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Propanorm - instructions for use, reviews, analogs and forms of release (tablets of 150 mg and 300 mg, injections in injectable vials and droppers) of a drug for the treatment of arrhythmia, tachycardia, extrasystole in adults, children and pregnancy

Propanorm - instructions for use, reviews, analogs and forms of release (tablets of 150 mg and 300 mg, injections in injectable vials and droppers) of a drug for the treatment of arrhythmia, tachycardia, extrasystole in adults, children and pregnancy

In this article, you can read the instructions for using the drug Propanorm. There are reviews of visitors to the site - consumers of this medication, as well as opinions of doctors specialists on the use of Propanorm in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Propanorm analogues in the presence of existing structural analogues.Use for the treatment of arrhythmia, tachycardia, extrasystole and other disorders of the heart rhythm in adults, children, as well as during pregnancy and lactation.

 

Propanorm - antiarrhythmic drug class 1C, blocks fast sodium channels. Has a weak beta-adrenoblocking activity (corresponding to approximately 1/40 of the Propranolol activity) and m-cholinoblocking effect. Antiarrhythmic effect is based on local anesthetic and direct membrane-stabilizing action on myocardiocytes, as well as blockade of adrenergic beta adrenoreceptors and calcium channels.

 

Local anesthetic effect approximately corresponds to the activity of procaine.

 

Propaphenone (the active substance of the preparation Propanorm), blocking the fast sodium channels, causes a dose-dependent decrease in the rate of depolarization and depresses the phase 0 of the action potential and its amplitude in the Purkinje fibers and contractile fibers of the ventricles, inhibits automatism. Slows down the Purkinje fibers. Lengthens the time spent on the sinoatrial node and atria. With the use of propafenone, the PQ interval is extended and the QRS complex (from 15 to 25) is expanded on the ECG, as well as the AN and HV intervals on the histogram.Slowing down the exercise, the drug lengthens the effective refractory period in the atria, AV-node, additional beams, 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. Has a negative inotropic effect, which usually manifests itself when the left ventricular ejection fraction is lower than 40%.

 

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

 

Composition

 

Propafenone hydrochloride + excipients.

 

Pharmacokinetics

 

After taking the drug, more than 95% of the propafenone is absorbed. Bioavailability of the drug increases non-linearly with increasing dose (from 5% to 12% with a single dose increase from 150 mg to 300 mg, and when taken in a dose of 450 mg - up to 40-50%). Binding to blood plasma proteins and internal organs is 85-97%. Permeability through the blood-brain barrier (BBB) ​​and the placental barrier is low. Propafenone is almost completely metabolized. 11 metabolites of the drug are described, pharmacologically active are 5-hydroxypropaphenone and N-depropylpropaphenone, which have comparable to propafenone antiarrhythmic activity.Oxidative metabolism depends on specific cytochrome, the activity of which is genetically determined. It is excreted in the urine - 38% in the form of metabolites (less than 1% unchanged), with bile - 53% (in the form of glucuronides and sulfates). With hepatic failure, excretion decreases.

 

Indications

  • prevention and treatment of supraventricular and ventricular extrasystoles;
  • prevention and treatment of paroxysmal rhythm disturbances (supraventricular - atrial fibrillation and flutter, Wolff-Parkinson-White syndrome);
  • prevention and treatment of atrial-ventricular re-entry of tachycardia;
  • prevention of persistent monomorphic ventricular tachycardia.

 

Forms of release

 

Tablets coated with 150 mg and 300 mg.

 

Solution for intravenous administration (injections in ampoules for injections and droppers).

 

Instructions for use and dosage

 

Pills

 

Inside, after eating. Tablets should be swallowed whole, washed down with a small amount of water.

 

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

 

To stop the paroxysm of atrial fibrillation, a loading dose of 600 mg is used - once orally.

 

Usually the daily dose is 450 mg (3 times a day for 150 mg every 8 hours). If necessary, increase the dose gradually (every 3-4 days) to 600 mg per day for 2 doses or up to 900 mg per day for 3 doses.

 

If, on the background of treatment, the QRS or QT interval is extended by more than 20% compared to the baseline values, or the PQ interval is extended by more than 50%, the QT interval is extended by more than 500 ms, the frequency and severity of the arrhythmia increase, the dose or temporarily interrupt the use of Propanorm.

 

In patients older than 70 years, as well as in patients with a body weight of less than 70 kg, smaller doses are used (the first dose is given in a hospital under ECG and blood pressure control).

 

When the liver function is broken (cumulation is possible), Propanorm is used in doses equal to 20-30% of the usual, if the renal function is impaired (Cl creatinine less than 10%), the initial dose is 50% of the initial dose.

 

Ampoules

 

When intravenous drip (in the form of a dropper), the initial dose is 500 μg / kg, if necessary, increase the dose to 1-2 mg / kg.

 

Side effect

  • bradycardia;
  • slowing of sinoatrial;
  • AV and intraventricular conduction;
  • decreased myocardial contractility (in predisposed patients);
  • arrhythmogenic action;
  • orthostatic hypotension;
  • nausea;
  • anorexia;
  • feeling of heaviness in the epigastrium;
  • constipation;
  • impaired liver function;
  • headache;
  • dizziness;
  • impaired vision;
  • leukopenia, agranulocytosis, thrombocytopenia;
  • oligospermia;
  • skin rash.

