TRANEXAMIC ACID- tranexamic acid tablet, film coated
Actavis Pharma, Inc.
Prior to prescribing tranexamic acid tablets, exclude endometrial pathology that can be associated with heavy menstrual bleeding.
The recommended dose of tranexamic acid tablets for women with normal renal function is two 650 mg tablets taken three times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation. Tranexamic acid tablets may be administered without regard to meals. Tablets should be swallowed whole and not chewed or broken apart.
In patients with renal impairment, the plasma concentration of tranexamic acid increased as serum creatinine concentration increased [see Clinical Pharmacology (12.3)]. Dosage adjustment is needed in patients with serum creatinine concentration higher than 1.4 mg/dL (Table 1).
|Tranexamic Acid Tablets|
|Serum Creatinine (mg/dL)||Adjusted Dose||Total Daily Dose|
|Cr above 1.4 and≤ 2.8||1300 mg (two 650 mg tablets) two times a day for a maximum of 5 days during menstruation||2600 mg|
|Cr above 2.8 and≤ 5.7||1300 mg (two 650 mg tablets) once a day for a maximum of 5 days during menstruation||1300 mg|
|Cr above 5.7||650 mg (one 650 mg tablet) once a day for a maximum of 5 days during menstruation||650 mg|
650 mg tablets
Do not prescribe tranexamic acid tablets to women who are
- using combination hormonal contraception
- known to have any of 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.
Concomitant Use of Hormonal Contraceptives
Combination hormonal contraceptives are known to increase the risk of venous thromboembolism, as well as arterial thromboses such as stroke and myocardial infarction. Because tranexamic acid tablets are antifibrinolytic, the risk of venous thromboembolism, as well as arterial thromboses such as stroke, may increase further when hormonal contraceptives are administered with tranexamic acid tablets. This is of particular concern in women who are obese or smoke cigarettes, especially smokers over 35 years of age.
Women using hormonal contraception were excluded from the clinical trials supporting the safety and efficacy of tranexamic acid tablets, and there are no clinical trial data on the risk of thrombotic events with the concomitant use of tranexamic acid tablets with hormonal contraceptives. However, there have been US postmarketing reports of venous and arterial thrombotic events in women who have used tranexamic acid tablets concomitantly with combination hormonal contraceptives. For this reason, concomitant use of tranexamic acid tablets with combination hormonal contraceptives is contraindicated. [see Contraindications(4.1) and Drug Interactions (7.1)].
Factor IX Complex Concentrates or Anti-Inhibitor Coagulant Concentrates
Tranexamic acid tablets is not recommended for women taking either Factor IX complex concentrates or anti-inhibitor coagulant concentrates because the risk of thrombosis may be increased [see Drug Interactions(7.3) and Clinical Pharmacology(12.3)].
All-Trans Retinoic Acid (Oral Tretinoin)
Exercise caution when prescribing tranexamic acid tablets to women with acute promyelocytic leukemia taking all-trans retinoic acid for remission induction because of possible exacerbation of the procoagulant effect of all-trans retinoic acid [see Drug Interactions(7.4) and Clinical Pharmacology(12.3)].
Retinal venous and arterial occlusion has been reported in patients using tranexamic acid. Patients should be instructed to report visual and ocular symptoms promptly. In the event of such symptoms, patients should be instructed to discontinue tranexamic acid tablets immediately and should be referred to an ophthalmologist for a complete ophthalmic evaluation, including dilated retinal examination, to exclude the possibility of retinal venous or arterial occlusion.
A case of severe allergic reaction to tranexamic acid tablets was reported in the clinical trials, involving a subject who experienced dyspnea, tightening of her throat, and facial flushing that required emergency medical treatment. A case of anaphylactic shock has also been reported in the literature, involving a patient who received an intravenous bolus of tranexamic acid.
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