CLINICAL PHARMACOLOGY Mechanism of Action
Levocetirizine, the active enantiomer of cetirizine, is an anti-histamine; its
principal effects are mediated via selective inhibition of H1 receptors. The
antihistaminic activity of levocetirizine has been documented in a variety of
animal and human models.
INDICATIONS AND USAGE Chronic Idiopathic Urticaria
Levocetirizine dihydrochloride tablets are indicated for the treatment of the
uncomplicated skin manifestations of chronic idiopathic urticaria in adults and
children 6 years of age and older. Pediatric use:
information in pediatric patients (age 6 months to 5 years) is approved for UCB
Inc.'s levocetirizine dihydrochloride drug product labeling. However, due to UCB
Inc.'s marketing exclusivity rights; this drug product is not labeled for such
use in those pediatric patients.
DOSAGE AND ADMINISTRATION
Levocetirizine is available as 5 mg breakable (scored) tablets, allowing for the
administration of 2.5 mg, if needed. Levocetirizine dihydrochloride tablets can
be taken without regard to food consumption.
Adults and Children 12 Years of Age and Older:
The recommended dose of levocetirizine is 5 mg (1 tablet) once daily in the
evening. Some patients may be adequately controlled by 2.5 mg (one-half tablet)
once daily in the evening.
Children 6 to 11 Years of Age:
The recommended dose of levocetirizine is 2.5 mg (one-half tablet) once daily in
the evening. The 2.5 mg dose should not be exceeded because the systemic
exposure with 5 mg is approximately twice that of adults.
Children 6 Months to 5 Years of Age:
Pediatric use information in pediatric patients (age 6 months to 5 years) is
approved for UCB Inc.'s levocetirizine dihydrochloride drug product labeling.
However, due to UCB Inc.'s marketing exclusivity rights; this drug product is
not labeled for such use in those pediatric patients.
Dose Adjustment for Renal and Hepatic Impairment:
In adults and children 12 years of age and older with: Mild renal impairment (creatinine clearance [CLCR]
= 50 to 80 mL/min): a dose of 2.5 mg once daily is recommended;
Moderate renal impairment (CLCR = 30 to 50 mL/min):
a dose of 2.5 mg once every other day is recommended;
Severe renal impairment (CLCR = 10 to 30 mL/min):
a dose of 2.5 mg twice weekly (administered once every 3 to 4 days) is
No dose adjustment is needed in patients with solely hepatic impairment.
In patients with both hepatic impairment and renal impairment,
adjustment of the dose is recommended.
End-stage renal disease patients (CLCR < 10 mL/min)
and patients undergoing hemodialysis: patient should not receive
levocetirizine dihydrochloride tablets.
National Institutes of Health, U.S. National Library of Medicine,
DailyMed Database. Provides access to the latest drug monographs submitted to the
Food and Drug Administration (FDA). Please review the latest applicable package insert for
additional information and possible updates. A local search
option of this data can be found here.
The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical
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