Propanorm tabs 150mg #50

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Propanorm user manual

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Propanorm is an antiarrhythmic drug.

Release form and composition

Dosage forms:
    Film-coated tablets: almost white or white, round biconvex (10 pcs. In a blister, 5 blisters in a cardboard box);
    Solution for intravenous (IV) administration: colorless transparent liquid (10 ml each in glass ampoules without color with a breaking point, in a blister strip 5 ampoules, in a cardboard box 2 packs).
1 tablet contains:
    Active ingredient: propafenone hydrochloride - 150 mg or 300 mg, which corresponds to the content of propafenone 135.7 mg or 271.05 mg;
    Auxiliary components: hypromellose 5, corn starch, granular microcellulose, copovidone, magnesium stearate, croscarmellose sodium, macrogol 6000, sodium lauryl sulfate, dimethicone emulsion with silicon dioxide, titanium dioxide.

Indications for use

The use of Propanorm is indicated for the prevention and treatment of arrhythmic pathologies:
    Paroxysmal rhythm disturbances (Wolff-Parkinson-White syndrome, supraventricular - atrial fibrillation and flutter);
    Ventricular and supraventricular premature beats;
    Atrioventricular re-entry (mechanism of re-entry of the impulse) tachycardia.
In addition, tablets are prescribed for the prevention of persistent monomorphic ventricular tachycardia.

Contraindications

    Severe arterial hypotension, severe bradycardia;
    Significant violation of water and electrolyte balance (including potassium metabolism);
    Severe chronic obstructive pulmonary disease (COPD);
    Concomitant use of ritonavir;
    Sick sinus syndrome;
    Atrioventricular block II-III degree;
    Expressed changes in the myocardium of organic genesis: refractory chronic heart failure with left ventricular ejection fraction less than 35%, cardiogenic shock (not including arrhythmic shock);
    Breastfeeding period;
    Age under 18;
    Hypersensitivity to the components of Propanorm.
In addition, the use of tablets is contraindicated:
    Violation of intra-atrial conduction;
    Distal or bundle branch block in the absence of a pacemaker;
    Myasthenia gravis;
    Uncontrolled chronic heart failure;
    Severe form of chronic heart failure in the stage of decompensation.
Care should be taken to prescribe Propanorm for mild to moderate COPD, patients with an established artificial heart rate driver, in old age.
Besides:
    Tablets: impaired renal and / or liver function, myasthenia gravis;
    Solution: bronchial asthma, organic myocardial damage, arterial hypotension, renal and / or hepatic failure, hyper- and hypokalemia.
The use of tablets and solution during pregnancy is indicated only for health reasons (especially in the first trimester), provided that the expected benefits of therapy for the mother exceed the potential threat to the fetus.


Method of administration and dosage

The tablets are taken orally, after meals, swallowing whole and drinking plenty of water.
The doctor prescribes and adjusts the dosage regimen individually, taking into account clinical indications.
The usual daily dose is 450 mg (150 mg 3 times a day every 8 hours). To achieve the desired therapeutic effect, an increase in the initial dose every 3-4 days up to 600 mg per day (in 2 divided doses) or up to a maximum daily dose of 900 mg in 3 divided doses may be shown.
The loading dose for the relief of atrial fibrillation paroxysm is 600 mg once.
If, against the background of the use of Propanorm, the frequency of occurrence and the severity of arrhythmias increases, it is recommended to reduce the dose or temporarily cancel Propanorm.
Patients with a body weight of less than 70 kg or over the age of 70 years are prescribed a reduced dose; use should be started in a hospital setting under the control of blood pressure (BP) and electrocardiography (ECG).
The dosage regimen for patients with impaired liver function should be 1 / 5-1 / 3 of the usual dose, with impaired renal function (with creatinine clearance less than 10%), the initial dose is reduced by 2 times.

Side effects

    Cardiovascular system: ventricular tachyarrhythmias, atrioventricular (AV) dissociation, bradycardia, worsening of the course of heart failure (with reduced left ventricular function), angina pectoris, sinoatrial (SA) block, intraventricular conduction disturbances, AV block, supraventricular tachycardia - orthostatic hypotension;
    Nervous system: dizziness, headache; rarely - diplopia, convulsions, blurred vision;
    Digestive system: dry mouth, change in taste, bitterness in the mouth, loss of appetite, nausea, heaviness in the epigastric zone, constipation, diarrhea; rarely - a functional disorder of the liver, cholestasis, cholestatic jaundice;
    Urogenital system: decreased potency, oligospermia;
    Allergic reactions: itching, rash, skin redness, exanthema, lupus-like syndrome, urticaria;
    Laboratory indicators: the appearance of antinuclear antibodies, agranulocytosis, leukopenia, increased duration of bleeding, thrombocytopenia;
    Others: bronchospasm, weakness, rash on the skin of a hemorrhagic nature.


Special instructions

The entire period of therapy should be accompanied by regular ECG, monitoring of the activity of hepatic transaminases, electrolyte balance (especially the level of potassium concentration in the blood).
If there are electrolyte imbalances, they should be corrected before using the drug.
Due to the increased risk of arrhythmogenic activity of propafenone, treatment should be started in a hospital setting.
The use of Propanorm for the treatment of ventricular arrhythmias has a more effective effect than class IA and IB antiarrhythmic drugs.
The bioavailability of the drug in patients with hepatic insufficiency is 70% higher than usual, so they should be prescribed a reduced dose and regularly monitor laboratory parameters.
Patients with an artificial pacemaker should be very careful when determining the indications and dose of the drug.
With prolonged use of anticoagulants and hypoglycemic agents, the patient requires regular clinical observation and careful monitoring of laboratory parameters.
Against the background of the application of the solution on the ECG, the appearance of brugada-like changes and the diagnosis of an asymptomatic course of the Brugada syndrome are possible. Therefore, the administration of the drug should be accompanied by an electrocardiological examination.
In case of manifestation of AV blockade of the III degree, SA blockade or frequently repeated extrasystoles while taking propafenone, therapy should be canceled.
Due to the risk of proarrhythmogenic effects, the use of the drug is indicated only for the intended purpose and under the supervision of a physician.
Propanorm affects the ability to concentrate attention, the speed of psychomotor reactions, therefore, during the period of treatment, the patient should refrain from driving vehicles and mechanisms.

Drug interactions

With the simultaneous use of Propanorm:
    Lidocaine enhances the cardiodepressant effect of the drug, so this combination is contraindicated;
    Propranolol, indirect anticoagulants, metoprolol, cyclosporine increase their concentration in blood plasma;
    Digoxin increases the risk of developing glycosidic intoxication;
    Warfarin enhances its effect against the background of blocking metabolism;
    Local anesthetics increase the risk of central nervous system damage;
    Tricyclic antidepressants, beta-blockers can enhance the antiarrhythmic effect of the drug;
    Amiodarone increases the likelihood of pirouette-type tachycardia;
    Quinidine, cimetidine increase the concentration of propafenone in blood plasma by 20%;
    Rifampicin, accelerating metabolism, reduces the therapeutic effect of the drug (dose adjustment is required).
With concomitant therapy with drugs that inhibit bone marrow hematopoiesis, the risk of myelosuppression increases.
The likelihood of developing side effects of Propanorm increases when combined with drugs that have a negative inotropic effect or inhibit AV and SA nodes.

Terms and conditions of storage

Keep out of the reach of children.
Store in a place protected from light and moisture at a temperature of 15-25 ° C.
Shelf life: tablets - 3 years, solution - 4 years.

Terms of sell

You don't need a prescription to buy Propanorm.