Novocainamide tablets 250mg, No. 20

Applied for various heart rhythm disturbances: ventricular arrhythmias (including after myocardial infarction), atrial tachycardia, atrial flutter and atrial flutter.

Inside, regardless of the meal.

With ventricular extrasystole - 025-1 g, then 025-05 g every 3-6 hours (if necessary, the daily dose can be increased to 3-4 g) with paroxysms of atrial fibrillation - 10-15 g.

After 1 hour (in the absence of effect), another 05 g and then every 2 hours for 05-10 g (until the seizure of the paroxysm but not more than 4 hours).

The highest daily dose is 3 g (sometimes 4 g).

1 tablet contains:

active substance : procainamide hydrochloride (novocainamide) 250.0 mg,

excipients: lactose monohydrate (milk sugar) 31.0 mg, potato starch 16.0 mg, calcium stearate (calcium stearic acid) 3.0 mg.

• Hypersensitivity to the drug II and III degree atrioventricular block (in the absence of an artificial pacemaker)

• bundle branch block

• arrhythmias associated with intoxication, cardiac glycosides

• pirouette ventricular tachycardia

• chronic heart failure

• arterial hypotension

• cardiogenic shock

• severe atherosclerosis

• systemic connective tissue diseases (including systemic lupus erythematosus)

• bronchial asthma

• leukopenia

• lactation period

• age up to 18 years (efficacy and safety have not been established).

Carefully:

Renal and / or liver dysfunction

elderly age

myasthenia gravis

myocardial infarction

prolongation of the QT interval

pregnancy.

Trade name of the drug

Novocainamide

International non-proprietary name

Procainamide

Dosage form

pills

Composition

1 tablet contains:

active substance : procainamide hydrochloride (novocainamide) 250.0 mg,

excipients: lactose monohydrate (milk sugar) 31.0 mg, potato starch 16.0 mg, calcium stearate (calcium stearic acid) 3.0 mg.

Description

Tablets of white or white color with a slightly creamy shade of a flat-cylindrical shape with a beveled and scored.

Pharmacotherapeutic group

antiarrhythmic agent

ATX code

C01BA

Pharmacodynamics:

Class 1A antiarrhythmic drug has a membrane stabilizing effect. Inhibits the incoming fast current of sodium ions reduces the rate of depolarization in phase 0. Inhibits conductivity slows down repolarization. Reduces the excitability of the atrial and ventricular myocardium. Increases the duration of the effective refractory period of the action potential (in the affected myocardium - to a greater extent). The deceleration of conduction, which is observed regardless of the magnitude of the resting potential, is more pronounced in the atria and ventricles, less in the atrioventricular node.

The indirect M-anticholinergic effect in comparison with quinidine and disopyramide is less pronounced, therefore, a paradoxical improvement in atrioventricular conduction is usually not observed.

Affects phase 4 depolarization reduces the automatism of intact and affected myocardium, inhibits the function of the sinus node and ectopic pacemakers in some patients. The active metabolite, N-acetylprocainamide (N-APA), has a pronounced activity of class III antiarrhythmic drugs and lengthens the duration of the action potential. Has a weak negative inotropic effect (without a significant effect on the minute volume of blood). Has vagolytic and vasodilating properties, which causes tachycardia and a decrease in blood pressure (BP) of total peripheral vascular resistance.

Electrophysiological effects are manifested in the widening of the QRS complex and lengthening of the PQ and QT intervals. The time to achieve the maximum effect when taken orally is 60-90 minutes.

Pharmacokinetics:

After oral administration, up to 95% of the dose taken is absorbed. Bioavailability - 85%. In plasma, it binds to blood proteins - 15-20%. The maximum concentration in blood plasma when taken orally is reached after 1-2 hours, the maximum concentration is 10 ?g / ml. Penetrates the blood-brain and placental barrier and is secreted in breast milk.

Has a 'first pass' effect, metabolized in the liver to form an active metabolite - N-APA. About 25% of the administered procainamide is converted to the specified metabolite, however, upon rapid acetylation or in chronic renal failure, 40% of the dose is converted.

In chronic renal failure or chronic heart failure, the metabolite rapidly accumulates in the blood to toxic concentrations, while the concentration remains within acceptable limits.

The half-life is 25-45 hours. In chronic renal failure - 11-20 hours. It is excreted by the kidneys, with 50-60% unchanged in the bile. Procainamide and N-APA are eliminated by hemodialysis but not by peritoneal dialysis.

