Propanorm, pills 300mg, 50pcs

Composition

1 coated tablet contains:

Propafenone hydrochloride 300 mg., which corresponds to the content of propafenone 271.05 mg.

Auxiliary substances:

Microcrystalline granulated cellulose,

corn starch,

copovidone,

sodium croscarmellose,

magnesium stearate,

sodium lauryl sulfate,

hypromellose 5,

macrogol 6000,

titanium dioxide,

dimethicone emulsion with silicon dioxide.

Pharmacological action

Class IC antiarrhythmic drug that blocks fast sodium channels.

Has a weak point ?- adrenoblocking activity (corresponds to approximately 1/40 of the activity of propranolol) and m-holinoblocking effect. The antiarrhythmic effect is based on local anaesthetic and direct membrane-stabilizing action on myocardiocytes, as well as on the blockade of adrenergic receptors. ?- adrenoreceptors and calcium channels.

The local anaesthetic effect corresponds approximately to the activity of procaine.

Propafenone, blocking fast sodium channels, causes a dose-dependent decrease in the depolarization rate and inhibits phase 0 of the action potential and its amplitude in Purkinje fibers and ventricular contractile fibers, inhibits automatism. Slows down the flow of Purkinje fibers.

Lengthens the time spent on the sinoatrial node and atria. When propafenone is used, the PQ interval is lengthened and the QRS complex is expanded (from 15 to 25) on the ECG, as well as the AH and HV intervals on the gisogram.

By slowing down conduction, the drug prolongs the effective refractory period in the atria, AV node, additional bundles, and, to a lesser extent, ventricles. There are no significant changes in the QT interval.

Electrophysiological effects are more pronounced in ischemic than in normal myocardium. It has a negative inotropic effect, which usually manifests itself when the left ventricular ejection fraction decreases below 40%.

The effect of the drug begins 1 hour after ingestion, reaches a maximum in 2-3 hours and lasts 8-12 hours.

Indications

• Prevention and treatment of supraventricular and ventricular extrasystoles.
• Prevention and treatment of paroxysmal rhythm disorders (supraventricular-atrial fibrillation and flutter, Wolf-Parkinson-White syndrome).
• Prevention and treatment of atrioventricular tachycardia.
• Prevention of persistent monomorphic ventricular tachycardia.

Use during pregnancy and lactation

The use of propafenone during pregnancy, especially in the first trimester, is possible only if the expected benefit to the mother exceeds the potential risk to the fetus.

Contraindications

• Severe forms of chronic heart failure (in the stage of decompensation), uncontrolled chronic heart failure.
• Cardiogenic shock (excluding hypotension due to tachycardia and antiarrhythmic shock).
• Severe bradycardia.
• Severe arterial hypotension.
• Sinoatrial block, violation of intraatrial conduction.
• Block of Gis bundle legs.
• Intraventricular bifascicular block and grade II and III AV block (without pacemaker installation).
• SSSU.
• Tachycardia-bradycardia syndrome.
• Myocardial infarction.
• Digoxin intoxication.
• Hypersensitivity to the components of the drug

Caution should be exercised when prescribing the drug in the following cases: :

• COPD.
• Myasthenia gravis (including myasthenia gravis).
• Heart failure (ejection fraction less than 30%).
• Cardiomyopathy.
• Arterial hypotension.
• Hepatic cholestasis.
• Hepatic and / or renal insufficiency.
• Electrolyte disturbances (must be corrected before prescribing propafenone).
• Patients over the age of 70 years.
• Patients with permanent or temporary pacemakers.
• Simultaneous use with other antiarrhythmic drugs of similar action.

Side effects

From the cardiovascular system: bradycardia, AV dissociation, ventricular tachyarrhythmias, angina pectoris, worsening of the course of heart failure (in patients with reduced left ventricular function), sinoatrial block, AV block, intraventricular conduction disorders, supraventricular tachyarrhythmias, when taken in high doses – orthostatic hypotension.

From the digestive system: changes in taste, dry mouth, bitterness in the mouth, nausea, decreased appetite, a feeling of heaviness in the epigastrium, constipation or diarrhea; rarely-liver function disorders, cholestatic jaundice, cholestasis.

From the central nervous system: headache, dizziness; rarely-blurred vision, diplopia, convulsions.

