Actranex Film-Coated Tablet

Short-term use for hemorrhage or risk of hemorrhage in patients w/ increased fibrinolysis or fibrinogenolysis.

Adult Local fibrinolysis 15-25 mg/kg (2-3 tab) bid-tid. Prostatectomy Prophylaxis & treatment in high-risk patients should be started pre- or post-op w/ injectable form; followed by 2 tab tid-qid until macroscopic hematuria is no longer present. Menorrhagia 2 tab tid as needed for up to 4 days. Consider increasing dosage if there is heavy menstrual bleeding. Max: 4 g (8 tab) daily. Epistaxis 2 tab tid for 7 days where recurrent bleeding is anticipated. Cervix conization 3 tab tid. Traumatic hyphema 2-3 tab tid, based on 25 mg/kg tid. Hemophilia in dental extraction management 2-3 tab every 8 hr, based on 25 mg/kg. Hereditary angioneurotic edema 2-3 tab bid-tid intermittently (in patients w/ awareness of onset of illness) or regularly. Ped patient 25 mg/kg/dose. Patient w/ renal insufficiency serum creatinine 250-500 micromol/L 15 mg/kg/day, 120-249 micromol/L 15 mg/kg bid.

May be taken with or without food: Swallow whole, do not chew/break.

Hypersensitivity. Active thromboembolic disease; history of venous or arterial thrombosis; fibrinolytic conditions following consumption coagulopathy; history of convulsions. Severe renal impairment.

Risk of mechanical anuria in case of hematuria of renal origin (especially in hemophilia). Perform regular eye exam (eg, visual acuity, slit lamp, IOP, visual fields) & LFTs in long-term therapy of patients w/ hereditary angioneurotic edema. Not to be used by patients w/ irregular menstrual bleeding until source of irregular bleeding has been determined. Consider alternative treatment if tranexamic acid does not adequately reduce mthly bleeding. Patients w/ thrombophilia w/ past thromboembolic event & family history of thromboembolic disease should use tranexamic acid only if there is substantial medical implication & under close medical supervision. Not to be used in cases of enhanced fibrinolysis caused by disseminated intravascular coagulation. W/draw treatment in patients w/ visual disturbances. Increased risk of VTE, & arterial thromboses (eg, stroke & MI) w/ concomitant use of combined hormonal contraceptives. Elevated blood levels in patients w/ renal impairment. Pregnancy & lactation. Clinical experience in menorrhagic childn <15 yr is not available. Limited data on efficacy, posology & safety in ped population.

GI disturbances (nausea, vomiting & diarrhea).

May increase thrombotic risk associated w/ combined hormonal contraceptives. May decrease efficacy of both tissue plasminogen activators & tranexamic acid when co-administered. May increase risk of thrombosis w/ factor IX complex conc or anti-inhibitor coagulant conc. Possible exacerbation of procoagulant effect of all-trans retinoic acid in patients w/ acute promyelocytic leukemia.

Haemostatics

B02AA02 - tranexamic acid ; Belongs to the class of amino acid antifibrinolytics. Used in the treatment of hemorrhage.

Rx