Cordaron

Cordarone is a drug with antiarrhythmic action.

Release form and composition

Cordarone is available in the following dosage forms:

• Tablets: round, from white with a creamy tinge to white, with a fault line on one side, with a chamfer and with a bevel from the edges to the fault line on both sides, with a heart symbol above the fault line and the number “200” under the line faults (10 pieces in blisters, 3 blisters in a carton box);
• Solution for intravenous administration: light yellow color, transparent (in colorless glass ampoules of 3 ml, 6 ampoules in plastic cellular packaging, 1 package in a carton box).

The composition of 1 tablet includes:

• Active ingredient: Amiodarone hydrochloride - 200 mg;
• Auxiliary components: corn starch, lactose monohydrate, magnesium stearate, povidone K90F, anhydrous colloidal silicon dioxide.

The composition of 1 ampoule includes:

• Active ingredient: Amiodarone hydrochloride - 150 mg;
• Auxiliary components: polysorbate 80 - 300 mg; benzyl alcohol - 60 mg; water for injection - up to 3 ml.

Indications for use

Cordarone in pill form:

• Prevention of recurrent life-threatening ventricular arrhythmias, including ventricular fibrillation and ventricular tachycardia (therapy should be started in the hospital with careful cardiac monitoring);
• Prevention of recurrence of supraventricular paroxysmal tachycardia, including documented episodes of recurrent sustained supraventricular paroxysmal tachycardia in patients with organic heart disease; documented bouts of recurrent sustained supraventricular paroxysmal tachycardia in patients without organic heart disease in cases when antiarrhythmic drugs of other classes are ineffective or there are contraindications to their use; documented bouts of recurrent resistant supraventricular paroxysmal tachycardia in patients with Wolff-Parkinson-White syndrome;
• Prevention of atrial flutter and atrial fibrillation (atrial fibrillation);
• Prevention of sudden arrhythmic death in patients at high risk (after recent myocardial infarction, with clinical manifestations of chronic heart failure and a reduced left ventricular ejection fraction, as well as patients with more than 10 ventricular extrasystoles in 1 hour);
• Treatment of rhythm disorders in patients with ischemic heart disease and / or impaired left ventricular function.

Cordarone in the form of a solution for intravenous administration:

• Relief of paroxysmal tachycardia, including relief of supraventricular paroxysmal tachycardia, with a high frequency of ventricular contractions, especially with Wolff-Parkinson-White syndrome; relief of ventricular paroxysmal tachycardia; relief of stable and paroxysmal forms of atrial fibrillation (atrial fibrillation) and atrial flutter;
• Cardioreanimation in cardiac arrest caused by ventricular fibrillation resistant to defibrillation.

Contraindications

• Syndrome of the sinus node weakness (sinus block, sinus bradycardia) in the absence of a pacemaker - an artificial pacemaker (due to the danger of "stopping" the sinus node);
• AV block II-III degree in the absence of a permanent pacemaker;
• Violations of intraventricular conduction (two-and three-beam blockade) in the absence of a permanent pacemaker. With such conduction disorders, intravenous administration of Cordarone is possible only in specialized departments under the cover of a temporary pacemaker;
• Hypomagnesemia, hypokalemia;
• Cardiogenic shock, collapse, severe hypotension;
• Functional disorders of the thyroid gland (hyperthyroidism, hypothyroidism);
• Prolongation of the QT interval (acquired or congenital);
• Simultaneous use with drugs that can prolong the QT interval and lead to the development of paroxysmal tachycardias, including ventricular pirouette tachycardia: sotalol; class IA antiarrhythmic drugs (hydroquinidine, quinidine, procainamide, disopyramide); class III antiarrhythmic drugs (ibutilid, dofetilide, bretillus tosylate); other (non-antiarrhythmic) drugs (eg, bepridil); tricyclic antidepressants; Vincamine; cisapride; azoles; some phenothiazines neuroleptics (cyamemazine, chlorpromazine, flufenazine, levomepromazine, trifluoperazine, thioridazine), benzamides (veralipride, sulpiride, amisulpride, tiaprid, sulpridide), butyrophenones (haloperidol, tridloidazine, halidridine, halidridine, halidridine, halopridine, triopluzidine, halopuridine) macrolide antibiotics (in particular, spiramycin, erythromycin when administered intravenously); pentamidine when administered parenterally; antimalarials (chloroquine, quinine, halofantrine, mefloquine); mizolastine; difemanil methyl sulfate; fluoroquinolones; terfenadine, astemizol;
• Pregnancy and lactation period;
• Age up to 18 years (safety and efficacy for this age group of patients have not been established);
• Hypersensitivity to the drug.

Intravenous-jet administration of Cordarone is contraindicated in severe respiratory failure, arterial hypotension, heart failure, or cardiomyopathy (due to the possible weighting of these conditions).

