Mioritmil

General characteristics. Structure:

Active ingredient: amiodarone; 1 tablet contains Amiodaronum of a hydrochloride 200 mg; excipients: lactose monohydrate, potato starch, povidone, cellulose microcrystallic, кросповидон, magnesium stearate.

Pharmacological properties:

Pharmacodynamics. Antiarrhytmic means of the III class. Has antiarrhytmic and anti-anginal effect.

Antiarrhytmic properties:

–       extension 3 phases of action potential of cardiomyocytes is caused mainly by reduction of current of potassium ions (a class III on Vogen-Williams's classification);

–       delay of a cordial rhythm thanks to oppression of automatism of a sinus node. This effect is not blocked by atropine;

–       non-competitive alpha and beta and anti-adrenergic action;

–       delay of sinuatrial, atrial and nodal carrying out an impulse in a myocardium which than quicker a rhythm, especially is expressed;

–       lack of changes from intra ventricular conductivity;

–       increase in the refractory period and reduction of excitability of a myocardium at the atrial, nodal and ventricular levels;

–       delay of conductivity and lengthening of the refractory periods in additional atrioventricular conduction paths.

Other properties:

–       reduction of consumption of oxygen through moderate reduction of peripheric resistance of vessels and reduction of heart rate;

–       increase in a coronary blood-groove thanks to direct action on unstriated muscles of vessels of a myocardium and maintenance of cordial emission against the background of the reduced arterial pressure and peripheric resistance of vessels and in the absence of negative inotropic effects.

Pharmaceutical characteristics.
Main physical and chemical properties: tablets of color, white or white with slightly creamy shade, a ploskotsilindrichesky form, with a facet and risky.

Indications to use:

Prevention of a recurrence:

– life-threatening ventricular tachycardia: drug is appointed only in the conditions of a hospital under observation;

– documentary simptomny and disabling ventricular tachycardia;

– documentary supraventricular tachycardia if the need for purpose of drug is defined at patients with a disease, resistant to other treatment, or with existence of contraindications to other methods of treatment of fibrillation of ventricles.

Treatment of supraventricular tachycardia: delay or reduction of fibrillation of auricles or atrial flutter.

Patients can apply Amiodaronum with coronary heart disease and/or left ventricular dysfunction of heart (see the section "Pharmacodynamics").

Route of administration and doses:

Appoint the adult inside in time or after food, without chewing, with a small amount of liquid.

Initial treatment.

The usual mode of dosing – 3 tablets a day within 8-10 days.

In certain cases for initial treatment higher doses (4-5 tablets a day), but always – during a short span and with monitoring of the electrocardiogram are used.

The supporting treatment.

The minimal effective dose which can be various depending on the patient has to be defined and vary from 0,5 tablets a day (1 tablet for 2 days) up to 2 tablets a day.

Features of use:

Use during pregnancy or feeding by a breast.

Pregnancy. Use of this medicine during pregnancy is contraindicated, since the II trimester of pregnancy.

Feeding by a breast. Amiodaronum and its metabolites together with iodine are excreted in breast milk in concentration big, than their concentration in mother's plasma. Because of risk of development of a hypothyroidism in newborn feeding by a breast contraindicated at treatment Amiodaronum.

Children.

Safety and efficiency of use of Amiodaronum to children were not estimated today therefore purpose of this drug is not recommended to children.

Effects from heart. Prior to use of drug it is necessary to execute an ECG. At patients of advanced age against the background of administration of drug delay of heart rate can amplify. Amiodaronum induces changes of an ECG. These changes include lengthening of an interval of Q owing to the extended repolarization, with possible emergence of a tooth of U. It is a sign of therapeutic effect of drug, but not its toxicity.

Emergence against the background of treatment of AV-blockade of II or III degrees, sinuatrial blockade or bifastsikulyarny blockade demands drug withdrawal. Development of AV-blockade of the I degree demands an intensification of observation of the patient.

