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| |  Zyrtec Approved For Allergic Rhinitis In Children Two To Five Years Old NEW YORK, NY -- June 3, 1998 – The United States Food and Drug Administration has approved Pfizer Inc. and UCB Pharma’s antihistamine Zyrtec(R) (cetirizine HCl) for the treatment of seasonal allergic rhinitis, perennial allergic rhinitis and chronic idiopathic urticaria in children down to the age of two years old. Zyrtec was initially approved for patients 12 years and older in January 1996 and was subsequently approved down to the age of six years in September 1996. Zyrtec is the first and only once-daily prescription antihistamine indicated for use in pediatric patients under the age of six years. Zyrtec is available in a 1 mg per 1 ml alcohol-free and dye-free fruity banana-grape flavour syrup. The recommended initial dose of Zyrtec Syrup in children aged two to five years is 2.5 mg (1/2 teaspoon) once daily. The dosage in this age group can be increased to a maximum dose of 5 mg per day given as 1 teaspoon (5 mg) once daily, or as 1/2 teaspoon (2.5 mg) given every 12 hours, depending on symptom severity and patient response. Zyrtec is also available as 5 mg and 10 mg tablets. The effectiveness of Zyrtec for the treatment of seasonal and perennial allergic rhinitis and chronic idiopathic urticaria in this pediatric age group of two to 11 years is based on an extrapolation of the demonstrated efficacy of Zyrtec in adults in these conditions and the likelihood that the disease course, pathophysiology and the drug's effect are substantially similar between these two populations. Clinical studies support the safety of Zyrtec in children in this age group. In studies, side effects were mild or moderate including drowsiness, fatigue and dry mouth in adults and drowsiness, headache, sore throat and stomach pain in children. Drowsiness occurred in between 11 percent and 14 percent in adults, depending on dose, compared to six percent taking placebo. In children, drowsiness occurred in between two percent and four percent, depending on dose, compared to one percent taking placebo. Approximately six million children suffer from seasonal allergies. If one parent has allergies, chances are one in three that each child will have an allergy. If both parents have allergies, it is much more likely (seven in 10) that their children will have allergies. "Because it may be difficult to discern the difference between cold and allergy symptoms, many parents frequently mistake allergy symptoms for those associated with a cold and do not seek appropriate medical attention," said James Kemp, M.D., clinical professor, department of pediatrics, University of California, San Diego. "Once a diagnosis is made, avoidance of allergy triggers, such as pollen and animal dander, along with treatment, can play a key role in controlling nagging symptoms." More information on: Zyrtec, Pfizer Inc. and UCB Pharma
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