Indications:

Applied for various heart rhythm disturbances: ventricular arrhythmias (including after myocardial infarction), atrial tachycardia, atrial flutter and atrial flutter.

Contraindications:

• Hypersensitivity to the drug II and III degree atrioventricular block (in the absence of an artificial pacemaker)

• bundle branch block

• arrhythmias associated with intoxication, cardiac glycosides

• pirouette ventricular tachycardia

• chronic heart failure

• arterial hypotension

• cardiogenic shock

• severe atherosclerosis

• systemic connective tissue diseases (including systemic lupus erythematosus)

• bronchial asthma

• leukopenia

• lactation period

• age up to 18 years (efficacy and safety have not been established).

Carefully:

Renal and / or liver dysfunction

elderly age

myasthenia gravis

myocardial infarction

prolongation of the QT interval

pregnancy.

Method of administration and dosage:

Inside, regardless of the meal.

With ventricular extrasystole - 025-1 g, then 025-05 g every 3-6 hours (if necessary, the daily dose can be increased to 3-4 g) with paroxysms of atrial fibrillation - 10-15 g.

After 1 hour (in the absence of effect), another 05 g and then every 2 hours for 05-10 g (until the seizure of the paroxysm but not more than 4 hours).

The highest daily dose is 3 g (sometimes 4 g).

Side effects:

From the side of the central nervous system: dizziness headache myasthenia gravis hallucinations convulsions drowsiness depression psychotic reactions with productive symptoms ataxia.

From the digestive system : bitterness in the mouth, nausea, diarrhea.

On the part of the hematopoietic system and the hemostatic system : with prolonged use - leukopenia thrombocytopenia neutropenia agranulocytosis hypoplastic and hemolytic anemia with a positive Coombs test.

From the senses: taste disturbances.

From the side of the cardiovascular system: a pronounced decrease in LD asystole, heart failure, a decrease in myocardial contractility, atrioventricular blockade, ventricular paroxysmal tachycardia.

Allergic reactions: skin rash, angioedema.

Others: lupus-like syndrome, fever.

Overdose:

It has a small therapeutic breadth, therefore, severe intoxication can easily occur (especially with the simultaneous use of other antiarrhythmic drugs).

Symptoms: bradycardia sinoatrial and atrioventricular block asystole lengthening of the QT interval paroxysms of polymorphic ventricular tachycardia persistent decrease in blood pressure pulmonary edema dry mouth mydriasis delirium convulsions coma respiratory arrest.

Treatment : if the above symptoms of an overdose appear, an urgent doctor's consultation is necessary. Before the arrival of the doctor, it is recommended to drink a large amount of liquid (2-3 liters) and induce vomiting. Treatment is symptomatic. Hemodialysis.

Interaction:

Plasma concentration is increased by cimetidine ranitidine beta-blockers amiodarone trimethoprim quinidine ofloxacin.

Cannot be combined with sparfloxacin.

Enhances the effect of muscle relaxants quinidine lidocaine.

In combination with lidocaine, the cardiodepressant effect is enhanced.

Reduces the activity of anti-myasthenic drugs.

Special instructions:

In connection with the possible inhibition of myocardial contractility and a decrease in blood pressure, the drug should be prescribed with great caution in myocardial infarction.

When using novocainamide during pregnancy, there is a potential risk of drug accumulation and the development of arterial hypotension in the mother, which can lead to uteroplacental insufficiency.

Impact on the ability to drive vehicles. Wed and fur .:

Care should be taken when driving or performing work requiring increased attention and quick response.

Release form / dosage:

Tablets 250 mg.

Packaging:

10 tablets in a blister strip packaging.

20 tablets in a jar of light-shielding glass.

A jar or 2 blister packs, together with instructions for use, are placed in a cardboard box.

Storage conditions:

In a place protected from light and out of reach of children at a temperature not exceeding 30 ? C.

Shelf life:

3 years.

Do not use after the expiration date.

Vacation conditions

On prescription

Manufacturer

Open Joint Stock Company 'ORGANIKA' (OJSC 'ORGANIKA'), 654034, Kemerovo region, Novokuznetsk, Kuznetsk highway, 3, Russia

Marketing Authorization Holder / Organization Receiving Consumer Claims:

OJSC 'ORGANIKA'