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VERO-AMIODARONE

special instructions

Except in urgent cases, intravenous administration of amiodarone should be carried out only in the intensive care unit with constant monitoring of the ECG (due to the possibility of developing bradycardia and proarrhythmogenic effects) and lowering blood pressure.
The injectable form of amiodarone should be administered only as an infusion (except in cases of cardiac resuscitation due to cardiac arrest caused by ventricular fibrillation resistant to cardioversion (see "Dosage and Administration"), since even a very slow intravenous bolus may cause an excessive decrease in blood pressure, heart failure or severe respiratory failure.

In order to avoid reactions at the injection site (see “Side Effects”), the injectable form of amiodarone is recommended to be administered through a central venous catheter. Only in the case of cardiac resuscitation for cardiac arrest caused by ventricular fibrillation refractory to cardioversion, in the absence of central venous access (no central venous catheter in place), the injectable form of amiodarone can be administered into a large peripheral vein with maximum blood flow.

If treatment with amiodarone must be continued after cardiac resuscitation, the drug should be administered intravenously through a central venous catheter under constant monitoring of blood pressure and ECG.

Amiodarone should not be mixed in the same syringe or dropper with other medications.

Due to the possibility of the development of interstitial pneumonitis when severe shortness of breath or a dry cough appears after the administration of amiodarone, both accompanied and not accompanied by a deterioration in the general condition (increased fatigue, fever), it is necessary to perform a chest x-ray and, if necessary, discontinue the drug, since interstitial pneumonitis can lead to the development of pulmonary fibrosis. However, these phenomena are generally reversible with early discontinuation of amiodarone with or without the administration of glucocorticosteroids. Clinical manifestations usually disappear within 3-4 weeks. Recovery of the X-ray picture and lung function occurs more slowly (several months).

Following mechanical ventilation (eg, surgery) in patients receiving amiodarone, rare cases of acute respiratory distress syndrome, sometimes fatal, have been reported (possible interaction with high doses of oxygen). Therefore, it is recommended to strictly monitor the condition of such patients.

In patients receiving long-term treatment with amiodarone for cardiac arrhythmias, an increase in the incidence of ventricular fibrillation and/or an increase in the sensitivity threshold of the pacemaker or implanted artificial pacemaker has been reported, which may reduce their effectiveness. Therefore, before starting and during treatment with amiodarone, their correct functioning should be regularly monitored.

Due to the prolongation of the period of repolarization of the ventricles of the heart, the pharmacological effect of amiodarone causes certain changes in the ECG: prolongation of the QT interval, QTc (corrected), and the possible appearance of U waves. Allowable QT prolongation is no more than 450 ms or no more than 25% of the original value. These changes are not a manifestation of the toxic effect of the drug, but require monitoring to adjust the dose and assess the possible proarrhythmogenic effect. If II-III degree AV block, sinoatrial block or double-bundle intraventricular block develops, treatment with amodarone should be discontinued. If 1st degree AV block occurs, it is necessary to intensify monitoring of the patient.

If visual impairment occurs (blurred visual perception, decreased visual acuity), it is necessary to conduct a full ophthalmological examination, including fundus examination. If optic neuropathy or optic neuritis develops, treatment with amiodarone is discontinued due to the risk of blindness.

During the first 24 hours after starting use of the injectable form of amiodarone, severe acute liver damage may develop with the development of liver failure, sometimes with death. Regular monitoring of liver function is recommended before starting amiodarone use and regularly during amiodarone treatment. If the activity of “liver” transaminases increases, 3 times higher than the upper limit of normal, the dose of amiodarone should be reduced or discontinued.

General anesthesia. Before surgery, the anesthesiologist should be informed that the patient is receiving amiodarone. Treatment with amiodarone may increase the hemodynamic risk inherent in local or general anesthesia. This particularly applies to its bradycardic and hypotensive effects, decreased cardiac output and conduction disturbances.

