TRANEXAMIC ACID tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Tranexamic Acid (UNII: 6T84R30KC1) (Tranexamic Acid - UNII:6T84R30KC1)

Available from:

Amring Pharmaceuticals, Inc.

INN (International Name):

Tranexamic Acid

Composition:

Tranexamic Acid 650 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 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 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., thrombogenic valvul

Product summary:

Tranexamic acid USP tablets are provided as white oval-shaped 650 mg 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].

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

TRANEXAMIC ACID- TRANEXAMIC ACID TABLET
AMRING PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TRANEXAMIC ACID USP
TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
TRANEXAMIC ACID USP
TABLETS.
TRANEXAMIC ACID, USP TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1986
INDICATIONS AND USAGE
Tranexamic acid USP tablets is an antifibrinolytic indicated for the
treatment of cyclic heavy menstrual
bleeding in females of reproductive potential. (1)
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)
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)
DOSAGE FORMS AND STRENGTHS
Tablets: 650 mg (3)
CONTRAINDICATIONS
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)
WARNINGS AND PRECAUTIONS
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 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 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. (5.2)
Cerebral edema and cerebral infarction may be caused by use of