).

Very rarely:

Several cases of bronchospasm have been described, especially in patients with bronchial asthma.

Several cases of acute respiratory syndrome, sometimes ending fatally, most often - immediately after surgical intervention(possibly influenced high concentration oxygen during mechanical ventilation) (see Special instructions and precautions for use.).

Nervous system disorders:

Tremor or other extrapyramidal symptoms

Sleep disturbances, including nightmares.

Sensory, motor or mixed peripheral neuropathies.

Infrequently:

Myopathies. Peripheral sensorimotor neuropathies and / or myopathies, usually reversible after discontinuation of the drug with prolonged use of amiodarone. They may develop only after several months, sometimes after several years of treatment. They are usually reversible after discontinuation of the drug. However, recovery may be incomplete, very slow, and appear only a few months after withdrawal.

Very rarely:

cerebellar ataxia,

benign intracranial hypertension, headache. The appearance of headaches requires examination to determine the causes.

Liver disorders:

Liver dysfunction has been noted elevated level serum transaminases. The following events have been reported:

Common: acute hepatopathy with elevated serum transaminases and/or jaundice, including death; in such cases, treatment should be discontinued.

Very rare: there are reports of chronic hepatitis at long-term treatment. The histology is consistent with pseudo-alcoholic hepatitis. clinical symptoms and laboratory changes may be minimal (non-permanent hepatomegaly, transaminase levels increased up to 1.5-5 times compared to normal); therefore, regular monitoring of liver function is recommended during treatment. Even a moderate increase in transaminase levels observed after treatment lasting more than 6 months may indicate chronic hepatic disorders. Clinical and biological abnormalities usually regress after discontinuation of the drug; however, there are several reports of irreversible changes.

Heart disorder:

Common: Mostly mild and dose-dependent bradycardia.

Uncommon: conduction disturbances (sinoatrial block, atrioventricular block of varying degrees)

Very rare: In some cases (sinus node dysfunction, elderly patients), severe bradycardia or, in exceptional cases, sinus node arrest have been described.

Frequency unknown:

Pirouette-type tachycardia (torsades de pointes) (see Special Instructions and

precautions for use and Interaction with other medicinal products and other forms of interaction).

Gastrointestinal disorders:

Very common: benign gastrointestinal disorders (nausea, vomiting, taste sensations), usually occurs at the beginning of treatment and disappears when the dosage is reduced

Reproductive system disorders:

Very rare: epididymitis.

Impotence.

Violations by:

Very rare: vasculitis.

Influence on the result of laboratory and instrumental studies:

Very rare: renal dysfunction with mild elevation of creatinine

Blood and lymphatic disorders:

Very rarely:

Thrombocytopenia

Hemolytic anemia

aplastic anemia

Immune system disorders:

Angioedema (Quincke's edema) (unknown).

Overdose

Seek immediate medical attention or go to the emergency room if

Admission Information high doses cases sinus bradycardia, attacks of ventricular tachycardia, in particular ventricular tachycardia of the "pirouette" type, and liver damage. Treatment should be symptomatic. Considering the pharmacokinetic profile of the drug, it is recommended to monitor the patient's condition for a sufficiently long time, monitoring is especially important. heart rate. Neither amiodarone nor its metabolites are removed during dialysis.

Interaction with other drugs

Be sure to inform your doctor about all the medicines that you are taking together with Kordaron, even if this happens on a case-by-case basis.

Drugs that cause Torsade de Pointes arrhythmias or prolong the QT interval

A/ Drugs that cause arrhythmias of the Torsade de Pointes type

The concomitant administration of drugs that can cause torsade de pointes arrhythmia is contraindicated (see section 4.3):

Class 1a antiarrhythmics, sotalol, bepridil

Non-antiarrhythmic agents such as vincamine, sultopride, IV erythromycin, pentamidine (when used parenterally) as available increased risk development of potentially lethal arrhythmias such as torsade de pointes.

B/ Drugs that prolong the QT interval

The co-administration of amiodarone with drugs that prolong the QT interval should be based on a careful assessment possible benefits and risk for each patient, since the risk of developing torsade de pointes arrhythmias may be increased (see section 4.4), and QT interval prolongation in patients should be monitored.

Fluoroquinolones should be avoided in patients receiving amiodarone.

Medicines that slow the heart rate or disturbing automatism or conduction:

Beta blockers and inhibitors calcium channels that reduce the heart rate (verapamil, diltiazem), since automatism disorders (excessive bradycardia) and conduction may develop.

Medications that can cause hypokalemia:

stimulant laxatives, which can cause hypokalemia, thereby increasing the risk of developing torsades de pointes, other types of laxatives should be used.

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 according to its indication.

CYP 2C9 substrates

Amiodarone increases the concentration of CYP 2C9 substrates such as warfarin or phenytoin by inhibiting cytochrome P450 2C9.

Caution should be exercised when using the following medicines in combination with cordarone:

Diuretics that cause hypokalemia (both monodrugs and combined).

Systemic corticosteroids (gluco-, mineralo-), tetracosactide.

Amphotericin B (i.v.).

It is necessary to prevent the development of hypokalemia and correct it if it occurs. The QT interval should be monitored and should not be given in case of torsade de pointes arrhythmia. antiarrhythmic drugs(ventricular pacing should be started, IV magnesium may be used).

General anesthesia:

Potentially serious complications have been reported in patients undergoing general anesthesia: bradycardia (resistant to atropine), hypotension, conduction disturbances, decreased cardiac output.

