Potent Inhibition of Histamine‐Induced Wheal and Flare1

Significant Wheal Inhibition, Significant Flare Inhibition

Placebo-controlled, randomized, double-blind, single oral-dose, crossover study in 18 healthy adults. Responses were measured before the intake of drug and at predetermined time intervals thereafter for a 24-hour period. The objective was to compare histamine-induced wheal and flare responses as determined by surface area.

* The clinical relevance of histamine wheal skin testing is unknown

1. Grant JA, Riethuisen J-M, Moulaert B, DeVos C. A double-blind, randomized, single-dose, crossover comparison of levocetirizine with ebastine, fexofenadine, loratadine, mizolastine, and placebo: suppression of histamine-induced wheal-and-flare response during 24 hours in healthy male subjects. Ann Allergy Asthma Immunol. 2002;88:190-197.

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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