Prokainamid-Eskom (Procainamide-Eskom)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceProcainamideProcainamide
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    • Dosage form: & nbspsolution for intravenous and intramuscular administration
    Composition:

    1 ml of the solution contains:

    active substance: procainamide hydrochloride (in terms of procainamide) 100 mg,

    Excipients: sodium disulfite 5.0 mg, water for injection up to 1.0 ml.

    Description:

    Transparent colorless or slightly yellowish liquid.

    Pharmacotherapeutic group:antiarrhythmic drug
    ATX: & nbsp

    C.01.B.A   Antiarrhythmic drugs Ia class

    C.01.B.A.02   Procainamide

    Pharmacodynamics:

    Antiarrhythmic drug IA class. It inhibits the incoming fast current of sodium ions, reduces the rate of depolarization into phase 0. Depresses the conductivity, slows repolarization. Reduces the excitability of the myocardium of the atria and ventricles. Increases the duration of the effective refractory period of the action potential (in the affected myocardium - to a greater extent).The conduction slowdown, which is observed irrespective of the resting potential, is more pronounced in the atria and ventricles, less in the atrioventricular (AV) node.

    Indirect M-holinoblokiruyuschy effect, compared with quinidine and disopyramide, is less, so the paradoxical improvement AV conductivity is usually not noted.

    It affects the depolarization phase 4, reduces the automatism of the intact and affected myocardium, inhibits the function of the sinus node and ectopic rhythm drivers in some patients.

    Active metabolite - N-acetylprocainamide (N-APA) has a pronounced activity of antiarrhythmic drugs of the III class, lengthens the duration of the action potential.

    Has a weak negative inotropic effect (without a significant effect on the minute volume of blood). It has vagolytic and vasodilating properties, which causes tachycardia and lowering of arterial pressure (BP), total peripheral vascular resistance (OPSS).

    Electrophysiological effects are manifested in the broadening of the complex QRS and lengthening intervals PQ and QT. Time to achieve the maximum effect for intravenous administration (IV) - immediately, with intramuscular (IM) - 15-60 minutes.

    Pharmacokinetics:

    Penetrates through the blood-brain barrier, it is secreted with breast milk. Metabolized in the liver with the formation of an active metabolite - N-acetyl-procainamide, has the effect of a "first pass". About 25% of the administered procainamide is converted into the specified metabolite, but with rapid acetylation or chronic renal failure (CRF), 40% dose. With CRF or chronic heart failure, the metabolite quickly accumulates in the blood to toxic concentrations, while the concentration of procainamide remains within acceptable limits.

    Half-life is 2.5-4.5 hours; with CRF - 11-20 hours; N-acetylprokainamide - about 6 hours. About 25% of the injected drug is excreted by the kidneys (50-60% unchanged), with bile.

    Indications:

    Ventricular arrhythmias: ventricular tachycardia, ventricular extrasystole.

    Atrial tachycardia, flicker and / or atrial flutter.

    Contraindications:

    Hypersensitivity to the drug; ventricular arrhythmia caused by intoxication with cardiac glycosides, sinoatrial and atrioventricular blockade II-III degree (in the absence of an implanted pacemaker),chronic heart failure in the stage of decompensation, arterial hypotension, cardiogenic shock, systemic lupus erythematosus (including in the anamnesis), the period of breastfeeding, ventricular tachycardia of the "pirouette" type, an extended interval QT, leukopenia, age under 18 years (efficacy and safety not established), flutter or fibrillation of the ventricles.

    Carefully:

    In connection with a possible reduction in myocardial contractility and a decrease in blood pressure, caution should be given to prescribing with myocardial infarction. Perhaps the arrhythmogenic effect.

    Myocardial blockade of the first bundle, myasthenia gravis, bronchial asthma, hepatic and / or renal failure, chronic heart failure, ventricular tachycardia with occlusion of the coronary artery, surgical interventions (including surgical dentistry), severe atherosclerosis, elderly age .

    Pregnancy and lactation:

    Apply only if the benefit to the mother exceeds the potential risk to the fetus / child.

