COMPOSITIONS :
Tranexamic Acid Injection 250 mg/5 ml, each ml contains : Tranexamic acid 50 mg.
DESCRIPTIONS :
Tranexamic Acid contains Tranexamic acid as active ingredient is available in film coated tablet 500 mg, injection 250 mg/5 ml and 500 mg/5 ml.
INDICATIONS :
- For local fibrinolysis such as epistaxis, prostatectomy, cervical conization
- Hereditary angioneurotic edema
- Abnormal bleeding after surgery in general
- Bleeding after dental surgery in people with haemophilia
- Menorrhagia
DOSAGE AND ADMINISTRATIONS :
Tranexamic Acid Injection 250 mg/5 ml :
A day 1 – 2 ampoules (5 – 10 ml) is injected intravenously or intramuscularly, divided into 1 – 2 doses. At the time or after surgery, if needed can be given intravenously as much as 2 – 10 ampoules (10 – 50 ml) by drip infusion.
The dose of Tranexamic Acid must be adjusted according to the condition of each patient according to the age or clinical condition.
CONTRAINDICATIONS :
- Patients receiving thrombin therapy.
- Patients with a history of hypersensitivity to any of the ingredients of this product.
WARNINGS AND PRECAUTIONS :
- Careful use in renal insufficiency patients because of the risk of accumulation.
- Guidelines for patients/patients with severe renal insufficiency.
| Creatinine serum | Dosage (IV) | Dosage frequency |
| 120 – 250 μmol/l | 15 mg/kgBW | 2 × daily |
| 250 – 500 μmol/l | 15 mg/kgBW | Every 24 hours |
| > 500 μmol/l | 7.5 mg/kgBW | Every 24 hours |
- Tranexamic acid is not indicated in hematuria caused by the renal parenchyma, in this condition fibrin deposition often occurs and may worsen the disease.
- Tranexamic acid is used in pregnant women only if it is clearly needed.
- Careful use in breastfeeding mothers to avoid risk to the baby.
- Patients with thrombosis (for example, cerebral thrombosis, myocardial infarction or thrombophlebitis, etc.) and in patients at high risk of thrombosis (Tranexamic acid can stabilize thrombosis).
- Patients receiving coagulopathy therapy (concomitant administration with Heparin and others) (Tranexamic acid can stabilize thrombosis).
- Postoperative patients, who are lying for long periods, as well as patients undergoing astriction (venous thrombosis appears to occur in these patients and Tranexamic acid can stabilize thrombosis. Pulmonary embolism has been reported in relation to the end of the patient’s lying period or astriction termination).
- Patients with renal failure (blood concentration can be increased).
- Patients with a history of hypersensitivity to any of the ingredients of this product.
- Caution for intravenous administration : In intravenous administration, the drug is injected slowly. (Symptoms such as nausea, chest discomfort, palpitations and decreased blood pressure are rare). If given intravenously, it is recommended to inject it slowly as well as administration/injection with calcium preparations (10 ml /1 – 2 minutes).
- Caution for intramuscular administration : In intramuscular administration, several things need to be considered to avoid damage to tissues, nerves and others :
- Drug injections must be done carefully to avoid contact with nerves.
- If repeated injections are needed, the injection site should be replaced (for example, an alternative between the right arm and the left arm). Special attention needs to be given when the drug is administered to premature babies, newborns, nursing infants and children).
- If at the time of injection it causes pain or if blood flows into the syringe, remove the needle as quickly as possible and inject it in another place.
- Attention when opening the ampoule : To avoid contamination with foreign objects, before opening the ampoule, ampoules can be wiped using swab alcohol.
- Retinal degeneration because Tranexamic acid has been reported after high-dose and long-term administration in dogs.
DRUG INTERACTIONS :
Caution when administered concurrently with drugs :
- Trombin :
- Signs, symptoms and therapy : Concomitant administration may cause a tendency of thrombosis.
- Mechanisms and risk factors : Concomitant administration increases the tendency of thrombosis due to the presence of thrombogenic properties in this product.
- Tranexamic acid solution should not be added to the blood transfusion or injection solution containing Penicillin.
Caution when administered concurrently with drugs :
- Hemocoagulation
- Signs, symptoms and therapy : Concomitant administration in high doses may cause a tendency of thrombosis.
- Mechanisms and risk factors : Because this product contains antiplasmin action, fibrin clots that are formed due to hemokoagulase can persist in the bloodstream and in a relatively long period of time can prolong the thrombotic period.
- Batroxobin
- Signs, symptoms and therapy : Concomitant administration may cause thromboembolism.
- Mechanisms and risk factors : Tranexamic acid inhibits the decomposition of desA fibrin polymers produced by Batroxobin.
- Coagulation factor drugs (eptacog-alpha and others)
- Signs, symptoms and therapy : Coagulation can be activated further in places with high local fibrinolysis, such as the oral cavity.
- Mechanisms and risk factors : Coagulation factors encourage hemostatic action by activating the coagulation system, while Tranexamic acid promotes hemostatic action through inhibition of the fibrinolysis system.
- Giving to elderly patients : Because elderly patients tend to have decreased physiological function, careful observation and measures such as reducing doses are recommended in this group of patients.
ADVERSE REACTIONS :
- Adverse reactions on the administration of Tranexamic acid injection :
- Clinically significant adverse reactions (unknown frequency).
- Shock
Because shock may occur, patients should be monitored carefully and if abnormalities are found, appropriate measures such as discontinue therapy should be done. - Rapid administration by intravenous may cause dizziness and hypotension.
- The incidence of postsurgical seizure have been reported in patients undergoing macro-vascular surgery guided by cardiopulmonary by-pass and receiving perioperative Tranexamic acid therapy and seizure events have also been reported in patients undergoing dialysis. Patients should be monitored carefully and appropriate measures such as discontinue therapy should be done if abnormalities are observed.
| Frequency of adverse reactions | |||
| 0.1% to < 1% | < 0.1% | Unknown | |
| Hypersensitivity | Itching, redness and others | ||
| Gastrointestinal | Nausea, vomiting | Anorexia, diarrhea | |
| Eye | Temporary impaired color vision (for intravenous injection) | ||
| Others | Drowsiness, headache | ||
PRESENTATIONS :
| Tranexamic Acid Injection 250 mg/5 ml
Reg. No. GKL0402336543A1 |
Box, 10 ampoules @ 5 ml |
STORAGE :
STORE BELOW 30°C, PROTECT FROM LIGHT
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
PT. BERNOFARM
Sidoarjo – Indonesia
