TRANEXAMIC ACID tablet, film coated

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

TRANEXAMIC ACID (UNII: 6T84R30KC1) (TRANEXAMIC ACID - UNII:6T84R30KC1)

Prieinama:

Bryant Ranch Prepack

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

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 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) Tranexamic acid tablets are contraindicated in females with reproductive potential with known hypersensitivity to tranexamic acid [see Warnings and Precautions (5.2) and Adverse Reactions (6.1)]. Risk Summary Tranexamic acid tablets are not indicated for use in pregnant women. There are no available data

Produkto santrauka:

Tranexamic acid tablets are provided as white to off-white, oval-shaped, unscored, film coated 650 mg tablets.  Each tablet is debossed with “WPI 3720 ” on one side of the tablet and are supplied as: Quantity Package Type NDC Number 30 tablets HDPE Bottle 0591-3720-30 Storage Store at 20º to 25º C (68º to 77º F). [See USP Controlled Room Temperature]. Tranexamic acid tablets are provided as white to off-white, oval-shaped, unscored, film coated 650 mg tablets. Each tablet is debossed with “WPI 3720” on one side of the tablet. NDC: 63629-8599-1: 8 TABLETs in a BOTTLE, PLASTIC Storage Store at 20º to 25º C (68º to 77º F). [See USP Controlled Room Temperature]. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

TRANEXAMIC ACID- TRANEXAMIC ACID TABLET, FILM COATED
BRYANT RANCH PREPACK
----------
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, FOR ORAL USE
INITIAL U.S. APPROVAL: 1986
INDICATIONS AND USAGE
Tranexamic acid tablets are 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
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 tablets use.
Concomitant use of tranexamic acid 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
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 edema and cerebral infarction may be caused by use of
tranexamic acid tablets in patients
with subarachnoid hemorrhage. (5.3)
Ligneous conj