Cordaron tabs 200mg #30

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Cordaron user manual

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Cordaron is an antiarrhythmic drug.

Release form and composition

Dosage forms:
    Divisible tablets: from white with a creamy shade to white, round in shape with a chamfer on two sides, bevel from the edges to the fracture line on one side and engraving: above the dividing line - a symbol in the form of a heart, under the line - the number 200 (10 pcs. in blisters, in a carton box 3 blisters);
    Solution for intravenous (intravenous) 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, anhydrous colloidal silicon dioxide, povidone K90F;
    Solution: benzyl alcohol, polysorbate 80, water for injection.

Indications for use

The use of Cordaron in the form of tablets is indicated for the prevention of relapses:
    Supraventricular paroxysmal tachycardia: attacks of recurrent persistent supraventricular paroxysmal tachycardia, fixed in patients with organic heart disease; attacks of recurrent persistent supraventricular paroxysmal tachycardia, fixed in patients without organic heart disease (with the ineffectiveness of antiarrhythmic drugs of other classes or contraindications to their use); attacks of recurrent persistent supraventricular paroxysmal tachycardia, fixed in patients with Wolff-Parkinson-White syndrome;
    Ventricular arrhythmias that pose a threat to the patient's life, including ventricular tachycardia and ventricular fibrillation (with inpatient treatment with careful cardiac monitoring);
    Atrial fibrillation (atrial fibrillation) and atrial flutter.
In addition, tablets are prescribed for the treatment of patients with arrhythmias associated with impaired left ventricular function and / or ischemic heart disease (IHD).
The tablets are taken to prevent sudden arrhythmic death in patients who have recently had myocardial infarction, who have clinical manifestations of chronic heart failure or more than 10 ventricular extrasystoles in 1 hour and a decreased left ventricular ejection fraction (less than 40%).
The use of Cordaron 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 with Wolff-Parkinson-White syndrome), persistent and paroxysmal forms of atrial fibrillation (atrial fibrillation) and atrial flutter.
Also, Cordaron injections are used for cardiac resuscitation in cardiac arrest, against the background of ventricular fibrillation, resistant to defibrillation.

Contraindications

Contraindications to the use of tablets and solution:
    Age under 18;
    Atrioventricular (AV) block II and III degree, two- and three-beam blockade in patients without a pacemaker;
    Syndrome of weakness of the sinus node (sinus blockade, sinus bradycardia), except in cases of correction by an artificial pacemaker (pacemaker);
    Simultaneous use with drugs that lengthen 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 (bretilium tosylate, ibutilide, sothalolidelide); other drugs with no antiarrhythmic action: vincamine, bepridil, phenothiazines (fluphenazine, cyamemazine, chlorpromazine, levomepromazine, trifluoperazine, thioridazine), benzamides (sultoprid, amisulpride, sulpride, veraliprid, tiaprid, serprofenosol) cisapride, tricyclic antidepressants, azoles, macrolide antibiotics (including spiramycin, erythromycin when administered intravenously), antimalarial drugs (chloroquine, halofantrine, quinine, mefloquine), diphemanil methyl sulfate, pentamidine only when administered parenterally and astinolisol, phtorochondine terfenadine;
    Hypomagnesemia, hypokalemia;
    Prolongation of the QT interval, including congenital;
    The period of pregnancy and breastfeeding;
    Dysfunction of the thyroid gland (hyperthyroidism, hypothyroidism);
    Hypersensitivity to the components of Cordaron and to iodine.
Care should be taken to prescribe Cordaron to patients with grade I AV block, arterial hypotension, severe chronic (NYHA functional class III – IV) or decompensated heart failure, hepatic failure, bronchial asthma, severe respiratory failure, and elderly patients.
Tablets should not be taken for interstitial lung disease.
Additional contraindications to the use of the solution:
    Severe arterial hypotension, cardiogenic shock, collapse;
    Intraventricular conduction disorders (two- and three-beam blockade) in the absence of a permanent pacemaker;
    Heart failure, arterial hypotension, cardiomyopathy or severe respiratory failure - for intravenous jet injection.
All of these contraindications should not be taken into account when carrying out cardiac resuscitation in case of cardiac arrest against the background of ventricular fibrillation resistant to cardioversion.
The use of amiodarone in pregnant women is possible with ventricular arrhythmias that threaten the life of the mother, if the expected clinical effect outweighs the potential risk and danger to the fetus.


