Tablets, coated: almost white or white color, a round biconvex form (on 10 pieces in the blister, in a cardboard pack of 5 blisters);
Solution for intravenous (in/in) introductions: colourless transparent liquid (on 10 ml in glass ampoules without color with a break point, in a blister strip packaging of 5 ampoules, in a cardboard pack 2 packagings).

1 tablet contains:

Active ingredient: a propafenona a hydrochloride – 150 mg or 300 mg that corresponds to the maintenance of a propafenon of 135,7 mg or 271,05 mg;
Auxiliary components: a gipromelloza 5, starch corn, the microcellulose granulated коповидон, magnesium stearate, sodium of a kroskarmelloz, a macrogoal 6000, sodium lauryl sulfate, an emulsion of a dimetikon from silicon dioxide, titanium dioxide.

1 ml of solution contains:

Active ingredient: a propafenona a hydrochloride – 3,5 mg;
Auxiliary components: dextroses (glucose) monohydrate, water for injections.

Indications to use

Tablets, coated
Propanorm's use is shown for prevention and treatment of arhythmic pathologies:

Paroxysmal disturbances of a rhythm (a WPW-syndrome, supraventricular – fibrillation and an atrial flutter);
Ventricular and supraventricular premature ventricular contraction;
Atrioventricular re-entry (mechanism of a repeated return entrance of an impulse) tachycardia.

Besides, tablets are appointed for prevention of steady monomorphic ventricular tachycardia.

Solution for in/in introductions
Solution is appointed for stopping of paroxysms of fibrillation of auricles, by atrial flutters, supraventricular tachycardias, a WPW-syndrome, ventricular tachycardias (in the absence of disturbances of sokratitelny function of a left ventricle).

Contraindications

The expressed arterial hypotension, the expressed bradycardia;
Considerable disturbance of water and electrolytic balance (including potassium metabolism);
Severe form of the chronic obstructive pulmonary disease (COPD);
Simultaneous use of a ritonavir;
Sick sinus syndrome;
Atrioventricular block of the II-III degree;
The expressed changes of a myocardium of organic genesis: refractory chronic heart failure at fraction of emission of a left ventricle is less than 35%, cardiogenic shock (not including arhythmic shock);
Breastfeeding period;
Age up to 18 years;
Hypersensitivity to drug components.

Besides, use of tablets is contraindicated:

Disturbance of intra-atrial conduction;
Distal blockade or blockade of legs of a ventriculonector in the absence of an electrocardiostimulator;
Myasthenia;
Uncontrollable chronic heart failure;
Severe form of chronic heart failure in a decompensation stage.

Additional contraindications to use of solution for in/in injections:

Acute coronary syndrome;
Brugad's syndrome;
gravis myasthenia;
Disturbance of conductivity of excitement between auricles and ventricles, intra ventricular, sinuatrial blockade at patients without electrocardiostimulator;
Lengthening of an interval of QT;
Simultaneous use of tricyclic antidepressants, a tsizaprida, fenotiazin, a bepridil, macroleads for intake (QT of means extending an interval).

With care it is necessary to appoint Propanorm at HOBL of easy and average degree, to patients with the established artificial pacemaker of heart, at advanced age.

Besides:

Tablets: renal failures and/or liver, gravis myasthenia;
Solution: bronchial asthma, organic lesions of a myocardium, arterial hypotension, a renal and/or liver failure, hyper - and a hypopotassemia.

Use of tablets and solution during pregnancy is shown only according to vital indications (especially in the I trimester), on condition of exceeding of the expected advantage of therapy for mother over potential threat for a fruit.

Route of administration and dosage

Tablets, coated
Pill is taken inside, after food, swallowing entirely and washing down with enough water.

The doctor appoints the dosing mode and adjusts individually, taking into account clinical indications.

Usual daily dose – 450 mg (on 150 mg 3 times a day every 8 hours). For achievement of desirable therapeutic effect increase in an initial dose each 3-4 days to 600 mg a day (in 2 receptions) or to the maximum daily dose of 900 mg – in 3 receptions can be shown.

