Kordaron - use and contraindications. When Kordaron is prescribed: instructions for use Kordaron side effects

Relapse prevention:
- life-threatening ventricular arrhythmias and ventricular fibrillation (treatment should be started in a hospital with careful cardiac monitoring);
- 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 diseases hearts when antiarrhythmic products 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 high-risk patients, later recently myocardial infarction myocardial infarction with more than 10 ventricular extrasystoles per hour, clinical manifestations of chronic heart failure and reduced left ventricular ejection fraction (- Kordaron is especially recommended for patients with organic heart diseases (including coronary heart disease) accompanied by dysfunction of the left ventricle.
The injectable form of cordarone is intended for use in cases where a rapid achievement of an antiarrhythmic effect is required or if its oral administration is not possible. For hospital use only.

Pharmachologic effect:
Class III antiarrhythmic product. 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 potassium current through the channels of the cell membranes of cardiomyocytes, and a decrease in the automatism of the sinus node (which leads to bradycardia that does not respond to the effects of atropine). The drug non-competitively blocks a- and b-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 a- and b-adrenergic receptors, an increase in coronary blood flow by direct action on the smooth muscles of the arteries, maintaining cardiac output by reducing pressure in the aorta and a decrease in peripheral resistance .
Kordaron does not have a significant negative inotropic effect, reduces myocardial contractility, mainly after intravenous administration.
It affects the metabolism of thyroid hormones, inhibits the conversion of T3 to T4 (thyroxine-5-deiodinase blockade) and blocks the uptake of these hormones by cardiocytes and hepatocytes, which leads to a weakening of the stimulating effect of thyroid hormones on the myocardium. It is determined in the blood plasma for 9 months after stopping its intake.
Therapeutic effects are observed after 1 week (from several days to 2 weeks) after the start of taking the substance inside.
With the on / in the introduction of Kordaron, its activity reaches a maximum after 15 minutes and disappears approximately 4 hours after the introduction. Despite the fact that the amount of Cordarone administered in the blood rapidly decreases, tissue saturation with the product is achieved. In the absence of repeated injections, the product is gradually excreted. With the resumption of its introduction or with the appointment of a product for oral administration, its tissue reserve is formed.

Kordaron method of administration and dose:
Tablets.
Loading dose: Various regimens can be used.
In the hospital: the initial dose, divided into several doses, ranges from 600-800 mg to (up to a maximum of 1200 mg) per day until a total dose of 10 g is reached (usually over 5-8 days).
Outpatient: the initial dose, divided into several doses, ranges from 600 mg to 800 mg per day until a total dose of 10 g is reached (usually over 10-14 days).
Maintenance dose: 3 mg/kg body weight each day and may range from 100 mg/day to 400 mg/day as a single dose. The lowest effective dose should be used according to individual therapeutic outcome.
Since Cordarone has a very long half-life, it can be taken every second day (200 mg can be given every other day, and 100 mg is recommended to be taken every day); you can also take breaks (2 days a week).
Prepapat should be taken only as directed by a physician.

Injection.
Intravenous infusion.
The recommended loading dose for adults is 5 mg/kg of patient body weight, administered in 250 ml of 5% glucose solution over 20 minutes to 2 hours. The introduction can be repeated 2-3 times for 24 hours. The infusion rate should be adjusted according to the results.
The therapeutic effect of the product appears during the first minutes of administration and then gradually decreases, so a maintenance infusion is necessary.
Recommended maintenance dose for adults: 10-20 mg/kg/day (approximately 600 to 800 mg/day, the highest dose is 1200 mg/day) in 250 ml of 5% glucose solution for several days. From the first day of infusion, it is necessary to begin the transition to oral administration of the product.

Intravenous injection.
The recommended adult dose is 5 mg/kg and must be administered over at least 3 minutes. Re-injection should be performed no earlier than 15 minutes later. after the first injection. If necessary, continue treatment should be used intravenous infusion.
For children over 3 years of age, the recommended dose is 5 mg/kg. The pediatrician is responsible for the use of the product in babies.
It is not necessary to mix Kordaron in one syringe with other products.

