Amiodarone - instructions for use, doses, side effects, contraindications

Active substance: Amiodarone hydrochloride in terms of 100% substance - 150.0 mg; Excipients: sodium acetate trihydrate 3.0 mg; acetic acid is ice - 0.02211 ml; 1 M acetic acid solution to pH 3.5; polysorbate 80 (Tween 80) 300.0 mg; gasoline - 60.0 mg; water for injection - up to 3.0 ml.

Description:Transparent liquid with a yellowish or greenish tinge.

Pharmacotherapeutic group:Antiarrhythmic drug

ATX: & nbsp

C.01.B.D.01 Amiodarone

Pharmacodynamics:

Amiodarone belongs to the third class of antiarrhythmic drugs (repolarization inhibitors) and has a unique mechanism of antiarrhythmic action: in addition to the properties of class III antiarrhythmics (potassium channel blockade), it has the effects of class I antiarrhythmics (sodium channel blockade), class IV antiarrhythmics (calcium channel blockade) and uncompetitive beta-adrenergic blocking action.

In addition to antiarrhythmic action, he has antianginal, coronary dilatory, alpha and beta adrenoblocking effects. The severity of the action of amiodarone reaches a maximum after 15 minutes after its intravenous administration and stops after approximately 4 hours.

Antiarrhythmic properties are due to:

- increasethe duration of the third phase of the action potential of cardiomyocytes (mainly due to the blocking of the ion current in the potassium channels - the effect of the class III antiarrhythmic drug according to Williams classification);

- a decrease in the automatism of the sinus node, leading to a decrease in the heart rate (heart rate);

- non-competitive blockade of alpha- and beta-adrenergic receptors;

- slowing of intracardiac (sinoatrial, atrial and atrioventricular - AV) conduction. This action is more pronounced with tachycardia. Significant influence on intraventricular conduction amiodarone does not render;

- an increase in the duration of the refractory period and a decrease in the excitability of the myocardiocytes of the atria and ventricles, as well as an increase in the duration of the refractory period of the AV node;

- slowing the speed of the exercise and increasing the duration of the refractory period in additional beams of the atrioventricular conduction.

Other effects of amiodarone:

- decrease in oxygen consumption by myocardium due to a moderate decrease in total peripheral vascular resistance (OPSS) and heart rate, as well as myocardial contractility;

- increased coronary blood flow due to direct effects on the tone of the coronary arteries;

- maintaining the value of cardiac output despite a slight decrease in myocardial contractility (due to a decrease in OPSS and afterload);

- influence on the exchange of thyroid hormones: inhibition of transformation T₃ in T₄ (blockade of thyroxine-5-deiodinase) and blocking the seizure of these hormones by myocardiocytes and hepatocytes, leading to a weakening of the stimulating effect of thyroid hormones;

- restoration of cardiac activity in case of cardiac arrest caused by ventricular fibrillation, resistant to defibrillation.

Pharmacokinetics:

The concentration in the blood of the parenterally administered amiodarone decreases very rapidly due to the intensive distribution of the drug. Amiodarone has a large volume of distribution and can accumulate in almost all tissues, especially in adipose tissue, as well as in the liver, lungs, spleen and cornea.

The connection with plasma proteins is 95% (62% with albumin, 33% with beta-lipoproteins).

Amiodarone is metabolized in the liver with the participation of isoenzymes CYP3A4 and CYP2C8. Its main metabolite, desethylamiodarone, is pharmacologically active and can enhance the antiarrhythmic effect of the basic compound. Amiodarone and desethylamiodarone in vitro have the ability to inhibit isoenzymes CYP1A1, CYP1A2, CYP2C9, CYP2C19, CYP2D6, CYP3A4, CYP2A6, CYP2B6 and CYP2C8. Amiodarone and desethylamiodarone are also capable of inhibiting some transporters (P-glycoprotein- P-gp) and carrier of organic cations (PKK2). In vivo interaction of amiodarone with substrates of isozymes CYP3A4, CYP2C9, CYP2D6. It is brought out very slowly, mainly with bile through the intestine. Amiodarone and its metabolites are determined in blood plasma for 9 months after discontinuation of treatment. Amiodarone and its metabolites are not dialyzed.