Combinations with β-blockers other than sotalol (a contraindicated combination) and esmolol (a combination requiring special caution when used), verapamil and diltiazem can only be considered in the context of the prevention of life-threatening ventricular arrhythmias and in the case of restoration of cardiac activity in cardiac arrest caused by ventricular fibrillation resistant to cardioversion.

Electrolyte imbalances, especially hypokalemia: It is important to consider situations that may be accompanied by hypokalemia as predisposing to proarrhythmic effects. Hypokalemia should be corrected before starting amiodarone.

Side effects of the drug (see "Side Effects") are usually dose dependent; Therefore, care should be taken when determining the minimum effective maintenance dose to avoid or minimize the occurrence of adverse effects.

Amiodarone may cause thyroid dysfunction, especially in patients with a personal or family history of thyroid dysfunction. Therefore, in case of switching to oral amiodarone during treatment and several months after the end of treatment, careful clinical and laboratory monitoring should be carried out. If thyroid dysfunction is suspected, the concentrations of T3, T4 and TSH in the blood serum should be determined.

Clinical manifestations are usually mild, so symptoms such as weight loss, the occurrence of rhythm disturbances, angina attacks, and the development of CHF should alert the doctor. The diagnosis is confirmed by identifying a decrease in the concentration of thyroid-stimulating hormone (TSH) in the blood serum, determined using an ultrasensitive TSH test. In this case, amiodarone should be discontinued. Recovery usually occurs within a few months after treatment is stopped. First, clinical manifestations disappear, then normalization of thyroid function indicators occurs. Severe cases of thyrotoxicosis, which can sometimes be fatal (both due to the thyrotoxicosis itself and due to a dangerous imbalance between myocardial oxygen demand and oxygen supply), require emergency treatment. Treatment should be selected individually in each specific case: antithyroid drugs (which may not always be effective), glucocorticosteroids, beta-blockers.

Possible suppression of bone marrow function, manifested by the development of normocytic normochromic anemia, thrombocytopenia or neutropenia, possible formation of granulomas, in addition, in post-registration studies or observations, cases of the development of agranulocytosis, hemolytic anemia, pancytopenia were identified. Symptoms may regress after discontinuation of the drug and the prescription of glucocorticosteroids; if the drug is re-prescribed, they may recur.

While taking amiodarone, the development of undesirable mental phenomena is possible, including changes in consciousness, hallucinations and delirium. The developed condition may be resistant to the use of benzodiazepine drugs; discontinuation of amiodarone is necessary.

The use of amiodarone can cause the development of unpleasant skin phenomena, the most commonly reported development of increased photosensitivity and changes in skin tone (more often in patients under 60 years of age), less often - reversible alopecia.

Severe adverse events may develop, including toxic epidermal necrolysis, exfoliative dermatitis, bullous dermatosis, cutaneous vasculitis, linear IgA-dependent dermatosis, psoriasis, skin cancer, pruritus.

Patients should be instructed about the possibility of photosensitivity reactions, the need to avoid exposure to sunlight and use sunscreen if necessary. Increased sensitivity to sunlight may persist for several months after stopping amiodarone. In most cases, manifestations are limited to sensations of redness, burning or "twitching" of the skin exposed to intense sunlight, but severe phototoxic reactions can develop. Hypersensitivity reactions associated with the use of the drug include the cutaneous reactions listed above, as well as anaphylactic and anaphylactoid reactions, including shock, angioedema, lupus erythematosus, drug reaction with eosinophilia and systemic symptoms. It is possible to develop cross-allergic reactions to amiodarone in patients with hypersensitivity to iodine-containing contrast agents.

The safety and effectiveness of amiodarone have not been studied in children. Vero-amiodarone injection contains benzyl alcohol. Cases of severe choking with fatal outcome have been reported in newborns after intravenous administration of solutions containing benzyl alcohol.

Instructions for use AMIODARONE

Medicines that can cause torsades de pointes are primarily class Ia and class III antiarrhythmic drugs and some antipsychotics. Hypokalemia is a predisposing factor, as is bradycardia or congenital or acquired prolongation of the QT interval.

