How to take cordarone for atrial fibrillation. Detailed instructions for use with cordarone tablets and ampoules, reviews from patients and doctors about the drug and its analogues. Composition and pharmacological action

INN: Amiodarone

Manufacturer: HINOIN Pharmaceutical and Chemical Products Plant CJSC

Anatomical-therapeutic-chemical classification: Amiodarone

Registration number in the Republic of Kazakhstan: No. RK-LS-5No. 013050

Registration period: 09.10.2013 - 09.10.2018

ALO (Included in the List of free outpatient drug provision)

Instructions

Trade name

Cordarone®

International nonproprietary name

Amiodarone

Dosage form

Tablets divisible 200 mg

Compound

One tablet contains

active substance - amiodarone hydrochloride 200 mg,

excipients: lactose monohydrate, corn starch, povidone K90F, anhydrous colloidal silicon dioxide, magnesium stearate.

Description

Round tablets, white to slightly cream in color, scored for breaking and engraved with a heart symbol and “200” on one side of the tablet.

Pharmacotherapeutic group

Drugs for the treatment of heart diseases. Antiarrhythmic drugs of classes I and III. Class III antiarrhythmic drugs. Amiodarone.

ATX code C01ВD01.

Pharmacological properties

Pharmacokinetics

Amiodarone is slowly absorbed and has a high affinity for various tissues. Oral bioavailability varies from 30% to 80% in different patients (average value about 50%). After a single dose, peak plasma concentrations are achieved within 3-7 hours. Therapeutic effects, on average, are observed a week after starting to take the drug (from several days to two weeks). Amiodarone has a long half-life, taking into account individual differences in patients (from 20 to 100 days). During the first days of treatment, the drug accumulates in most tissues of the body, especially fatty tissue. Elimination begins within a few days and steady-state plasma concentrations are achieved within several months, depending on the individual patient's response. These characteristics explain the use of saturating doses in order to achieve drug accumulation in tissues, which is necessary to obtain a therapeutic effect.

Part of the iodine contained in the drug is released and found in the urine in the form of iodide, this corresponds to 6 mg for every 200 mg dose of amiodarone per day. The rest of the drug, and therefore most of the iodine, is excreted in the feces after passing through the liver.

Since the renal excretion of amiodarone is negligible, normal doses can be administered to patients with renal impairment.

After discontinuation of the drug, its removal from the body continues for several months; the residual effect of the drug over a period of more than 10 days and up to 1 month should be taken into account.

Pharmacodynamics

The antiarrhythmic activity of the drug is ensured through the following mechanisms of action:

Extends the 3rd phase of the potential of cardiac muscle activity, which is expressed mainly in a decrease in potassium current (Class III according to the Vaughan Williams classification);

Reduces sinus automatism to bradycardia that does not respond to atropine;

Non-competitively suppresses alpha and beta adrenergic activity;

Slows down conduction in the sinoatrial node, atria and atrioventricular (AV) node, especially with an accelerated heart rate;

Does not affect intraventricular conduction;

Increases the refractory period and reduces atrial, atrioventricular and ventricular excitability of the myocardium;

Slows down conduction and lengthens the refractory period of additional atrioventricular pathways.

Other properties

Moderately reduces peripheral resistance and heart rate, which leads to a decrease in oxygen consumption;

Increases coronary output by directly affecting myocardial arterial smooth muscle and maintains cardiac output by reducing pressure and peripheral resistance. Does not have a significant negative inotropic effect.

There was a significant reduction in overall mortality by 13% in favor of amiodarone (CI95% 0.78 - 0.99; p = 0.030) and rhythm-related mortality by 29% (CI95% 0.59 - 0.85; p = 0.0003).

Indications for use

Prevention of relapse:

Ventricular tachycardia that is life-threatening: treatment should be initiated in a hospital setting under close monitoring

Clinically confirmed, symptomatic and disabling ventricular arrhythmia

Clinically confirmed, supraventricular tachycardia with an established need for treatment, if resistance is observed when taking other drugs or there are contraindications for their use

Ventricular fibrillation

Treatment of supraventricular tachycardia: slowing or reducing atrial fibrillation or flutter.

Amiodarone may be used in patients with coronary artery disease (coronary artery disease) and/or left ventricular dysfunction.

Directions for use and doses

Initial treatment

The usual dosage regimen is 3 tablets per day, for 8-10 days.

In some cases, higher doses (4 or 5 tablets per day) may be used at the beginning of treatment, but only for a short time and with electrocardiographic monitoring.

Maintenance treatment

The minimum effective dose should be determined, according to the individual response, it can range from ½ tablet per day (1 tablet every other day) to 2 tablets per day.

Side effects

Very common (≥10%)

Microdeposits in the cornea, almost always present in adults, are usually localized in the area under the pupil and are not a contraindication to continued treatment. In exceptional cases, they may be accompanied by the perception of colored and blinding light or blurred vision. Microdeposits in the cornea, which are formed by a complex of lipids, always disappear after stopping treatment.

In the absence of any clinical symptoms of dysthyroidism, the level of “dissociated” thyroid hormone (increased T4 levels with normal or slightly decreased T3 levels) is not a reason to interrupt treatment.

In cases of liver damage; these cases were diagnosed by elevated serum transaminase levels. As a rule, a moderate and isolated increase in transaminase levels (from 1.5 to 3 times higher than normal) decreases after dose reduction or even spontaneously.

Gastrointestinal disturbances (nausea, vomiting, dysgeusia), usually occurring during initial treatment and disappearing when the dose is reduced.

Often (≥1%,<10%)

Lilac or bluish-gray pigmentation of the skin that occurs with high daily doses given over a long period of time. After discontinuation of treatment, this pigmentation slowly disappears (from 10 to 24 months).

Hypothyroidism has a classic form: weight gain, sensitivity to cold, apathy, drowsiness; a clear increase in the level of thyroid-stimulating hormone is a signal for its diagnosis. Interruption of treatment results in a gradual return to normal thyroid function over 1-3 months; therefore, discontinuation of the drug is not of great importance. If indicated, amiodarone treatment may be continued in combination with L-thyroxine-based organ replacement therapy, with dosage adjusted based on thyroid-stimulating hormone levels.

Hyperthyroidism is more often misleading: with few symptoms (slight unexplained weight loss, decreased effectiveness of antiangina and/or antiarrhythmic drugs); psychiatric forms in older people or even thyrotoxicosis.

A decrease in thyroid-stimulating hormone levels measured with an ultrasensitive method confirms the diagnosis. It is important to pause amiodarone treatment: this is usually sufficient to initiate clinical recovery within 3-4 weeks. Severe cases can lead to the death of the patient, so proper treatment must be started immediately.

If thyrotoxicosis is a concern, either in itself or due to its effects on unstable myocardial balance, and the effectiveness of synthetic antithyroid agents is inconsistent, then immediate corticosteroid therapy (1 mg/kg) for a sufficiently long period of time (3 months) is recommended. Cases of hyperthyroidism have been reported several months after discontinuation of amiodarone treatment.

Diffuse interstitial or alveolar pneumopathy and bronchiolitis obliterans with organizing pneumonia, sometimes fatal. The appearance of increasing dyspnea or dry cough - either isolated or in connection with a deterioration in general condition (fatigue, weight loss, general malaise) requires radiological monitoring and, if necessary, cessation of treatment. These types of pneumopathy can develop into pulmonary fibrosis.

