TRANEXAMIC ACID- tranexamic acid tablet

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Prasco Laboratories

INN (International Adı):

Tranexamic Acid

Kompozisyon:

Tranexamic Acid 650 mg

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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 known to have 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) Venous and arterial thrombosis or thromboembolism, as well as cases of retinal artery and retinal vein occlusions, have been reported with tranexamic acid. Do not prescribe Tranexamic Acid Tablets to women with known hypersensitivity to tranexamic acid [see Warnings and Precautions (5.2) and Adverse Reactions (6.1) ]. Tranexamic

Ürün özeti:

Tranexamic Acid Tablets are provided as white oval-shaped tablets. Each tablet is debossed with the marking "XP650"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].

Yetkilendirme durumu:

New Drug Application Authorized Generic

Ürün özellikleri

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
Warnings and Precautions (5.1)
4/2011
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 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
The risk of thrombotic and thromboembolic events may increase further
when hormonal contraceptives are
administered with tranexamic acid tablets, especially in women who are
obese or smoke cigarettes. Women using
hormonal contraception should use tranexamic acid tablets only if
there is a strong medical need and the benefit of
treatment will outweigh the potential increased risk of a thrombotic
event. Do not use tranexamic acid tablets in women
who are taking more than the approved dose of a hormonal
contraceptive. (5.1)
Concomitant use of tranexamic acid tablet