Combinations with

Drugs that can cause ventricular tachycardia of the “pirouette” type.
Class Ia antiarrhythmic drugs (quinidine, hydroquinidine, isopyramide).
Class III antiarrhythmic drugs (dofetilide, ibutilide, sotalol).
Other drugs, such as bepridil, cisapride, difemanil, IV ritromycin, mizolastine, IV vincamine, moxifloxacin, IV spiramycin.
Sultopride.

The risk of ventricular rhythm disturbances (pirouette-type tachycardia) increases.

These contraindications do not apply to the use of amiodarone for cardiopulmonary resuscitation in cardiac arrest refractory to electrical defibrillation.

Not recommended combinations with

Cyclosporine

There may be an increase in the level of cyclosporine in plasma, associated with a decrease in the metabolism of the drug in the liver, with possible nephrotoxic manifestations.

Determination of the level of cyclosporine in the blood, checking renal function and reviewing the dosage during treatment with amiodarone and after discontinuation of the drug.

Diltiazem for injection

Risk of bradycardia and atrioventricular block. If a combination is unavoidable, strict clinical and continuous ECG monitoring should be established.

Verapamil for injection

Risk of bradycardia and atrioventricular block. If a combination is unavoidable, strict clinical and continuous ECG monitoring should be established.

Antiparasitic drugs that can cause torsade de pointes (halofantrine, pentamidine, lumefantrine)

If the combination is unavoidable, preliminary control of the QT interval and ECG monitoring is necessary.

Neuroleptics that can cause ventricular tachycardia of the “pirouette” type:

Some phenothiazine antipsychotics (chlorpromazine, cyamemazine, levomepromazine, thioridazine, trifluoperazine), benzamides (amisulpride, sulpiride, tiapride, veralipride), butyrophenones (droperidol, haloperidol), other antipsychotics (pimozide).

The risk of ventricular rhythm disturbances (pirouette-type tachycardia) increases.

Methadone

The risk of ventricular rhythm disturbances (pirouette-type tachycardia) increases. Recommended:

ECG and clinical observation.

Combinations requiring precautions when using Amiodarone with:

Oral anticoagulants:

Increased anticoagulation effect and risk of bleeding, due to increased concentrations of anticoagulants in plasma. The need for more frequent monitoring of the level of prothrombin in the blood and MHO (INR), as well as adaptation of doses of anticoagulants during treatment with amiodarone and after discontinuation of the drug.

Beta blockers, with the exception of sotalol (contraindicated combination) and esmolol (combination requiring caution when used)

Violations of contractility, automatism and conduction (suppression of compensatory sympathetic mechanisms). Clinical and ECG monitoring.

Beta blockers prescribed for heart failure (bisoprolol, carvedilol, metoprolol)

Impaired contractility and conduction (synergistic effect) with the risk of developing severe bradycardia. Increased risk of ventricular arrhythmias, especially torsade de pointes.

Regular clinical and electrocardiographic monitoring is necessary.

Cardiac glycosides

Disorders of automaticity (excessive bradycardia) and atrioventricular conduction (synergism of action). When using digoxin, its concentration in plasma increases (due to decreased clearance of the alkaloid).

It is necessary to carry out clinical and ECG monitoring, as well as determination of plasma digoxin levels); It may be necessary to change the dose of digoxin.

Diltiazem for oral administration

Risk of bradycardia and atrioventricular block, especially in the elderly. Clinical and ECG control.

Verapamil for oral administration

Risk of bradycardia and atrioventricular block, especially in the elderly. Clinical and ECG control.

Essex scraper

Violations of contractility, automatism and conduction (suppression of compensatory sympathetic mechanisms). Clinical and ECG monitoring.

Hypokalemic drugs: potassium-sparing diuretics (in monotherapy or combination), stimulant laxatives, amphotericin B (iv), glucocorticoids (systemic), tetracosactide.

The risk of ventricular rhythm disturbances increases, especially tachycardia of the “pirouette” type (hypokalemia is a predisposing factor). Clinical and ECG monitoring, laboratory tests.

