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| |  FDA Approves Antihistamine Claritin (Loratadine) For Treatment Of Allergy Symptoms In Children KENILWORTH, NJ -- December 8, 2000 -- Schering-Plough Corporation announced that Claritin® (loratadine) Syrup 10 mg/10mL has received marketing approval from the U.S. Food and Drug Administration FDA) for the relief of nasal and non-nasal symptoms of seasonal allergic rhinitis and for the treatment of chronic idiopathic urticaria (CIU), or hives of unknown cause, in children two to five years old. Claritin Syrup is the only once-daily nonsedating antihistamine to be indicated for seasonal allergy sufferers as young as two years of age. Claritin Syrup 10 mg/10mL was previously indicated for the relief of nasal and non-nasal symptoms of seasonal allergic rhinitis and for the treatment of CIU in patients six years of age or older. The recommended dose of Claritin Syrup for children two to five years of age is one teaspoon (5mg) once daily. The recommended dose for patients six years of age and older is two teaspoons (10 mg) once daily. "Parents frequently assume their children's sniffling and sneezing is just a cold when in many cases the root cause may be seasonal allergies, which can have a profound effect on the well-being of a child," said John Georgitis, M.D., pediatric allergist and immunologist at Wake Forest University Hospital, Winston-Salem, N.C. "That is why it is imperative for parents to see a physician so their children's symptoms can be properly diagnosed and treated. With this new indication for Claritin Syrup, physicians can assure parents that there is a safe, nonsedating treatment for their children's seasonal allergies." Two studies evaluated the safety of 5 mg (one teaspoon) loratadine syrup in children ages two to five years. A single-dose, open-label bioavailability study characterized the pharmacokinetic profiles of loratadine. A randomized, double-blind, placebo-controlled, parallel group study assessed the tolerability of 5 mg (one teaspoon) of loratadine syrup after multiple doses. Loratadine syrup or placebo was given once daily for 15 days to children with a history of allergic rhinitis or CIU. Single and multiple doses of Claritin Syrup were well tolerated. In children two to five years of age, no unexpected adverse events were reported in the clinical studies. Adverse events that occurred more frequently than placebo were diarrhea, epistaxis (nosebleed) and pharyngitis. In children six to 12 years of age, the most common side effects seen with Claritin Syrup occurred about as often as they did with placebo, including nervousness, wheezing, fatigue and hyperactivity. Related Links: ClaritinŽ (loratadine) and Schering-Plough Corporation.
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