Tio-normik

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT TIO-NORMIK (TIO-NORMIK)

Composition:

Active substance: 1 ml of the preparation contains 25 mg of morpholine salt of thiatic acid, equivalent to 16.6 mg of thiatic acid;

Excipient: water for injections.

Pharmaceutical form. Solution for injection.

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

Pharmacotherapeutic group. Cardiological preparations. Other cardiological preparations. Thiatic acid.

ATC code C01EB23.

Pharmacological Properties.

Pharmacodynamics.

The pharmacological effect of thiotanic 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 stimulation of oxidation processes in the Krebs cycle, thereby preserving the intracellular pool of adenosine triphosphate (ATP). The presence of a sulfur-containing thiol group in the molecular structure of thiotanic acid—known for its redox properties—and a tertiary nitrogen atom, which binds 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 radical-scavenging enzymes—superoxide dismutase, catalase, and glutathione peroxidase—prevents the initiation of reactive oxygen species.

The action of thiotanic 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 stabilization and subsequent reduction of myocardial necrosis and ischemic areas. Improvement in blood rheological properties is achieved through activation of the fibrinolytic system. Enhanced myocardial metabolism, increased contractility, and support for normalization of cardiac rhythm allow thiotanic acid to be recommended for the treatment of patients with various forms of ischemic heart disease.

In addition to its use in cardiology, thiotanic acid is also applied in the treatment of liver and other internal organ diseases due to its pronounced hepatoprotective properties. The drug prevents hepatocyte destruction, reduces the extent of fatty infiltration and the spread of centrilobular liver necrosis, supports 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.

Maximum plasma concentration of thiotanic acid is reached within 0.84 hours after intramuscular administration and within 0.1 hours after intravenous administration. Protein binding in blood does not exceed 10%. Thiotanic acid accumulates predominantly in the kidneys—31%. Significant accumulation also occurs in the colon, heart, and spleen; the lowest levels are found in the small intestine and lungs (1–2%).

Clinical characteristics.

Indications.

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

In 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 forms of interaction.

The medicinal product can be used in combination with basic therapeutic agents for ischemic heart disease as a cardioprotective agent. As a hepatoprotective agent, it may be combined with conventional treatment methods for hepatitis of corresponding etiology.

Special precautions for use.

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.

Caution is advised when driving vehicles or operating other complex machinery in case of adverse reactions affecting the central or peripheral nervous system.

Method of Administration and Dosage

For myocardial infarction and unstable angina, administer the drug intravenously slowly at a rate of 2 ml/min: 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 course: 14 days.

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

For angina at rest and post-infarction cardiosclerosis, administer the drug intramuscularly, 2 ml of 25 mg/ml solution 3 times daily. Treatment course: 20–30 days.

For chronic hepatitis with marked 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 course: 20–30 days.

For liver cirrhosis, treatment course is 60 days. Begin therapy with intramuscular administration of 2 ml of 25 mg/ml solution (50 mg) 3 times daily for 5 days, followed by continuation of treatment 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. In such cases, the drug should be discontinued. 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, mainly elderly, taking other medications, the following may occur:

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

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

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

Respiratory system disorders: dyspnea, asthma.

Reporting suspected adverse reactions

Reporting of suspected adverse reactions after drug registration is of great importance. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare and pharmacy professionals, as well as patients or their legal representatives, are encouraged to report all suspected adverse reactions and lack of drug efficacy via the automated pharmacovigilance information system at: 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 an ampoule, 5 ampoules in a blister, 2 blisters in a cardboard box.

2 ml in an ampoule, 10 ampoules in a blister, 1 blister in a cardboard box.

4 ml in an ampoule, 5 ampoules in a blister, 2 blisters in a cardboard box.

Prescription status. Prescription only.

Manufacturer.

Limited liability company "Pharmaceutical Company "Zdorov'ya".

Manufacturer's address and location of business activities.

Ukraine, 61013, Kharkiv region, city of Kharkiv, Shevchenka Street, 22.