Abstract
SCH 434 is a combination tablet containing the nonsedating antihistamine, loratadine (5 mg), and the well-established nasal decongestant, pseudoephedrine sulfate (120 mg), for twice daily dosing. The efficacy and safety of SCH 434 was compared with its individual components in a 14-day, placebocontrolled, randomized, double-blind, parallel-group, multi-center study in the symptomatic treatment of seasonal allergic rhinitis; 437 patients were evaluated for safety, 417 of whom were also evaluated for efficacy. Throughout the study, SCH 434 provided a significantly greater degree of overall symptom relief than either component alone or placebo. Loratadine alone was also superior to placebo on day 4 and at end point and superior to pseudoephedrine alone on day 4 in decreasing total symptom score. All treatments were well tolerated and no serious or unusual adverse experiences were reported; adverse experiences associated with SCH 434 were typical of the side effects commonly associated with the use of pseudoephedrine. The combination provides for a safe, effective, and convenient alternative for patients requiring the benefits of both an antihistamine and nasal decongestant, but who cannot tolerate, or wish to avoid, the sedative effects of traditional antihistamines.
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