Hemoxamine Ampoules-film coated tablet Antifibrinolytic agent Composition : Each film coated tablet or ampoule (5 ml) contains : Tranexamic acid 500 mg Properties : Hemoxamine contains antifibrinolytic agent (tranexamic acid) which inhibits fibrinolysis( fibrin dissolution ) . Absorption of tranexamic acid after oral administration represents 30-50 %of the ingested dose and bioavailability is not affected by food intake . After intravenous dose of 1 gm , the plasma concentration time curve shows a triexponential decay with a half –life of about 2 hours for the terminal elimination phase, 95 % of dose is excreted unchanged in urine . Indications & usage : For prophylaxis and treatment of hemorrhage associated with excessive fibrinolysis e.g. Prostatectomy . Dental extraction in patient with hemophilia . Recurrent epistaxis . Upper gastrointestinal hemorrhage . Post operative hemorrhage . Hereditary angioedema or angioneurotic edema . Menorrhagia ( primary or secondary due to IUDs ) . After tonsillectomy . Thrombolytic overdose . Rectal bleeding in patients with left sided proctcolitis . Contra-indications : Hemoxamine is contraindicated in the following cases : Thromboembolic disease . Patients with acquired defective color vision . Patients with subarachnoid hemorrhage . Side effects : Disturbance in color vision ( if occurs , treatment should be discontinued ). Gastrointestinal disturbances ( nausea , vomiting , diarrhea ) may occur but disappear when the dose is reduced . Hypotension has been observed if IV injection is too rapid ( to avoid this , solution should not be injected more rapidly than 1 ml / minute ) . Warnings & precautions : * Caution is required when using Hemoxamine in the following cases : Pregnancy (use only if clearly needed as tranexamic acid may pass through Placenta ) . Lactation ( as tranexamic acid may be excreted in human milk ) . Renal impairment ( dose should be reduced ) . Massive hematuria ( avoid if risk of ureteric obstruction ) . * Monitoring of liver function tests are recommended in long term treatment of hereditary angioedema . * For patients who are to be treated continually with tranexamic acid for longer than several days , an ophthalmological examination before commencing and at regular intervals during the course of treatment is advised . * N.B. Hemoxamine solution should not be mixed with IV solution containing penicillin Dosage & administration : Unless otherwise prescribed by the physician , the following dosage is administered : Oral therapy : 25 mg/kg body weight (3-4) times daily . Parenteral therapy : 10 mg/kg body weight (3-4) times daily . For patients with moderate to severe impaired renal function the following dosage is recommended . Serum creatinine ( μ mol / L ) I V dose Oral dose 120 – 250 10 mg/kg twice daily 15 mg/kg twice daily 250 – 500 10 mg/kg once daily 15 mg/kg once daily > 500 10 mg/kg every 48 hours or 5 mg/kg once daily 15 mg/kg every 48 hours or 7.5 mg/kg once daily Packing : Hemoxamine ampoules : Box of 5 ampoules each of 5 ml . Hemoxamine tablets : Box of 20 tablets (2 strips each 10 tablets). Storage : Store at controlled room temperature (15 – 30) o C . |