Early withdrawal of amiodarone, associated with or unrelated to corticosteroid therapy, leads to regression of disorders. Clinical symptoms usually disappear within 3-4 weeks. Radiological and functional improvement usually occurs more slowly (several months). Several cases of pleurisy have been reported, mainly associated with interstitial pneumopathy.

Tremor or other extrapyramidal symptoms

Sleep disturbances, including nightmares

Sensory, motor or mixed peripheral neuropathies

Acute liver damage with increased blood transaminase levels and/or jaundice, sometimes fatal, requiring discontinuation of treatment

Moderate bradycardia depending on dose

Not often (≥0.1%,<1%)

Myopathy

Cerebellar ataxia

Benign intracranial hypertension, headache. The appearance of isolated headaches requires research into the cause underlying this disorder.

Conduction disorders (sinoauricular block of varying degrees)

Rarely (≥0.01,<0.1)

Hyponatremia, which may indicate SIADH/SIADH (syndrome of inappropriate antidiuretic hormone secretion)

Very rarely(<0.01%)

Optic neuropathy (optic neuritis) with blurred vision, decreased vision and papillary edema in the fundus. The outcome may be a more or less severe decrease in visual acuity. No relationship with amiodarone has been identified to date. However, in case of any other obvious cause, it is recommended to stop treatment

Erythema during radiotherapy

Skin rashes are usually not very specific

Exfoliative dermatitis, drug relationship not clearly established

Alopecia

SIADH/SIADH (syndrome of inappropriate antidiuretic hormone secretion), particularly when used in combination with drugs that can cause hyponatremia.

Bronchospasm, especially in patients with asthma

Acute respiratory distress syndrome, sometimes fatal or following surgery (suggested association with high doses).

Chronic liver damage during long-term treatment

Histology is consistent with pseudoalcoholic hepatitis. The abstract nature of the clinical and biological picture (intermittent hepatomegaly, increased blood transaminase levels 1.5-5 times higher than normal) is the basis for regular monitoring of liver function.

The diagnosis of chronic liver damage should be considered in the case of even a moderate increase in blood transaminase levels occurring after treatment lasting more than 6 months. Clinical and biological abnormalities usually resolve after cessation of treatment. Several cases of irreversible outcome have been reported.

Severe bradycardia and rarely sinus node failure (sinus node dysfunction, elderly patients).

- epididymitis; the relationship with the drug has not been established.

Vasculitis

Renal failure with moderate increase in creatinine

Thrombocytopenia.

Frequency unknown (cannot be estimated from available data)

Pulmonary hemorrhages, sometimes found in association with hemoptysis. These pulmonary effects often occur in association with amiodarone-induced pneumopathy.

Cases of angioedema.

Contraindications

Sinus bradycardia and sinoatrial heart block in the absence of correction by an artificial cardiac pacemaker

Sick sinus syndrome in the absence of correction with an artificial cardiac pacemaker (risk of sinus node arrest)

Violations of atrioventricular conduction of a high degree in the absence of correction by an artificial cardiac pacemaker

Hyperthyroidism due to possible exacerbation caused by amiodarone use

Known hypersensitivity reactions to iodine, amiodarone or one of the excipients

Pregnancy

Lactation period

Combination with drugs that can cause torsades de pointes:

Class Ia antiarrhythmics (quinidine, hydroquinidine, disopyramide)

Class III antiarrhythmics (sotalol, dofetilide, ibutilide)

Other drugs such as: arsenic compounds, bepridil, cisapride, difemanil, dolasetron IV, erythromycin IV, mizolastine, moxifloxacin, spiramycin IV, toremifene, vincamine IV (see “Drug Interactions”).

Drug interactions

Antiarrhythmic drugs

Many antiarrhythmic drugs reduce the automaticity, conductivity and contractility of the heart.

Combination administration with different classes of antiarrhythmic drugs can provide a beneficial therapeutic effect, but is most often a very sensitive process requiring close clinical and ECG monitoring.

Combined use with antiarrhythmic drugs that cause torsades de pointes (amiodarone, disopyramide, quinidine compounds, sotalol, etc.) is contraindicated.

Combined use with antiarrhythmic drugs of the same class is not recommended, except in exceptional cases associated with an increased risk of adverse effects on the heart.

Combined use with drugs that have negative inotropic properties that cause bradycardia and/or that slow atrioventricular conduction is a sensitive process requiring clinical and ECG monitoring.

Drugs that can cause torsade de pointes (TdP)

This severe form of arrhythmia can be caused by a number of medications, antiarrhythmic drugs, or otherwise.

Hypokalemia is a predisposing factor, as is bradycardia or congenital or acquired pre-existing QT prolongation.

Drugs that can cause torsade de pointes include class II and III antiarrhythmics and some antipsychotics.

With regard to erythromycin, spiramycin and vincamine, this interaction applies only to dosage forms administered intravenously.

The use of a torsadogenic drug with another torsadogenic drug is generally contraindicated.

However, methadone and some subgroups are an exception to this rule:

Antipsychotics that can induce torsade de pointes are also not recommended and are not contraindicated for use with other torsadogenic drugs.

Many drugs can cause bradycardia. This applies in particular to Class Ia antiarrhythmics, beta blockers, some Class III antiarrhythmics, some calcium channel blockers, digitalis, pilocarpine and anticholinesterase drugs.

Contraindicated combinations(see "Contraindications")

Ia(quinidine, hydroquinidine, disopyramide)

- class antiarrhythmic drugsIII(dofetilide, ibutilide, sotalol)

- other drugs such as: arsenic compounds, bepridil, cisapride, difemanil, dolasetron IV, erythromycin IV, mizolastine, moxifloxacin, spiramycin IV, toremifene, vincamine IV

Increased risk of developing ventricular arrhythmia, in particular torsade de pointes.

Cyclosporine

Increased concentrations of cyclosporine in the blood due to decreased liver metabolism with a risk of nephrotoxic effects.

Analysis of cyclosporine blood concentrations, monitoring of renal function and dose adjustment of cyclosporine during treatment with amiodarone.

Injectable diltiazem

Injectable verapamil

Risk of bradycardia and atrioventricular heart block.

If this combination cannot be avoided, careful clinical observation and continuous ECG monitoring will be important.

If possible, stop 1 of 2 treatments. If this combination cannot be avoided, preliminary control of the QT interval and ECG monitoring will play an important role.

Neuroleptics that can cause torsades de pointes: (amisulpride, chlopromazine, cyamemazine, droperidol, fluphenazine, haloperidol, levomepromazine, pimozide, pipamperone, pipotiazine, sertindole, sulpiride, sultopride, tiapride, zuclopenthixol).

Increased risk of ventricular arrhythmia, in particular torsade de pointes.

Methadone

Increased risk of ventricular arrhythmia, in particular torsade de pointes.

Combinations requiring precautions during use

Oral anticoagulants

Increased anticoagulant effect and risk of bleeding.

More frequent INR monitoring. Adjust the oral dose of the anticoagulant during treatment with amiodarone and 8 days after stopping treatment.

Beta blockers other than sotalol (contraindicated combination) and esmolol (combination requiring precautions for use)

Impaired conductivity and automatism (depressed compensatory sympathetic mechanisms). ECG and clinical monitoring required.

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

Impaired automaticity and cardiac conduction with the risk of excessive bradycardia.

Increased risk of ventricular arrhythmia, in particular torsade de pointes. Regular clinical and ECG monitoring is necessary.

Dabigatran

Increased serum concentrations of dabigatran are associated with an increased risk of bleeding. Clinical monitoring and dose adjustment of dabigatran as needed, not to exceed 150 mg/day.

