Country: Ամերիկայի Միացյալ Նահանգներ
language: անգլերեն
source: NLM (National Library of Medicine)
Tranexamic Acid (UNII: 6T84R30KC1) (Tranexamic Acid - UNII:6T84R30KC1)
Prasco Laboratories
Tranexamic Acid
Tranexamic Acid 650 mg
ORAL
PRESCRIPTION DRUG
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. 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) - 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.,
Tranexamic Acid Tablets are provided as white oval-shaped tablets. Each tablet is debossed with the marking "FP650"and are supplied as: Storage Store at room temperature 25° C (77° F); excursions permitted to 15-30° C (59-86° F). [See USP Controlled Room Temperature].
New Drug Application Authorized Generic
TRANEXAMIC ACID- TRANEXAMIC ACID TABLET PRASCO LABORATORIES ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE TRANEXAMIC ACID TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TRANEXAMIC ACID TABLETS. TRANEXAMIC ACID TABLETS INITIAL U.S. APPROVAL: 1986 RECENT MAJOR CHANGES Contraindications (4.1) 10/2013 Warnings and Precautions (5.1) 10/2013 INDICATIONS AND USAGE Tranexamic Acid Tablets is an antifibrinolytic indicated for the treatment of cyclic heavy menstrual bleeding. (1) DOSAGE AND ADMINISTRATION 1,300 mg (two 650 mg tablets) three times a day (3,900 mg/day) for a maximum of 5 days during monthly menstruation (2.1) Renal impairment: Dosage adjustment is needed if serum creatinine concentration (Cr) is higher than 1.4 mg/dL (2.2) Cr above 1.4 mg/dL and ≤ 2.8 mg/dL: 1,300 mg (two 650 mg tablets) two times a day (2,600 mg/day) for a maximum of 5 days during menstruation Cr above 2.8 mg/dL and ≤ 5.7 mg/dL: 1,300 mg (two 650 mg tablets) once a day (1,300 mg/day) for a maximum of 5 days during menstruation Cr above 5.7 mg/dL: 650 mg (one 650 mg tablet) once a day (650 mg/day) for a maximum of 5 days during me nstruation DOSAGE FORMS AND STRENGTHS Tablets: 650 mg (3) CONTRAINDICATIONS Women who are using combination hormonal contraception (4.1) Women with 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) WARNINGS AND PRECAUTIONS Concomitant use of tranexamic acid tablets with Factor IX 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 effects may occur with tranexamic acid tablets. Immediately discontinue use if visual or ocular symptoms occur. (5.1) In case of severe allergic reaction, discontinue tranexamic acid tablets and seek immediate medical attention. (5.2) Cerebral read_full_document