Lidocaine

Risk of increased lidocaine plasma concentrations, with the possibility of neurological and cardiac side effects, due to amiodarone's decreased metabolism of lidocaine in the liver. Clinical and ECG monitoring, if necessary, dose adjustment of lidocaine during treatment with amiodarone and after its discontinuation.

Orlistat

Risk of decreased plasma concentrations of amiodarone and its active metabolite. Clinical and, if necessary, ECG monitoring.

Phenytoin (and, by extrapolation, fosphenytoin)

An increase in the level of phenytoin in plasma with symptoms of overdose, especially of a neurological nature (decreased metabolism of phenytoin in the liver). Clinical monitoring and determination of plasma phenytoin levels; if possible, reduce the dose of phenytoin.

Simvastatin

Increased risk of side effects (depending on dose) such as rhabdomyolysis (decreased metabolism of simvastatin in the liver). The dose of simvastatin should not exceed 20 mg/day.

If a therapeutic effect is not achieved at this dose, you should switch to another statin that does not interact with this type of interaction.

Tacrolimus

An increase in the level of tacrolimus in the blood due to inhibition of its metabolism by amiodarone. Measurement of tacrolimus blood levels, monitoring of kidney function and leveling of tacrolimus levels should be carried out.

Drugs that cause bradycardia:

Many drugs can cause bradycardia. This is especially true for class 1a antiarrhythmic drugs, beta blockers, some class III antiarrhythmic drugs, some calcium channel blockers, digitalis, pilocarpine and anticholinesterase agents.

Risk of excessive bradycardia (cumulative effect).

Combinations to Consider

Drugs that cause bradycardia:

calcium channel blockers with bradycardic effect (verapamil), beta blockers (except sotalol), clonidine, guanfacine, digitalis alkaloids, mefloquine, cholinesterase inhibitors (donezepil, galantamine, rivastigmine, tacrine, ambemonium, pyridostigmine, neostigmine), pilocarpine.

Risk of excessive bradycardia (cumulative effects).

Incompatibilities

When PVC material or medical equipment plasticized with 2-diethylhexyl phthalate (DEHP) is used in the presence of amiodarone injection solution, DEHP may be released. To minimize exposure to DEHP, it is recommended that the solution be final diluted before infusion in DEHP-free equipment.

Amiodarone, 10 pcs., 3 ml, 50 mg/ml, concentrate for solution for intravenous administration

Intravenous bolus administration of the drug Amiodarone is usually not recommended due to hemodynamic risks (development of a pronounced decrease in blood pressure, vascular collapse); intravenous drip administration of the drug is preferable.

Intravenous jet administration of the drug Amiodarone should be carried out only in the intensive care unit with constant monitoring of ECG (due to the possibility of developing excessive bradycardia and arrhythmogenic effects) and blood pressure (due to the possibility of lowering blood pressure).

In order to avoid reactions at the injection site, it is recommended that Amiodarone be administered through a central venous catheter. Only in the case of cardiac resuscitation for cardiac arrest caused by ventricular fibrillation resistant to defibrillation, in the absence of central venous access (no central venous catheter in place), Amiodarone can be administered into a large peripheral vein with maximum blood flow. If it is necessary to continue treatment with Amiodarone after cardiac resuscitation, Amiodarone should be administered intravenously through a central venous catheter under constant monitoring of blood pressure and ECG.

Amiodarone should not be mixed in the same syringe or dropper with other medications. Do not administer other drugs into the same infusion line as Amiodarone.

Cardiac reactions

The occurrence of new rhythm disturbances or worsening of existing rhythm disturbances, sometimes with fatal outcome, has been reported. It is very important to make a differential diagnosis between the insufficient effectiveness of the drug and its arrhythmogenic effect, whether combined or not with an aggravation of the severity of cardiovascular pathology. Arrhythmogenic effects have been reported significantly less frequently with Amiodarone than with other antiarrhythmic drugs and have generally been observed in the presence of factors that prolong the QT interval, such as drug interactions and/or electrolyte disturbances. Despite the ability of Amiodarone to prolong the QT interval, it has shown low activity in provoking torsade de pointes (TdP).

