Zyrtec

[Certirizine]

ZYRTEC is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. (See Geriatric Patients and Renal Impairment subsections in CLINICAL PHARMACOLOGY).

Pediatric Use

The safety of ZYRTEC has been demonstrated in pediatric patients aged 6 months to 11 years. The safety of ZYRTEC, at daily doses of 5 or 10 mg, has been demonstrated in 376 pediatric patients aged 6 to 11 years in placebo-controlled trials lasting up to four weeks and in 254 patients in a non-placebo-controlled 12-week trial. The safety of cetirizine has been demonstrated in 168 patients aged 2 to 5 years in placebo-controlled trials of up to 4 weeks duration. On a mg/ kg basis, most of the 168 patients received between 0.2 and 0.4 mg/ kg of cetirizine HCl.

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The safety of cetirizine in 399 patients aged 12 to 24 months has been demonstrated in a placebo-controlled 18-month trial, in which the average dose was 0.25 mg/ kg bid, corresponding to a range of 4 to 11 mg/ day. The safety of ZYRTEC syrup has been demonstrated in 42 patients aged 6 to 11 months in a placebo-controlled 7-day trial. The prescribed dose was 0.25 mg/ kg bid, which corresponded to a mean of 4.5 mg/ day, with a range of 3.4 to 6.2 mg/ day.

The effectiveness of ZYRTEC for the treatment of allergic rhinitis and chronic idiopathic urticaria in pediatric patients aged 6 months to 11 years is based on an extrapolation of the demonstrated efficacy of ZYRTEC in adults with these conditions and the likelihood that the disease course, pathophysiology and the drug's effect are substantially similar between these two populations.

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