It was reported about cases of emergence of new arrhythmia or deterioration in already existing and treated arrhythmia (see. "Side reactions").

The Aritmogenny effect of Amiodaronum weak or even below that majority of antiarrhytmic means is also usually shown against the background of use of some combinations of medicines (see the section "Interaction with Medicines and Other Types of Interactions") or in the presence of disturbances of electrolytic balance.
Disturbances from a thyroid gland. This medicine contains iodine in this connection influences results of some indicators of function of a thyroid gland (binding of a radioiodine, the proteinaceous and connected iodine). But definition of indicators of function of a thyroid gland (TZ, T4, vch-TTG) at the same time can be carried out.
Amiodaronum can cause dysfunction of a thyroid gland, especially at patients with dysfunction of a thyroid gland in the anamnesis. Quantitative determination of content of TTG is recommended at all patients prior to drug use, and then is regular during treatment and within several months after drug withdrawal, and also in case of clinical suspicion of dysfunction of a thyroid gland (see the section "Side reactions").

Disturbances from lungs. Emergence of an asthma or dry cough, both isolated, and associated with deterioration in the general state, has to be considered as a possible sign of pulmonary toxicity of drug, for example development of an intersticial pneumopathy and demands radiological inspection of the patient (see the section "Side reactions").

Disturbances from a liver. Regular monitoring of function of a liver is recommended at the beginning of administration of drug, further periodically during treatment by Amiodaronum (see. "Side reactions"). It is necessary to reduce a dose of Amiodaronum or to cancel this drug if levels of transaminases increase more than by 3 times in comparison with normal values of these indicators.

Neuromuscular disturbances. Amiodaronum can cause touch, motor or mixed peripheral neuropathy and a myopathy (see the section "Side reactions").

Disturbances from organs of sight. At emergence of an illegibility of sight or decrease in visual acuity it is necessary to execute immediately full ophthalmologic inspection, including a fundoskopiya. Development of neuropathy or optic neuritis, caused by Amiodaronum, demands drug withdrawal as continuation of treatment can lead to progressing of disturbances up to a blindness (see the section "Side reactions").

The disturbances connected with interactions with other medicines.

Combinations (see the section "Interaction with Medicines and Other Types of Interactions") with such drugs as: beta-blockers, except a sotalol (a contraindicated combination) and an esmolola (a combination which demands precautionary measures at use), verapamil and diltiazem, have to be considered only for prevention of life-threatening ventricular arrhythmias. Use of Amiodaronum is not recommended in combination with cyclosporine, diltiazem (for injections) and verapamil (for injections), some antiparasitics (галофантрин, люмефантрин and pentamidine), some neuroleptics (амисульприд, Chlorpromazinum, циамемазин, Droperidolum, Fluphenazin, a haloperidol, levomepromazinum, Pimozidum, пипамперон, пипотиазин, сертиндол, Sulpiridum, сультоприд, тиаприд, зуклопентиксол) and methadone (see the section "Interaction with Medicines and Other Types of Interactions").

The disturbances connected with excipients. This medicine contains lactose. In this regard it is not recommended for use to patients with intolerance of a galactose, deficit of lactase of Sami or a sprue of glucose and a galactose (rare hereditary diseases).

Electrolytic disturbances, especially hypopotassemia: it is important to consider situations which can be associated with a hypopotassemia that can promote manifestation of pro-arhythmic effects of drug. The hypopotassemia needs to be eliminated prior to use of Amiodaronum. It is necessary to carry out monitoring of level of potassium in blood serum.

The undesirable effects provided below are most often connected with the excessive use of medicine, they can be avoided or minimized careful observance of the minimum maintenance dose.

During treatment patients are recommended to avoid solar radiation or to take protective measures against solar radiation.

Safety and efficiency of Amiodaronum at children were not estimated in controlled clinical trials.

Because of possible increase in a threshold of a defibrillation and/or stimulation by the implanted cordial defibrillators or artificial pacemakers it is necessary to check this threshold before treatment by Amiodaronum and several times later began its uses, and also every time at correction of a dose.

