Rotarymil 200 mg tablets No. 30 *

Author Ольга Кияница

2017-05-11

Amount in a package 30
Product form Pills
Manufacturer Rivopharm (Switzerland-Netherlands)
Registration certificate UA/12887/01/01
The main medicament Rotarythmil
morion code 167783

Rotarylmil (ROTARITMIL) instructions for use

Composition

active ingredient: amiodarone hydrochloride; 1 tablet contains amiodarone hydrochloride 200 mg
auxiliary substances: corn starch, lactose monohydrate, povidone (K90), magnesium stearate, silicon dioxide colloid, corn starch.

Dosage form

Pills.

Pharmacological group

Cardiological preparations. Antiarrhythmic drugs of the III class . The code of automatic telephone exchange С01B D01.

Indications

  • Tachyarrhythmias associated with Wolff-Parkinson-White syndrome;
  • flutter and fibrillation of the ventricles, when it is impossible to use other drugs;
  • all types of paroxysmal tachycardia, including supraventricular, nodal and ventricular tachycardia, atrial fibrillation, when other drugs can not be used.
  • The tablet form of the drug is used only to treat severe rhythm disturbances that pose a danger to the life of the patient and are resistant to other medications or if other drugs are contraindicated.

Treatment should be started and monitored only in a hospital or under the supervision of a specialist.

Contraindications

  • Hypersensitivity to the components of the drug and iodine
  • sinus bradycardia, sinoatrial blockade, except when an artificial pacemaker is connected (danger of stopping the sinus node);
  • blockade of II-III degree and blockade of the legs of the bundle of His (in the absence of a pacemaker);
  • congenital or acquired lengthening of the QT interval;
  • severe heart failure
  • severe arterial hypotension, collapse, shock
  • simultaneous administration with drugs that can prolong the QT interval and induce the development of paroxysmal tachycardias, including polymorphic ventricular torsade de pointes (pirouette)
  • interstitial lung disease,
  • simultaneous administration of MAO inhibitors;
  • thyroid dysfunction (hypo- and hyperthyroidism)
  • hypokalemia, hypomagnesemia;
  • During pregnancy and breastfeeding.

Dosing and Administration

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

Rotarmitil is taken orally before meals and with plenty of water.

Adults.

Dose of saturation.

Treatment usually begins with 200 mg (1 tablet) 3 times a day for a week, reducing the dose to 200 mg twice a day for the next week.

Supportive dose.

Use the minimum effective dose, depending on the patient's response to the drug. After the saturation period, the dose can be reduced to 200 mg or 100 mg per day. Occasionally, the patient may require a higher maintenance dose. The maintenance dose should be regularly reviewed, especially if it exceeds 200 mg per day.

Too high doses with maintenance therapy can cause side effects, which are believed to be associated with high levels of amiodarone and its metabolites in the body tissues.

Since Rotarythmil has a very long half-life, it can be taken every other day (200 mg can be taken every other day, and 100 mg is recommended daily). You can take breaks in taking the drug 2 days a week. The mode of taking the drug is determined individually.

Patients of advanced age.

As for all patients, it is very important to apply the minimum effective dose. Elderly patients may show increased sensitivity to the action of Rotarythmil even with the administration of usual doses of the drug. Particular attention should be paid to monitoring the function of the thyroid gland.

Adverse Reactions

Adverse reactions, listed below, are classified by organs and systems and frequency of occurrence: very often (≥ 10%);often (≥ 1% and <10%); infrequently (≥ 0.1% and <1%); rarely (≥ 0.01% and <0.1%); very rarely (<0.01%).

From the cardiovascular system:

often: a bradycardia (mostly of moderate severity and dose-dependent) infrequently - the development or intensification of arrhythmias, sometimes to cardiac arrest; conduction disruption (sinoatrial blockade, AV blockade of various degrees). In general, these adverse reactions may occur with simultaneous use with drugs that prolong the period of repolarization of the ventricles of the heart or in cases of electrolyte balance disorders;
very rarely expressed bradycardia and, in exceptional cases, stopping the sinus node, which requires the withdrawal of treatment, especially in elderly people and / or in patients with sinus node dysfunction; vasculitis.

On the part of the organs of vision:

Very often, microdeposition in the epithelium of the cornea, usually in the area under the pupil, consisting of complex fat layers, disappear after the drug is discontinued and do not require discontinuation of treatment. Sometimes they can cause visual disturbances in the form of a color halo or fuzziness of contours in bright light;
very rarely neuritis / neuropathy of the optic nerve, therefore, when blurred vision or reduced visual acuity amiodarone is recommended to conduct a complete ophthalmological examination, including fundoscopy, and in case of optic neuritis, stop taking the drug.