The load dose when stopping a paroxysm of fibrillation of auricles makes 600 mg once.

If against the background of Propanorm's use the frequency of emergence and weight of arrhythmia raises, recommended to lower a dose or to temporarily cancel drug.

Patients with body weight is less than 70 have some or 70 years are aged more senior appoint a reduced dose, it is necessary to begin use in the conditions of a hospital under control of the arterial pressure (AP) and an electrocardiography (ECG).

The dosing mode for patients with the broken function of a liver has to make 1/5-1/3 from a usual dose, with an impaired renal function (at clearance of creatinine it is less than 10%) the initial dose is reduced twice.

Solution for intravenous (in/in) introductions
Solution is intended for in/in jet or drop introduction.

For infusion solution it is possible to use only 5% glucose solution!

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

The mode of dosing is set by the doctor on the basis of data of an electrocardiography and clinical condition of the patient individually.

The recommended dosing:

In/in jet introduction: slowly – the drug is administered within 10 minutes from calculation for 1,5-2 mg on 1 kg of weight of the patient. For achievement of clinical effect in 90-120 minutes it is possible to enter this dose repeatedly;
Short-term infusion: within 60-180 minutes with a speed of 0,5-1 mg of drug a minute – from calculation for 0,5-2 mg on 1 kg of weight. For achievement of clinical effect in 60-120 minutes the procedure can be repeated;
Long infusions: to 560 mg a day that is equivalent to 160 ml of solution of Propanorm.

The daily dose should not exceed 560 mg.

For treatment of heavy arrhythmia use of short-term and long infusions is shown.

It is necessary to carry out the procedure of administration of drug under careful control of a condition of the patient, in case of considerable change of the heart rate (HR), expansion more than for 25% of the QRS complex or lengthening of an interval of QT more than for 20%, it is necessary to stop infusion immediately!

At an impaired renal function and/or a liver use even of usual therapeutic doses can cause cumulation of a propafenon of a hydrochloride in an organism. At this category of patients use of titratsionny doses of drug under careful control of an ECG and concentration of active agent in a blood plasma is shown.

After cultivation of solution for in/in introductions to 5% glucose solution stability (physical and chemical) drug remains within 72 hours at a temperature of 25 °C. But from the point of view of microbiology it is necessary to prepare solution before direct use. In case of need solution, ready for infusion, can be used within the next few 24 hours provided that temperature of its storage will not exceed 2-8 °C.

Side effects

Tablets, coated

Cardiovascular system: ventricular tachyarrhythmias, atrioventricular (AV) dissociation, bradycardia, deterioration in course of heart failure (at reduced function of a left ventricle), stenocardia, sinuatrial (SA) blockade, disturbances of intra ventricular conductivity, AV blockade, supraventricular tachyarrhythmias, against the background of high doses – orthostatic hypotension;
Nervous system: dizziness, headache; seldom – a diplopia, spasms, a sight illegibility;
Alimentary system: dryness in a mouth, change of flavoring feelings, bitterness in a mouth, a loss of appetite, nausea, weight in an epigastric zone, a lock, diarrhea; seldom – functional disorder of a liver, a cholestasia, cholestatic jaundice;
Urinogenital system: decrease in a potentiality, oligospermatism;
Allergic reactions: skin itch, rash, erubescence, dieback, volchanochnopodobny syndrome, small tortoiseshell;
Laboratory indicators: emergence of antinuclear antibodies, agranulocytosis, leukopenia, increase in duration of bleeding, thrombocytopenia;
Others: bronchospasm, weakness, enanthesis of hemorrhagic character.

