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Montelukast Dose Selection in Children Ages 2 to 5 Years: Comparison of Population Pharmacokinetics between Children and Adults
Author(s) -
Knorr Barbara,
Nguyen Ha H.,
Kearns Gregory L.,
Villaran Cesar,
Boza Maria L.,
Reiss Theodore F.,
Rogers John D.,
Zhang Ji,
Larson Patrick,
Spielberg Stephen
Publication year - 2001
Publication title -
the journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.92
H-Index - 116
eISSN - 1552-4604
pISSN - 0091-2700
DOI - 10.1177/00912700122010492
Subject(s) - montelukast , pharmacokinetics , medicine , tolerability , asthma , population , area under the curve , leukotriene receptor , pharmacology , anesthesia , adverse effect , environmental health
Montelukast, a leukotriene receptor antagonist, has demonstrated efficacy and tolerability in the treatment of asthma in patients age 6 years and older. The purpose of this open, one‐period, multicenter population pharmacokinetic study was to identify a chewable tablet (CT) dose of montelukast for administration to children ages 2 to 5 years with asthma, yielding a single‐dose pharmacokinetic profile (area under the plasma concentration‐time curve [AUC]) comparable to that of the 10 mg film‐coated tablet (FCT) dose in adults. Because patient numbers were small and the volume of blood that could be collected from individual 2‐ to 5‐year‐old patients was limited, a population pharmacokinetic approach was used to estimate population AUC (AUC pop ). The 4 mg CT dose of montelukast was well tolerated and yielded an AUC pop (2721 ng·h/mL) similar to that of the adult AUCpop (2595 ng·h/mL) observed after a 10 mg FCT dose. These results support the selection of a 4 mg once‐daily CT dose of montelukast for future efficacy and safety studies in children ages 2 to 5 years with asthma.