RYTMONORM

Active material: Propafenone
When ATH: C01BC03
CCF: Antiarrhythmic drugs. Class IC
When CSF: 01.11.01.01.03
Manufacturer: ABBOTT GmbH & Co. KG (Germany)

Pharmaceutical form, composition and packaging

Excipients: hydroxypropyl 2910, corn starch, Croscarmellose sodium, magnesium stearate, microcrystalline cellulose, Purified water.

The composition of the shell: hydroxypropyl 2910, macrogol 400, macrogol 6000, Titanium dioxide.

10 PC. – packings Valium planimetric (2) – packs cardboard.
10 PC. – packings Valium planimetric (5) – packs cardboard.
10 PC. – packings Valium planimetric (10) – packs cardboard.

Indications for use of the drug

• cimptomaticheskie and requiring treatment supraventricular tachycardia, such as, AV-functional tachycardia, supraventricular tachycardia with WPW- syndrome, or paroxysmal atrial fibrillation;
• severe and life-threatening ventricular tachycardia symptomatic.

Dosage regimen

Selection of individual doses must be under constant observation from multiple cardiology ECG monitoring and control of blood pressure.

When the expansion of the QRS complex (more 20%), or extended depending on the frequency of the QT interval, necessary to reduce the dose or stop the drug to normalize the ECG.

With the limited function of the liver and / or kidneys use of therapeutic doses can lead to accumulation of the drug. In these cases, the drug may ECG monitoring and drug concentration in blood plasma.

Unless indicated differently:

The daily dose of propafenone during the selection of doses and during maintenance therapy ranges from 450 to 600 mg(corresponding 3-4 Film-coated tablets) and it should be divided throughout the day on 2-3 admission.

In some cases, the daily dose may be increased to 900 mg (corresponding 6 Film-coated tablets), which should be divided into three doses during the day. In exceptional cases, the daily dose can be exceeded (under the strict control of the cardiac).

These data are valid for patients with a body weight of about 70 kg. With less body weight daily dose should be reduced accordingly.

The dosage of propafenone to patients in the elderly or in patients with acute myocardial changes selected with extreme caution, gradually. Higher doses can be performed only at intervals 3-4 day.

In the appointment of antiarrhythmic drugs in patients with ventricular arrhythmia requires constant cardiac monitoring and the availability of equipment for emergency cardiac care, and the ability to monitor control. During therapy need regular monitoring studies (monthly – Standard ECG, and 1 once every 3 of the month – EKGi long as needed – ECG stress).

With the deterioration of the individual parameters, eg, expansion of the QRS complex, or QT prolongation of more than 25%, PQ interval or over 50%, QT interval prolongation, or more than 500 ms, or increasing the number or severity of cardiac arrhythmias, necessary to control therapy.

Patients with severely limited left ventricular function (LVEF less 35%) or structural myocardial disorders need special care (gradually) prescribe the dose. These patients recommended therapeutic dose increase required only in cases, when set pharmacokinetic Steady-state levels, which, usually, achieved through 5-8 days. This allows these patients to reduce the risk of proarrhythmic effect in the initial phase of therapy.

Because of the bitter taste of anesthetics and the surfactant action of the active substance,film-coated tablets should be taken after a meal entirely, nerazzhevyvaya, drinking a small amount of liquid. Duration of treatment is determined by a physician.

Side effect

Pharmaceutical formulations along with the desired – the main effect and can have undesirable, so-called side effects . Side effects , observed when using propafenone (optionally for each patient), listed below.

Sometimes, particularly when administered at high initial doses, can develop disorders of the gastrointestinal tract, such as loss of appetite, nausea and vomiting urge, fullness, constipation, dry mouth, bitter taste and numbness language, and paresthesia (violation of the sensitivity), blurred vision and dizziness.

Especially in elderly patients with reduced myocardial function of the use of propafenone can sometimes lead to abnormal regulation of blood flow to the pressure drop, that may occur while taking the vertical position of the body or with prolonged standing (orthostatic syndrome). This may cause pro-arrhythmic effect by a change or enhancement of cardiac arrhythmias, which can lead to a strong limitation of cardiac activity and possible cardiac arrest. These pro-arrhythmic effect is to slow down or heart rate (bradycardia), or in violation of the excitation (eg, sinoatrialnaya, atrioventricular, or intraventrikulyarnaya blockade), or acceleration of heart rate (eg, the newly evolved ventricular tachycardia). In very rare cases, it may come as atrial or ventricular fibrillation. Perhaps increased heart failure.

