Atf-long®

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

Composition:

Active substance: 1 tablet contains ATP-LONG equivalent to 100% substance with a content of total adenine nucleotides 6.3 mg – 10 mg;

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

Pharmaceutical form. Tablets.

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

Pharmacotherapeutic group.

Cardiological agents. ATC code C01EB10.

Pharmacological Properties.

Pharmacodynamics.

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

ATF-LONG® affects metabolic processes in the myocardium, normalizes energy metabolism, the activity of ion-transport membrane systems of cells, lipid composition of membranes, and the activity of membrane-bound enzymes. It improves the antioxidant defense system of the myocardium, exerts anti-ischemic and membrane-stabilizing actions, 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. ATF-LONG® prevents structural and functional damage to cardiomyocyte plasma membranes by maintaining the quantitative and qualitative composition of membrane lipids, through inhibition of membrane-bound phospholipase activity. ATF-LONG® suppresses the intensity of lipid peroxidation (LPO) processes, thereby reducing the accumulation in membranes of hydrolysis and peroxidation products of fatty acid phospholipids, such as lysophospholipids, which possess pronounced detergent properties and can induce disturbances in the contractile and rhythmic activity of the heart during ischemia. In experimental myocardial ischemia, the drug increases the activity of Na+-K+-ATPase and Ca2+-Mg2+-ATPase, as well as the calcium-binding potential of the membrane. ATF-LONG® improves indices of central and peripheral hemodynamics, coronary circulation, and normalizes myocardial contractility, thereby enhancing physical performance. Under ischemic conditions, the drug reduces myocardial oxygen consumption, activates cardiac functional status, 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 into the body, ATF-LONG® slowly degrades, forming adenosine.

Clinical characteristics.

Indications.

Use as part of combination therapy for:

• ischemic heart disease, stable and unstable angina pectoris, exertional angina, and angina with documented vascular spasm;
• 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 or any of 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 forms of interaction.

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 (Magnesium sulfate) and other magnesium-containing preparations 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 effect of alpha- and beta-adrenergic blockers, 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 predisposed to bronchospasm.

During prolonged use, monitor serum potassium and magnesium levels.

The medicinal product contains sugar powder and lactose; therefore, it should be used with caution in patients with diabetes mellitus. The drug is contraindicated in patients with hereditary glucose-galactose malabsorption or hereditary sucrase-isomaltase deficiency. Consumption of products containing caffeine (coffee, tea, cola-containing beverages) 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 influence reaction rate while 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.

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, regardless of food intake.

In acute cardiac conditions (angina attack, arrhythmia), ATF-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 a physician; on average, it lasts 20−30 days. If necessary, the course may be repeated after 10−15 days.

Children.

Do not use in children.

Overdose.

Symptoms: bradycardia, atrioventricular block, arterial hypotension, and syncope associated with a sudden drop in blood pressure may occur. 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, or 1 blister without secondary packaging.

Supply category. Over-the-counter.

Manufacturer.

Pharmaceutical Company "Farkos" LLC.

Manufacturer's location and address of business activity.

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

Marketing authorization holder.

Pharmaceutical Company "Farkos" LLC.

Address of the marketing authorization holder.

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