Medicines for digitalis

Weakened automaticity (excessive bradycardia) and impaired atrioventricular conduction. When using digoxin, there is an increase in its level in the blood, associated with a decrease in its clearance.

ECG and clinical monitoring, as well as monitoring digoxin blood levels and adjusting the digoxin dose if necessary.

Orally administered diltiazem

Risk of bradycardia or atrioventricular heart block, particularly in elderly patients. ECG and clinical monitoring required.

Some macrolides (azithromycin, clarithromycin, roxithromycin)

Increased risk of ventricular arrhythmia, in particular torsade de pointes. ECG and clinical monitoring during concomitant administration.

Orally administered verapamil

Risk of bradycardia and atrioventricular heart block, particularly in elderly patients.

Esmolol

Violations of contractile function, automatism and conduction of the heart (suppression of compensatory sympathetic mechanisms). ECG and clinical monitoring required.

Hypokalemic agents: hypokalemic diuretics (in monotherapy or in combination), stimulant laxatives, amphotericin B (IV route), glucocorticoids (systemic route), tetracosactide

Increased risk of ventricular arrhythmia, in particular torsades de pointes (hypokalemia is a predisposing factor).

Hypokalemia should be corrected before drug administration, and ECG, blood electrolyte monitoring, and clinical monitoring should also be performed.

Lidocaine

Risk of increased lidocaine plasma concentrations with the possibility of neurological and cardiac adverse effects due to the reduced hepatic metabolism caused by amiodarone.

Clinical and ECG monitoring, if necessary, control of lidocaine concentrations in plasma. If necessary, adjust the dosage 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 is required.

Phenotoin (and by extrapolation fosphenytoin)

Increased plasma concentrations of phenytoin with symptoms of overdose, in particular neurological symptoms (reduced metabolism of phenytoin by the liver). Clinical monitoring, monitoring of phenytoin plasma concentrations and possible dose adjustment).

Simvastatin

Increased risk of adverse effects (depending on concentration), such as rhabdomyolysis (reduced hepatic metabolism of simvastatin). Do not exceed the simvastatin dose of 20 mg/day or use another statin not affected by this type of interaction.

Tacrolimus

Increased levels of tacrolimus in the blood due to inhibition of its metabolite by amiodarone. Measure tacrolimus blood levels, monitor renal function, and adjust the dose of tacrolimus when coadministered with amiodarone and after discontinuation of amiodarone.

Drugs that cause bradycardia

Increased risk of ventricular arrhythmia, in particular torsade de pointes. Clinical and ECG monitoring is required.

Combinations to Consider

Pilocarpine

Risk of excessive bradycardia (additional effects of drugs that cause bradycardia).

Special instructions

A meta-analysis was conducted of thirteen controlled, randomized, prospective trials involving 6,553 patients with recent myocardial infarction (78%) or chronic heart failure (22%).

The average follow-up period for patients ranged from 0.4 to 2.5 years. The daily maintenance dose averaged 200 to 400 mg.

This meta-analysis demonstrated a significant reduction in overall mortality by 13% in favor of amiodarone (CI95% 0.78 - 0.99; p = 0.030) and rhythm-related mortality by 29% (CI95% 0.59 - 0.85; p = 0.0003).

However, these results need to be interpreted with caution, taking into account the heterogeneity of the studies included in the analysis (heterogeneity due mainly to the selected population, length of follow-up period, methodology used and study results).

The percentage of treatment discontinuations was higher in the amiodarone group (41%) than in the placebo group (27%).

Hypothyroidism was detected in 7% of patients taking amiodarone compared with 1% in the placebo group. Hyperthyroidism was diagnosed in 1.4% of patients taking amiodarone, compared with 0.5% in the placebo group. Interstitial pneumopathy occurred in 1.6% of patients taking amiodarone, compared with 0.5% in the placebo group.

Warnings

Cardiac effects

An ECG must be performed before starting treatment

The reduction in heart rate may be worse in older patients.

The electrocardiogram changes during treatment with amiodarone. This change caused by Cordarone is a prolongation of the QT interval, which reflects prolongation of repolarization, possibly with the appearance of a U wave; this is a sign of therapeutic impregnation rather than toxicity.

The onset of 2nd and 3rd degree atrioventricular block, sinoauricular heart block or bifascicular block should be grounds for temporary cessation of treatment. First degree atrioventricular block should warrant closer monitoring.

The onset of a new arrhythmia or worsening of a previous, treated arrhythmia has been reported (see "Side effects").

The arrhythmogenic effect of amiodarone is weak, even less than the arrhythmogenic effect of most antiarrhythmic drugs, and mainly occurs in combination with certain drugs (see “Drug Interactions”) or with electrolyte imbalances.

Effects on the thyroid gland

The presence of iodine in the drug interferes with some thyroid function tests (radioactive iodine binding, protein-bound iodine); however, thyroid function assessment is still possible (T3, T4, USTSH).

Amiodarone may cause thyroid abnormalities, particularly in patients with a history of thyroid dysfunction. Testing for thyroid-stimulating hormone is recommended for all patients before starting treatment and then on a regular basis during treatment and several months after stopping treatment, as well as in the case of clinical suspicion of dysthyroidism (see “Side effects”).

Effects on the lungs

The occurrence of dyspnea or dry cough, alone or in association with deteriorating general condition, should suggest the possibility of pulmonary toxicity, such as interstitial pneumopathy, and require radiological monitoring.

Effects on the liver

Effects on the neuromuscular system

Amiodarone can cause sensory, motor and mixed peripheral neuropathy and myopathy.

Effect on the eyes

In case of blurred vision or decreased visual acuity, a complete ophthalmic examination, including the fundus, should be performed promptly. Treatment with amiodarone should be discontinued if amiodarone-induced neuropathy or optic neuritis occurs due to the potential risk of blindness.

Effects caused by interactions with other medicinal products

In combination with (see “Drug Interactions”):

Beta blockers with the exception of sotalol (contraindicated combination) and esmolol (combination requiring precautions),

Verapamil and diltiazem,

should only be considered for the prevention of life-threatening ventricular arrhythmia.

Effects caused by excipients

This medicinal product contains lactose. Therefore, the drug is not recommended for patients with galactose intolerance. Lapp lactase deficiency or glucose/galactose malabsorption syndrome (rare hereditary diseases).

Precautions for use

Electrolyte disturbances, in particular hypokalemia: It is important to take into account situations that may be associated with hypokalemia, which contributes to the onset of proarrhythmic effects.

Hypokalemia must be corrected before administering amiodarone.

The unwanted effects mentioned below are usually associated with excessive drug levels; they can be avoided or their severity can be reduced by careful selection of the minimum effective dose.

In children, the safety and effectiveness of amiodarone have not been assessed through controlled clinical trials.

Due to the possible increase in defibrillation and/or pacing threshold of implantable cardiac defibrillators or pacemakers, the threshold should be checked before starting treatment and several times during treatment with amiodarone, as well as whenever the dose is adjusted.

Anesthesia

Before surgery, the anesthesiologist must be informed that the patient is being treated with amiodarone.

Long-term treatment with amiodarone may increase the hemodynamic risk associated with general or local anesthesia in terms of adverse effects. Adverse effects include, but are not limited to, bradycardia, hypotension, decreased cardiac output, and conduction disturbances.

Moreover, some cases of acute respiratory failure have been reported in patients treated with amiodarone in the immediate postoperative period. Therefore, it is recommended that these patients be closely monitored during mechanical ventilation.

