Clinical studies of ALLEGRA tablets and capsules did not include sufficient numbers of subjects aged 65 years and over to determine whether this population responds differently from younger subjects. The safety of ALLEGRA at a dose of 30 mg twice daily has been demonstrated in 438 pediatric subjects 6 years to 11 years of age in two placebo-controlled 2-week seasonal allergic rhinitis trials.
The clinical significance of these observations is unknown. Because many drugs are excreted in human milk, caution should be exercised when ALLEGRA is administered to a nursing woman. The safety of ALLEGRA at doses of 15mg and 30 mg given once and twice a day has been demonstrated in 969 pediatric subjects (6 months to 5 years of age) with allergic rhinitis in 3 pharmacokinetic studies and 3 safety studies. This is based on the results from 3 clinical studies using histamine induced skin wheals and flares coupled with population pharmacokinetic analysis.
ALLEGRA 30 mg tablets are available in: high-density polyethylene (HDPE) bottles of 100 (NDC 0088-1106-47) with a polypropylene screw cap containing a pulp/wax liner with heatsealed foil inner seal and HDPE bottles of 500 (NDC 0088-1106-55) with a polypropylene screw cap containing a pulp/wax liner with heat-sealed foil inner seal.
The safety of ALLEGRA for the treatment of chronic idiopathic urticaria in subjects 6 months to 11 years of age is based on cross-study comparison of the pharmacokinetics of ALLEGRA in adult and pediatric subjects and on the safety profile of fexofenadine in both adult and pediatric subjects at
120 Mg-Allegra equal to or higher than the recommended dose.