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Separately, Andrx has received approval for loratadine/pseudoephedrine sulfate, the generic equivalent to Schering-Plough Corp.'s Claritin-D 24.
The once-daily formulations include tablets, syrup, orally disintegrating RediTabs, and Claritin-D 24-hour (loratadine/pseudoephedrine sulfate) extended-release tablets formulated with a decongestant.
In this double-blind, placebo-controlled, crossover, parallel study, we treated 20 adults who had seasonal allergic rhinitis with once-daily fixed-combination loratadine/pseudoephedrine sulfate to observe its effect on relieving symptoms, primarily nasal congestion.
The goal of this study was to further evaluate the efficacy of loratadine/pseudoephedrine in relieving nasal congestion in patients with seasonal allergic rhinitis, and to assess by several different measures of effectiveness its effect on other common parameters associated with allergic rhinitis.
We undertook this double-blind, placebo-controlled, crossover, parallel trial at the University of Chicago to study the effect of loratadine/pseudoephedrine on nasal congestion caused by natural exposure to seasonal allergens in patients who had seasonal allergic rhinitis.
Treatment with loratadine/pseudoephedrine resulted in a mean improvement in CSA1 measurements of 0.073 ([pm]0.089) [cm.sup.2], while placebo resulted in a mean worsening of 0.006 ([pm]0.246) [cm.sup.2].
During loratadine/pseudoephedrine treatment, the mean redness score improved by 1.00 ([pm]6.0) point; during placebo treatment, the mean score decreased by 1.10 ([pm]4.07) points.
The difference in mean nasal symptom scores before and after loratadine/pseudoephedrine treatment was 0.60 ([pm]1.16) points.
The pre- and post-treatment difference in mean eye symptom scores was 0.57 ([pm]1.32) points during loratadine/pseudoephedrine therapy.
The mean score for symptoms other than those involving the nose and eyes rose 0.18 ([pm]0.77) points after loratadine/pseudoephedrine treatment, but the difference was not clinically important or statistically significant.
The patients' quality of sleep appeared to worsen slightly after loratadine/pseudoephedrine treatment, as the mean score fell 0.12 ([pm]1.40) points.
The company, which hopes to begin shipping the items by the middle of the year, will offer 5/120 mg and 10/240 mg loratadine/pseudoephedrine tablets as well as loratadine rapid-disintegration tablets.
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- Lorand Eotvos
- Loránd Eötvös
- Lóránd Eötvös
- Lorand Von Eotvos
- Lórand von Eötvös
- Lóránd Von Eötvös
- Loranthus europaeus
- Loranthus europaeus
- Lorbeer, Hans
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- Lorca, Federico García
- Lord (only) knows, the