Antares

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT ANTAres® (ANTARES®)

Composition:

Active substance: morpholine salt of thiatic acid;

1 tablet contains 200 mg of the morpholine salt of thiatic acid, calculated as 100% substance, equivalent to 133 mg of thiatic acid;

Excipients: potato starch, povidone, powdered sugar, microcrystalline cellulose, calcium stearate.

Pharmaceutical form. Tablets.

Main physicochemical properties: white or almost white, round-shaped tablets with a flat surface, beveled edges, and a score line.

Pharmacotherapeutic group. Cardiovascular drugs. Other cardiac preparations. Thiatic acid.

ATC Code C01EB23.

Pharmacological Properties

Pharmacodynamics

The pharmacological effect of thiotropic acid is due to its anti-ischemic, membrane-stabilizing, antioxidant, and immunomodulatory actions.

The drug's effect is achieved by enhancing compensatory activation of anaerobic glycolysis and activating oxidation processes in the Krebs cycle, thereby preserving the intracellular adenosine triphosphate (ATP) pool. The presence of thiol sulfur in the molecular structure of thiotropic acid—exhibiting redox properties—and tertiary nitrogen, which binds excess hydrogen ions, promotes activation of the antioxidant system. The strong reducing properties of the thiol group lead to reactions with active oxygen species and lipid radicals. Reactivation of radical-scavenging enzymes—superoxide dismutase, catalase, and glutathione peroxidase—prevents the formation of active oxygen species.

The action of thiotropic acid results in inhibition of lipid peroxidation in ischemic areas of the myocardium, reduced myocardial sensitivity to catecholamines, prevention of progressive suppression of cardiac contractile function, and promotes stabilization and reduction of myocardial necrosis and ischemia zones. Improvement of blood rheological properties occurs via activation of the fibrinolytic system. Enhanced myocardial metabolism, increased contractility, and support for normalization of cardiac rhythm allow recommendation of thiotropic acid for treatment of patients with various forms of ischemic heart disease.

In addition to its use in cardiology, thiotropic acid is applied in the treatment of liver and other internal organ diseases, taking into account its pronounced hepatoprotective properties. The drug prevents hepatocyte destruction, reduces the degree of fatty infiltration and spread of centrilobular liver necroses, promotes reparative regeneration of hepatocytes, and normalizes protein, carbohydrate, lipid, and pigment metabolism within them. It increases the rate of bile synthesis and excretion and normalizes its chemical composition.

Pharmacokinetics

After oral administration, the drug is rapidly absorbed, with absolute bioavailability of 53%. Maximum plasma concentration is reached within 1.6 hours after a single 200 mg dose. The elimination half-life is approximately 8 hours.

Clinical characteristics.

Indications.

In complex treatment of ischemic heart disease: angina pectoris, myocardial infarction, postinfarction cardiosclerosis; cardiac arrhythmias.

In complex treatment of chronic hepatitis of various etiologies, including alcoholic hepatitis; liver cirrhosis.

Contraindications.

Hypersensitivity to thiatic acid and to other components of the drug; acute renal failure.

Interaction with other medicinal products and other types of interactions.

Antares**®**, as a cardioprotective medicinal agent, can be used in combination with basic therapeutic agents for ischemic heart disease.

As a hepatoprotective agent, it may be combined with conventional treatments for hepatitis.

Special precautions for use

If a patient has an intolerance to certain sugars, consult a physician before taking this medicinal product.

Use during pregnancy or breastfeeding

The efficacy and safety of the medicinal product during pregnancy or breastfeeding have not been studied.

Ability to influence reaction rate when driving vehicles or operating machinery
Currently, no reports are available; however, the possibility of developing dizziness should be taken into account.

Dosage and Administration.

For stable angina pectoris, Anatares**®** should be administered orally, 200 mg three times daily. Treatment course: 8 weeks.

For angina at rest, myocardial infarction, and post-infarction cardiosclerosis, Anatares**®** should be administered orally, 200 mg three times daily for 20–30 days.

For cardiac arrhythmias, Anatares**®** should be administered orally or sublingually, 200 mg three times daily.

For liver diseases, Anatares**®** should be administered orally, 200 mg three times daily for 20–30 days.

The duration of treatment should be determined individually by a physician, depending on the severity and course of the disease.

Children. Experience with the use of the medicinal product in children is insufficient.

Overdose.

In case of overdose, urinary concentration of sodium and potassium increases. In such cases, the medicinal product should be discontinued.

Treatment is symptomatic.

Adverse reactions.

The medicinal product is usually well tolerated.

In patients with increased individual sensitivity, the following may occur:

Skin and subcutaneous tissue disorders: pruritus, hyperemia of the skin, rash, urticaria, angioneurotic edema.

When used as part of combination therapy, mainly in elderly patients, the following may occur:

Immune system disorders: anaphylactic shock;

Nervous system disorders: dizziness, tinnitus;

Gastrointestinal disorders: symptoms of dyspepsia, including dry mouth, nausea, vomiting; abdominal distension;

Respiratory, thoracic and mediastinal disorders: dyspnea, wheezing;

General disorders: general weakness, fever.

During the post-marketing surveillance period, the following reactions have also been observed, although a causal relationship with the use of the medicinal product Antaros**®** has not been established:

Cardiovascular disorders: arterial hypertension, tachycardia.

Reporting of adverse reactions after medicinal product registration is of great importance. It enables continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals, pharmacists, as well as patients or their legal representatives are encouraged to report all suspected adverse reactions and lack of efficacy via the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua/.

Shelf life. 2 years.

Storage conditions.

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

Keep out of reach and sight of children.

Packaging. 10 tablets in a blister, 3 or 9 blisters per carton; 15 tablets in a blister, 6 blisters per carton.

Prescription status. Prescription only.

Manufacturer.

JSC "Kyivmedpreparat".

LLC "MARIFARM".

Manufacturer's address and location of business operations.

139 Saksaganskogo Street, Kyiv, 01032, Ukraine.

Minarikova Street 8, Maribor, 2000, Slovenia.