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| |  CLARITIN-D Safety Labeling Changes Cleared by FDA KENILWORTH, N.J., Feb. 20, 1997 -- Schering Laboratories today reported that the allergy medications CLARITIN-D(R) 12 Hour (5 mg loratadine, 120 mg pseudoephedrine sulfate) and CLARITIN-D(R) 24 Hour (10 mg loratadine, 240 mg pseudoephedrine sulfate) Extended Release Tablets are the first antihistamine/decongestant combinations to be labeled as safe for use in seasonal allergic rhinitis patients with concomitant asthma. "The U.S. Food and Drug Administration (FDA) cleared changes to the products' prescribing information based on the results of a six-week, placebo- controlled study of 193 patients with seasonal allergic rhinitis and concomitant, mild to moderate asthma, in which CLARITIN-D improved seasonal allergy symptoms with no decrease in pulmonary function. According to the labeling, "This supports the safety of administering CLARITIN-D to seasonal allergic rhinitis patients with asthma." Until now, the safety of antihistamine/decongestant combinations, which have been used successfully for many years in treating seasonal allergy symptoms, had not been firmly established for use in patients with concomitant asthma. CLARITIN-D 12 Hour and CLARITIN-D 24 Hour are the only antihistamine/decongestant combination products with such labeling. "The combination of loratadine and pseudoephedrine plays an important role in alleviating symptoms in patients with seasonal allergic rhinitis," said William Storms, M.D., practicing allergist in Colorado Springs and assistant clinical professor at the University of Colorado Health Science Center in Denver. "This new labeling affirms that CLARITIN-D can be used safely by patients with seasonal allergic rhinitis and concomitant asthma." Approximately 8 million people in the United States suffer from allergic rhinitis with concomitant asthma. Allergic rhinitis is characterized by sneezing, nasal congestion, runny nose, and itchy, watery eyes, while asthma symptoms include wheezing, chest tightness and coughing. Available by prescription, CLARITIN-D 12 Hour and CLARITIN-D 24 Hour combine the world's leading non-sedating antihistamine, loratadine, with an oral decongestant. CLARITIN-D 12 Hour and CLARITIN-D 24 Hour provide relief of nasal symptoms and congestion in convenient once- or twice- daily dosages, without the black box warning regarding potential cardiovascular risks in the labeling of certain other prescription antihistamines. CLARITIN has more than 3 billion patient days of use worldwide and is the leading non-sedating antihistamine in the United States and around the world. For allergy management and treatment information, consumers can call 1-800-CLARITIN. Schering Laboratories is the U.S. prescription pharmaceutical marketing arm of Schering-Plough Corporation (NYSE: SGP), a research-based company engaged in the discovery, development, manufacturing and marketing of pharmaceutical and health care products worldwide.
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