In very rare cases observed severe complications from the side respiratory system(spicy respiratory distress adult syndrome), sometimes fatal, usually immediately postoperative period. It can be assumed possible relationship with high oxygen concentration.

Amiodarone and/or its metabolites, deethylamiodarone, inhibit CYP3A4, CYP2C9, CYP2D6 and P-glycoprotein and may increase exposure to their substrates.

Due to long period elimination half-life of amiodarone Interactions may occur for several months after discontinuation of amiodarone.

P-gp substrates

Amiodarone is a P-gp inhibitor. It is assumed that simultaneous application with P-gp substrates will increase their exposure.

Digitalis:

A violation of automatism (excessive bradycardia) and atrioventricular conduction (synergistic action) may develop; in addition, an increase in the concentration of digoxin in plasma is possible due to a decrease in the clearance of digoxin.

ECG and plasma digoxin levels should be monitored, and patients should be monitored for clinical signs digitalis toxicity. May need to be corrected therapeutic dose digitalis.

warfarin

Combining warfarin with amiodarone may enhance the effect of an oral anticoagulant, thereby increasing the risk of bleeding. Need more

regularly monitor the level of prothrombin and adjust the dose of -oral anticoagulants as in the process of treatment with amiodarone, treatment with amiodarone.

Phenytoin

The combination of phenytoin with amiodarone can lead to an overdose of phenytoin with the development neurological manifestations. Clinical monitoring should be carried out and the dose of phenytoin should be reduced as soon as signs of overdose appear; plasma phenytoin levels should be determined.

substratesCYP2D6

Flecainide

Amiodarone increases plasma concentrations of flecainide by inhibiting cytochrome CYP 2D6. Therefore, the dose of amiodarone should be reduced.

Substrates CYP P450 ZA4

When these drugs are given concomitantly with amiodarone, an inhibitor of CYP3A4, it may lead to more high level their plasma concentrations, which can cause possible increase their toxicity:

Cyclosporine: Its combination with amiodarone may increase the plasma level of cyclosporine, so the dose should be adjusted.

Fentanyl: Combining it with amiodarone may increase pharmacological effects fentanyl and increase the risk of its toxicity.

Statins. With the concomitant use of amiodarone with statins metabolized by CYP3A 4, such as simvastatin, atorvastatin and lovastatin, the risk of muscle toxicity increases.

Other drugs metabolized by CYP 3A4: lidocaine, tacrolimus, sildenafil, midazolam, triazolam, dihydroergotamine, ergotamine, colchicine.

Drugs with a negative inotropic effect that cause bradycadia and / or depress the AV node: monitoring of clinical manifestations and ECG is necessary.

Antiarrhythmic drugs various groups: Their use may be beneficial, but requires careful monitoring and ECG verification.

CYP3A4 inhibitors and CYP2C8 inhibitors have the potential to inhibit the metabolism of amiodarone and increase its exposure.

Application features

Cardiac effects

Before starting treatment, an ECG should be performed.

In elderly patients, the heart rate may decrease more pronouncedly.

The pharmacological action of amiodarone causes changes in the ECG: prolongation of the QT interval (due to prolongation of repolarization) with the possible appearance of a U wave; these changes are the result of therapeutic saturation, not toxicity.

The drug should be discontinued in the event of 2nd and 3rd degree atrioventricular block, sinoatrial block or bifascicular block. In the case of the development of atrioventricular blockade of the 1st degree, monitoring should be strengthened.

There are reports of the emergence of new types of arrhythmias or aggravation of previously existing ones (see. Side effect).

The arrhythmogenic effect of amiodarone is weak, less than that of most antiarrhythmic drugs, and usually occurs in combination with certain drugs (see Interactions with Other Drugs and Other Forms of Interaction) or electrolyte imbalance.

Thyroid symptoms

Amiodarone contains iodine and therefore may interfere with the results of some tests used to assess thyroid function (binding radioactive iodine, PBI). However, thyroid function can be monitored by determining the level of blood hormones (T3, T4, TSH).

Amiodarone may cause thyroid dysfunction, especially in patients with a history of thyroid dysfunction. Therefore, before the start of treatment, regularly (for example, every 6 months) during treatment and several months after the end of treatment, it is necessary to measure TSH level in serum. If thyroid dysfunction is suspected during treatment with amiodarone, TSH levels should also be measured (see Side Effects).

Pulmonary symptoms

Bouts of dyspnea or dry cough may be associated with pulmonary toxicity, such as the development of interstitial pneumonitis.

Patients who experienced episodes of dyspnea after physical activity, as the only symptom or against the background of a deterioration in the general condition of the patient (fatigue, weight loss and fever), a fluorographic cell should be performed. Continued treatment with amiodarone should be considered because interstitial pneumonitis is often reversible with early withdrawal of amiodarone (clinical symptoms resolve within 3–4 weeks, radiological changes and improvement lung function observed for several months). The possibility of using corticosteroids should be evaluated.

In very rare cases, severe respiratory complications, sometimes fatal ( acute syndrome respiratory failure in adults), usually after surgery. These complications may develop due to interactions associated with high oxygen concentrations.

With oral therapy, acute (severe hepatocellular liver failure or liver damage, sometimes fatal) or chronic disorders liver function; in this regard, it is recommended to reduce the dose of amiodarone or stop treatment with the drug if the level of transaminase exceeds the norm by more than 3 times.

Clinical and biological symptoms chronic kidney failure with oral therapy, they can be mild in severity (enlargement of the liver, an increase in the level of aminotransferases 5 times higher than normal) and reversible when the drug is discontinued, but deaths have also been reported.

