Atp-long®

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT ATP-LONG® ATP-LONG®

Composition:

Active substance: 1 tablet contains ATP-LONG®, recalculated to 100% substance — 20 mg (containing total adenine nucleotides — 12.6 mg);

Excipients: menthol, sugar powder; lactose monohydrate; magnesium stearate; colloidal anhydrous silicon dioxide.

Pharmaceutical form. Menthol-flavored tablets.

Main physicochemical properties: white, round tablets with a flat surface and beveled edges, with a bevel and a score line on one side.

Pharmacotherapeutic group.

Cardiological agents. ATC code C01E B10.

Pharmacological properties.

Pharmacodynamics.

ATP-LONG® is a medicinal product of a new class of compounds — multiligand coordination complexes with macroergic phosphates. Its molecule consists of adenosine-5'-triphosphate (ATP), the amino acid histidine, and magnesium and potassium salts, producing a unique pharmacological effect specific only to this compound, which is not inherent to any individual chemical component (ATP, histidine, K+, Mg++).

ATP-LONG® affects metabolic processes in the myocardium, normalizes energy metabolism, membrane ion-transport system activity, membrane lipid composition, activity of membrane-bound enzymes, improves the myocardial antioxidant defense system, exerts anti-ischemic and membrane-stabilizing actions, and has an antiarrhythmic effect in supraventricular tachycardia.

The medicinal product has an energy-sparing effect due to inhibition of the enzyme 5'-nucleotidase activity, which regulates the rate of hydrolysis of energy substrates. ATP-LONG® prevents structural and functional damage to cardiomyocyte plasma membranes by maintaining the quantitative and qualitative composition of membrane lipids and by inhibiting the activity of membrane-bound phospholipases. ATP-LONG® reduces the intensity of lipid peroxidation (LPO) processes, thereby decreasing the accumulation in membranes of hydrolysis and peroxidation products of fatty acid phospholipids, lysophospholipids, which have pronounced detergent properties and the ability to induce disturbances in cardiac contractile and rhythmic activity during ischemia. In experimental myocardial ischemia, the drug increases the activity of Na+-K+-ATPase and Ca2+, Mg2+-ATPase, as well as the membrane calcium-binding potential. ATP-LONG® improves central and peripheral hemodynamic parameters, coronary circulation, and normalizes myocardial contractility, resulting in enhanced physical performance. Under ischemic conditions, the drug reduces myocardial oxygen consumption, activates cardiac functional status, increases cardiac output, thereby reducing the frequency of angina attacks and dyspnea during physical exertion.

ATP-LONG® restores normal sinus rhythm in patients with paroxysmal supraventricular tachycardia, atrial fibrillation and flutter, and also reduces the activity of ectopic rhythm foci (atrial and ventricular extrasystoles).

ATP-LONG® normalizes tissue concentrations of potassium and magnesium and reduces uric acid concentration.

Pharmacokinetics.

After administration into the body, ATP-LONG® slowly degrades, forming adenosine.

Clinical characteristics.

Indications.

Use in complex therapy:

• ischemic heart disease, stable and unstable angina pectoris, exertional angina, and angina with documented coronary spasm;
• previous myocardial infarction, post-infarction myocardial syndrome (diffuse and focal cardiosclerosis), ischemic cardiomyopathy;
• cardiac arrhythmias;
• neurocirculatory asthenia, cardiogenic neurosis;
• cardiomyopathies;
• myocarditis;
• fatigue syndrome.

Contraindications.

• Hypersensitivity to the drug and its components;
• acute myocardial infarction;
• cardiogenic and other types of shock;
• obstructive diseases of the bronchopulmonary system;
• severe forms of bronchial asthma;
• sinoatrial block;
• second- and third-degree atrioventricular block;
• hyperkalemia, hypermagnesemia;
• hemorrhagic stroke.

Interaction with other medicinal products and other forms of interactions.

ATP-LONG® must not be used concomitantly with cardiac glycosides due to increased risk of atrioventricular block.

Concomitant use with potassium-sparing diuretics, potassium supplements, and ACE inhibitors increases the risk of hyperkalemia; concomitant use with Magnesia and other magnesium-containing products increases the risk of hypermagnesemia.

Dipyridamole enhances the therapeutic effect of ATP-LONG®; whereas xanthinol nicotinate, caffeine, theophylline, and aminophylline reduce it.

ATP-LONG® may enhance the antianginal effect of alpha- and beta-adrenoblockers, calcium channel blockers, and nitrates.

Special precautions for use.

Use with caution in cases of pronounced arterial hypotension; concomitantly with cardiac glycosides (due to increased risk of developing atrioventricular block), and in patients predisposed to bronchospasm.

During prolonged use, serum potassium and magnesium levels should be monitored.

The medicinal product contains sucrose and lactose; therefore, patients with diabetes mellitus should use the drug with caution. The drug is contraindicated in patients with hereditary glucose-galactose malabsorption or hereditary sucrase-isomaltase deficiency. Consumption of products containing caffeine (coffee, tea, cola drinks) should be limited.

Use during pregnancy or breastfeeding.

There are no clinical data on the safety and efficacy of the drug during pregnancy; therefore, its use in pregnant women is contraindicated. Breastfeeding should be discontinued during treatment.

Ability to influence reaction rate when driving or operating machinery.

If dizziness or hypotension occurs during treatment with the drug, patients should refrain from driving or operating machinery.

Dosage and Administration

ATF-LONG® tablets should be taken sublingually (under the tongue) and held until completely dissolved. The single dose is 10*–40 mg, 3–4 times daily, independent of food intake.

In acute cardiac conditions (angina attack, arrhythmia), ATF-LONG® tablets should be taken at a dose of 10*–80 mg until improvement of symptoms. The maximum daily dose is 160 mg.

The treatment duration is determined by a physician; on average, it lasts 20–30 days. If necessary, the course may be repeated after 10–15 days.

* Use at the appropriate dosage strength.

Children

Do not use in children.

Overdose

Symptoms: possible development of bradycardia, atrioventricular block, arterial hypotension, and syncope due to sudden drop in blood pressure.
Treatment: discontinue the drug and initiate symptomatic therapy. Administer atropine sulfate for bradycardia.

Side effects.

From the skin and subcutaneous tissue: skin rashes, itching, facial hyperemia, Quincke's edema.

From the respiratory system: bronchospasm.

From the cardiovascular system: decreased arterial pressure, tachycardia, atrioventricular block, coronary artery spasm, which may lead to myocardial infarction.

From the gastrointestinal tract: nausea, epigastric discomfort, increased gastrointestinal motility.

From the urinary system: increased diuresis.

From the nervous system: headache, dizziness.

From the vascular system: sensation of warmth.

From the immune system: allergic reactions, including skin rashes, itching, Quincke's edema.

With prolonged and uncontrolled use – hyperkalemia or hypermagnesemia.

Shelf life. 3 years.

The medicinal product should not be used after the expiry date stated on the packaging.

Storage conditions.

Store in the original packaging at a temperature not exceeding +25 °C.

Keep out of reach of children.

Packaging.

10 tablets per blister; 3 or 4 blisters per carton, labeled in Ukrainian and Russian languages.

Availability category. Over-the-counter.

Manufacturer.

LLC "Pharmaceutical Company "Pharmacos".

Manufacturer's address and location of business activity.

360, Svyato-Pokrovska Street, town of Hostomel, city of Irpin, Kyiv region, Ukraine, 08290.

Marketing Authorization Holder.

LLC Pharmaceutical Company "Pharmacos".

Address of the Marketing Authorization Holder.

50-A, Zodchykh Street, Kyiv, Ukraine, 03162.