Cordarone contraindications:
Tablets.
- Hypersensitivity to iodine and/or amiodarone.
- Syndrome of weakness of the sinus node (sinus bradycardia, sinoatrial blockade), except in cases of correction by an artificial pacemaker (danger of "stopping" the sinus node).
- Violations of atrioventricular and intraventricular conduction
(atrioventricular blockade (II-III stage), blockade of the legs of the bundle of His) in the absence of an artificial pacemaker (pacemaker).
- Combination with products that can cause polymorphic ventricular tachycardia of the "pirouette" type;
- Thyroid dysfunction (hypothyroidism, hyperthyroidism).
- Hypokalemia, heart failure (in the stage of decompensation).
- Pregnancy.
- Lactation period.
- Childhood(up to 18 years) (efficacy and safety not established).
- Simultaneous reception of MAO inhibitors.
- Interstitial lung disease

Injection.
Kordaron for intravenous administration is not recommended in such cases:
allergy to iodine or amiodarone;
sinus bradycardia, sinoatrial heart block;
sinus node weakness syndrome, except for cases of correction by a pacemaker;
severe conduction disturbances in the absence of an artificial pacemaker,
in combination with products that can cause paroxysmal ventricular tachycardia;
thyroid dysfunction;
pregnancy, except in exceptional cases;
lactation;
children under 3 years old.

Cordarone side effects:
Organs of vision: deposition of lipofuscin in the epithelium of the cornea (in this case, usually there are no subjective complaints in patients); in rare cases, if the deposits are significant and partially fill the pupil, there are complaints of luminous dots or "fog" before the eyes in bright light.
Dermatological reactions: otosensitization, which usually manifests itself in the form of erythema of exposed skin; in some cases, there may be a slight pigmentation on exposed areas of the skin.
Endocrine status: with a long appointment, in rare cases, the development of hypothyroidism is possible, much less often - hyperthyroidism.
Cardiovascular system: when using high doses of Kordaron, also in predisposed patients, bradycardia, slowing of AV conduction, and arterial hypotension may occur.
Nervous system: isolated cases of development of peripheral neuropathy, tremor.
Gastrointestinal tract and liver: infrequently nausea, heaviness in the epigastrium, abnormal liver function.
Respiratory system: cases of development of pneumonitis, alveolitis are described;
With parenteral use, a feeling of heat, increased sweating are possible; bronchospasm, apnea (in patients with severe respiratory failure); increase in intracranial pressure; locally - phlebitis.

Use with other medicinal products:
To enhance the antianginal effect, it is advisable to combine the use of Kordaron with long-acting nitrate products.
It is possible to prescribe Kordaron simultaneously with cardiotonic products, in particular, with digitalis products, however, in this case, the risk of developing bradycardia increases.
Kordaron can be prescribed in combination with anticoagulants, diuretics.
Taking Kordaron inside for a long period of time preceding the operation does not adversely affect anesthetic and resuscitation measures. There was no interaction of Kordaron with droperidol, fenoperidine, chlorprothixene, dextromoramide, pancuronium bromide, pentobarbital.
It is not recommended to prescribe Kordaron simultaneously with verapamil, MAO inhibitors. It is not recommended to use Kordaron in combination with beta-blockers (with the exception of some severe cases with specific hemodynamic features).

Release form:
Tablets, solution for intravenous injections.
30 tablets of 200 mg Cordarone are packed in PVC/aluminum hot seal blisters. The blisters are packed in a cardboard box. Cartons containing 6 type I clear glass ampoules.

Overdose:
There is no information regarding overdose of intravenous amiodarone. There is some information regarding acute overdose of oral amiodarone tablets. Several cases of sinus bradycardia, cardiac arrest, attacks of ventricular tachycardia, paroxysmal tachycardia "torsade de pointes", circulatory and liver dysfunction, decreased blood pressure Treatment should be symptomatic (gastric lavage, the appointment of cholestyramine, with bradycardia - beta-adrenergic stimulants or the installation of a pacemaker, with tachycardia of the “feasting” type - in / in magnesium salts, slowing down pacing). Neither amiodarone nor its metabolites are removed during hemodialysis.

Storage conditions:
Solution - at room temperature (not more than 25 ° C), in the original cardboard box, in a dry place out of the reach of children. Tablets - at temperatures below 30 ° C.

Conditions for dispensing from 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.

