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

From Merck Research Laboratories, Rahway, New Jersey (Dr Knorr, Dr Maganti, Dr Ramakrishnan, Dr Tozzi, Dr Migoya); the Division of Pediatric Pharmacology and Medical Toxicology, Children's Mercy Hospitals and Clinics, Kansas City, Missouri, and the Departments of Pediatrics and Pharmacology, University of Missouri-Kansas City, Kansas City, Missouri (Dr Kearns).

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.

Key Words: Bronchiolitis • population pharmacokinetics • controlled clinical trial • pediatrics

Address for reprints: Barbara Knorr, MD, Merck Research Laboratories, Respiratory & Allergy Department, RY34B-332, 126 East Lincoln Avenue, Rahway, NJ 07065; e-mail: Barbara_knorr{at}merck.com.

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