Tranexamic acid is the generic equivalent of the brand-name drug Tranexamic Acid. Licensed pharmacies, clinics, doctor's offices, and veterinary practices can source wholesale Tranexamic acid through Premier Pharma with same-day fulfillment on in-stock SKUs.
FDA Drug Information
Indications & Usage
1 INDICATIONS AND USAGE Tranexamic Acid Tablets are indicated for the treatment of cyclic heavy menstrual bleeding in females of reproductive potential [see Clinical Studies ( 14 )]. Tranexamic Acid Tablets are an antifibrinolytic indicated for the treatment of cyclic heavy menstrual bleeding in females of reproductive potential. ( 1 )
Adverse Reactions
6 ADVERSE REACTIONS Most common adverse reactions in clinical trials (≥ 5%, and more frequent in tranexamic acid-treated subjects compared to placebo-treated subjects) are headache, sinus and nasal symptoms, back pain, abdominal pain, musculoskeletal pain, joint pain, muscle cramps, migraine, anemia and fatigue. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact ANI Pharmaceuticals, Inc. at 1-855-204-1431 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience Because…
Drug Interactions
7 DRUG INTERACTIONS No drug-drug interaction studies were conducted with tranexamic acid tablets. Concomitant therapy with tissue plasminogen activators may decrease the efficacy of both tranexamic acid and tissue plasminogen activators. ( 7.2 ) 7.1 Combined Hormonal Contraceptives Because tranexamic acid is antifibrinolytic, concomitant use of combined hormonal contraception and tranexamic acid may increase the thrombotic risk associated with combined hormonal contraceptives. For this reason, c…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION • 1,300 mg three times a day (3,900 mg/day) for a maximum of 5 days during monthly menstruation ( 2.1 ) • Renal impairment : Lower dosage is needed (for a maximum of 5 days during menstruation) if serum creatinine concentration (Cr) is higher than 1.4 mg/dL ( 2.2 ) o Cr above 1.4 mg/dL and ≤ 2.8 mg/dL: 1,300 mg two times a day (2,600 mg/day) o Cr above 2.8 mg/dL and ≤ 5.7 mg/dL: 1,300 mg once a day (1,300 mg/day) o Cr above 5.7 mg/dL: 650 mg once a day (650 mg/day) 2.…
Patient Counseling Information
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Thromboembolic Risk Inform patients that tranexamic acid tablets may increase the risk of venous and arterial thrombosis or thromboembolism and to contact their healthcare provider for any signs or symptoms suggestive of thromboembolism [see Warnings and Precautions ( 5.1 )]. Advise patients to discontinue use of tranexamic acid tablets and promptly report visual and ocular symptoms to their health care provider as retinal venous and arterial occlusion have been reported in pat…
Source: FDA. For professional use only. Not a substitute for prescribing information.
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