Allaforte sustained-release tablets 50 mg 10 pcs. (Lappakonytyna hydrobromide)

Release form

Extended-release tablets

Pharmacological action

The active ingredient of the preparation is the hydrobromide salt of the alkaloid of lappaconitine with accompanying alkaloids, obtained from the grass of the white wrestler or the rhizomes and roots of the white wrestler - Aconitum leucostomum Worosch., or from the rhizomes of the high northern wrestler Koelle (A. excelsum Reichenb.), Ranunculaceae family - Ranunculaceae, or from the technical sum of the ranunculaceae alkaloids.

Indications

Supraventricular and ventricular premature beats, paroxysmal atrial fibrillation and flutter, paroxysmal supraventricular tachycardia, including with Wolf-Parkinson-White syndrome, paroxysmal ventricular tachycardia (in the absence of organic myocardial changes).

Contraindications

Hypersensitivity to the drug, sinoatrial blockade, AV block II and III degree (without artificial pacemaker), cardiogenic shock, right bundle branch block, combined with blockade of one of the branches of the left leg, severe arterial hypotension (systolic blood pressure less than 90 mm Hg), chronic heart failure III-IV functional class according to NYHA classification, severe left ventricular myocardial hypertrophy ( 1.4 cm), the presence of post-infarction cardiosclerosis, acute coronary syndrome, Brugada syndrome, arrhythmogenic cardiomyopathy (dysplasia) of the right ventricle, severe dysfunction of the liver and / or kidneys, under 18 years of age, lactose intolerance, lactase deficiency or glucose-galactose deficiency absorption, syndrome of an extended or shortened QT interval, heart defects, history of arrhythmogenic effect of any antiarrhythmic drug, pregnancy, period of breastfeeding, alcohol abuse, AV block I degree with an extension of the PQ interval of more than 200 ms, dilated cardiomyopathy, restrictive cardiomyopathy, myocarditis, lack of antiarrhythmic effect in the history of Allapinin.

Special instructions

When canceling a previous ineffective antiarrhythmic therapy, treatment with Allafort should be started at a time exceeding 2-5 half-lives of these drugs (depending on their dose) in order to avoid a mutually reinforcing adverse effect on the function of the cardiac conduction system. In the case of amiodarone, which has a very long half-life, the use of the drug Allaforte is possible immediately after the cancellation of the previous drug, but additional safety precautions are required, as when conducting combination therapy. Compared with the non-prolonged form of lappaconitine hydrobromide, the Allaforte preparation provides a slower absorption and even distribution of the concentration of the active substance in the blood between doses, which leads to a decrease in the incidence and severity of side effects. Before starting the use of the drug, it is necessary to eliminate violations of the water-electrolyte balance, during the treatment period, monitoring of the electrolyte content in the blood is necessary. Every patient who takes Allaforte must undergo an electrocardiographic and clinical examination before starting therapy and during its period for early detection of side effects, assessing the effectiveness of the drug and the need to continue therapy. In patients with an established artificial pacemaker, the threshold for its stimulation may increase. Pacemakers must be checked and reprogrammed if necessary. With the development of headache, dizziness, diplopia, the dose of the drug should be reduced. With the appearance of sinus tachycardia against the background of prolonged use of the drug, the use of beta-blockers is indicated. As with other IC class antiarrhythmic drugs, serious undesirable effects may occur in patients with significant organic myocardial changes when using the drug. The use of the Allaforte drug for patients with coronary heart disease and stable angina pectoris requires special control using a physical exercise test, because transient myocardial ischemia and high heart rate are one of the predisposing factors for the arrhythmogenic effects of class IC drugs. When using IC class antiarrhythmic drugs, patients with severe organic myocardial changes are predisposed to the development of serious side effects. The use of the drug Allaforte in such patients is possible only in exceptional cases, by decision of a consultation of doctors.

