Powerful Relief for Patients Age 6 and Up!

XYZAL® is indicated in patients age 6 and up for:

XYZAL Oral Solution - tutti-frutti flavor
  1. Relief of symptoms associated with seasonal and perennial allergic rhinitis
  2. Treatment of uncomplicated skin manifestations of chronic idiopathic urticaria

Convenient once-daily dosing in an alcohol-free oral solution.

Proven safety profile at twice the recommended dose


Adverse reactions in subjects aged 6-12 years reported in ≥2% for XYZAL 5 mg in placebo-controlled clinical trials 4 and 6 weeks in duration

Convenient once-daily dosing in an alcohol-free oral solution

Recommended dose for children 6 to 11 years of age is 2.5 mg (1 teaspoon or 1/2 tablet) once daily in the evening. The 2.5 mg dose should not be exceeded.

For patients age 12 and up, the recommended dose of XYZAL® is 5 mg (2 teaspoons or 1 tablet) once daily in the evening. Some patients may be adequately controlled by 2.5 mg (1 teaspoon or 1/2 tablet) once daily in the evening.

The recommended dose is derived from:

  1. A cross-study comparison of the systemic exposure of XYZAL® in adult and pediatric patients
  2. The evaluation of safety of XYZAL® 5 mg once daily in 2 placebo-controlled clinical trials with 243 pediatric patients (6-12 years of age)

The extrapolation of demonstrated efficacy of XYZAL® 5 mg once daily in patients 12 years of age and older

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Indications

XYZAL® (levocetirizine dihydrochloride) is indicated for the relief of symptoms associated with perennial allergic rhinitis and the treatment of uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 months of age and older, and for relief of symptoms of seasonal allergic rhinitis in adults and children 2 years of age and older.

Important Safety Information

The use of XYZAL is contraindicated in: patients with a known hypersensitivity to levocetirizine or any of the ingredients of XYZAL or to cetirizine (observed reactions range from urticaria to anaphylaxis); patients with end-stage renal disease with a creatinine clearance less than 10 mL/min or patients undergoing hemodialysis; and pediatric patients aged 6 months to 11 years with renal impairment.

Patients should be cautioned against engaging in hazardous occupations requiring complete mental alertness such as driving or operating machinery when taking XYZAL. Concurrent use of XYZAL with alcohol or other central nervous system (CNS) depressants should be avoided. In clinical trials, the most common adverse reactions in ≥2% of adult and adolescent patients (12 years of age and older) taking XYZAL 2.5 mg or XYZAL 5 mg once daily or placebo were somnolence (5%, 6%, 2%), nasopharyngitis (6%, 4%, 3%), fatigue (1%, 4%, 2%), dry mouth (3%, 2%, 1%), and pharyngitis (2%, 1%, 1%), respectively.

In clinical trials, the most common adverse reactions in ≥2% of pediatric patients 6 to 12 years of age taking XYZAL 5 mg once daily or placebo were pyrexia (4%, 2%), cough (3%, <1%), somnolence (3%, <1%), and epistaxis (2%, <1%), respectively. The most common adverse reactions in ≥2% of pediatric patients 1 to 5 years of age taking XYZAL 1.25 mg twice daily or placebo were pyrexia (4%, 2%), diarrhea (4%, 3%), vomiting (4%, 3%), and otitis media (3%, 0%), respectively. The most common adverse reactions in pediatric patients 6 to 11 months of age taking XYZAL 1.25 mg once daily or placebo were diarrhea (13%, 4%) and constipation (7%, 4%), respectively.

XYZAL is a trademark of UCB Group of companies.
© 2009 UCB, Inc. and sanofi-aventis U.S. LLC. All rights reserved. X1257-1109
Last Updated: January 2010