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Pharmacokinetics and Safety of Montelukast in Children Aged 3 to 6 Months
Author(s) -
Knorr Barbara,
Maganti Lata,
Ramakrishnan Rohini,
Tozzi Carol A.,
Migoya Elizabeth,
Kearns Gregory
Publication year - 2006
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 - 10.1177/0091270006288324
Subject(s) - montelukast , pharmacokinetics , tolerability , medicine , confidence interval , area under the curve , population , oral administration , gastroenterology , adverse effect , asthma , environmental health
The single‐dose population estimate of the area under the concentration‐time curve (AUC pop ) from time zero to infinity (AUC 0‐∞ ), maximum plasma concentration (C max ), and time to C max (t max ) of montelukast 4‐mg oral granules were investigated in infants aged 3 to 6 months. Montelukast concentrations were quantitated after a single 4‐mg dose of montelukast oral granules. Pharmacokinetic parameters were determined using a population‐based approach with a nonlinear mixed‐effect, 1‐compartment model with first‐order absorption and elimination. Ninety‐five percent confidence intervals for the AUC pop ratio (3 to 6 months/6 to 24 months) were determined. Safety and tolerability were assessed. Montelukast 4‐mg oral granules in children 3 to 6 months of age yielded systemic exposure (AUC pop = 3644.3 ± 481.5 ng.h/mL) similar to that observed in children aged 6 to 24 months (3226.6 ± 250.0 ng.h/mL). Systemic exposure after a 4‐mg dose of montelukast as oral granules is similar in children aged 3 to 6 months and 6 to 24 months.