There are no known cases of intentional overdose with LYSTEDA (tranexamic acid tablets) and no subjects in the clinical program took more than 2 times the prescribed amount of LYSTEDA (tranexamic acid tablets) in a 24-hour period ( > 7800 mg/day). However, cases of overdose of tranexamic acid have been reported. Based on these reports, symptoms of overdose may include gastrointestinal (nausea, vomiting, diarrhea); hypotensive (e.g., orthostatic symptoms); thromboembolic (arterial, venous, embolic); visual impairment; mental status changes; myoclonus; or rash. No specific information is available on the treatment of overdose with LYSTEDA (tranexamic acid tablets) . In the event of overdose, employ the usual supportive measures (e.g., clinical monitoring and supportive therapy) as dictated by the patient's clinical status.

Thromboembolic Risk

Do not prescribe LYSTEDA (tranexamic acid tablets) to women who are known to have the following conditions:

• Active thromboembolic disease (e.g., deep vein thrombosis, pulmonary embolism, or cerebral thrombosis)
• A history of thrombosis or thromboembolism, including retinal vein or artery occlusion
• An intrinsic risk of thrombosis or thromboembolism (e.g., thrombogenic valvular disease, thrombogenic cardiac rhythm disease, or hypercoagulopathy)

Venous and arterial thrombosis or thromboembolism, as well as cases of retinal artery and retinal vein occlusions, have been reported with tranexamic acid.

Hypersensitivity to Tranexamic Acid

Do not prescribe LYSTEDA (tranexamic acid tablets) to women with known hypersensitivity to tranexamic acid [see WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS].

Last reviewed on RxList: 5/19/2011
This monograph has been modified to include the generic and brand name in many instances.