Anesthesia.
The anesthesiologist has to be warned before operation that the patient accepts Amiodaronum.
Prolonged treatment by Amiodaronum can strengthen the hemodynamic risk associated with the general and local anesthesia that will be expressed through side effects. Bradycardia, arterial hypotension, reduction of cordial emission and disturbance of cordial conductivity belong to such side effects, in particular. Besides, at the patients receiving Amiodaronum in the early postoperative period several cases acute respiratory a distress syndrome were observed. In this regard it is recommended to carry out for such patients careful observation during artificial ventilation of the lungs (see the section "Side reactions").

Ability to influence speed of response at control of motor transport or work with other mechanisms.

During treatment it is necessary to be careful at control of motor transport or work with other mechanisms demanding the increased concentration of attention and speed of psychomotor reactions because of possible development of side reactions from an organ of sight and a nervous system.

Side effects:

Side effects were classified by categories "Sistema-Organ-Klass" and by frequency as follows: very often (> 10%), it is frequent (> 1%, <10%); infrequently (> 0,1%, <1%), it is rare (> 0,01%, <0,1%), is very rare (<0,01%).

From organs of sight: very often – microdeposits in a cornea, almost at all adult persons, usually within the site under a pupil which do not demand cancellation of Amiodaronum. In exceptional cases they are associated with color Galo in dazzle light or with sight misting. Microdeposits in a cornea represent difficult lipidic deposits and always completely reversible after drug withdrawal, is very rare – a neuropathy of an optic nerve (optic neuritis) with an illegibility of sight and deterioration in sight, and also, by results of survey of an eyeground, with a papilledema which can progress before more or less heavy decrease in visual acuity. Relationship of cause and effect of this by-effect with reception of Amiodaronum it is not established today. However in the absence of other obvious reasons of development of this by-effect it is recommended to cancel Amiodaronum.

From skin and hypodermic cellulose: very often – a photosensitization. It is recommended to avoid impact of sunlight (and ultraviolet radiation in general) during treatment; often – xanthopathies of cyanotic or cyanotic-gray color which arise against the background of long reception of high daily doses and slowly disappear after drug withdrawal (within 10-24 months); very seldom – an erythema against the background of radiation therapy. Skin rashes, usually are not specific. Exfoliative dermatitis though relationship of cause and effect of this by-effect is accurately not established today with administration of drug. Allopecia.

Endocrine frustration.

Side effects from a thyroid gland: very often – except for cases when there are clinical signs of dysfunction of a thyroid gland, "the changes which are not connected with administration of drug" from the content of hormones of a thyroid gland in blood (the increased T4 level, the normal or a little reduced T3 level) do not demand drug withdrawal; often – the hypothyroidism causes typical symptoms: increase in body weight, intolerance of cold, apathy, drowsiness. Substantial increase of the TTG level confirms this diagnosis. Eutireoidizm is usually reached within 1-3 months after the termination of administration of drug. Drug withdrawal is not obligatory: in case use of Amiodaronum has reasonable indications, treatment by this drug can continue in combination with replacement hormonal therapy by hormones of a thyroid gland with left thyroxine use. Doses of left thyroxine can be modified depending on the TTG levels. It is more difficult to establish a hyper thyroidism: the symptomatology is less expressed (a small causeless degrowth of a body, insufficient efficiency of anti-anginal and/or antiarrhythmic medicines); at patients of advanced age mental symptoms, even a thyrotoxicosis are observed.

Considerable decrease in level of highly sensitive TTG confirms this diagnosis. In that case it is necessary to cancel surely Amiodaronum that, as a rule, is enough for approach of clinical normalization within 3-4 weeks. As serious cases of this by-effect can be fatal, it is necessary to begin appropriate therapy urgently.

In case the thyrotoxicosis is the reason of problems (as directly, and through its influence on vulnerable balance of a myocardium), variability of efficiency of synthetic anti-thyroid drugs causes need to recommend reception of high doses of corticosteroids (1 mg/kg) during quite long span (3 months).