The above contraindications to the use of Cordarone during cardiac resuscitation in cardiac arrest caused by ventricular fibrillation resistant to defibrillation do not apply.

Cordarone should be used with caution in elderly patients (due to the high risk of developing severe bradycardia), as well as in the following diseases / conditions:

• Hypotension;
• Bronchial asthma;
• Decompensated or severe heart failure (NYHA class III-IV functional classes);
• Liver failure;
• Severe respiratory failure;
• AV blockade I degree.

Dosing and Administration

Cordarone in the form of tablets should be taken before ingestion by mouth, drinking plenty of water. The drug is used only on prescription.

Load ("saturating") dose: various saturation schemes may be used.

Inpatient treatment: the initial daily dose can vary from 600-800 mg to the maximum - 1200 mg. The daily dose should be divided into several doses. The drug is taken before reaching a total dose of 10 g (usually 5-8 days).

Outpatient treatment: the initial daily dose is usually 600-800 mg. The daily dose should be divided into several doses. The drug is taken before reaching a total dose of 10 g (usually in 10-14 days).

Maintenance dose: different patients may vary from 100 to 400 mg per day. It is necessary to apply the smallest effective dose determined by the individual therapeutic effect.

Since Cordaron has a very long half-life, it is possible to use it every other day or with two days off a week.

The average therapeutic dose: a single 200 mg, daily 400 mg.

Maximum dose: single - 400 mg; daily - 1200 mg.

Intravenous Cordarone is used in cases when it is necessary to achieve a fast antiarrhythmic effect or when it is impossible to take the drug inside.

In addition to urgent clinical situations, Cordaron should be used only in the intensive care unit in a hospital under the constant control of blood pressure and electrocardiogram (ECG).

Cordarone with intravenous administration can not be mixed with other drugs. Do not simultaneously enter other drugs in the same line of the infusion system.

Injection solution is used only diluted. For dilution Cordarone can only use 5% glucose solution (dextrose). Due to the nature of the dosage form, it is not recommended to use the concentration of the infusion solution less than that obtained by diluting 2 ampoules in 0.5 l of 5% glucose solution (dextrose).

To avoid the development of reactions at the injection site, Cordarone must be administered through the central venous catheter, except in cases of cardio-resuscitation in ventricular fibrillation, which is resistant to defibrillation. In this case, in the absence of central venous access, the use of peripheral veins (the largest peripheral vein with maximum blood flow) can be used to administer Cordarone.

For severe cardiac arrhythmias when it is impossible to take the drug inside (except in cases of cardio-resuscitation with cardiac arrest caused by fibrillation of the ventricles resistant to defibrillation), Cordarone can be administered intravenously through the central venous catheter or intravenous-jet.

For intravenous-drip infusion through a central venous catheter, the loading dose is usually 5 mg / kg body weight per 250 ml of 5% glucose solution (dextrose). If possible, the drug is administered using an electronic pump for 20-120 minutes. Within 24 hours the procedure can be repeated up to 3 times. Depending on the clinical effect, the rate of administration of Cordarone may be adjusted. Due to the fact that the therapeutic effect of the drug gradually decreases after the cessation of the infusion, if necessary, continue therapy with injection solution, it is recommended to switch to the constant intravenous-drip injection of Cordarone.

Maintenance doses: 10–20 mg / kg per day (usually 600–800 mg, but if necessary, an increase to 1200 mg per 24 hours is possible) in 250 ml of 5% glucose solution (dextrose) within a few days. From the first day of therapy, it is recommended to start gradually switching to the intake of Cordarone (per day - 3 tablets of 200 mg, if necessary, the dose can be increased to 4-5 tablets).

Intravenous jet administration can be performed only in emergency cases with the ineffectiveness of other types of therapy, and only in intensive care units under constant monitoring of blood pressure and ECG. Such an introduction is usually not recommended due to the high hemodynamic risk (collapse and a sharp drop in blood pressure).

The dose is usually 5 mg / kg body weight. Intravenous-jet administration of Cordarone should be carried out for at least 3 minutes (except in cases of cardio-resuscitation with ventricular fibrillation resistant to defibrillation). Repeated administration of the drug should not be carried out earlier than 15 minutes after the first injection, even if the contents of only one ampoule were used during the first injection of the solution (due to the possibility of an irreversible collapse). If necessary, further use of the drug, it should be administered in the form of infusion.

During cardio-resuscitation in cardiac arrest caused by ventricular fibrillation, which is resistant to defibrillation, intravenous-jet administration at a dose of 300 mg (5 mg / kg) diluted in 20 ml of 5% glucose solution (dextrose) is indicated. If it was not possible to stop the fibrillation, an additional intravenous-jet can be administered Kordaron in a dose of 150 mg (2.5 mg / kg).

