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| |  FDA Approves Zyrtec-D (Cetirizine/Pseudoephedrine) for Allergies/Nasal Congestion NEW YORK, NY -- August 15, 2001 -- Pfizer Inc said today that the U.S. Food and Drug Administration has approved Zyrtec-D 12 Hour (cetirizine HCl/pseudoephedrine HCl), an antihistamine with decongestant for the treatment of a broad range of allergies and nasal congestion. Zyrtec-D 12 Hour is the only prescription oral antihistamine/decongestant combination medicine approved to treat both year-round indoor and outdoor allergies as well as nasal congestion. Fifty-nine percent of people with allergies suffer from both seasonal and year-round allergies, and 30 percent of all allergy sufferers also experience nasal congestion. The most common allergy symptoms include stuffy or runny nose, itchy and watery eyes, sneezing and congestion. "Treating people with allergies can be very complicated due to the wide range of allergies which often times require diverse treatment regimens," said Joe Feczko, M.D., senior vice president, Pfizer. "For those who suffer from year-round and seasonal allergies, Zyrtec-D provides the same antihistamine benefits of Zyrtec [cetirizine HCl] with an added decongestant to alleviate nasal congestion." Zyrtec-D 12 Hour is available in 5mg tablets and is taken twice a day with or without food to relieve allergy symptoms and nasal congestion. Zyrtec-D 12 Hour is indicated for patients 12 years of age and older, and can be safely used by patients with seasonal and year-round allergies who have concomitant mild to moderate asthma. Zyrtec was introduced in 1996 and is the only once-daily, prescription antihistamine indicated for both seasonal and year-round allergies. Zyrtec is approved for children as young as two years, and is also available in an alcohol-free, dye-free, banana-grape flavored syrup. Zyrtec is given as a single dose, with or without food. Zyrtec and Zyrtec-D 12 Hour are marketed worldwide by the Belgian company UCB S.A. and licensed by Pfizer in the United States and Canada. Pfizer and UCB co-promote Zyrtec in the United States. In studies for U.S. approval of Zyrtec, most side effects were mild or moderate, including drowsiness, fatigue, and dry mouth in adults. Drowsiness occurred in 11 percent to 14 percent of adults, depending on dose, compared to 6 percent taking placebo. Due to its pseudoephedrine component, Zyrtec-D 12 Hour is contraindicated in patients with narrow-angle glaucoma, urinary retention, severe hypertension, or severe coronary artery disease and in patients receiving monoamine oxidase (MOA) inhibitor therapy or within 14 days of stopping such treatment. It should also be used with caution in patients with hypertension, diabetes mellitus, ischemic heart disease, increased intraocular pressure, hyperthyroidism, renal impairment, or prostatic hypertrophy. Care should be taken in the concomitant administration of other sympathomimetic amines because combined effects on the cardiovascular system may be harmful to the patient.
SOURCE: Pfizer Inc. Related Link: Pfizer Inc.
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