Composition

For 1 tablet:

active ingredient: Lappaconitine hydrobromide (Allapinin) (in terms of 100% substance) 0.050 g

Excipients: pregelatinized starch, lactose monohydrate, hypromellose, calcium stearate, silicon dioxide col loid (Aerosil A-380) - sufficient amount to obtain a tablet weighing 0.350 g

Dosage and administration of

The drug should be started under medical supervision. Inside, after eating, swallowing the whole tablet and drinking a small amount of water at room temperature. Tablets are strictly forbidden to break, crush or chew! The dose of the drug Allaforte is selected individually. Treatment should begin with the appointment of 25 mg tablets every 8 hours. If there is no or insufficient therapeutic effect, the dose should be increased - 25 mg tablets every 6 hours or 50 mg tablets every 12 hours. The therapeutic effect of the drug at its first use or at an increase in its dose should be judged no earlier than after 2-3 days of regular use of the drug. To prevent unwanted effects of the drug on the conduction system of the heart, its use and dose increase should be monitored using an ECG. It is advisable to register the ECG 1-2 hours after taking the next single dose of the drug. With a prolongation of the PQ interval to 300 ms or the development of atrial-ventricular blockades of a higher degree, the dose should be reduced, if necessary, temporarily discontinuing treatment. Safe is the extension of the QRS complex by up to 25% of the original, but the QRS should not exceed 140 ms. Elongation of the QRS complex in excess of 50% of the original or more than 160 ms is unacceptable! The maximum daily dose of the drug is 100 mg (25 mg 4 times a day or 50 mg 2 times a day). At a dose of more than 100 mg per day, the drug is not recommended due to the lack of controlled clinical trials. The transfer of patients taking the drug Allapinin to treatment with Allaforte is carried out by a simple replacement, starting from the moment of the next administration of one drug to another using the same doses and the interval between doses. The duration of treatment and the correction of the dosage regimen (dose increase) is determined by the doctor.

Side effects

According to the World Health Organization, unwanted effects are classified according to their frequency of development as follows: very often (? 10% of prescriptions) often (? 1% and

Drug Interactions

Inductors of microsomal liver enzymes do not affect the effectiveness of lappaconitine hydrobromide.

Lappaconitine hydrobromide enhances the effect of non-depolarizing muscle relaxants.

With the simultaneous use of lappaconitine hydrobromide with other antiarrhythmic drugs, the risk of developing side effects associated with an effect on the function of the sinus node and atrial ventricular conduction increases. An individual dose selection of each of these drugs is required.

In a clinical study using lappaconitine hydrobromide with standard antihypertensive therapy with angiotensin converting enzyme inhibitors, angiotensin II receptor antagonists, slow calcium channel blockers of dihydropyridine derivatives, beta-blockers did not observe an increase or decrease in the antihypertensive effect.

There is no evidence of an adverse effect of lappaconitine hydrobromide on the efficacy and safety of indirect anticoagulants.

Overdose of

The drug has a small therapeutic breadth, so severe intoxication can easily occur (especially with the use of other antiarrhythmic drugs).

Symptoms: prolongation of the PQ and QT interval, expansion of the QRS complex, increase in the amplitude of the T wave, bradycardia, sinoatrial and atrioventricular block, asystole, paroxysms of polymorphic ventricular tachycardia, decreased myocardial contractility, marked decrease in blood pressure, dizziness, headache, fog intestinal disorders.

Treatment: symptomatic, gastric lavage, defibrillation, dobutamine, diazepam, if necessary - mechanical ventilation and indirect heart massage.

For the treatment of ventricular tachycardia, do not use antiarrhythmic drugs of IA and IC class.

Storage conditions

In the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Term hodnosty

3 years

Active ingredient

Lappaconitine hydrobrom Id



pharmacy terms and conditions

prescription

Form of Treatment

tablets

Appointment

for Adults on purpose doctor

Indications

Arrhythmia

Possible product names

Allaforte sustained-release tablets 50 mg 10 pcs.



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