$14.00
Manufacturer: Slovenia
Treatment with the drug should be started and, as a rule, monitored only in a hospital setting or under the supervision of a specialist.
Treatment of severe cardiac arrhythmias that do not respond to other treatments, or when other treatments cannot be used.
Tachyarrhythmias associated with premature ventricular excitation syndrome (Wolf-Parkinson-White syndrome).
Tachyarrhythmias of all types, including supraventricular, nodular and ventricular tachycardia; flutter and atrial fibrillation ventricular fibrillation; when other medicines cannot be used.
Amiocordin for administration should be used when a rapid response to treatment is required or oral administration of Amiocordin is not possible.
Description
Ingredients
active ingredient: amiodarone hydrochloride;
1 ampoule (3 ml) contains 150 mg amiodarone hydrochloride;
excipients: benzyl alcohol, polysorbate 80, water for injection.
Dosage form
Injection.
Basic physical and chemical properties: transparent, slightly yellowish solution without visible mechanical impurities.
Pharmacotherapeutic group
Class III antiarrhythmic drugs. ATX code C01B D01.
Pharmacodynamics
Amiodarone has antiarrhythmic and antianginal effects and is a class III antiarrhythmic drug according to the Vaughan-Williams classification.
antiarrhythmic properties.
Increase in the third phase of the action potential without affecting the level or frequency of the rise.
An isolated increase in the third phase of the action potential occurs due to a decrease in the passage of potassium through the potassium channel, while no changes occur in the work of the sodium and calcium channels.
Bradycardic action by reducing the automatism of the sinus node. Atropine does not act as an antagonist of this action.
Non-competitively blocks alpha and beta adrenoceptors.
Slows down sinotrial, atrial and nodular conduction, which occurs more intensely in the presence of a high heart rate.
Does not affect ventricular conduction.
Increases the refractory period and reduces myocardial excitability at the atrial, nodular and ventricular levels.
Slows down conduction and lengthens the refractory period of accessory atrioventricular pathways.
There is no negative inotropic effect.
Cardiopulmonary resuscitation in cardiac arrest is associated with ventricular fibrillation resistant to electrical impulse therapy. The safety and efficacy of administering amiodarone to patients experiencing out-of-hospital cardiac arrest due to ventricular fibrillation refractory to electrical impulse therapy was studied in two double-blind trials: the ARREST trial, which compared amiodarone to placebo, and the ALIVE trial, which amiodarone has been compared with lidocaine.
The primary endpoint of both studies was the number of patients surviving at the time of admission to inpatient care.
In the ARREST study, 504 patients who experienced out-of-hospital cardiac arrest due to ventricular fibrillation or pulseless ventricular tachycardia refractory to three or more defibrillations and adrenaline were randomized into 2 groups, in one of which patients were rapidly injected into a peripheral vein with amiodarone at a dose of 300 mg diluted in 20 ml of 5% glucose solution (246 patients) and placebo in another (258 patients). Amiodarone statistically significantly increased the chances of successful resuscitation and hospitalization: among 197 patients (39%) who were alive at the time of hospitalization, there were 44% of patients in the amiodarone group compared with 34% of patients in the placebo group (p = 0.03) .
After adjusting for other predictors of outcome, the adjusted odds ratio for survival to hospital admission for the amiodarone group compared with the placebo group was 1.6 (95% CI: 1.1-2.4; p = 0.02 ). In the amiodarone group, compared with the placebo group, there was a higher incidence of arterial hypotension (59% compared to 48%, p = 0.04) and bradycardia (41% compared to 25%, p = 0.004).
In the ALIVE study, 347 patients with ventricular fibrillation refractory to three or more defibrillations, epinephrine and another defibrillation, or recurrent ventricular fibrillation after an initially successful defibrillation, were randomized to receive amiodarone (5 mg/kg est. body weight, diluted in 30 ml of 5% glucose solution) and the corresponding placebo, which mimicked lidocaine, or in the group receiving lidocaine (1.5 mg / kg at a concentration of 10 m / ml) and the corresponding placebo, which mimicked amiodarone and contained the same solvent (polysorbate 80 ).
Amiodarone significantly increased the chances of successful resuscitation and hospitalization in 347 patients included in the study: 22.8% in the amiodarone group (41 patients out of 180) compared with 12% in the lidocaine group (20 out of 167 patients), p = 0.009. After adjusting for other prognostic factors that influenced survival, the adjusted odds ratio for survival to hospital admission for the amiodarone group compared with the lidocaine group was 2.49 (95% CI: 1.28-4.85; p = 0.007). There was no difference between the two treatment groups in the number of patients requiring treatment for bradycardia with atropine or for low blood pressure with dopamine. as well as differences in the number of patients treated with lidocaine (in addition to treatment prescribed within the study). The number of patients who experienced cardiac arrest after defibrillation and administration of the study drug was statistically significantly higher in the lidocaine group (28.9%) than in the amiodarone group (18.4%), p = 0.04.
