Abstract

Review of pantoprazole in pediatrics

Author(s): Vasundhara Tolia

This article summarizes the effect of pantoprazole, a proton pump inhibitor (PPI) on suspected or objectively demonstrated gastroesophageal reflux disease (GERD) symptoms in pediatric age range from premature infants to 16 years of age. All interventional studies in English language are reviewed including pharmacokinetic and pharmacodynamic reports. Oral pantoprazole was evaluated in preterm infants, neonates, infants, children and adolescents in multiple trials designed to meet US FDA requirements. Its PK and PD profile has been reported for both oral and intravenous routes. Its disposition was similar to that in adults and showed no evidence of accumulation when repeated doses were studied. In CYP2C19 and CYP3A4 slow metabolizers, the half-life was prolonged; however, data on pharmacogenomics is limited. Its adverse effect profile was similar to that in adults. It was efficacious in resolving gastroesophageal reflux (GER) symptoms partially or completely in 1–16-year-old subjects and in healing erosive esophagitis, however, it has been approved for treating GERD in patients between the ages of 5–16 years for up to 8 weeks only. It was not effective in treating infants under 1 year of age with symptoms suggestive of GERD and because of unavailability of formulation appropriate for children younger than 5 years; it is not approved for use under this age. Further studies are needed to expand the understanding of pantoprazole treatment in infants.