In rare cases, there is a sense of fatigue, headache, mental disorders in a state of fear and confusion, worry, nightmares, sleep disorders, also (rarely) in overdose – convulsive events.

Sometimes there are also extrapyramidal symptoms (involuntary movement disorders), allergic skin manifestations, such as redness, itch, rash or hives and bronchospasm in patients with a tendency to bronchospasm.

In rare cases may develop cholestasis (bile stasis), as an expression of hyperergic-allergic reactions and / or liver function abnormalities.

In some cases, as a result of high dosages of propafenone potency and decrease the number of sperm in eyyakulyate. These effects are completely reversible after discontinuation of the drug.

Considering, propafenone that treatment can be vital for the patient, the drug should not be stopped because of side effects without doctor's advice.

Isolated cases have been described increase of antinuclear antibodies (with respect to cell nuclei), lupus syndrome and leukopenia, or granulocytopenia, thrombocytopenia (reduction in the number of granulocyte / platelet count), it completely disappears after drug withdrawal. There are isolated cases of agranulocytosis.

Contraindications

Diseases and conditions, in which, along with the expected effect of a high probability of complications – in this case the use of the drug is permissible only under medical supervision. To the doctor can assess the presence of contraindications, it requires information on previous and concomitant diseases, simultaneously carried on other therapy, and the nature of lifestyle and habits of the patient. Contraindications may occur after initiation of treatment with this drug. In any case, you must inform the doctor.

Propafenone should not be used when:

• symptomatic heart failure (the weakness of the myocardium);
• cardiogenic shock (except in cases, due to arrhythmia);
• severe symptomatic bradycardia (painful slowdown in the rhythm of the heart);
• first 3 months after myocardial infarction, or with limited heart function (left ventricular ejection fraction of less than 35), except for patients with life-threatening ventricular cardiac arrhythmia;
• with severe sinoatrial , atrioventricular and intraventricular disorders of conduction of excitation in the heart;
• sick sinus syndrome ( bradycardia syndrome – tachycardia);
• severe hypotension ( at abnormally low rates of blood pressure;
• expressed electrolyte imbalance (eg, potassium metabolism disorders);
• severe obstructive pulmonary disease;
• Myasthenia gravis;
• hypersensitivity towards propafenone.

Pregnancy and lactation

During pregnancy, especially for the first time 3 month and during breastfeeding propafenone should be taken only under strict conditions.

Cautions

When propafenone therapy can change the sensitivity threshold stimulation pacemakers. Necessary to carry out verification functions pacemaker, and if necessary - re-programming.

In applying the drug should be considered: hitherto not been proved, that the treatment of cardiac arrhythmias in any Class I antiarrhythmic drugs contributes to lengthening life.

Effects on ability to drive vehicles and management mechanisms

Use of the drug may reduce the patient's ability to drive vehicles and other equipment. This action is enhanced by alcohol.

Drug Interactions

The simultaneous use of some drugs can have an impact on the effect of their actions. If you just before the start of treatment prolafenonom taking other drugs, or permanently take them, or going along with them to take propafenone, inform the attending physician. The doctor will determine the possibility of incompatibility between these drugs and the need for special measures when receiving propafenone, such as the appointment of a new dosage.

In simultaneous reception with drugs a group of local anesthetics(such as implanting pacemakers, surgical or dental work), as well as other drugs, which reduce heart rate and / or cardiac contractility (eg, beta-blockers, tricyclic antidepressants), to consider the possibility of potentiating the action.

Also described cases increasing the concentration of propranolol, metoprolol, desipramine, cyclosporine and digoxin in plasma.

In one case, the supplemental Ritmonorma observed a two-fold increase in the plasma concentration of theophylline. When the relevant symptoms of overdose, necessary to determine the concentration in plasma and reduce the dose if necessary.

Cases have also been described to increase the level of concentration of the drug in the plasma at the same time taking cimetidine and quinidine.

Simultaneous administration of propafenone and phenobarbital or rifampicin may reduce the plasma concentration of propafenone, possible to subtherapeutic levels.

There may be interaction of propafenone with oral anticoagulants (potentiation of the anticoagulant action). In these cases, we recommend careful monitoring of blood clotting.

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

Keep out of the reach of children.

After the expiration of the said period of validity is not allowed to use the drug.