Neumuscular symptoms

Amiodarone can cause sensory, motor, or mixed peripheral neuropathies and myopathies (see Adverse Effects). Resolution of symptoms is usually observed within a few months after discontinuation of amiodarone treatment, however, some symptoms may persist.

Ophthalmic symptoms

If vision is blurred or visual acuity is reduced, a complete ophthalmologic examination, including fundus examination, should be performed promptly. If neuropathy or neuritis develops optic nerve caused by amiodarone, the drug must be discontinued, as there is a possibility of developing blindness

Combinations (see Drug Interactions and Other Forms of Interaction) with:

beta-adrenergic blockers, except for sotalol (contraindicated combination) and esmolol (a combination that requires caution when using);

verapamil and diltiazem should only be used for the prevention of life-threatening ventricular arrhythmias. Since the drug contains lactose, it is contraindicated in patients suffering from congenital galactosemia, glucose-galactose malabsorption syndrome or lactase deficiency.

Precautionary measures

Side effects (see Adverse Effects) are generally dose dependent and therefore the lowest effective therapeutic dose should be used.

Patients should be advised to avoid sunlight and use sun protection measures during treatment (see Adverse Effects).

Monitoring clinical condition(see Special instructions and precautions for use and Side effects).

In addition, since amiodarone can lead to hypothyroidism or hyperthyroidism, especially in patients with a history of thyroid disorders, it is recommended to initiate clinical and biological monitoring (TSH) before using amiodarone. This monitoring should be continued during treatment and for several months after its termination. If thyroid dysfunction is suspected, serum TSH levels should be measured.

Increases in ventricular defibrillation and/or pacing threshold of a pacemaker or implantable cardiac defibrillator have been reported, potentially affecting drug efficacy, especially in the context of long-term use antiarrhythmic drugs.

In this regard, before and during treatment with amiodarone, a periodic check of the operation of the device used should be performed.

Thyroid disease (see side effects)

Amiodarone contains iodine and therefore may interfere with radioiodine intake. However, thyroid function test results (free T3, free T4, TSH) remain interpretable. Amiodarone inhibits the peripheral conversion of thyroxine (T4) to triiodothyronine (T3) and may cause local biochemical changes in patients with normal function thyroid gland (increase in the level of free T4 against the background of a slight decrease or even maintenance of the normal level of free T3). Similar phenomena do not require discontinuation of amiodarone treatment.

The basis for suspicion of hypothyroidism is the development of the following clinical symptoms: weight gain, cold intolerance, reduced activity, excessive bradycardia. The diagnosis is confirmed by a marked increase in serum TSH levels. Recovery of thyroid function to normal usually occurs within 1 to 3 months after discontinuation of therapy. In life-threatening cases, amiodarone therapy may be continued in combination with L-thyroxine. The dose of L-thyroxine is adjusted according to the level of TSH.

Pediatric Patients

The efficacy and safety of amiodarone in children has not been established, therefore, the use of the drug in pediatric patients is not recommended. Currently available data are presented in the Pharmacodynamics and Pharmacokinetics sections.

Anesthesia (see Interaction with other medicinal products and other forms of interaction and Side effects)

Before surgery, the anesthesiologist should be notified that the patient is taking amiodarone.

Medicine contains lactose monohydrate (71 mg). The drug should not be taken by patients with hereditary lactose intolerance, galactose intolerance or malabsorption of glucose-galactose.

Release form

10 split tablets in PVC / aluminum blister. 3 blisters in a cardboard box along with instructions for use.

Self-medication can be harmful to your health.
It is necessary to consult a doctor, and also read the instructions before use.

Class III antiarrhythmic drug
Preparation: CORDARON

The active substance of the drug: amiodarone
ATX encoding: C01BD01
CFG: Antiarrhythmic drug
Registration number: P No. 014833/01-2003
Date of registration: 12.03.03
The owner of the reg. Award: SANOFI WINTHROP INDUSTRIE (France)

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 when normal conditions applications. 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 current of potassium through the channels cell membranes 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 reducing peripheral resistance.
Cordarone 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.

Suction
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 blood plasma is reached after 3-7 hours.
Distribution
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 individual characteristics 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.
breeding
Elimination by ingestion 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 has importance when choosing a dose, because it takes at least 1 month to stabilize the plasma concentration, 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 for renal failure in medium doses. Amiodarone and its metabolites are not subject to dialysis.

Indications for use:

Relief of ventricular attacks 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 sustainable form atrial fibrillation (atrial fibrillation) and atrial flutter.
Prevention of relapses
- 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 diseases heart when antiarrhythmic drugs 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 recent myocardial infarction myocardium with more than 10 ventricular extrasystoles in 1 hour, clinical manifestations chronic heart failure and decreased left ventricular ejection fraction (<40%).
Kordaron is especially recommended for patients with organic heart disease (including coronary artery disease), accompanied by dysfunction of the left ventricle.
Kordaron for intravenous administration is intended for use only in a hospital in cases where a rapid achievement of an antiarrhythmic effect is required or when oral administration of the drug is not possible.

For oral administration
When prescribing the drug in a loading dose, various schemes can be used. When used in a hospital, the initial dose, divided into several doses, ranges from 600-800 mg / day to a maximum of 1200 mg / day (usually within 5-8 days).
For outpatient administration, the initial dose, divided into several doses, ranges from 600 mg to 800 mg / day (usually within 10-14 days).
The maintenance dose is determined at the rate of 3 mg / kg of body weight per day and can range from 100 mg / day to 400 mg / day when taken 1 time / day. The lowest effective dose should be used. Because Amiodarone has a very long half-life and can be taken every second day (200 mg can be given every other day, while 100 mg is recommended daily) or taken intermittently (2 days a week).

