Xyzal label

Xyzal

Xyzal Recall

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Side Effects & Adverse Reactions

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Manufacturer Warnings

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FDA Labeling Changes

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Uses

1.1 Seasonal Allergic Rhinitis

XYZAL® is indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 2 years of age and older.

1.2 Perennial Allergic Rhinitis

XYZAL is indicated for the relief of symptoms associated with perennial allergic rhinitis in adults and children 6 months of age and older.

1.3 Chronic Idiopathic Urticaria

XYZAL is indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 months of age and older.

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History

There is currently no drug history available for this drug.

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Other Information

Levocetirizine dihydrochloride, the active component of XYZAL tablets and oral solution, is an orally active H1‑receptor antagonist. The chemical name is (R)-[2-[4-[(4-chlorophenyl) phenylmethyl]-1-piperazinyl] ethoxy] acetic acid dihydrochloride. Levocetirizine dihydrochloride is the R enantiomer of cetirizine hydrochloride, a racemic compound with antihistaminic properties. The empirical formula of levocetirizine dihydrochloride is C21H25ClN2O3•2HCl. The molecular weight is 461.82 and the chemical structure is shown below:

Chemical Structure

Levocetirizine dihydrochloride is a white, crystalline powder and is water soluble.

XYZAL 5 mg tablets are formulated as immediate release, white, film-coated, oval-shaped scored tablets for oral administration. The tablets are imprinted on both halves of the scored line with the letter Y in red (Opacode® Red). Inactive ingredients are: microcrystalline cellulose, lactose monohydrate, colloidal anhydrous silica, and magnesium stearate. The film coating contains hypromellose, titanium dioxide, and macrogol 400.

XYZAL 0.5 mg/mL oral solution is formulated as an immediate release, clear, colorless liquid. Inactive ingredients are: sodium acetate trihydrate, glacial acetic acid, maltitol solution, glycerin, methylparaben, propylparaben, saccharin, flavoring (consisting of triacetin, natural & artificial flavors, dl-alpha-tocopherol), purified water.

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Xyzal Manufacturers

  • Ucb Farchim S.a.
    Xyzal | Ucb Farchim S.a.
    No Recall

    Xyzal | Ucb Farchim S.a.

    Xyzal | Ucb Farchim S.a.

    XYZAL is available as 2.5 mg/5 mL (0.5 mg/mL) oral solution and as 5 mg breakable (scored) tablets, allowing for the administration of 2.5 mg, if needed. XYZAL can be taken without regard to food consumption.

    2.1 Adults and Children 12 Years of Age and Older

    The recommended dose of XYZAL is 5 mg (1 tablet or 2 teaspoons [10 mL] oral solution) once daily in the evening. Some patients may be adequately controlled by 2.5 mg (1/2 tablet or 1 teaspoon [5 mL] oral solution) once daily in the evening.

    2.2 Children 6 to 11 Years of Age

    The recommended dose of XYZAL is 2.5 mg (1/2 tablet or 1 teaspoon [5 mL] oral solution) once daily in the evening. The 2.5 mg dose should not be exceeded because the systemic exposure with 5 mg is approximately twice that of adults [see Clinical Pharmacology (12.3)].

    2.3 Children 6 months to 5 Years of Age

    The recommended initial dose of XYZAL is 1.25 mg (1/2 teaspoon oral solution) [2.5mL] once daily in the evening. The 1.25 mg once daily dose should not be exceeded based on comparable exposure to adults receiving 5 mg [see Clinical Pharmacology (12.3)].

    2.4 Dose Adjustment for Renal and Hepatic Impairment

    In adults and children 12 years of age and older with:

    Mild renal impairment (creatinine clearance [CLCR] = 50-80 mL/min): a dose of 2.5 mg once daily is recommended; Moderate renal impairment (CLCR = 30-50 mL/min): a dose of 2.5 mg once every other day is recommended; Severe renal impairment (CLCR = 10-30 mL/min): a dose of 2.5 mg twice weekly (administered once every 3-4 days) is recommended; End-stage renal disease patients (CLCR < 10 mL/min) and patients undergoing hemodialysis should not receive XYZAL.

