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LYSTEDA
Menorrhagia
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Drug Name:

LYSTEDA Rx

Generic Name and Formulations:
Tranexamic acid 650mg; tabs.

Company:
Ferring Pharmaceuticals, Inc.

Therapeutic Use:

Indications for LYSTEDA:

Cyclic heavy menstrual bleeding.

Adult:

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.

Children:

Premenarchal: not recommended.

Contraindications:

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.

Warnings/Precautions:

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.

Interactions:

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.

Pharmacological Class:

Antifibrinolytic.

Adverse Reactions:

Headache, sinus/nasal symptoms, pain (back, abdomen, musculoskeletal, joint), muscle cramps, migraine, anemia, fatigue; visual/ocular events, severe allergic reaction, ligneous conjunctivitis.

How Supplied:

Tabs—30, 100

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