Novokainamide (Novocainamide)

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 preparation contains:

    active substance: novocaineamide (procainamide hydrochloride) 100 mg;

    Excipients: sodium disulfite (sodium metabisulphite) 5 mg, water for injection up to 1 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, expressed 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 antiarrhythmic activity, lengthens the duration of the action potential. Has a weak negative inotropic effect (without a significant effect on the minute volume of blood (IOC)). Has m-holinoblokiruyuschee and vazodilatiruyuschee effect, which causes tachycardia and lowering blood pressure (BP), a common 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 with intravenous administration - immediately,when intramuscular - 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 "first passage" through the liver. 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.

    The half-life is 2.5-4.5 h; with CRF - 11-20 hours; N-acetylprocainamide for about 6 hours. About 25% injected drug is excreted by the kidneys (50-60% in unmodified form), and through the intestine with bile.

    Indications:

    Ventricular arrhythmias: ventricular tachycardia, ventricular extrasystole.

    Atrial rhythm disturbances: atrial tachycardia, atrial fibrillation and 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), arterial hypotension, cardiogenic shock; ventricular tachycardia of the "pirouette" type, an elongated interval QT, leukopenia, age under 18 years (efficacy and safety not established).

    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.

    Blockade of the bundle legs, Atrioventricular block of the 1st degree, chronic heart failure in the stage of decompensation, myasthenia gravis gravis, bronchial asthma, hepatic and / or renal failure, ventricular tachycardia with occlusion of the coronary artery, systemic lupus erythematosus (including in the anamnesis), 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.

    At appointment during pregnancy there is a potential risk of development of an arterial hypotension at mother that can lead to a fetoplacental insufficiency.

    If it is necessary to use during lactation, breastfeeding should be discontinued.

    Dosing and Administration:

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

    With heart failure of grade II, the dose is reduced (by 1/3 or more). Intramuscularly Introduce 5-10 ml (up to 20-30 ml per day). With intravenous administration, the drug is diluted in a 5% solution of dextrose (glucose) or 0.9% solution of sodium chloride.

    The rate of administration should not exceed 50 mg / min. In this case, a constant monitoring of the heart rate (heart rate), blood pressure and ECG is necessary. | |

    The highest dose for adults with intramuscular and intravenous (drop) administration: single - 1 g (10 ml of the drug), daily - 3 g (30 ml of the drug). When you switch to taking the medication inside, the first dose is administered 3-4 hours after stopping the intravenous infusion.

    Side effects:

    From the central nervous system: general weakness,hallucinations, depression, myasthenia gravis, dizziness, headache, insomnia, seizures, 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.

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

    Allergic reactions: skin rash.

    Overdose:

    Symptoms: the drug has a small therapeutic latitude, so heavy intoxication can easily occur (especially with the simultaneous use of other antiarrhythmics): bradycardia, sinoatrial and atrioventricular blockades, asystole, lengthening of the interval QT, paroxysms of polymorphic ventricular tachycardia, decreased myocardial contractility, persistent decline in blood pressure, pulmonary edema, convulsions, coma, respiratory arrest.

    Treatment: symptomatic. To treat ventricular tachycardia, do not use antiarrhythmic drugs IA or 1C classes. Sodium bicarbonate can eliminate the expansion of the complex QRS or arterial hypotension.
    Interaction:

    Strengthens the effect of depolarizing muscle relaxants (suxamethonium salts), hypotensive, antiarrhythmic agents, side effects of brethil tosylate.

    With simultaneous use with antihistamines, m-cholinoblocking effects may be enhanced; with pimozide - lengthening of the interval QT.

    Reduces the activity of antimiasthenic drugs.

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

    With combined therapy with antiarrhythmic drugs of Class III, the risk of arrhythmogenic effect increases.

    Drugs that inhibit bone marrow hematopoies increase the risk of myelosuppression.
    Special instructions:

    Before intravenous administration, it is necessary to dilute, inject 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 intravenous and intramuscular injection, 100 mg / ml.

    Packaging:

    5 ml into neutral glass ampoules.5 ampoules per contour cell packaging made of polyvinyl chloride film.

    1 or 2 contoured cell packs with scarifier ampoule ceramic or knife for opening ampoules and instructions for use in a pack of cardboard. When using ampoules with a fracture ring or break point, the knife or scarifier is not inserted.
    Storage conditions:

    Store in a 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:LP-000399
    Date of registration:28.02.2011
    Expiration Date:28.02.2016
    The owner of the registration certificate:BINNOFARM, CJSC BINNOFARM, CJSC Russia
    Manufacturer: & nbsp
    Representation: & nbspBINNOFARM CJSC BINNOFARM CJSC Russia
    Information update date: & nbsp28.02.2016
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