Tranexamic Acid In Sodium Chloride

Tranexamic Acid in Sodium Chloride Injection is indicated in patients with hemophilia for short-term use (two to eight days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction.

• •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. Infuse no more than 10 mL/minute to avoid hypotension (
  2.1 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. Infuse no more than 10 mL/minute to avoid hypotension

  [see Warnings and Precautions ]

  . 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.
  ).
• •Reduce the dosage for patients with renal impairment (
  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

  *Dose reduction is recommended for all doses, both before and after tooth extraction.
  Serum Creatinine (mg/dL)	Tranexamic Acid in Sodium Chloride Injection 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

  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:

  • 1.000000000000000e+00Always inspect the solution container before and after removal from the overwrap.
  • 2.000000000000000e+00Place the solution container on a clean, flat surface. Remove the solution container from the overwrap.
  • 3.000000000000000e+00Check the solution container for leaks by squeezing firmly. If leaks are found discard.
  • 4.000000000000000e+00Do not use if the solution is cloudy or a precipitate is present.

  To Prepare for Administration:

  • 1.000000000000000e+00Immediately before inserting the infusion set, break off BLUE Infusion Port Cap with the arrow pointing away from the solution container.
  • 2.000000000000000e+00Use a non-vented infusion set or close the air-inlet on a vented set.
  • 3.000000000000000e+00Close the roller clamp of the infusion set.
  • 4.000000000000000e+00Hold the base of the BLUE Infusion Port., twist and push spike until fully inserted.
  • 5.000000000000000e+00The BLUE Infusion Port contains a self-sealing septum that helps prevent leakage after removing the spike. The infusion port is not intended to be spiked more than once.
  • 6.000000000000000e+00Suspend solution container from hanger hole.
  • 7.000000000000000e+00For Single Use Only. Discard unused portion.
  ,
  8.6 Renal Impairment

  Reduce the dosage of Tranexamic Acid in Sodium Chloride Injection in patients with renal impairment, based on the patient's serum creatinine

  [see Dosage and Administration , Clinical Pharmacology ].
  ).

Injection: 1,000 mg of tranexamic acid in 100 mL (10 mg/mL), colorless solution in a single-dose bag for intravenous use

Available data from published studies, case series and case reports with tranexamic acid use in pregnant women in the second and third trimester and at the time of delivery have not clarified whether there is a drug-associated risk of miscarriage or adverse maternal or fetal outcomes. There are 2 (0.02%) infant cases with structural abnormalities that resulted in death when tranexamic acid was used during conception or the first trimester of pregnancy; however, due to other confounding factors the risk of major birth defects with use of tranexamic acid during pregnancy is not clear.

Tranexamic acid is known to pass the placenta and appears in cord blood at concentrations approximately equal to maternal concentration (

Reproduction studies performed in mice, rats, and rabbits have not revealed any adverse effects on the fetus due to tranexamic acid administered during organogenesis. Doses examined were multiples of up to 3 times (mouse), 6 times (rat), and 3 times (rabbit) the maximum human dose based on body surface area in the mouse, rat, and rabbit, respectively

The estimated background risk for major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in the clinically recognized pregnancies is 2-4% and 15-20%, respectively.

It is not known whether tranexamic acid use in pregnant women may cause a drug-associated risk of miscarriage or adverse maternal or fetal outcomes. For decisions regarding the use of Tranexamic Acid in Sodium Chloride Injection during pregnancy, the potential risk of Tranexamic Acid in Sodium Chloride Injection administration on the fetus should always be considered along with the mother's clinical need for Tranexamic Acid in Sodium Chloride Injection; an accurate risk-benefit evaluation should drive the treating physician's decision.

• •Risk of Thrombosis with concomitant use of Factor IX: Avoid concomitant use (
  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. These medications include but are not limited to, Factor IX Complex concentrates, Anti-inhibitor Coagulant concentrates, and hormonal contraceptives

  [see Drug Interactions , Use in Specific Populations ]

  .
  ).
• •Seizures: Inadvertent injection into neuraxial system may result in seizures (
  5.2 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.
  ).
• •Hypersensitivity Reactions: In case of severe reaction, discontinue use and seek immediate medical attention (
  5.3 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. Tranexamic Acid in Sodium Chloride Injection is contraindicated in patients with a history of hypersensitivity to tranexamic acid.
  ).
• •Visual Disturbances: Visual or ocular adverse effects may occur. Discontinue use if visual or ocular symptoms occur (
  5.4 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 in Sodium Chloride Injection if changes in ophthalmological examination occurs.
  ).
• •Dizziness. Advise patients not to drive if dizziness occurs (
  5.5 Dizziness

  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 in Sodium Chloride Injection affects them.
  ).