Allaforte sustained release pills 50mg, 10pcs

Composition

For 1 tablet: Active ingredient: Lappaconitine hydrobromide (Allapinine) (based on 100% of the substance) 0.050 GW Auxiliary substances: pregelatinized starch, lactose monohydrate, hypromellose, calcium stearate, colloidal silicon dioxide (aerosil A-380) – sufficient amount to obtain a tablet weighing 0.350 g

Pharmacological action

The Active ingredient of the preparation is a hydrobromic salt of the alkaloid lappaconitin with concomitant alkaloids, obtained from the grass of the white – tailed wrestler or from the rhizomes and roots of the white – tailed wrestler – Aconitum leucostomum Worosch., or from the rhizomes with roots of the northern wrestler (high wrestler) – Aconitum septentrionale Koelle (A. excelsum Reichenb. ), buttercup family-Ranunculaceae, or from the technical sum alkaloids of the buttercup family.

Indications

Supraventricular and ventricular extrasystole, paroxysmal form of atrial fibrillation and flutter, paroxysmal supraventricular tachycardia, including in Wolf-Parkinson-White syndrome, paroxysmal ventricular tachycardia (in the absence of organic changes in the myocardium).

Use during pregnancy and lactation

Animal studies have shown that lappaconitin hydrobromide in doses of 1-5 mg / kg does not have a teratogenic and embryotoxic effect. The use of the drug during pregnancy is not recommended due to the lack of controlled studies. It is possible to use the drug only for vital indications, if the intended benefit to the mother exceeds the potential risk of side effects in the fetus/child. There are no data on the excretion of lappaconitin hydrobromide in breast milk. The use of the drug is not recommended during breastfeeding. If the use of Allaforte during lactation is necessary, breast-feeding should be discontinued.

Recommendations for use

The drug should be started under the supervision of a doctor. Inside, after eating, swallowing the tablet whole and drinking a small amount of water at room temperature. Tablets are strictly forbidden to break, crush or chew!The dose of Allaforte is selected individually. Treatment should begin with the appointment of tablets of 25 mg every 8 hours. In the absence or insufficiency of a therapeutic effect, the dose should be increased – tablets of 25 mg every 6 hours or tablets of 50 mg every 12 hours. To judge the therapeutic effect of the drug at its first use or with an increase in its dose, it is necessary not earlier than after 2-3 days of regular use of the drug. To prevent undesirable effects of the drug on the cardiac conduction system, its use and dose increase should be monitored using an ECG. It is advisable to register an ECG 1-2 hours after taking the next single dose of the drug. If the PQ interval is prolonged to 300 ms or a higher degree of atrioventricular block develops, the dose should be reduced, if necessary, temporarily discontinuing treatment. It is safe to extend the QRS complex by up to 25% of the initial value, but the QRS duration should not exceed 140 ms. It is unacceptable to extend the QRS complex beyond 50% of the original value or more than 160 ms! The maximum daily dose of the drug is 100 mg (25 mg 4 times a day or 50 mg 2 times a day). In a dose of more than 100 mg per day, the drug is not recommended due to the lack of controlled clinical studies. Transfer of patients taking Allapinin to treatment with Allaforte is carried out by simple replacement, starting from the moment of the next intake of one drug to another with the same doses and the interval between doses. The duration of treatment and adjustment of the dosage regimen (increasing the dose) is determined by the doctor.

Contraindications

Hypersensitivity to the components of the drug, sinoatrial blockade, AV blockade of II and III degrees (without an artificial pacemaker), cardiogenic shock, blockage of the right bundle branch combined with blockage of one of the branches of the left leg, severe arterial hypotension (systolic blood pressure less than 90 mm Hg), chronic heart failure of NYHA functional class III-IV, severe left ventricular hypertrophy (≥1.4 cm), the presence of post-infarction cardiosclerosis, acute coronary syndrome, Brugada syndrome, arrhythmogenic cardiomyopathy (dysplasia) of the right ventricle, severe liver and/or kidney dysfunction, age up to 18 years, lactose intolerance, lactase deficiency or glucose-galactose malabsorption, long or short QT syndrome, heart defects, arrhythmogenic effect of any antiarrhythmic drug in the anamnesis, pregnancy, breastfeeding, alcohol abuse, grade I AV block with a prolonged PQ interval of more than 200 ms, dilated cardiomyopathy, restrictive cardiomyopathy, myocarditis, no antiarrhythmic effect during treatment with Allapinin in the anamnesis.

Side effects

According to the World Health Organization, adverse events are classified according to their frequency as follows: very common (≥10% of prescriptions); common (≥1% and <10%); uncommon (≥0.1% and <1%); rare (≥0.01% and <0.1%); very rare (Disorders of the nervous system are very common: dizziness, headache, a feeling of heaviness in the head, ataxia. Disorders of the skin and subcutaneous tissues often: allergic reactions, hyperemia of the skin. Visual disturbances are very common: diplopia. Cardiac disorders very often: violations of intraventricular and AV conduction; ECG changes: prolongation of the PQ interval, expansion of the QRS complex; often: sinus tachycardia (with prolonged use), increased blood pressure; infrequently: arrhythmogenic effect.

Interaction

Inducers of microsomal liver enzymes do not affect the effectiveness of lappaconitin hydrobromide. Lappaconitin hydrobromide enhances the effect of non-depolarizing muscle relaxants. Concomitant use of lappaconitine hydrobromide with other antiarrhythmic agents increases the risk of side effects associated with the effect on sinus node function and atrioventricular conduction. Individual selection of doses of each of these drugs is required. In a clinical study, when using lappaconitin hydrobromide against the background of standard antihypertensive therapy with angiotensin-converting enzyme inhibitors, angiotensin II receptor antagonists, “slow” calcium channel blockers of dihydropyridine derivatives, beta-blockers, no increase or weakening of the antihypertensive effect was observed. There are no data on the adverse effects of lappaconitin hydrobromide on the efficacy and safety of indirect anticoagulants.

Overdose

The drug has a small therapeutic breadth, so severe intoxication can easily occur (especially with the simultaneous use of other antiarrhythmic agents). Symptoms: prolongation of the PQ and QT interval, expansion of the QRS complex, increased T wave amplitude, bradycardia, sinoatrial and atrioventricular block, asystole, paroxysms of polymorphic ventricular tachycardia, decreased myocardial contractility, pronounced decrease in blood pressure, dizziness, blurred vision, headache, gastrointestinal disorders. Treatment: symptomatic, gastric lavage, defibrillation, use of dobutamine, diazepam; if necessary, artificial ventilation of the lungs and indirect heart massage. For the treatment of ventricular tachycardia, do not use class IA and IC antiarrhythmics.

Storage conditions

In a place protected from light, at a temperature not exceeding 25 °C. Keep out of reach of children.

Shelf life

3 years

Active ingredient

Lappaconitine hydrobromide

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Description

For adults as directed by your doctor

Indications

Arrhythmia