Side effects

During therapy may develop disorders of some body systems:

• Respiratory system: very rarely - cough, interstitial pneumonitis, shortness of breath, apnea and / or bronchospasm (in patients with severe respiratory failure, especially in bronchial asthma), acute respiratory distress syndrome (sometimes fatal);
• Cardiovascular system: often - bradycardia (usually a moderate decrease in heart rate), a decrease in blood pressure, usually transient and moderate (cases of collapse or severe arterial hypotension were observed with too rapid administration of the drug or overdose); very rarely - arrhythmogenic effect (the emergence of new arrhythmias, including ventricular tachycardia "pirouette", or exacerbation of existing ones, sometimes with subsequent cardiac arrest. These effects are mainly observed when using Cordaron along with drugs that prolong the period of ventricular repolarization of the heart or in case of abnormal contents blood electrolytes); severe bradycardia or, in rare cases, a stop of the sinus node, which requires cessation of therapy, especially in patients with sinus dysfunction and / or elderly patients, flushing of the skin of the face; with unknown frequency - ventricular tachycardia of the "pirouette" type;
• Musculoskeletal system: with unknown frequency - pain in some parts of the spine (lumbar and lumbosacral);
• Immune system: very rarely - anaphylactic shock; with unknown frequency - angioedema (angioedema);
• Digestive system: very rarely - nausea;
• Endocrine system: with unknown frequency - hyperthyroidism;
• Nervous system: very rarely - headache, benign intracranial hypertension (pseudotumor of the brain);
• Skin and subcutaneous tissue: very rarely - excessive sweating, feeling of heat; with unknown frequency - urticaria;
• Biliary tract and liver: very rarely - an isolated increase in the activity of hepatic transaminases in the blood serum (usually moderate, the excess of normal values ​​decreases by 1.5-3 times with decreasing doses or even spontaneously), acute liver damage (within 24 hours after administration of Cordarone) with jaundice and / or increased transaminase, including the development of liver failure, sometimes fatal;
• Local reactions: often - reactions at the injection site (infection, infiltration, erythema, pain, necrosis, edema, thrombophlebitis, pigmentation, extravasation, induration, inflammation, cellulitis, phlebitis).

special instructions

Since the severity of side effects depends on the doses taken, therapy should be carried out with the smallest effective doses.

During the period of treatment, avoid exposure to direct sunlight or take the necessary protective measures (wear appropriate clothing and apply sunscreen).

Before initiating therapy, an ECG study should be conducted and the content of potassium in the blood should be determined. Prior to the use of Cordarone, hypokalemia should be corrected.

Due to the fact that amiodarone can lead to the development of hypothyroidism or hyperthyroidism, especially in patients with a history of thyroid disease, before taking Cordaron, it is necessary to conduct a laboratory and clinical examination to detect thyroid dysfunction.

Every 6 months it is recommended to carry out an X-ray examination of the lungs and pulmonary functional tests regardless of the absence or presence of pulmonary symptoms.

A dry cough or shortness of breath may indicate pulmonary toxicity, which requires pulmonary functional tests and an x-ray of the lungs.

With the development of a sinoatrial blockade, AV blockade of grade II and III, or two-beam intraventricular blockade, therapy should be interrupted. With AV block I degree, it is necessary to strengthen the monitoring of the patient.

With a decrease in visual acuity or blurred vision, an ophthalmologic examination should be urgently carried out. With the development of neuritis or optic nerve neuropathy, Cordaron should be canceled due to the risk of developing blindness.

Prior to the surgical intervention, the anesthesiologist must be informed of the therapy being conducted.

Before you start taking the drug, it is recommended to conduct thorough monitoring of functional liver tests (determination of transaminase activity).

Laboratory and clinical signs of chronic liver failure while taking Kordaron inside may be minimal and reversible after discontinuation of the drug, but there are reports of deaths in the liver.

In addition to urgent cases, intravenous administration of Cordarone should be carried out only in the intensive care unit with constant ECG monitoring.

It must be remembered that even slow intravenous-jet injection of the drug can cause the development of excessive lowering of blood pressure and circulatory collapse.

During the first days after the start of Cordarone in the form of a solution for injection, severe acute liver damage can occur with the development of liver failure (in some cases fatal).

Patients with paroxysms of severe rhythm disturbances during the period of therapy should preferably refrain from activities requiring quick psychomotor reactions and increased concentration of attention (driving and potentially dangerous activities).

Drug interaction

Since the simultaneous use of Cordarone with certain drugs can lead to the development of undesirable consequences (cause bidirectional ventricular tachycardia such as "pirouette", hypokalemia, increase the duration of the QT interval, etc.) during the period of therapy, the use of other drugs should be coordinated with the doctor.

Terms and conditions of storage

Keep out of the reach of children.

Shelf life:

• Tablets - 3 years at temperatures up to 30 ° C;
• Solution for intravenous administration - 2 years at temperatures up to 25 ° C.