Tranexamic acid: Indication, Dosage, Side Effect, Precaution

Concise Prescribing Info Full Prescribing Info

Dosage/Direction for Use Administration Contraindications Special Precautions Adverse Reactions Pregnancy Category (US FDA) Overdosage Drug Interactions Action Storage CIMS Class ATC Classification

Full Prescribing Info

Dosage/Direction for Use

Oral
Short-term management of haemorrhage
Adult: Localised: 1-1.5 g (or 15-25 mg/kg) bid or tid.
Renal impairment: Mild to moderate: Serum creatinine level (mcmol/L): 120-249: 15 mg/kg bid. 250-500: 15 mg/kg daily. Severe: Contraindicated.

Oral
Hereditary angioedema
Adult: 1-1.5 g bid or tid given intermittently or continuously, depending on patient condition.
Renal impairment: Mild to moderate: Serum creatinine level (mcmol/L): 120-249: 15 mg/kg bid. 250-500: 15 mg/kg daily. Severe: Contraindicated.

Oral
Menorrhagia
Adult: 1 g tid during menstruation as necessary for up to 5 days, may be increased for heavy bleeding. Max: 4 g daily.
Renal impairment: Mild to moderate: Serum creatinine level (mcmol/L): 120-249: 15 mg/kg bid. 250-500: 15 mg/kg daily. Severe: Contraindicated.

Oral
Patients with haemophilia undergoing dental extraction
Adult: 1.5 g (or 25 mg/kg) 8 hourly.
Renal impairment: Mild to moderate: Serum creatinine level (mcmol/L): 120-249: 15 mg/kg bid. 250-500: 15 mg/kg daily. Severe: Contraindicated.

Intravenous
Short-term management of haemorrhage
Adult: Local: 0.5-1 g bid or tid. General: 1 g (or 15 mg/kg) 6-8 hourly. Doses are administered by slow inj at a rate of 1 mL/min.
Renal impairment: Mild to moderate: Serum creatinine level (mcmol/L): 120-249: 10 mg/kg 12 hourly. 250-500: 10 mg kg 24 hourly. >500: 5 mg/kg 24 hourly. Severe: Contraindicated.
Incompatibility: Incompatible with benzylpenicillin.

Administration

May be taken with or without food.

Contraindications

Hypersensitivity. Active thromboembolic disease (e.g. pulmonary embolism, DVT), history of venous or arterial thrombosis (including retinal vein or artery occlusion), disseminated intravascular coagulation, fibrinolytic conditions after consumption coagulopathy, history of convulsions. Concomitant use with hormonal contraceptives. Severe renal impairment.

Special Precautions

Patients with enormous haematuria from upper urinary tract, history of thromboembolic diseases. Women with subarachnoid haemorrhage or irregular menstrual cycle. Mild to moderate renal impairment. Pregnancy and lactation. Patient Counselling This drug may cause dizziness, if affected, do not drive or operate machinery. Monitoring Parameters Perform eye examinations at baseline then regularly during treatment.

Adverse Reactions

Significant: Visual and ocular disturbance (e.g. impaired colour vision), retinal vein or artery occlusion, ligneous conjunctivitis, thromboembolic events, convulsions. Blood and lymphatic system disorders: Anaemia. Gastrointestinal disorders: Diarrhoea, nausea, vomiting, abdominal pain. General disorders and administration site conditions: Fatigue. Musculoskeletal and connective tissue disorders: Musculoskeletal pain, muscle cramps. Nervous system disorders: Headache, migraine. Respiratory, thoracic and mediastinal disorders: Nasal and sinus symptoms.
Potentially Fatal: Severe hypersensitivity reactions including anaphylaxis.

Pregnancy Category (US FDA)

Overdosage

Symptoms: Convulsions, dizziness, headache, hypotension, nausea, vomiting. Management: Supportive treatment.

Drug Interactions

Antagonistic effects with thrombolytics (e.g. alteplase, reteplase). Increased risk of thrombosis with factor IX complex concentrates or anti-inhibitor coagulant concentrates. May enhance the procoagulant effect of all-trans retinoic acid (oral tretinoin) in women with acute promyelocytic leukaemia.
Potentially Fatal: Concomitant use with hormonal contraceptives may increase the risk of venous thromboembolism or arterial thrombosis (e.g. MI, stroke).

Action

Tranexamic acid inhibits fibrinolysis by blocking the binding of plasminogen and plasmin to fibrin, thus preventing dissolution of the haemostatic plug.
Absorption: Absorbed from the gastrointestinal tract. Bioavailability: Approx 45% (oral). Time to peak plasma concentration: 2.5 hours after oral administration (range: 1-5 hours).
Distribution: Widely distributed throughout the body. It crosses the placenta and enters breast milk. Volume of distribution: 9-12 L. Plasma protein-binding: Approx 3%, mainly to plasminogen.
Excretion: Via urine (>95%, as unchanged drug). Elimination half-life: Approx 2-11 hours.

Storage

Intravenous: Store at 25°C. Oral: Store at 25°C.

CIMS Class

Haemostatics

ATC Classification

B02AA02 - tranexamic acid ; Belongs to the class of amino acid antifibrinolytics. Used in the treatment of hemorrhage.

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