PARSIPPANY, N.J., June 5, 2000 -- Aventis Pharmaceuticals announced today 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 6 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, California and lead investigator of the clinical study, Safety of Fexofenadine HCl in Children Treated for Seasonal Allergic Rhinitis. "Allegra 30-mg tablets offer 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 6 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 6-11 years are headache (7.2% vs. 6.6%), upper respiratory tract infection (4.3% vs. 1.7%), coughing (3.8% vs. 1.3%), and accidental injury (2.9% vs. 1.3%).
Allegra 60-mg capsules are well tolerated with side effects similar to placebo.
Contact: Charles F. Rouse III