Severe bradycardia.

When Amiodarone was used in combination with sofosbuvir in combination with other direct-acting antiviral drugs against viral hepatitis C, such as daclatasvir, simeprevir, ledipasvir, cases of severe, potentially life-threatening bradycardia, as well as heart block, were observed. Therefore, the simultaneous use of these drugs with Amiodarone is not recommended.

If concomitant use of these drugs with Amiodarone cannot be avoided, close monitoring of patients is recommended after initiating sofosbuvir in combination with other direct-acting antivirals. After starting concomitant use of sofosbuvir, patients who are at high risk of developing bradyarrhythmias should be monitored continuously in a hospital setting for at least 48 hours.

Due to the long half-life of amiodarone, appropriate monitoring should also be performed in patients who have stopped taking amiodarone within the last few months before starting treatment with sofosbuvir in combination with other direct acting antivirals.

Patients taking the above drugs against hepatitis C virus in combination with Amiodarone, either simultaneously with other drugs that slow the heart rate or without combination with such drugs, should be informed about symptoms indicating the development of bradycardia and heart block. If they occur, they should seek medical attention immediately.

Pulmonary disorders

The appearance of shortness of breath or dry cough may be associated with pulmonary toxicity, in particular the development of interstitial pneumonitis. In very rare cases, the development of interstitial pneumonitis has been observed after intravenous administration of the drug Amiodarone. If the development of interstitial pneumonitis is suspected in patients who experience severe shortness of breath, either isolated or in combination with a deterioration in general condition (fatigue, weight loss, fever), an X-ray examination of the lungs should be performed. The need for Amiodarone should be re-evaluated as interstitial pneumonitis is usually reversible if the drug is discontinued early (clinical symptoms usually resolve within 3-4 weeks, followed by a slower improvement in radiographic findings and pulmonary function over several months). Treatment with glucocorticosteroids should be considered.

In addition, in very rare cases, usually immediately after surgery, a serious respiratory complication (adult acute respiratory distress syndrome), sometimes fatal, has been observed in patients treated with amiodarone; the possibility of a connection between its development and interaction with high oxygen concentrations is assumed.

Liver disorders

Careful monitoring of liver function tests (monitoring the activity of liver transaminases) is recommended before starting the use of Amiodarone and regularly during treatment with the drug. During the first 24 hours after intravenous administration of Amiodarone, acute liver damage (including hepatocellular failure or liver failure, sometimes fatal) and chronic liver damage may occur. Therefore, if the activity of “liver” transaminases increases, 3 times higher than the upper limit of normal, the dose of Amiodarone should be reduced or discontinued.

Clinical and laboratory signs of chronic liver failure when using the drug Amiodarone orally can be minimally expressed (hepatomegaly, increased transaminase activity 5 times the upper limit of normal) and reversible after discontinuation of the drug, but cases of death have been reported.

Severe bullous reactions

Treatment with Amiodarone should be stopped immediately if symptoms and manifestations of life-threatening or even fatal reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis appear, namely the appearance of a progressive skin rash, often with blistering, or the appearance of damage to the mucous membranes.

Visual disorders

If decreased visual acuity or blurred vision occurs, a complete ophthalmological examination, including funduscopy (examination of the fundus of the eye), should be immediately performed. The manifestation of neuropathy and/or optic neuritis requires discontinuation of amiodarone due to the possible development of blindness.

Drug interactions

The simultaneous use of Amiodarone with the following drugs is not recommended: beta-blockers, blockers of “slow” calcium channels, slowing heart rate (verapamil, diltiazem), laxatives, stimulating intestinal motility, which can cause hypokalemia.

Hypokalemia

Hypokalemia should be corrected before starting Amiodarone.

