Кордарон®

General characteristics. Structure:

Active ingredient: Amiodaronum hydrochloride of 150 mg
Excipients
Benzyl alcohol of 60 mg
Polysorbate-80 of 300 mg
Water for injections to 3,0 ml

Description: Transparent solution of light yellow color.

Pharmacological properties:

Pharmacodynamics. Amiodaronum belongs to the III class of antiarrhytmic drugs (a class of inhibitors of repolarization) and possesses the unique mechanism of antiarrhytmic action as in addition to properties of antiaritmik of the III class (blockade of potassium channels) it has effects of antiaritmik of the I class (blockade of natrium channels), antiaritmik of the IV class (blockade of calcium channels) and the non-competitive beta blocking action.
Except antiarrhytmic action it has anti-anginal, coronarodilator, alpha and beta and adrenoceptor blocking effects.
Antiarrhytmic properties:
- increase in duration of the 3rd phase of action potential of cardiomyocytes, generally due to blocking of ionic current in potassium channels (effect of antiarrhytmic means of the III class on Williams's classification);
- the reduction of automatism of a sinus node leading to reduction of heart rate;
- non-competitive blockade of alpha and beta adrenergic receptors;
- the delay of sinuatrial, atrial and atrioventricular conduction which was more expressed at tachycardia;
- lack of changes of conductivity of ventricles;
- increase in the refractory periods and reduction of excitability of a myocardium of auricles and ventricles, and also increase in the refractory period of an atrioventricular node;
- delay of carrying out and increase in duration of the refractory period in additional bunches of atrioventricular carrying out.
Other effects:
- decrease in consumption of oxygen a myocardium due to moderate decrease in the general peripheric resistance and heart rate, and also reduction of contractility of a myocardium due to beta and adrenoceptor blocking action;
- increase in a coronary blood-groove due to direct impact on a tone of coronary arteries;
- preservation of cordial emission, despite some reduction of contractility of a myocardium, due to decrease in the general peripheric resistance and pressure in an aorta;
- influence on exchange of thyroid hormones: inhibition of transformation of T3 into T4 (blockade of a thyroxine-5-deiodinase) both the blocking of capture of these hormones cardiocytes and hepatocytes leading to weakening of the stimulating influence of thyroid hormones on a myocardium.
- recovery of cordial activity at the cardiac standstill caused by fibrillation of ventricles resistant to cardioversion.
Pharmacokinetics. At intravenous administration of Kordaron his activity reaches a maximum in 15 minutes and disappears approximately in 4 hours after introduction. After introduction of Amiodaronum its concentration in blood quickly decreases in connection with intake of drug in fabric. For lack of repeated injections drug is gradually removed. When resuming its intravenous administration or at purpose of drug inside Amiodaronum collects in fabrics. Amiodaronum has the large volume of distribution and can collect almost in all fabrics, in particular in fatty tissue and except it in a liver, lungs, a spleen and a cornea
Communication with proteins of a blood plasma makes 95% (62% - with albumine, 33,5% - with beta lipoproteins).
It is metabolized in a liver. The main metabolite - дезэтиламиодарон - pharmacological is active and can strengthen antiarrhytmic effect of the main connection. Amiodaronum is inhibitor of hepatic isoenzymes of a microsomal oxidation: CYP2C9, CYP2D6, CYP3A4, CYP3A5, CYP3A7.
It is generally removed with bile and a stake through intestines. Removal of Amiodaronum very slow. Amiodaronum and its metabolites are defined in a blood plasma for 9 months after the treatment termination.
Amiodaronum and its metabolites are not exposed to dialysis.

Indications to use:

Stopping of attacks of a Bouveret's disease
• stopping of attacks of a ventricular Bouveret's disease;
• stopping of attacks of a supraventricular Bouveret's disease with high frequency reductions of ventricles, in particular against the background of a WPW-syndrome;
• stopping of a paroxysmal and steady form of a ciliary arrhythmia (fibrillation of auricles) and atrial flutter.
- Cardioresuscitation at the cardiac standstill caused by fibrillation of ventricles resistant to cardioversion.