Indications:

Cessation of paroxysmal tachyarrhythmias:

- attacks of ventricular paroxysmal tachycardia;

- attacks of supraventricular paroxysmal tachycardia with a high incidence of ventricular contractions, especially against the background of Wolff-Parkinson-White syndrome;

- paroxysmal and permanent form of atrial fibrillation;

- atrial flutter.

Cardioreanimation in case of cardiac arrest caused by ventricular fibrillation, resistant to defibrillation.

Contraindications:

All of the following contraindications do not apply to the use of the drug during cardiac revival with cardiac arrest caused by ventricular fibrillation resistant to defibrillation.

Intravenous fluid administration is contraindicated in the case of arterial hypotension, severe respiratory failure, cardiomyopathy or heart failure (possibly weighting these conditions).

- Hypersensitivity to iodine, amiodarone or excipients of the drug.

- Syndrome of weakness of the sinus node (sinus bradycardia, sinoatrial block), except for cases of using an artificial pacemaker (the danger of "stopping" the sinus node).

- AV blockade II-III degree in the absence of a permanent artificial pacemaker.

- Violations of intraventricular conduction (two- and three-beam blockades) in the absence of a permanent artificial pacemaker (pacemaker). With such conductivity disorders, the use of the drug Amiodarone intravenously is possible only in specialized departments under the guise of a temporary pacemaker (pacemaker).

- Simultaneous use with drugs that can prolong the QT interval and cause the development of paroxysmal tachycardias, including polymorphic ventricular tachycardia of the pirouette type (see section "Interaction with other drugs"):

- antiarrhythmic drugs: IA class (quinidine, hydroquinidine, disopyramide, procainamide); antiarrhythmic drugs of the III class (dofetilid, ibutilid, brethil tosylate); sotalol; beprideil;

- other (non-antiarrhythmic) drugs, such as wincamine, some neuroleptics: phenothiazines (chlorpromazine, cyamemazine, levomepromazine, thioridazine, trifluoperazine, fluphenazine), benzamides (amisulpride, sultopride, sulpride, tiapride, verialpyride), butyrophenones (droperidol, haloperidol), sertindole, pimozide; cisapride; tricyclic antidepressants; macrolide antibiotics (in particular erythromycin with intravenous administration, spiramycin); azoles; antimalarial drugs (quinine, chloroquine, mefloquine, halofantrine); pentamidine with parenteral administration; diphenamyl methyl sulfate; misolastine; astemizole, terfenadine; fluoroquinolones.

- Congenital or acquired lengthening of the QT interval.

- Pronounced decrease in blood pressure (BP), cardiogenic shock, collapse.

- Hypokalemia, hypomagnesemia.

- Thyroid dysfunction (hypothyroidism, hyperthyroidism).

- Pregnancy, the period of breastfeeding (see.section "Application during pregnancy and during breast-feeding").

- Age to 18 years (effectiveness and safety not established).

Carefully:Arterial hypotension, cardiomyopathy, severe decompensated heart failure (III-IV functional class according to the classification of the New York Heart Association (NYHA)), severe respiratory failure due to interstitial lung diseases, hepatic insufficiency, bronchospastic syndrome, advanced age (high risk of severe bradycardia), AV blockade of the 1st degree.

Pregnancy and lactation:

Pregnancy

Currently available clinical information is not sufficient to determine whether it is possible or impossible to develop developmental defects in the embryo when using amiodarone in the first trimester of pregnancy. Since the fetal thyroid begins to bind iodine only from the 14th week of pregnancy, then it is not expected to affect her amiodarone in the case of its earlier use. Excess iodine during the use of the drug after this period may lead to the appearance of laboratory symptoms of hypothyroidism in newborns or even to the formation of a clinically significant goiter in it.

