Allapinin tablets 25 mg - instructions for use, dose, side effects, contraindications

Active substanceLappakonitina hydrobromideLappakonitina hydrobromide

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Allapin® tablets 25 mg

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FARMTSENTR VILAR, ZAO Russia

Allaforte®

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FARMTSENTR VILAR, ZAO Russia

Dosage form: & nbsppills

Composition:

For one tablet:

Active substance:
Lappakonitina hydrobromide with concomitant alkaloids (Allapinin®) (in terms of 100% of the substance), or	0.025 g
Lappakonitina hydrobromide with concomitant alkaloids (Lappakonitina hydrobromide) (in terms of 100% of the substance)	0.025 g
Excipients:
Sugar (sugar), or sugar refined sugar or sugar	- 0.0655 g
Potato starch (sort "extra")	- 0.0075 g
Calcium stearate	- 0.001 g
Croscarmellose sodium	- 0.001 g
Weight of a tablet	- 0.1 g.

Description:Tablets are round, biconvex, white.

Pharmacotherapeutic group:Antiarrhythmic drug

ATX: & nbsp

C.01.B.G Other antiarrhythmic drugs I class

Pharmacodynamics:

Pharmacological properties

Allapinin® is a hydrobromic salt of the alkaloid lappakonitina with concomitant alkaloids, obtained from the grass of a white- Aconitum leucostomum Worosch. and rhizomes with the roots of the fighter of the north (high wrestler) Aconitum septentrionale Koelle (A. excelsum Reichenb.), sem. buttercup - Ranunculaceae.

Pharmacodynamics

Antiarrhythmic drug IC class.

It blocks "fast" sodium channels of cardiomyocyte membranes. Causes slowing of atrioventricular (AV) and intraventricular conduction, shortens the effective, and functional refractory periods of the atria, AV node, fascicle His fibers Purkinje, does not affect the duration of the interval QT, the conductivity along AV node in the anterograde direction, heart rate (heart rate) and blood pressure (BP), myocardial contractility (with the initial absence of heart failure). Does not inhibit the automaticity of the sinus node, does not have a negative inotropic effect, does not have antihypertensive and m-cholinolytic action.

Has mild antispasmodic, coronary dilatation, local anesthetic and sedative action.

When ingested, the effect develops in 40-60 minutes, reaches a maximum after 4-5 hours and lasts 8 hours or more.

Pharmacokinetics:

Ingestion lappaconitin hydrobromide quickly absorbed in the gastrointestinal tract, the maximum concentration in blood plasma is reached on average after 80 minutes. The bioavailability of lappaconitin hydrobromide is 56%, which is due to the effect of "primary transmission" through the liver.The main pharmacologically active metabolite is deacetyl lapaconitin. Half-life (T_1/2) is 1,2-2,4 hours. With prolonged use inside, an increase in T_1/2.

In chronic renal failure T_1/2increases 2-3 times, with cirrhosis of the liver - 3-10 times.

In chronic heart failure II-III functional class by classification NYHA absorption of lappaconitin hydrobromide is slow (the maximum concentration in the blood plasma is reached after 2 hours). It is excreted by the kidneys in a modified form (up to 28%), the rest - through the intestine.

Indications:Supraventricular and ventricular extrasystole, paroxysms of fibrillation and atrial flutter; paroxysmal supraventricular tachycardia, including those with Wolff-Parkinson-White syndrome (WPW), paroxysmal ventricular tachycardia (in the absence of organic changes in the myocardium).

Contraindications:

Hypersensitivity to the drug, sinoatrial blockade, AV blockade of II and III degree (without artificial pacemaker), cardiogenic shock, blockade of the right leg of the bundle of His, combined with the blockade of one of the branches of the left leg, severe arterial hypotension (systolic blood pressure less than 90 mm Hg), moderate and severe chronic heart failure III-IV functional class by classification NYHA, severe left ventricular myocardial hypertrophy (≥1.4 cm), the presence of myocardial infarction, severe liver and / or kidney disease, age 18 years (efficacy and safety have not been established), fructose intolerance syndrome and disorders absorption of glucose / galactose deficiency or sucrase / isomaltase (preparation comprisessucrose).

