Active substanceTrifosadeninTrifosadenin
Dosage form: & nbspsolution for intravenous administration
Composition:

1 ml of the solution contains:

active substance: sodium adenosine triphosphate disubstituted 10.00 mg;

Excipients: sodium hydroxide solution of 2M to pH 7.0 - 7.3, water for injection up to 1 ml.

Description:Transparent, colorless or slightly yellowish liquid.
Pharmacotherapeutic group:Metabolic means
ATX: & nbsp

C.01.E.B   Other drugs for the treatment of heart disease

Pharmacodynamics:

Metabolic agent, has antihypertensive and antiarrhythmic effect, dilates coronary and cerebral arteries. Is a natural macroergic compound. It is formed in the body as a result of oxidative reactions and in the process of glycolytic digestion of carbohydrates. Contained in many organs and tissues, but most of all - in skeletal muscles.

Improves metabolism and energy supply of tissues. Splitting into ADP and inorganic phosphate, trifosadenine releases a large amount of energy used for muscle contraction, protein synthesis, urea, intermediate products of metabolism, etc. Subsequently, decay products are included in the resynthesis of ATP. Under the influence of trifosadenin, there is a decrease in blood pressure and relaxation of smooth muscles, nerve impulses are improved in the autonomic ganglia and transmission of excitation with n.vagus on the heart, increases the contractility of the myocardium. Trifosadenin suppresses automatism of the sinus-atrial node and Purkinje fibers (blockade of Ca2+channels and an increase in permeability for K+).

It is not possible to track the kinetics of parenterally administered ATP because of the high voltage of various reactions taking place with the participation of its own ATP. At the same time, it is known that sodium adenosine triphosphate rapidly disintegrates at the injection site at adenosine and phosphate residues, which are further used for the synthesis of new ATP molecules.

Indications:

Suppression of paroxysms of supraventricular tachycardia (excluding fibrillation and / or atrial flutter).

Contraindications:

Hypersensitivity to the drug, acute myocardial infarction, severe arterial hypotension, severe bradycardia, sinus node weakness syndrome, atrioventricular blockade of II-III degree (with the exception of patients with an artificial pacemaker), chronic obstructive pulmonary disease, bronchial asthma, elongated interval syndrome QT, acute and chronic heart failure in the stage of decompensation, pregnancy, lactation, age under 18 years.

Children

The experience of using the drug in children (under 18 years) is absent.

Carefully:

Bradycardia, atrioventricular block of the 1st degree, blockade of the bundle of the bundle, fibrillation and atrial flutter, arterial hypotension, ischemic heart disease, hypovolemia, pericarditis, stenosis of the heart valves, arteriovenous shunt "left to right", cerebral circulatory insufficiency, conditions after heart transplantation (less 1 year).

Pregnancy and lactation:

Data on the use of the drug during pregnancy and breastfeeding are absent.

Dosing and Administration:

The drug is injected intravenously rapidly into the central or large peripheral vein,3 mg for 2 seconds under ECG monitoring and blood pressure; if necessary, after 1-2 minutes, re-enter 6 mg, after 1-2 minutes - 12 mg.

Treatment is stopped when the AV blockade develops at any of the stages of administration.

Side effects:

The incidence of side effects is classified according to the recommendations of the World Health Organization: very often - more than 1/10; often more than 1/100 and less than 1/10; infrequently - more than 1/1000 and less than 1/100; rarely - more than 1/10000 and less than 1/1000; very rarely - more than 1/10000; The frequency is not set (the frequency can not be estimated from the available data).

From the side of the cardiovascular system: Very often - a rush of blood to the skin, discomfort in the chest (the feeling of "compression of the" pain), bradycardia, sinus arrest, atrioventricular block, various atrial and ventricular premature beats, ventricular tachycardia; infrequently - sinus tachycardia, palpitation; very rarely - atrial fibrillation, severe bradycardia not cropped atropine and requires setting an artificial pacemaker, ventricular fibrillation, tachycardia type "pirouette"; frequency is not established - a marked decrease in blood pressure, asystole / cardiac arrest,sometimes fatal (in patients with ischemic heart disease).

From the central nervous system: often - headache, dizziness, various phobias; infrequently - a feeling of "pressure" in the head; very rarely transient increased intracranial pressure; frequency not established - loss of consciousness / fainting, convulsions.

From the side of the organ of vision: infrequently - impaired vision.