Indications
Treatment with Amiocordin (amiodarone hydrochloride) should be started and, as a rule, monitored only in a hospital setting or under the supervision of a specialist.
Treatment of severe cardiac arrhythmias that do not respond to other treatments, or when other treatments cannot be used.
Tachyarrhythmias associated with premature ventricular excitation syndrome (Wolf-Parkinson-White syndrome).
Tachyarrhythmias of all types, including supraventricular, nodular and ventricular tachycardia; flutter and atrial fibrillation ventricular fibrillation; when other medicines cannot be used.
Amiocordin for administration should be used when a rapid response to treatment is required or oral administration of Amiocordin is not possible.
Contraindications
Hypersensitivity to iodine, amiodarone or other components of Amiocordin (amiodarone hydrochloride).
Sinus bradycardia, sinoatrial heart block in the absence of an endocardial pacemaker (artificial pacemaker).
Weak sinus syndrome in the absence of an endocardial pacemaker (risk of sinus arrest).
Violation of AV conduction of a high degree in the absence of an endocardial pacemaker.
Hyperthyroidism – since an exacerbation of the disease is possible while taking amiodarone.
Vascular insufficiency (vascular collapse).
Severe arterial hypotension.
Age up to 3 years (due to the presence of benzyl alcohol).
II and III trimesters of pregnancy.
breastfeeding period.
Simultaneous use with drugs that can cause paroxysmal tachycardia of the torsades de pointes type (with the exception of antiparasitic drugs, antipsychotics and methadone):
- class Ia antiarrhythmic drugs (quinidine, hydroquinidine, disopyramide);
- class III antiarrhythmic drugs (sotalol, dofetilide, ibutilide);
- other drugs such as arsenic compounds, bepridil, cisapride, citalopram, escitalopram, difemanil, intravenous dolasetron, domperidone, dronedarone, intravenous erythromycin, levofloxacin, mequitazine, mizolastine, moxifloxacin, prucalopride, intravenous spiramycin, toremifene, vincamine for intravenous administration (see section “Interaction with other medicinal products and other forms of interaction”);
- telaprevir;
- cobicistat.
These contraindications do not apply to the use of amiodarone for cardiopulmonary resuscitation in cardiac arrest that occurs due to ventricular fibrillation and is resistant to external electrical impulse therapy.
Directions
For reasons related to the dosage form of the drug, Amiocordin (amiodarone hydrochloride) should be used at a concentration of at least 300 mg (2 ampoules) in 500 ml of 5% glucose (glucose) solution. Amiocordin, solution for injection, can only be administered in an isotonic (5%) solution of glucose (glucose).
Do not dilute the drug with isotonic sodium chloride solution, as sedimentation is possible, and do not mix with other drugs in the same infusion system!
Amiocordin (amiodarone hydrochloride), solution for injection should be administered only when the necessary equipment for cardiac control, defibrillation and pacing is available.
Amiocordin (amiodarone hydrochloride), solution for injection can be used before cardioversion with direct current.
Amiocordin (amiodarone hydrochloride) should be administered via a central vein, except in cases requiring the use of cardiopulmonary resuscitation in cardiac arrest due to ventricular fibrillation, which is resistant to external electrical impulse therapy. If the introduction through the central veins is not possible, you can administer the drug through the peripheral veins (see section “Peculiarities of use”).
In severe arrhythmias, when oral administration of the drug is impossible , except for cardiopulmonary resuscitation during cardiac arrest, which occurred due to ventricular fibrillation and is resistant to external electrical impulse therapy, infusion through the central veins.
The loading dose is usually 5 mg/kg of the patient’s body weight and is administered only in isotonic (5%) glucose (glucose) solution, preferably with an electric infusion pump over a time interval of 20 minutes to 2 hours. The introduction can be repeated 2-3 times within 24 hours. Due to the short-term effect of the drug, its maintenance infusion is necessary.
Maintenance dose of 10-20 mg / kg per day (average 600-800 mg to 1.2 g per day) in 250 ml of 5% glucose (glucose) solution for several days. From the first day of infusion, it is necessary to begin the transition to oral administration of the drug (200 mg 3 times a day). If necessary, the dose can be increased to 1200 mg per day.
In the case of cardiopulmonary resuscitation in cardiac arrest that occurs due to ventricular fibrillation and is resistant to external electrical impulse therapy , it is recommended to use a central venous catheter, provided that it is available and ready; otherwise, the drug can be administered through the most peripheral vein with the greatest flow.
The initial intravenous dose is 300 mg (or 5 mg/kg) dissolved in 20 ml of 5% glucose (glucose) solution, the injection should be carried out quickly.
Additional administration of 150 mg amiodarone (or 2.5 mg/kg) is possible if ventricular fibrillation persists.
Do not mix with other drugs in the same syringe.
pediatric population.
The safety and efficacy of amiodarone in children have not been determined. Due to the content of benzyl alcohol, intravenous amiodarone is contraindicated in premature and full-term newborns, infants and children under the age of 3 years
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