FENAZEPAM IC

INSTRUCTIONS for medical use of the medicinal product ANTARES^®(ANTARES^®)

Composition

active substance: morpholine salt of thiazotonic acid; 1 tablet contains morpholine salt of thiazotonic acid in terms of 100% substance 200 mg, which is equivalent to 133 mg of thiazotonic acid; excipients: potato starch, povidone, powdered sugar, microcrystalline cellulose, calcium stearate.

Pharmaceutical form

Tablets.

Main physical and chemical properties

Tablets are white or almost white in color, round in shape with a flat surface, with a notch and a ridge.

Pharmacotherapeutic group

Cardiological preparations. Other cardiological preparations. Thiazotonic acid. ATC code C01E B23.

Pharmacological properties

Pharmacodynamics

The pharmacological effect of thiazotonic acid is due to its anti-ischemic, membrane-stabilizing, antioxidant, and immunomodulating effects.

The effect of the preparation is realized due to the enhancement of compensatory activation of anaerobic glycolysis and activation of oxidation processes in the Krebs cycle with preservation of the intracellular pool of adenosine triphosphate (ATP). The presence in the structure of the thiazotonic acid molecule of a thiol sulfur group, which has oxidative-reductive properties, and a tertiary nitrogen atom that binds excess hydrogen ions, leads to the activation of the antioxidant system. The strong reducing properties of the thiol group cause a reaction with active forms of oxygen and lipid radicals. The reactivation of anti-radical enzymes - superoxide dismutase, catalase, and glutathione peroxidase - prevents the formation of active oxygen forms.

The effect of thiazotonic acid leads to the inhibition of lipid oxidation processes in ischemic areas of the myocardium, a decrease in the sensitivity of the myocardium to catecholamines, prevents the progressive suppression of the contractile function of the heart, and contributes to the stabilization and reduction of the area of necrosis and ischemia of the myocardium. The improvement of the rheological properties of blood is carried out due to the activation of the fibrinolytic system. The improvement of metabolic processes in the myocardium, the increase in its contractile ability, and the promotion of normalization of heart rhythm make it possible to recommend thiazotonic acid for the treatment of patients with various forms of ischemic heart disease.

In parallel with the use in cardiology, thiazotonic acid is used in the treatment of liver diseases and other internal organs, taking into account its high hepatoprotective properties. The preparation prevents the destruction of hepatocytes, reduces the degree of fatty infiltration and the spread of centrilobular necrosis of the liver, promotes the processes of reparative regeneration of hepatocytes, normalizes protein, carbohydrate, lipid, and pigment metabolism in them. It increases the rate of synthesis and secretion of bile, normalizes its chemical composition.

Pharmacokinetics

After oral administration, the preparation is quickly absorbed, its absolute bioavailability is 53%. The maximum concentration in plasma is reached 1.6 hours after a single dose of 200 mg. The half-life is almost 8 hours.

Clinical characteristics

Indications

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

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

Contraindications

Increased sensitivity to thiazotonic acid and to other components of the medicinal product; acute renal failure.

Interaction with other medicinal products and other types of interactions

Antares^®as a cardioprotective medicinal product can be used in combination with basic means of therapy for ischemic heart disease.

As a hepatoprotective agent, it can be combined with the appointment of traditional methods of treating hepatitis.

Special instructions

If the patient has established intolerance to some sugars, it is necessary to consult a doctor before taking this medicinal product.

Use during pregnancy or breastfeeding

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

Ability to affect the speed of reaction when driving vehicles or other mechanisms

There are no reports to date, however, it is necessary to take into account the possibility of developing dizziness.

Method of administration and doses

In stable angina pectoris, Antares^®should be prescribed at a dose of 200 mg orally 3 times a day. The course of treatment is 8 weeks.

In angina pectoris at rest, myocardial infarction, post-infarction cardiosclerosis, Antares^®should be prescribed at a dose of 200 mg orally 3 times a day for 20-30 days.

In cardiac arrhythmias, Antares^®should be prescribed at a dose of 200 mg orally or sublingually 3 times a day.

In liver diseases, Antares^®should be prescribed at a dose of 200 mg orally 3 times a day for 20-30 days.

The duration of the treatment course is determined by the doctor individually, depending on the severity and course of the disease.

Children

There is insufficient experience with the use of the medicinal product in children.

Overdose

In case of overdose, the concentration of sodium and potassium in the urine 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:

• from the skin and subcutaneous tissue: itching, hyperemia of the skin, rash, urticaria, angioedema.

When taken in combination therapy, mainly in elderly patients, the following may occur:

• from the immune system: anaphylactic shock;
• from the central and peripheral nervous system: dizziness, tinnitus;
• from the gastrointestinal tract: manifestations of dyspeptic phenomena, including dryness of the mouth, nausea, vomiting; bloating;
• from the respiratory system, organs of the thoracic cavity and mediastinum: shortness of breath, dyspnea;
• general disorders: general weakness, fever.

During the post-registration surveillance period, reactions were also observed, the connection of which with the use of the medicinal product Antares^®has not been proven:

• from the cardiovascular system: arterial hypertension, tachycardia.

Reporting of adverse reactions

Reporting of adverse reactions after the registration of the medicinal product is of great importance. This allows for the monitoring of the benefit/risk ratio when using this medicinal product. Medical and pharmaceutical workers, as well as patients or their authorized representatives, should report all cases of suspected adverse reactions and lack of efficacy of the medicinal product through the Automated Information System for Pharmacovigilance at the link: https://aisf.dec.gov.ua/.

Shelf life

2 years.

Storage conditions

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

Store in a place inaccessible to children.

Packaging

10 tablets in a blister pack, 3 or 9 blister packs in a carton; 15 tablets in a blister pack, 6 blister packs in a carton.

Release category

Prescription only.

Manufacturer

Joint-Stock Company "Kyivmedpreparat).

Limited Liability Company "MARIFARM).

Location of the manufacturer and address of the place of its activity

Ukraine, 01032, Kyiv, Saksaganskogo Street, 139.

Minarikova Street, 8, Maribor, 2000, Slovenia.