Safety, pharmacokinetics, and pharmacodynamics of S-(−)-pantoprazole sodium injections after single and multiple intravenous doses in healthy Chinese subjects

Jiao, Huiwen; Sun, Liang; Li, Yue-Qi; Yu, Lei; Zhang, Hongwen; Wang, Meifeng; Yu, Liyuan; Yuan, Zi-Qing-Yun; Xie, Ling; Chen, Juan; Meng, Ling; Zhang, Xuehui; Wang, Yongqing

doi:10.1007/s00228-017-2372-6

Cited by 3 publications

(2 citation statements)

References 19 publications

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“…Approximately 80% of pantoprazole metabolites are excreted by the kidneys and retained in the stool ( 17 ). The plasma clearance rate is 11 l/h, as so pantoprazole has relatively fewer adverse side effects compared with other pharmacological agents ( 18 ). Side effects include occasional dizziness, insomnia, drowsiness, nausea, diarrhea, constipation, rash, muscle pain, arrhythmia, increased aminotransferases and decreased granulocytes ( 19 ).…”

Section: Discussionmentioning

confidence: 99%

Pantoprazole‑induced acute kidney injury: A case report

Peng

Zheng³

et al. 2018

Exp Ther Med

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The present study reports a case of pantoprazole-induced acute kidney disease. The patient was diagnosed with acute kidney injury with wide interstitial inflammation and eosinophil infiltration. Following 1 month of glucocorticoid therapy, the patient's serum creatinine and urea nitrogen decreased to within normal ranges. The presentation, clinical course, diagnosis and prognosis of pantoprazole-induced acute kidney injury are discussed herein to highlight the importance of early and correct diagnosis for good prognosis. Disease characteristics include short-term increased serum creatinine levels that respond to glucocorticoid treatment. The patient had no history of chronic kidney disease or proteinuria and presented with increased serum creatinine following treatment with pantoprazole. Following the end of pantoprazole treatment, short-term RRT and long-term prednisolone was administered, then serum creatinine returned to normal. Pantoprazole-induced acute kidney injury is commonly misdiagnosed and late diagnosis results in poor patient prognoses. Misdiagnosis leads to the administration of treatments that may exacerbate the condition, so appropriate diagnosis and treatment for pantoprazole-induced acute kidney injury is necessary.

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Section: Discussionmentioning

confidence: 99%

Pantoprazole‑induced acute kidney injury: A case report

Peng

Zheng³

et al. 2018

Exp Ther Med

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“…The results indicated the possibility of in vivo chiral inversion of PAN enantiomers since considerable plasmatic concentrations of R ‐(+)‐PAN were found in the case of two subjects [88]. This method was further applied to assess the safety, pharmacokinetics, and pharmacodynamics of S ‐(−)‐PAN sodium injections following the administration of single and multiple intravenous doses in healthy Chinese subjects [89]. A similar LC–MS/MS method was developed by the same research group for the stereoselective pharmacokinetics of RAB using Chiralpak IC CSP and RP conditions.…”

Section: Hplc Methodsmentioning

confidence: 99%

Chiral separation in the class of proton pump inhibitors by chromatographic and electromigration techniques: An overview

et al. 2021

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Chiral separation in the class of proton pump inhibitors by chromatographic and electromigration techniques: An overviewProton pump inhibitors (PPIs) are benzimidazole-derivative chiral sulfoxides, frequently used in the treatment of gastric hyperacidity-related disorders. Due to their stereoselective metabolism, the eutomeric forms of PPIs can present a more advantageous pharmacokinetic profile by comparison with the distomers or racemates. Moreover, two representatives of the class are used in therapy both as racemates and as pure enantiomers (esomeprazole, dexlansoprazole). A relatively large number of enantioseparation methods employed for the stereoselective determination of PPIs from pharmaceutical, biological, and environmental matrices were published in the past three decades. The purpose of the current overview is to provide a systematic survey of the available chiral separation methods published since the introduction of PPIs in the therapy up to the present. Analytical and bioanalytical methods using different chromatographic and electromigration techniques reported for the enantioseparation of omeprazole, lansoprazole, pantoprazole, rabeprazole, ilaprazole, and tenatoprazole are included. The analytical conditions of the presented methods are summarized in three comprehensive tables, while a critical discussion of the applied techniques, possible mechanism of enantiorecognition, and future perspectives on the topic are also presented.

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Physiologically‐based pharmacokinetic modeling of pantoprazole to evaluate the role of CYP2C19 genetic variation and obesity in the pediatric population

Thompson,

Jeong,

Helfer

et al. 2024

CPT Pharmacom & Syst Pharma

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Pantoprazole is a proton pump inhibitor indicated for the treatment of gastroesophageal reflux disease, a condition that disproportionately affects children with obesity. Appropriately dosing pantoprazole in children with obesity requires understanding the body size metric that best guides dosing, but pharmacokinetic (PK) trials using traditional techniques are limited by the need for larger sample sizes and frequent blood sampling. Physiologically‐based PK (PBPK) models are an attractive alternative that can account for physiologic‐, genetic‐, and drug‐specific changes without the need for extensive clinical trial data. In this study, we explored the effect of obesity on pantoprazole PK and evaluated label‐suggested dosing in this population. An adult PBPK model for pantoprazole was developed using data from the literature and accounting for genetic variation in CYP2C19. The adult PBPK model was scaled to children without obesity using age‐associated changes in anatomical and physiological parameters. Lastly, the pediatric PBPK model was expanded to children with obesity. Three pantoprazole dosing strategies were evaluated: 1 mg/kg total body weight, 1.2 mg/kg lean body weight, and US Food and Drug Administration‐recommended weight‐tiered dosing. Simulated concentration–time profiles from our model were compared with data from a prospective cohort study (PAN01; NCT02186652). Weight‐tiered dosing resulted in the most (>90%) children with pantoprazole exposures in the reference range, regardless of obesity status or CYP2C19 phenotype, confirming results from previously published population PK models. PBPK models may allow for the efficient study of physiologic and developmental effects of obesity on PK in special populations where clinical trial data may be limited.

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Safety, pharmacokinetics, and pharmacodynamics of S-(−)-pantoprazole sodium injections after single and multiple intravenous doses in healthy Chinese subjects

Cited by 3 publications

References 19 publications

Pantoprazole‑induced acute kidney injury: A case report

Pantoprazole‑induced acute kidney injury: A case report

Chiral separation in the class of proton pump inhibitors by chromatographic and electromigration techniques: An overview

Physiologically‐based pharmacokinetic modeling of pantoprazole to evaluate the role of CYP2C19 genetic variation and obesity in the pediatric population

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