Method of administration and dosage

    Tablets: orally, before meals, with a little water. Dosage is prescribed by the doctor based on clinical indications and the patient's condition. The loading dose in a hospital 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 performed within 10-14 days at a daily dose of 0.6-0.8 g. The maintenance dose should be the minimum effective, selected individually, and may range from 0.1 to 0.4 g per day. The average therapeutic single dose is 0.2 g, the daily dose is 0.4 g. The maximum single dose is 0.4 g, the 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 Cordaron inside. In addition to special emergency clinical situations, the solution should be used only in intensive care of a hospital under constant monitoring of blood pressure and an electrocardiogram (ECG). Do not mix the solution with other agents, enter into the same line of the infusion system, or use undiluted. For dilution, it is necessary to use only 5% dextrose (glucose) solution, the concentration of the resulting solution should be no less than when diluting 6 ml of Cordaron in 500 ml of 5% dextrose (glucose). The introduction should always be made through a central venous catheter, introduction through the peripheral veins is allowed for cardiac resuscitation in case of ventricular fibrillation resistant to cardioversion, in the absence of central venous access. In severe cardiac arrhythmias, in case of impossibility of taking Cordaron orally, intravenous drip through a central venous catheter is recommended in the usual loading dose at the rate of 0.005 g per 1 kg of patient weight in 250 ml of 5% dextrose (glucose) solution. It should be administered within 20-120 minutes, preferably using an electronic pump. It can be injected 2-3 times within 24 hours, the correction of the injection rate depends on the clinical effect. The maintenance daily dose of amiodarone is usually prescribed in the amount of 0.6-0.8 g, an increase of up to 1.2 g in 250 ml of 5% dextrose (glucose) solution is allowed. Within 2-3 days of intravenous administration, you should gradually switch to taking the drug inside. Intravenous jet injection during cardiac resuscitation in case of cardiac arrest against the background of ventricular fibrillation resistant to cardioversion is recommended at a dose of 0.3 g of Cordaron diluted in 20 ml of 5% dextrose (glucose) solution. In the absence of a clinical effect, additional administration of 0.15 g of amiodarone is possible.

Side effects

The use of Cordaron can cause side effects common to each of the forms:
    From the respiratory system: very rarely - bronchospasm and / or apnea against the background of severe respiratory failure, especially bronchial asthma; acute respiratory distress syndrome (sometimes immediately after surgery, sometimes fatal);
    From the side of the cardiovascular system: often - moderate (dose-dependent) bradycardia; very rarely - severe bradycardia or stopping of the sinus node (in exceptional cases), more often in patients with sinus node dysfunction and elderly patients;
    From the side of the nervous system: very rarely - headache, benign intracranial hypertension.
The use of tablets can cause the following side effects:
    From the side of the cardiovascular system: infrequently - AV-blockade of various degrees, sinoatrial blockade (conduction disturbance), the emergence of new or aggravation of existing arrhythmias; the frequency is unknown - the progression of chronic heart failure (against the background of long-term therapy);
    On the part of the respiratory system: often - cases of development of alveolar or interstitial pneumonitis, obliterating bronchiolitis with pneumonia (sometimes fatal), pleurisy, pulmonary fibrosis, severe shortness of breath or dry cough with symptoms of worsening general condition (increased fatigue, weight loss, increased body temperature ) or without; frequency unknown - pulmonary hemorrhage;
    On the part of the digestive system: very often - nausea, vomiting, decreased appetite, decreased taste or loss of taste, a feeling of heaviness in the epigastrium (especially at the beginning of use, after lowering the dose passes), isolated abrupt disruption 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, pseudo-alcoholic 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;
    On the part of the skin: very often - photosensitization; often - transient skin pigmentation (with prolonged therapy); very rarely - erythema, skin rash, alopecia, exfoliative dermatitis (the connection with Cordaron has not been confirmed);
    From the nervous system: often - extrapyramidal symptoms (tremors), sleep disturbances, nightmares; rarely - myopathy and / or peripheral neuropathies (sensorimotor, mixed, motor); very rarely - cerebellar ataxia;
    Endocrine disorders: often - hypothyroidism (with a high level of thyroid-stimulating hormone (TSH) in the blood serum, it is necessary to cancel the drug), hyperthyroidism; very rarely - syndrome of impaired secretion of antidiuretic hormone;
    Others: very rarely - epididymitis, vasculitis, impotence (the connection with amiodarone has not been confirmed), hemolytic anemia, thrombocytopenia, aplastic anemia.
The use of Cordaron in the form of a solution causes undesirable effects:
    From the side of the cardiovascular system: often - a moderate and transient decrease in blood pressure (BP); very rarely - proarrhythmogenic effect, progression of heart failure, rush of blood to the skin of the face (with intravenous jet injection);
    Immune system disorders: very rarely - anaphylactic shock; frequency unknown - angioedema;
    From the respiratory system: very rarely - shortness of breath, cough, interstitial pneumonitis;
    On the part of the skin: very rarely - increased sweating, a feeling of heat;
    From the digestive system: very often - nausea; very rarely - an increase or decrease in the activity of liver enzymes in the blood (isolated), acute liver damage (sometimes fatal);
    Reactions at the injection site: often - pain, edema, induration, erythema, necrosis, infiltration, extravasation, inflammation, phlebitis (including superficial), thrombophlebitis, cellulitis, pigmentation, infection.