The loading dose of Kordaron is initially 5-7 mg/kg of body weight in 250 ml of a 5% dextrose (glucose) solution for 30-60 minutes. The therapeutic effect of Kordaron appears during the first minutes of administration and disappears gradually, which requires correction of the rate of its administration in accordance with the results of treatment.
For maintenance therapy, the drug is prescribed as a continuous or intermittent (2-3 times / day) intravenous infusion in a 5% dextrose (glucose) solution for several days at a dose of up to 1200 mg / day. After intravenous administration at a loading dose, instead of continuing intravenous infusion, it is possible to switch to taking Kordarone orally at a dose of 600-800 mg to 1200 mg / day. From the first day of intravenous administration of Kordaron, it is advisable to start a gradual transition to taking the drug orally.
When conducting intravenous injections, the drug at a dose of 5 mg / kg is administered for at least 3 minutes. Kordaron should not be taken in the same syringe with other drugs!
For intravenous infusion, concentrations below 600 mg/l should not be used. For the preparation of solutions for intravenous administration, use only 5% dextrose (glucose) solution.

Side effects of Kordaron:

Solution for intravenous administration
Systemic reactions: sensation of heat, increased sweating, decrease in blood pressure (usually moderate and transient); cases of severe arterial hypotension or collapse (were reported with overdose or too rapid administration), moderate bradycardia (in some cases, especially in elderly patients, severe bradycardia and, in exceptional cases, stop the sinus node, requiring discontinuation of therapy); rarely - proarrhythmic action. At the beginning of therapy, there is an increase in the activity of hepatic transaminases in the blood serum, which usually remains moderate (1.5-3 times the upper limit of normal /ULN/) and, as a rule, normalizes with a decrease in dose or even spontaneously. With a significant increase in the level of transaminases, treatment should be discontinued. There are separate reports of cases of acute liver failure with high levels of hepatic transaminases in the blood serum and / or jaundice (some fatal). In isolated (extremely rare) cases, anaphylactic shock, benign intracranial hypertension (pseudotumor of the brain), bronchospasm and / or apnea have been observed in patients with severe respiratory failure, especially in patients with bronchial asthma. Several cases of acute respiratory distress were observed, mainly associated with interstitial pneumonitis.
Local reactions: phlebitis (may be avoided by using a central venous catheter).
For oral administration
From the side of the cardiovascular system: bradycardia (mostly moderate and dose-dependent); in some cases (with dysfunction of the sinus node, in the elderly) - severe bradycardia; in exceptional cases - sinus blockade; rarely - conduction disturbances (sinoatrial blockade, AV blockade of various degrees, intraventricular blockade); in some cases - the emergence of new arrhythmias or aggravation of existing ones, in some cases - with subsequent cardiac arrest (according to the available data, it is impossible to establish a connection with the use of the drug, with the severity of heart damage or with treatment failure). These effects are observed mainly in cases of joint use of Kordaron with drugs that prolong the period of repolarization of the ventricles of the heart (QTc interval) or in violation of the electrolyte balance.
On the part of the organ of vision: microdeposits of lipofuscin in the cornea of ​​the eye (almost always present) are usually limited to the pupil area, reversible after discontinuation of the drug, sometimes lead to visual impairment in the form of a colored halo in bright light or a feeling of fog; in some cases, neuropathy / optic neuritis (the relationship with the intake of amiodarone has not yet been clearly established).
Dermatological reactions: photosensitivity; erythema (during radiotherapy); in some cases - a rash (usually non-specific), exfoliative dermatitis (the relationship with the drug has not been formally established); with prolonged use in high doses - grayish or bluish pigmentation of the skin (slowly disappears after stopping treatment).
From the endocrine system: an increase in the level of T3 in the blood serum (T4 remains normal or slightly reduced) in such cases, in the absence of clinical signs of thyroid dysfunction, drug withdrawal is not required); possible development of hypothyroidism (mild weight gain, reduced activity, more pronounced / compared with expected / bradycardia); hyperthyroidism (both during therapy and within a few months after discontinuation of the drug). Suspicion of hyperthyroidism may occur with the following mild clinical symptoms: weight loss, arrhythmias, angina pectoris, heart failure. The diagnosis is confirmed by a clear decrease in serum TSH. Amiodarone should be discontinued.
From the digestive system: nausea, vomiting, taste disturbances (usually occur at the beginning of therapy when used in loading doses and decrease with dose reduction); at the beginning of treatment - an isolated increase (1.5-3 times higher than ULN) in the activity of hepatic transaminases (decrease with a decrease in the dose of the drug or even spontaneously); in some cases - acute liver dysfunction and / or jaundice (require drug withdrawal), fatty hepatosis, cirrhosis. Clinical symptoms and laboratory changes may be minimal (hepatomegaly is possible, an increase in liver transaminase activity is increased up to 1.5-5 times compared with VGN); therefore, regular monitoring of liver function is recommended during treatment.
From the respiratory system: in some cases - pneumonitis, fibrosis, pleurisy, bronchiolitis obliterans with pneumonia (sometimes fatal), bronchospasm in patients with severe respiratory diseases (especially with bronchial asthma), acute respiratory distress syndrome in adults.
From the side of the central nervous system and peripheral nervous system: rarely - sensorimotor peripheral neuropathies and / or myopathies (usually reversible after discontinuation of the drug), extrapyramidal tremor, cerebellar ataxia; in rare cases - benign intracranial hypertension, nightmares.
Allergic reactions: rarely - vasculitis, kidney damage with increased creatinine levels, thrombocytopenia; in some cases - hemolytic anemia, aplastic anemia.
Others: alopecia; in some cases - epididymitis, impotence (the connection with the use of the drug has not been established).

