Hemostat

Hemostat

tranexamic acid

Manufacturer:

Aristopharma

Distributor:

KTZ
Full Prescribing Info
Contents
Tranexamic acid.
Action
Tranexamic acid is an antifibrinolytic agent, which competitively inhibits the activation of plasminogen to plasmin.
Indications/Uses
Short-term use for haemorrhage or risk of haemorrhage in increased fibrinolysis or fibrinogenolysis.
Local fibrinolysis occurs in the following conditions: Prostatectomy and bladder surgery, menorrhagia, epistaxis, conisation of the cervix, traumatic hyphaema, management of dental extraction in patients with coagulopathies, ulcerative colitis, hematuria, gastrointestinal haemorrhage.
General fibrinolysis as in prostatic and pancreatic cancer; after thoracic and other major surgery; in obstetrical complication eg, abruptio placenta and postpartum haemorrhage; in leukemia and liver diseases and in connection with thrombolytic therapy with streptokinase.
Hereditary angioneurotic oedema.
Dosage/Direction for Use
Capsule: 15-25 mg/kg 2-3 times daily. Menorrhagia: 1 g 3 times daily for up to 4 days. Maximum Dose: 4 g daily.
Hereditary Angioedema: 1-1.5 g 2-3 times daily.
Injection: Local Fibrinolysis: 0.5-1 g 3 times daily by slow IV.
Contraindications
Patients with history of thromboembolic disease and severe renal impairment.
Special Precautions
Patients with irregular menstrual bleeding should not use tranexamic acid until the cause of the irregularity has been established. If menstrual bleeding is not adequately reduced by tranexamic acid, an alternative treatment should be considered. Patients with a high risk for thrombosis (a previous thromboembolic event and a family history of thromboembolic disease) should not use tranexamic acid only if there is a strong medical indication and under strict medical supervision.
Use in pregnancy: Although there is no evidence from animal studies of teratogenic effect, the usual caution with the use of drugs in pregnancy should be observed.
Use in lactation: Tranexamic acid is excreted into breastmilk, but it is not likely to influence the child at therapeutic doses.
Use in children: Clinical experience with tranexamic acid in menorrhagic children <15 years is not available.
Use in the elderly: No reduction in dosage is necessary unless there is evidence of renal failure.
Use In Pregnancy & Lactation
Use in pregnancy: Although there is no evidence from animal studies of teratogenic effect, the usual caution with the use of drugs in pregnancy should be observed.
Use in lactation: Tranexamic acid is excreted into breastmilk, but it is not likely to influence the child at therapeutic doses.
Side Effects
Gastrointestinal discomfort like nausea, vomiting, diarrhoea is common but disappears when dosage is reduced. Disturbances in color vision and thromboembolic events reported rarely; giddiness on rapid IV injection.
Storage
Store below 30°C and away from light.
MIMS Class
ATC Classification
B02AA02 - tranexamic acid ; Belongs to the class of amino acid antifibrinolytics. Used in the treatment of hemorrhage.
Presentation/Packing
Cap 500 mg x 2 x 10's. Inj (amp) 250 mg/5 mL x 5's.
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