XYZAL (levocetirizine dihydrochloride) Label

These highlights do not include all the information needed to use XYZAL safely and effectively. See full prescribing information for XYZAL. XYZAL (levocetirizine dihydrochloride) 5 mg tablets 2.5 mg/5 mL (0.5 mg/mL) oral solution Initial U.S. Approval: 1995 ---------------------------RECENT MAJOR CHANGES--------------------------Dosage and Administration (2) 01/2008 Dosage and Administration, Adults & Children 12 Years & Older (2.1) 01/2008 Dosage and Administration, Children 6 to 11 Years (2.2) 01/2008 ---------------------------INDICATIONS AND USAGE---------------------------XYZAL is a histamine H1-receptor antagonist indicated for: • The relief of symptoms associated with seasonal and perennial allergic rhinitis (1.1) • The treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria (1.2) ----------------------DOSAGE AND ADMINISTRATION-----------------------• Adults and children 12 years of age and older: 5 mg (1 tablet or 2 teaspoons [10 mL] oral solution) once daily in the evening (2.1) • Children 6 to 11 years of age: 2.5 mg (1/2 tablet or 1 teaspoon [5 mL] oral solution) once daily in the evening (2.2) • Renal Impairment Adjust the dose in patients 12 years of age and older with decreased renal function (2.3, 8.6, 12.3) -----------------------DOSAGE FORMS AND STRENGTHS-------------------• Immediate release breakable (scored) tablets, 5 mg (3) • Immediate release oral solution, 2.5 mg per 5 mL (0.5 mg per mL) (3) ------------------------------CONTRAINDICATIONS-----------------------------• Patients with a known hypersensitivity to levocetirizine or any of the ingredients of XYZAL or to cetirizine (4) • Patients with end-stage renal impairment at less than 10 mL/min creatinine clearance or patients undergoing hemodialysis (2.3, 4) • Children 6 to 11 years of age with renal impairment (2.3, 4) ------------------------WARNINGS AND PRECAUTIONS----------------------• Avoid engaging in hazardous occupations requiring complete mental alertness such as driving or operating machinery when taking XYZAL (5.1). • Avoid concurrent use of alcohol or other central nervous system depressants with XYZAL (5.1). ------------------------------ADVERSE REACTIONS-----------------------------The most common adverse reactions (rate ≥2% and > placebo) were somnolence, nasopharyngitis, fatigue, dry mouth, and pharyngitis in subjects 12 years of age and older, and pyrexia, somnolence, cough, and epistaxis in children 6 to 12 years of age (6.1).