It was reported about hyper thyroidism cases during the period by duration up to several months after cancellation of Amiodaronum.

Other endocrine frustration.

Cases SISAH (syndrome of inadequate secretion of antidiuretic hormone), especially are very rare if drug is used along with medicines which can induce a hyponatremia. See. "Results of researches".

From respiratory system, a thorax and a mediastinum: often – it was reported about cases of an intersticial or diffusion alveolar disease of lungs and an obliterating bronchiolitis with organizing pneumonia (OBOP), sometimes fatal. Emergence of an asthma at an exercise stress or dry cough, both isolated, and associated with deterioration in the general state of health (increased fatigue, decrease in body weight and small fervescence), demands radiological inspection and, if necessary, drug withdrawal as these diseases of lungs can lead to pulmonary fibrosis.

Early cancellation of Amiodaronum, together with purpose of therapy by corticosteroids or without it, conducts to symptomatology obsolescence. Clinical signs usually disappear within 3-4 weeks, improvements of a X-ray pattern and pulmonary function occurs more slowly (within several months).

It was reported about several cases of development of the pleurisy which is usually associated with an intersticial pneumopathy; very seldom – a bronchospasm, especially at patients with bronchial asthma.

Acute respiratory distress syndrome, in some cases – with a lethal outcome, sometimes in the early postoperative period after surgical intervention (it was suspected possible interaction with high doses of oxygen) (see the sections "Special Security Measures" and "Features of Use").

Frequency is unknown (it cannot be estimated according to available data): it was reported about cases of pulmonary bleeding which in certain cases can demonstrate a pneumorrhagia, respiratory insufficiency. These pulmonary side effects are often associated with the pneumopathy induced by Amiodaronum.

From a nervous system: often – a tremor or other extrapyramidal symptomatology. Sleep disorders, including nightmares. The touch, motor or mixed peripheral neuropathy; seldom – a myopathy. The touch, motor or mixed peripheral neuropathy and a myopathy can develop in several months of treatment, but sometimes they arise in several years. These by-effects, as a rule, the return after drug withdrawal.

However recovery can be incomplete, very slow and be observed only in several months after the termination of administration of drug very seldom – a cerebellar ataxy. Benign intracranial hypertensia, headache. When developing single headaches it is necessary to execute inspection for definition of their possible reason.

From a liver and biliary tract: it was reported about cases of damage of a liver; these cases were diagnosed on increase in level of transaminases in blood serum. It was reported about the following by-effects: very often – usually moderate and isolated

increase in activity of transaminases (norms are 1,5-3 times higher), which disappeared after drug withdrawal or is spontaneous; often – acute damage of a liver with increase in level of transaminases in blood and/or jaundice, sometimes fatal which demands drug withdrawal; very seldom – chronic damage of a liver, cirrhosis which demands prolonged treatment, a liver failure. Histologic changes correspond to a picture of pseudo-alcoholic hepatitis. As clinical and laboratory signs are not accurately expressed (the variable hepatomegalia, increase in level of transaminases in blood is 1,5-5 times higher than norm), regular monitoring of function of a liver is shown.

In case of increase in the level of transaminases in blood even moderated, arising later administration of drug within more than 6 months it is necessary to suspect development of chronic damage of a liver. These clinical and biological changes usually disappear after drug withdrawal. It was reported about several irreversible cases of such changes.
From heart: often – the bradycardia usually moderate and dozozavisimy; infrequently – disturbance of conductivity of a myocardium (sinuatrial blockade, AV-blockade of various degree), is very rare – the expressed bradycardia and, in exceptional cases, refusal of a sinus node about which it was reported in several cases (against the background of dysfunction of a sinus node, at patients of advanced age), emergence or deterioration in displays of arrhythmia which are followed by stenocardia attacks.

From a digestive tract: very often – small digestive disturbances (nausea, vomiting, a dysgeusia) which usually arise in an initiation of treatment drug and disappear after reduction of its dose.

