TRIAZOPHAM

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT TRIAZOFAM (TRIAZOFAM)

Composition:

Active substance: thiatic acid;

1 ml of solution contains 50 mg of morpholine salt of thiatic acid, recalculated to 100% substance, equivalent to 33.3 mg of thiatic acid;

Excipient: water for injections.

Pharmaceutical form. Solution for injection.

Main physicochemical properties: transparent colorless or slightly yellowish liquid.

Pharmacotherapeutic group.

Cardiological preparations. Other cardiological preparations. Thiatic acid. ATC code C01EB23.

Pharmacological properties.

Pharmacodynamics.

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

The drug's effect is realized through enhanced compensatory activation of anaerobic glycolysis and stimulation of oxidation processes in the Krebs cycle, preserving the intracellular ATP pool. The presence of a thiol sulfur in the molecular structure of thiotazic acid—exhibiting redox properties—and a tertiary nitrogen capable of binding excess hydrogen ions contributes to 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 initiation of reactive oxygen species.

The action of thiotazic 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—along with reduction—of myocardial necrosis and ischemic areas. Improvement in blood rheological properties occurs via activation of the fibrinolytic system. Enhanced myocardial metabolic processes, increased contractility, and support for normalization of cardiac rhythm allow thiotazic acid to be recommended for treatment of patients with various forms of ischemic heart disease.

Pharmacokinetics.

Maximum plasma concentration of thiotazic 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%. Thiotazic acid accumulates predominantly 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 complex treatment of ischemic heart disease: angina pectoris, myocardial infarction.

Contraindications.

Hypersensitivity to thiotropic acid, acute renal failure.

Pregnancy and lactation period.

Children under 18 years of age.

Interaction with other medicinal products and other types of interactions.

The drug Triazopham can be used in combination with basic therapeutic agents for ischemic heart disease.

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.

Caution should be exercised when driving or operating complex machinery in case of adverse reactions affecting the central or peripheral nervous system.

Dosage and Administration.

For myocardial infarction and unstable angina, administer the drug intravenously slowly at a rate of 2 ml/min, injecting 2 ml of 50 mg/ml solution (100 mg); or by intravenous infusion at a rate of 20–30 drops per minute (2 ml of 50 mg/ml solution diluted in 150–250 ml of 0.9% sodium chloride solution); or by intramuscular injection of 2 ml of 50 mg/ml solution (100 mg) 2–3 times daily. Treatment duration is 14 days.

For effort angina, administer the drug by intramuscular injection of 4 ml of 50 mg/ml solution twice daily (daily dose – 400 mg). Treatment duration is 14 days.

Children.

Experience with use 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. Treatment is symptomatic.

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, urticaria;

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

Other: fever, chills, and injection site reactions.

In patients (mostly 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, decreased blood pressure;

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

Respiratory system disorders: dyspnea, asthma.

Reporting suspected adverse reactions

Reporting suspected adverse reactions after drug registration is important. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals and pharmacists, as well as patients or their legal representatives, should 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 a polyethylene ampoule. 10 ampoules per cardboard pack.

4 mL in a polyethylene ampoule. 10 ampoules per cardboard pack.

Prescription category.

Prescription only.

Manufacturer: LLC "FARMASEL".

Manufacturer's address and location of business activity.

3, Prorizna Street, village Kvitneve, Brovary District, Kyiv Oblast, 07408, Ukraine.