Contraindications to the drug:

For oral administration
- SSSU (sinus bradycardia, sinoatrial block) except for cases of correction by an artificial pacemaker;
- disorders of AV and intraventricular conduction (AV block II and III degree, bundle branch block) in the absence of an artificial pacemaker (pacemaker);
- thyroid dysfunction (hypothyroidism, hyperthyroidism);
- hypokalemia;
- heart failure (in the stage of decompensation);
- simultaneous reception of MAO inhibitors;
- interstitial lung disease;

- pregnancy;
- lactation;

For solution for intravenous administration
- SSSU (sinus bradycardia, sinoatrial blockade) with the exception of patients with an artificial pacemaker (danger of stopping the sinus node);
- AV block II and III degree, violations of intraventricular conduction (blockade of two and three legs of the bundle of His); in these cases, intravenous amiodarone can be used in specialized departments under the cover of an artificial pacemaker (pacemaker);
- acute cardiovascular insufficiency (shock, collapse);
- severe arterial hypotension;
- simultaneous use with drugs that can cause polymorphic ventricular tachycardia of the "pirouette" type;
- dysfunction of the thyroid gland (hypothyroidism, hyperthyroidism);
- pregnancy;
- lactation;
- age up to 18 years (efficacy and safety have not been established);
- Hypersensitivity to iodine and/or amiodarone.
In / in the introduction is contraindicated in severe impairment of lung function (interstitial lung disease), cardiomyopathy or decompensated heart failure (possibly worsening of the patient's condition).
Use with caution in chronic heart failure, liver failure, bronchial asthma, in old age (due to the high risk of developing severe bradycardia).

Use during pregnancy and lactation.

During pregnancy, Kordaron is prescribed only for health reasons, because. the drug has an effect on the thyroid gland of the fetus.
Amiodarone is excreted in breast milk in significant quantities, so the drug is contraindicated for use during lactation.

Special instructions for the use of Kordaron.

An ECG study is recommended before and during treatment. 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, QTc, U waves may appear. An increase in the QTc interval is not more than 450 ms or not more than 25% of the initial value. 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.
It should be borne in mind that in elderly patients there is a more pronounced decrease in heart rate.
With the development of AV block II or III degree, sinoatrial or bifascicular blockade, treatment with Cordaron should be discontinued.
The appearance of shortness of breath or an unproductive cough may be associated with the toxic effect of Kordaron on the lungs. In patients with increasing dyspnoea during physical exertion, regardless of the deterioration of their general condition (increased fatigue, weight loss, fever), a chest x-ray should be performed before starting therapy. Respiratory disorders are mostly reversible with early withdrawal of amiodarone. Clinical symptoms usually disappear within 3-4 weeks, and then there is a slower recovery of the x-ray picture and lung function (several months). Therefore, consideration should be given to reevaluating amiodarone therapy and prescribing corticosteroids.
If there is blurred vision or a decrease in visual acuity while taking Kordaron, it is recommended to conduct a complete ophthalmological examination, including fundoscopy. Cases of optic neuropathy and / or optic neuritis require a decision on the advisability of using Kordaron.
Cordarone contains iodine (200 mg contains 75 mg of iodine), so it can affect the results of tests for the accumulation of radioactive iodine in the thyroid gland, but does not affect the reliability of determining T3, T4 and TSH. Amiodarone can cause thyroid dysfunction, especially in patients with a history of thyroid dysfunction (including family history). Therefore, before the start of treatment, 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 measured. When signs of hypothyroidism appear, normalization of thyroid function is usually observed within 1-3 months after stopping treatment. In life-threatening situations, treatment with amiodarone may be continued, with simultaneous additional administration of levothyroxine. Serum TSH levels serve as a guideline for the dosage of levothyroxine. If signs of hyperthyroidism appear, 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 than the normalization of the level of hormones that reflect the function of the thyroid gland occurs. In severe cases, urgent medical intervention is required. Treatment in each individual case is selected individually and includes antithyroid drugs (which may not always be effective), corticosteroids, beta-blockers.
Kordaron for intravenous administration is used only in a specialized department of a hospital under constant monitoring of ECG, blood pressure. In this case, Kordaron should be administered as infusions, and not as injections, due to the risk of hemodynamic disturbances (arterial hypotension, acute cardiovascular insufficiency).
In / in injections of Kordaron should be carried out only in emergency situations, when there are no other therapeutic options, and only in cardio intensive care units with continuous ECG monitoring.
When Cordarone is administered as an injection, a dose of about 5 mg/kg should be administered over at least 3 minutes. The injection should not be repeated earlier than 15 minutes after the first injection, even if the latter consisted of only one ampoule (irreversible collapse is possible).
Special care is required when infusing the drug in case of arterial hypotension, severe respiratory failure, decompensated cardiomyopathy or severe heart failure.
Patients should avoid prolonged sun exposure and UV exposure (or use sunscreen).
Influence on the ability to drive vehicles and control mechanisms
Currently, there is no evidence that Kordaron affects the ability to drive vehicles and control mechanisms.