From mammary glands and reproductive system: very seldom – an epididymite, impotence. Relationship of cause and effect of this by-effect is accurately not established today with reception of this medicine.

From vessels: very seldom – a vasculitis.

Results of researches: seldom – exceptional cases of a hyponatremia can demonstrate development of the syndrome of inadequate secretion of antidiuretic hormone (SISAH), especially if drug is accepted along with medicines which can induce a hyponatremia; very seldom – damage of kidneys with moderate increase in level of creatinine.

From blood and lymphatic system: very seldom – thrombocytopenia, hemolitic anemia.

From immune system: frequency is unknown (it cannot be estimated according to available data) – was reported about cases of a Quincke's disease, allergic reactions, including skin rashes.

Interaction with other medicines:

Antiarrhytmic drugs. Many antiarrhythmic drugs suppress cordial automatism, conductivity and contractility of a myocardium.

Simultaneous use of the antiarrhytmic means belonging to different classes can provide achievement of favorable therapeutic effect, but most often treatment by such combination is very delicate process which demands careful clinical and ECG monitorings. Simultaneous use of antiarrhytmic means which can induce emergence of torsades de pointes (such as Amiodaronum, Disopyramidum, connection quinidine, соталол, etc.), contraindicated.
Simultaneous use of antiarrhytmic means of the same class is not recommended, except exceptional cases as such treatment increases risk of cardial side effects.

Simultaneous use with medicines which have negative inotropic effect promote delay of a cordial rhythm and/or slow down atrioventricular conductivity, is delicate process which demands careful clinical and ECG monitorings.

Medicines which can induce development of torsades de pointes.

This serious arrhythmia can be induced by some medicines irrespective of whether they belong to antiarrhythmic drugs. Advantage factors are a hypopotassemia (see the section "The Drugs Reducing the Content of Potassium"), bradycardia (see the section "The Drugs Which Are Slowing Down a Cordial Rhythm") either the inborn or acquired earlier existing lengthening of an interval of QT.

The antiarrhytmic drugs Ia and III of classes and some neuroleptics, in particular, belong to medicines which can cause development of torsadesdepointes. For erythromycin, Spheromycinum and a vinkamitsin it is interaction is implemented only when using their dosage forms which are entered in the intravenous way.

Simultaneous use of two medicines, each of which is drug which promotes emergence of torsadesdepointes, usually contraindicated.
However methadone and some subgroups of drugs, is an exception of this rule:
– antiparasitic drugs (галофантрин, люмефантрин, pentamidine) are only not recommended for use together with other means which promote emergence of torsades de pointes;

– neuroleptics which can induce torsadesdepointes are also not recommended for use together with other means which promote emergence of torsadesdepointes, but such combination is not contraindicated.

The drugs which are slowing down a cordial rhythm.

Many medicines can cause bradycardia. It, in particular, concerns the antiarrhythmic drugs Ia of a class, beta-blockers, some antiarrhytmic drugs III of a class, some blockers of calcium channels, drugs of a foxglove, Pilocarpinum and antikholinesterazny drugs.

Combinations are contraindicated (see the section "Contraindications")

Medicines which can induce emergence of torsades de pointes (except for antiparasitic drugs, neuroleptics and methadone; see the subsection "Unrecommended Combinations"):

– antiarrhytmic means of Ia of a class (quinidine, hydroquinidine, Disopyramidum),
– antiarrhytmic means of the III class (дофетилид, ибутилид, соталол),
– other medicines, such as compounds of arsenic, bepridit, цизаприд, difemanit, доласетрон intravenously, erythromycin intravenously, мизоластин, винкамицин intravenously, moxifloxacin, Spheromycinum intravenously, торемифен.

Increase in risk of development of ventricular arrhythmias, especially torsades de pointes.
Unrecommended combinations (see the section "Features of Use").

Cyclosporine. Increase in serumal concentration of cyclosporine because of deterioration in his metabolism in a liver, with risk of manifestation of nephrotoxic effects.

