Tranexamic Acid
Class: Antifibrinolytics
Manufacturer: TABROS PHARMA (PVT) LTD Karachi, Pakistan
Dosage Form: Capsule, Injection
Similar Brands:
Uses:
For short-term use (2 to 8 days) in hemophilia patients to reduce or prevent haemorrhage and to reduce the need for replacement therapy during and following tooth extraction.
For many hemostatic purposes including prevention of bleeding after surgery or trauma (e.g. tonsillectomy and adenoidectomy, prostrate surgery, ocular trauma and cervical conisation), and to prevent TR bleeding of subarachnoid haemorrhage, spontaneous bleeding in hemophilia and spontaneous or postoperative corneal oedema.
To treat primary or IUD-induced menorrhagia, gastric and intestinal haemorrhage, recurrent epistxis and hereditary angioneurotic edema. The drug also inhibits induced hyperfibrinolysis during thrombolytic treatment with plasminogen activators.
Dosage:
For dental extraction in patients with haemophilia: immediately before surgery, substitution therapy is given with HEMSAMIC 10mg/kg IV. After surgery, give 25mg/kg orally 3 to 4 times daily for 2 to 8 days.
Alternative: Give 25mg/kg orally, 3 to 4 times/day beginning one day prior to surgery.
Parenteral: 10mg/kg 3 to 4 times/day for patients unable to take oral medication.
| HEMSAMIC Dosage | |||
| ORAL DOSE
15-25mg/kg 3-4 times daily |
I.V DOSE
10-15mg/kg 3 times daily |
CONTINUOUS INFUSION
25-50mg/kg daily |
|
| Adults
(Appr. 670kg) |
2-3 caps of 500mg 3-4 times daily | 1-3 Ampoules of 500mg TID | 3-6 Ampoules of 500mg daily |
| CHILDREN
(Appr. 30kg) |
2-3 caps of 250mg 3-4 times daily | 1-2 Ampoules of 250mg of 250mg TID | 3-6 Ampoules of 250mg daily |
Dose should be reduced in renal impairment
Impaired renal function (moderate to severe):
The following dosages are recommended:
| HEMSAMIC Dosage | ||
| Serum Creatinine (umol/l.) | IV DOSE | Capsule |
| 120-250 (1.36-2.83mg/dl) | 10mg/kg bid | 15mg/kg bid |
| 250-500 (2.83-5.66mg/dl) | 10mg/kg day | 15mg/kg day |
| >500 (>5.66mg/dl) | 10mg/kg every 48 hours or 5mg/kg every 24 hours | 10mg/kg every 48 hours or 7.5mg/kg every 24 hours |
Preparation of solution
For IV infusion, HEMSAMIC may be mixed with most solutions for infusion such as electrolyte, carbohydrate, amino acids & dextran solutions. Prepare mixture the same day solution is to be used. Heparin may be added to solution for injection. Do not mix with blood. The drug is a synthetic amino acid. DO NOT mix with solutions containing penicillin.
Side Effects:
There is no known case of over dosage. Treatment includes usual supportive measures.
Warnings & Precautions:
Retinal changes
No retinal changes have been repeated in patients treated with HEMSAMIC for weeks to months in the clinical trials. However focal areas or retinal degeneration have developed in cats, dogs, rabbits and rats following oral or IV HEMSAMIC at doses between 125 and 1600mg/kg (3 to 40 times the recommended human dose) from 6 days to 1 year. The incidence of such lesions has varied from 25% to 100% and was dose related. At lower doses some lesions are reversible.
Visual abnormalities
Often poorly characterized, are the most frequently reported post-marketing adverse reactions. For patients who are to be treated for longer than several days, perform an ophthalmological examination (including visual acuity, colour vision, visual fields) before and at regular intervals during treatment. Discontinue HEMSAMIC if changes are found.
Precautions
Renal effects
Reduce dose in patients with renal insufficiency because of accumulation.
Carcinogenesis
Leukemia in male mice receiving HEMSAMIC up to 5g/kg/day may have been related treatment. Hyperplasia of the billiary tract and cholangiona and adenocarcinoma of the intrahepatic billiary system have been reported in one strain of rats after dietary administration exceeding the maximum tolerated dose for 22 months. Subsequent similar studies in a different strain of rat have failed to show hyperplastic/neoplastic changes in the live.
Pregnancy & Lactation:
Reproduction studies in mice, rats and rabbits have not revealed any evidence of impaired fertility or adverse effects on the foetus. There are no adequate and well controlled studies in pregnant woman, however, HEMSAMIC passes the placenta and appears in cord blood ant concentrations approximately equal to material concentrations. Use only if clearly needed.
Usage in lactation
HEMSAMIC is present in breast milk at 1% of the corresponding serum levels. Exercise caution when administering to nursing women.
Drug Interactions:
Contraindications:
Acquired defective colour vision: prohibits one endpoint of toxicity.
Subarachnoid haemorrhage: Celebral infractionmay be caused by HEMSAMIC in patients with suarachnoid haemorrhage.
Price: Ksh
Notes:
Capsule
Each capsule contains: Tranexamic Acid 250mg
Each capsule contains: Tranexamic Acid 500mg
Injection
Each 5ml Ampoule Contains: Tranexamic Acid 250mg
Each 5ml Ampoule Contains: Tranexamic Acid 250mg