FDA approves new chewable formulation of Zyrtec® aimed at young allergy sufferers

Mar 22 2004

Grape-Flavored Chewable Tablets Offer Efficacy and Convenience for Young Allergy Sufferers

Pfizer Inc and UCB Pharma today announced the approval of a new chewable formulation of Zyrtec® (cetirizine HCl) for the treatment of seasonal and perennial allergic rhinitis (inflammation of the nasal passages) and chronic idiopathic urticaria (itching and hives of unknown causes) in children aged two years and older. The approval by the US Food and Drug Administration makes Zyrtec the first and only prescription antihistamine available in both syrup and chewable form.

"This new chewable formulation provides more convenience and flexibility for a trusted antihistamine,” said Gail Shapiro, MD, Senior Partner, Allergist, Northwest Asthma and Allergy Center, Clinical Professor of Pediatrics, University of Washington School of Medicine and past President of the American Academy of Allergy, Asthma and Immunology. “The chewable option will appeal to physicians, parents, and patients. It offers physicians another option to better meet our patient’s individual needs; for parents it offers easy administration; for patients it offers Zyrtec’s 24-hour symptom relief in a pleasant tasting, easy-to-chew tablet.”

The grape-flavored tablets are formulated to be taken once daily with or without food or water. They will be available in 5 mg and 10 mg doses to allow physicians the flexibility of prescribing the proper dose for children of different ages.

Zyrtec is the number-one prescribed antihistamine by pediatricians and allergists.1 The new chewable formulation, which can be used by children as young as two years old, provides physicians with another Zyrtec option for their pediatric patients. Zyrtec syrup is available for babies as young as six months with year-round allergies or continuing hives. Zyrtec Chewable Tablets are bioequivalent to Zyrtec tablets and offer the same efficacy as Zyrtec tablets and syrup in a convenient formulation. The new chewable tablets will be available in a 30-tablet blister pack containing three cards of 10. Individual, foil-wrapped tablets can be easily removed by separating or bending the packaging perforation. As with all medications, Zyrtec Chewable Tablets should be kept out of the reach of children.

“The development of the chewable formulation of Zyrtec underscores Pfizer and UCB Pharma’s continued commitment to pediatric allergy patients,” said Dr. Benjamin Kramer, senior medical director at Pfizer and a board certified allergist. “We believe that the concept of a convenient, good-tasting medication could help improve children’s compliance with allergy medicine. And, increased compliance with allergy medicine may also improve health-related quality of life.”

Zyrtec syrup is the only antihistamine—Rx or OTC—FDA approved to treat indoor allergies and hives in infants down to the age of six months; no other antihistamine has received such FDA approval. With its proven history of indoor and outdoor symptom relief, no other allergy medication is approved to treat more allergies than Zyrtec.

About ZYRTEC

Zyrtec (cetirizine HCl) is a prescription antihistamine for the treatment of seasonal and perennial allergies as well as continuing hives in adults and children. It can be used in adults and children down to two years old, and for some of these allergies, it can even be used in infants as young as six months. In infants, 6 to 23 months old, side effects were like those of a sugar pill and included being cranky, fussy, and not able to sleep. Other side effects were feeling tired and looking uncomfortable. In studies with children aged 2 to 11 years old, side effects included drowsiness, headache, sore throat, and stomachache. Most were mild or moderate.

Most children weren't bothered by side effects enough to stop taking Zyrtec. In studies with adults and children 12 years and older, the most common side effect was drowsiness; others included dry mouth and tiredness. Most were mild to moderate, but most people weren’t bothered enough to stop taking Zyrtec.