24 Hour Extended Release Tablets

Clinical trials of loratadine; pseudoephedrine sulfate 24 hour extended release tablets involved a total of approximately 2000 patients with seasonal allergic rhinitis. One study involved 879 patients, who received either the combination product (loratadine 10 mg and pseudoephedrine sulfate 240 mg), loratadine (10 mg once daily) or pseudoephedrine sulfate (120 mg twice daily) alone, or placebo, in a double-blind randomized design. Improvement in nasal and non-nasal symptoms of seasonal allergic rhinitis including nasal congestion in patients receiving loratadine; pseudoephedrine sulfate 24 hour extended release tablets was significantly greater than in placebo recipients, and generally greater than that achieved with loratadine or pseudoephedrine sulfate alone. In this study, loratadine; pseudoephedrine sulfate 24 hour extended release tablets were well tolerated, with a frequency of sedation similar to that seen with placebo, and a frequency of nervousness and insomnia similar to that seen with pseudoephedrine sulfate given alone.

In another study of 469 patients, once-daily administration of loratadine; pseudoephedrine sulfate 24 hour extended release tablets provided effects similar to those achieved with twice-daily administration of loratadine; pseudoephedrine sulfate 12 hour extended release tablets, a combination product containing 5 mg loratadine plus 120 mg pseudoephedrine sulfate, extended release.

The end of dosing interval efficacy of the pseudoephedrine component of loratadine; pseudoephedrine sulfate 24 hour extended release tablets on the symptom of nasal stuffiness was evaluated in a study of 695 patients who were randomized to receive loratadine; pseudoephedrine sulfate 24 hour extended release tablets, loratadine; pseudoephedrine sulfate tablets, or placebo. Patients who received loratadine; pseudoephedrine sulfate 24 hour extended release tablets had significantly more improvement in nasal stuffiness scores at the end of the dosing interval than those patients receiving loratadine; pseudoephedrine sulfate tablets or placebo throughout the course of the trial.

12 and 24 Hour Extended Release Tablets

In a 6-week, placebo-controlled study of 193 patients with seasonal allergic rhinitis and concomitant mild to moderate asthma, loratadine; pseudoephedrine sulfate 12 and 24 hour extended release tablets twice daily improved seasonal allergic rhinitis signs and symptoms with no decrease in pulmonary function or adverse effect on asthma symptoms. This supports the safety of administering loratadine; pseudoephedrine sulfate 12 and 24 hour extended release tablets to seasonal allergic rhinitis patients with asthma.

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