Pregnancy

Preclinical studies have not demonstrated any teratogenic effects. The absence of teratogenic effects in preclinical studies does not guarantee similar effects in humans. To date, substances that cause malformations in humans have been proven to be teratogenic in animals in studies conducted adequately in two species.

In a clinical context, there are insufficient relevant data available to evaluate the possible teratogenic effect of amiodarone when administered during the first trimester of pregnancy.

Because the fetal thyroid gland begins to bind iodine from 14 weeks of amenorrhea, no effects on the fetal thyroid gland are expected with early administration.

Iodine overload due to use of this drug outside of this period may cause biological or even clinical fetal hypothyroidism (struma).

Therefore, the use of this drug is contraindicated starting from the 2nd trimester of pregnancy.

Lactation

Amiodarone and its metabolite, together with iodine, are excreted into breast milk in concentrations exceeding those in maternal plasma. Due to the risk of hypothyroidism in the newborn infant, breastfeeding is contraindicated in patients being treated with this drug.

Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms

Caution should be exercised when performing activities that require increased attention.

Overdose

Symptoms: sinus bradycardia, ventricular arrhythmia, including torsade de pointes, liver failure.

Treatment: symptomatic. Taking into account the kinetic profile of the drug, cardiac monitoring is recommended for 1 month.

Some facts about the product:

Instructions for use

Price in online pharmacy website: from 221

Description of the drug

Cordarone is a drug (hereinafter referred to as medicinal product), which belongs to the group of antiarrhythmic drugs. Weakened myocardial activity or oxygen starvation of its cells leads to the development of pathologies of the cardiovascular system. The use of Cordarone helps normalize heart rhythm, block potassium and sodium channels, and prevent sudden death in patients with post-infarction or with cardiovascular failure. The drug is available in our pharmacy. The price of Cordarone depends on the form of release. The instructions for use of Cordarone indicate that the drug is used both for long-term maintenance therapy and for prophylactic purposes. It refers to “emergency” medications (for life-threatening conditions). The uniqueness of Cordarone lies in its wide spectrum of action. It is able to eliminate any type of arrhythmia. Also, under the influence of Cordarone, high blood pressure normalizes and coronary vessels expand. The description states that under the influence of the drug, the heart muscle is supplied with the necessary amount of oxygen. The drug (hereinafter referred to as the drug) exhibits a coronary dilatator, antianginal and beta-blocking effect. Treatment should be carried out under the supervision of a qualified specialist.

Release form, composition

Cordarone is produced in several dosage forms for maximum ease of use. The tablets are round in shape, white or cream in color. They are packaged in blisters of ten pieces (3 blisters in one package). The drug is also supplied to pharmacies in the form of a clear solution with a yellowish tint, which is contained in glass ampoules of 3 ml each. Manufacturers use amiodarone as the main active ingredient of Cordarone. One tablet contains 200 mg of the main component and 50 mg in 1 ml. The list of additional substances of Cordarone depends on the dosage form. The composition of the tablets, in addition to the active component, contains silicon dioxide, povidone, magnesium stearate, lactose monohydrate, corn starch. The composition of the drug for intravenous administration additionally contains water for injection, polysorbate, and benzyl alcohol. In our pharmacy, Cordarone is available in the form of a solution in ampoules and in tablet form.

Pharmacological action

The active substance Cordarone, penetrating into the body, exhibits an antiarrhythmic effect. Amiodarone has alpha and beta adrenergic blocking, antianginal, coronary dilation, and hypotensive properties. Cordarone helps normalize the process of oxygen supply to the heart muscle. It affects the activity at the ?-receptors and ?-receptors, it slows down, but is not completely blocked. Also, under the influence of Cordarone, depolarization of the cell membranes of the sinus node slows down and antiventicular conduction is inhibited. The medication makes the sympathetic nervous system less susceptible and reduces the tone of the coronary arteries. As a result, the heart rate normalizes, blood flow improves, the energy reserve of the myocardium increases and blood pressure decreases. Cordarone, when used regularly, lengthens the action potential of myocardiocytes and regulates electrophysiological processes in the myocardium. Thus, the antiarrhythmic characteristics of the LA are manifested. Cordarone tablets slow down antioventicular, atrial and sinoatrial conduction during tachycardia. The bioavailability level reaches 50% on average. About 95% binds to plasma proteins. The peak concentration of the main substance is observed 3-7 hours after penetration into the body. A stable therapeutic effect is recorded 6-7 days after the start of the course of treatment. Amiodarone accumulates in the spleen, lungs, liver, and adipose tissue. Its metabolism occurs in the liver. The active component is excreted through the intestines and is divided into two phases. The duration of the first stage is 4-20 hours. The second stage of elimination of the substance ranges from 25 to 100 days, depending on the dosage and duration of the therapeutic course. If the patient took Cordarone tablets for an extended period of time, the half-life of the active substance can reach 40 days. According to reviews of Cordarone, the drug solution acts 15-20 minutes after administration.

Indications

Before taking drugs, you need to find out what Cordarone helps with, how it should be taken and what the main indications for use are. The need to prescribe medications is determined by the attending physician, based on the diagnosis. The list of main indications for prescribing Cordarone includes: 1. Fatal ventricular arrhythmia. 2. Angina. 3. Supraventicular arrhythmia. 4. Chagas myocarditis, which is accompanied by arrhythmia. 5. Parasistology. 6. Ventricular fibrillation. 7. Atrial flutter. 8. Atrial paroxysm. 9. Supraventricular paroxysmal tachycardia. 10. Atrial fibrillation. 11. Post-infarction condition, in which there is a high risk of sudden death. The instructions for use of Cordarone indicate that the drug can be used for preventive purposes. To avoid negative reactions from internal organs or systems, you should follow your doctor’s recommendations and take Cordarone according to the regimen he has drawn up.

Dosage

The dosage of Cordarone and the method of its use are determined by the dosage form and the characteristics of the pathology. LP does not have an analgesic effect, so it is not used for pain. The tablets are intended for oral administration and should be taken with plenty of water. Patients often ask when to take Cordarone, before or after meals. Experts recommend taking the drug before meals to avoid changes in its pharmacokinetic characteristics. The standard instructions describe in detail how to take Cordarone. The standard initial dose of LP ranges from 600 to 800 mg per 24 hours. This amount is divided into two or three doses. After 5-10 days of using Cordarone, the dosage begins to be gradually reduced to 300-400 mg/day. Next, doctors transfer patients to a maintenance dose, which does not exceed 200 mg/24 hours. Should be taken twice. The maximum permissible single dose of Cordarone tablets is 40 mg, and the daily dose is 1200 mg. The average duration of the therapeutic course is 10-14 days.

Cordarone solution

When diagnosing acute disturbances in the rhythm of contraction of the heart muscle, Cordarone in ampoules is often prescribed. The solution is intended for administration into a vein. The amount of the drug is calculated according to a certain scheme: for each kilogram of body weight, 5 mg. For patients with chronic heart failure, the dosage is halved (2.5 mg per 1 kg). The injection procedure lasts about 10-20 minutes. The instructions for use of Cordarone say that the solution can only be used in stationary conditions. Self-medication can be dangerous for the patient’s general condition and lead to a number of complications. Cordarone in Moscow can only be purchased with a prescription from a doctor.

