Tranexamic Acid 650 mg Tablet — Generic For Lysteda — Advagen

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

• 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

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 conjunctivitis has been reported in patients taking Tranexamic acid tablets. (

5.4)

Adverse Reactions

Most common adverse reactions in clinical trials (≥ 5%, and more frequent in tranexamic acid tablets-treated subjects compared to placebo-treated subjects) are headache, sinus and nasal symptoms, back pain, abdominal pain, musculoskeletal pain, joint pain, muscle cramps, migraine, anemia and fatigue. (

6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Advagen Pharma Ltd. at 866-488-0312 or FDA at 1-800-FDA-1088 or

www.fda.gov/medwatch.

Drug Interactions

Concomitant therapy with tissue plasminogen activators may decrease the efficacy of both tranexamic acid tablets and tissue plasminogen activators. (

7.2)

Use In Specific Populations

Geriatric use: Tranexamic acid tablets are not indicated for use in postmenopausal women (

8.5)

Renal impairment: A lower dosage is needed. (

2.2,

8.6)

Hepatic impairment: No dosage adjustment is needed. (

8.7)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 12/2024