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A Comparative Study of the Side Effects Between Pseu :doephedrine in Loratadine Plus Pseudoephedrine Sul fate Repetabs Tablest and Loratadine + Pseudoephedrine Tablet in Treatment of Allergic Rhinitis in Thai Patients

PAKPOOM SUPIYAPHUN, M.D.*, LADDA CHOCHAIPANICHNON, M.D.*, VIRACHAI KEREKHANJANARONG, M.D.*, SUPINDA SAENGPANICH, M.D.*

Affiliation : *Department of Otolaryngology, Faculty of Medicine, Chulalongkom University, Bangkok 10330, Thailand. t Loratadine plus Pseudoephedrine Sulfate Repetabs Tables = Clarinase Repetab® (Schering-Piough Ltd.)

Abstract
The objective of the study was to evaluate the adverse reactions of Loratadine plus Pseudoephedrine Sulfate Repetabs Tables (LTD+PSE Repetabs) (Loratadine 5 mg +Pseudoephedrine 120 mg) twice daily with that of loratadine (5 mg) twice daily and pseudoephedrine (60 mg) quarter daily in the treatment of patients with allergic rhinitis. The study was designed as an investigator blind, parallel group study. In this study, 56 patients were equally separated into 2 groups and treated for 14 days with either L TD+PSE Repetabs or loratadine + pseudoephedrine tablet. Both groups were comparable in age, gender, weight; baseline systolic blood pressure, diastolic blood pressure and pulse rate. The change of systolic blood pressure, diastolic blood pressure, and pulse rate did not reach cli nical significance throughout the study period. There was no significant difference in occurrences of insomnia, palpitation, mouth dryness and anxiety. However, the incidence of patients with tremor at day 14 in the loratadine +pseudoephedrine tablet group was significantly higher than the LTD+PSE = Repetabs group (39% vs 10.7%, p-value 0.03). Furthermore, one patient in the loratadine + pseudoephedrine tablet group had to discontinue medication at day 7 due to insomnia. In conclusion, LT D+PSE Repetabs is well tolerated and has fewer adverse effects when compared to the lorata dine + pseudoephedrine tablet.

Keywords : Pseudoephedrine, Loratadine, Drug Side Effects, Allergic Rhinitis


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JMed Assoc Thai
MEDICAL ASSOCIATION OF THAILAND
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