Route of administration and doses:

Kordaron (injection form) is intended for use when bystry achievement of antiarrhytmic effect is required or if drug use inside is impossible.
Except for urgent clinical situations drug has to be used only in a hospital in the block of an intensive care under constant control of an ECG and arterial pressure!
At in introduction Kordaron it is impossible to mix with other drugs or at the same time to administer other drugs through the same venous access. To apply only in a divorced look. For Kordaron's cultivation it is necessary to use only 5% solution of a dextrose (glucose). Due to the features of a dosage form of drug it is not recommended to use concentration of infusion solution, it is less than 2 ampoules received at cultivation in 500 ml of 5% of a dextrose (glucose).
In order to avoid reactions in an injection site Amiodaronum has to be entered through the central venous catheter, except for cardioresuscitation cases at fibrillation of ventricles, resistant to cardioversion when, in the absence of the central venous access, for administration of drug peripheral veins (the largest peripheral vein with the maximum blood-groove) (can be used see. "Special instructions").
Heavy disturbances of a cordial rhythm, in cases when administration of drug inside is impossible (except for cardioresuscitation cases at the cardiac standstill caused by fibrillation of ventricles resistant to cardioversion).
Intravenous and drop introduction through the central venous catheter
Usually load dose makes 5 mg/kg of body weight in 250 ml of 5% of solution of a dextrose (glucose) and is entered whenever possible with use of an electronic pomp within 20-120 minutes. It can 2-3 times within 24 hours are entered repeatedly. Rate of administering of drug is adjusted depending on clinical effect. Therapeutic action appears within the first minutes of introduction and gradually decreases after the infusion termination therefore in need of continuation of treatment by injection Kordaron it is recommended to pass to constant intravenous and drop administration of drug.
Maintenance doses: 10-20 mg/kg / 24 hour (usually 600-800 mg, but can be increased to 1200 mg within 24 hours) in 250 ml of 5% of solution of a dextrose (glucose) within several days. From the first day of infusion it is necessary to begin gradual transition to Kordaron's reception in (3 tablets on 200 mg a day). The dose can be increased to 4 or even 5 tablets on 200 mg a day.
Cardioresuscitation at the cardiac standstill caused by fibrillation of ventricles resistant to cardioversion
Intravenous jet introduction (see. "Special instructions")
The first dose makes 300 mg (or 5 mg/kg) a kordarona, after cultivation in 20 ml of 5% of solution of a dextrose (glucose) and is entered intravenous струйно.
If fibrillation is not stopped, then perhaps additional intravenous and jet introduction of Kordaron in a dose of 150 mg (or 2,5 mg/kg).

Features of use:

Except for urgent cases, intravenous administration of Kordaron has to is carried out only in the block of an intensive care at constant control of an ECG (in connection with a possibility of development of bradycardia and aritmogenny action) and lowerings of arterial pressure.
Injection Kordaron it is necessary to enter only in the form of infusion as even very slow intravenous and jet introduction can cause an excessive lowering of arterial pressure, heart failure or heavy respiratory insufficiency.
To avoid emergence of reactions in an injection site (see. "Side effect") the injection form of Kordaron is recommended to be entered through the central venous catheter. Only in case of cardioresuscitation at the cardiac standstill caused by fibrillation of a ventricle resistant to cardioversion, in the absence of the central venous access (lack of the established central venous catheter) the injection form of Kordaron can be entered into a large peripheral vein with the maximum blood-groove.
If after cardioresuscitation treatment by Kordaron has to continue, then Kordaron it is necessary to enter intravenous капельно through the central venous catheter under constant control of arterial pressure and an ECG.
Kordaron it is impossible to mix in one syringe or a dropper with other medicines.
Due to a possibility of development of an intersticial pneumonitis at emergence after Kordaron's introduction of the expressed asthma or dry cough which both are followed and which are not followed by deterioration in the general state (increased fatigue, temperature increase) it is required to carry out a X-ray analysis of a thorax and, if necessary, to cancel drug as the intersticial pneumonitis can lead to development of pulmonary fibrosis. However these phenomena are generally reversible at early cancellation of Amiodaronum with purpose of corticosteroids or without their appointment. Clinical manifestations usually disappear within 3-4 weeks. Recovery of a X-ray pattern and function of lungs happens more slowly (several months).
After artificial ventilation of the lungs (for example, at reduction of surgical interventions) at patients to whom Kordaron was entered, exceptional cases of development acute respiratory a syndrome distress, sometimes with a lethal outcome (the possibility of interaction with high doses of oxygen is supposed) were celebrated (see. "Side effect"). Therefore it is recommended to exercise strict control of a condition of such patients.
Within the first days after the beginning of use of an injection form of Kordaron can sometimes develop crushing acute damage of a liver with development of a liver failure with a lethal outcome. Regular control of function of a liver is recommended during treatment by Kordaron.
General anesthesia
Before surgical intervention of the anesthesiologist it is necessary to inform of what the patient receives Kordaron. Treatment by Kordaron can strengthen the hemodynamic risk inherent in local or general anesthesia. In particular it belongs to its bradikarditichesky and hypotensive effects, decrease in cordial emission and disturbances of conductivity.
Combinations with beta adrenoblockers, except a sotalol (a contraindicated combination) and an esmolola (the combination demanding extra care at use), verapamil and diltiazem, can be considered only in the context of prevention of life-threatening ventricular arrhythmias and in case of recovery of cordial activity at the cardiac standstill caused by fibrillation of a ventricle resistant to cardioversion.
Disturbances of electrolytic exchange, in particular hypopotassemia: it is important to take into account to a situation which can be followed by a hypopotassemia as contributing to the pro-arhythmic phenomena. The hypopotassemia has to be corrected prior to Kordaron's use.
Before an initiation of treatment Kordaron recommends to carry out registration of an ECG, and potassium level in blood serum and whenever possible determination of level of hormones of a thyroid gland (T3, T4 and TTG).
Side effects of drug (see. "Side effect") usually depend on a dose; therefore it is necessary to be careful when determining the minimum effective maintenance dose to avoid or reduce emergence of undesirable effects to a minimum.
Amiodaronum can cause dysfunctions of a thyroid gland, especially in patients with dysfunctions of a thyroid gland in own or family anamnesis. Therefore in case of transition to Kordaron's reception inside during treatment and several months after the end of treatment it is necessary to carry out careful clinical and laboratory control. At suspicion of dysfunction of a thyroid gland it is necessary to carry out determination of the TTG level in blood serum.
At children safety and efficiency of Amiodaronum was not studied. Injection Kordaron's ampoules contain benzyl alcohol. It was reported about development in newborns of sharp suffocation from the death after intravenous administration of the solutions containing benzyl alcohol.

Side effects:

Frequency of side effects was determined as follows: very often (> 10%), it is frequent (> 1%, <10); infrequently (> 0,1%, <1%); seldom (> 0,01%, <0,1%) and it is very rare, including separate messages (<0,01%), frequency is unknown (according to the available data frequency cannot be determined).
From cardiovascular system
Often
- Bradycardia (usually moderate urezheniye of ChSS).
- Lowering of arterial pressure usually moderate and passing. Cases of the expressed arterial hypotension or a collapse were observed at overdose or too bystry administration of drug.
Very seldom
- Aritmogenny action (there are messages on developing of new arrhythmias including polymorphic ventricular tachycardia like "pirouette", or aggravation existing, in certain cases - with the subsequent cardiac standstill), however at Amiodaronum it is expressed less, than at the majority of antiarrhytmic means. These effects are observed generally in cases of use of Kordaron together with the medicines extending the period of repolarization of ventricles of heart (QTc interval) or at disturbances of electrolytic balance (see. "Interaction with other medicines"). In the light of the available data it is impossible to define whether emergence of these disturbances of a rhythm by Kordaron is caused, or it is connected with weight of cardial pathology, or is a consequence of inefficiency of treatment.
- The expressed bradycardia or, in exceptional cases, a stop of a sinus node which were noted at some patients (patients with dysfunction of a sinus node and patients of advanced age).
- Rushes of blood to face skin.
- Progressing of heart failure (it is possible at intravenous and jet introduction).
From the endocrine Frequency system it is unknown the Hyperthyroidism.
From respiratory system
Very seldom
- Cough, short wind, intersticial pneumonitis.
- A bronchospasm and/or an apnoea at patients with heavy respiratory insufficiency, especially at patients with bronchial asthma.
- An acute respiratory distress a syndrome, sometimes with a lethal outcome and sometimes directly after surgical interventions (the possibility of interaction with high doses of oxygen is supposed) (see. "Special instructions").
From the alimentary system Very seldom
- Nausea.
- The isolated increase in activity of "hepatic" transaminases in blood serum, usually moderate (1,5-3 multiple exceeding of normal values) and decreasing at reduction of a dose or is even spontaneous.
- Acute damage of a liver (within 24 hours after introduction of Amiodaronum) with increase in transaminases and/or jaundice, including development of a liver failure, sometimes fatal (see. Special instructions).
From integuments Very seldom
- Feeling of heat, the increased sweating. From the central nervous system
Very seldom
- Benign intracranial hypertensia (brain pseudoneoplasm), headache.
Disturbances from immune system
Very seldom
- Acute anaphylaxis. Frequency is unknown
- Quincke's disease.
Disturbances from skeletal and muscular and connecting fabric
Frequency is unknown
- Pains in lumbar and lumbosacral department of a backbone of Reaction in an injection site
Often
- Inflammatory reactions, such as superficial phlebitis, at introduction directly to a peripheral vein. Reactions in an injection site, such as pain, erythema, hypostasis, necrosis, transudation, infiltration, inflammation, consolidation, thrombophlebitis, phlebitis, cellulitis, infection, pigmentation.

Interaction with other medicines:

Heavy arrhythmia, such as polymorphic ventricular tachycardia like "pirouette" (torsade de pointes) can be caused by a number of medicines, first of all antiarrhytmic means 1A both the III class and some neuroleptics (see below). The hypopotassemia, bradycardia or the inborn or acquired lengthening of an interval FROM can be the contributing factors for its development.
Contraindicated combinations (see. "Contraindications")
- With the drugs capable to cause polymorphic ventricular tachycardia like "pirouette" (torsade de pointes) (at their combination to Amiodaronum the risk of development of potentially lethal ventricular tachycardia like "pirouette" increases):
- antiarrhytmic means: 1A of a class (quinidine, hydroquinidine, Disopyramidum, procaineamide), III class (дофетилид, ибутилид, bretylium tosylate), соталол;
- other (not antiarrhytmic) drugs, such as bepridit; Vincaminum; some neuroleptics: fenotiazina (Chlorpromazinum, циамемазин, levomepromazinum, thioridazine, трифлуоперазин, Fluphenazin), benzamides (амисульприд, сультоприд, сульприд, тиаприд, вералиприд), phenyl propyl ketones (Droperidolum, haloperidol), сертиндол, Pimozidum; tricyclic antidepressants; цизаприд; makrolidny antibiotics (erythromycin at intravenous administration, Spheromycinum); azoles; protivomyalyariyny means (quinine, chloroquine, мефлохин, галофантрин, лумефантрин); pentamidine at parenteral administration; difemanit methyl sulfate; мизоластин; астемизол, терфенадин; ftorkhinolona (in particular moxifloxacin).
Not recommended combinations
- With beta adrenoblockers, the antagonists of calcium who are slowing down ChSS (verapamil, diltiazem) as there is a risk of development of disturbances of automatism (the expressed bradycardia) and conductivity.
- With the laxatives stimulating an intestines peristaltics which can cause a hypopotassemia which increases risk of development of ventricular tachycardia like "pirouette". At a combination to Amiodaronum it is necessary to use laxatives of other groups.
The combinations demanding care at use
- With the drugs capable to cause a hypopotassemia:
- the diuretics causing a hypopotassemia (in monotherapy or a combination);
- Amphotericinum In (in/in);
- system glucocorticosteroids;
- тетракозактид.
Increase in risk of development of ventricular disturbances of a rhythm, in particular ventricular tachycardia like "pirouette" (the hypopotassemia is the contributing factor). Control of the level of electrolytes in blood if necessary correction of a hypopotassemia and constant clinical and electrocardiographic observation of the patient is necessary. In case of development of ventricular tachycardia like "pirouette" it is not necessary to apply antiarrhytmic means (ventricular cardiostimulation, perhaps intravenous administration of salts of magnesium has to be begun).
- With procaineamide (see. "interaction. Contraindicated combinations"
Amiodaronum can increase plasma concentration of procaineamide and its metabolite of N-atsetilprokainamida that can increase risk of development of side effects of procaineamide.
- With anticoagulants of indirect action
Amiodaronum increases concentration of warfarin at the expense of inhibition of P450 2C9 cytochrome. At a warfarin combination with Amiodaronum strengthening of effects of indirect anticoagulant is possible that increases risk of development of bleedings. The thicket should control a prothrombin time (MNO) and to carry out correction of doses of anticoagulant both during treatment by Amiodaronum, and after its cancellation.
- With cardiac glycosides (foxglove drugs)
Possibility of disturbances of automatism (the expressed bradycardia) and atrioventricular conductivity. Besides, at a digoxin combination with Amiodaronum increase in concentration of digoxin in a blood plasma is possible (because of decrease in its clearance). Therefore at a digoxin combination to Amiodaronum it is necessary to define concentration of digoxin in blood and to control possible clinical and electrocardiographic displays of digitalis intoxication. Decrease in doses of digoxin can be required.
- With esmololy
Disturbances of contractility, automatism and conductivity (suppression of compensatory reactions of a sympathetic nervous system). Carrying out clinical and ECG monitoring is required.
- With Phenytoinum (and, on extrapolation, with fosfenitoiny)
