Montelukast adult (10-mg film-coated tablet) and pediatric (5-mg chewable tablet) dose selections Barbara Knorr, MDa, Sherry Holland, PhDb, J.Douglas.

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Montelukast adult (10-mg film-coated tablet) and pediatric (5-mg chewable tablet) dose selections Barbara Knorr, MDa, Sherry Holland, PhDb, J.Douglas Rogers, PhDc, Ha H. Nguyen, PhDd, Theodore F. Reiss, MDa Journal of Allergy and Clinical Immunology Volume 106, Issue 3, Pages S171-S178 (September 2000) DOI: 10.1067/mai.2000.109424 Copyright © 2000 Mosby, Inc. Terms and Conditions

Fig. 1 The AUC (●) and Cmax (□) of montelukast as a function of dose in adults. Both relationships are linear. Journal of Allergy and Clinical Immunology 2000 106, S171-S178DOI: (10.1067/mai.2000.109424) Copyright © 2000 Mosby, Inc. Terms and Conditions

Fig. 2 The plasma concentration of montelukast for 24 hours after 1 dose of 9-mg intravenous montelukast (□) or 10-mg FCT of montelukast (●) in adults. (Adapted courtesy of Kluwer Academic/Plenum Publishers, from Cheng H, Leff JA, Amin R, Gertz BJ, De Smet M, Noonan N, et al. Pharmacokinetics, bioavailability, and safety of montelukast sodium (MK-0476) in healthy males and females. Pharmacol Res 1996;13:445-8.) Journal of Allergy and Clinical Immunology 2000 106, S171-S178DOI: (10.1067/mai.2000.109424) Copyright © 2000 Mosby, Inc. Terms and Conditions

Fig. 3 The plasma concentration of montelukast for 24 hours after 1 oral CT dose of 2-, 5-, and 10-mg or a 10-mg FCT dose in adults. The Tmax is shorter with the CT. Cmax is proportional to the CT dose. (Note, at the 24-hour timepoint for the 2-mg CT dose, the mean plasma concentration was 0.6 ng/mL and is not represented in the figure.) Journal of Allergy and Clinical Immunology 2000 106, S171-S178DOI: (10.1067/mai.2000.109424) Copyright © 2000 Mosby, Inc. Terms and Conditions

Fig. 4 AUC as a function of patient weight in adults and pediatric patients. Each point represents the AUC of a single subject resulting from a single oral dose normalized to a 10-mg CT dose. The solid line is the resulting line of regression. Journal of Allergy and Clinical Immunology 2000 106, S171-S178DOI: (10.1067/mai.2000.109424) Copyright © 2000 Mosby, Inc. Terms and Conditions

Fig. 5 The effect of age and pubertal stage (Tanner stage) on AUC at each respective dose in children or adolescents. The 5-mg dose was administered as a CT; all other doses were administered as FCTs. Journal of Allergy and Clinical Immunology 2000 106, S171-S178DOI: (10.1067/mai.2000.109424) Copyright © 2000 Mosby, Inc. Terms and Conditions

Fig. 6 Actual AUC0-∞ values (6- to 8-year-olds) or AUC0-∞ values normalized to the 5-mg CT dose (9- to 14- year-olds) were compared with actual adult AUC0-∞ (10-mg FCTs). The gray horizontal lines represent the geometric mean AUC ± 2 SDs for the 10-mg FCT dose in adults. The bottom and the top of each box represent the 25th and 75th percentile of the AUC data, respectively. The white line within each box represents the median. The bars represent the furthest data points within a predefined nonoutlier range. Asterisks represent potential outliers. The outlier range is defined as the interval (25th percentile value -1.5[75th-25th percentile values], 75th percentile value + 1.5[75th-25th percentile values]). (From Knorr B, Larson P, Nguyen HH, Holland S, Reiss TF, Chervinsky P, et al. Montelukast dose selection in 6- to 14-year-olds: comparison of single-dose pharmacokinetics in children and adults. J Clin Pharmacol 1999;39:786-93. Copyright © 1999 by Sage Publications, Inc. Reprinted by permission of Sage Publications, Inc.) Journal of Allergy and Clinical Immunology 2000 106, S171-S178DOI: (10.1067/mai.2000.109424) Copyright © 2000 Mosby, Inc. Terms and Conditions