Carefully:Carefully apply with AV blockade of I degree, violation of intraventricular conduction, sick sinus syndrome (SSS), bradycardia, expressed serious disturbances of peripheral circulation, angle-closure glaucoma, benign prostatic hypertrophy, conduction abnormalities on Purkinje fibers, blockade of a bundle branch block, disturbance of water-electrolyte metabolism (hypokalemia, hyperkalemia, hypomagnesaemia), simultaneous reception of other antiarrhythmic means

Pregnancy and lactation:

Application of the drug Allapinin® in pregnancy is not recommended. Perhaps the use of the drug only for health reasons, if the expected benefit to the mother outweighs the potential risk to the fetus / baby.

There is no data on the isolation of lappaconitin hydrobromide in breast milk.The use of the drug is not recommended during breastfeeding. If the use of the drug during lactation is necessary, breastfeeding should be discontinued.

Dosing and Administration:

Inside, after eating, squeezed a small amount of water at room temperature, do not grind.

Take 1 tablet (25 mg) every 8 hours, with no therapeutic effect - every 6 hours.

It is possible to increase the single dose to 2 tablets (50 mg) every 6-8 hours. The maximum daily dose is 300 mg (12 tablets).

The duration of treatment and correction of the dosing regimen (increase in dose) is determined by the doctor.

Side effects:

When using the drug, dizziness, headache, a feeling of heaviness in the head, hyperemia of the skin, ataxia, diplopia, allergic reactions, possible intraventricular and AV conduction, sinus tachycardia (with prolonged use), arrhythmogenic action.

ECG changes: lengthening of the interval PQ, expansion of the complex QRS.

Overdose:

Symptoms: has a small therapeutic latitude, so heavy intoxication can easily occur (especially with the simultaneous use of other antiarrhythmics): lengthening intervals PR and QT, expansion of the complex QRS, an increase in the amplitude of the T wave, bradycardia, sinoatrial and AV blockade, asystole, paroxysms of polymorphic ventricular tachycardia, decreased myocardial contractility, marked decrease in blood pressure; dizziness, blurred vision, headache, gastrointestinal disorders.

Treatment: symptomatic; for the treatment of ventricular tachycardia, do not use antiarrhythmics IA or IC class; sodium hydrogen carbonate can eliminate the expansion of the complex QRS, bradycardia and arterial hypotension.

Interaction:

Inducers of microsomal liver enzymes reduce efficacy, increase the risk of toxic effects of lappaconitin hydrobromide.

With the simultaneous use of lappaconitin hydrobromide with other antiarrhythmic agents, the risk of arrhythmogenic action increases.

Lappakonitina hydrobromide enhances the effect of nondepolarizing muscle relaxants.

Special instructions:

Before the beginning application of the drug Allapinin®, it is necessary to eliminate disturbances in water-electrolyte metabolism, during the period of therapy a control of the water-electrolyte balance of blood is necessary.

In patients who underwent acute myocardial infarction or in patients with heart failure, as well as in patients with an established pacemaker, the threshold of its stimulation may increase.

With the development of headache, dizziness, diplopia should reduce the dose of the drug Allapinin®.

When sinus tachycardia occurs against a background of prolonged use preparation shows the use of beta-blockers (low doses).

1 tablet of the drug Allapinin® contains 0.074 g of carbohydrates, which corresponds to 0.01 XE (bread units).

Effect on the ability to drive transp. cf. and fur:

When using the drug, care should be taken when carrying out potentially hazardous activities requiring special attention and quick reactions (transport management, work with moving mechanisms).

Form release / dosage:Tablets, 25 mg.

Packaging:

For 10 or 30 tablets in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.

One, two, three or five contour cell packs No. 10 or one outline cell packing No. 30 together with a medical instruction are placed in a pack of cardboard for the consumercontainers.

Storage conditions:

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

Keep out of the reach of children.

Shelf life:5 years. Do not use after expiry date.

Terms of leave from pharmacies:On prescription

Registration number:P N000405 / 02

Date of registration:15.08.2007 / 01.08.2011

Expiration Date:Unlimited

The owner of the registration certificate:FARMTSENTR VILAR, ZAO FARMTSENTR VILAR, ZAO Russia

Manufacturer: & nbsp

FARMTSENTR VILAR, ZAO Russia

Representation: & nbspFARMCENTER VILAR CJSC FARMCENTER VILAR CJSC Russia

Information update date: & nbsp07.07.2017

Illustrated instructions

Instructions

Allapin® tablets 25 mg (Allapinin®)