Single-dose, multiple-dose, and population pharmacokinetics of pantoprazole in neonates and preterm infants with a clinical diagnosis of gastroesophageal reflux disease (GERD)
The pharmacokinetic profile of pantoprazole granules was assessed in neonates and preterm infants with gastroesophageal reflux disease (GERD) in a multicenter, randomized, open-label trial. Patients were randomly assigned to either the pantoprazole 1.25 mg (approx. 0.6 mg/kg) or 2.5 mg (approx. 1.2-...
| Publicado en: | European Journal of Clinical Pharmacology Vol. 66; no. 6; pp. 555 - 562 |
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| Autores principales: | , , , , , , , |
| Formato: | clinical trial research Journal Article |
| Publicado: |
Springer Nature
Jun2010
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=105203229&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 105203229 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 00316970 NP9 jtl: European Journal of Clinical Pharmacology issn: 00316970 maglogo: N pubinfo: dt: Jun2010 vid: 66 iid: 6 pid: 237 pub: Springer Nature place: New York, New York artinfo: ui: 105203229 105203229 2010657527 10.1007/s00228-010-0811-8 NLM20306184 105203229 ppf: 555 ppct: 7 formats: fmt: @attributes: type: P tig: atl: Single-dose, multiple-dose, and population pharmacokinetics of pantoprazole in neonates and preterm infants with a clinical diagnosis of gastroesophageal reflux disease (GERD) aug: au: Ward R Tammara B Sullivan S Stewart D Rath N Meng X Maguire M Comer G affil: Pediatric Pharmacology Program, Department of Pediatrics, University of Utah, 417 Wakara, Suite 3510 Salt Lake 84108 USA sug: subj: Gastroesophageal Reflux Diagnosis Pantoprazole Sodium Pharmacodynamics Childbirth, Premature Evaluation Clinical Trials Demography Descriptive Statistics Funding Source Human Infant Infant, Newborn Pantoprazole Sodium Administration and Dosage Proton Pump Inhibitors Therapeutic Use Race Factors Safety Infant: 1-23 months Infant, Newborn: birth-1 month ab: The pharmacokinetic profile of pantoprazole granules was assessed in neonates and preterm infants with gastroesophageal reflux disease (GERD) in a multicenter, randomized, open-label trial. Patients were randomly assigned to either the pantoprazole 1.25 mg (approx. 0.6 mg/kg) or 2.5 mg (approx. 1.2-mg/kg) group and treated for >=5 consecutive days. Blood was sampled either at 0, 2, 8, and 18 h postdose or at 0, 1, 4, and 12 h postdose on day 1 and at 3 and 6 h postdose after >=5 consecutive doses. Cytochrome P450 2C19 (CYP2C19) and CYP3A4 genotypes were determined. Safety was monitored. Population pharmacokinetics (popPK) analyses were conducted using nonlinear mixed-effects modeling. The popPK modeling of the pantoprazole 1.25 mg and 2.5 mg groups obtained mean (±standard deviation) estimates for the area under the plasma concentration versus time curve (AUC) of 3.54 (±2.82) and 7.27 (±5.30) ug h/mL, respectively, and mean estimates for half-life of 3.1 (±1.5) and 2.7 (±1.1) h, respectively. Pantoprazole did not accumulate following multiple-dose administration. The two patients with the CYP2C19 poor metabolizer genotype had a substantially higher AUC than extensive metabolizers. No safety-related discontinuations occurred. In preterm infants and neonates, pantoprazole granules were generally well tolerated, mean exposures with pantoprazole 2.5 mg were slightly higher than that in adults who received 40 mg. While the half-life was longer, accumulation did not occur. pubtype: Academic Journal doctype: clinical trial research Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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