Amiodaronum can increase plasma concentration of Phenytoinum at the expense of inhibition of P450 2C9 cytochrome therefore at Phenytoinum combination to Amiodaronum development of overdose of Phenytoinum is possible that can lead to emergence of neurologic symptoms; clinical monitoring is necessary and, at the first signs of overdose, Phenytoinum dose decline, definition of concentration of Phenytoinum in a blood plasma is desirable.
- With flekainidy
Amiodaronum increases plasma concentration of a flekainid at the expense of inhibition of CYP 2D6 cytochrome. In this connection correction of doses of a flekainid is required.
- With the drugs which are metabolized in the help of P450 3A4 cytochrome
At a combination of Amiodaronum, CYP 3A4 inhibitor, to these drugs increase in their plasma concentration is possible that can lead to increase in their toxicity and/or strengthening of pharmakodinamichesky effects and I can demand decrease their doses. Such drugs are listed below.
- Cyclosporine
The increase in level of cyclosporine in a blood plasma connected with decrease in metabolism of drug in a liver that can increase nephrotoxic effect of cyclosporine is possible. Definition of concentration of cyclosporine in blood, control of function of kidneys and correction of the mode of dosing of cyclosporine during treatment by Amiodaronum and after drug withdrawal is necessary.
- Fentanyl
The combination with Amiodaronum can increase pharmakodinamichesky effects of fentanyl and increase risk of development of its toxic effects.
- Other drugs which are metabolized by means of CYP 3A4: lidocaine (risk of development of a sinus bradycardia and neurologic symptoms), такролимус (risk of nephrotoxicity), sildenafit (risk of increase in its side effects), midazolam (risk of development of psychomotor effects), to triazoles, dihydroergotamine, ergotamine, симвастатин and other statines which are metabolized by means of CYP 3A4 (increase in risk of muscular toxicity, a rabdomioliz in this connection the dose of a simvastatin should not exceed 20 mg a day, at its inefficiency should be passed to reception of other statine which is not metabolized by means of CYP 3A4).
- With orlistaty
Risk of decrease in concentration of Amiodaronum and its active metabolite in a blood plasma. ECG control is necessary clinical and, if necessary.
- With a clonidine, guanfatsiny, cholinesterase inhibitors (donepezil, Galantaminum, rivastigminy, takriny, an ambenoniya chloride, pyridostigmine bromide, a neostigmina bromide), Pilocarpinum
Risk of development of excessive bradycardia (cumulative effects).
- With Cimetidinum, grapefruit juice
Delay of metabolism of Amiodaronum and increase in its plasma concentration, is possible increase in pharmakodinamichesky and side effects of Amiodaronum.
- With drugs for an inhalation anesthesia
It was reported about a possibility of development of the following heavy complications in the patients receiving Amiodaronum when receiving the general anesthesia by them: bradycardia (resistant to administration of atropine), arterial hypotension, disturbances of conductivity, decrease in cordial emission.
Very exceptional cases of heavy complications from respiratory system were observed (an acute respiratory distress a syndrome of adults), sometimes fatal which developed directly after surgical intervention which emergence contacts high concentration of oxygen.
- With a radioiodine
Amiodaronum contains iodine in the structure and therefore can break absorption of a radioiodine that can distort results of a radio isotope research of a thyroid gland.
- With rifampicin
Rifampicin is the powerful inductor CYP3A4, at combined use with Amiodaronum it can reduce plasma concentration of Amiodaronum and dezetilamiodaron.
- With St. John's Wort drugs
The St. John's Wort is the powerful inductor CYP3A4. In this regard decrease in plasma concentration of Amiodaronum and reduction of its effect is theoretically possible (clinical data are absent).
- With HIV protease inhibitors (including индинавир)
Inhibitors of HIV protease are CYP3A4 inhibitors. At simultaneous use with Amiodaronum can increase concentration of Amiodaronum in blood.
- With klopidogrely,
Klopidogrel, being inactive tiyenopirimidinovy drug is metabolized in a liver with formation of active metabolites. Interaction between klopidogrely and Amiodaronum which can lead to decrease in efficiency of a klopidogrel is possible.
- With dextromethorphan
Dextromethorphan is CYP2D6 and CYP3A4 substrate. Amiodaronum inhibits CYP2D6 and can theoretically increase plasma concentration of a dektrometorfan.

