Properties
What is it?
Tranedex-500 Tablets (Tranexamic Acid B.P. 500mg) Composition: Each film-coated tablet contains: Tranexamic Acid BP 500mg Pharmacology Pharmacodynamics: Tranexamic acid has a strong inhibitory effect on the activation of plasminogen, i.e., the conversion of plasminogen to plasmin in the fibrinolytic system. The half-life is 1-2 hours. Plasma protein binding is 3% at therapeutic levels in plasma. Plasma protein binding is entirely due to binding to plasminogen. Tranexamic acid is excreted unchanged in the urine. Pharmacokinetics: Tranexamic acid is rapidly absorbed from the gastrointestinal tract. Peak serum levels are reached in 2-3 hours. Approximately 40% of the dose is excreted in the urine within the first 24 hours after oral administration. After intravenous administration, 45% of the dose is excreted in the urine within the first day. Indications: Hereditary angioneurotic edema. Increased local fibrinolysis when diagnosis indicates hyperfibrinolysis, during cervical conization, tooth extraction in patients with coagulopathy (with antihemophilic factor), epistaxis, hyphema, and menorrhagia (hypermenorrhea). Contraindications: Tranexamic acid should not be used in patients with a history of thrombosis risk if anticoagulant therapy is not possible concurrently. The preparation should not be used in patients with acquired color vision defects. If color vision impairment develops during the course of treatment, the use of the preparation should be discontinued. Dosage and Administration Dosage: Cervical conization - 2-3 tablets every 8-12 hours. For 12 days after surgery. Epistaxis: 2-3 tablets every 8-12 hours for 10 days. Hyphema: 2-4 tablets every 8-12 hours for 7 days. Dental surgery in patients with coagulopathy: 2 hours before surgery, also use factors VIII and IX, 25mg orally or 10mg IV/kg. After surgery, 25mg/kg tranexamic acid is used orally 3-4 times a day for 6-8 days. After surgery, the patient usually does not require further replacement therapy. Method of administration: Orally, preferably with water. Warnings and Precautions: Warnings: In patients for whom tranexamic acid is to be used for several weeks, ophthalmological examination (visual acuity, color vision, fundus, visual field, etc.) is recommended if possible before starting treatment and regularly during treatment. Pregnancy: The safety of tranexamic acid during pregnancy has not been established. No harmful effects have been described. A woman who had fibrinolytic bleeding in the fourth month of pregnancy was treated with tranexamic acid for 64 days. The total dose was 356g. Labor occurred spontaneously at 30 weeks of gestation and was normal. The newborn was healthy. In the treatment of placental abruption, which was prevented by tranexamic acid, the patient already had 2 spontaneous abortions related to placental abruption. Bleeding indicating abruption developed at 26 weeks of gestation. Pathological proteolysis was determined, mainly due to activation of the fibrinolytic system. Approximately 250g of tranexamic acid was used IV and orally between 26 and 33 weeks of gestation. Bleeding stopped and a healthy baby was born by cesarean section. Tranexamic acid crosses the placenta. After a 10mg/kg IV injection, the concentration in fetal serum can reach 30 µg/mL. Fibrinolytic activity is very high in newborns. It is unknown whether a reduction in activity is harmful during the first few hours of life. Precautions: Caution is required in case of renal insufficiency due to the risk of accumulation. Hematuria from the upper urinary tract has been described, as well as, in isolated cases, obstruction of passage in the tract. Renal insufficiency: In patients with creatinine concentrations of 120-250 µmol/L, 15mg orally or 10mg IV tranexamic acid twice daily. With serum creatinine concentrations of 250-500 µmol/L, the dosage should be 15mg orally or 10mg IV at 24-hour intervals. With serum creatinine concentrations of 500 µmol/L or more, the same dose should be used at 48-hour intervals. Tranexamic acid therapy is not indicated in hematuria caused by diseases of the renal parenchyma. Intravascular fibrin precipitation occurs in this case and can worsen the disease. Additionally, in massive renal hemorrhage from any cause during antifibrinolytic therapy, there is a risk of thrombus retention in the renal pelvis. Lactation: Tranexamic acid is excreted in breast milk at a concentration of only one-hundredth of the serum level. Researchers believe that tranexamic acid can be used during lactation without risk to the infant. Side Effects: In addition to the intended effects, the medication may cause undesirable effects. However, not all side effects may develop, and medical supervision is required if they occur. Gastrointestinal symptoms (nausea, vomiting, diarrhea) occur but disappear with dose reduction. Isolated cases of dizziness or decreased blood pressure have been reported. Note on animal experimental data: In dogs, retinal changes have been described after prolonged use of high doses of tranexamic acid, and in cats after 250mg/kg IV injection daily for 14 days. Such changes were not observed in rats where the maximum tolerated dose was used. Retinal changes have not been described in patients treated with tranexamic acid for several weeks or months. Storage: Store in a dark and dry place, at a temperature not exceeding 25°C. Dispensing Rule: Pharmaceutical product group II, dispensed with prescription form N3. Manufactured in India: Zee Laboratories Limited Behind 47, Industrial Area, Paonta Sahib - 173025, H.P. (India)