Drug overdose:

Symptoms: sinus bradycardia, cardiac arrest, ventricular tachycardia, paroxysmal ventricular tachyarrhythmias of the "pirouette" type, circulatory disorders, liver dysfunction, decreased blood pressure.
Treatment: symptomatic therapy is carried out (gastric lavage, the appointment of cholestyramine, with bradycardia - beta-adrenostimulators or the installation of a pacemaker, with tachycardia of the "pirouette" type - in / in the introduction of magnesium salts, slowing pacemaker). Amiodarone and its metabolites are not removed by dialysis.
There is no information on overdose with the on / in the introduction of Kordaron.

Interaction Cordarone with other drugs.

While taking Kordaron with antiarrhythmic drugs (including bepridil, class I A drugs, sotalol), as well as with vincamine, sultopride, erythromycin for intravenous administration, pentamidine for parenteral administration, the risk of developing polymorphic paroxysmal ventricular tachycardia of the "pirouette" type increases. Therefore, these combinations are contraindicated.
Combination therapy with beta-blockers, some calcium channel blockers (verapamil, diltiazem) is not recommended. disturbances of automatism (manifested by bradycardia) and conduction may develop.
It is not recommended to use Kordaron simultaneously with laxatives (stimulating intestinal motility), which can cause hypokalemia, tk. the risk of developing ventricular tachycardia of the "pirouette" type increases.
With caution, Kordaron should be used simultaneously with drugs that cause hypokalemia (diuretics, systemic corticosteroids and mineralocorticoids, tetracosactide, amphotericin B / for intravenous administration /), because development of ventricular tachycardia of the "pirouette" type is possible.
With the simultaneous use of Kordaron with oral anticoagulants, the risk of bleeding increases (therefore, it is necessary to control the level of prothrombin and adjust the dose of anticoagulants).
With the simultaneous use of Kordaron with cardiac glycosides, automatism disturbances (manifested by severe bradycardia) and atrioventricular conduction disturbances may be observed. In addition, it is possible to increase the concentration of digoxin in the blood plasma due to a decrease in its clearance (therefore, it is necessary to control the concentration of digoxin in the blood plasma, conduct ECG and laboratory monitoring, and, if necessary, change

Dosage and method of application of the drug.

cardiac glycosides).
With the simultaneous use of Kordaron with phenytoin, cyclosporine, flecainide, an increase in the concentration of the latter in the blood plasma is possible (therefore, the concentration of phenytoin, cyclosporine, flecainide in the blood plasma should be monitored and, if necessary, their dose should be adjusted).
Cases of bradycardia (resistant to atropine), arterial hypotension, conduction disturbances, and a decrease in cardiac output in patients taking Kordaron and undergoing general anesthesia are described.
When using oxygen therapy in the postoperative period in patients treated with Kordaron, rare cases of the development of severe respiratory complications, sometimes ending in death (acute respiratory distress syndrome in adults), are described.
When used together with simvastatin, it is possible to increase the risk of side effects (primarily rhabdomyolysis) due to impaired metabolism of simvastatin (if such a combination is necessary, the dose of simvastatin should not exceed 20 mg / day, if the therapeutic effect is not achieved at this dose, you should switch to taking another lipid-lowering drug).

Conditions of sale in pharmacies.

The drug is dispensed by prescription. The drug in the form of a solution for intravenous administration is intended for use only in a hospital setting.

Terms of the storage conditions of the drug Kordaron.

The drug in the form of tablets should be stored at room temperature (not higher than 30°C). The shelf life of the tablets is 3 years. The drug in the form of a solution for intravenous administration should be stored in a dry place at a temperature not exceeding 25 ° C. The shelf life of the solution for intravenous administration is 2 years.

Pills

Relapse prevention:

Life-threatening ventricular arrhythmias, including ventricular tachycardia and ventricular fibrillation (treatment should be initiated in a hospital with close 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 per hour, clinical manifestations of chronic heart failure and a 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;

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

Form of release of the drug Kordaron

Tablets 200 mg; blister 10, cardboard pack 3;

Compound
Divisible tablets 1 tab.
amiodarone hydrochloride 200 mg
excipients: lactose monohydrate; corn starch; magnesium stearate; povidone K90F; silicon dioxide colloidal anhydrous
in a blister 10 pcs.; in a box of 3 blisters.

Solution for intravenous administration 3 ml
amiodarone hydrochloride 150 mg
excipients (per ampoule): benzyl alcohol - 60 mg; polysorbate 80 - 300 mg; water for injection - up to 3 ml
in ampoules of 3 ml; in a box of 6 pcs.

Pharmacodynamics of Cordaron

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 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.

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 of Cordaron

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. Its main metabolite, deethylamiodarone, is pharmacologically active and may enhance the antiarrhythmic effect of the main compound.

Amiodarone is an inhibitor of hepatic isoenzymes of microsomal oxidation: CYP2C9, CYP2D6, CYP3A4, CYP3A5, CYP3A7.

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 T1 / 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 T1 / 2 (first phase) - 4-21 hours, T1 / 2 in the 2nd phase - 25-110 days (20-100 days). After prolonged oral administration, the average T1 / 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 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 eliminated. 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.

Use of Cordarone during pregnancy

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).

Contraindications to the use of Cordaron

Common for both dosage forms

Hypersensitivity to iodine, amiodarone or excipients of the drug;

Weak sinus syndrome (sinus bradycardia, sinoatrial block), 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 tachycardias, including polymorphic ventricular tachycardia of the "pirouette" type (torsade de pointes) (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 not 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.

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

Use with caution in arterial hypotension, decompensated or severe chronic (III-IV FC 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 of the first degree .

Side effects of Cordaron

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).

Pills.