Contraindications:

- Hypersensitivity to iodine, Amiodaronum or excipients of drug.
- A sick sinus syndrome (a sinus bradycardia, sinuatrial blockade), in lack of an artificial pacemaker (pacemaker) (danger of "stop" of a sinus node).
- An atrioventricular block (the II-III Art.), in lack of a constant artificial pacemaker (pacemaker).
- Disturbances of intra ventricular conductivity (two - and trekhpuchkovy blockade) in lack of a constant artificial pacemaker (pacemaker). At such disturbances of conductivity Kordaron's use is intravenously possible only in specialized departments under cover of a temporary pacemaker (pacemaker).
- A combination to the drugs capable to extend an interval of QT and to cause development of Bouveret's diseases, including polymorphic ventricular tachycardia like "pirouette" (torsade de pointes) (see. "Interaction with other medicines"):

- antiarrhytmic means: HECTARE of a class (quinidine, hydroquinidine, Disopyramidum procaineamide); antiarrhytmic means of the III class (дофетилид, ибутилид, bretylium tosylate); соталол;
- other (not antiarrhytmic) drugs, such as bepridit; Vincaminum; some neuroleptics: fenotiazina (Chlorpromazinum, циамемазин, levomepromazinum, thioridazine, трифлуоперазин, Fluphenazin), benzamides (амисульприд, сультоприд, сульприд, тиаприд, вералиприд), phenyl propyl ketones (Droperidolum, haloperidol), сертиндол, Pimozidum; цизаприд; tricyclic antidepressants; makrolidny antibiotics (in particular erythromycin at intravenous administration, Spheromycinum); azoles; antimalarial means (quinine, chloroquine, мефлохин, галофантрин); pentamidine at parenteral administration; difemanit methyl sulfate; мизоластин; астемизол, терфенадин; ftorkhinolona.
- The inborn or acquired lengthening of an interval of QT.
- The expressed arterial hypotension, a collapse, cardiogenic shock.
- Hypopotassemia, hypomagnesiemia.
- Dysfunction of a thyroid gland (hypothyroidism, hyperthyroidism).
- Pregnancy (see. "Pregnancy and period of a lactation").
- The lactation period (see. "Pregnancy and period of a lactation").
- Age up to 18 years (efficiency and safety are not established).
All listed above contraindications do not belong to Kordaron's use when performing cardioresuscitation at the cardiac standstill caused by fibrillation of a ventricle resistant to cardioversion.
With care
At arterial hypotension, dekompensirovanny or heavy (the III-IV FC HSN on NYHA classification) heart failure, heavy respiratory insufficiency, a liver failure, bronchial asthma, at patients of advanced age (high risk of development of the expressed bradycardia), at an atrioventricular block of the I degree.
Pregnancy and period of a lactation
Pregnancy
Clinical information available now is insufficient for definition of an opportunity or impossibility of developing of malformations at an embryo at use of Amiodaronum in the first trimester of pregnancy.
As the thyroid gland of a fruit begins to connect iodine only from 14th week of pregnancy (amenorrhea), influence of Amiodaronum on it in case of its earlier use is not expected. Excess of iodine at use of drug after this period can lead to emergence of laboratory symptoms of a hypothyroidism in the newborn or even to formation at it clinically significant craw.
In view of impact of drug on a thyroid gland of a fruit, Amiodaronum it is contraindicated during pregnancy, except for special cases when the expected advantage exceeds risks (at zhizneugrozhayushchy ventricular disturbances of a rhythm
hearts).
Lactation period
Amiodaronum is allocated in breast milk in significant amounts therefore it is contraindicated during feeding by a breast (therefore during this period drug it is necessary to cancel or stop breastfeeding).

Overdose:

There is no information on overdose of intravenous Amiodaronum. There is some information concerning acute overdose of Amiodaronum accepted inside in tablets. Several cases of a sinus bradycardia, a cardiac standstill, attacks of ventricular tachycardia, a Bouveret's disease like "pirouette", disturbances of blood circulation and function of a liver, the expressed lowering of arterial pressure are described.
Treatment has to be symptomatic (at bradycardia - beta адреностимуляторов or installation of a pacemaker, at tachycardia like "pirouette"-в / in administration of salts of magnesium, urezhayushchy cardiostimulation). Neither Amiodaronum, nor its metabolites are removed during a hemodialysis. There is no specific antidote.

Storage conditions:

To store at a temperature not above 25 °C. To store in the place, unavailable to children. List B. Period of validity
2 years. Not to use drug after the period of validity specified on packaging.

Issue conditions:

According to the recipe

Packaging:

Solution for intravenous administration of 50 mg/ml.
On 3 ml in ampoules of colourless glass (type I) with a point of a break and two marking rings on an upper part of an ampoule. On 6 ampoules in a plastic blister strip packaging without covering (pallet). On 1 pallet together with the application instruction in a cardboard pack.