Tracid 500 mg Injection

Tracid 500 mg Injection

DESCRIPTION

TRACID (Tranexamic Acid) is an antifibrinolytic agent used to treat serious bleeding. Tranexamic acid is a competitive inhibitor of plasminogen activation. Tranexamic acid is about 10 times more potent (in vitro) than Aminocaproic Acid. Tranexamic acid binds more strongly than Aminocaproic Acid to both the strong and weak receptor sites of the plasminogen.

COMPOSITION

Tablet : Each film-coated tablet contains Tranexamic Acid BP 500 mg.

Injection IV/IM : Each 5ml ampoule contains Tranexamic Acid BP 500 mg.

INDICATIONS

TRACID (Tranexamic Acid) tablet and Injection are indicated in haemorrhage or risk of haemorrhage in increased fibrinolysis or fibrinogenolysis. Local fibrinolysis may occur in the following conditions:

Prostatectomy and bladder surgery, Menorrhagia, Epistaxis, Conisation of the cervix , Management of dental extraction in patients with coagulopathies, Ulcerative colitis, Haematuria, Gastrointestinal

haemorrhage, General fibrinolysis as in prostatic and pancreatic cancer; after thoracic and other major surgery; in obstetrical complications such as abruptio placentae and post-partum haemorrhage; in leukaemia and liver diseases and in connection with thrombolytic therapy with streptokinase. TRACID is also indicated for

Hereditary angioneurotic oedema.

DOSAGE AND ADMINISTRATION

TRACID (Tranexamic Acid) IV/IM administration is necessary only if it is difficult to give adequate doses by mouth.

The recommended adult standard dose is 2-3 tablets of 500 mg (15-25 mg/Kg), or 5-10 ml by slow IV/IM injection at a rate of 1mL/minute, two to three times daily.

For the indications listed below the following doses are recommended.

Prostatectomy: 5-10 ml by slow IV/IM injection every eight hours (the first injection being given during the operation) for the first three days after surgery; thereafter 1-1.5 g orally three to four times daily until macroscopic haematuria is no longer present.

Menorrhagia: 1 g (2 tablets) orally three times daily for up to four days.

Maximum dose 4 g daily. TRACID therapy is initiated when bleeding has become profuse.

Epistaxis: 1.5 g orally three times daily for four to ten days. TRACID solution for injection may be applied topically to the nasal mucosa of patients suffering from epistaxis. This can be done by soaking a gauze strip in the solution, and then packing the nasal cavity.

Haematuria: 1-1.5 g orally 2-3 times daily until macroscopic haematuria is no longer present.

Conisation of the Cervix: 1.5 g orally 3 times a day for 12 to 14 days post-operatively.

Dental Surgery in Patients with Coagulopathies: Immediately before surgery, 10 mg per kg body-weight should be given IV/IM. After surgery, 25 mg per kg body-weight are given orally three to four times daily for six to eight days.

General Fibrinolysis: 1.0 g (10 ml) by slow IV/IM injection three to four times daily.

Hereditary Angioneurotic Oedema: 1-1.5 g orally two to three times daily as intermittent or continuous treatment depending on whether the patient has prodromal symptoms or not.

In case of renal insufficiency: For patients with impaired renal function, the following dosages are recommended:

PRECAUTION

The dose of TRACID tablet and Injection should be reduced in patients with renal insufficiency because of the risk of accumulation.

Pregnancy (Category B): Reproduction studies performed in mice, rats, and rabbits have not revealed any evidence of impaired fertility or adverse effects on the fetus due to Tranexamic Acid. There are no adequate and well-controlled studies in pregnant women.

Nursing Mothers: Tranexamic Acid is present in the mother’s milk at a concentration of about a hundredth of the corresponding serum levels.

Caution should be exercised when TRACID is administered to a nursing woman.

Pediatric Use: The drug has had limited use in pediatric patients, principally in connection with tooth extraction. The limited data suggest that dosing instructions for adults can be used for pediatric patients needing Tranexamic Acid therapy.

CONTRAINDICATION

TRACID is contraindicated in active thromboembolic disease, such as deep vein thrombosis, pulmonary embolism and cerebral thrombosis.

Subarachnoid haemorrhage.Tracid is also contraindicated in hypersensitivity to Tranexamic Acid or any of the ingredients.

SIDE EFFECT

There is no known case of side effect of TRACID tablets and Injection.

Symptoms of side effects may be nausea, vomiting, diarrhoea,

dizziness, disturbed color vision etc.

DRUG INTERACTION

It interacts with penicillin type antibiotic. Co-administration with

penicillin should be cautious.

SUPPLY

Tablet: : Each box contains 2X10's tablets in blisters.

Injection IV/IM : Each box contains 3 ampoules in a blister.