From the digestive system:

very often: nausea, vomiting, loss of appetite, dullness or loss of taste, a feeling of heaviness in the epigastric region, especially at the beginning of treatment, disappears after a dose reduction.
Blood and lymphatic system:

Very rarely hemolytic anemia, aplastic anemia, thrombocytopenia
in patients taking amiodarone, there were cases of development of bone marrow granulomas. The clinical significance of this is unknown.

Hepatobiliary system:

Very often an isolated increase in the activity of transaminases in the serum at the beginning of treatment, usually moderate (1.5-3 times higher than normal). Normalization of these indicators occurs with a decrease in the dose or even spontaneously;
often: acute violations of the liver (including liver failure), sometimes lethal, with high levels of transaminase activity in the serum and / or jaundice. With a significant increase in the level of transaminases, treatment should be discontinued.During the treatment with amiodarone, periodic monitoring of liver function
very rarely chronic liver disease (pseudo-alcoholic hepatitis, cirrhosis), sometimes with a fatal outcome.

From the respiratory system:

Often: toxic effects on lung tissue, sometimes fatal (hypersensitive pneumonitis, alveolar / interstitial pneumonitis or fibrosis, pleurisy, obliterating bronchiolitis associated with pneumonia). Pulmonary disorders, mainly reversible with early withdrawal of the drug. Clinical symptoms usually disappear within 3-4 weeks, and then a slower recovery of the radiographic pattern and lung function (within a few months). Therefore, in such cases it is necessary to consider the necessity of amiodarone abolition and the expediency of prescribing SCS;
very rarely bronchospasm in patients with severe respiratory failure, especially in patients with bronchial asthma; acute respiratory distress syndrome, sometimes with a fatal outcome, most often immediately after surgery (possibly after interaction with high doses of oxygen).

Cases of pulmonary hemorrhage have been reported (the exact frequency is unknown).

Endocrine disorders:

often: hypothyroidism, hyperthyroidism, sometimes fatal;
very rarely the syndrome of inadequate secretion of ADH (SIADH).

From the skin:

very often photosensitization;
often: grayish or bluish pigmentation of exposed skin, especially in cases of prolonged treatment with high doses of the drug after discontinuation of treatment, this pigmentation slowly disappears (within 10-12 months)
very rarely erythema during radiotherapy; rashes, usually nonspecific; exfoliative dermatitis alopecia
urticaria (frequency is unknown).

From the nervous system:

often: tremor or other extrapyramidal symptoms, sleep disorders, in particular nighttime delirium;
infrequently sensorimotor, motor and mixed peripheral neuropathy and / or myopathy, usually reversible after drug withdrawal
very rarely cerebellar ataxia, benign intracranial hypertension (pseudotumor of the brain), headache, dizziness.

The immune system:

angioedema (there were several reports, the exact frequency is unknown).

Reproductive system:

very rarely epididymitis, orchitis, impotence.

Overdose

When signs of an overdose appear, it is usually sufficient to reduce the dose of the drug or temporarily stop taking it.

In the case of simultaneous administration of a large dose of the drug, liver dysfunction, sinus bradycardia, cardiac arrest, attacks of ventricular tachycardia, paroxysmal tachycardia of the pirouette type may be noted. Possible slowing of AV-conduction, worsening of the existing heart failure.

Treatment: gastric lavage and reception of activated charcoal in case the drug was taken recently. There is no specific antidote. Amiodarone and its metabolites are removed during dialysis. In other cases, treatment is symptomatic. With the development of bradycardia, the appointment of beta-adrenoreceptors or installation of a pacemaker, with tachycardia such as "pirouette" - the introduction of magnesium salts or pacing.

Given the pharmacokinetic profile of amiodarone, it is recommended to monitor the patient's condition (especially cardiac fainting) for a long time.

Amiodarone and its metabolites are excreted by hemodialysis.

Use during pregnancy and lactation

During pregnancy, Rotarythmil is prescribed only in exceptional cases and according to vital indications, since the drug affects the thyroid gland of the fetus.

If you need to use the drug during breastfeeding, you should stop breastfeeding.

Children

For children (under the age of 18 years), the effectiveness and safety of Rotarythmil is not established.

