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LYSTEDA™ (tranexamic acid) Tablets is indicated for the treatment of cyclic heavy menstrual bleeding [see Clinical Studies].
Prior to prescribing LYSTEDA, exclude endometrial pathology that can be associated with heavy menstrual bleeding.
DOSAGE AND ADMINISTRATION
The recommended dose of LYSTEDA for women with normal renal function is two 650 mg tablets taken three times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation. LYSTEDA may be administered without regard to meals. Tablets should be swallowed whole and not chewed or broken apart.
In patients with renal impairment, the plasma concentration of tranexamic acid increased as serum creatinine concentration increased [see CLINICAL PHARMACOLOGY]. Dosage adjustment is needed in patients with serum creatinine concentration higher than 1.4 mg/dL (Table 1).
Table 1: Dosage of LYSTEDA
in Patients with Renal Impairment
|Serum Creatinine (mg/dL)||Adjusted Dose||Total Daily Dose|
|Cr above 1.4 and ≤ 2.8||1300 mg (two 650 mg tablets) two times a day for a maximum of 5 days during menstruation||2600 mg|
|Cr above 2.8 and ≤ 5.7||1300 mg (two 650 mg tablets) once a day for a maximum of 5 days during menstruation||1300 mg|
|Cr above 5.7||650 mg (one 650 mg tablet) once a day for a maximum of 5 days during menstruation||650 mg|
Dosage Forms And Strengths
650 mg tablets
Storage And Handling
LYSTEDA (tranexamic acid) tablets are provided as white oval-shaped tablets. Each tablet is debossed with the marking “FP650” and are supplied as:
|Quantity||Package Type||NDC Number|
|30 tablets||HDPE bottle||55566-2100-2|
|100 tablets||HDPE bottle||55566-2100-1|
Store at room temperature 25° C (77° F); excursions permitted to 15-30° C (59-86° F). [See USP Controlled Room Temperature].
Manufactured for: Ferring Pharmaceuticals Inc. Parsippany, NJ 07054. By: Mikart, Inc. Atlanta, GA 30318. Rev. 10/2013This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 10/25/2013
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