Allegra

[Fexofenadine]

Nonteratogenic Effects.

Dose-related decreases in pup weight gain and survival were observed in rats exposed to an oral dose of 150 mg/kg of terfenadine (approximately 3 times the maximum recommended daily oral dose of fexofenadine hydrochloride in adults based on comparison of fexofenadine hydrochloride AUCs).

Nursing Mothers

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There are no adequate and well-controlled studies in women during lactation. Because many drugs are excreted in human milk, caution should be exercised when fexofenadine hydrochloride is administered to a nursing woman.

Pediatric Use

The recommended dose in patients 6 to 11 years of age is based on cross-study comparison of the pharmacokinetics of ALLEGRA in adults and pediatric patients and on the safety profile of fexofenadine hydrochloride in both adult and pediatric patients at doses equal to or higher than the recommended doses. The safety of ALLEGRA tablets at a dose of 30 mg twice daily has been demonstrated in 438 pediatric patients 6 to 11 years of age in two placebo-controlled 2-week seasonal allergic rhinitis trials. The safety of ALLEGRA for the treatment of chronic idiopathic urticaria in patients 6 to 11 years of age is based on cross-study comparison of the pharmacokinetics of ALLEGRA in adult and pediatric patients and on the safety profile of fexofenadine in both adult and pediatric patients at doses equal to or higher than the recommended dose.

The effectiveness of ALLEGRA for the treatment of seasonal allergic rhinitis in patients 6 to 11 years of age was demonstrated in one trial (n=411) in which ALLEGRA tablets 30 mg twice daily significantly reduced total symptom scores compared to placebo, along with extrapolation of demonstrated efficacy in patients ages 12 years and above, and the pharmacokinetic comparisons in adults and children. The effectiveness of ALLEGRA for the treatment of chronic idiopathic urticaria in patients 6 to 11 years of age is based on an extrapolation of the demonstrated efficacy of ALLEGRA in adults with this condition and the likelihood that the disease course, pathophysiology and the drug's effect are substantially similar in children to that of adult patients.

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