    When prescribing the drug during pregnancy, there is a potential risk of developing arterial hypotension in the mother,which can lead to uteroplacental insufficiency.

    Dosing and Administration:

    Intravenously: 100-500 mg at a speed of 25-50 mg / min (under the control of blood pressure and electrocardiograms (ECG)) to stop paroxysm (maximum dose - 1 g) or intravenously drip: 500-600 mg for 25-30 minutes. The maintenance dose for intravenous drip infusion is 2-6 mg / min., If necessary, start taking the drug inside 3-4 hours after stopping the infusion.

    With heart failure II the degree of dose is reduced (by 1/3 or more). Intramuscularly inject 5-10 ml (up to 20-30 ml per day). With intravenous administration, the drug is diluted in a 5% glucose solution or 0.9% sodium chloride solution. The rate of administration should not exceed 0.05 g / min. In this case, a constant monitoring of the heart rate, blood pressure and ECG is necessary.

    The highest dose for adults with intramuscular and intravenous (drip) introduction: single-dose - 1 g (10 ml of the drug), daily - 3 g (30 ml of the drug). When switching to taking the drug inside, the first dose is prescribed 3-4 hours after the cessation of IV infusion.

    Side effects:

    From the central nervous system: general weakness, - hallucinations, depression, myasthenia gravis, dizziness, headache, insomnia, convulsions, psychotic reactions with productive symptoms, ataxia.

    From the digestive system: bitter taste in the mouth, diarrhea, nausea, vomiting.

    From the side of the cardiovascular system: reduction of blood pressure, ventricular paroxysmal tachycardia.

    From the sense organs: a taste disorder.

    With rapid on / in the introduction of possible collapse, violation of atrial or intraventricular conduction, asystole.

    Allergic reactions: skin rash.

    Overdose:

    Symptoms: the drug has a small therapeutic latitude, so severe intoxication can easily occur (especially with the use of other anti-arrhythmic agents): bradycardia, sinoatrial and atrioventricular blockades, asystole, lengthening of the interval Q-T, paroxysms of polymorphic ventricular tachycardia, decreased myocardial contractility, persistent arterial hypotension, pulmonary edema, convulsions, coma, respiratory arrest.

    Treatment: hemodialysis. With a decrease in blood pressure - the administration of norepinephrine or phenylephrine. To treat ventricular tachycardia caused by an overdose of procainamide, do not use antiarrhythmics IA or IC classes. Sodium bicarbonate can eliminate the expansion of the complex QRS or arterial hypotension.

    Interaction:

    Strengthens the effect of antiarrhythmic, hypotensive, anticholinergic and cytostatic agents, muscle relaxants, side effects of brethil tosylate.

    With simultaneous use with antihistamines, atropine-like effects can be enhanced; with pimozode - lengthening of the interval Q-T.

    Reduces the activity of antimiasthenic drugs.

    Cimetidine, ranitidine reduce renal clearance of procainamide and prolong the half-life.

    When combined therapy with antiarrhythmic drugs III class risk of arrhythmogenic effect increases.

    Medicines, which inhibit bone marrow hematopoiesis, increases the risk of myelosuppression.

    Special instructions:

    Before / in the application must be diluted, injected at a rate of not more than 50 mg / min; should be used only in a hospital.

    When carrying out therapy, it is necessary to carry out constant monitoring of blood pressure, ECG, peripheral blood formulas (at the end of therapy).

    In elderly patients, the development of arterial hypotension is more likely.

    Form release / dosage:

    Solution for intramuscular and intravenous administration, 100 mg / ml.

    Packaging:

    5 ml of the drug in ampoules.

    For 5 or 10 ampoules in contour cell packs from a polyvinyl chloride film.

    For 1 or 2 outline carton packs along with instructions for use in a cardboard pack.

    Storage conditions:

    In the dark place at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    5 years.

    Do not use after the expiry date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LSR-004346/09
    Date of registration:01.06.2009
    The owner of the registration certificate:ESKOM NPK, OAO ESKOM NPK, OAO Russia
    Manufacturer: & nbsp
    Representation: & nbspESKOM NPK, OAOESKOM NPK, OAO
    Information update date: & nbsp04.09.2015
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