Pharmacokinetics and Safety of Montelukast in Children Aged 3 to 6 Months

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.