Synonyms:
Amiodarone

Cordarone composition:
Tablets.
Active substance: Amiodarone hydrochloride - 200 mg.
Excipients:
- Lactose monohydrate 200 mesh. - 71.0 mg;
- Corn starch - 66.0 mg;
- Polyvidone K90F - 6.0 mg;
- Silicon colloidal anhydrous dioxide - 2.4 mg;
- Magnesium stearate - 4.6 mg per divided tablet weighing 350.0 mg;

Injection.
Active substance: Amiodarone hydrochloride 150 mg;
Excipients:
- Benzyl alcohol - 60 mg;
- Polysorbate 80 - 300 mg;
Water for injection 3.0 ml.

Additionally:
Tablets.
An ECG study is recommended before and during treatment. Due to the prolongation of the period of repolarization of the ventricles of the heart, pharmachologic effect Cordarone will cause certain ECG changes: prolongation of the Q-T interval, Q-Tc (corrected), U waves may appear. An increase in the Q-Tc interval of no more than 450 ms or no more than 25% of the original value is acceptable. These changes are not a manifestation of the toxic effect of the product, however, they require monitoring for dose adjustment and assessment of the possible proarrhythmic effect of Kordaron.
In older people, slowing of the heart rate with the development of bradycardia is possible.
The appearance of shortness of breath or an unproductive cough may be associated with the toxic effect of Kordaron on the lungs.
With the development of atrioventricular block II and III degree, sino-atrial block or bifascicular intraventricular block, treatment should be discontinued.
Since Kordaron contains iodine, it is recommended to conduct a study of thyroid function before and during treatment. Taking Kordaron may distort the results of a radioisotope study of the thyroid gland, but does not affect the reliability of determining the content of T3, T4 and TSH in blood plasma.
Before starting and during treatment, it is recommended to determine the level of potassium in the blood serum.

Injection.
- Intravenous administration Cordarone should usually be used by intravenous infusion rather than syringe injection due to the danger
occurrence of hemodynamic disorders (arterial hypotension, acute cardiovascular failure).
- Intravenous injection of Cordarone with a syringe in the form of an injection should be carried out only in emergency situations, when there are no other therapeutic options, and only in cardiac intensive care units with continuous electrocardiographic monitoring.
- When Cordarone is administered by syringe as an injection, a dose within 5 mg / kg must be administered at least for 3 minutes repeatedly.
The injection should not be repeated earlier than after 15 minutes. after the first injection, even if the last one consisted of only one ampoule
(Irreversible collapse is possible).
Do not mix in the same syringe with other medicinal products. If long-term treatment is necessary, it is necessary to switch to intravenous infusions.
- Cordarone for intravenous injection should only be used in specialized hospital departments under constant supervision
(ECG, BP).
- Use with caution in case of arterial hypotension, severe respiratory failure, decompensated cardiomyopathies or severe heart failure.
General Anesthesia: Before surgery, the anesthesiologist should be informed that the patient is taking amiodarone.
Before starting treatment with Kordaron, it is recommended to register an ECG, determine the level of thyroid hormones (T3, T4 and TSH) and potassium in the blood serum.
The side effects of the product usually depend on the dose; therefore, care must be taken when determining the minimum effective maintenance dose in order to avoid or minimize the occurrence of undesirable effects.
Patients should be warned to avoid sunlight during treatment or to take protective measures (eg, sunscreen).
Amiodarone may cause thyroid dysfunction, especially in patients with a history of thyroid dysfunction or a family history. Therefore, before starting 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.

PHARMACEUTICAL FORM, COMPOSITION AND PACKAGING

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.

PHARMACHOLOGIC EFFECT

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 non-competitively blocks α- and β-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 α- and β-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

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 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.

breeding

Elimination by ingestion proceeds in 2 phases: T1 / 2 in the α-phase - 4-21 hours, T1 / 2 in the β-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 in special clinical situations

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

INDICATIONS

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 relapses

Life-threatening ventricular arrhythmias and ventricular fibrillation (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 (Cordaron is especially recommended for patients with organic heart diseases (including . with 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.

DOSING MODE

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).

For solution for intravenous administration

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 EFFECT

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 (brain pseudotumor), bronchospasm and/or apnea have been reported 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 cardio-vascular 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 / neuritis optic nerve(A connection with amiodarone use 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 thyroid dysfunction drug discontinuation 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 side 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 (possible hepatomegaly, increased activity of hepatic transaminases increased up to 1.5-5 times compared with VGN); therefore, regular monitoring of liver function is recommended during treatment.

