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:

Apotex Corp.

INN (International Name):

TRANEXAMIC ACID

Composition:

TRANEXAMIC ACID 650

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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)   - Active thromboembolic disease (e.g., deep vein thrombosis, pulmonary embolism, or cerebral thrombosis) Active thromboembolic disease (e.g., deep vein thrombosis, pulmonary embolism, or cerebral thrombosis) - A history of thrombosis or thromboembolism, including retinal vein or artery occlusi

Product summary:

Tranexamic acid tablets, USP are provided as white to off-white, oval, biconvex 650 mg tablets. Engraved “APO” on one side, “TRA 650” on the other side. They are supplied as:   Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Preserve in tight, light-resistant containers.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TRANEXAMIC ACID- TRANEXAMIC ACID TABLET
APOTEX CORP.
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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
• 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 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 a