Solution for in/in introductions

Cardiovascular system: very often – a heart consciousness, conductivity disturbances; often – bradycardia, at reduced sokratitelny function of a left ventricle – weighting of a course of heart failure; SA blockade, AV blockade, ventricular tachyarrhythmias, disturbances of intra ventricular conductivity, supraventricular tachyarrhythmias, at reception in high doses – a considerable lowering of arterial pressure (including postural and orthostatic hypotension); seldom – pro-arrhythmias (increase of pulse (tachycardia), fibrillations of ventricles); frequency is unknown – deterioration in a course of chronic heart failure;
Nervous system: very often – dizziness; often – a syncope; infrequently – confusion of consciousness, alarm, a headache, paresthesia, an ataxy; seldom – an illegibility of visual perception, a diplopia; frequency is unknown – extrapyramidal symptoms, spasms;
Alimentary system: often – a xerostomia, dispeptic frustration, taste disturbance; infrequently – a cholestasia, liver diseases, hepatitis, jaundice; frequency is unknown – an emetic desire;
Mammary glands and generative organs: seldom – impotence; frequency is unknown – passing decrease in quantity of spermatozoa;
Connecting fabrics and musculoskeletal system: seldom – a syndrome with symptoms of a system lupus erythematosus;
Laboratory researches: infrequently – thrombocytopenia, increase in activity of enzymes of a liver (an alkaline phosphatase, alaninaminotranspherase, an asparaginaminotransferaza); seldom – an agranulocytosis, a leukopenia; frequency is unknown – a granulocytopenia;
Allergic reactions: infrequently – rash, an itch, erubescence, a small tortoiseshell;
Others: bronchospasm, weakness, arthralgia.

Special instructions

The entire period of therapy should be accompanied with regular carrying out an ECG, control of activity of hepatic transaminases, electrolytic balance (especially potassium concentration level in blood).

In the presence of disturbances of electrolytic balance they should be corrected prior to drug use.

Because of the increased risk of aritmogenny activity of a propafenon it is necessary to begin treatment in the conditions of a hospital.

Propanorm's use for treatment of ventricular disturbances of a rhythm has more effective effect, than the antiarrhytmic drugs IA and IB of a class.

Bioavailability of drug at patients with a liver failure is 70% higher usual therefore they should appoint a reduced dose and to regularly control laboratory parameters.

At patients with an artificial pacemaker of heart it is necessary to approach with extra care definition of indications and doses of drug.

At prolonged use of anticoagulants and hypoglycemic means the patient needs regular clinical observation and careful control of laboratory indicators.

Against the background of use of solution on an ECG emergence of brugadopodobny changes and diagnosing of an asymptomatic current of a syndrome of Brugad is possible. Therefore administration of drug should be accompanied with electrocardiological inspection.

In case of manifestation against the background of reception of a propafenon of AV of blockade of the III degree, SA of blockade or often repeating premature ventricular contraction therapy should be cancelled.

Because of risk of proaritmogenny influence use of drug is shown only to destination and under observation of the doctor.

Propanorm exerts impact on ability to concentrate attention, speed of psychomotor reactions therefore during treatment the patient should refrain from control of vehicles and mechanisms.

Medicinal interaction

At simultaneous use of Propanorm:

Lidocaine strengthens cardiodepressive effect of drug therefore this combination is contraindicated;
Propranolol, indirect anticoagulants, метопролол, cyclosporine increase the concentration in a blood plasma;
Digoxin increases risk of development of glikozidny intoxication;
Warfarin strengthens the action against the background of metabolism blocking;
Local anesthetics increase risk of damage of the central nervous system;
Tricyclic antidepressants, beta adrenoblockers can strengthen antiarrhytmic effect of drug;
Amiodaronum increases probability of emergence of tachycardia like "pirouette";
Quinidine, Cimetidinum promote increase in concentration of a propafenon in a blood plasma for 20%;
Rifampicin, accelerating metabolism, reduces therapeutic effect of drug (dose adjustment is required).

At the accompanying therapy by the means oppressing a marrowy hemopoiesis the risk of a miyelosupressiya increases.

The probability of development of side effects of Propanorm increases at a combination to the drugs possessing negative inotropic effect or oppressing AV and SA nodes.