Tranexamic Acid In Sodium Chloride

2 DOSAGE AND ADMINISTRATION Before Extraction: Administer 10 mg/kg actual body weight of Tranexamic Acid in Sodium Chloride Injection intravenously with replacement therapy.

After Extraction:

Administer 10 mg/kg actual body weight 3 to 4 times daily for 2 to 8 days. 1 ). 6 ). 1 Recommended Dosage The recommended dose of Tranexamic Acid in Sodium Chloride Injection is 10 mg/kg actual body weight intravenously administered as a single dose, immediately before tooth extractions.

1 )] . Following tooth extraction, Tranexamic Acid in Sodium Chloride Injection may be administered for 2 to 8 days at a dose of 10 mg/kg actual body weight three to four times daily, intravenously. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Do not use Tranexamic Acid in Sodium Chloride Injection if particulate matter or coloration is seen. Tranexamic Acid in Sodium Chloride Injection should NOT be mixed with blood. The drug is a synthetic amino acid and should NOT be mixed with solutions containing penicillin.

The premix flexible plastic container bag contains no preservative; discard any unused portion. 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 INSTRUCTIONS FOR USE: Check solution container composition, lot number, and expiry date.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not admix with other drugs. Do not use solution containers in series connections.

Do not remove solution container from its overwrap until immediately before use. The intact port cap provides visual tamper evidence. Do not use if a port cap is prematurely removed. Maintain strict aseptic technique during handling.

To Open:

5 )] Most common adverse reactions are nausea, vomiting, diarrhea, allergic dermatitis, giddiness, hypotension, and thromboembolic events ( 6 ). 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.

1 ). 2 ). 3 ).

Visual Disturbances:

Visual or ocular adverse effects may occur. 4 ). Dizziness. 5 ). 1 Thromboembolic Risk Tranexamic Acid in Sodium Chloride 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. Avoid concomitant use of Tranexamic Acid in Sodium Chloride Injection and medical products that are pro-thrombotic, as the risk of thrombosis may be increased.

3 )] . 2 Seizures 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 in Sodium Chloride Injection is not FDA approved and which uses doses of up to ten-fold higher than the recommended human dose and in patients inadvertently given tranexamic acid into the neuraxial system).

Tranexamic Acid in Sodium Chloride Injection 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 in Sodium Chloride Injection if seizures occur.

3 Hypersensitivity Reactions Cases of hypersensitivity reactions, including anaphylactic reactions, have occurred with use of intravenous tranexamic acid. Discontinue treatment with Tranexamic Acid in Sodium Chloride Injection if serious reaction occurs, provide appropriate medical management, and do not restart treatment.

4 CONTRAINDICATIONS Tranexamic Acid in Sodium Chloride 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.

1 )] . 3 )] . 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 ( 4 ).