From the side 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 CNS 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

For oral administration

SSSU (sinus bradycardia, sinoatrial blockade) except for cases of correction by an artificial pacemaker;

Violations of AV and intraventricular conduction (AV blockade II and III degree, blockade of the legs of the bundle of His) 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 failure (shock, collapse);

Severe arterial hypotension;

Simultaneous use with drugs that can cause polymorphic ventricular tachycardia of the "pirouette" type;

Thyroid dysfunction (hypothyroidism, hyperthyroidism);

Pregnancy;

Lactation;

Age up to 18 years (efficacy and safety not 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).

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

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), x-rays should be taken before starting therapy. chest. Respiratory disorders are mostly reversible with early withdrawal of amiodarone. Clinical symptoms usually resolve within 3-4 weeks, followed by a slower recovery 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 have used sunscreens).

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.

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-adrenergic stimulants or the installation of a pacemaker, with tachycardia of the "pirouette" type - intravenous administration 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.

DRUG INTERACTIONS

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 blockers is not recommended calcium channels(verapamil, diltiazem), because 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 an ECG and laboratory monitoring, and, if necessary, change the dosing regimen of 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 postoperative period in patients receiving Kordaron, rare cases of severe respiratory complications, sometimes ending in death (acute respiratory distress syndrome in adults), are described.

Co-administration with simvastatin may increase the risk side effects(primarily rhabdomyolysis) due to a violation of the 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 another lipid-lowering drug).

TERMS AND CONDITIONS OF DISCOUNT FROM 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 AND CONDITIONS OF STORAGE

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.

Cordarone is an antiarrhythmic drug, the main active ingredient of which is amiodarone hydrochloride.

The drug is available as a solution for intravenous injection and in the form of tablets. The active substance has coronary dilating, antianginal, hypotensive, alpha-adrenergic blocking, beta-adrenergic blocking effects.

In this article, we will consider why doctors prescribe Kordaron, including instructions for use, analogues and prices for this drug in pharmacies. Real REVIEWS of people who have already used Kordaron can be read in the comments.

Composition and form of release

Available in the form of tablets with a standard dosage of 200 mg. Distinctive features - on each tablet the symbol of a myocardium and quantity active ingredient. By these factors, fake analogues can be determined.

• The main active ingredient is amiodarone hydrochloride.

Clinico-pharmacological group: antiarrhythmic drug.

Indications for use

Kordaron is used in the following cases to relieve an attack:

• paroxysmal tachycardia;
• paroxysmal ventricular tachycardia;
• paroxysmal atrial fibrillation and its stable form (fibrillation and atrial flutter)
• paroxysmal supraventricular tachycardia with frequent contraction of the ventricles (Wolf-Parkinson-White syndrome).

With the help of Kordaron, relapse prevention is also carried out:

• atrial fibrillation and atrial flutter;
• life-threatening ventricular arrhythmias and ventricular fibrillation;
• paroxysmal supraventricular tachycardias, including documented seizures in organic heart disease;
• documented recurrent attacks of sustained paroxysmal supraventricular tachycardia with WPW syndrome;
• documented attacks of sustained paroxysmal supraventricular tachycardia without organic heart disease in case of ineffectiveness of previously used antiarrhythmic drugs or contraindications.

pharmachologic effect

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

The mechanism of pharmacological action is divided into several components:

• normalization of heart rate;
• increase in the energy potential of heart muscle cells;
• increase in AV conduction in comparison with ventricular processes;
• regulation of refractory processes with periodic contraction of the atria and ventricles of the heart muscle;
• blocking the conduction of an electrical impulse through potassium tubules;
• reducing the level of influence of automatic adjustment of impulse processes originating from the sinus node of the heart muscle;
• regulation of cardiac output and stabilization of the pulse wave.

To obtain a stable therapeutic effect, the drug must be taken for at least 10 days.

Instructions for use

According to the instructions for use, Kordaron tablets are taken orally, before meals, with a small amount of water. Dosing is prescribed by the doctor based on clinical indications and the patient's condition.

Loading ("saturation") dose: different schemes of saturation can be applied.

