Propanorm

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Instructions for use:

1. Release form and composition
2. Indications for use
3. Contraindications
4. Method of application and dosage
5. Side effects
6. Special instructions
7. Drug interactions
8. Analogs
9. Terms and conditions of storage
10. Terms of dispensing from pharmacies

Prices in online pharmacies:

from 302 rub.

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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 in glass ampoules without color with a break point, in a blister strip packaging 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.

1 ml of solution contains:

Active ingredient: propafenone hydrochloride - 3.5 mg;
Auxiliary components: dextrose (glucose) monohydrate, water for injection.

Indications for use

Coated tablets

The use of Propanorm is indicated for the prevention and treatment of arrhythmic pathologies:

Paroxysmal rhythm disturbances (Wolff-Parkinson-White syndrome, supraventricular - fibrillation and atrial 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.

Solution for intravenous administration

The solution is prescribed for the relief of paroxysms of atrial fibrillation, atrial flutter, supraventricular tachycardia, Wolff-Parkinson-White syndrome, ventricular tachycardia (in the absence of impaired contractile function of the left ventricle).

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 drug components.

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.

Additional contraindications to the use of solution for intravenous injection:

Acute coronary syndrome;
Brugada syndrome;
Myasthenia gravis;
Violation of the conduction of excitation between the atria and ventricles, intraventricular, sinoatrial blockade in patients without a pacemaker;
Prolongation of the QT interval;
Concomitant use of tricyclic antidepressants, cisapride, phenothiazines, bepridil, oral macrolides (QT-prolonging drugs).

Care should be taken to prescribe Propanorm for mild and 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 a 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

Film-coated

tablets 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 to 600 mg per day (in 2 divided doses) or to a maximum daily dose of 900 mg in 3 divided doses may be shown.

The loading dose for arresting paroxysm of atrial fibrillation is 600 mg once.

If, against the background of the use of Propanorm, the frequency and severity of arrhythmias increases, it is recommended to reduce the dose or temporarily cancel the drug.

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 should be reduced by 2 times.

Solution for intravenous (IV) administration

The solution is intended for intravenous jet or drip administration.

Only 5% glucose solution can be used for the infusion solution!

Long-term infusion should be carried out 3-5 minutes after intravenous administration of the drug.

The dosage regimen is established by the doctor on the basis of electrocardiography data and the patient's clinical condition individually.

Recommended dosage:

Intravenous jet injection: slowly - the drug is administered within 10 minutes at the rate of 1.5-2 mg per 1 kg of patient weight. To achieve a clinical effect after 90-120 minutes, you can re-enter this dose;
Short-term infusion: for 60-180 minutes at a rate of 0.5-1 mg of the drug per minute - at the rate of 0.5-2 mg per 1 kg of body weight. To achieve a clinical effect after 60-120 minutes, the procedure can be repeated;
Long-term infusion: up to 560 mg per day, which is equivalent to 160 ml of Propanorm solution.

The daily dose should not exceed 560 mg.

For the treatment of severe arrhythmias, the use of short and long-term infusions is indicated.

The procedure for administering the drug should be carried out under close monitoring of the patient's condition, in case of a significant change in the heart rate (HR), expansion of the QRS complex by more than 25% or lengthening of the QT interval by more than 20%, the infusion must be stopped immediately!

In case of impaired renal and / or liver function, the use of even usual therapeutic doses can cause the accumulation of propafenone hydrochloride in the body. In this category of patients, the use of titration doses of the drug is shown under close monitoring of the ECG and the concentrations of the active substance in the blood plasma.

After dilution of the solution for intravenous administration in 5% glucose solution, the stability (physical and chemical) of the drug is maintained for 72 hours at a temperature of 25 ° C. But from the point of view of microbiology, it is necessary to prepare the solution before direct use. If necessary, the solution ready for infusion can be used within the next 24 hours, provided that its storage temperature does not exceed 2-8 ° C.

Side effects

Film-coated tablets

Cardiovascular system: ventricular tachyarrhythmias, atrioventricular (AV) dissociation, bradycardia, worsening of the course of heart failure (with reduced left ventricular function), angina pectoris, sinoatrial (SA) blockade, intraventricular conduction disturbances, AV block, high dose supraventricular tachycardia - orthostatic hypotension;
Nervous system: dizziness, headache; rarely - diplopia, convulsions, blurred vision;
Digestive system: dry mouth, change in taste, bitterness in the mouth, decreased appetite, nausea, heaviness in the epigastric zone, constipation, diarrhea; rarely - functional liver disorder, 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, an increase in the duration of bleeding, thrombocytopenia;
Others: bronchospasm, weakness, rash on the skin of a hemorrhagic nature.

Solution for intravenous administration

Cardiovascular system: very often - a feeling of palpitations, conduction disturbances; often - bradycardia, with reduced contractile function of the left ventricle - worsening of the course of heart failure; SA block, AV block, ventricular tachyarrhythmias, intraventricular conduction disturbances, supraventricular tachyarrhythmias, when taken in high doses - a significant decrease in blood pressure (including postural and orthostatic hypotension); rarely - proarrhythmias (increased heart rate (tachycardia), ventricular fibrillation); frequency unknown - worsening of the course of chronic heart failure;
Nervous system: very often - dizziness; often fainting; infrequently - confusion, anxiety, headache, paresthesia, ataxia; rarely - blurred vision, diplopia; frequency unknown - extrapyramidal symptoms, convulsions;
Digestive system: often - dryness of the oral mucosa, dyspeptic disorders, taste disturbance; infrequently - cholestasis, liver disease, hepatitis, jaundice; frequency unknown - gagging;
Breasts and genitals: rarely - impotence; frequency unknown - transient decrease in sperm count;
Connective tissues and musculoskeletal system: rarely - a syndrome with symptoms of systemic lupus erythematosus;
Laboratory tests: infrequently - thrombocytopenia, increased activity of liver enzymes (alkaline phosphatase, alanine aminotransferase, asparaginine aminotransferase); rarely - agranulocytosis, leukopenia; frequency unknown - granulocytopenia;
Allergic reactions: infrequently - rash, itching, redness of the skin, urticaria;
Others: bronchospasm, weakness, arthralgia.

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 impairment 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 needs 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 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 as directed and under medical supervision.

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 glycoside 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 a 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.

Analogs

Propanorm analogs are: Propafenone, Ritmocard, Ritmonorm.

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 dispensing from pharmacies

Dispensed by prescription.

Propanorm: prices in online pharmacies

Drug name

Price

Pharmacy

Propanorm tablets p.o. 150mg 50 pcs.

302 RUB

Buy

Propanorm 150 mg film-coated tablets 50 pcs.

302 RUB

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Propanorm 300 mg film-coated tablets 50 pcs.

476 r

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Propanorm tablets p.o. 300mg 50 pcs.

RUB 537

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Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!