Since the cardiovascular system: 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 Cordarone® use in conjunction with drugs that prolong the period of repolarization of the ventricles of the heart (QTc interval) or in electrolyte imbalance (see "Interaction"). 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). The frequency is not known - the progression of chronic heart failure (with prolonged use).

On the part of the digestive system: 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 an increase in 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.

From the respiratory system: often - cases of interstitial or alveolar pneumonitis and bronchiolitis obliterans with pneumonia have been reported, sometimes resulting in death. 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, 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 bleeding.

From the sensory organs: 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 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.

On the part 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, cases of erythema may occur, there are reports of skin rashes, 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 Cordarone® use in conjunction 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"). 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").

On the part 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.

Injection site reactions: 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.

Dosage and administration of Kordaron

Pills. Inside, before meals, drinking plenty of water. The drug should be taken only as prescribed by a doctor!

Loading (“saturating”) dose: Various schemes of saturation can be used.

In the hospital: the initial dose, divided into several doses, is 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, 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 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® (injectable form) is intended for use in cases where a rapid achievement of an antiarrhythmic effect is required, or if it is impossible to use the drug inside.

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 or other drugs should be administered simultaneously through the same venous access. Use diluted only. To dilute 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, which is 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 infusion is stopped, therefore, if it is necessary to continue treatment with injectable Kordaron®, it is recommended to switch to a permanent intravenous drip of the drug.

Maintenance doses: 10–20 mg/kg/day (usually 600–800 mg, but may be increased to 1200 mg/day) in 250 ml of 5% dextrose (glucose) solution for several days. From the first day of infusion, a gradual transition to Cordarone® intake should begin (3 tablets, 200 mg per day). 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 Kordaron® at a dose of 150 mg (or 2.5 mg / kg) is possible.

Overdose of Kordaron

Symptoms: Several cases of sinus bradycardia, cardiac arrest, attacks of ventricular tachycardia, paroxysmal torsades de pointes, and liver damage have been described with very large oral doses. 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 pacing. 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.

Interactions of the drug Kordaron with other drugs

Severe arrhythmia, such as torsade de pointes, can be caused by a number of drugs, primarily class IA and III antiarrhythmics and some antipsychotics (see below). Predisposing factors for its development may be hypokalemia, bradycardia, or congenital or acquired prolongation of the QT interval.

Contraindicated combinations (see "Contraindications"):

Drugs that can cause polymorphic ventricular tachycardia type "pirouette" (torsade de pointes) (when combined with amiodarone increases the risk of potentially fatal ventricular tachycardia type "pirouette"):

Antiarrhythmic drugs: class IA (quinidine, hydroquinidine, disopyramide, procainamide), class III (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; tricyclic antidepressants; cisapride; macrolide antibiotics (erythromycin when administered intravenously, spiramycin); azoles; antimalarials (quinine, chloroquine, mefloquine, halofantrine, lumefantrine); pentamidine when administered parenterally; diphemanil methyl sulfate; mizolastin; astemizole; terfenadine; fluoroquinolones (in particular, moxifloxacin).

Beta-blockers, CCBs that slow down heart rate (verapamil, diltiazem), because there is a risk of developing disorders of automatism (severe bradycardia) and conduction.

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:

Drugs that can cause hypokalemia:

Diuretics causing hypokalemia (in monotherapy or combination);

Amphotericin B (i.v.);

Systemic GCS;

Tetracosactide.

An increased risk of developing ventricular arrhythmias, especially ventricular tachycardia of the "pirouette" type (hypokalemia is a predisposing factor). It is necessary to monitor the level of electrolytes in the blood, if necessary, correct hypokalemia and constant clinical and electrocardiographic monitoring of the patient. In the case of the development of ventricular tachycardia of the "pirouette" type, antiarrhythmic drugs should not be used (ventricular pacing should be started, intravenous administration of magnesium salts is possible).

Procainamide (see "Contraindicated combinations") - amiodarone may increase the plasma concentration of procainamide and its metabolite N-acetylprocainamide, which may increase the risk of side effects of procainamide.

Anticoagulants of indirect action. Amiodarone increases the concentration of warfarin by inhibiting cytochrome P4502C9. When warfarin is combined with amiodarone, the effects of an indirect anticoagulant may be enhanced, which increases the risk of bleeding. INR should be monitored more frequently and anticoagulant doses adjusted both during and after amiodarone treatment.

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.

Esmolol - violations of contractility, automatism and conduction (suppression of compensatory reactions of the sympathetic nervous system). Clinical and ECG monitoring is required.

Phenytoin (and, by extrapolation, fosphenytoin) - amiodarone can increase plasma concentrations of phenytoin due to inhibition of cytochrome P4502C9, therefore, when phenytoin is combined with amiodarone, an overdose of phenytoin may develop, which can lead to neurological symptoms; clinical monitoring is necessary and, at the first signs of an overdose, a dose reduction of phenytoin; it is desirable to determine the concentration of phenytoin in blood plasma.

Flecainide - Amiodarone increases the plasma concentration of flecainide by inhibiting cytochrome CYP2D6. In this connection, dose adjustment of flecainide is required.

In this medical article, you can get acquainted with the drug Kordaron. The instructions for use will explain in which cases you can take injections or tablets, what the medicine helps with, what are the indications for use, contraindications and side effects. The annotation presents the form of release of the drug and its composition.

In the article, doctors and consumers can only leave real reviews about Kordaron, from which you can find out if the drug helped in the treatment of arrhythmia and atrial and ventricular fibrillation in adults and children, for which it is also prescribed. The instructions list Cordarone analogues, drug prices in pharmacies, as well as its use during pregnancy.

