Composition:

Hemostat Capsule: Each capsule contains Tranexamic Acid BP 500 mg.

Hemostat Injection: Each 5 ml ampoule contains Tranexamic Acid BP 250 mg.

Pharmacology:

Tranexamic acid is an antifibrinolytic agent, which competitively inhibits the activation of plasminogen to plasmin.

Indications:

• Short-term use for haemorrhage or risk of haemorrhage in increased fibrinolysis or fibrinogenolysis.
• Local fibrinolysis occurs in the following conditions: Prostatectomy and bladder surgery, Menorrhagia, Epistaxis, Conisation of the cervix, Traumatic hyphaema, Management of dental extraction patient with coagulopathies, Ulcerative colitis, Hematuria, Gastrointestinal haemorrhage.
• General fibrinolysis as in prostatic and pancreatic cancer; after thoracic and other major surgery; in obstetrical complication such as abruptio placenta and post-partum haemorrhage; in leukemia and liver diseases and in connection with thrombolytic therapy with streptokinase. Hereditary angioneurotic oedema.

Dosage and administration:

• By mouth 15-25 mg / kg 2-3 times daily, Menorrhagia 1 g 3 times daily for up to 4 days; max. 4 g daily, hereditary angioedema, 1-1.5 g 2-3 times daily.
• By slow intravenous injection, local fibronolysis, 0.5-1 g 3 times daily.

Contra-indications:

Hemostat is contra-indicated in patients with history of thromboembolic disease and severe renal impairment.

Warnings and precautions:

Patients with irregular menstrual bleeding should not use Tranexamic Acid until the cause of the irregularity has been established. If menstrual bleeding is not adequately reduced by Tranexamic Acid, an alternative treatment should be considered. Patients with a high risk for thrombosis (a previous thromboembolic event and a family history of thromboembolic disease) should use Tranexamic Acid only if there is a strong medical indication and under strict medical supervision.

Use in pregnancy:

Although there is no evidence from animal studies of teratogenic effect, the usual caution with the use of drugs in pregnancy should be observed.

Use in Lactation:

Tranexamic acid is excreted into breast milk, but it is not likely to influence the child at therapeutic doses.

Use in children:

Clinical experience with Tranexamic Acid in menorrhagic children under 15 years of age is not available.

Use in elderly patients:

No reduction in dosage is necessary unless there is evidence of renal failure.

Side effects:

GI discomfort like nausea, vomiting, diarrhoea is common. But disappeared when dosage is reduced. Disturbances in color vision and thromboembolic events reported rarely; giddiness on rapid intravenous injection.

Storage:

Store in a cool & dry place, protect from light. Keep out of the reach of children.

Packing:

Hemostat Capsule: Each box contains 2 x 10 's Capsule in blister pack.

Hemostat Injection: Each box contains 1 x 5's ampoules.