Side effects

Incorrect use of Cordarone can provoke negative reactions. Before use, you should be aware of the side effects. The most common changes in the functioning of the digestive system: cholestasis, impaired sensitivity of taste buds, jaundice, loss of appetite, cirrhosis of the liver, nausea/vomiting, excessive secretion of liver enzymes; Central nervous system: ataxia, insomnia, paresthesia, depressive syndrome, memory impairment, increased fatigue, fatigue, headache, auditory hallucinations, intracranial hypertension; respiratory system: coughing attacks, shortness of breath, bronchospasm, alveolitis, fibrosis, apnea, pneumonia (interstitial); CVS: sinus bradycardia, tachycardia, sharp decrease in blood pressure, atrioventricular block. The listed symptoms go away on their own immediately after discontinuation of the drug and do not require additional treatment. If the therapeutic regimen is incorrectly selected, Cordarone can have a negative effect on the metabolic process and provoke hypothyroidism, thyrotoxicosis, or an increase in T4 levels. Side effects can also manifest themselves in the form of decreased potency, age spots on the skin, epididymitis, vasculitis or excessive sweating. Treatment with Cordarone tablets over a long period may provoke the development of thrombocytopenia, aplastic anemia, dermatitis, hemolytic anemia or allergic reactions. If a patient is allergic to the main active ingredient of a drug, an analogue of Cordarone should be selected. They are based on different components, but they have a similar therapeutic effect. In our pharmacy you can buy Cordarone and its substitutes, after consulting with your doctor.

Contraindications

Cordarone is a potent drug, so it has a number of contraindications. You should familiarize yourself with them before starting treatment. Doctors do not prescribe Cordarone for: 1. Hypersensitivity to its components. 2. Atrioventricular block (second/third degree). 3. Magnesium or potassium deficiency. 4. Sinus node dysfunction syndrome. 5. Improper functioning of the thyroid gland. 6. Prolonged QT interval. 7. Interstitial lung pathology. 8. Cardiogenic shock. 9. Collapse. With maximum caution and under the supervision of a qualified specialist, Cordarone is used to treat patients over 65 years of age with liver dysfunction and heart failure. The compatibility of Cordarone with some drugs may negatively affect the course of the disease or the patient's condition. If the patient is taking any medications, this should be reported to the doctor during the first examination. If there are contraindications, the doctor prescribes Cordarone analogues based on the principle of their effect on the body. It is strictly forbidden to change the medicine without a doctor's advice.

Use during pregnancy

To date, there is no necessary amount of data that would refute or confirm the safety of Cordarone use during pregnancy. It is known that the medication can affect the development of the child’s thyroid gland. Since clinical information is insufficient and it is difficult to determine whether a drug affects the development of the fetus or not, doctors do not recommend prescribing it to pregnant women. The use of Cordarone is allowed only in extreme cases, when the expected positive effect is higher than the possible harm. The active substance Cordarone has the ability to pass into breast milk in large quantities. It can negatively affect the development of the child and cause complications. In this regard, the drug is not prescribed during lactation. If there is a threat to the mother's life, breastfeeding should be interrupted for the period of treatment.

Use in old age

Elderly patients are at increased risk of developing signs of severe bradycardia. In this regard, treatment is carried out under the supervision of a specialist. There is also a need to adjust the daily dose. For persons over 60-65 years of age, the standard daily amount of Cordarone should be halved. During the therapeutic course, patients should not spend much time in direct sunlight. It is advisable to wear appropriate clothing or use a special sunscreen.

Application for children

Doctors do not prescribe Cordarone to children because there is not enough information regarding its safety. The drug is recommended for the treatment of patients over 18 years of age.

Special instructions

Cordarone is characterized by dose-dependent adverse reactions, so the therapeutic course must be started with the minimum effective dose. This will help prevent negative effects from occurring. In the absence of positive dynamics, the doctor may increase the daily amount of drugs. Before prescribing Cordarone tablets, specialists perform an ECG and check the level of potassium in the blood. If the levels are low, it becomes necessary to adjust the treatment regimen. Every three months, changes in transaminase activity, liver function and an ECG should be checked. The influence of Cordarone may affect the functioning of the thyroid gland. Before prescribing the drug, it is necessary to conduct an examination to identify pathologies or deviations in its activity. Once every five to six months, it is recommended to take an x-ray of the lungs. Cordarone contains iodine, so patients with allergies to this substance should consult a specialist before taking it. If surgical intervention is necessary, the anesthesiologist must be warned that the patient is taking pills, since the main substance of the drug may increase the hemodynamic risk. If the patient experiences shortness of breath or attacks of dry cough, this may indicate the development of interstitial pneumonitis. The condition may be accompanied by fever, weight loss, and fatigue. An x-ray of the lungs must be taken as soon as possible. Lethargy, weight gain, bradycardia, increased sensitivity to low air temperatures are signs of hypothyroidism. In this case, you need to contact a medical facility. The parenteral route of administration of Cordarone is carried out only in a hospital. At the same time, heart rate, blood pressure and ECG are monitored. Upon completion of the course of treatment, the therapeutic effect does not disappear within 10-30 days. Amiodarone can affect your ability to concentrate, so you should not drive a vehicle or engage in activities that require maximum concentration.

Overdose

If the patient has taken too much Cordarone, signs of overdose may appear. The condition is accompanied by more pronounced side effects, manifestations of sinus bradycardia, ventricular tachycardia, and liver damage. Also in clinical practice, cases of complete cardiac arrest as a result of an overdose have been recorded. The condition requires immediate treatment. First aid methods include gastric lavage. If the patient has recently taken Cordarone, he needs to drink Activated carbon (1 tablet per 10 kg). Further measures are determined by the doctor after conducting an examination and determining the degree of poisoning. Symptomatic therapy may include: cardiac pacing; use of cholestyramine; introduction of beta-agonists; injection of magnesium salts into a vein. It is impossible to remove the substance from the body using hemodialysis. To avoid an overdose, you must adhere to the treatment regimen that was drawn up by your doctor.

Drug interactions

The issue of Cordarone's compatibility with other medications needs to be given special attention, since they can neutralize each other's therapeutic effect. Cordarone can provoke ventricular tachycardia (“pirouette”) in combination with: Quinidine, Disopyramide, Ibutilide, Dofetilide, Vincamine, Cyamemazine, Chlorpromazine, Spiramycin, Droperidol, Aminsulpride, Erythromycin, Mefloquine, Mizolastine, Ibutilide, Astemizole, Hydroquinidine. Experts do not recommend simultaneously taking Cordarone and: 1. Medicines with laxative characteristics or stimulants of intestinal motility (the risk of ventricular arrhythmia “pirouette” increases). 2. Beta-blockers. 3. Calcium channel blockers. 4. Medicines that help slow down the heart rate. With extreme caution, it is allowed to combine Cordarone with teteracosactide, diuretics, systemic glucocorticosteroids, amphotericin B, as well as drugs that lead to the development of hypokalemia. Under the influence of Cordarone: the level of procainamide in the blood plasma increases; Digoxin accumulates, resulting in severe bradycardia; the effect of warfarin increases (increased risk of bleeding); the concentration of phenytoin and dextromethorphan increases (manifestation of neurological signs); the effectiveness of Clopidogrel is neutralized; the nephrotoxic effect of cyclosporine increases. The following agents help reduce the level of amiodarone in plasma: St. John's wort, rifampicin, orlistat.

Ethanol compatibility

Cordarone and alcohol are incompatible. With the simultaneous use of drugs and alcoholic beverages, there is an excessive load on the liver, increasing the risk of negative reactions. As a result, the degree of organ performance may decrease significantly. Alcoholic drinks and medications that contain ethanol neutralize the therapeutic effectiveness of Cordarone. Drinking alcohol is strictly prohibited during the course of treatment.