    No dose adjustment is needed in patients with solely hepatic impairment. In patients with both hepatic impairment and renal impairment, adjustment of the dose is recommended.

  • Physicians Total Care, Inc.
    Xyzal | Physicians Total Care, Inc.
    No Recall

    Xyzal | Physicians Total Care, Inc.

    Xyzal | Physicians Total Care, Inc.

    XYZAL is available as 2.5 mg/5 mL (0.5 mg/mL) oral solution and as 5 mg breakable (scored) tablets, allowing for the administration of 2.5 mg, if needed. XYZAL can be taken without regard to food consumption.

    2.1 Adults and Children 12 Years of Age and Older

    The recommended dose of XYZAL is 5 mg (1 tablet or 2 teaspoons [10 mL] oral solution) once daily in the evening. Some patients may be adequately controlled by 2.5 mg (1/2 tablet or 1 teaspoon [5 mL] oral solution) once daily in the evening.

    2.2 Children 6 to 11 Years of Age

    The recommended dose of XYZAL is 2.5 mg (1/2 tablet or 1 teaspoon [5 mL] oral solution) once daily in the evening. The 2.5 mg dose should not be exceeded because the systemic exposure with 5 mg is approximately twice that of adults [see Clinical Pharmacology (12.3)].

    2.3 Children 6 months to 5 Years of A

    The recommended initial dose of XYZAL is 1.25 mg (1/2 teaspoon oral solution) [2.5mL] once daily in the evening. The 1.25 mg once daily dose should not be exceeded based on comparable exposure to adults receiving 5 mg [see Clinical Pharmacology (12.3)].

    2.4 Dose Adjustment for Renal and Hepatic Impairment

    In adults and children 12 years of age and older with:

    Mild renal impairment (creatinine clearance [CLCR] = 50-80 mL/min): a dose of 2.5 mg once daily is recommended; Moderate renal impairment (CLCR = 30-50 mL/min): a dose of 2.5 mg once every other day is recommended; Severe renal impairment (CLCR = 10-30 mL/min): a dose of 2.5 mg twice weekly (administered once every 3-4 days) is recommended; End-stage renal disease patients (CLCR less than 10 mL/min) and patients undergoing hemodialysis should not receive XYZAL.

    No dose adjustment is needed in patients with solely hepatic impairment. In patients with both hepatic impairment and renal impairment, adjustment of the dose is recommended.

  • Lake Erie Medical Dba Quality Care Products Llc
    Xyzal | Lake Erie Medical Dba Quality Care Products Llc
    No Recall

    Xyzal | Lake Erie Medical Dba Quality Care Products Llc

    Xyzal | Lake Erie Medical Dba Quality Care Products Llc
    2 DOSAGE AND ADMINISTRATION

    XYZAL is available as 2.5 mg/5 mL (0.5 mg/mL) oral solution and as 5 mg breakable (scored) tablets, allowing for the administration of 2.5 mg, if needed. XYZAL can be taken without regard to food consumption.

    2.1 Adults and Children 12 Years of Age and Older

    The recommended dose of XYZAL is 5 mg (1 tablet or 2 teaspoons [10 mL] oral solution) once daily in the evening. Some patients may be adequately controlled by 2.5 mg (1/2 tablet or 1 teaspoon [5 mL] oral solution) once daily in the evening.

    2.2 Children 6 to 11 Years of Age

    The recommended dose of XYZAL is 2.5 mg (1/2 tablet or 1 teaspoon [5 mL] oral solution) once daily in the evening. The 2.5 mg dose should not be exceeded because the systemic exposure with 5 mg is approximately twice that of adults [see Clinical Pharmacology (12.3)].

    XYZAL is not indicated for children under 6 years of age.


  • Sanofi-aventis U.s. Llc
    Xyzal | Sanofi-aventis U.s. Llc
    No Recall

    Xyzal | Sanofi-aventis U.s. Llc

    Xyzal | Sanofi-aventis U.s. Llc

    XYZAL is available as 2.5 mg/5 mL (0.5 mg/mL) oral solution and as 5 mg breakable (scored) tablets, allowing for the administration of 2.5 mg, if needed. XYZAL can be taken without regard to food consumption.

