Tablets are divisible: from white with a creamy shade till white color, a round form with a facet on two parties, a bevel from edges to the line of a break on one of the parties and an engraving: over dividing risky – a symbol in the form of heart, under risky – figure 200 (on 10 pieces in blisters, in a cardboard pack 3 blisters);
Solution for intravenous (in/in) introductions: transparent liquid of light yellow color (on 3 ml in ampoules, in a box of 6 pieces).

Active ingredient – Amiodaronum a hydrochloride:

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

Auxiliary components:

Tablets: starch corn, lactoses monohydrate, magnesium stearate, silicon dioxide colloid anhydrous, K90F povidone;
Solution: benzyl alcohol, polysorbate 80, water for injections.

Indications to use

Kordaron's use in the form of tablets is shown for prevention of a recurrence:

Supraventricular Bouveret's diseases: the attacks of a recurrent steady supraventricular Bouveret's disease fixed at patients with organic heart diseases; the attacks of a recurrent steady supraventricular Bouveret's disease fixed at patients without organic heart diseases (at inefficiency of antiarrhytmic drugs of other classes or contraindications to their use); the attacks of a recurrent steady supraventricular Bouveret's disease fixed at patients with a WPW-syndrome;
The ventricular arrhythmias posing a threat for the patient's life including ventricular tachycardia and fibrillation of ventricles (at hospitalization with careful cardiomonitor control);
Ciliary arrhythmia (fibrillation of auricles) and atrial flutter.

Besides, tablets are appointed for treatment of patients with disturbance of a rhythm against the background of dysfunction of a left ventricle and/or the coronary heart disease (CHD).

Pill is taken for prevention of sudden arhythmic death at the patients who had recently a myocardial infarction, having clinical displays of chronic heart failure or more than 10 ventricular extrasystoles at 1 o'clock and the lowered fraction of emission of a left ventricle (less than 40%).

Use of drug in the form of solution is shown for stopping of attacks of a ventricular Bouveret's disease, a supraventricular Bouveret's disease with high frequency of reductions of ventricles (especially at a WPW-syndrome), a steady and paroxysmal form of a ciliary arrhythmia (fibrillation of auricles) and an atrial flutter.

Also Kordaron's injections use for cardioresuscitation at a cardiac standstill, against the background of the fibrillation of ventricles steady against a defibrillation.

Contraindications

Contraindications to use of tablets and solution:

Age up to 18 years;
Atrioventricular (AV) blockade of II and III degrees, two - and trekhpuchkovy blockade at patients without pacemaker;
Sick sinus syndrome (sinuatrial blockade, sinus bradycardia), except correction cases an artificial pacemaker (pacemaker);
Simultaneous use with the means extending an interval of QT and causing development of Bouveret's diseases including ventricular "piruetny" tachycardia: antiarrhytmic drugs IA of a class (hydroquinidine, quinidine, procaineamide, Disopyramidum) and III class (bretylium tosylate, ибутилид, дофетилид), соталол; other medicines not of antiarrhytmic action: Vincaminum, bepridit, fenotiazina (Fluphenazin, циамемазин, Chlorpromazinum, levomepromazinum, трифлуоперазин, thioridazine), benzamides (сультоприд, амисульприд, сульприд, вералиприд, тиаприд), Pimozidum, phenyl propyl ketones (a haloperidol, Droperidolum), сертиндол, цизаприд, tricyclic antidepressants, azoles, makrolidny antibiotics (including Spheromycinum, erythromycin at in introduction), antimalarial drugs (chloroquine, галофантрин, quinine, мефлохин), difemanit methyl sulfate, pentamidine only at parenteral administration, мизоластин, ftorkhinolona, астемизол and терфенадин;
Hypomagnesiemia, hypopotassemia;
Lengthening of an interval of QT, including inborn;
Period of pregnancy and breastfeeding;
Dysfunction of a thyroid gland (hyperthyroidism, hypothyroidism);
Hypersensitivity to components of drug and to iodine.

With care it is necessary to appoint Kordaron sick with AV blockade of the I degree, arterial hypotension, heavy chronic (the III-IV functional class on NYHA classification) or dekompensirovanny heart failure, a liver failure, bronchial asthma, heavy respiratory insufficiency and to patients of advanced age.

Pill cannot be taken at an intersticial pulmonary disease.

Additional contraindications to solution use:

The expressed arterial hypotension, cardiogenic shock, collapse;
Disturbances of intra ventricular conductivity (two - and trekhpuchkovy blockade) in the absence of a constant pacemaker;
Heart failure, arterial hypotonia, cardiomyopathy or heavy respiratory insufficiency – for in/in jet introductions.

