kapron tablets & ampoules

Composition

Each tablet or 5 ml ampoule contains: 500 mg Tranexamic acid.

Clinical pharmacology

Kapron® (Tranexamic acid) is an antifibrinolytic drug, acting by competitively inhibiting the activation of plasminogen to plasmin.

Kapron® stabilizes the fibrin structures, as defective fibrin formation or excessive rapid dissolution of fibrin results n excessive or recurrent bleeding, and that is through preventing the untimely dissolution of hemostatic fibrin by plasmin.

Furthermore, Kapron® increases collagen synthesis and granulation tissue, presumably by preserving the fibrin matrix.

Pharmacokinetics

Kapron® (Tranexamic acid) is absorbed from the gastrointestinal tract with peak plasma concentration occurring after about 3 hours. Bioavailability is about 30 to 50%.

Kapron® is widely distributed throughout the body and has very low protein binding. It diffuses across the placenta and is distributed into breast milk.

Kapron® has a plasma elimination half-life of about 2 hours. It is excreted in the urine mainly as unchanged drug.

Indications

1. Prevention of rebleeding of subarachnoid hemorrhage.
2. Treatment of primary or intrauterine device (IUD) – induced menorrhagia.
3. Treatment of gastric and intestinal hemorrhage.
4. Treatment of recurrent epistaxis.
5. Prevention of spontaneous or postoperative corneal edema.
6. Treatment of hereditary and non-hereditary angioedema.
7. Prevention of bleeding in acute promyelocytic leukemia.
8. Prevention of bleeding after bypass surgery.

Prevention of bleeding after surgery or trauma:

• Tooth extraction in patients with hemophilia
• Cervical conization
• Tonsillectomy and adenoidectomy
• Prostatic surgery
• Ocular trauma
• Oral surgery in patients taking anticoagulants

Precautions

Precaution is needed when Kapron® is used in patients with renal insufficiency, because of the risk of accumulation and in massive haematuria from the upper urinary tract since in a few cases ureteric obstruction has been reported.

Patients with a previous history of thromboemobolic disease should not be given Kapron® unless simultaneous treatment with anticoagulants can be given.

Adverse reactions

Tranexamic acid appears to be well tolerated. It can produce dose-related gastro-intestinal disturbances (such as: nausea, vomiting, diarrhea) and hypotension particularly after rapid intravenous administration.

Drug interactions

Kapron® (Tranexamic acid) can be mixed with most solutions such as: electrolyte, carbohydrate, amino acid and dextran solution.

It is compatible with heparin. The drug should not be mixed with transfusion blood or with infusion solutions containing penicillin.

Dosage

Kapron® is given by mouth and by slow intravenous injection or continuous infusion.

Administration by injection is usually changed to oral administration after few days.

Adult doses:

• Oral doses are 1 to 1.5 g (or 15 to 25 mg/kg) 2 to 4 times daily.
• Slow intravenous doses are 0.5 to 1 g (or 10 to 15 mg/kg) 3 times daily.
• Continuous intravenous infusion at a rate of 25 to 50 mg/kg/day.

Children doses:

15 to 25 mg/kg by mouth or 10 mg/kg I.V. usually administered 2 times a day.

How supplied

• Strips of 10 tablets in packs of 2 strips.
• Packs of 6 ampoules.

Keep all medicaments out of reach of children

Product of: AMOUN PHARMACEUTICAL CO. El-Obour City, Cairo, Egypt. ATC Code: B02AA02