 

Contraindications

  • severe forms of chronic heart failure;
  • severe arterial hypotension;
  • cardiogenic shock;
  • severe bradycardia;
  • syndrome of weakness of the sinus node (SSSU);
  • AV-blockade of 2 and 3 degrees;
  • violation of the electrolyte balance;
  • myasthenia gravis;
  • severe obstructive pulmonary disease;
  • hepatic cholestasis;
  • childhood;
  • hypersensitivity to propafenone.

 

Application in pregnancy and lactation

 

Application Propanorm during pregnancy is possible only if the intended benefit to the mother exceeds the potential risk to the fetus.

 

If it is necessary to use during the lactation period, the question of stopping breastfeeding should be solved.

 

Use in children

 

Contraindicated in childhood.

 

Application in elderly patients

 

In elderly patients, Propanorm is used in lower doses.

 

special instructions

 

With caution apply for violations of liver function, expressed violations of kidney function,as well as in combination with other antiarrhythmics with similar electrophysiological parameters.

 

Treatment should be started in a hospital, because the risk of arrhythmogenic action associated with the use of propafenone is increased. It is recommended that the previous antiarrhythmic therapy should be discontinued before the treatment with propafenone begins at a time equal to 2-5 half-lives.

 

Propanorm is characterized by pronounced individual differences in the concentration of active substance in the blood plasma, therefore, careful selection of doses for each patient is recommended.

 

Intravenous administration should be carried out under the constant control of blood pressure, heart rate and ECG. If during the course treatment or against the background of intravenous administration QRS or QT interval broadening is noted more than 20%, compared with the initial values, the dose should be reduced or propafenone should be temporarily discontinued. In elderly patients, patients with a body weight of less than 70 kg, propafenone is used in lower doses.

 

Impact on the ability to drive vehicles and manage mechanisms

 

They are used with caution in patients engaged in potentially dangerous activities requiring increased attention and speed of psychomotor reactions.

 

Drug Interactions

 

With simultaneous use with anticholinergics, anticholinergic action may be enhanced.

 

With simultaneous use with anticholinesterase agents (including with pyridostigmine), the effectiveness of pyridostigmine decreases with myasthenia gravis.

 

When used simultaneously with beta-adrenoblockers, tricyclic antidepressants, local anesthetics, the antiarrhythmic effect of propafenone in ventricular arrhythmias may be increased.

 

With simultaneous application, Propanorm may potentiate the effect of indirect anticoagulants.

 

With simultaneous application with phenobarbital, the excretion of propafenone from the body increases and its concentration in the blood plasma decreases. It is believed that other barbiturates react with propafenone in the same way.

 

At simultaneous application with Ketoconazole the case of development of cramps is described.

 

With simultaneous use, it is possible to increase plasma concentrations of propranolol, metoprolol, cyclosporin, digoxin.

 

With simultaneous use with rifampicin, the concentration of propafenone in the blood plasma decreases and its therapeutic effectiveness is significantly reduced.This is due to the fact that rifampicin induces isoenzymes CYP3A4 / 1A2 and phase 2 glucuronization of propafenone. Rifampicin does not affect the metabolism of propafenone, due to the activity of the isoenzyme CYP2D6.

 

With simultaneous application, cases of increasing the concentration of theophylline in the blood plasma and the development of toxic reactions are described.

 

Quinidine inhibits the metabolism of propafenone in the liver in individuals with a high metabolic rate, which leads to a significant increase in its concentration in the blood plasma. In this case, the effectiveness of propafenone does not change, because the production of its active metabolite (5-hydroxypropaphenone) simultaneously decreases by a factor of 2.

 

Quinidine increases the beta-blocking effects of propafenone in individuals with a high level of metabolism in the liver, only the initial active substance, and not metabolites, has beta-blocking activity.

 

It is not recommended to share the drug Propanorm and alcohol, due to the development of possible adverse reactions of inhibition from the nervous system.

 

With simultaneous use with cimetidine, a slight increase in the concentration of propaphenone in the blood plasma and the expansion of the QRS complex on the ECG are possible.

 

With the simultaneous use of Erythromycin can inhibit the metabolism of propafenone.

 

Analogues of the drug Propanorm

 

Structural analogs for the active substance:

  • Propaphenone;
  • Profen;
  • The rhythm monm.

 

Analogues for the pharmacological group (antiarrhythmics):

  • Adenocorus;
  • Allapinin;
  • Amiodarone;
  • Amiocordin;
  • Asparks;
  • Bretilate;
  • Hypertonplant (Gnafalin);
  • Dinexan;
  • Diphenine;
  • Cardiodarone;
  • Kinidin Durules;
  • Cordarone;
  • Lidocaine;
  • Multac;
  • Neo Giluritmal;
  • Nibentan;
  • Novocaineamide;
  • Opakorden;
  • Pamaton;
  • Panangin;
  • Panangin Forte;
  • Procainamide;
  • Propaphenone;
  • Profen;
  • Refralon;
  • Ritalmex;
  • Rhythmiodaron;
  • Rhythmodan;
  • Rhythm monm;
  • Sedacorone;
  • Trimecaine;
  • Etatsizin;
  • Ethmosin.

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