TRANEXAMIC ACID- tranexamic acid tablet

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Prasco Laboratories

DCI (Dénomination commune internationale):

Tranexamic Acid

Composition:

Tranexamic Acid 650 mg

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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.,

Descriptif du produit:

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].

Statut de autorisation:

New Drug Application Authorized Generic

Résumé des caractéristiques du produit

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