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Lysteda

Lysteda Recall

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Manufacturer Warnings

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FDA Labeling Changes

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Uses

LYSTEDA™ (tranexamic acid) Tablets is indicated for the treatment of cyclic heavy menstrual bleeding [see Clinical Studies (14)].

Prior to prescribing LYSTEDA, exclude endometrial pathology that can be associated with heavy menstrual bleeding.

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History

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Other Information

LYSTEDA is an antifibrinolytic drug. The chemical name is trans-4-aminomethyl-cyclohexanecarboxylic acid. The structural formula is:

                                        Chemical Structure

Tranexamic acid is a white crystalline powder. It is freely soluble in water and in glacial acetic acid and is very slightly soluble in ethanol and practically insoluble in ether. The molecular formula is C8H15N02 and the molecular weight is 157.2.

Tranexamic acid tablets are provided as white oval-shaped tablets and are not scored. Each tablet is debossed with the marking “XP650.” The active ingredient in each tablet is 650 mg tranexamic acid. The inactive ingredients contained in each tablet are: microcrystalline cellulose, colloidal silicon dioxide, pregelatinized corn starch, povidone, hypromellose, stearic acid, and magnesium stearate.

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Lysteda Manufacturers

  • Ferring Pharmaceuticals Inc.
    Lysteda | Ferring Pharmaceuticals Inc.
    No Recall

    Lysteda | Ferring Pharmaceuticals Inc.

    Lysteda | Ferring Pharmaceuticals Inc.
    2.1 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.

    2.2 Renal Impairment

    In patients with renal impairment, the plasma concentration of tranexamic acid increased as serum creatinine concentration increased [see Clinical Pharmacology (12.3)]. 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
  • Ferring Pharmaceuticals Inc.
    Lysteda | Ferring Pharmaceuticals Inc.
    No Recall

    Lysteda | Ferring Pharmaceuticals Inc.

    Lysteda | Ferring Pharmaceuticals Inc.
    2.1 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.

    2.2 Renal Impairment

    In patients with renal impairment, the plasma concentration of tranexamic acid increased as serum creatinine concentration increased [see Clinical Pharmacology (12.3)]. 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
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