Cordarone is an antiarrhythmic drug. Instructions for use informs that 200 mg tablets, injections in ampoules for intravenous injections have a coronary dilating, antianginal effect.

Release form and composition

Kordaron is produced in the form:

• tablets for oral administration in blisters of 10 pieces, 3 blisters in a cardboard box with attached instructions. On one side of the tablet there is an engraving in the form of a heart;
• solution for intravenous (in / in) administration: a clear liquid of light yellow color (3 ml in ampoules, 6 pcs in a box).

The main active ingredient of the drug is Amiodarone hydrochloride, 1 tablet contains 200 mg. Also, the composition of the drug includes a number of auxiliary components, including lactose monohydrate, which should be taken into account in patients with congenital lactose intolerance.

In 1 ml of solution - 50 mg of the active ingredient.

pharmachologic effect

In addition to the antiarrhythmic action, Kordaron has coronary dilating, antianginal, as well as alpha and beta adrenoblocking effects. The mechanism of the antiarrhythmic action of Kordaron is due to the ability of the drug to block the ion current in potassium channels and thereby increase the duration of the third phase of the action potential of cardiomyocytes.

It reduces the heart rate by reducing the automatism of the sinus node, blocks alpha and beta adrenoreceptors, slows down atrial, sinoatrial and AV conduction, and also reduces the excitability of the atrial and ventricular myocardium. The use of the drug allows you to achieve the desired effect after 7 days from the start of therapy. Sometimes this period takes from several days to two weeks.

Indications for use

What helps Kordaron? Tablets are prescribed to prevent relapse:

• atrial fibrillation (atrial fibrillation) and atrial flutter;
• life-threatening ventricular arrhythmias and ventricular fibrillation (treatment should be started in a hospital with careful cardiac monitoring);
• 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;
• 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 with WPW syndrome.

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

Solution

• relief of paroxysmal and stable forms of atrial fibrillation (atrial fibrillation) and atrial flutter;
• cardioresuscitation in cardiac arrest caused by ventricular fibrillation resistant to cardioversion;
• relief of attacks of supraventricular paroxysmal tachycardia with a high frequency of ventricular contractions (especially against the background of WPW syndrome);
• relief of attacks of ventricular paroxysmal tachycardia.

Instructions for use

Cordarone 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.

Injection: is 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.

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:

• sinus bradycardia;
• Congenital lactose intolerance or lactase deficiency;
• interstitial lung disease;
• Age up to 18 years;
• Simultaneous use of drugs that change the parameters of the electrocardiogram and can cause the development of paroxysmal tachycardia;
• Pregnancy and the period of breastfeeding;
• Individual intolerance to the components of the drug;
• Severe thyroid dysfunction (hyper or hypothyroidism);
• Hypokalemia or hypomagnesemia.

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

Side effects

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

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

• Respiratory system: apnea, bronchospasm, pleurisy, pulmonary fibrosis, alveolitis, anterstitial pneumonia, shortness of breath, cough.
• 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.
• Digestive system: cirrhosis of the liver, jaundice, cholestasis, toxic hepatitis, increased levels of liver enzymes, loss, dulling of taste perception, decreased appetite, vomiting, nausea.
• Nervous system: sleep disorders, memory disorders, peripheral neuropathy, paresthesia, auditory hallucinations, fatigue, depression, dizziness, weakness, headaches, optic neuritis, intracranial hypertension, ataxia, extrapyramidal manifestations.

Children, during pregnancy and lactation

Cordarone is contraindicated during pregnancy and lactation (breastfeeding).

Amiodarone is excreted in breast milk in significant quantities, therefore, if necessary, the use of the drug during lactation should stop breastfeeding.

Contraindicated in children and adolescents under 18 years of age (efficacy and safety not established).

special instructions

Before starting therapy, an ECG study and a blood test for the content of potassium in it should be performed. Hypokalemia must be corrected before starting the drug. Every 3 months during treatment, you need to undergo an ECG, monitor the activity of transaminases and other indicators of liver function.

Patients with a history of thyroid disease should be screened for dysfunction and thyroid disease before starting treatment. During therapy with Kordaron, an x-ray examination of the lungs and pulmonary functional tests should be performed every six months.

With the development of AV block II and III degree, sinoatrial block or two-bundle intraventricular block, Kordaron should be canceled. Long-term use of the drug may increase the hemodynamic risk when local or general anesthesia is administered.

drug interaction

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

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

Drugs that cause photosensitivity may cause an additive photosensitizing effect.

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.

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

Cordarone is able to suppress the absorption of sodium pertechnett, sodium iodide by the thyroid gland. The drug causes an increase in the effects of indirect anticoagulants (acenocoumarol and warfarin).

Cardiac glycosides, Verapamil, beta-blockers increase the likelihood of inhibition of atrioventricular conduction, the development of bradycardia. When prescribing warfarin, its dosage is reduced to 66%, when prescribing acenocoumarol - by 50%, control of prothrombin time is mandatory.

Cordaron's analogs

According to the structure, analogues are determined:

1. Amiodarone.

Keep the medicine away from children at room temperature. Shelf life of tablets - 3 years, solution for injection - 2 years

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 paroxysmal supraventricular 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 (with 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), ser tindol, 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.

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.

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

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Pharmacy24

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

PaniApteka

• Kordaron rr d / in. 150mg amp. 3ml №6

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BIOSPHERE

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

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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 supraventricular paroxysmal 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 blockade II and III degree or bifascicular intraventricular blockade, 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.

spravka03.net

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, maintenance of 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 (