Instructions Thiotriazolin solution for injection 25 mg/ml ampoule 4 ml No. 10
Composition
active substance: 1 ml of solution contains morpholinium salt of thiazide acid in terms of 100% substance 25 mg, which is equivalent to 16.6 mg of thiazide acid
excipients: water for injections.
Dosage form
Solution for injection.
Main physicochemical properties: transparent colorless or slightly yellowish liquid.
Pharmacotherapeutic group
Cardiological drugs. ATX code C01E B.
Pharmacological properties
Pharmacodynamics.
The pharmacological effect of thiazide acid is due to its anti-ischemic, membrane-stabilizing, antioxidant, and immunomodulatory effects.
The effect of the drug is realized by enhancing the compensatory activation of anaerobic glycolysis and activation of oxidation processes in the Krebs cycle with the preservation of the intracellular ATP pool. The presence in the structure of the thiazolidinedione molecule of sulfur thiol, which is characterized by redox properties, and tertiary nitrogen, which binds excess hydrogen ions, causes the activation of the antioxidant system. The strong reducing properties of the thiol group cause a reaction with reactive oxygen species and lipid radicals. Reactivation of antiradical enzymes - superoxide dismutase, catalase and glutathione peroxidase - prevents the initiation of reactive oxygen species.
The effect of thiazide acid leads to inhibition of lipid oxidation processes in ischemic areas of the myocardium, reduction of myocardial sensitivity to catecholamines, prevention of progressive inhibition of cardiac contractile function, stabilization and reduction of the necrosis and ischemia zones of the myocardium, respectively. Improvement of the rheological properties of the blood is achieved by activating the fibrinolytic system. Improvement of myocardial metabolic processes, increase of its contractility, promotion of normalization of heart rhythm allow us to recommend thiazide acid for the treatment of patients with various forms of ischemic heart disease.
In parallel with the use of the drug in cardiology, thiazide acid is used in the treatment of diseases of the liver and other internal organs, given its high hepatoprotective properties. The drug 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 their protein, carbohydrate, lipid and pigment metabolism. Increases the rate of synthesis and secretion of bile, normalizes its chemical composition.
Pharmacokinetics.
The maximum concentration of thiazide acid in the blood plasma is achieved after intramuscular administration - after 0.84 hours, after intravenous administration - after 0.1 hours. Binding to blood proteins does not exceed 10%. Thiazide acid accumulates mainly in the kidneys - 31%. In significant quantities, it accumulates in the colon, heart, spleen, the smallest - in the small intestine and lungs (1-2%).
Clinical characteristics.
Indication
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, fibrosis and cirrhosis of the liver.
Contraindication
Hypersensitivity to thiazide acid, acute renal failure.
Interaction with other medicinal products and other types of interactions
Thiotriazolin® as a cardioprotective drug can be used in combination with basic treatment agents for ischemic heart disease. As a hepatoprotective agent, it can be combined with the appointment of traditional methods of treating hepatitis of the corresponding etiology.
Application features
Missing.
Use during pregnancy or breastfeeding
Experience with the use of the drug during pregnancy or breastfeeding is insufficient.
Ability to influence reaction speed when driving vehicles or other mechanisms
In case of adverse reactions from the central and peripheral nervous system, caution should be exercised when driving vehicles and working with other complex mechanisms.
Method of administration and doses
In case of myocardial infarction and unstable angina, Thiotriazolin® should be administered intravenously slowly at 4 ml of a 25 mg/ml solution (100 mg) at a rate of 2 ml/min or intravenously drip at a rate of 20-30 drops per minute (4 ml of a 25 mg/ml solution is diluted in 150-250 ml of 0.9% sodium chloride solution) or administered intramuscularly at 4 ml of a 25 mg/ml solution (100 mg) 2-3 times a day. The course of treatment is 14 days.
For angina pectoris, Thiotriazolin® should be administered intramuscularly at 4 ml of a 25 mg/ml solution 2 times a day (daily dose – 200 mg). The course of treatment is 14 days.
In chronic hepatitis with pronounced activity of the process, Thiotriazolin® should be administered intramuscularly in the first 5 days at 2 ml of 25 mg/ml solution (50 mg each) 2-3 times a day or intravenously slowly at a rate of 2 ml/min at 4 ml of 25 mg/ml solution (100 mg) once a day, or drip at a rate of 20-30 drops per minute (2 ampoules of 25 mg/ml solution are diluted in 150-250 ml of 0.9% sodium chloride solution). From the 5th to the 20th day of therapy, Thiotriazolin® should be administered in tablets (100 mg 3 times a day).
In chronic hepatitis of minimal and moderate activity, Thiotriazolin® is administered intramuscularly in a dose of 2 ml of 25 mg/ml solution 3 times a day. The course of treatment is 20-30 days.
In case of liver cirrhosis, the course of treatment is 60 days. Treatment should be started with intramuscular injection of 2 ml of 25 mg/ml solution (50 mg) 3 times a day for 5 days, and then continue treatment with tablets (100 mg 3 times a day).
Children
Experience with the use of the drug in children is insufficient.
Overdose
In case of overdose, the concentration of sodium and potassium in the urine increases. In such cases, the drug must be discontinued. Treatment is symptomatic.
Adverse reactions
The drug is usually well tolerated. In patients with increased individual sensitivity, the following may occur:
Skin and subcutaneous tissue disorders: itching, skin hyperemia, rash, cases of urticaria;
from the immune system: cases of angioedema and anaphylactic shock have been described against the background of taking other drugs;
others: fever, cases of chills and changes at the injection site.
In patients, mainly elderly, when taking other drugs, the following may occur:
from the central and peripheral nervous system: general weakness, dizziness, tinnitus, headache;
from the cardiovascular system: tachycardia, arterial hypertension, cases of lowering blood pressure;
from the digestive tract: manifestations of dyspeptic phenomena, including dry mouth, nausea, bloating, vomiting;
Respiratory system: shortness of breath, wheezing.
Expiration date
5 years.
Storage conditions
Store in original packaging at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Packaging
2 ml in an ampoule, 10 ampoules in a contour blister pack, 1 contour blister pack in a pack. 4 ml in an ampoule, 5 ampoules in a contour blister pack, 2 contour blister packs in a pack.
Vacation category
According to the recipe.
Producer
PJSC "Halychpharm". Development of the NPO "Pharmatron" and the State Center for Pharmaceutical Research, Kharkiv.
Location of the manufacturer and its business address
Ukraine, 79024, Lviv, Opryshkivska St., 6/8.