From the respiratory system: very often - shortness of breath; infrequently - rapid breathing; very rarely - bronchospasm; frequency not established - respiratory failure, apnea / respiratory arrest.

From the gastrointestinal tract: often - nausea; infrequently - a metallic taste in the mouth; frequency not established - vomiting.

Other: infrequently - increased sweating, weakness; very rarely - reactions at the injection site (sensation of "tingling").

Overdose:

Symptoms: can be manifested by dizziness, arterial hypotension, short-term loss of consciousness, arrhythmia.

Treatment: the drug is immediately discontinued (due to a short half-life, the side effects quickly go away). If necessary, the introduction of xanthines (theophylline, aminophylline), which are competitive antagonists of trifosadenin and reduce its effect.

Interaction:

Dipyridamole - dipyridamole enhances the action of trifosadenin, in some cases up to asystole, therefore, simultaneous administration of drugs is not recommended. If it is necessary to administer trifosadenin, it is necessary to stop treatment with dipyridamole 24 hours before the administration of trifosadenin or reduce its dose.

Derivatives of purine (coffeine and theophylline) and xanthinal nicotinate - aminophylline, theophylline and other xanthines are competitive antagonists of trifosadenin, their use should be avoided within 24 hours before the administration of trifosadenin.

Xanthine-containing products (including tea, coffee, chocolate) should not be consumed 12 hours before the administration of the drug.

Carbamazepine can enhance the inhibitory effect of trifosadenin on atrioventricular conduction, which can lead to a complete atrioventricular blockade

Do not administer simultaneously with cardiac glycosides in large doses, as the risk of developing adverse reactions from the cardiovascular system increases.

Special instructions:

The introduction of the drug, as a rule, should be carried out only intravenously under medical supervision, while monitoring the function of the heart and blood pressure.

Because of the risk of developing arterial hypotension, the drug should be used with caution in patients with ischemic heart disease, hypovolemia, pericarditis, stenosis of the heart valves, arteriovenous shunt "from left to right," cerebral circulatory insufficiency. Sodium adenosine triphosphate-Darnitsa should be used with caution in patients who have recently had myocardial infarction, with severe chronic heart failure, a violation of the conduction system of the heart (atrioventricular blockade of the 1st degree, blockage of the bundle of the bundle) because of the possibility of their aggravation with the administration of the drug. With the development of angina pectoris, severe bradycardia, arterial hypotension, respiratory failure or asystole / cardiac arrest, the drug should be discontinued. The drug can cause seizures in predisposed patients (seizures in a history of various origins).

Previously, the drug was used for the following indications (currently due to low efficacy, the following indicationsare excluded): muscular dystrophy and atrophy, poliomyelitis, multiple sclerosis, coronary insufficiency, postinfarction cardiomyodystrophy, acute and chronic cardiovascular insufficiency, obliterating arterial diseases - intermittent claudication, Raynaud's disease, thromboangiitis obliterans (Buerger's disease), hereditary retinal pigmentary degeneration , weakness of labor.

Effect on the ability to drive transp. cf. and fur:The effect of the drug on the ability to drive vehicles and other mechanisms has not been studied.
Form release / dosage:Solution for intravenous administration.
Packaging:

1 ml in the ampoule.

It is allowed to paste a label with self-adhesive paper on the ampoule.

5 ampoules with a knife for opening ampoules or a scarifier ampoule in a contour cell box (cassette).

Two contour squares with instructions for medical use in the pack.

By 10 ampoule with a knife for opening ampoules or ampoule scapegrator in a contour cell (cassette). By 1 outline cell pack with instructions for medical application in a pack. For 10 ampoules with instructions for medical application, a knife for opening ampoules or a scarifier ampoule in the box with the corrugated liner. A box is pasted with a label-parcel post.

When packaging ampoules with a color break ring either a break point, A knife for opening ampoules or a scarifier ampoule is not embedded.

Storage conditions:

Store in the original packaging at a temperature of 2 ° C to 8 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription
Registration number:П N010635
Date of registration:25.04.2012 / 25.04.2013
Expiration Date:Unlimited
The owner of the registration certificate:DARNITSA PHARMACEUTICAL FIRM, CJSCDARNITSA PHARMACEUTICAL FIRM, CJSC Ukraine
Manufacturer: & nbsp
Information update date: & nbsp26.05.2018
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