Children

The safety and effectiveness of Amiodarone have not been studied in children. Amiodarone ampoules contain benzyl alcohol. Severe choking with fatal outcome has been reported in newborns after intravenous administration of solutions containing benzyl alcohol. Symptoms of the development of this complication are: acute development of suffocation, decreased blood pressure, bradycardia and collapse.

General and local anesthesia

Before surgery, the anesthesiologist should be informed that the patient has been administered the drug Amiodarone. Treatment with Amiodarone may increase the hemodynamic risk inherent in local or general anesthesia (in particular, slowing of heart rate, slowing of conduction and decreased contractility of the heart.)

Thyroid dysfunction

Amiodarone may cause thyroid dysfunction, especially in patients with a personal or family history of thyroid dysfunction. Therefore, in the case of a transition from internal administration of the drug Amiodarone to oral administration of the drug Amiodarone, both during treatment and for several months after the end of treatment, careful clinical and laboratory monitoring of thyroid function should be carried out. If thyroid dysfunction is suspected, serum TSH concentrations should be determined (using an ultrasensitive TSH test).

The drug Amiodarone contains iodine and therefore can interfere with the absorption of radioactive iodine, which can distort the results of a radioisotope study of the thyroid gland, but its use does not affect the reliability of determining the concentrations of T3, T4 and TSH in the blood plasma.

Impact on the ability to drive vehicles and machinery

There is no evidence that amiodarone impairs the ability to engage in activities requiring increased concentration and psychomotor speed. However, as a precaution, it is advisable for patients with paroxysms of severe arrhythmias to refrain from such activities during treatment with Amiodarone.

Amiodarone amp 50mg/ml 3ml N10 (Borisov)

