文档介绍：XYZAL- levocetirizine dihydrochloride tablet, film coated
XYZAL- levocetirizine dihydrochloride solution
UCB, Inc.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
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
mg/5 mL ( mg/mL) oral solution
Initial . Approval: 1995
INDICATIONS AND USAGE
XYZAL is a histamine H1-receptor antagonist indicated for:
The relief of symptoms associated with seasonal and perennial allergic rhinitis (, )
The treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria ()
DOSAGE AND ADMINISTRATION
Adults and children 12 years of age and older: 5 mg once daily in the evening ()
Children 6 to 11 years of age: mg once daily in the evening ()
Children 6 months to 5 years of age: mg (1/2 teaspoon oral solution) [] once daily in the evening ()
Renal Impairment
Adjust the dose in patients 12 years of age and older with decreased renal function (, )
DOSAGE FORMS AND STRENGTHS
Immediate release breakable (scored) tablets, 5 mg (3)
Immediate release oral solution, mg per 5 mL ( 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 disease at less than 10 mL/min creatinine clearance or patients undergoing hemodialysis
(4)
Children 6 months to 11 years of age with renal impairment (4)
WARNINGS AND PRECAUTIONS
Avoid engaging in hazardous occupations requiring complete mental alertness such as driving or ope