ATP-CARDIO

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT ATF-CARDIO (ATF-CARDIO)

Composition:

Active substance:

1 tablet contains adenosine-5′-triphosphate-histidinate-magnesium(II)-tripotassium salt octahydrate – 10 mg or 20 mg, corresponding to a content of total adenine nucleotides of 6.3 mg or 12.6 mg, respectively;

Excipients: sucrose, lactose monohydrate, corn starch, calcium stearate, sodium benzoate (E 211), colloidal anhydrous silicon dioxide.

Pharmaceutical form. Tablets.

Main physicochemical properties:

10 mg tablets: white, with flat surface and bevel;

20 mg tablets: white, with flat surface, bevel and score line.

Pharmacotherapeutic group. Cardiological medicinal products. Other cardiological medicinal products. Adenosine. ATC code C01EB10.

Pharmacological Properties.

Pharmacodynamics.

ATF-CARDIO is a medicinal product of a new class of substances, whose molecule consists of adenosine-5'-triphosphate (ATP), the amino acid histidine, and magnesium and potassium salts, exerting a unique pharmacological effect specific to this compound and not inherent to any of its individual chemical components.

ATF-CARDIO stimulates energy metabolism, normalizes the concentration of potassium and magnesium ions in tissues, improves the myocardial antioxidant defense system, and reduces uric acid concentration. It exerts anti-ischemic, membrane-stabilizing, and antiarrhythmic effects by normalizing metabolic processes in the myocardium during ischemia and hypoxia. It improves indices of central and peripheral hemodynamics and coronary circulation, enhances myocardial contractility, improves left ventricular function, and increases cardiac output, thereby improving physical performance, reducing the frequency of angina attacks and dyspnea during physical exertion. The medicinal product restores normal sinus rhythm in patients with paroxysmal supraventricular and supraventricular tachycardia, atrial fibrillation and flutter, and also reduces the activity of ectopic rhythm foci (atrial and ventricular extrasystoles).

Pharmacokinetics.

After administration, ATF-CARDIO slowly degrades in the body with the formation of adenosine.

Clinical characteristics.

Indications.

In complex therapy:

• ischemic heart disease, unstable angina, angina at rest and on exertion;
• post-infarction and myocarditis-induced cardiac sclerosis (diffuse and focal cardiac sclerosis);
• cardiac arrhythmias;
• vegetative-vascular dystonia;
• myocardiodystrophy;
• myocarditis;
• chronic fatigue syndrome.

Used to improve tolerance to physical exertion.

Contraindications.

• Hypersensitivity to the components of the drug;
• acute myocardial infarction;
• cardiogenic shock and other types of shock;
• obstructive diseases of the bronchopulmonary system;
• severe forms of bronchial asthma;
• sinoatrial block of grade II-III;
• atrioventricular (AV) blocks of grade II-III;
• hyperkalemia, hypermagnesemia;
• hemorrhagic stroke.

Interaction with other medicinal products and other types of interactions.

Cardiac glycosides: increased risk of developing atrioventricular block.

Potassium-sparing diuretics, potassium supplements, and ACE inhibitors: increased risk of hyperkalemia.

Magnerot and other magnesium-containing drugs: may lead to hypermagnesemia.

Dipyridamole enhances the therapeutic effect of ATP-CARDIO.

Xanthinol nicotinate, caffeine, theophylline, aminophylline: reduce the therapeutic effect of ATP-CARDIO.

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

Special precautions for use.

Use with caution:

• in pronounced arterial hypotension;
• with cardiac glycosides due to increased risk of atrioventricular block.

During prolonged use, monitoring of blood potassium and magnesium levels is required.

Prescribe with caution in patients with predisposition to bronchospasm.

The drug contains sucrose and lactose; therefore, patients with diabetes mellitus should use the drug with caution. The drug is contraindicated in patients with hereditary fructose intolerance, glucose-galactose malabsorption, or sucrose-isomaltase deficiency.

Limit consumption of products containing caffeine (coffee, tea, cola drinks).

Use during pregnancy or breastfeeding.

Use in pregnant women is contraindicated.

Breastfeeding should be discontinued during treatment.

Ability to affect reaction rate while driving or operating machinery.

If dizziness or decreased arterial pressure occurs during treatment, patients should refrain from driving or operating vehicles and machinery.

Method of Administration and Dosage.

ATF-CARDIO tablets should be administered sublingually and held under the tongue until completely dissolved. The single dose is 10–40 mg, 3–4 times daily, regardless of food intake. 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. Maximum daily dose − 160 mg.

Children.

Do not use in children.

Overdose.

Overdose may lead to the development of bradycardia, AV block, arterial hypotension, and syncope.

Treatment. Discontinue the drug and initiate symptomatic therapy. In case of bradycardia, administer atropine sulfate.

Adverse Reactions.

Immune system, skin and subcutaneous tissue: allergic reactions, including skin rashes, pruritus, angioedema, facial flushing.

Respiratory system: bronchospasm.

Cardiovascular system: decreased arterial pressure, tachycardia, AV block, coronary artery spasm, which may lead to myocardial infarction.

Nervous system: headache, dizziness.

Gastrointestinal tract: nausea, epigastric discomfort, increased gastrointestinal motility.

Urinary system: increased diuresis.

Vessels: sensation of warmth.

With prolonged and uncontrolled use – hyperkalemia or hypermagnesemia.

Reporting of suspected adverse reactions

Reporting of adverse reactions after drug registration is of great importance. It enables ongoing monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals and patients, or their legal representatives, should report any suspected adverse reactions and lack of efficacy via the Automated Pharmacovigilance Information System at the following link: https://аіsf.dec.gov.ua.

Shelf life.

2 years.

Storage conditions.

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

Keep out of reach of children.

Packaging.

10 tablets in a blister, 4 blisters per pack.

Supply category.

Over-the-counter.

Manufacturer.

Public Joint-Stock Company "Scientific and Production Center "Borshchahivskiy Chemical and Pharmaceutical Plant".

Manufacturer's address and location of its business activity.

17, Miru Street, Kyiv, 03134, Ukraine.