Age-Dependent Pharmacokinetics of Lansoprazole in Neonates and Infants
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ORIGINAL RESEARCH ARTICLE
© 2008 Adis Data Information BV. All rights reserved.
Age-Dependent Pharmacokinetics of Lansoprazole in Neonates and Infants Weijiang Zhang, Michael Kukulka, Galen Witt, Debra Sutkowski-Markmann, Janine North and Stuart Atkinson TAP Pharmaceutical Products Inc., Lake Forest, Illinois, USA
Abstract
Background: Evidence suggests that age may affect the pharmacokinetics of lansoprazole in pediatric patients, but little information is available in neonates and infants. Objective: To determine the pharmacokinetics of lansoprazole in neonates and infants 28 days, but 10 weeks–1 year. Lansoprazole was well tolerated in all patients. Conclusions: The pharmacokinetics of lansoprazole in pediatric patients are age dependent, with those aged ≤10 weeks showing higher plasma exposure and lower plasma clearance than those aged >10 weeks–1 year. Thus, pediatric patients aged ≤10 weeks require a lower dose of lansoprazole than pediatric patients aged >10 weeks to achieve similar plasma exposure.
Background Gastroesophageal reflux disease (GERD) is the reflux of gastric contents into the esophagus or oropharynx, producing symptoms
such as heartburn, regurgitation, chest pain, difficulty in swallowing, coughing, and hoarseness.[1,2] The prevalence of gastroesophageal reflux in infants is believed to be as high as 20–50%, which is much greater than that observed in adults.[3-5] In infants
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28 days but 10 weeks of age would achieve a similar AUC to a 30-mg dose of lansoprazole in adults. Mean CL/F in pediatric subjects >10 weeks of age (0.71 L/ h/kg) is higher than that in adults (approximately 0.2 L/h/kg). There are few published studies comparing the pharmacokinetics of PPIs in neonates and infants. However, in common © 2008 Adis Data Information BV. All rights reserved.
with our findings, other available data suggest that neonates and very young infants tend to have a greater exposure and lower CL/F than older infants when given the same dose.[12,14,24-26] In a multiple-dose study by Tran and colleagues,[12] 22 pediatric patients aged 18 days–14.1 years with a variety of gastric-acid-related disorders were administered lansoprazole at a mean dosage of 0.7 ± 0.2 mg/kg/day for an average of 12.6 days. The only participant 10 weeks–1 year. Thus, pediatric patients aged ≤10 weeks require a lower dose of lansoprazole than pediatric patients aged >10 weeks to achieve similar plasma exposure. However, the effectiveness of lansoprazole therapy in subjects
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