Storage conditions and periods

The shelf life of the drug is three years from the date of manufacture (date on the packaging). Cordarone storage conditions must be observed. Store the drug out of reach of children at a temperature not exceeding 30°C.

> Cordarone (tablets)

This information cannot be used for self-medication!
Consultation with a specialist is required!

Cordarone belongs to class III antiarrhythmic drugs and contains the active substance amiodarone. The drug is produced in the form of round white tablets, which are engraved in the shape of a heart and the number “200”, which indicates the dose of the drug.

The medicinal effect of this drug develops quite slowly, so it cannot be used to relieve sudden attacks of arrhythmia, however, amiodarone is almost ideal as a prophylactic agent. Its undoubted advantage is the fact that it is not excreted from the body in the urine, which means it can be used even in patients with severely reduced kidney function.

The tablet form of cordarone is used, firstly, to prevent relapses of life-threatening arrhythmias: ventricular tachycardia and ventricular fibrillation, as well as for tachycardias emanating from other parts of the heart. In addition, the drug is used to prevent sudden cardiac death in people at high risk: patients after a heart attack, people who have more than 10 ventricular extrasystoles in an hour, or people suffering from chronic heart failure.

This antiarrhythmic should be taken before meals with plenty of water. The dosage of the drug should be indicated exclusively by the doctor monitoring the patient’s heart condition. It should be noted that the drug, due to its slow elimination, is quite convenient to use, since it can be taken only once a day, or less often (as the doctor says). Missing one dose of amiodarone does not lead to withdrawal syndrome, characterized by the occurrence of a heart attack.

Being a very strong drug, cordarone has a very wide range of adverse reactions. The most common are cardiac conduction disorders, nausea, vomiting, changes in taste, liver dysfunction, including toxic damage, and damage to lung tissue (pneumonitis, pleurisy or pneumonia). Sometimes vision may decrease, although this effect is transient and disappears after stopping or reducing the dose of the drug. The endocrine system can also be affected - there is an increase or decrease in the functions of the thyroid gland. Finally, involuntary muscle twitching may occur in various parts of the body.

All these side effects most often stop after adjusting the dose or stopping the drug completely.

The drug also has contraindications, the most serious of which are cardiac conduction disorders - blockades of any kind, as well as a decrease in the concentration of potassium and magnesium in the blood, dysfunction of the thyroid gland, and some lung diseases. It is prohibited to take the drug during pregnancy and lactation, and it cannot be purchased for children under 18 years of age.

When prescribing any amiodarone-containing medication, the doctor must take into account what other medications the patient is taking, since some of them may increase the severity of adverse reactions of the antiarrhythmic or reduce its effectiveness.

An overdose of this medication is very dangerous, as it can cause a catastrophic slowdown in heart rate. The lack of a specific antidote and the ineffectiveness of conventional procedures, which are usually performed to quickly remove other drugs from the body, force one to be extremely careful about the use of amiodarone and make it absolutely unsuitable for self-medication. Fortunately, the drug is sold only by prescription, which means it is impossible to buy it at a pharmacy at the request of “something from the heart.”

Cordarone is a cardiovascular drug. Dispensed only with a doctor's prescription.

Pharmacological action of Cordarone

Cordarone is a third class antiarrhythmic drug. Eliminates angina pectoris and arrhythmia, helps block adrenergic receptors, slow down sinoatrial, atrial and nodal conduction, without affecting intraventricular conduction.

The drug also reduces myocardial excitability and lengthens the refractory period. Cordarone also has an antianginal effect due to a decrease in myocardial oxygen consumption. This occurs due to a decrease in heart rate and a decrease in total vascular peripheral resistance. Due to its direct effect on the muscles of the arteries, Cordarone increases coronary blood flow; in addition, the drug supports cardiac output and reduces myocardial contractility.

According to reviews, Cordarone reaches maximum activity 15 minutes after intravenous administration, and the medicinal effect on the body continues for four hours. Gradually, the amount of the drug in the blood decreases, but this does not prevent it from saturating the tissues. If the patient does not receive repeated injections, the drug is eliminated from the body within several months.

Release form

Cordarone is available in the form of solution and tablets.

Indications for use of Cordarone

Cordarone is used to relieve attacks of paroxysmal tachycardia, to relieve paroxysmal ventricular and supraventricular tachycardia, accompanied by a high frequency of ventricular contractions, to remove paroxysmal and stable forms of atrial fibrillation, as well as atrial flutter.

According to reviews of Cordarone, the drug is effective in the treatment of patients suffering from heart diseases of organic origin (including coronary heart disease), which are accompanied by changes in left ventricular function.

Instructions for use of Cordarone

According to the instructions, Cordarone tablets are taken according to several regimens.

Outpatient treatment begins with taking 600 to 800 milligrams of the drug per day, divided into several times. After a period of 10 to 14 days, when the total amount of the drug taken reaches 10 grams, the patient is recommended to take a maintenance dose, which is prescribed at the rate of 3 milligrams per kilogram of weight (on average, from 100 to 400 milligrams per day).

During inpatient treatment, the patient is first prescribed to take the drug from 600 to 800 grams per day (the maximum dose is 1200 milligrams). Over 5-8 days, increase to 10 grams.

Since Cordarone has a long half-life, the drug can be taken daily in the amount of 100 milligrams and every second day in the amount of 200 milligrams. Breaks in taking the drug are allowed two days a week.

Cordarone solution is used for intravenous injections and infusions. When performing an infusion, the loading dose for an adult is 5 milligrams per kilogram of body weight. Cordarone is dissolved in 250 milliliters of 5% glucose. The infusion lasts from 20 minutes to 2 hours. During the day, the administration is repeated 2-3 times.

Over time, the effect of the drug gradually decreases, so a maintenance infusion is recommended, for which adults are prescribed the drug at a rate of 10 to 20 milligrams per 1 kilogram of weight (an average of 600 to 800 milligrams per day, the maximum dose is no more than 1200 milligrams) . This dose is also diluted in 250 milliliters of 5% glucose before administration.

The dose recommended for adult patients is 5 milligrams per 1 kilogram of weight. The procedure is carried out within three minutes, the next injection is no earlier than 15 minutes after the previous one. If it is necessary to continue treatment, it is recommended to switch to infusion administration.

Cordarone can also be used by children after they reach the age of three. Dosage – 5 milligrams per 1 kilogram of weight. The syringe should not contain any other drug except Cordarone; mixing it with other drugs is not allowed.

In case of an overdose of the drug, the following are possible: sinus bradycardia, paroxysmal ventricular tachycardia, cardiac arrest, ventricular tachycardia of the “pirouette” type, impaired liver and circulatory function, decreased blood pressure.

To eliminate the symptoms of overdose, symptomatic treatment is prescribed, including gastric lavage, taking cholestyramine; for pirouette-type tachycardia, intravenous administration of magnesium salts, as well as reducing cardiac pacing; for bradycardia, beta stimulators or the installation of a pacemaker are prescribed.

Side effects of Cordarone

The use of the drug can lead to: deposition of lipofuscin in the corneal epithelium, photosensitivity, hypothyroidism, hyperthyroidism, bradycardia, hypotension, decreased AV conductivity, alveolitis, nausea, impaired liver function, heaviness in the epigastrium.

There are reviews of Cordarone as a drug that provokes tremor and the development of peripheral neuropathy.

With parenteral administration, fever, sweating, apnea, bronchospasm, phlebitis, and increased intracranial pressure may occur.

