Atf-long®

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

Composition:

Active substance: 1 tablet contains ATP-LONG calculated to 100% substance – 20 mg
(containing total adenine nucleotides 12.6 mg);

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

Medicinal form. Tablets.

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

Pharmacotherapeutic group.
Cardiological preparations. ATC code: C01EB10.

Pharmacological properties.

Pharmacodynamics.

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

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

The medicinal product provides an energy-sparing effect by inhibiting the activity of the enzyme 5'-nucleotidase, which regulates the rate of hydrolysis of energy substrates. ATP-LONG® prevents structural and functional damage to cardiomyocyte plasma membranes by maintaining quantitative and qualitative membrane lipid composition, through inhibition of membrane-bound phospholipase activity. 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, such as lysophospholipids, which possess pronounced detergent properties and can provoke disturbances in cardiac contractile and rhythmic activity 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 capacity. ATP-LONG® improves parameters of central and peripheral hemodynamics and coronary blood flow, normalizes myocardial contractility, resulting in increased physical performance. Under ischemic conditions, the drug reduces myocardial oxygen consumption, activates cardiac functional state, 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 with formation of adenosine.

Clinical characteristics.

Indications.

To be used in complex therapy for:

• ischemic heart disease, stable and unstable angina, exertional angina, and angina with documented vasospasm;
• previous myocardial infarction, post-infarction myocardial syndrome (diffuse and focal cardiosclerosis), ischemic cardiomyopathy;
• cardiac arrhythmias;
• neurocirculatory dystonia, 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.

ATF-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 drugs increases the risk of hypermagnesemia.

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

ATF-LONG® may enhance the antianginal effects 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 atrioventricular block), and in patients with a tendency towards bronchospasm.

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

The medicinal product contains powdered sugar 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.

Clinical data on the safety and efficacy of the drug during pregnancy are lacking; therefore, its use in pregnant women is contraindicated. Breastfeeding should be discontinued during the treatment period.

Ability to affect reaction speed when driving or operating machinery.

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

Dosage and Administration.

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

In acute cardiac conditions (angina attack, arrhythmia), ATF-LONG® tablets should be taken at a dose of 10*–80 mg until the condition improves. Maximum daily dose — 160 mg.

The treatment duration is determined by a physician, averaging 20–30 days. If necessary, the course can be repeated after 10–15 days.

* Use in the appropriate dosage.

Children.

Not recommended for use in children.

Overdose.

Symptoms: possible development of bradycardia, atrioventricular block, arterial hypotension, and syncope associated with 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 in a blister; 3 or 4 blisters per carton labeled in Ukrainian and Russian languages; 1 blister without secondary packaging.

Dispensing category. Over-the-counter.

Manufacturer.

LLC "Pharmaceutical Company "PharCoS".

Manufacturer's address and place of business.

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

Marketing Authorization Holder.

LLC Pharmaceutical Company "PharCoS".

Address of the Marketing Authorization Holder.

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