Instructions Triazofam solution for injection 25 mg/ml ampoules 4 ml No. 10
Composition
active ingredient: thiazide acid;
1 ml of solution contains 25 mg of morpholinium salt of thiazide acid, calculated as 100% substance, 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. Other cardiological drugs. Thiazide acid. ATX code C01E B23.
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 area of myocardial necrosis and ischemia, respectively. Improvement of the rheological properties of blood is carried out 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%).
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 arrhythmia.
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
Thiazide acid as a cardioprotective drug can be used in combination with basic agents for the treatment of ischemic heart disease. As a hepatoprotective agent, it can be combined with the appointment of traditional methods of treating hepatitis of the appropriate etiology.
Application features
Missing.
Use during pregnancy or breastfeeding.
Experience with the use of the drug during pregnancy or breastfeeding is insufficient.
The ability to influence the 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, the drug is 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 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, the drug is administered intramuscularly in a dose of 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 severe activity of the process, the drug Triazofam should be administered intramuscularly in the first 5 days at 2 ml (50 mg) 2-3 times a day or intravenously slowly at a rate of 2 ml/min at 4 ml of a 25 mg/ml solution (100 mg) 1 time a day, or drip at a rate of 20-30 drops per minute (2 ampoules of a 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, prescribe the tablet form (100 mg 3 times a day).
In chronic hepatitis of minimal and moderate activity, the drug 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.
Side effects
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 while taking other drugs;
others: fever, cases of chills and changes at the injection site.
Patients (mostly elderly) may experience the following when taking other medications:
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 system: manifestations of dyspeptic phenomena, including dry mouth, nausea, bloating, vomiting;
Respiratory system: shortness of breath, wheezing.
Reporting of suspected adverse reactions
Reporting adverse reactions after the registration of a medicinal product is important. This allows monitoring of the benefit/risk ratio when using this medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all cases of suspected adverse reactions and lack of efficacy of the medicinal product via the Automated Information System for Pharmacovigilance at the link: https://aisf.dec.gov.ua.
Expiration date
2 years.
Storage conditions
Store in original packaging at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Packaging
2 ml or 4 ml in an ampoule, 10 ampoules in a cardboard pack.
Vacation category
According to the recipe.
Producer
LLC "PHARMACELL".
Location of the manufacturer and address of its place of business.
Ukraine, 07408, Kyiv region, Brovarskyi district, Kvitneve village, Prorizna st., 3.