Contraindications to the use of Cordarone

According to the instructions, it is not recommended to prescribe Cordarone tablets if the patient is intolerant to amiodarone or iodine, with weakness of the sinus node, changes in intraventricular and atrioventricular conduction, dysfunction of the thyroid gland, hypokalemia, heart failure, interstitial pulmonary disease.

In addition, the drug in tablets is contraindicated in children under 18 years of age, as well as in nursing and pregnant women.

Cordarone is not allowed to be administered intravenously to children under three years of age and to breastfeeding women. The drug is prescribed to pregnant women only in exceptional cases.

The simultaneous use of Cordarone with antiarrhythmic drugs, as well as with sultopride, vincamine, pentamidine for parenteral administration, erythromycin for intravenous administration is not recommended, since the development of ventricular tachycardia of the “pirouette” type is possible.

It is prohibited to carry out combination therapy with beta-blockers, as well as individual calcium channel blockers (these include: verapamil, diltiazem). The consequences of simultaneous use of Cordarone with these drugs may be a violation of automaticity (in the form of bradycardia) and conduction.

It is prohibited to take Cordarone together with laxatives, drugs that cause hypokalemia, anticoagulants, cardiac glycosides, cyclosporine, phenytoin, flecainide, simvastatin. In addition, according to the instructions, Cordarone is not recommended for patients who have undergone general anesthesia.

Storage conditions and periods

It is recommended to store the drug in tablet form in a dark place at above-zero temperatures not exceeding 30°C. Shelf life – three years. Cordarone solution for intravenous administration is stored in a dry place where the temperature does not exceed 25°C. Shelf life is two years.

Instructions for use:

Cordarone is an antiarrhythmic drug.

Release form and composition

Dosage forms:

Dividable tablets: from white with a creamy tint to white, round in shape with a chamfer on both sides, a bevel from the edges to the break line on one side and engraving: above the dividing line - a heart-shaped symbol, under the line - the number 200 (10 each pcs. in blisters, 3 blisters in a cardboard pack);
Solution for intravenous (i.v.) administration: transparent light yellow liquid (3 ml in ampoules, 6 pcs. in a box).

Active ingredient: amiodarone hydrochloride:

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

Auxiliary components:

Tablets: corn starch, lactose monohydrate, magnesium stearate, colloidal anhydrous silicon dioxide, povidone K90F;
Solution: benzyl alcohol, polysorbate 80, water for injection.

Indications for use

The use of Cordarone in tablet form is indicated for the prevention of relapses:

Supraventricular paroxysmal tachycardia: attacks of recurrent sustained supraventricular paroxysmal tachycardia, recorded in patients with organic heart disease; attacks of recurrent sustained supraventricular paroxysmal tachycardia recorded in patients without organic heart disease (with the ineffectiveness of antiarrhythmic drugs of other classes or contraindications to their use); attacks of recurrent sustained supraventricular paroxysmal tachycardia recorded in patients with Wolff-Parkinson-White syndrome;
Ventricular arrhythmias that pose a threat to the patient’s life, including ventricular tachycardia and ventricular fibrillation (during inpatient treatment with careful cardiac monitoring);
Atrial fibrillation (atrial fibrillation) and atrial flutter.

In addition, tablets are prescribed for the treatment of patients with rhythm disturbances due to impaired left ventricular function and/or coronary heart disease (CHD).

The tablets are taken to prevent sudden arrhythmic death in patients who have recently suffered a myocardial infarction, have clinical manifestations of chronic heart failure or more than 10 ventricular extrasystoles in 1 hour and a reduced left ventricular ejection fraction (less than 40%).

The use of the drug in the form of a solution is indicated for the relief of attacks of ventricular paroxysmal tachycardia, supraventricular paroxysmal tachycardia with a high frequency of ventricular contractions (especially in Wolff-Parkinson-White syndrome), persistent and paroxysmal forms of atrial fibrillation (atrial fibrillation) and atrial flutter.

Cordarone injections are also used for cardiac resuscitation in case of cardiac arrest, against the background of ventricular fibrillation, resistant to defibrillation.

Contraindications

Contraindications to the use of tablets and solution:

Age up to 18 years;
Atrioventricular (AV) block of the second and third degree, two- and three-fascicle blocks in patients without a pacemaker;
Sick sinus syndrome (sinoatrial block, sinus bradycardia), except in cases of correction with an artificial pacemaker (pacemaker);
Concomitant use with drugs that prolong the QT interval and cause the development of paroxysmal tachycardia, including ventricular “pirouette” tachycardia: class IA antiarrhythmic drugs (hydroquinidine, quinidine, procainamide, disopyramide) and class III (bretylium tosylate, ibutilide, dofetilide), sotalol; Other drugs are not antiarrhythmic effects: vincamine, beephil, phenotiazins (flufenasin, cyamemazine, chlorpromazine, leftompromazine, trifluoperazin, thioridase), Benzamides (sultopride, amisiprides, suldides, veralivat, tiapid), pimoside, butyleol, botirol, caperidol) Tindol, cisapride, tricyclic antidepressants, azoles, macrolide antibiotics (including spiramycin, erythromycin when administered intravenously), antimalarials (chloroquine, halofantrine, quinine, mefloquine), difemanil methyl sulfate, pentamidine only when administered parenterally, mizolastine, fluoroquinolones, astemizole and terfenadine;
Hypomagnesemia, hypokalemia;
Prolongation of the QT interval, including congenital;
Pregnancy and breastfeeding period;
Thyroid dysfunction (hyperthyroidism, hypothyroidism);
Hypersensitivity to the components of the drug and to iodine.

Cordarone should be prescribed with caution to patients with first degree AV block, arterial hypotension, severe chronic (III-IV functional class according to the NYHA classification) or decompensated heart failure, liver failure, bronchial asthma, severe respiratory failure and elderly patients.

The tablets should not be taken if you have interstitial lung disease.

Additional contraindications to the use of the solution:

Severe arterial hypotension, cardiogenic shock, collapse;
Intraventricular conduction disorders (two- and three-fascicle blockades) in the absence of a permanent pacemaker;
Heart failure, arterial hypotension, cardiomyopathy or severe respiratory failure - for intravenous bolus administration.

All of these contraindications should not be taken into account when performing cardiac resuscitation in case of cardiac arrest due to ventricular fibrillation, resistant to cardioversion.

The use of amiodarone in pregnant women is possible for ventricular cardiac arrhythmias that pose a threat to the life of the mother, if the expected clinical effect outweighs the potential risk and danger to the fetus.

