title: Helicobacter pylori treatment in children: defining a dose for rabeprazole as a part of a triple therapy regimen.
abstract: The proton pump inhibitor, rabeprazole, has been studied in children for the treatment of gastroesophageal reflux disease (GERD). In adults, rabeprazole is indicated for Helicobacter pylori eradication in combination with amoxicillin and clarithromycin. Nonlinear mixed effects modeling was conducted to estimate pharmacokinetic (PK) parameters for rabeprazole and its thioether metabolite from 336 subjects, 35% of whom were children 1-11 years with GERD from phase I and III studies. A 2-compartment disposition model with a transit absorption model provided the best fit for rabeprazole PK. The steady-state area under the concentration-time curves given several candidate doses were simulated to identify a dose per each body weight group that is comparable to a 20 mg twice-daily dose in adults, which is the recommended dose for treatment of H. pylori in adults. Simulations provided the following recommended twice-daily weight-based doses for children ≥1 year and <16 years: 10 mg for 6-10 kg, 15 mg for 10-30 kg, and 20 mg for ≥30 kg.
authors: Janssen Research & Development, LLC, Raritan, NJ, USA.
authors: Holly
authors: H
authors: Kimko
authors: An
authors: A
authors: Thyssen
authors: Diane R
authors: DR
authors: Mould
authors: Erik
authors: E
authors: Mannaert
authors: William R
authors: WR
authors: Treem
mesh_terms: D000293:Adolescent; D000658:Amoxicillin / Q000008:administration & dosage; D019540:Area Under Curve; D001835:Body Weight; D002648:Child; D002675:Child, Preschool; D017291:Clarithromycin / Q000008:administration & dosage; D017321:Clinical Trials, Phase I as Topic; D017326:Clinical Trials, Phase III as Topic; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori; D006801:Humans; D007223:Infant; D008297:Male; D054328:Proton Pump Inhibitors / Q000008:administration & dosage* / Q000493:pharmacokinetics* / Q000627:therapeutic use; D064750:Rabeprazole / Q000008:administration & dosage* / Q000493:pharmacokinetics* / Q000627:therapeutic use
chemical_list: D054328:Proton Pump Inhibitors; D064750:Rabeprazole; D000658:Amoxicillin; D017291:Clarithromycin
keywords: Helicobacter pylori; children; proton pump inhibitor; rabeprazole; triple therapy