Special security measures

Patients with impaired tolerance to carbohydrates, such as congenital galactosemia, glucose-galactose malabsorption syndrome, lactase deficiency, contraindicated its use because of the content of lactose in the preparation.

Amiodarone can cause serious adverse reactions from the organs of vision, heart, lungs, liver, thyroid, skin, peripheral nervous system. Since the occurrence of these reactions may be delayed in time, the condition of patients with prolonged treatment should be carefully monitored. Also, given that adverse events are dose-dependent, minimal effective doses should be used with maintenance therapy.

Before a surgical operation, it is necessary to warn the anesthesiologist that the patient has received / receives amiodarone (threat of respiratory distress syndrome).

To prevent undesirable effects, it is necessary to carefully prescribe concomitant therapy, taking into account the clinically significant interactions of amiodarone.

Application features

It should be used with caution elderly people, patients receiving cardiac glycosides, because of the risk of developing severe bradycardia, severe conduction disorders with the possible occurrence of idioventricular rhythm, especially when using high doses. If such conditions occur, treatment with Rotarhythm should be discontinued, beta-adrenomimetics or glucagon may be used, and if necessary, cardiac stimulation.

After a long half-life of amiodarone, if the bradycardia is severe, you need to consider the feasibility of connecting an artificial pacemaker.

The use of the tablet form of amiodarone is not contraindicated for latent or manifesting heart failure, but caution should be exercised, as existing heart failure may worsen. In such cases, Rotaritmil should be used in conjunction with appropriate drugs.

Amiodarone treatment may include changes in the ECG: prolongation of the QT interval (due to prolongation of repolarization), appearance of the U wave, deformation of the T wave. These changes are not a manifestation of the toxicity of the preparation.

In elderly patients, a significant reduction in heart rate is possible.

Treatment with the drug should be discontinued in the event of AV blockade II or III degree, sinoatrial blockade or bifascicular blockade.

Amiodarone shows a low proarrhythmic effect, which manifests itself mainly when used with drugs that prolong the period of repolarization of the ventricles or in cases of electrolyte balance disorders (especially with hypokalemia).Violation of electrolyte balance is desirable to adjust before treatment Rotaritmil. There were reports of the occurrence of new arrhythmias or the intensification of pre-existing arrhythmias, sometimes lethal.

Before the start of treatment, each patient should conduct an ECG, determine the level of potassium in the blood plasma. It is recommended that ECG monitoring be performed during treatment.

Amiodarone may cause a defibrillation threshold and / or a pacing threshold in patients with implanted cardioverter-defibrillators or pacemakers, which can adversely affect the effectiveness of the device. It is recommended to carry out regular tests to ensure proper functioning of the device after the start of treatment or changing the dosage.

Amiodarone can cause thyroid dysfunction (hypothyroidism, hyperthyroidism), especially in patients with a history of dysfunction (including family history), in elderly patients. Therefore, before the start of treatment, during treatment (every 6 months) and for several months after completion of treatment, it is necessary to conduct a thorough clinical and laboratory monitoring of thyroid function.

If thyroid dysfunction is suspected, TSH serum levels should be measured.

In life-threatening situations, when hypothyroidism occurs, amiodarone treatment can be prolonged in combination with levothyroxine, the dose of which is adjusted in accordance with the levels of thyroid hormones. The euthyroid condition, as a rule, is restored 3 months after the cessation of amiodarone treatment.

Hyperthyroidism may occur during treatment with amiodarone or several months after its termination. Reported cases of lethal flow of hyperthyroidism, so when it occurs amiodarone needs to be canceled. Clinical recovery depended for several months.

In cases of severe thyroid hyperactivity, it is necessary to consider the advisability of using antithyroid drugs, possibly in combination with corticosteroids.

Rotarythmil contains iodine, so it can influence the results of tests of accumulation of radioactive iodine in the thyroid gland, but does not affect the level of hormones T3, T4, TTG.

In the case of impaired vision or visual acuity, a complete ophthalmologic examination, including examination of the fundus, should be carried out immediately. It is necessary to stop taking amiodarone in case of appearance of neuropathy and / or optic neuritis caused by amiodarone, since there is a risk of their progression to complete blindness.In the future, an annual ophthalmological examination of such patients is recommended.

Reception of amiodarone can cause different reactions from the liver, including cirrhosis, hepatitis, jaundice and severe hepatocellular insufficiency, sometimes fatal (mainly with prolonged therapy, especially after amiodarone administration in the first 24 hours). Therefore, prior to treatment, during treatment with Rotarhythm, it is recommended that the liver function (transaminase activity) be checked regularly (every 6 months) for early detection of its damage. With a significant increase in the level of transaminases, treatment should be discontinued.

