Trenaxa (tranexamic acid) solution for injections 100 mg/ml. 10 ml. vials №5

Description

Trenaxa (tranexamic acid) solution for injections 100 mg/ml. 10 ml. vials №5

Composition

active substance: tranexamic acid;

1 ml of solution contains tranexamic acid 100 mg;

Excipients: water for injections, hydrochloric acid or sodium hydroxide (for pH adjustment).

Dosage form

Solution for injection.

Basic physical and chemical properties: transparent solution, free from visible particles.

Pharmacotherapeutic group

Antihemorrhagic drugs. Fibrinolysis inhibitors.
ATX code B02A A02.

Pharmacological properties

It is an antihemorrhagic agent. It is an inhibitor of fibrinolysis. Specifically inhibits the activation of plasminogen (profibrinolysin), its transformation into plasmin (fibrinolysin). It has a systemic and local hemostatic effect in bleeding, which is associated with an increase in fibrinolysis (menorrhagia, platelet pathology). Also, tranexamic acid has an anti-allergic, anti-inflammatory effect by inhibiting the formation of kinins, other active peptides involved in reactions of this type.

Indications

Trenaxa solution is used:

• with bleeding or the risk of bleeding due to increased fibrinolysis, as generalized (during operations, in the postoperative period, after childbirth, manual separation of the placenta, with chorionic detachment, bleeding during pregnancy, with malignant neoplasm of the pancreas or prostate glands, with hemophilia, hemorrhagic complications fibrinolytic therapy, with thrombocytopenic purpura, liver diseases, leukemia, after streptokinase therapy), and local bleeding (pulmonary, uterine, nasal, gastrointestinal, hematuria, after conization of the cervix for carcinoma, after prostatectomy, tooth extraction in individuals with hemorrhagic diathesis);
• with surgical intervention on the bladder;
• during surgical procedures against the background of a systemic inflammatory reaction (peritonitis, sepsis, pancreatic necrosis, preeclampsia, shock, other critical conditions).

Contraindications

Trenaxa solution is not used:

• if you are allergic to tranexamic acid;
• with intolerance to auxiliary components;
• with a history of thromboembolic diseases;
• with a high risk of thrombosis, thrombophlebitis;
• with macroscopic hematuria;
• with coagulopathy due to disseminated intravascular coagulation (diffuse intravascular coagulation) without fibrinolysis activation;
• with myocardial infarction;
• with subarachnoid hemorrhage;
• with a history of seizures;
• in case of violation of color vision;
• with severe kidney failure.

Application during pregnancy and lactation

There have been no strictly controlled clinical studies of the safety of tranexamic acid during pregnancy. No teratogenic or embryotoxic effects were found.
The drug is prescribed to pregnant women if the expected health benefits to the mother outweigh the risk to the fetus.
The drug is used in childbirth and cesarean section.
The active substance passes into breast milk in small amounts. If there is a need for treatment, the question of stopping breastfeeding is decided.

Method of administration and dosage

Trenaxa solution is used intravenously (jet, drip).
The dosage regimen is selected individually depending on the clinical situation.
The standard dose for generalized fibrinolysis is 15 mg / kg every 6-8 hours intravenously slowly (the recommended rate of administration is 1 ml / minute).
The standard dose for local fibrinolysis is 0.5-1 g 2-3 times a day intravenously slowly (1 ml / minute).
With prostatectomy, bladder surgery – 1 g during surgery, then 1 g every 8 hours for three days, after which they switch to tablet forms of tranexamic acid (until the disappearance of macrohematuria).
With the risk of bleeding against the background of a systemic inflammatory reaction – 10-11 mg / kg 20-30 minutes before surgery.
For children from one year old, the maximum dose should not exceed 20 mg / kg / day, the maximum single dose is 10 mg / kg.

Overdose

Symptoms: convulsions, nausea, orthostatic symptoms, dizziness, vomiting, arterial hypotension, headache, increased manifestations of adverse reactions.
Treatment: the appointment of symptomatic therapy, forced diuresis, maintenance of the water-salt balance.

Side effects:

• Gastrointestinal disorders: nausea, heartburn, vomiting, diarrhea, discomfort in the intestines and stomach.
• Neurological disorders: convulsions, drowsiness, dizziness.
• Cardiovascular disorders: arterial hypotension, orthostatic hypotension, chest pain, tachycardia, thromboembolism, pulmonary embolism, deep vein thrombosis, cerebral vessels.
• Urinary disorders: acute necrosis of the renal cortex.
• Ophthalmic disorders: chromatopsia, impairment, blurred vision.
• General disorders: weakness, manifestations of hypersensitivity (including anaphylaxis, allergic dermatitis, skin rashes, itching, urticaria).