Tranexamic acid (Teovexal) intravenous 50 mg/ml 5 ml – [10 ampoules]

Antifibrinolytic agent, is a competitive (at high concentrations – non-competitive) inhibitor of plasminogen activation and its conversion into plasmin. It has local and systemic hemostatic, as well as anti-allergic and anti-inflammatory effects by inhibiting the formation of kinins and other active peptides involved in allergic and inflammatory reactions.

It has local and systemic hemostatic action in bleeding associated with increased fibrinolysis (platelet pathology, menorrhagia). Also tranexamic acid by inhibiting the formation of kinins and other active peptides involved in allergic and inflammatory reactions has anti-allergic and anti-inflammatory effects.

Tranexamic acid at a concentration of 1 mg/ml does not aggregate platelets in vitro and at concentrations up to 10 mg/ml has no effect on platelet count, clotting time or various clotting factors in whole blood or citrate blood in a healthy person. On the other hand, tranexamic acid at both 1 mg/ml and 10 mg/ml blood concentrations prolongs thrombin time.

Prevention and treatment of bleeding due to generalized or localized fibrinolysis in adults and children 1 year and older, including:

? menorrhagia and metrorrhagia;

? gastrointestinal bleeding;

? bleeding after surgical interventions on the prostate and urinary tract;

bleeding during surgical interventions in the nose, mouth and pharynx (adenoidectomy, tonsillectomy, tooth extraction);

? bleeding during thoracic, abdominal or other major surgical interventions (including cardiac surgery);

? Obstetric and gynecologic bleeding (including bleeding during gynecologic surgery);

? Bleeding caused by the use of fibrinolytic drugs.

? Hypersensitivity to tranexamic acid or other components of the drug;

? Severe chronic renal insufficiency (glomerular filtration rate [GFR] less than 30 mg/ml/1.73 m2) due to risk of cumulation;

? venous and arterial thrombosis at present or in the anamnesis (deep leg thrombosis, pulmonary embolism, intracranial thrombosis, etc.) when simultaneous anticoagulant therapy is impossible;

fibrinolysis due to consumption coagulopathy (hypocoagulable stage of disseminated intravascular coagulation syndrome [DIC]);

? history of seizures;

? acquired color vision disorder;

? subarachnoid hemorrhage (due to the risk of cerebral edema, ischemia, and cerebral infarction);

? treatment of menorrhagia in patients under 16 years of age (no experience);

? age less than 1 year (no experience).

 

• Intravenously by drip or stream slowly; infusion rate 1 ml/min.
• Rapid intravenous administration should be avoided!
• Adult patients:
• ? menorrhagia and metrorrhagia, gastrointestinal bleeding: 500 mg (1 ampoule of 100 mg/ml drug or 2 ampoules of 50 mg/ml drug)
• 2-3 times a day from the time the bleeding develops until it stops;
• treatment of bleeding after prostate and urinary tract surgery: 1000 mg (2 vials of the preparation in a dosage of 100 mg/ml or 4 vials of the preparation in a dosage of 50 mg/ml) 3 times daily from the moment of bleeding until it stops;
• ? prevention and treatment of bleeding during surgical interventions in the nose, mouth and pharynx: 10-15 mg/kg body weight every 6-8 hours until bleeding stops;
• ? prevention and treatment of bleeding during cardiac surgery: a loading dose of 15 mg/kg after induction of anesthesia prior to surgery, followed by intravenous infusion at a rate of 4.5 mg/kg/hour during the entire operation; tranexamic acid at a dose of 0.6 mg/kg in a heart-lung machine is recommended;
• ? treatment of obstetric and gynecologic bleeding (including bleeding during gynecologic surgical interventions): 15 mg/kg body weight every 6-8 hours from the onset of bleeding until it stops;
• ? treatment of bleeding caused by the use of fibrinolytic drugs: 10 mg/kg of body weight every 6-8 hours from the development of bleeding until it stops.
• In case of necessity of prolonged (more than 48 hours) hemostatic therapy it is recommended to use tranexamic acid preparations in tablet dosage form.
• Children over 1 year of age:
• There is limited experience with tranexamic acid preparations in children. Recommended drug dose for treatment of bleeding caused by local and generalized fibrinolysis is 20 mg/kg/day.
• Administration of the drug in special groups of patients:
• Renal dysfunction.
• In patients with mild to moderate impairment of renal excretory function it is necessary to correct the dose and the administration rate of tranexamic acid:
• Serum creatinine concentration Glomerular filtration rate Tranexamic acid dose Frequency of administration
• administration
• 120-249 μmol/L
• (1.36-2.82 mg/dL) 60-89 mL/min/1.73m2 15 mg/kg body weight 2 times daily
• 250-500 μmol/L
• (2.83-5.66 mg/dL) 30-59 mL/min/1.73m2 15 mg/kg body weight once daily
• Impaired liver function
• No dose adjustment is required in patients with hepatic impairment.
• Elderly age.
• No dose adjustment is required in elderly patients in the absence of renal impairment.
• Procedure for use of the polymer ampoule: