Atp-long®

INSTRUCTIONS for medical use of the medicinal product АТФ-ЛОНГ® ATP-LONG®

Composition:

Active substance: 1 tablet contains ATP-LONG, calculated as 100% substance with the content of total adenine nucleotides 6.3 mg – 10 mg;

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

Pharmaceutical form. Menthol-flavored tablets.

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

Pharmacotherapeutic group.

Cardiological preparations. ATC code C01EB10.

Pharmacological properties.

Pharmacodynamics.

ATF-LONG® is a medicinal product of a new class of substances — multiligand coordination compounds 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 to this compound, which is not inherent to any of its individual chemical components (ATP, histidine, K+, Mg++).

ATF-LONG® affects metabolic processes in the myocardium, normalizes energy metabolism, enhances the activity of cellular membrane ion-transport systems, improves lipid composition of membranes, increases the activity of membrane-bound enzymes, enhances the myocardial antioxidant defense system, and exerts anti-ischemic, membrane-stabilizing, and antiarrhythmic effects in supraventricular tachycardia.

The drug provides an energy-sparing effect by inhibiting the activity of the enzyme 5'-nucleotidase, which regulates the rate of hydrolysis of energy substrates. ATF-LONG® prevents structural and functional damage to cardiomyocyte plasma membranes by maintaining the quantitative and qualitative lipid composition of membranes through inhibition of membrane-bound phospholipases. ATF-LONG® reduces the intensity of lipid peroxidation (LPO) processes, thereby decreasing the accumulation in membranes of hydrolysis and peroxidation products of phospholipid fatty acids, such as lysophospholipids, which possess strong detergent properties and can disrupt the contractile and rhythmic functions of the heart during ischemia. In experimental myocardial ischemia, the drug enhances the activity of Na+-K+-ATPase and Ca2+-Mg2+-ATPase, as well as the membrane calcium-binding potential. ATF-LONG® improves central and peripheral hemodynamics, coronary circulation, and normalizes myocardial contractility, thereby increasing physical performance. Under ischemic conditions, the drug reduces myocardial oxygen consumption, activates cardiac function, and increases cardiac output, thus reducing the frequency of angina attacks and dyspnea during physical exertion.

ATF-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).

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

Pharmacokinetics.

After administration, ATF-LONG® slowly degrades in the body, forming adenosine.

Clinical characteristics.

Indications.

To be used in complex therapy for:

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

Contraindications.

• Hypersensitivity to the drug and its components;
• acute myocardial infarction;
• cardiogenic shock 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 types of interactions.

ATP-LONG® must not be used concomitantly with cardiac glycosides due to increased risk of developing 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 preparations 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 effects of alpha- and beta-adrenoblockers, calcium channel blockers, and nitrates.

Special precautions for use.

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

During prolonged use, it is necessary to monitor blood levels of potassium and magnesium.

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 intolerance to glucose-galactose or sucrose-isomaltose. 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 the treatment period.

Ability to affect reaction rate when driving or operating machinery.

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

Dosage and Administration.

ATP-LONG® tablets should be taken sublingually and held under the tongue until completely dissolved. The single dose is 10−40 mg, 3−4 times daily, independently of food intake.

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

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

Children.

Not recommended for use in children.

Overdose.

Symptoms: possible development of bradycardia, atrioventricular block, arterial hypotension, and syncope associated with a sudden drop in blood pressure. Treatment: discontinue the drug and initiate symptomatic therapy. In case of bradycardia, administer atropine sulfate.

Adverse reactions.

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.

Prescription status. Over-the-counter (without prescription).

Manufacturer.

LLC "Pharmaceutical Company "FARCOС".

Address of manufacturer and location of business activity.

360, Sviato-Pokrovska Street, S/T Hostomel, Irpin, Kyiv region, 08290, Ukraine.

Marketing Authorization Holder.

LLC Pharmaceutical Company "FARCOС".

Address of Marketing Authorization Holder.

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