Directions for use and dosage

Tablets: orally, before meals, with a small amount of water. The dosage is prescribed by the doctor based on clinical indications and the patient’s condition. The loading dose in a hospital setting is increased, starting with a daily dose of 0.6-0.8 g (up to 1.2 g) divided into several doses, until a total dose of 10 g is reached after 5-8 days of administration; Outpatient saturation up to 10 g is carried out over 10-14 days at a daily dose of 0.6-0.8 g. The maintenance dose should be the minimum effective, selected individually, can range from 0.1 to 0.4 g per day. The average therapeutic single dose is 0.2 g, daily dose is 0.4 g. The maximum single dose is 0.4 g, daily dose is 1.2 g. Tablets can be taken every other day or with a break 2 days a week;
Solution for injection: intended for intravenous administration to achieve a rapid antiarrhythmic effect or when it is impossible to take the drug orally. In addition to special emergency clinical situations, the solution should be used only in intensive care hospital conditions under constant monitoring of blood pressure and electrocardiogram (ECG). The solution should not be mixed with other agents, administered into the same infusion line, or used undiluted. For dilution, it is necessary to use only a 5% dextrose (glucose) solution; the concentration of the resulting solution must be no less than when diluting 6 ml of the drug in 500 ml of 5% dextrose (glucose). Administration should always be done through a central venous catheter; administration through peripheral veins is allowed for cardiac resuscitation in ventricular fibrillation resistant to cardioversion in the absence of central venous access. In case of severe cardiac arrhythmias, if it is impossible to take the drug orally, intravenous drip administration through a central venous catheter is recommended at the usual loading dose at the rate of 0.005 g per 1 kg of patient weight in 250 ml of a 5% dextrose (glucose) solution. It should be administered over 20-120 minutes, preferably using an electronic pump. It can be administered 2-3 times within 24 hours, adjustment of the rate of administration depends on the clinical effect. The maintenance daily dose of amiodarone is usually prescribed in the amount of 0.6-0.8 g, which can be increased to 1.2 g in 250 ml of a 5% dextrose (glucose) solution. Over the course of 2-3 days of intravenous administration, you should gradually switch to taking the drug orally. Intravenous jet administration during cardiac resuscitation during cardiac arrest due to ventricular fibrillation, resistant to cardioversion, is recommended at a dose of 0.3 g of the drug diluted in 20 ml of a 5% dextrose (glucose) solution. If there is no clinical effect, additional administration of 0.15 g of amiodarone is possible.

Side effects

The use of Cordarone can cause side effects common to each of the forms:

From the respiratory system: very rarely - bronchospasm and/or apnea due to severe respiratory failure, especially bronchial asthma; acute respiratory distress syndrome (sometimes immediately after surgery, sometimes fatal);
From the cardiovascular system: often – moderate (dose-dependent) bradycardia; very rarely - severe bradycardia or sinus node arrest (in exceptional cases), more often in patients with sinus node dysfunction and elderly patients;
From the nervous system: very rarely - headache, benign intracranial hypertension.

The use of tablets can cause the following side effects:

From the cardiovascular system: infrequently - AV block of varying degrees, sinoatrial block (conduction disturbance), the emergence of new or aggravation of existing arrhythmias; frequency unknown - progression of chronic heart failure (during long-term therapy);
From the respiratory system: often - cases of development of alveolar or interstitial pneumonitis, bronchiolitis obliterans with pneumonia (sometimes fatal), pleurisy, pulmonary fibrosis, severe shortness of breath or dry cough with symptoms of deterioration in general condition (fatigue, weight loss, increased body temperature ) or without it; frequency unknown - pulmonary hemorrhage;
From the digestive system: very often - nausea, vomiting, loss of appetite, decreased sense of taste or loss thereof, a feeling of heaviness in the epigastrium (especially at the beginning of use, it goes away after reducing the dose), isolated spasmodic disturbance of the activity of liver enzymes in the blood serum; often - jaundice, acute liver damage, liver failure (sometimes fatal); very rarely - chronic liver diseases such as cirrhosis, pseudoalcoholic hepatitis (sometimes fatal);
From the senses: very often - transient visual impairment (blurred contours in bright light) caused by the deposition of complex lipids in the corneal epithelium; very rarely – optic neuritis or optic neuropathy;
From the skin: very often – photosensitivity; often – transient skin pigmentation (with long-term therapy); very rarely - erythema, skin rash, alopecia, exfoliative dermatitis (no connection with the drug has been confirmed);
From the nervous system: often - extrapyramidal symptoms (tremor), sleep disturbances, nightmares; rarely – myopathy and/or peripheral neuropathies (sensorimotor, mixed, motor); very rarely - cerebellar ataxia;
Endocrine disorders: often - hypothyroidism (if the level of thyroid-stimulating hormone (TSH) in the blood serum is high, the drug must be discontinued), hyperthyroidism; very rarely - syndrome of impaired secretion of antidiuretic hormone;
Other: very rarely - epididymitis, vasculitis, impotence (no connection with amiodarone has been confirmed), hemolytic anemia, thrombocytopenia, aplastic anemia.

The use of Cordarone in the form of a solution causes undesirable effects:

From the cardiovascular system: often – moderate and transient decrease in blood pressure (BP); very rarely - proarrhythmogenic effect, progression of heart failure, flushing of the face (with intravenous jet administration);
Immune system disorders: very rarely - anaphylactic shock; frequency unknown - angioedema;
From the respiratory system: very rarely - shortness of breath, cough, interstitial pneumonitis;
From the skin: very rarely - increased sweating, feeling of heat;
From the digestive system: very often – nausea; very rarely - increased or decreased activity of liver enzymes in the blood (isolated), acute liver damage (sometimes fatal);
Reactions at the injection site: often - pain, swelling, induration, erythema, necrosis, infiltration, extravasation, inflammation, phlebitis (including superficial), thrombophlebitis, cellulitis, pigmentation, infection.

Special instructions

The drug should be taken only as prescribed by a doctor!

Side effects of Cordarone are dose-dependent, so treatment should be carried out in minimal effective doses.

During the period of use of the drug, patients should avoid exposure to direct sunlight.

The prescription of the drug should be made taking into account the data of an ECG and blood test to determine the potassium content. Correction of hypokalemia must occur before starting treatment. Treatment should be accompanied by regular monitoring of ECG (once every 3 months) and liver function indicators.

Patients with and without thyroid disease should undergo laboratory and clinical examinations of the thyroid gland before starting amiodarone therapy, during treatment, and for several months after discontinuation of the drug.

If functional disorders are suspected, it is necessary to determine the level of TSH in the blood serum.

During the period of use of the drug, patients should undergo X-ray examination of the lungs and pulmonary function tests every 6 months.

During long-term therapy of patients with a pacemaker or implanted defibrillator, it is necessary to regularly monitor their correct functioning.

When first degree AV block appears, it is necessary to intensify monitoring. In case of development of sinoatrial block, AV block of II and III degrees, or double-bundle intraventricular block, treatment should be discontinued.

An ophthalmological examination with examination of the fundus should be performed if visual acuity decreases and blurred vision appears. In patients with optic neuritis or neuropathy that developed while taking amiodarone, further use of the drug should be discontinued.

Before the operation, you must inform the anesthesiologist about taking the drug.

Long-term therapy with Cordarone may increase the hemodynamic risk associated with anesthesia.

In addition, in rare cases, patients may experience acute respiratory distress syndrome immediately after surgery, requiring careful monitoring during artificial ventilation.

IV jet administration should be carried out for at least 3 minutes, repeated administration is possible only 15 minutes after the first.

During the administration of the drug, the development of interstitial pneumonitis is possible, therefore, in the event of severe shortness of breath or a dry cough, with or without a deterioration in the general condition (fatigue, increased body temperature), the patient should undergo a chest x-ray. If the X-ray picture is abnormal, the drug must be discontinued, as the disease may develop pulmonary fibrosis.

It is possible to develop severe acute liver damage with the development of liver failure (sometimes with death) during the first day of injection use; it is necessary to regularly monitor liver function during therapy.

Concomitant use with verapamil, diltiazem and beta-blockers, except esmolol and sotalol, is only possible for the prevention of life-threatening ventricular arrhythmias and restoration of cardiac activity after cardiac arrest caused by ventricular fibrillation resistant to cardioversion.

Drug interactions

Only the attending physician can determine the possibility of concomitant therapy, taking into account the condition and clinical indications of the patient.