Zolya

INSTRUCTION for medical use of the medicinal product ZOLYA (ZOLJA)

Composition:

Active substance: thiocyanic acid;

1 ml of the preparation contains 25 mg of morpholine salt of thiocyanic acid, equivalent to 16.6 mg of thiocyanic acid;

Excipient: water for injections.

Pharmaceutical form. Solution for injection.

Main physicochemical characteristics: clear, colorless or slightly yellowish liquid.

Pharmacotherapeutic group. Cardiological preparations. Other cardiological preparations. Thiocyanic 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 through enhanced compensatory activation of anaerobic glycolysis and activation of oxidation processes in the Krebs cycle, preserving the intracellular ATP pool. The presence of a sulfur thiol group in the molecular structure of thiotropic acid, which exhibits redox properties, and a tertiary nitrogen atom capable of binding excess hydrogen ions, promotes activation of the antioxidant system. The strong reducing properties of the thiol group lead to reactions with reactive oxygen species and lipid radicals. Reactivation of anti-radical enzymes—superoxide dismutase, catalase, and glutathione peroxidase—prevents the initiation of reactive 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 depression of cardiac contractile function, and 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 contractile function, and support of cardiac rhythm normalization make thiotropic acid suitable 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 the drug's pronounced hepatoprotective properties. The drug prevents hepatocyte destruction, reduces fatty infiltration and the spread of centrilobular liver necrosis, supports regenerative processes in 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.

Maximum plasma concentration of thiotropic acid is achieved after intramuscular administration within 0.84 hours and after intravenous administration within 0.1 hours. Plasma protein binding does not exceed 10%. Thiotropic acid predominantly accumulates in the kidneys (31%). Significant accumulation also occurs in the colon, heart, and spleen, while minimal accumulation is observed in the small intestine and lungs (1–2%).

Clinical characteristics.

Indications.

In the complex treatment of ischemic heart disease: angina pectoris, myocardial infarction, post-infarction cardiosclerosis; as an additional agent in the therapy of cardiac arrhythmias.

In the complex treatment of chronic hepatitis, alcoholic hepatitis, liver fibrosis, and cirrhosis.

Contraindications.

Hypersensitivity to thiotropic acid, acute renal failure.

Interaction with other medicinal products and other types of interactions.

The drug, as a cardioprotective agent, can be used in combination with basic therapies for ischemic heart disease. As a hepatoprotective agent, it may be combined with conventional treatments for hepatitis of corresponding etiology.

Special precautions.

None.

Use during pregnancy or breastfeeding.

There is insufficient experience with the use of the drug during pregnancy or breastfeeding.

Ability to affect reaction speed when driving or operating machinery.

If adverse reactions involving the central or peripheral nervous system occur, caution should be exercised when driving vehicles or operating other complex machinery.

Administration and Dosage.

For myocardial infarction and unstable angina, administer the drug intravenously slowly at a rate of 2 ml/min, giving 4 ml of 25 mg/ml solution (100 mg); or by intravenous infusion at a rate of 20–30 drops per minute (4 ml of 25 mg/ml solution diluted in 150–250 ml of 0.9% sodium chloride solution); or intramuscularly, 4 ml of 25 mg/ml solution (100 mg) 2–3 times daily. Treatment duration is 14 days.

For exertional angina, administer the drug intramuscularly, 4 ml of 25 mg/ml solution twice daily (daily dose – 200 mg). Treatment duration is 14 days.

For angina at rest and postinfarction cardiosclerosis, administer the drug intramuscularly, 2 ml of 25 mg/ml solution 3 times daily. Treatment duration is 20–30 days.

For chronic hepatitis with pronounced disease activity, during the first 5 days administer the drug intramuscularly, 2 ml of 25 mg/ml solution (50 mg) 2–3 times daily; or intravenously slowly at a rate of 2 ml/min, 4 ml of 25 mg/ml solution (100 mg) once daily; or by intravenous infusion at a rate of 20–30 drops per minute (2 ampoules of 25 mg/ml solution diluted in 150–250 ml of 0.9% sodium chloride solution).

From day 5 to day 20 of therapy, administer the drug in tablet form (100 mg three times daily).

For chronic hepatitis of minimal or moderate activity, administer the drug intramuscularly, 2 ml of 25 mg/ml solution 3 times daily. Treatment duration is 20–30 days.

For liver cirrhosis, treatment duration is 60 days. Begin treatment with intramuscular administration of 2 ml of 25 mg/ml solution (50 mg) 3 times daily for 5 days, followed by continuation of therapy with tablets (100 mg three times daily).

Children.

Experience with the use of the drug in children is insufficient.

Overdose.

In case of overdose, concentration of sodium and potassium in urine increases. The drug should be discontinued in such cases. Symptomatic treatment is recommended.

Adverse Reactions

The drug is generally well tolerated. In patients with increased individual sensitivity, the following may occur:

Skin and subcutaneous tissue disorders: itching, skin hyperemia, rash, cases of urticaria.

Immune system disorders: angioneurotic edema and anaphylactic shock have been reported in association with the use of other drugs.

Other: fever, chills, and injection site reactions.

In patients, predominantly elderly, receiving other medicinal products, the following may occur:

Central and peripheral nervous system disorders: general weakness, dizziness, tinnitus, headache.

Cardiovascular system disorders: tachycardia, arterial hypertension, cases of decreased arterial pressure.

Gastrointestinal disorders: dyspeptic symptoms including dry mouth, nausea, abdominal distension, vomiting.

Respiratory system disorders: dyspnea, asthma-like symptoms.

Reporting of adverse reactions

Reporting suspected adverse reactions after drug registration is of great importance. It enables ongoing monitoring of the benefit-risk balance of the medicinal product. Healthcare and pharmacy professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy through the Automated Information System for Pharmacovigilance 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 of children.

Packaging

2 ml in ampoules, 10 units (5×2) in blisters, in a cardboard box; 4 ml in ampoules, 10 units (5×2) in blisters, in a cardboard box.

Prescription status

Prescription only.

Manufacturer

Limited Liability Company "Pharmaceutical Company "Zdorovya".

Manufacturer's address and place of business

22, Shevchenka Street, Kharkiv, Kharkiv Oblast, 61013, Ukraine.