All specified contraindications should not be considered when performing cardioresuscitation at a cardiac standstill against the background of the fibrillation of ventricles steady against cardioversion.

Use of Amiodaronum for pregnant women is possible at the ventricular disturbances of a heart rhythm posing a threat of life of mother if the expected clinical effect exceeds potential risk and danger to a fruit.

Route of administration and dosage

Tablets: orally, to food, washing down with a small amount of water. Dosing is appointed by the doctor on the basis of clinical testimonies and a condition of the patient. The load dose in the conditions of a hospital is increased, since a daily dose of 0,6-0,8 g (up to 1,2 g) divided into several receptions, before achievement of a total dose of 10 g after 5-8 days of reception; on an outpatient basis saturation to 10 g is made within 10-14 days in a daily dose 0,6-0,8 g. The maintenance dose has to be minimum effective, is selected individually, can make from 0,1 to 0,4 g a day. An average therapeutic single dose – 0,2 g, daily – 0,4 g. The maximum single dose – 0,4 g, daily – 1,2 g. A pill can be taken every other day or with a break in reception 2 days a week;
Solution for injections: it is intended for in/in introductions for achievement of bystry antiarrhytmic effect or at impossibility of administration of drug inside. Except special emergency clinical situations solution needs to be used only in the conditions of an intensive care of a hospital under constant control of the ABP and the electrocardiogram (ECG). It is impossible to mix solution with other means, to enter into the same line of system for infusions or to apply in not divorced look. For cultivation it is necessary to use only 5% solution of a dextrose (glucose), concentration of the received solution has to be not less, than at cultivation of 6 ml of drug in 500 ml of 5% of a dextrose (glucose). Introduction should be made always through the central venous catheter, introduction through peripheral veins is allowed for cardioresuscitation at fibrillation of ventricles, resistant to cardioversion, in case of lack of the central venous access. At heavy disturbances of a cordial rhythm, in case of impossibility of administration of drug inside, drop in/in introduction through the central venous catheter it is recommended in a usual load dose at the rate of 0,005 g on 1 kg of weight of the patient in 250 ml of 5% of solution of a dextrose (glucose). It is necessary to enter within 20-120 minutes, it is desirable by means of an electronic pomp. It can be entered within 24 hours 2-3 times, correction of rate of administering depends on clinical effect. The supporting daily dose of Amiodaronum is appointed usually of 0,6-0,8 g, increase to 1,2 g in 250 ml of 5% of solution of a dextrose (glucose) is allowed. Within 2-3 days into introductions it is necessary to pass gradually to administration of drug inside. Intravenous jet administration in the course of cardioresuscitation at a cardiac standstill against the background of fibrillation of ventricles, resistant to cardioversion, is recommended in a dose of 0,3 g of drug of 5% of solution of a dextrose (glucose) divorced in 20 ml. In case of lack of clinical effect perhaps additional introduction of 0,15 g of Amiodaronum.

Side effects

Kordaron's use can cause the general for each of forms side effects:

From respiratory system: very seldom – a bronchospasm and/or an apnoea against the background of heavy respiratory insufficiency, especially bronchial asthma; an acute respiratory distress syndrome (sometimes right after surgery, sometimes with a lethal outcome);
From cardiovascular system: often – moderate (dozozavisimy) bradycardia; very seldom – the expressed bradycardia or a stop of a sinus node (in exceptional cases), is more often at patients with dysfunction of a sinus node and patients of advanced age;
From a nervous system: very seldom – a headache, benign intracranial hypertensia.

Use of tablets can become the reason of the following side effects:

From cardiovascular system: infrequently – AV blockade of different degrees, sinuatrial blockade (conductivity disturbance), emergence new or aggravation of the existing arrhythmias; frequency is unknown – progressing of chronic heart failure (against the background of long therapy);
From respiratory system: often – cases of development of an alveolar or intersticial pneumonitis, an obliterating bronchiolitis with pneumonia (sometimes with a lethal outcome), pleurisy, pulmonary fibrosis, the expressed short wind or dry cough with symptoms of deterioration in the general state (increased fatigue, weight reduction, fervescence) or without it; frequency is unknown – pulmonary bleeding;
From the alimentary system: very often – nausea, vomiting, a loss of appetite, decrease in flavoring feelings or their loss, feeling of weight in epigastriums (especially at the beginning of use, after a dose decline passes), the isolated spasmodic disturbance of activity of liver enzymes in blood serum; often – jaundice, acute damage of a liver, a liver failure (sometimes with a lethal outcome); very seldom – chronic diseases of a liver, such as cirrhosis, pseudo-alcoholic hepatitis (sometimes fatal);
From sense bodys: very often – the passing vision disorder (an illegibility of contours at bright lighting) caused by adjournment in an epithelium of a cornea of difficult lipids; very seldom – an optic neuritis or visual neuropathy;
From integuments: very often – a photosensitization; often – a passing xanthopathy (at long therapy); very seldom – an erythema, skin rash, an alopecia, exfoliative dermatitis (communication with drug is not confirmed);
From a nervous system: often – extrapyramidal symptoms (tremor), sleep disorders, dreadful dreams; seldom – a myopathy and/or peripheral neuropathy (sensomotor, mixed, motor); very seldom – a cerebellar ataxy;
Endocrine disturbances: often – a hypothyroidism (at the high level of thyritropic hormone (TTG) of blood serum it is necessary to cancel drug), a hyperthyroidism; very seldom – a syndrome of disturbance of secretion of antidiuretic hormone;
Others: very seldom – an epididymite, a vasculitis, impotence (communication with Amiodaronum is not confirmed), hemolitic anemia, thrombocytopenia, aplastic anemia.