At the beginning of treatment, an isolated increase in the activity of transaminases in the blood serum is possible, usually moderate (1.5-3 times higher than normal). Normalization of these indicators occurs with a decrease in the dose or even spontaneously.

It has been reported chronic liver disease when treated with a drug for more than 6 months (pseudo-alcoholic hepatitis, cirrhosis). Clinical symptoms and laboratory changes may be minimal (possible hepatomegaly, transaminase level, increased 1.5-5 times compared with normal). Therefore, during the treatment, regular monitoring of liver function is recommended. Clinical and laboratory anomalies usually decrease after drug withdrawal, however, a lethal outcome was reported rarely.

It is not desirable to drink alcohol during treatment with Rotarythmil, although there have been no reports of potentiation of negative effects on the liver.

Amiodarone can cause the appearance of peripheral sensorimotor neuropathy and / or myopathy with prolonged use, usually reversible after drug withdrawal. However, the recovery may be incomplete, very slow, and only a few months after drug withdrawal.

The appearance of dyspnea and nonproductive cough may be related to expression of toxicity of amiodarone respiratory system (hypersensitivity pneumonitis, alveolar / interstitial pneumonitis or fibrosis, pleuritis, bronchiolitis obliterans with pneumonia).

Patients who develop shortness of breath or cough productive, both alone and with the deterioration of the general condition (fatigue, weight loss, fever), carry chest radiography and, if necessary, to remove the drug.

Such cases pneumopathy may lead to pulmonary fibrosis, but they are mostly reversible with early cancellation of amiodarone as the application of corticosteroids with or without them. Clinical symptoms usually disappear within 3-4 weeks, and then there is a slow recovery radiographic and lung function (for several months).

In some cases, pleural effusion can be observed associated with interstitial pneumonia.

In patients with severe respiratory failure and especially in asthmatic patients and in some cases may occur bronchospasm.

In some cases, patients receiving amiodarone observed acute distress syndrome immediately after surgery (possible incompatibility with a high concentration of oxygen). When using the mechanical ventilation is recommended careful monitoring of such patients.

Not recommended for use Rotaritmil with beta-blockers (except esmolol, and sotalol), certain calcium channel blockers (verapamil, diltiazem injectable form), laxatives that stimulate bowel motility and can cause hypokalaemia. Also, while the use of flecainide Rotaritmilom is necessary, given the increase in the plasma level of the latter, respectively, to reduce the dose of flecainide and carefully monitor the patient's condition.

During treatment with amiodarone is not recommended to consume grapefruit juice because of the risk of increased blood concentrations of amiodarone.

The ability to influence the reaction rate when driving vehicles or other mechanisms

During treatment Rotaritmilom advisable to refrain from driving and potentially hazardous activities that require high concentration and speed of psychomotor reactions.

Interaction with other drugs and other interactions

Contraindicated in combination with drugs able to induce a polymorphic ventricular tachycardia type "pirouette" (torsade de pointes) (when combined with amiodarone increased risk of potentially lethal ventricular tachycardia type "pirouette"):

  • antiarrhythmic agents: class 1A (quinidine, gidrohinidin, disopyramide, procainamide), class III (dofetilide, ibutilide, bretylium tosylate), sotalol;
  • other (neprotiaritmichni) drugs such as bepridil; vincamine; some neuroleptics: phenothiazines (Chlorpromazine, tsiamemazin, levomepromazine, thioridazine, trifluoperazine, fluphenazine) benzamide (amisulpride, sultopride, sulprid, tiapride, veraliprid) butirofenonov (droperidol, haloperidol), sertindole, pimozide; tricyclic antidepressants; cisapride; macrolide antibiotics (erythromycin when administered intravenously, spiramycin) azoles; antimalarials (quinine, chloroquine, mefloquine, halofantrine, Lumefantrine) Pentamidine when administered parenterally; difemanil methyl sulfate; mizolastine; astemizole; terfenadine; fluoroquinolones (particularly moxifloxacin).

non-recommended combination

with beta-blockers, blockers "slow" calcium channels that slow the heart rate (verapamil, diltiazem), because of the risk of violations of automatism (severe bradycardia) and conduction
with laxatives, stimulating peristalsis agents that can cause hypokalemia, which increases the risk of ventricular tachycardia type "pirouette". In combination with amiodarone should be used laxatives other groups.

