For U.S. Healthcare Professionals Only
PRESCRIBING INFORMATION PRESCRIBING INFORMATION XYZ'S OF XYZAL ONCE-DAILY DOSING SAFETY INFORMATION REIMBURSEMENT ORAL SOLUTION
XYZ'S OF XYZAL
XYZ'S OF XYZAL
YOUR ALLERGY APPOINTMENT
FOR HEALTHCARE PROFESSIONALS
Dr. Porter
Fast and Long-Lasting Relief

In an Environmental Exposure Unit Study:1,2

  • Onset of action was seen at 60 minutes
  • Efficacy was demonstrated at the end of the 24-hour dosing interval

Fast onset and long duration of action

Two-day, placebo-controlled, randomized, double-blind, single-center, parallel-group Environmental Exposure Unit study in 373 patients 16 years of age or older with a documented history of ragweed-induced seasonal allergic rhinitis for at least 2 seasons previous to the study. The study consisted of 3 periods, with pollen exposure starting at 8 am on Day 1 and 8:30 am on Day 2. Period 1 began with drug intake at 10 am and continued until 3 pm. Period 2 ran from 8:30 am the next morning until 10 am. Period 3 began with administration of second dose at 10 am and continued until 2:30 pm. The primary endpoint was the reduction from baseline in the Major Symptom Complex (scale: 0-36; MSC= sum of runny nose, sniffles, itchy nose, nose blows, sneezes, and watery eyes) over period 1. Secondary endpoints included the onset and duration of action and the reduction in Total Symptom Complex score, nasal obstruction score, and individual symptoms over periods 1, 2, and 3.

1.Day JH, Briscoe MP, Rafeiro E, Ratz JD. Comparative clinical efficacy, onset and duration of action of levocetirizine and desloratadine for symptoms of seasonal allergic rhinitis in subjects evaluated in the Environmental Exposure Unit (EEU). Int J Clin Pract. 2004;58:109-118.
2. Data on file, UCB, Inc.

Next
Print this page
Make text larger
 

Indications and Important Safety Information

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

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 impairment at less than 10 mL/min creatinine clearance or patients undergoing hemodialysis; and pediatric patients aged 6 to 11 years with impaired renal function.

Patients should be cautioned against engaging in hazardous occupations requiring complete mental alertness and motor coordination, such as operating machinery or driving a motor vehicle, after ingestion of XYZAL. Concurrent use of XYZAL with alcohol or other central nervous system (CNS) depressants should be avoided because additional reductions in alertness and additional impairment of CNS performance may occur.

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, XYZAL 5 mg, 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 (6-12 years of age) taking XYZAL 5 mg included pyrexia (4% vs 2% placebo), cough (3% vs <1% placebo), somnolence (3% vs <1% placebo), and epistaxis (2% vs <1% placebo).

XYZAL® is a trademark of UCB Group of companies.
© 2008 UCB, Inc. and sanofi-aventis U.S. LLC. All rights reserved. X1147-1108

Last Updated: December 2008
sanofi aventis logo
Home | Terms of Use | Privacy Policy | Medical Information 1-866-822-0068 | Contact Us 1–888–NOW–XYZAL (1–888–669–9992) | X-Factor Ringtone

Close