TRANEXAMIC ACID — tranexamic acid injection
Caplin Steriles Limited
1 INDICATIONS & USAGE
Tranexamic acid injection is indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction.
2 DOSAGE & ADMINISTRATION
2.1 Recommended Dosage
The recommended dose of Tranexamic acid is 10 mg/kg actual body weight intravenously administered as a single dose, immediately before tooth extractions. Infuse no more than 1 mL/minute to avoid hypotension [see Warnings and Precautions (5.1)]. Following tooth extraction, Tranexamic acid 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.
2.2 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
|Serum Creatinine (mg/dL)||Tranexamic acid Intravenous Dosage|
|1.36 to 2.83 (120 to 250 micromol/L)||10 mg/kg twice daily|
|2.83 to 5.66 (250 to 500 micromol/L)||10 mg/kg daily|
|>5.66 (>500 micromol/L)||10 mg/kg every 48 hours or 5 mg/kg every 24 hours|
* Dose reduction is recommended for all doses, both before and after tooth extraction.
3 DOSAGE FORMS & STRENGTHS
Injection: 1000 mg tranexamic acid (100 mg/mL) clear and colorless solution in 10 mL single-dose vials
Tranexamic acid Injection is contraindicated:
• In patients with subarachnoid hemorrhage. Anecdotal experience indicates that cerebral edema and cerebral infarction may be caused by Tranexamic acid in such patients.
• In patients with active intravascular clotting [see Warnings and Precautions (5.1)]. • In patients with hypersensitivity to tranexamic acid or any of the ingredients [see Warnings and Precautions (5.4)].
5 WARNINGS AND PRECAUTIONS
5.1 Thromboembolic Risk
Tranexamic acid 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. Avoid concomitant use of Tranexamic acid and medical products that are pro-thrombotic, as the risk of thrombosis may be increased. These medications include but are not limited to, Factor IX Complex concentrates, Anti-inhibitor Coagulant concentrates, and hormonal contraceptives [see Drug Interactions (7.1), Use in Specific Populations (8.3)].
5.2 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.
Tranexamic acid 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). Tranexamic acid is not approved and not recommended for neuraxial administration. Consider dose reduction during surgery and dose adjustments for patients with clinical conditions such as renal dysfunction. Closely monitor the patient during surgery. Consider electroencephalogram (EEG) monitoring for patients with history of seizures or who experience myoclonic movements, twitching, or show evidence of focal seizures. Discontinue Tranexamic acid if seizures occur.
5.4 Hypersensitivity Reactions
Cases of hypersensitivity reactions, including anaphylactic reactions, have occurred with use of intravenous tranexamic acid. Discontinue treatment with Tranexamic acid if serious reaction occurs, provide appropriate medical management, and do not restart treatment. Tranexamic acid is contraindicated in patients with a history of hypersensitivity to tranexamic acid.
5.5 Visual Disturbances
Although not seen in humans, focal areas of retinal degeneration have been observed in cats and dogs following oral or intravenous tranexamic acid at doses between 250 to 1600 mg/kg/day (1.6 to 22 times the recommended usual human dose based on body surface area) from 6 days to 1 year. No retinal changes have been observed in eye examinations of patients treated with tranexamic acid for up to 8 years. Patients expected to be treated for greater than 3 months may consider ophthalmic monitoring including visual acuity and optical coherence tomography at regular intervals.Discontinue Tranexamic acid if changes in ophthalmological examination occurs.
Tranexamic acid may cause dizziness. Concomitant use of other drugs that may also cause dizziness may worsen this effect. Advise patients to avoid driving or using machines until they know how Tranexamic acid affects them.
6 ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
• Thromboembolic Risk [see Warnings and Precautions (5.1)]
• Seizures [see Warnings and Precautions (5.3)]
• Hypersensitivity Reactions [see Warnings and Precautions (5.4)]
• Visual Disturbances [see Warnings and Precautions (5.5)]
• Dizziness [see Warnings and Precautions (5.6)]
6.2 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.
Thromboembolic events (e.g., 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.
7 DRUG INTERACTIONS
7.1 Prothrombotic Medical Products
Avoid concomitant use of Tranexamic acid with medical products that are prothrombotic because concomitant use can further increase the risk of thromboembolic adverse reactions associated with tranexamic acid [see Warnings and Precautions (5.1), Use in Specific Populations (8.3)].
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