In view of the possible effects on the thyroid of the fetus amiodarone contraindicated during pregnancy, except when the expected benefit of its use by a pregnant woman exceeds the risk in the fetus (with life-threatening ventricular arrhythmias).

Breastfeeding period

Amiodarone is excreted in breast milk in significant quantities, so it is contraindicated during breastfeeding (the drug should be canceled or stopped breastfeeding).

Dosing and Administration:

Amiodarone (concentrate for the preparation of a solution for intravenous administration) is intended for use in those cases when rapid antiarrhythmic effect is required or its administration is not possible.

Except for urgent clinical situations, the drug should be used only in a hospital in an intensive care unit under the constant monitoring of ECG and blood pressure!

The drug is used only in diluted form. To dilute the drug Amiodarone should be used only 5% solution of dextrose (glucose). Do not add other drugs to the infusion solution!

Due to the peculiarities of the dosage form of the drug, it is not possible to administer an infusion solution with a concentration of less than 0.6 mg / ml (2 ampules in 500 ml of a 5% solution of dextrose (glucose)).

To avoid local reactions, the drug Amiodarone should be administered through a central venous catheter, except in cases of cardiac resuscitation in ventricular fibrillation resistant to defibrillation, where it is possible to administer the drug to large peripheral veins - in the absence of central venous access (see section "Special instructions").

Intravenous drip introduction through a neutral venous catheter

Usually the loading dose is 5 mg / kg of body weight, administered whenever possible with the infusomat for 0.3-2 hours. The intravenous drip administration can be repeated 2-3 times within 24 hours. The rate of administration of the drug is adjusted depending on the clinical effect. The therapeutic effect appears during the first minutes of administration and gradually decreases after the cessation of infusion, so if it is necessary to continue treatment with the drug Amiodarone it is recommended to switch to a permanent intravenous drip introduction of the drug. Supportive treatment: 10-20 mg / kg / day of body weight (average 600-800 mg / day, maximum dose 1200 mg / day) for several days. From the first day of infusion, you should begin a gradual transition to taking the drug inside (3 tablets of 200 mg per day). The dose can be increased to 4 or even 5 tablets per day.

Intravenous Injection

Intravenous fluid administration is usually not recommended because of the risk of hemodynamic complications (there may be a sharp drop in blood pressure and collapse).

Intravenous fluid administration should be performed only in urgent cases with ineffectiveness of other types of treatment and only in the intensive care unit under constant monitoring of ECG and blood pressure.

The dose is 5 mg / kg body weight. With the exception of cases of cardiac retention in ventricular fibrillation resistant to defibrillation, intravenous spray administration of the drug Amiodarone must be carried out for at least 3 minutes. Repeated administration of the drug should not be performed earlier than 15 minutes after the first injection, even if the contents of only one ampoule were initially introduced (the possibility of developing an irreversible collapse).

If there is a need to continue the administration of the drug Amiodarone, it should be administered as an infusion.

Cardioreanimation in case of cardiac arrest caused by ventricular fibrillation resistant to defibrillation

Intravenous Injection (see section "Special instructions") It is recommended to use a central venouscatheter, in case of its absence, the drug Amiodarone must be injected into the largest peripheral vein.

The initial dose is 300 mg (5 mg / kg body weight), after dilution in 20 ml of 5% dextrose (glucose) solution to a concentration of 15 mg / ml.

If fibrillation does not stop, an additional intravenous jet injection of the drug Amiodarone in a dose of 150 mg (or 2.5 mg / kg body weight) to a concentration of 7.5 mg / ml.

Do not mix in the same syringe with other drugs!

Side effects:

The frequency of side effects is given in accordance with the classification of the World Health Organization: very often - not less than 10%; often - not less than 1% and less than 10%; infrequently - not less than 0.1% and less than 1%; rarely - not less than 0.01% and less than 0.1%; very rarely - less than 0.01%, including isolated cases; frequency unknown - according to the available data, the frequency can not be determined.

