Tranexamic Acid

Tranexamic Acid

Tranexamic Acid Recall

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Questions & Answers

Side Effects & Adverse Reactions

Focal areas of retinal degeneration have developed in cats, dogs, and rats following oral or intravenous tranexamic acid at doses between 250 to 1600 mg/kg/day (6 to 40 times the recommended usual human dose) from 6 days to 1 year. The incidence of such lesions has varied from 25% to 100% of animals treated and was dose-related. At lower doses, some lesions have appeared to be reversible.

Limited data in cats and rabbits showed retinal changes in some animals with doses as low as 126 mg/kg/day (only about 3 times the recommended human dose) administered for several days to two weeks.

No retinal changes have been reported or noted in eye examinations in patients treated with tranexamic acid for weeks to months in clinical trials.

However, visual abnormalities, often poorly characterized, represent the most frequently reported postmarketing adverse reaction in Sweden. For patients who are to be treated continually for longer than several days, an ophthalmological examination, including visual acuity, color vision, eye-ground, and visual fields, is advised, before commencing and at regular intervals during the course of treatment. Tranexamic acid should be discontinued if changes in examination results are found.

Convulsions have been reported in association with tranexamic acid treatment, particularly in patients receiving tranexamic acid during cardiovascular surgery and in patients inadvertently given tranexamic acid into the neuraxial system.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

Tranexamic acid 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.

History

There is currently no drug history available for this drug.

Other Information

Each mL of the sterile solution for intravenous injection contains 100 mg Tranexamic Acid, USP and Water for Injection, USP to 1 mL.FORMULATION

Chemical Name: trans-4-(aminomethyl) cyclohexanecarboxylic acid

Structural Formula:

structure

Molecular Formula: C8H15NO2                        Molecular Weight: 157.2

Tranexamic Acid, USP is a white crystalline powder. The aqueous solution for injection has a pH of 6.5 to 8.0.

Tranexamic Acid Manufacturers


  • Heritage Pharmaceuticals Inc.
    Tranexamic Acid Injection, Solution [Heritage Pharmaceuticals Inc.]
  • American Health Packaging
    Tranexamic Acid Tablet, Film Coated [American Health Packaging]
  • Akorn, Inc.
    Tranexamic Acid Injection, Solution [Akorn, Inc.]
  • Nexus Pharmaceuticals Inc
    Tranexamic Acid Injection, Solution [Nexus Pharmaceuticals Inc]
  • App Pharmaceuticals, Llc
    Tranexamic Acid Injection, Solution [App Pharmaceuticals, Llc]
  • Prasco Laboratories
    Tranexamic Acid Tablet [Prasco Laboratories]
  • Watson Laboratories, Inc.
    Tranexamic Acid Tablet, Film Coated [Watson Laboratories, Inc.]
  • Mylan Institutional Llc
    Tranexamic Acid Injection, Solution [Mylan Institutional Llc]
  • Fresenius Kabi Usa, Llc
    Tranexamic Acid Injection, Solution [Fresenius Kabi Usa, Llc]
  • X-gen Pharmaceuticals, Inc.
    Tranexamic Acid Injection, Solution [X-gen Pharmaceuticals, Inc.]
  • Prasco Laboratories
    Tranexamic Acid Tablet [Prasco Laboratories]
  • Apotex Corp.
    Tranexamic Acid Tablet [Apotex Corp.]
  • Acella Pharmaceuticals
    Tranexamic Acid Injection, Solution [Acella Pharmaceuticals]
  • X-gen Pharmaceuticals, Inc.
    Tranexamic Acid Injection, Solution [X-gen Pharmaceuticals, Inc.]
  • American Regent, Inc.
    Tranexamic Acid Injection, Solution [American Regent, Inc.]
  • Heritage Pharmaceuticals Inc.
    Tranexamic Acid Injection, Solution [Heritage Pharmaceuticals Inc.]
  • Golden State Medical Supply, Inc.
    Tranexamic Acid Tablet [Golden State Medical Supply, Inc.]

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