Combinations requiring caution when using

With drugs capable of causing hypokalemia: diuretics, causing hypokalemia (monotherapy or in combination), amphotericin B (a), systemic glucocorticosteroids tetrakozaktid. Increased risk of ventricular arrhythmias, especially ventricular tachycardia type "pirouette" (hypokalaemia is a predisposing factor). Necessary to monitor the level of electrolytes in the blood, if necessary - correction of hypokalaemia and continuous clinical and electrocardiographic monitoring the patient. In the case of ventricular tachycardia type "pirouette" should not apply antiarrhythmics (ventricular pacing should be initiated, possibly administration of magnesium salts).
With procainamide: Amiodarone may increase the concentration of procainamide and its metabolite N-acetylprocainamide plasma may increase the risk of side effects of procainamide.
With indirect anticoagulants: the combination of warfarin with amiodarone may increase the effect of indirect anticoagulants, which increases the risk of bleeding. Prothrombin time must be monitored frequently (MHS) and perform correction of both doses of anticoagulant during treatment with amiodarone and after its cancellation.
With cardiac glycosides (preparations of Digitalis): possibility of automatism disorders (bradycardia) and atrioventricular conduction. In addition, with the combination of digoxin with amiodarone may increase digoxin concentrations in plasma (due to lower its clearance). Therefore, in combination with digoxin amiodarone is necessary to determine the concentration of digoxin in blood and to control the possible clinical and electrocardiographic glycosides digitalis intoxication. You may need to reduce the dose of digoxin.
With esmolol: impaired contractility, automaticity and conduction (inhibition of compensatory reactions of the sympathetic nervous system). Requires clinical and ECG monitoring.
Phenytoin and C, respectively, fosphenytoin: when combined with phenytoin amiodarone may develop phenytoin overdosing that can lead to the appearance of neurological symptoms. Requires clinical monitoring and, when the first signs of overdose, reduced doses of phenytoin, phenytoin desirable definition plasma concentrations.
With flecainide: amiodarone, flecainide increases the concentration in plasma, and therefore the correction required doses flecainide.
With drugs which are metabolized via the cytochrome P450 ZA4: these drugs may increase the plasma concentration that may lead to increased toxicity and / or enhance the pharmacodynamic effects and may require a reduction of their doses:
cyclosporine - may increase cyclosporine nephrotoxicity. Necessary to determine the concentration of cyclosporine in the blood, kidney function control and treatment regimens correction cyclosporin during treatment with amiodarone and after drug withdrawal

Fentanyl - combination with amiodarone may enhance the pharmacodynamic effects of fentanyl and increase the risk of its toxic effects.

Other drugs which are metabolized via CYP ZA4: lidocaine - risk of sinus bradycardia and neurological symptoms), tacrolimus (risk of nephrotoxicity), sildenafil (risk of increased side effects of sildenafil), midazolam (risk of psychomotor effects), triazolam, dihydroergotamine, ergotamine, simvastatin and other statin drugs, which are metabolized via CYP ZA4 (increased muscle the risk of toxicity, rhabdomyolysis, and therefore the simvastatin dose should not exceed 20 mg per day should be at its ineffectiveness to transfer the patient to receive another statin not metabolized via CYP ZA4).

Since orlistat: a risk reduction of the concentration of amiodarone and its active metabolite in the blood plasma. There should be a clinical and, if necessary, ECG monitoring.
With clonidine, guanfacine, cholinesterase inhibitors (donepezil, galantamine, rivastigmine, tacrine, ambenonium chloride, pyridostigmine, neostigmine bromide), pilocarpine: risk of excessive bradycardia (cumulative effects).
With cimetidine, grapefruit juice: amiodarone slowing metabolism and increasing its concentration in the plasma, may increase the pharmacodynamic and side effects of amiodarone.
With preparations for inhalation anesthesia: there is the possibility of severe complications in patients taking amiodarone when administered to them general anesthesia: bradycardia (resistant to atropine), hypotension, conduction disturbances, decreased cardiac output. There were very rare cases of severe complications of the respiratory system.
With radioactive iodine: amiodarone may interfere with the absorption of radioactive iodine, can distort the results of radioisotope studies of the thyroid gland.
With Rifampicin: in the combined use with amiodarone it can reduce the concentration of amiodarone and dezetilamiodarona plasma.
With drugs Hypericum: theoretically possible reduction in plasma concentration of amiodarone and its reduction effect (clinical data available).
With HIV inhibitors (including indinavir) while the use of amiodarone can increase the concentration of amiodarone in the blood.
Since clopidogrel: may reduce the effectiveness of clopidogrel.
Dextromethorphan: theoretically amiodarone can increase the concentration of the dextro-metorfanu plasma.

