title: Pharmacokinetics of gadobenate dimeglumine in children 2 to 5 years of age undergoing MRI of the central nervous system.
abstract: OBJECTIVE
  To determine the pharmacokinetic profile of gadobenate dimeglumine in children aged between 2 and 5 years.
  
  
  METHODS
  Fifteen children scheduled to undergo contrast-enhanced MRI for suspected disease of the central nervous system received a single intravenous injection of 0.1 mmol/kg gadobenate dimeglumine. Children were stratified into three age groups: 2 to <3 years, 3 to <4 years, and 4 to 5 (i.e., <6 years). Serial blood and urine samples collected at prespecified time-points before and after contrast administration were analyzed for gadolinium concentrations. Pharmacokinetic parameters were calculated using noncompartmental and compartmental techniques.
  
  
  RESULTS
  Mean values of 65.7 μg/mL for highest blood gadolinium concentration, 0.2 L/h/kg for blood clearance, 0.32 L/kg for steady-state volume of distribution, and 1.2 h for terminal elimination half-life were determined across all age groups combined. On average, more than 80% of the dose was eliminated in the urine during the first 24 h after administration. All pharmacokinetic parameters were similar between age groups and no effects of gender were noted. No adverse events considered related to gadobenate dimeglumine administration were reported.
  
  
  CONCLUSIONS
  In terms of pharmacokinetic profile no dosage adjustment from the approved adult gadobenate dimeglumine dose of 0.1 mmol/kg bodyweight is necessary in children aged between 2 and 5 years.
authors.affiliation: Global Medical and Regulatory Affairs, Bracco Diagnostics Inc, Monroe, New Jersey, USA.
authors.forename: Gianpaolo
authors.initials: G
authors.lastname: Pirovano
authors.forename: Miles A
authors.initials: MA
authors.lastname: Kirchin
authors.forename: Vito
authors.initials: V
authors.lastname: Lorusso
authors.forename: Rutu
authors.initials: R
authors.lastname: Patel
authors.forename: Ningyan
authors.initials: N
authors.lastname: Shen
mesh_terms: D000375:Aging / Q000378:metabolism* / Q000473:pathology; D001921:Brain / Q000033:anatomy & histology* / Q000378:metabolism*; D002675:Child, Preschool; D003287:Contrast Media / Q000493:pharmacokinetics; D005260:Female; D006801:Humans; D008279:Magnetic Resonance Imaging / Q000379:methods*; D008297:Male; D008536:Meglumine / Q000031:analogs & derivatives* / Q000493:pharmacokinetics; D008657:Metabolic Clearance Rate; D009942:Organometallic Compounds / Q000493:pharmacokinetics*
chemical_list: D003287:Contrast Media; D009942:Organometallic Compounds; C064572:gadobenic acid; D008536:Meglumine
keywords: children; gadobenate dimeglumine; pharmacokinetics