The use of XYZAL(R) is contraindicated in: patients with a known hypersensitivity to levocetirizine or any of the ingredients of XYZAL(R) 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(R). Concurrent use of XYZAL(R) 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 greater than or equal to 2% of adult and adolescent patients (12 years of age and older) taking XYZAL(R) 2.5 mg, XYZAL(R) 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 greater than or equal to 2% of pediatric patients (6-12 years of age) taking XYZAL(R) 5 mg included pyrexia (4% vs 2% placebo), cough (3% vs < 1% placebo), somnolence (3% vs < 1% placebo), and epistaxis (2% vs < 1% placebo).
Please visit http://www.XYZAL.com for full prescribing information.
About Allergic Conditions
Many people suffer from the symptoms associated with common allergic
conditions. The immune system of allergy sufferers over-reacts to something
in the environment, leading to symptoms that affect
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