Quantitative definition of serumal concentration of cyclosporine, monitoring of function of kidneys and dose adjustment of cyclosporine against the background of treatment by Amiodaronum.
Diltiazem for injections. Risk of development of bradycardia and atrioventricular block.
If use of this combination it is impossible to avoid, very important to exercise careful clinical control and continuous monitoring of an ECG.

Verapamil for injections. Risk of development of bradycardia and atrioventricular block.
If use of this combination it is impossible to avoid, very important to exercise careful clinical control and continuous monitoring of an ECG.

Antiparasitic drugs which can induce torsades de pointes (галофантрин, люмефантрин, pentamidine). Increase in risk of development of ventricular arrhythmias, especially torsades de pointes.

If it is possible, it is necessary to cancel 1 or 2 drugs. If use of this combination it is impossible to avoid, very important to execute preliminary estimate of an interval of QT and implementation of monitoring of an ECG.

Neuroleptics which can induce torsades de pointes (амисульприд, Chlorpromazinum, циамемазин, Droperidolum, Fluphenazin, a haloperidol, levomepromazinum, Pimozidum, пипамперон, пипотиазин, сертиндол, Sulpiridum, сультоприд, тиаприд, зуклопентиксол). Increase in risk of development of ventricular arrhythmias, especially torsades de pointes.

Methadone. Increase in risk of development of ventricular arrhythmias, especially torsades de pointes.
Combinations which demand precautionary measures at use.

Peroral anticoagulants. Strengthening of anticoagulating effect and increase in risk of hemorrhagic complications.

More frequent control of MNO. Correction of a dose of peroral anticoagulant against the background of treatment by Amiodaronum and within 8 days after drug withdrawal is possible.

Beta-blockers, except a sotalol (a contraindicated combination) and an esmolola (a combination which demands precautionary measures at use). Disturbances of automatism and conductivity (oppression of compensatory sympathetic mechanisms). ECG and clinical monitoring.

The beta-blockers applied to treatment of heart failure (бисопролол, карведилол, метопролол, небиволол). Disturbances of automatism and conductivity of a myocardium with risk of excessive delay of a cordial rhythm.

Increase in risk of development of ventricular arrhythmias, especially torsades de pointes. Clinical and regular ECG monitoring.

Dabigatran. Increase in plasma concentration of a dabigatran with increase in risk of the hemorrhagic phenomena.

Clinical monitoring and dose adjustment of a dabigatran if necessary, but is not higher than 150 mg/days.

Foxglove drugs. Automatism suppression (excessive delay of a cordial rhythm) and disturbance of atrioventricular conductivity.

When using digoxin increase in level of digoxin in blood is observed because of
 reduction of clearance. An ECG and clinical monitoring, quantitative determination of level of digoxin in blood and, if necessary, digoxin dose adjustment.

Diltiazem for oral administration. Risk of development of bradycardia or an atrioventricular block, especially at patients of advanced age. ECG and clinical monitoring.

Some macroleads (azithromycin, кларитромицин, рокситромицин). Increase in risk of development of ventricular arrhythmias, especially torsades de pointes. An ECG and clinical monitoring against the background of simultaneous use of these drugs.

Verapamil for oral administration. Risk of development of bradycardia and an atrioventricular block, especially at patients of advanced age. ECG and clinical monitoring.

Esmolol. Disturbance of contractility, automatism and conductivity (oppression of compensatory sympathetic mechanisms). ECG and clinical monitoring.

The drugs reducing the content of potassium: diuretics which reduce the content of potassium (separately or in a combination), the stimulating laxatives, Amphotericinum In (at intravenous administration), glucocorticoids (at system use), тетракозактид. Increase in risk of ventricular arrhythmia, especially torsades de pointes (the hypopotassemia is the advantage factor).

It is necessary to eliminate a hypopotassemia before prescription of medicine and to carry out monitoring of an ECG, content of electrolytes and clinical monitoring.