Pharmacological properties

Pharmacodynamics. Rotaritmil is the main representative of the class III antiarrhythmic drugs (class repolarization inhibitors) performs antiangialny, koronarorozshiryuyuchy, alpha- and beta-adrenoceptor blocking effect.

The mechanism of action caused by the blockade of amiodarone ion channels of cell membranes cardiomyocytes (mainly potassium, very slightly - calcium and sodium), a decrease in the sinus node automaticity and noncompetitive inhibition of α- and β-adrenergic activity.

Antiarrhythmic effect of amiodarone due to its ability to significantly prolong action potential (phase 3) and thus prolong the refractory periods and to reduce the excitability of the myocardium of the atria and ventricles, increase the duration of refractory periods in the additional beams atrioventricular conducting, AV-node leads to a decrease sinus node automaticity, slow impulse conduction in all portions of the cardiac conduction system (sinoatrialnuyu slows, atrial, and AV-wire Bridges), a decrease of excitability. In this case there are no changes in ventricular conduction.

Antianginal effect of the drug due to a decrease in myocardial oxygen demand (by reducing the frequency of heart beat heart rate and moderate reduction in peripheral resistance) and an increase in coronary blood flow due to the direct effect on the smooth muscles of the coronary arteries. It supports cardiac output, reducing the pressure in the aorta and peripheral vascular resistance.

Preparation somewhat reduces peripheral vascular resistance and systemic arterial pressure; does not exercise significant influence on the myocardial contractility. Absence of negative inotropic effect allows the use Rotaritmil in heart failure.

In its structure, amiodarone similar thyroid hormones and the drug affects the exchange of thyroid hormones inhibits the conversion TK T4 (block thyroxine-5-deiodinase) and blocking capture these hormones kardiotsitamy and hepatocytes, which leads to a weakening of the stimulating effect of thyroid hormones on the myocardium.

Pharmacokinetics. Pharmacokinetics is characterized by significant individual variations.

After ingestion, amiodarone is slowly absorbed, bioavailability varies between 30-80% (an average of about 50%). After a single dose, the maximum concentration in the blood plasma is reached after 3-7 hours. However, the therapeutic effect usually develops one week after the start of the drug (from several days to two weeks). Amiodarone is inherent in a large enough and varying volume of distribution due to extensive accumulation in various tissues (fatty tissue, intensively perfused organs such as the liver, lungs and spleen). Excretion begins in a few days, a stable concentration in the blood plasma is reached within one or several months. Amiodarone is metabolized in the liver. Its main metabolite, desethylamiodarone, is pharmacologically active and can enhance the antiarrhythmic effect of the main compound.Amiodarone inherent in a long half-life with a significant individual variability (therefore, when choosing a dose, for example, increasing or decreasing it, it should be remembered that at least 1 month must pass to stabilize a new concentration of amiodarone in the plasma). Amiodarone is mainly excreted with bile and feces. Excretion in the urine is insignificant, which makes it possible to prescribe the drug in usual doses to patients with renal insufficiency.Amiodarone and its metabolites are excreted during hemodialysis.

Taking into account the peculiarities of pharmacokinetics in order to obtain a therapeutic effect, an initial saturating dose should be used to ensure the accumulation of the drug in the tissues. The presence of a cumulative effect provides a duration of action within 10-45 days after discontinuation of treatment.

Each dose of amiodarone (200 mg) contains 75 mg of iodine. Part of the iodine is released from the drug and found in the urine in the form of iodide (6 mg per 24 hours with a daily dose of amiodarone 200 mg). A significant portion of the iodine remains in the drug being excreted with feces after passing through the liver, however with prolonged administration of amiodarone iodine concentrations can reach 60-80% of the concentration of amiodarone.

Basic physical and chemical properties

Round tablets of white color with a resolution of a dash.

Shelf life

3 years. Do not use after the expiration date.

Storage conditions

Store at a temperature not exceeding 30 ° C in a place inaccessible to children.

Packaging

10 tablets in a blister pack. For 3 blisters in a cardboard box.

Category of leave

On prescription.


0.00 avg. rating (0% score) - 0 votes - votes