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| |  Allegra (Fexofenadine) Available In US For Children With Seasonal Allergic Rhinitis Or Chronic Idiopathic Urticaria PARSIPPANY, NJ -- June 5, 2000 -- Aventis Pharmaceuticals announced that Allegra® (fexofenadine HCl) 30-mg tablets, twice daily (bid), are now available by prescription for the relief of seasonal allergic rhinitis (SAR) and chronic idiopathic urticaria (CIU) in children aged six to 11 years. "Seasonal allergies affect up to six million children in the United States," said Eli Meltzer, M.D., of the Allergy and Asthma Group and Research Center, San Diego, CA, and lead investigator of the clinical study, Safety of Fexofenadine HCl in Children Treated for Seasonal Allergic Rhinitis. "Allegra 30-mg tablets offers physicians a safe, nonsedating allergy treatment that can help in the management of children's seasonal allergies." In a study of 411 pediatric patients, Allegra 30-mg tablets bid significantly reduced total symptom scores compared to placebo and was well tolerated among children aged six to 11 years. Such allergy symptoms, including runny nose, itchy, watery, red eyes, sneezing and itchy nose, palate and throat can hinder the enjoyment of outdoor activities that children like to pursue. Allegra 30-mg tablets are nonchewable and are smaller than a chocolate chip. This pediatric dose is an addition to the Allegra family of products currently available for patients 12 and older, including Allegra® (fexofenadine HCl) 60-mg capsules, Allegra-D® (fexofenadine HCl 60 mg/pseudoephedrine HCl 120 mg) Extended-Release Tablets and Allegra® (fexofenadine HCl) 180-mg tablets. In clinical trials, adverse events with Allegra 30-mg tablets were similar to placebo. The most commonly reported with Allegra 30-mg tablets and placebo in seasonal allergic rhinitis patients six to11 years are headache (7.2 percent vs. 6.6 percent), upper respiratory tract infection (4.3 percent vs. 1.7 percent), coughing (3.8 percent vs. 1.3 percent), and accidental injury (2.9 percent vs. 1.3 percent). Allegra 60-mg capsules are well tolerated with side effects similar to placebo. Compared to placebo, the most commonly reported adverse events with Allegra in seasonal allergic rhinitis patients 12 and older are cold or flu (2.5 percent vs. 1.5 percent), nausea (1.6 percent vs. 1.5 percent), and menstrual pain (1.5 percent vs. 0.3 percent). The most commonly reported adverse events with Allegra 60-mg tablets in CIU patients 12 years and older are back pain (2.2 percent vs. 1.1 percent), sinusitis (2.2 percent vs. 1.1 percent), dizziness (2.2 percent vs. 0.6 percent), and drowsiness (2.2 percent vs. 0.0 percent). Because Allegra-D (fexofenadine HCl 60 mg/pseudoephedrine HCl 120 mg) Extended-Release Tablets contain pseudoephedrine (the decongestant in most over-the-counter allergy medicines), Allegra-D must not be taken in conjunction with MAO inhibitors (medicines that treat depression) or if you retain urine or have glaucoma, severe high blood pressure, or severe heart disease. Also, let your doctor know before you take Allegra-D if you have high blood pressure, diabetes, heart disease, glaucoma, thyroid disease, impaired kidney function, or symptoms of an enlarged prostate such as difficulty urinating. The most commonly reported adverse experiences with Allegra-D compared to pseudoephedrine alone were headache (13.0 percent vs. 17.4 percent), insomnia (12.6 percent vs. 13.3 percent), and nausea (7.4 percent vs. 5.0 percent). The most commonly reported adverse events with Allegra(R) (fexofenadine HCl) 180 mg and placebo, respectively, in SAR patients 12 years and older are headache (10.6 percent vs. 7.5 percent), upper respiratory tract infection (3.2 percent vs. 3.1 percent), and back pain (2.8 percent vs. 1.4 percent). Related Links: Allegra (fexofenadine HCl) and Aventis Pharmaceuticals.
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