From the cardiovascular system:

Often - bradycardia (usually a moderate decrease in heart rate); a decrease in blood pressure (usually mild and transient, cases of marked decrease in blood pressure or collapse are observed in overdose or too rapid administration of the drug).

Rarely - arrhythmogenic effect (less than most antiarrhythmic drugs, there are reports of new arrhythmias, including ventricular pirouette tachycardia, or exacerbation of existing, in some cases - subsequent cardiac arrest). The arrhythmogenic effect is observed mainly in cases of application of amiodarone together with drugs that extend the QT interval_from or against the background of existing water-electrolyte disorders (see the section "Interaction with other drugs"). Based on the available data it is impossible to determine whether the occurrence of these rhythm disturbances is caused by the action of amiodarone, the manifestation of the cardiovascular pathology itself, or is a consequence of ineffective treatment.

- Pronounced bradycardia or, in exceptional cases, stopping the sinus node (requiring the cessation of amiodarone treatment, especially in patients with sinus node weakness and / or elderly patients).

- "Tides" of blood to the skin of the face, accompanied by a feeling of heat.

Frequency unknown - ventricular tachycardia of the type "pirouette" (see Fig.section "Interaction with other medicinal products", subsection "Pharmacodynamic interaction"; section "Special instructions").

From the endocrine system:

Frequency unknown hyperthyroidism.

From the respiratory system, chest and mediastinum:

Rarely - cough, shortness of breath, interstitial pneumonitis. In these cases, consideration should be given to the possibility of amiodarone withdrawal and the advisability of administering glucocorticosteroids (see section "Special instructions").

- Bronchospasm and / or apnea in patients with severe respiratory failure, especially in patients with bronchial asthma.

- Severe respiratory complications (acute respiratory distress syndrome of adults) are sometimes fatal (see section "Special instructions").

From the gastrointestinal tract:

Rarely - nausea.

From the liver and biliary tract

Rarely - an isolated increase in the activity of "hepatic" transaminases in the blood serum (the severity of the increase is usually moderate, the excess of normal values is 1.5-3 times observed at the beginning of treatment and decreases with decreasing dose or even spontaneously).

- Acute liver damage (within the first 24 hours after intravenous administration of amiodarone) - increased activity of "liver" transaminases and / or jaundice, the development of liver failure, sometimes fatal (see section "Special instructions").

From the skin and subcutaneous tissues:

Rarely - increased sweating, a feeling of heat.

Frequency unknown - hives.

From the central nervous system:

Rarely - benign intracranial hypertension (pseudotumor of the brain), headache.

From the immune system:

Rarely - anaphylactic shock.

Frequency unknown - angioedema (edema of Quincke).

From the side of the musculoskeletal and connective tissue:

Frequency unknown - Pain in the lumbar and lumbosacral spine.

General disorders and disorders at the site of administration:

Often - local reactions: pain at the injection site, erythema, edema, necrosis, extravasation, infiltration, inflammation, compaction, thrombophlebitis, phlebitis, phlegmon, infections, skin pigmentation.

Overdose:

Information on an overdose of amiodarone (concentrate for the preparation of a solution for intravenous administration) is not available.Several cases of acute overdose of amiodarone taken internally, manifested by sinus bradycardia, paroxysmal ventricular tachycardia as pirouette, cardiac arrest, circulatory disturbances and liver function, marked decrease in blood pressure are described.

Treatment - symptomatic (with bradycardia - the use of beta-adrenomimetics or the installation of a pacemaker, with ventricular tachycardia of the type "pirouette" - intravenous injection of magnesium salts, carrying out pacing pacemaking). Neither amiodarone, nor its metabolites are removed during hemodialysis. There is no specific antidote.

Interaction:

Pharmacodynamic interaction

Preparations, They can cause a bidirectional ventricular tachycardia of the type "pirouette"

Co-administration of such drugs is contraindicated, as the risk of potentially lethal ventricular tachycardia increases by the type of "pirouette". Such drugs include:

- Antiarrhythmics: IА class (quinidine, hydroquinidine, disopyramide, procainamide), sotalol, beprideal.