• In the hospital: the initial dose, divided into several doses, ranges from 600-800 mg (up to a maximum of 1200 mg) / day until a total dose of 10 g is reached (usually within 5-8 days).
• Outpatient: the initial dose, divided into several doses, is from 600 to 800 mg per day until a total dose of 10 g is reached (usually within 10-14 days).

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

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

Contraindications

You can not use the drug in such cases:

1. Hypersensitivity to Kordaron or its components;
2. The use of Kordaron in any trimester of pregnancy;
3. Increased concentration of potassium ions in the blood;
4. Syndrome of weakness of the sinus node of the conduction system of the heart;
5. Increased concentration of magnesium ions in the blood;
6. Violation of the functional activity of the thyroid gland;
7. Individual intolerance to Kordaron or its components;
8. Congenital prolongation of the Q-T interval;
9. The use of Kordaron during breastfeeding;
10. Acquired prolongation of the Q-T interval;
11. Mixing Kordaron in one syringe with other medicines.

The simultaneous use of Kordaron with Quinidine, Disopyramide, Trifluoperazine, Amisulpride, Sulpiride, Veralipride, Droperidol, Haloperidol, Pimozide, Sertindole, Dofetilide, Bretylium Tosylate, Vincamine, Cyamemosine, Thioridazine, Fluphenazine, Levomepromazine, Cisapride, tricyclic antidepressant drugs, Chlopyramiromycin is prohibited. , Sultopride, Erythromycin, drugs of the azole group, Chloroquine, Halofantrine, Difemanil methyl sulfate, Astemizole, drugs of the fluoroquinolone group, Hydroquinidine, Procainamide, Ibutilide, Sotalol, Bepridil, Chlorpromazine, Mefloquine, Pentamidine, Mizolastine and Terfenadine.

Side effects

During the use of the drug Kordaron, undesirable effects are possible in the form of:

1. nausea;
2. Tremor;
3. Pulmonitis;
4. Alveolitis;
5. Lipofuscin deposits in the corneal epithelium;
6. photosensitivity;
7. Bradycardia;
8. arterial hypotension;
9. Deceleration of AV conduction;
10. liver dysfunction;
11. peripheral neuropathy.
12. With prolonged therapy or use in high doses: the development of hypothyroidism, hyperthyroidism.

Due to the fact that the side effects of amiodarone are dose-dependent, it is recommended to use the drug in the lowest effective doses in order to minimize the possibility of their occurrence.

During treatment, patients should avoid exposure to direct sunlight or take appropriate protective measures (use sunscreen, etc.).

Kordaron's analogs

Structural analogues for the active substance:

• amiodarone;
• Amyocordin;
• Vero Amiodarone;
• Cardiodarone;
• Opacorden;
• Rhythmiodarone;
• Sedacoron.

Attention: the use of analogues must be agreed with the attending physician.

Price

The average price of KORDARON in pharmacies (Moscow) is 310 rubles.

Terms of dispensing from pharmacies

The drug is dispensed by prescription.

1. Zina

   I was prescribed the use of cordarone according to the scheme: 3 days, 2 tabs three times a day, 3 days, 1 tab 3 times a day, 3 days, 1 tab 2 times a day, then 1 tab per day until the end of the package. For at least 6 months, I had to be protected from heart failure. Alas… 3 days after stopping the Cordarone pills, everything resumed, though in a weakened sensation. I save myself by taking 1/2 tablet a day with coronal. I need to go back to the cardiologist

2. Valentin Semenovich

   I am 76 years old. Rhythm disturbance since 30 years. The number of systoles per minute was 30 with a pulse of 60 beats per minute. I tried different drugs - it's useless (maybe at that time there was no effective drugs). During a consultation at the cardiological center, the patient was diagnosed with ventricular extrasystole and Cordarone was recommended. I have been taking it for over 40 years, 100-200 mg per day in the morning. Of the side effects can be noted:

   - periodic decrease in heart rate (mainly in the morning) to no more than 50 beats / min. On average, the pulse is 60-65 beats / min;
   - a slight increase in the size of the thyroid gland.

   Against the background of cordarone (dose not more than 200 mg / day), individual systoles are observed (2-3 systoles per minute); rarely skip group or even double systoles. In one of the anamnesis during the operation (and even then the cardiologists question this) atrial fibrillation without paroxysms was recorded. Now the cardiologist recommends changing the drug. But I fear (better is the enemy of good). The general opinion about the drug is unambiguously positive.

