Description
Latin name
PROPANORM
Release form
Coated tablets.
Packaging
In a blister pack of 10 tablets. In the package of 5 blisters.
Pharmacological action
Class IC antiarrhythmic drug, blocks fast sodium channels.
Possesses weak -adrenergic blocking activity (corresponding to approximately 1/40 of the activity of propranolol) and m-anticholinergic effect. The antiarrhythmic effect is based on a local anesthetic and direct membrane stabilizing effect on myocardiocytes, as well as on the blockade of adrenergic -Adrenoreceptors and calcium channels.
The local anesthetic effect approximately corresponds 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 contractile fibers of the ventricles, inhibits automatism. Slows down Purkinje fibers. Extends the time spent on the sinoatrial node and atria. When using propafenone, the PQ interval lengthens and the QRS complex (from 15 to 25) expands on the ECG, as well as the AN and HV intervals on the histogram. Slowing down the conduction, the drug lengthens the effective refractory period in the atria, AV node, extra bundles, and, to a lesser extent, the ventricles. No significant changes in the QT interval were observed. Electrophysiological effects are more pronounced in ischemic than in normal myocardium. It has a negative inotropic effect, which usually manifests itself with a decrease in the ejection fraction of the left ventricle below 40%.
The drug begins 1 hour after ingestion, reaches a maximum after 2-3 hours and lasts 8-12 hours.
Indications
– Prevention and treatment of supraventricular and ventricular extrasystoles.
– Prevention and treatment of paroxysmal arrhythmias (supraventricular – atrial fibrillation and flutter, Wolff-Parkinson-White syndrome).
– Prevention and treatment of atrial ventricular re-entry tachycardia.
– Prevention of sustained monomorphic ventricular tachycardia.
Contraindications
– Severe forms of chronic heart failure (at the stage of decompensation), uncontrolled chronic heart failure.
– Cardiogenic shock (with the exception of arterial hypotension due to tachycardia, and antiarrhythmic shock).
– Severe bradycardia.
– Severe arterial hypotension.
– Sinoatrial block, intra-atrial dysfunction.
– Blockade of the legs of the bundle of His.
– Intraventricular bifascicular block and AV block II and III degree (without installing a pacemaker).
– SSSU.
– Tachycardia-bradycardia syndrome.
– Myocardial infarction.
– Lactation (breastfeeding).
– Children and adolescents under 18 years of age (efficacy and safety not established).
– Digoxin intoxication.
– Hypersensitivity to the drug.
With caution, the drug should be prescribed in the following cases:
– COPD.
– Myasthenia gravis (including myasthenia gravis).
– Heart failure (ejection fraction of less than 30%).
– Cardiomyopathy.
– Arterial hypotension.
– Hepatic cholestasis.
– Hepatic and / or renal failure.
– Electrolyte disturbances (must be corrected before the appointment of propafenone).
– Patients over the age of 70.
– Patients with a permanent or temporary pacemaker.
– Concomitant use with other antiarrhythmic drugs of similar effect.
Use during pregnancy and lactation
Use of propafenone during pregnancy, especially in the first trimester, is possible only if the expected benefit to the mother outweighs the potential risk to the fetus.
Composition
1 coated tablet contains: Propafenone hydrochloride 300 mg
Excipients: microcrystalline granular cellulose, corn starch, copovidone, croscarmellose sodium, magnesium stearate, sodium laurylate 5, laurolella emulsion of dimethicone with silicon dioxide.
Dosage and administration
The dosage regimen is set individually and adjusted by the doctor.
The drug is taken after a meal. The tablets should be swallowed whole without chewing, washed down with a small amount of water.
The drug is prescribed 150 mg 3 times / 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 to a maximum of 900 mg / day (divided into 3 doses).
If, during treatment, an increase in the QRS complex or QT interval by more than 20% compared with the initial values, or an extension of the PQ interval by more than 50%, an extension of the QT interval by more than 500 ms, an increase in the frequency and severity of arrhythmia, should be reduced dose or temporarily interrupt the use of Propanorm.
Use in case of impaired liver function: In case of impaired liver function (cumulation is possible) Propanorm is used in doses of 20-30% of the usual.
Application for impaired renal function: In case of impaired renal function (creatinine clearance <10 ml / min), the initial dose is 50% of the initial. – Use in elderly patients and patients weighing less than 70 kg In patients older than 70 years, as well as in patients weighing <70 kg, lower doses are used (the first dose is given in a hospital under the supervision of ECG and blood pressure). Side effects of From the cardiovascular system: bradycardia, AV dissociation, ventricular tachyarrhythmias, angina pectoris, worsening heart failure (in patients with decreased left ventricular function), sinoatrial block, AV block, ventricular ventricle, ventricular when taken in high doses, orthostatic hypotension. From the digestive system: taste change, dry mouth, bitterness in the mouth, nausea, decreased appetite, a feeling of heaviness in epigastrium, constipation or diarrhea rarely – liver dysfunction, cholestatic jaundice, cholestasis. From the side of the central nervous system: headache, dizziness rarely – blurred vision, diplopia, convulsions. From the hemopoietic system: leukopenia, agranulocytosis, an increase in bleeding time, thrombocytopenia, the appearance of antinuclear antibodies. From the reproductive system: oligospermia, decreased potency. Allergic reactions: skin rash, itching, exanthema, redness of the skin, urticaria, lupus-like syndrome. Other: weakness, bronchospasm, hemorrhagic skin rash. Drug interaction Cannot combine Propanorm with lidocaine because increases the cardio-depressive effect. With the simultaneous use of propafenone increases the concentration of propranolol, metoprolol, digoxin (increases the risk of glycoside intoxication), indirect anticoagulants, cyclosporine in blood plasma. When used together, propafenone enhances the action of warfarin (by blocking metabolism). When used with beta-blockers, tricyclic antidepressants, increased antiarrhythmic action may occur. When used with topical anesthetics, the risk of CNS involvement is increased. Cimetidine and quinidine, by slowing metabolism, increase the concentration of propafenone in plasma by 20%, rifampicin – reduces. When used with propafenone, amiodarone increases the risk of pirouette tachycardia. Drugs that inhibit the sinoatrial node and the AV site and have a negative inotropic effect, when used with propafenone, increase the risk of side effects. Bone hematopoietic drugs, when used with propafenone, increase the risk of myelosuppression. Overdose At single dose, 2 times higher than the daily, symptoms of intoxication can appear after 1 hour, maximum – after several hours. – Symptoms: persistent decrease in blood pressure, nausea, dry mouth, vomiting, mydriasis, drowsiness, extrapyramidal disorders, confusion, bradycardia, QT interval prolongation, ventricular and intraventricular conduction, ventricular ducts, ventricular ducts – blockade, asystole, coma, convulsions, delirium, pulmonary edema. – Treatment: gastric lavage, defibrillation, administration of dobutamine, diazepam if necessary – IVL and indirect cardiac massage. Hemodialysis is ineffective. Storage conditions – The drug should be stored in a dry, dark place at a temperature of 15 ° to 25 ° C. – Keep out of the reach of children. – Do not use after the expiration date. Expiration 2 years. Active ingredient Propafenone Possible product names s , 3 N50 TABLE P / CAPTURE / About Propanorm 300mg Tab. p / pl / rev X50 (R) Propanorm 300mg Tab. P / o X50 (R) Propanorm 300mg Tab. P / o X50 / until 04.2008 /
