TRANEXAMIC ACID tablet, film coated

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

Actavis Pharma, Inc.

INN (Rahvusvaheline Nimetus):

TRANEXAMIC ACID

Koostis:

TRANEXAMIC ACID 650 mg

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

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

Toote kokkuvõte:

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].

Volitamisolek:

Abbreviated New Drug Application

Toote omadused

TRANEXAMIC ACID- TRANEXAMIC ACID TABLET, FILM COATED
ACTAVIS PHARMA, INC.
----------
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