Kordaron's use in the form of solution causes undesirable effects:

From cardiovascular system: often – a moderate and passing lowering of arterial pressure (ABP); very seldom – proaritmogenny action, progressing of heart failure, rushes of blood to face skin (at in jet introduction);
Disturbances from immune system: very seldom – an acute anaphylaxis; frequency is unknown – a Quincke's disease;
From respiratory system: very seldom – short wind, cough, an intersticial pneumonitis;
From integuments: very seldom – the increased sweating, feeling of heat;
From the alimentary system: very often – nausea; very seldom – increase or decrease of the activity of liver enzymes in blood (isolated), acute damage of a liver (sometimes with a lethal outcome);
Reactions in an injection site: often – pain, hypostasis, consolidation, an erythema, a necrosis, infiltration, transudation, an inflammation, phlebitis (including superficial), thrombophlebitis, cellulitis, pigmentation, an infection.

Special instructions

Drug should be accepted only on doctor's orders!

Side effects of Kordaron have dozozavisimy character therefore treatment should be carried out by minimal effective doses.

During drug use patients have to avoid influence of direct sunshine.

Purpose of drug has to be made taking into account data of research ECG and blood on determination of content of potassium. Correction of a hypopotassemia has to take place prior to treatment. Treatment should be accompanied with regular control of an ECG (1 times in 3 months) and indicators of function of a liver.

To patients with diseases of a thyroid gland, and without them, prior to therapy by Amiodaronum, during treatment and within several months after drug withdrawal it is necessary to conduct laboratory and clinical examinations of a thyroid gland.

In case of suspicions on functional disturbances it is necessary to determine the TTG level in blood serum.

Content of iodine in drug does not exert impact on reliability of determination of the TTG level, _{T3 and T4 hormones} in a blood plasma, but can distort results of a radio isotope research of a thyroid gland.

During drug use patients have to pass each 6 months X-ray inspection of lungs and functional pulmonary trials.

At long therapy of patients with a pacemaker or the implanted defibrillator it is necessary to control correctness of their functioning regularly.

At emergence of AV blockade of the I degree it is necessary to double the watch. In case of development of sinuatrial blockade, AV blockade of II and III degrees or dvukhpuchkovy intra ventricular blockade treatment should be stopped.

It is necessary to conduct ophthalmologic examination with survey of an eyeground at decrease in sharpness and emergence of a vagueness of sight. The patient with the optic neuritis or neuropathy which developed against the background of reception of Amiodaronum, it is necessary to cancel further use of drug.

Before operation it is necessary to inform the anesthesiologist of administration of drug.

Long therapy by Kordaron can increase the hemodynamic risk characteristic of anesthesia.

Besides, in rare instances at patients right after surgery there can come the acute respiratory distress syndrome demanding careful control at artificial ventilation of the lungs.

It is necessary to carry out to jet introduction within not less than 3 minutes, repeated introduction is possible only in 15 minutes after the first.

Against the background of administration of drug development of an intersticial pneumonitis therefore in case of severe short wind or dry cough, with deterioration in the general state (increased fatigue, fervescence) or without it, the patient should carry out a thorax X-ray analysis is possible. At disturbance of a X-ray pattern drug needs to be cancelled as the disease can develop pulmonary fibrosis.

Development of crushing acute damage of a liver with development of a liver failure is possible (sometimes with a lethal outcome) within the first days of injection use, it is regularly necessary to control function of a liver during therapy.

Simultaneous use with verapamil, diltiazem and beta adrenoblockers, except an esmolol and a sotalol, is possible only for prevention of life-threatening ventricular arrhythmias and recovery of cordial activity after the cardiac standstill caused by fibrillation of ventricles resistant to cardioversion.

During therapy by the patient it is recommended to refrain from control of vehicles and mechanisms.