Ampoules-film coated tablet
Each film coated tablet or ampoule (5 ml) contains :
Tranexamic acid 500 mg
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.
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 .
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 .
Hemoxamine solution should not be mixed with IV solution containing
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 .
( 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
Hemoxamine ampoules : Box of 5 ampoules each of 5 ml .
Hemoxamine tablets : Box of 20 tablets (2 strips each 10 tablets).
Store at controlled room temperature (15 – 30) o C .