Generic Name and Formulations:
Tranexamic acid 650mg; tabs.
Ferring Pharmaceuticals, Inc.
Indications for LYSTEDA:
Cyclic heavy menstrual bleeding.
Treat for up to 5 days during menses. Swallow whole. ≥18yrs: Normal renal function (serum creatinine ≤1.4mg/dL): 1300mg three times daily; Cr >1.4–2.8mg/dL: 1300mg twice daily; Cr >2.8–5.7mg/dL: 1300mg once daily; Cr >5.7mg/dL: 650mg once daily.
Premenarchal: not recommended.
Active thromboembolic (eg, DVT, PE, cerebral thrombosis). History or risk of thrombosis or thromboembolism (eg, retinal vein or artery occlusion; thrombogenic valvular disease, thrombogenic cardiac rhythm disease, hypercoagulopathy). Concomitant combination hormonal contraceptives.
Exclude endometrial pathology prior to initiation. Not for use in postmenopausal women. Discontinue immediately if retinal venous or arterial occlusion occurs. Subarachnoid hemorrhage (cerebral edema/infarction may occur). Acute promyelocytic leukemia treated with oral tretinoin (increased procoagulant effect). Renal impairment. Pregnancy (Cat.B). Nursing mothers.
See Contraindications. Increased risk of thrombotic events (eg, stroke, MI) with hormonal contraceptives (esp. in obese or smokers >35yrs old), Factor IX complex concentrates, anti-inhibitor coagulant concentrates, oral tretinoin. Tissue plasminogen activators (tPAs) may decrease efficacy of both tranexamic acid and tPAs.
Headache, sinus/nasal symptoms, pain (back, abdomen, musculoskeletal, joint), muscle cramps, migraine, anemia, fatigue; visual/ocular events, severe allergic reaction, ligneous conjunctivitis.
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