From the hematopoietic system: leukopenia, agranulocytosis, increased bleeding time, thrombocytopenia, the appearance of antinuclear antibodies.

On the part of the reproductive system: oligospermia, decreased potency.

Allergic reactions: skin rash, pruritus, exanthema, redness of the skin, urticaria, lupus-like syndrome.

Others: weakness, bronchospasm, hemorrhagic skin rashes.

Interaction

Do not combine Propanorm with lidocaine, because the cardiodepressive effect increases.

When used concomitantly, propafenone increases the concentration of propranolol, metoprolol, digoxin (increases the risk of glycoside intoxication), indirect anticoagulants, cyclosporine in blood plasma.

When used concomitantly, propafenone enhances the effect of warfarin (by blocking metabolism).

When used concomitantly with beta-blockers, tricyclic antidepressants, it is possible to increase the antiarrhythmic effect.

When used concomitantly with local anesthetics, the risk of CNS damage increases.

Cimetidine and quinidine, slowing down the metabolism, increase the concentration of propafenone in plasma by 20%, rifampicin-reduces.

When used concomitantly with propafenone, amiodarone increases the risk of developing pirouette-type tachycardia.

Drugs that depress the sinoatrial node and AV node and have a negative inotropic effect, when used simultaneously with propafenone, increase the risk of side effects.

Drugs that inhibit bone marrow hematopoiesis, when used simultaneously with propafenone, increase the risk of myelosuppression.

How to take, course of use and dosage

The dosage regimen is set individually and adjusted by the doctor.

The drug is taken after a meal. Tablets should be swallowed whole, without chewing, with a small amount of water.

The drug is prescribed 150 mg 3 times a day (every 8 hours). The daily dose is 450 mg.

The dose is increased gradually (every 3-4 days) to 600 mg/day (divided into 2 doses) or up to a maximum of 900 mg/day (divided into 3 doses).

If during treatment there is an extension of the QRS complex or QT interval by more than 20% compared to baseline values, or an extension of the PQ interval by more than 50%, an extension of the QT interval by more than 500 msec, an increase in the frequency and severity of arrhythmia, the dose should be reduced or the use of Propanorm should be temporarily interrupted.

Application in case of impaired liver function: In case of impaired liver function (accumulation is possible), Propanorm is used in doses of 20-30% of the usual.

Use in patients with impaired renal function: In patients with impaired renal function ( creatinine clearance

– Use in elderly patients and in patients with a weight of less than 70 kg In patients older than 70 years, as well as in patients with a body weight of

Overdose

With a single dose of 2 times the daily dose, symptoms of intoxication may appear in 1 hour, maximum-in a few hours.

Symptoms: persistent decrease in blood pressure, nausea, dry mouth, vomiting, mydriasis, drowsiness, extrapyramidal disorders, confusion, bradycardia, prolongation of the QT interval, atrial and intraventricular conduction disorders, ventricular tachyarrhythmias, paroxysms of polymorphic ventricular tachycardia, sinoatrial block, AV block, asystole, coma, convulsions, delirium, pulmonary edema.

Treatment: gastric lavage, defibrillation, use of dobutamine, diazepam; if necessary – mechanical ventilation and indirect heart massage. Hemodialysis is ineffective.

Special instructions

ECG monitoring is necessary during the course of treatment, especially at the beginning of therapy.

Treatment is recommended to start in a hospital setting, as the risk of arrhythmogenic effects associated with the use of propafenone is increased.

Propanorm should be used under the control of blood electrolyte balance (especially potassium concentration) and ECG; periodically, the activity of hepatic transaminases should be determined.

In the treatment of ventricular arrhythmias, propafenone is more effective than Class IA and class IB antiarrhythmic drugs.

Indications and dosage should be determined especially carefully for patients with an installed pacemaker.

It is necessary to conduct clinical and laboratory monitoring of patients undergoing long-term treatment with anticoagulants and hypoglycemic drugs, while simultaneously using Propanorm.

If treatment involves sinoatrial block or grade III AV block, or frequently recurring extrasystole, then treatment should be interrupted.

Given the possibility of proarrhythmogenic effects, the drug is recommended to be used only as prescribed and under the supervision of a doctor.

– Use in patients with impaired liver function: In patients with hepatic insufficiency, the bioavailability of propafenone increases by 70%, in such patients it is recommended to reduce the dose and conduct regular monitoring of laboratory parameters. Whe