Tranexamic Acid

2 DOSAGE AND ADMINISTRATION Before Extraction: Administer 10 mg/kg actual body weight of tranexamic acid injection intravenously with replacement therapy. 1 ) After Extraction: Administer 10 mg/kg actual body weight 3 to 4 times daily for 2 to 8 days.

Infuse no more than 1 mL/minute to avoid hypotension. 1 ) Reduce the dosage for patients with renal impairment. 1 Recommended Dosage The recommended dose of tranexamic acid injection is 10 mg/kg actual body weight intravenously administered as a single-dose, immediately before tooth extractions.

1 )]. Following tooth extraction, tranexamic acid injection may be administered for 2 to 8 days at a dose of 10 mg/kg actual body weight 3 to 4 times daily, intravenously. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

For intravenous infusion, tranexamic acid injection may be mixed with most solutions for infusion such as electrolyte solutions, carbohydrate solutions, amino acid solutions, and Dextran solutions. Heparin may be added to tranexamic acid injection.

Tranexamic acid injection should NOT be mixed with blood. The drug is a synthetic amino acid and should NOT be mixed with solutions containing penicillin. Discard any unused portion. The diluted mixture may be stored for up to 4 hours at room temperature prior to patient administration.

2 Recommended Dosage for Patients With Varying Degrees of Renal Impairment * For patients with moderate to severe impaired renal function, the following dosages are recommended: Table 1: Recommended Dosage in Patients With Varying Degrees of Renal Impairment * Dose reduction is recommended for all doses, both before and after tooth extraction.

66 (>500 micromol/L) 10 mg/kg every 48 hours or 5 mg/kg every 24 hours

6 )] Most common adverse reactions are nausea, vomiting, diarrhea, allergic dermatitis, giddiness, hypotension, and thromboembolic events. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Avenacy Inc. gov/medwatch . 2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of tranexamic acid.

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Gastrointestinal disturbances (nausea, vomiting, diarrhea) may occur and may resolve with dose-reduction.

Allergic dermatitis and giddiness have been reported. Hypotension has been reported when intravenous injection is too rapid. , deep vein thrombosis, pulmonary embolism, cerebral thrombosis, acute renal cortical necrosis, and central retinal artery, vein obstruction and cases associated with concomitant use of combination hormonal contraceptives) have been rarely reported in patients receiving tranexamic acid for indications other than hemorrhage prevention in patients with hemophilia.

Convulsion, cromatopsia, and visual impairment have also been reported. Anaphylaxis or anaphylactoid reactions have been reported that are suggestive of a causal relationship.

5 WARNINGS AND PRECAUTIONS Risk of Thrombosis with Concomitant Use of Factor IX: Avoid concomitant use. 1 ) Risk of Medication Errors Due to Incorrect Route of Administration: FOR INTRAVENOUS USE ONLY. 2 ) Seizures: Inadvertent injection into neuraxial system may result in seizures.

3 ) Hypersensitivity Reactions: In case of severe reaction, discontinue use and seek immediate medical attention. 4 ) Visual Disturbances: Visual or ocular adverse effects may occur. Discontinue use if visual or ocular symptoms occur.

5 ) Dizziness: Advise patients not to drive if dizziness occurs. 1 Thromboembolic Risk Tranexamic acid injection is contraindicated in patients with active intravascular clotting. Tranexamic acid is an antifibrinolytic and may increase the risk of thromboembolic events.

Venous and arterial thrombosis or thromboembolism has been reported in patients treated with tranexamic acid injection. Avoid concomitant use of tranexamic acid injection and medical products that are pro-thrombotic, as the risk of thrombosis may be increased.

3 )] . 2 Risk of Medication Errors Due to Incorrect Route of Administration Tranexamic acid injection is for intravenous use only. Serious adverse reactions including seizures and cardiac arrythmias have occurred when tranexamic acid injection was inadvertently administered intrathecally instead of intravenously.

Confirm the correct route of administration for tranexamic acid injection and avoid confusion with other injectable solutions that might be administered at the same time as tranexamic acid injection. Syringes containing tranexamic acid injection should be clearly labeled with the intravenous route of administration.

3 Seizures Tranexamic acid injection may cause seizures, including focal and generalized seizures. The most common setting for tranexamic acid-induced seizures has been during cardiovascular surgery (a setting in which tranexamic acid is not FDA-approved and which uses doses of up to 10-fold higher than the recommended human dose and in patients inadvertently given tranexamic acid into the neuraxial system).

4 CONTRAINDICATIONS Tranexamic acid injection, USP is contraindicated: In patients with subarachnoid hemorrhage. Anecdotal experience indicates that cerebral edema and cerebral infarction may be caused by tranexamic acid injection in such patients.

1 )] . 4 )] . In patients with subarachnoid hemorrhage, due to risk of cerebral edema and cerebral infarction. ( 4 ) In patients with active intravascular clotting. ( 4 ) In patients with severe hypersensitivity reactions to tranexamic acid or any of the ingredients.

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