Medicines that can cause torsades de pointes are primarily class Ia and class III antiarrhythmic drugs and some antipsychotics. Hypokalemia is a predisposing factor, as well as bradycardia or congenital or acquired prolongation of the QT interval. Combinations with - Drugs that can cause torsade de pointes (TdP) are contraindicated. - Class Ia antiarrhythmic drugs (quinidine, hydroquinidine, isopyramide). - Class Ia antiarrhythmic drugs. III (dofetilide, ibutilide, sotalol). - Other drugs, such as bepridil, cisapride, difemanil, IV ritromycin, mizolastine, IV vincamine, moxifloxacin, IV spiramycin. - Sultopride. Increases the risk of ventricular rhythm disturbances (tachycardia type "pirouette"). These contraindications do not apply to the use of amiodarone for cardiopulmonary resuscitation in the event of cardiac arrest resistant to electrical defibrillation. Not recommended combinations with Cyclosporine Possible increase in the level of cyclosporine in plasma associated with a decrease in the metabolism of the drug in the liver, with possible nephrotoxic manifestations .Determining the level of cyclosporine in the blood, checking renal function and reviewing the dosage during treatment with amiodarone and after discontinuation of the drug. Diltiazem for injection Risk of bradycardia and atrioventricular block. If the combination is unavoidable, strict clinical and continuous ECG monitoring must be established. Verapamil for injection Risk of bradycardia and atrioventricular block. If a combination is unavoidable, it is necessary to establish strict clinical and constant ECG monitoring. Antiparasitic drugs that can cause torsades de pointes (halofantrine, pentamidine, lumefantrine) If the combination is unavoidable, preliminary control of the QT interval and ECG monitoring is necessary. Neuroleptics that can cause ventricular tachycardia of the “pirouette” type: Some phenothiazine neuroleptics (chlorpromazine, cyamemazine, levomepromazine, thioridazine, trifluoperazine), benzamides (amisulpride, sulpiride, tiapride, veralipride), butyrophenones (droperidol, haloperidol), other neuroleptics (pimozide). The risk of ventricular rhythm disturbances increases. (tachycardia of the “pirouette” type).MethadoneThe risk of ventricular rhythm disturbances (tachycardia of the “pirouette” type increases). Recommended: ECG and clinical observation. Combinations requiring precautions when using Amiodarone with: Oral anticoagulants: Increased anticoagulant effect and risk of bleeding, due to increased plasma concentrations of anticoagulants. The need for more frequent monitoring of the level of prothrombin in the blood and MHO (INR), as well as adaptation of doses of anticoagulants during treatment with amiodarone and after discontinuation of the drug. Beta blockers, with the exception of sotalol (a contraindicated combination) and esmolol (a combination that requires caution in use) Violations contractility, automaticity and conductivity (suppression of compensatory sympathetic mechanisms). Clinical and ECG monitoring. Beta blockers prescribed for heart failure (bisoprolol, carvedilol, metoprolol) Contractility and conduction disorders (synergistic effect) with the risk of developing severe bradycardia. Increased risk of ventricular arrhythmias, especially tachycardia of the “pirouette” type. Regular clinical and electrocardiographic monitoring is required. Cardiac glycosides Impairments of automaticity (excessive bradycardia) and atrioventricular conduction (synergism of action). When using digoxin, an increase in its concentration in plasma (due to decreased clearance of the alkaloid). It is necessary to carry out clinical and ECG monitoring, as well as determine the level of digoxin in plasma); It may be necessary to change the dose of digoxin. Oral diltiazem Risk of bradycardia and atrioventricular block, especially in the elderly. Clinical and ECG monitoring. Oral verapamil Risk of bradycardia and atrioventricular block, especially in the elderly. Clinical and ECG monitoring. Esmolol Disorders of contractility, automaticity and conduction (suppression of compensatory sympathetic mechanisms). Clinical and ECG monitoring. Hypokalemic drugs: potassium-sparing diuretics (in monotherapy or combination), stimulant laxatives, amphotericin B (iv), glucocorticoids (systemic), tetracosactide. Increases the risk of ventricular rhythm disturbances, especially tachycardia of the “pirouette” type "(hypokalemia is a predisposing factor). Clinical and ECG monitoring, laboratory tests. Lidocaine Risk of increased plasma concentrations of lidocaine, with the possibility of neurological and cardiac side effects, due to amiodarone's reduction in the metabolism of lidocaine in the liver. Clinical and ECG monitoring, if necessary, dose adjustment of lidocaine during treatment with amiodarone and after its discontinuation. Orlistat Risk of decreased plasma concentrations of amiodarone and its active metabolite. Clinical and, if necessary, ECG monitoring, Phenytoin (and, by extrapolation, fosphenytoin) Increased plasma levels of phenytoin with symptoms of overdose, especially of a neurological nature (decreased metabolism of phenytoin in the liver). Clinical monitoring and determination of plasma phenytoin levels; if possible, reduce the dose of phenytoin. Simvastatin Increased risk of side effects (depending on dose) such as rhabdomyolysis (decreased metabolism of simvastatin in the liver). The dose of simvastatin should not exceed 20 mg per day. If a therapeutic effect cannot be achieved at this dose, you should switch to another statin that does not interact with this type of interaction. Tacrolimus An increase in the level of tacrolimus in the blood due to inhibition of its metabolism by amiodarone. Blood levels of tacrolimus should be measured, renal function monitored, and tacrolimus levels leveled off. Drugs that cause bradycardia: Many drugs can cause bradycardia. This is especially true for class Ia antiarrhythmic drugs, beta blockers, some class III antiarrhythmic drugs, some calcium channel blockers, digitalis, pilocarpine and anticholinesterase agents. Risk of excessive bradycardia (cumulative effect). Combinations to consider Drugs that cause bradycardia: calcium channel blockers with bradycardic effect (verapamil), beta blockers (except sotalol), clonidine, guanfacine, digitalis alkaloids, mefloquine, cholinesterase inhibitors (donezepil, galantamine, rivastigmine, tacrine, ambemonium, pyridostigmine, neostigmine), pilocarpine. Risk of excessive bradycardia (cumulative effects). Incompatibilities When using PVC material or medical equipment plasticized with 2-diethylhexyl phthalate (DEHP) in the presence of amiodarone injection solution, DEHP may be released. To minimize exposure to DEHP, it is recommended that the solution be final diluted before infusion in DEHP-free equipment.