Tranexamin

Tranexamin

tranexamic acid

Manufacturer:

Pacific Pharma (Korea)

Distributor:

AA Medical
Full Prescribing Info
Contents
Tranexamic acid.
Description
Each ampoule (5ml) contains: Tranexamic acid 500 mg.
Indications/Uses
Hemorrhagic complications in association with general fibrinolysis (leukemia, purpura, aplastic anemia, per- and post-operative hemorrhage).
Hemorrhagic complications in association with local fibrinolysis (pneumorrhagia, nephrorrhagia, prostatectomy, pre- and post-operative hemorrhage).
Dosage/Direction for Use
Tranexamin lnj. 500mg should be administered intravenously by slow injection (If the injection is given too quickly, rarely nausea, chest pain, palpitation, decreasing the blood pressure, dizziness may occur).
Adult: Administer 250-500mg as tranexamic acid per day in one or two divided I.V. or I.M. If necessary, such as bleeding with intra/post-operative, administer 500-1000mg by IV or 500-2500mg by IV instillation per once.
Dosage should be properly adjusted by ages or symptoms.
Overdosage
No cases of overdosage have been reported. Symptoms may be nausea, vomiting, orthostatic hypotension. Maintain a high fluid intake to promote renal excretion.
Contraindications
Patients receiving thrombin. Patients with a history or risk of thrombosis. Patients with hypersensitivity to tranexamic acid or any of the ingredients. Tranexamin injection should not be added to blood for transfusion, or to injections containing penicillin.
Warnings
Injectable ampoule can cause side effects due to glass fraction mixed.
Carefully cut the ampoule, especially when used for the children and elderly.
Special Precautions
Patients with thrombus (cerebral thrombosis, myocardial infarction, thrombophlebitis) or risk of thrombosis (there is concerns to be stable thrombus)
Patients with consumption coagulopathy (should be concomitantly use with heparin) (there is concerns to be stable thrombus).
Patients lying in bed after surgery or patients with pressure hemostasis treatment (increasing the risk of thrombosis because it is easy to occur vein thrombosis. Pulmonary thromboembolism have been reported when moving the bed or stopping the pressure.
Patient with renal insufficiency, because of the risk of accumulation.
In patients with disseminated intravascular coagulation (DIC) treatment must be restricted to those in whom there is predominant activation of the fibrinolytic system with acute severe bleeding. Tranexamin lnj. 500mg must not be administered in DIC with predominant activation of the coagulation system. Administration of Tranexamin lnj. 500mg in DIC should be considered only when appropriate haematological laboratory facilities and expertise are available.
Others: In the dog, retina changes have been observed after long-term administration of large doses of tranexamic acid.
Compatibility have been reported when concomitantly used with the following solutions; reserpine, tannic phenetidine, concomitant use of methyltestosterone and ethylestradiol, lipid thromboplastin, tissue thromboplastin, sulfadimethoxine.
Thrombus formation have been reported when concomitantly largely used with the drugs with actions on hemostasis (lipid thromboplastin) by intravenously.
Effects on ability to drive and use machines: Not known.
Geriatric precautions: Generally, the aged have poor physiological functions. Should administer with cautions such as decreasing the dose of this drug.
Use In Pregnancy & Lactation
Although there is no evidence from animal studies of a teratogenic effect, should be given with caution because Tranexamic acid crosses the placenta.
Tranexamic acid passes over into the breast milk during lactation in concentrations 1/100 of the corresponding serum levels. However, it is considered that there is no antifibrinolytic effects on the infant.
Adverse Reactions
Shock: Shock may occur rarely, should be monitored fully. If abnormal symptoms occur, stop administering immediately and do proper treatments.
Hypersensitivity: Rarely hypersensitivity such as pruritus, rash or flushing may occur. In this case, stop administering immediately and do proper treatments.
Eyes: Temporary disturbance of color vision may occur.
Urinary system: Urinary tract obstructions in patient with large bleeding (especially hemophilia) from upper urinary tract have been reported.
Gastrointestinal system: Nausea, vomiting, diarrhea may occur but disappear when the dose is reduced.
Others: Rarely, drowsiness, headache may occur. Rarely thrombosis have been reported.
Drug Interactions
Thrombin: thrombus formation is increased when concomitantly used with thrombin because it promotes the thrombus formation.
Thrombosis may occur when concomitantly used with the drugs with actions on hemostasis or hemocoagulase, should be given with caution.
Thrombosis may occur when concomitantly used with Batroxobin, should be given with caution.
It may enhance the coagulation on strong fibrinolytic activity site such as mouth when concomitantly used with coagulation factor such as Eptacog alfa. Should be given with caution.
Storage
Hermetic container, store at room temperature (1-30°C).
Shelf-Life: 36 months after manufacturing date.
MIMS Class
ATC Classification
B02AA02 - tranexamic acid ; Belongs to the class of amino acid antifibrinolytics. Used in the treatment of hemorrhage.
Presentation/Packing
Inj (colorless and clear solution) (amp) 500 mg/5 mL x 10's.
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