Tranexamic Acid

TRANEXAMIC ACID- tranexamic acid tablet, film coated
Watson Laboratories, Inc.

1 INDICATIONS AND USAGE

Tranexamic acid tablets are indicated for the treatment of cyclic heavy menstrual bleeding [see Clinical Studies ( 14) ].

Prior to prescribing Tranexamic acid tablets, exclude endometrial pathology that can be associated with heavy menstrual bleeding.

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage

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.

2.2 Renal Impairment

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).

Table 1. Dosage of Tranexamic Acid Tablets in Patients with Renal Impairment
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

3 DOSAGE FORMS AND STRENGTHS

650 mg tablets

4 CONTRAINDICATIONS

4.1 Thromboembolic Risk

Do not prescribe 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.

4.2 Hypersensitivity to Tranexamic Acid

Do not prescribe Tranexamic acid tablets to women with known hypersensitivity to tranexamic acid [see Warnings and Precautions ( 5.2) and Adverse Reactions ( 6.1) ].

5 WARNINGS AND PRECAUTIONS

5.1 Thromboembolic Risk

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 [see Contraindications(4.1) and Drug Interactions(7.1)].

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. There have been US postmarketing reports of venous and arterial thrombotic events in women who have used Tranexamic acid tablets concomitantly with combined hormonal contraceptives. Women using hormonal contraception, especially those who are obese or smoke, should use Tranexamic acid tablets only if there is a strong medical need and the benefit of treatment will outweigh the potential increased risk of a thrombotic event. Do not use Tranexamic acid tablets in women who are taking more than the approved dose of a hormonal contraceptive.

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)].

Ocular Effects

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.

5.2 Severe Allergic Reaction

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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