Tranexamic acid

Tranexamic acid USP tablets are indicated for the treatment of cyclic heavy menstrual bleeding in females of reproductive potential [see Clinical Studies (14) ]. Tranexamic acid USP tablets is an antifibrinolytic indicated for the treatment of cyclic heavy menstrual bleeding in females of reproductive potential. ( 1 )

• 1,300 mg three times a day (3,900 mg/day) for a maximum of 5 days during monthly menstruation 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 Cr above 1.4 mg/dL and ≤ 2.8 mg/dL: 1,300 mg two times a day (2,600 mg/day) Cr above 2.8 mg/dL and ≤ 5.7 mg/dL: 1,300 mg once a day (1,300 mg/day) Cr above 5.7 mg/dL: 650 mg once a day (650 mg/day) Recommended Testing Prior to Tranexamic Acid USP Tablets Administration Prior to prescribing tranexamic acid USP tablets, exclude endometrial pathology that can be associated with heavy menstrual bleeding
• Recommended Dosage The recommended dosage of tranexamic acid USP tablets for patients with normal renal function is 1300 mg orally three times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
• Tranexamic acid USP tablets may be administered with or without food
• Swallow tablets whole; do not chew or break apart
• Dosage Recommendations in Patients with Renal Impairment The recommended dosage (for a maximum of 5 days during monthly menstruation) in patients with renal impairment with serum creatinine concentration higher than 1.4 mg/dL is described in Table 1
• Table 1
• Recommended Dosage of Tranexamic Acid USP Tablets in Patients with Renal Impairment Serum Creatinine (mg/dL) Recommended Dosage (maximum of 5 days during menstruation) Total Daily Dose Above 1.4 and ≤ 2.8 1300 mg two times a day 2600 mg Above 2.8 and ≤ 5.7 1300 mg once a day 1300 mg Above 5.7 650 mg once a day 650 mg

Tablets: 650 mg white oval-shaped debossed with the marking “FP650” Tablets: 650 mg ( 3 )

• The safety and effectiveness of tranexamic acid USP tablets have been established in females of reproductive potential
• Efficacy is expected to be the same for post-menarchal females under the age of 17 as for those 17 years and older. Tranexamic acid USP tablets are not indicated before menarche

Tranexamic acid USP tablets are indicated for females of reproductive potential and is not intended for use by postmenopausal women.

• Advise the patient to read the FDA-approved patient labeling ( Patient Information )
• Thromboembolic Risk Inform patients that tranexamic acid USP 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 ]
• Advise patients to discontinue use of tranexamic acid USP tablets and promptly report visual and ocular symptoms to their health care provider as retinal venous and arterial occlusion have been reported in patients using tranexamic acid USP tablets [see Warnings and Precautions ]. …

Concomitant use of combined hormonal contraceptives ( 4.1 ) Active thromboembolic disease or a history or intrinsic risk of thrombosis or thromboembolism, including retinal vein or artery occlusion ( 4.1 ) Hypersensitivity to tranexamic acid ( 4.2 ) 4.1 Thromboembolic Risk Tranexamic acid USP tablets are contraindicated in females of reproductive potential who are [see Warnings and Precautions (5.1) ]: Using combined hormonal contraception Known to have any of the following conditions: Active th …

No drug-drug interaction studies were conducted with tranexamic acid USP tablets. Concomitant therapy with tissue plasminogen activators may decrease the efficacy of both tranexamic acid USP tablets and tissue plasminogen activators. ( 7.2 ) 7.1 Combined Hormonal Contraceptives Because tranexamic acid USP tablets are antifibrinolytic, concomitant use of combined hormonal contraception and tranexamic acid USP tablets may increase the thrombotic risk associated with combined hormonal contraceptives. For this reason, concomitant use of tranexamic acid USP tablets with combined hormonal contraceptives is contraindicated [see Contraindications (4) and Warnings and Precautions (5.1) ] . …

Thromboembolism, including retinal occlusion, has been reported with tranexamic acid USP tablets use. Concomitant use of tranexamic acid USP tablets with combined hormonal contraceptives, Factor I X complex concentrates, anti-inhibitor coagulant concentrates or all-trans retinoic acid (oral tretinoin) may increase the risk of thrombosis. ( 5.1 ) Visual or ocular adverse reactions may occur with tranexamic acid USP tablets. Immediately discontinue use if visual or ocular symptoms occur. ( 5.1 ) In case of severe allergic reaction, discontinue tranexamic acid USP tablets and seek immediate medical attention. …

Most common adverse reactions in clinical trials (≥ 5%, and more frequent in tranexamic acid USP tablets-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 Nordic Pharma, Inc. at 1-844-267-4641 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . …

8.1 Pregnancy Risk Summary Tranexamic acid USP tablets are not indicated for use in pregnant women. There is no available data on tranexamic acid USP tablets use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Tranexamic acid crosses the placenta. …

There are no known cases of intentional overdose with tranexamic acid USP tablets and no subjects in the clinical program took more than 2 times the prescribed amount of tranexamic acid USP 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. …

Storage Store at room temperature 25° C (77° F); excursions permitted to 15-30° C (59-86° F). [See USP Controlled Room Temperature].

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.