- Other (non-antiarrhythmic) drugs, such as: wincamine; some neuroleptics: phenothiazines (chlorpromazine, tsiammazin, levopromazin, thioridazine, trifluoperazine, fluphenazine), benzamides (amisulfpride, sultopride, sulpride, tiapride, velapride), butyrophenones (droperidol, canterRidol), sertindole, pimozide; tricyclic antidepressants; cisapride; macrolide antibiotics (erythromycin with intravenous administration, spiramycin); azoles; antimalarial drugs (quinine, chloroquine, mefloquine, halofantrine, lumefantrine); pentamidine with parenteral administration; diphenamyl methyl sulfate; misolastine; astemizole; terfenadine.

Drugs that increase the duration of the QT interval

The combined use of amiodarone with these drugs should be based on a careful assessment of the relationship between expected benefit and potential risk (increased risk of developing pirouette-type ventricular tachycardia), using these combinations, it is necessary to constantly monitor the patient's ECG (for elongation of the QT interval), potassium and magnesium in the blood. In patients receiving amiodarone, fluoroquinolones should be avoided, including moxifloxacin.

Drugs that reduce heart rate or cause automatic or conduction disorders

Simultaneous reception of these drugs with amiodarone is not recommended. Beta-adrenoblockers, blockers of "slow" calcium channels, decreasing heart rate (verapamil, diltiazem), can lead to the development of excessive bradycardia and cause conduction disorders.

Preparations, capable of causing hypokalemia, which increases the risk of developing ventricular tachycardia by the type of "pirouette"

Combination of amiodarone with:

- laxatives, stimulating intestinal peristalsis (if necessary, laxatives of other groups should be prescribed). Caution is required when using amiodarone in conjunction with:

- diuretics, causing hypokalemia (in monotherapy or in combination with other drugs);

- systemic corticosteroids (glucocorticosteroids, mineralocorticosteroids) and tetracosactide;

- amphotericin B (intravenous administration).

During treatment with amiodarone it is necessary to regularly monitor the electrolyte content in the blood and the duration of the QT interval. In the case of ventricular tachycardia of the type "pirouette" should not be usedantiarrhythmic drugs (ventricular pacing should be started, and intravenous magnesium salts may be injected).

Preparations for inhalation anesthesia:

The possibility of developing the following serious complications in patients taking amiodarone on the background of general anesthesia: bradycardia (resistant to atropine administration), arterial hypotension, intracardiac conduction disturbance, reduction of cardiac output. There were very rare cases of severe complications from the respiratory system (acute respiratory distress syndrome of adults - sometimes fatal, which developed immediately after surgery, the occurrence is associated with high concentrations of oxygen).

Preparations, truncating heart rate:

Clonidine, guanfacine; cholinesterase inhibitors (donepezil, galantamine, rivastigmine, tacrine, ambenonium chloride, pyridostigmine bromide, neostigmine bromide); m-cholinomimetics (pilocarpine); beta-blockers - increase the risk of developing excessive bradycardia.

Influence of amiodarone on other drugs

Amiodarone and / or its metabolite, desethylamiodarone, inhibit the isoenzymes CYP1A1, CYP1A2, CYP3A4, CYP2C9, CYP2D6, which can increase the system exposure time of preparations that are their substrates. Due to the high duration of amiodarone excretion, this interaction can be observed even a few months after discontinuation of its administration.

Medications, which are substrates of the isoenzyme CYP3A4

When a combination of amiodarone - inhibitor of the isoenzyme CYP3A4 with these drugs may increase their plasma concentrations, which may lead to an increase in their toxicity and / or increased pharmacodynamic effects and may require a reduction in their doses.