Special instructions

Cordaron should only be taken as directed by a doctor!
Side effects of Cordaron are dose-dependent, therefore, treatment should be carried out with the minimum effective doses.
During the period of use of the drug, patients should avoid exposure to direct sunlight.
The appointment of the drug should be made taking into account the data of the ECG and blood tests to determine the potassium content. Correction of hypokalemia should be completed before starting treatment. Treatment should be accompanied by regular monitoring of the ECG (1 time in 3 months) and liver function indicators.
Patients with and without thyroid diseases, before starting therapy with amiodarone, during treatment and for several months after discontinuation of Cordaron, should undergo laboratory and clinical examination of the thyroid gland.
In case of suspicion of functional disorders, it is necessary to determine the level of TSH in the blood serum.
The iodine content in the preparation does not affect the reliability of determining the level of TSH, T3 and T4 hormones in the blood plasma, but it can distort the results of a radioisotope study of the thyroid gland.
During the period of use of the drug, patients should undergo an X-ray examination of the lungs and pulmonary functional tests every 6 months.
During long-term therapy of patients with a pacemaker or an implanted defibrillator, it is necessary to regularly monitor the correctness of their functioning.
With the appearance of AV block of the 1st degree, it is necessary to strengthen supervision. In case of development of sinoatrial blockade, AV-blockade of II and III degrees or two-beam intraventricular blockade, treatment should be discontinued.
An ophthalmological examination should be carried out with an examination of the fundus with a decrease in acuity and the appearance of blurred vision. Patients with optic neuritis or neuropathy that develop while taking amiodarone, further use of Cordaron should be canceled.
Before the operation, it is necessary to inform the anesthesiologist about the intake of the drug Cordaron.
Long-term therapy with Cordaron may increase the hemodynamic risk associated with anesthesia.
In addition, in rare cases, patients immediately after surgery may experience acute respiratory distress syndrome, which requires careful monitoring with mechanical ventilation.
IV jet injection should be carried out for at least 3 minutes, repeated administration is possible only 15 minutes after the first.
Against the background of the introduction of Cordaron, the development of interstitial pneumonitis is possible, therefore, in the event of severe shortness of breath or dry cough, with or without deterioration of the general condition (increased fatigue, fever), the patient should undergo a chest X-ray. If the x-ray picture is disturbed, the drug must be canceled, since the disease can develop pulmonary fibrosis.
It is possible to develop severe acute liver damage with the development of liver failure (sometimes fatal) during the first day of injection, it is necessary to regularly monitor liver function during therapy.
Simultaneous use with verapamil, diltiazem and beta-blockers, except for esmolol and sotalol, is possible only for the prevention of life-threatening ventricular arrhythmias and restoration of cardiac activity after cardiac arrest caused by ventricular fibrillation resistant to cardioversion.
During the period of therapy, patients are advised to refrain from driving vehicles and mechanisms.

Drug interactions

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

Terms and conditions of storage

Keep out of reach of children at temperatures up to 30 ° C.
Shelf life is 3 years.

Terms of sell

You can buy Cordaron without a doctor's prescription.