Lidocaine. Risk of increase in plasma concentration of lidocaine, with possible neurologic and cardial side effects, in connection with oppression by Amiodaronum of metabolism of drug in a liver. Clinical and ECG monitoring, and also, if necessary, quantitative definition of plasma concentration of lidocaine. If necessary – dose adjustment of lidocaine against the background of treatment by Amiodaronum and after its cancellation.

Orlistat. Risk of reduction of plasma concentration of Amiodaronum and its active metabolite. Clinical monitoring and, if necessary, monitoring of an ECG.

Phenytoinum (by extrapolation – фосфенитоин). Increase in plasma concentration of Phenytoinum with overdose signs, especially neurologic signs (oppression of metabolism of Phenytoinum in a liver). Clinical monitoring, quantitative definition of plasma concentration of Phenytoinum correction of a dose is also possible.

Simvastatin. Increase in risk of emergence of the side effects depending on concentration such, as рабдомиолиз (oppression of metabolism of a simvastatin in a liver). Considering this type of interaction, it is not necessary to exceed a dose of a simvastatin of 20 mg a day or to use other statine.

Takrolimus. Increase in concentration of a takrolimus in blood because of oppression of his metabolism by Amiodaronum. Quantitative definition of concentration of a takrolimus in blood, monitoring of function of kidneys and dose adjustment of a takrolimus against the background of simultaneous use of Amiodaronum and at its cancellation.

Flekainid. Amiodaronum increases concentration of a flekainid in a blood plasma owing to inhibition of CYP 2D6 cytochrome. Therefore the dose of a flekainid needs to be adjusted.

Medicines which are metabolized by P450 3A4 cytochrome (fentanyl, sildenafit, midazolam, to triazoles, dihydroergotamine, ergotamine, statines, including аторвастатин, ловастатин). Appointment them with Amiodaronum which is inhibitor of this enzyme, increases concentration of these drugs in a blood plasma, and, as a result, is possible strengthening of their toxicity.

The drugs which are slowing down a cordial rhythm. Increase in risk of development of ventricular arrhythmias, especially torsades de pointes. Clinical and ECG monitoring.

Combinations which require special attention.

Pilocarpinum. Risk excessive delay of a cordial rhythm (the additive effects of drugs which are slowing down a cordial rhythm).

Contraindications:

Sinus bradycardia, sinuatrial heart block in the absence of an endocardial pacemaker (an artificial pacemaker).

Sick sinus syndrome in the absence of an endocardial pacemaker (risk of a stop of a sinus node).

Disturbances of atrioventricular conductivity of high degree in the absence of an endocardial pacemaker.

Dysfunction of a thyroid gland.

Hypersensitivity to iodine, Amiodaronum or to one of excipients.
In a combination with medicines which can induce developing of piruetny ventricular tachycardia (torsades de pointes):

– antiarrhytmic means of Ia of a class (quinidine, hydroquinidine, Disopyramidum),

– antiarrhytmic means of the III class (соталол, дофетилид, ибутилид),

– other medicines, such as compounds of arsenic, bepridit, цизаприд, difemanit, доласетрон intravenously, erythromycin intravenously, мизоластин, Vincaminum intravenously, moxifloxacin, Spheromycinum intravenously, торемифен (see the section "Interaction by Medicines and Other Types of Interactions").

Overdose:

Cases of acute intake of high doses of Amiodaronum are insufficiently documented. torsades de pointes, and damages of a liver was reported about several cases of emergence of a sinus bradycardia, ventricular arrhythmia, especially. Treatment has to be symptomatic. Considering a pharmacokinetic profile of this drug, monitoring of a condition of the patient, especially cordial function, during rather long span is recommended. Amiodaronum and its metabolites are not removed by means of dialysis.

Storage conditions:

Period of validity. 2 years. To store in original packaging in the place, unavailable to children, at a temperature not above 25 °C.

Issue conditions:

According to the recipe

Packaging:

On 10 tablets in a blister strip packaging; on the 3rd blister strip packagings in a pack.