Such drugs include: ciclosporin, fentanyl, inhibitors of HMG-CoA reductase - statins: simvastatin, atorvastatin and lovastatin (the risk of development of rhabdomyolysis during their simultaneous administration with amiodarone increases, if necessary, the administration of statins that are not metabolized with the help of the CYP3A4 isoenzyme); lidocaine (risk of developing sinus bradycardia and neurologic symptoms), tacrolimus (risk of nephrotoxicity), sildenafil, midazolam, triazolam, dihydroergotamine, ergotamine, colchicine.

Drugs that are a substrate isoenzyme CYP2D6 and CYP3A4

Dextromethorphan - amiodarone inhibits the isoenzymes CYP2D6 and CYP3A4 and can theoretically increase the plasma concentration of dextromethorphan.

Clopidogrel, which is an inactive thienopyrimidine drug metabolized in the liver with the formation of active metabolites. Possible interaction between clopidogrel and amiodarone, which can lead to a decrease in the effectiveness of clopidogrel.

Medications, which are substrates of the isoenzyme CYP2S9

Amiodarone increases the concentration in the blood of drugs that are substrates of the isoenzyme CYP2C9, for example, warfarin or phenytoin.

Warfarin - when combined with amiodarone, an increased risk of bleeding may occur. It should be more often (both during treatment with amiodarone and after stopping its administration) to monitor prothrombin time (by determining the International Normalized Ratio) and, if necessary, adjust the dosage regimen.

Phenytoin - when combined with amiodarone, the development of an overdose of phenytoin may occur, which may lead to the appearance of neurologic symptoms; Clinical monitoring is necessary and, at the first signs of an overdose, a decrease in the dose of phenytoin. It is desirable to determine the concentration of phenytoin in the blood plasma.

Medications, which are substrates of the isoenzyme CYP2D6

Flecainide - amiodarone increases its plasma concentration, in connection with which a correction of the doses of the latter is required.

Medications, which are substrates of P-gp Amiodarone is an inhibitor of P-gp, co-administration with drugs that are substrates of P-gp may cause an increase in systemic exposure of the latter.

Cardiac glycosides (digitalis preparations) - possibly as a pharmacodynamic interaction - a decrease in automatism (pronounced bradycardia) and AV conduction, and pharmacokinetic - with the combined administration of digoxin with amiodarone, an increase in the concentration of digoxin in the blood plasma is possible (due to a decrease in its clearance, it is necessary to control the concentration of digoxin in the blood and timely detection clinical manifestations of digitalis intoxication).You may need to reduce the dosage of digoxin.

Dabigatran - caution should be exercised with the simultaneous use of amiodarone with dabigatran because of the risk of bleeding. Dabigatran dose may need to be adjusted in accordance with the instructions in its instructions for use.

The effect of other drugs on amiodarone

Inhibitors of isoenzymes CYP3A4 and CYP2C8 can inhibit the metabolism of amiodarone and increase its concentration in the blood and, accordingly, enhance its pharmacodynamic actions (including, causing the development of side effects).

It is recommended to avoid the simultaneous administration of amiodarone and inhibitors of the isoenzyme CYP3A4, for example, grapefruit juice and some medicines, such as cimetidine, and HIV protease inhibitors (incl. indinavir). Inhibitors of HIV protease when used with amiodarone may increase the concentration of the latter in the blood.

Inductors of the isoenzyme CYP3A4

Rifampicin is a strong inducer of the isoenzyme CYP3A4, when combined with amiodarone, plasma concentrations of amiodarone and desethylamiodarone may decrease.

Preparations of St. John's Wort are a strong inducer of the isoenzyme CYP3A4. In this regard, we can expect a decrease in plasma concentrations of amiodarone and a decrease in its effect (no clinical data are available).

Special instructions:

Except in urgent cases, intravenous administration of the drug Amiodarone should be performed only in intensive care units with constant monitoring of ECG (due to the possibility of developing excessive bradycardia and arrhythmogenic action) and blood pressure (due to the possibility of its significant reduction even with slow intravenous fluid injection and development of vascular collapse).

