J Clin Pharmacol
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PEDIATRICS

Pharmacokinetics and Safety of Montelukast Oral Granules in Children 1 to 3 Months of Age With Bronchiolitis

Gregory L. Kearns, PharmD, PhD, FCP, Susan Lu, PharmD, Lata Maganti, PhD, Xiujiang (Susie) Li, PhD, Elizabeth Migoya, PharmD, Tuli Ahmed, MS, Barbara Knorr, MD and Theodore F. Reiss, MD

From the Children's Mercy Hospitals and Clinics, Kansas City, Missouri (Dr Kearns); Departments of Pediatrics and Pharmacology, University of Missouri-Kansas City, Kansas City, Missouri (Dr Kearns); Merck Research Laboratories, Rahway, New Jersey (Dr Lu, Dr Maganti, Dr Migoya, Dr Knorr, Dr Reiss); and Merck Research Laboratories, West Point, Pennsylvania (Dr Li, Ms Ahmed).

The single-dose pharmacokinetics of montelukast 4-mg oral granules and tolerability of daily administration of 2 different doses of montelukast (4 mg and 8 mg given once daily for 7 days) versus placebo were evaluated in 12 infants 1 to 3 months of age with bronchiolitis or a history of bronchiolitis and asthma-like symptoms. The population area under the concentration-time curve estimate after a single 4-mg dose of montelukast was 13 195.7 ± 2309.8 (standard error) ng.hr/mL, 3.6 times higher than historical values in infants 3 to 24 months of age. Six patients had 10 total clinical adverse experiences; none was considered serious or drug related. Three patients had transient drug-related increases in aspartate aminotransferase (montelukast 8 mg [n = 2]; placebo [n = 1]). Despite increased systemic exposure after administration of a single dose of montelukast 4-mg oral granules in infants 1 to 3 months of age compared with that in pediatric patients 3 to 24 months of age, administration of montelukast at 4 and 8 mg once daily for 7 days in 1- to 3-month-old infants was generally well tolerated.

Key Words: Montelukast • infants • bronchiolitis • pharmacokinetics • safety

Address for correspondence: Gregory L. Kearns, PhD, Division of Pediatric Clinical Pharmacology and Medical Toxicology, Children's Mercy Hospitals and Clinics, 2401 Gillham Road, Kansas City, MO 64108; e-mail: gkearns{at}cmh.edu.


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