NEW YORK, Aug. 14 /PRNewswire/ -- 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 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 2 years,
and is also available in an alcohol-free, dye-free fruity banana-grape
flavored syrup. Zyrtec is given as a single dose, with or without food.
Zyrtec (cetirizine HCl) 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.
Pfizer Inc discovers, develops, manufactures and markets leading
prescription medicines, for humans and animals, and many of the world's best
known over-the-counter brands.
UCB Pharma is a subsidiary of UCB S.A., a Belgian research-based
pharmaceutical and chemicals group with worldwide operations.
SOURCE Pfizer Inc
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CONTACT:
Vanessa McGowan of Pfizer, +1-212-733-3784
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