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Pharmacologic evaluation of loratadine (SCH 29851), chlorpheniramine and placebo
Authors:R. L. Batenhorst  A. S. Batenhorst  D. A. Graves  T. S. Foster  M. Kung  R. P. Gural  H. J. Amkraut
Affiliation:(1) Drug Product Evaluation Unit, College of Pharmacy, University of Kentucky Medical Center, Lexington, Kentucky, USA;(2) College of Medicine, University of Kentucky Medical Center, Lexington, Kentucky, USA;(3) Department of Pharmacology, Schering-Plough Corporation, Kenilworth, NJ, USA;(4) Department of Biostatistics, Schering-Plough Corporation, Kenilworth, NJ, USA;(5) Section for Drug Evaluation Department of Pharmacy Practice College of Pharmacy RM 244 (m/c 886), University of Illinois at Chicago, 60612 Chicago, IL, USA
Abstract:Summary The antihistaminic effect of loratadine (160 mg) was compared in twenty-four normal male volunteers to chlorpheniramine maleate (4 mg) and placebo in a double blinded 3-way cross-over study of latin square design. After receiving single oral doses of each medication, the wheal response to serial 0.1 ml intradermal histamine (2 µg) and saline (control) injections were recorded over a 24-h period. The calculated wheal areas were compared to baseline measurements. The results were analyzed by analysis of variance. Loratadine exhibited a more pronounced inhibition of histamine wheal formation than placebo or chlorpheniramine maleate (p<0.003). In contrast to chlorpheniramine maleate which had a duration of action of only 3 h, loratadine inhibited the response for the entire observation period between 1 and 24 h post-dose. Although sedation was observed less frequently with loratadine (Placebo,n=2; chlorpheniramine,n=3; and loratadine,n=1), the relative incidence were not statistically significant.
Keywords:loratadine  chlorpheniramine  placebo  histamine  pharmacodynamics  adverse effects
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