To avoid the development of the reaction at the injection site (see the section "Side effect"), the drug Amiodarone it is recommended to enter through a central venous catheter. In the case of cardiorespiratory measures for cardiac arrest caused by ventricular fibrillation resistant to defibrillation and the absence of an established central venous catheter, the drug Amiodarone, can be injected into a large peripheral vein with maximum blood flow. If it is necessary to continue treatment after cardiorehabilitation, the drug Amiodarone should be injected intravenously via a central venous catheter under the constant monitoring of blood pressure and ECG.

Amiodarone should not be mixed in one syringe or dropper with other medications. Do not inject other drugs into the same line of the infusion system as the drug Amiodarone.

Despite the ability of amiodarone to prolong the duration of the QT interval, it comparatively rarely provokes the development of ventricular tachycardia as pirouette.

In connection with the potential for development in very rare cases of interstitial pneumonitis after intravenous administration of the drug Amiodarone the appearance after intravenous pronounced dyspnoea or dry cough as accompanied and not accompanied by the deterioration of the general condition (fatigue, fever) required to conduct radiography of the chest, and, if necessary, remove the drug. These phenomena are mainly reversible (within 3-4 weeks) with early cancellation of the drug Amiodarone (in some cases with the appointment of glucocorticosteroids). Normalization of the radiographic pattern and function of the lungs occurs more slowly (in a few months).

After mechanical ventilation (for example, during surgical interventions) in patients who were injected amiodarone, there were rare cases of development of acute adult respiratory distress syndrome, sometimes with a lethal outcome (it is assumed that it is possible to interact with high doses of oxygen in the respiratory mixture) (see "Side effect" section), which requires strict monitoring of the condition of such patients.

It is recommended that liver status be monitored regularly (monitoring the activity of "liver" transaminases) before starting amiodarone and during its administration. During the first 24 hours after intravenous administration of the drug Amiodarone, acute liver damage (hepatocellular insufficiency or hepatic insufficiency, including fatal ones) can develop, as well as its chronic lesions. Treatment with drug Amiodarone should be discontinued when the activity of "liver" transaminases increases more than 3 times the upper limit of the norm.

Before surgery, the anesthesiologist should be informed of the patient's amiodarone, since its administration may increase the risk of hemodynamic disorders (bradycardia, lowering of blood pressure, cardiac output, intracardiac conduction) during local or general anesthesia.

Effect on the ability to drive transp. cf. and fur:

There is no evidence that amiodarone violates the ability to engage in activities that require increased concentration and speed of psychomotor reactions. However, as a precautionary measure for patients with paroxysms of severe rhythm disturbances during drug treatment Amiodarone it is desirable to refrain from such activities.

Form release / dosage:

Concentrate for the preparation of a solution for intravenous administration, 50 mg / ml.

Packaging:

3 ml per ampoule with a capacity of 5 ml.

10 ampoules together with a knife or scarifier for opening ampoules and instructions for medical use in a cardboard box.

5 ampoules in a blister pack. 1 or 2 blister packs with ampoules together with a knife or scarifier for opening ampoules and instructions for medical use in a pack of cardboard.

10 ampoules together with a knife or scarifier for opening ampoules and instructions for medical use in a pack with a cardboard insert for fixing ampoules.

In the case of using ampoules with a break ring or a notch and a break point, the imposition of a knife or scarifier for opening ampoules is not provided.

Storage conditions:

In the dark place at a temperature of 15 to 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after expiry date.

Terms of leave from pharmacies:On prescription

Registration number:LP-002800

Date of registration:29.12.2014

Expiration Date:29.12.2019

The owner of the registration certificate:BORISOVSKIY FACTORY OF MEDPREPARATES, OJSC BORISOVSKIY FACTORY OF MEDPREPARATES, OJSC Republic of Belarus

Manufacturer: & nbsp

BORISOVSKIY FACTORY OF MEDPREPARATES, OJSC Republic of Belarus

Information update date: & nbsp09.08.2017

Illustrated instructions

Instructions

Amiodarone (Amiodaron)