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Lysteda

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Lysteda

Lysteda

INDICATIONS

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

Recommended Dosage

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.

Renal Impairment

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

LYSTEDA
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

HOW SUPPLIED

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

 

Storage

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. 10/2013

Last reviewed on RxList: 10/25/2013
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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