3. Anonymous

   I take Cordarone 2 weeks. 1 tablet at a dose of 200 mg. The condition is terrible: nausea, loss of appetite, some bouts of weakness. In a word, I refused, tomorrow I'm going to the doctor.

Instructions for use:

Cordarone is an antiarrhythmic drug.

Release form and composition

Dosage forms:

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

The active substance is amiodarone hydrochloride:

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

Auxiliary components:

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

Indications for use

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

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

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

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

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

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

Contraindications

Contraindications to the use of tablets and solution:

• Age up to 18 years;
• Atrioventricular (AV) blockade II and III degree, two- and three-beam blockade in patients without a pacemaker;
• Sinus node weakness syndrome (sinoatrial blockade, sinus bradycardia), except in cases of correction by an artificial pacemaker (pacemaker);
• Simultaneous use with agents that prolong the QT interval and cause the development of paroxysmal tachycardia, including ventricular "pirouette" tachycardia: class IA antiarrhythmic drugs (hydroquinidine, quinidine, procainamide, disopyramide) and class III (bretylium tosylate, ibutilide, dofetilide), sotalol; other non-antiarrhythmic drugs: vincamine, bepridil, phenothiazines (fluphenazine, cyamemazine, chlorpromazine, levomepromazine, trifluoperazine, thioridazine), benzamides (sultopride, amisulpride, sulpride, veraliprid, tiapride), pimozide, butyrophenones (haloperidol, droperidol), sertindole, cisapride, tricyclic antidepressants, azoles, macrolide antibiotics (including spiramycin, erythromycin when administered intravenously), antimalarial drugs (chloroquine, halofantrine, quinine, mefloquine), diphemanil methyl sulfate, pentamidine only when parenteral administration, 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 threaten the life of the mother, if the expected clinical effect exceeds 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. Except in special emergency clinical situations, the solution should only be used under conditions 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 peripheral veins allowed for cardioresuscitation in ventricular fibrillation resistant to cardioversion, in the absence of 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. supportive daily dose amiodarone is usually prescribed in the amount of 0.6-0.8 g, an increase to 1.2 g in 250 ml of a 5% dextrose (glucose) solution is allowed. 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 surgical operation, 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 different degrees, sinoatrial blockade (impaired conduction), 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 diseases liver 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 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 thyroid gland.

In case of suspicion of 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 every 6 months x-ray examination lung and lung function tests.

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 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 analogues are: Amiocordin, Amiodarone, Amiodarone-SZ, Vero-Amiodarone, 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.

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

1 ml of solution contains 50 mg of 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 , an inhibitor of repolarization.

Pharmacodynamics and pharmacokinetics

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

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

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, 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 , supraventricular arrhythmias, atrial flutter, atrial paroxysm , ventricular arrhythmia in patients with Chagas myocarditis , arrhythmias in coronary insufficiency, parasystole .

Contraindications

Cordarone is not prescribed for sinus bradycardia intolerance to iodine, amiodarone, at cardiogenic shock , collapse, hypokalemia, , arterial hypotension, interstitial lung diseases, taking MAO inhibitors, hypokalemia, 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, dizziness, weakness, headaches, optic neuritis, ataxia, extrapyramidal manifestations .

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

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

Respiratory system: , bronchospasm , pleurisy, anterstitial pneumonia, shortness of breath, cough.

Digestive system:, jaundice, cholestasis, toxic hepatitis, elevated liver enzymes, loss, dulling of taste perception, loss of appetite, vomiting, nausea.

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

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

Appointment required cholestyramine , gastric lavage, installation of a pacemaker. found to be ineffective.

Interaction

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

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

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

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

cardiac glycosides , 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 pertechnetta sodium , 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, the level of electrolytes in plasma.

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. With absence clinical picture thyroid dysfunction, antiarrhythmic treatment is continued.

It is recommended to use special sunscreens, avoid direct sunlight to prevent development 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 in its composition, which can provoke false-positive tests for the determination radioactive iodine in the thyroid gland.

At surgical interventions the team should be informed about the use of the medicinal product due to the possibility of developing distress syndrome sharp form.

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

What can replace the remedy? Analogues can be called drugs:, Amyocordin , Aritmil , Cardiodarone , Rotarymil .