J Med Assoc Thai 2002; 85 (6):722

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A Comparative Study of the Side Effects Between Pseudoephedrine in Loratadine Plus Pseudoephedrine Sulfate Repetabs Tables and Loratadine + Pseudoephedrine Tablet in Treatment of Allergic Rhinitis iri Thai Patients
Supiyaphun P Mail, Chochaipanichnon L , Kerekhanjanarong V , Saengpanich S

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%
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,
L TD+PSE Repetabs is well tolerated and has fewer adverse effects when compared to the lorata-
dine + pseudoephedrine tablet.
Key word : Pseudoephedrine, Loratadine, Drug Side Effects, Allergic Rhinitis

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