    2.1 Adults and Children 12 Years of Age and Older

    The recommended dose of XYZAL is 5 mg (1 tablet or 2 teaspoons [10 mL] oral solution) once daily in the evening. Some patients may be adequately controlled by 2.5 mg (1/2 tablet or 1 teaspoon [5 mL] oral solution) once daily in the evening.

    2.2 Children 6 to 11 Years of Age

    The recommended dose of XYZAL is 2.5 mg (1/2 tablet or 1 teaspoon [5 mL] oral solution) once daily in the evening. The 2.5 mg dose should not be exceeded because the systemic exposure with 5 mg is approximately twice that of adults [see Clinical Pharmacology (12.3)].

    2.3 Children 6 months to 5 Years of Age

    The recommended initial dose of XYZAL is 1.25 mg (1/2 teaspoon oral solution) [2.5mL] once daily in the evening. The 1.25 mg once daily dose should not be exceeded based on comparable exposure to adults receiving 5 mg [see Clinical Pharmacology (12.3)].

    2.4 Dose Adjustment for Renal and Hepatic Impairment

    In adults and children 12 years of age and older with:

    Mild renal impairment (creatinine clearance [CLCR] = 50-80 mL/min): a dose of 2.5 mg once daily is recommended; Moderate renal impairment (CLCR = 30-50 mL/min): a dose of 2.5 mg once every other day is recommended; Severe renal impairment (CLCR = 10-30 mL/min): a dose of 2.5 mg twice weekly (administered once every 3-4 days) is recommended; End-stage renal disease patients (CLCR < 10 mL/min) and patients undergoing hemodialysis should not receive XYZAL.

    No dose adjustment is needed in patients with solely hepatic impairment. In patients with both hepatic impairment and renal impairment, adjustment of the dose is recommended.

  • Ucb, Inc.
    Xyzal | Ucb, Inc.
    No Recall

    Xyzal | Ucb, Inc.

    Xyzal | Ucb, Inc.

    XYZAL is available as 2.5 mg/5 mL (0.5 mg/mL) oral solution and as 5 mg breakable (scored) tablets, allowing for the administration of 2.5 mg, if needed. XYZAL can be taken without regard to food consumption.

    2.1 Adults and Children 12 Years of Age and Older

    The recommended dose of XYZAL is 5 mg (1 tablet or 2 teaspoons [10 mL] oral solution) once daily in the evening. Some patients may be adequately controlled by 2.5 mg (1/2 tablet or 1 teaspoon [5 mL] oral solution) once daily in the evening.

    2.2 Children 6 to 11 Years of Age

    The recommended dose of XYZAL is 2.5 mg (1/2 tablet or 1 teaspoon [5 mL] oral solution) once daily in the evening. The 2.5 mg dose should not be exceeded because the systemic exposure with 5 mg is approximately twice that of adults [see Clinical Pharmacology (12.3)].

    2.3 Children 6 months to 5 Years of Age

    The recommended initial dose of XYZAL is 1.25 mg (1/2 teaspoon oral solution) [2.5mL] once daily in the evening. The 1.25 mg once daily dose should not be exceeded based on comparable exposure to adults receiving 5 mg [see Clinical Pharmacology (12.3)].

    2.4 Dose Adjustment for Renal and Hepatic Impairment

    In adults and children 12 years of age and older with:

    Mild renal impairment (creatinine clearance [CLCR] = 50-80 mL/min): a dose of 2.5 mg once daily is recommended; Moderate renal impairment (CLCR = 30-50 mL/min): a dose of 2.5 mg once every other day is recommended; Severe renal impairment (CLCR = 10-30 mL/min): a dose of 2.5 mg twice weekly (administered once every 3-4 days) is recommended; End-stage renal disease patients (CLCR < 10 mL/min) and patients undergoing hemodialysis should not receive XYZAL.

    No dose adjustment is needed in patients with solely hepatic impairment. In patients with both hepatic impairment and renal impairment, adjustment of the dose is recommended.

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