SUMMARY
The active ingredient in PROTONIX I. V. (intravenous pantoprazole sodium) for Injection is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1 H -benzimidazole, a compound that inhibits gastric acid secretion.
Gastroesophageal Reflux Disease Associated with a History of Erosive Esophagitis
PROTONIX I.V. for Injection is indicated for short-term treatment (7 to 10 days) of adult patients with gastroesophageal reflux disease (GERD) and a history of erosive esophagitis.
Safety and efficacy of PROTONIX I.V. for Injection as a treatment of patients with GERD and a history of erosive esophagitis for more than 10 days have not been demonstrated.
Pathological Hypersecretion Including Zollinger-Ellison Syndrome
PROTONIX I.V. for Injection is indicated for the treatment of pathological hypersecretory conditions including Zollinger-Ellison Syndrome in adults.
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NEWS HIGHLIGHTS
Published Studies Related to Protonix Injection (Pantoprazole)
Randomised clinical trial: daily pantoprazole magnesium 40 mg vs. esomeprazole
40 mg for gastro-oesophageal reflux disease, assessed by endoscopy and symptoms. [2014]
AIM: To compare the efficacy of pantoprazole-Mg and esomeprazole in GERD... CONCLUSIONS: Pantoprazole-Mg 40 mg was at least as effective as esomeprazole
Efficacy of S-pantoprazole 20 mg compared with pantoprazole 40 mg in the
treatment of reflux esophagitis: a randomized, double-blind comparative trial. [2012]
esophagitis... CONCLUSION: The efficacy and safety of 20 mg S-pantoprazole were comparable to
Effect of gastric acid suppression with pantoprazole on the efficacy of sevelamer
hydrochloride as a phosphate binder in haemodialysis patients: a pilot study. [2012]
Sevelamer hydrochloride (HCL) is thought to require an appropriately acidic
environment in order to bind gastrointestinal phosphate. Changes in gastric
acidity with acid suppressants may therefore alter the efficacy of sevelamer HCL... Although our study did not find a significant drug
interaction, given the high prevalence of acid suppressant use in dialysis
patients, physicians should be aware of the potential influence of acid
suppression on the efficacy of phosphate binders and regularly assess the
clinical need for acid suppression therapy.
Randomized, open-label, multicentre pharmacokinetic studies of two dose levels of pantoprazole granules in infants and children aged 1 month through <6 years with gastro-oesophageal reflux disease. [2011.08.01]
BACKGROUND AND OBJECTIVE: The primary objective of this study was to characterize the pharmacokinetic profile of pantoprazole delayed-release granules in infants and children aged 1 month to <6 years with gastro-oesophageal reflux disease (GORD). The studies described in this manuscript were conducted to fulfil the requirements of the paediatric written request for pantoprazole by the US FDA... CONCLUSIONS: Exposure increased with increasing doses of pantoprazole granules, even though wide interindividual variability was observed. Compared with that in adults receiving pantoprazole 40 mg, exposure obtained with the 1.2 mg/kg dose was similar in study 1 and slightly lower in study 2. Pantoprazole was generally well tolerated in infants and children aged 1 month through <6 years with GORD. Trial registration numbers (ClinicalTrials.gov): NCT00259012 (study 1) and NCT00141817 (study 2).
Pharmacodynamic evaluation of pantoprazole therapy on clopidogrel effects: results of a prospective, randomized, crossover study. [2011.06]
CONCLUSIONS: Pantoprazole therapy used at high doses is not associated with modulation of the pharmacodynamic effects of clopidogrel, irrespective of timing of drug administration. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01170533.
Clinical Trials Related to Protonix Injection (Pantoprazole)
Intravenous (IV) Pantoprazole in Erosive Esophagitis [Completed]
The aim of this study is to examine whether pantoprazole (Protonix) given through continuous
intravenous infusion for 72 hours is superior to Protonix given through once a day IV
injection in the treatment of erosive esophagitis.
Pharmacokinetics of Pantoprazole and CYP2C19 Activity in Children and Adolescents With GERD: A Pilot Study [Recruiting]
The World Health Organization has declared childhood obesity to be "one of the most serious
public health challenges of the 21st century,"
(http://www. who. int/dietphysicalactivity/childhood). Given that obese children are generally
excluded from clinical trials, little to no information exists regarding the impact of
obesity on drug disposition and drug action, creating a gap in physicians' knowledge on how
to appropriately select the dose of many critical medications (e. g., anticancer agents), so
as to prevent toxicity associated with overdosing, while avoiding the harms of
under-treatment. The proposed study will examine the effect of obesity on the metabolism of
a commonly used medication, the proton pump inhibitor pantoprazole, by exploring the
relationships between age, obesity, basal metabolic rate and genetic control of the enzyme
primarily responsible for pantoprazole metabolism. We will also validate a simple breath
test that can be used to predict pantoprazole dose requirement for obese children.
The study is designed to test the following experimental hypotheses:[13C]-pantoprazole
pharmacokinetic parameters are not different between non-obese and obese children and
adolescents, collectively (both age groups combined) or stratified by age group (SA 1)
[13C]-pantoprazole pharmacokinetic parameters or DOB values (and thus, CYP2C19 activity) are
not different between males and females (SA 1 & 2) [13C]-pantoprazole pharmacokinetic
parameters and DOB (Delta over baseline) values (and thus, CYP2C19 activity) are independent
of age over the age range of 6 to 17 years (SA 1 & 2) Obesity does not alter the relative
contributions of CYP2C19-dependent and non-CYP2C19-dependent (i. e., CYP3A4) metabolism of
pantoprazole, as measured by the urinary ratio of 4-hydroxy-pantoprazole to pantoprazole
sulfone (SA 1 & 2) The [13C]-pantoprazole breath test, by determining DOB at discrete time
point(s), is a non-invasive measure of CYP2C19 phenotype (SA 2) Clearance of pantoprazole
(surrogate for CYP2C19 activity) is a function of REE in obese and non-obese children and
adolescents (SA 3) Pantoprazole clearance (surrogate for CYP2C19 activity) is associated
with fat distribution, as determined by waist-to-hip ratios (SA 3)
Bioequivalence Study of Pantoprazole 40 mg DR Tablets and Protonix 40 mg Tablets [Completed]
The objective of this study was to determine the single-dose bioequivalence of the test
product, a potential generic 40 mg pantoprazole delayed-release tablet formulation, compared
with the reference product, a pantoprazole 40 mg delayed-release tablet formulation
(Protonix, Wyeth Pharmaceuticals), following a single dose in the fasted state.
Pantoprazole With Doxorubicin for Advanced Cancer Patients With Extension Cohort of Patients With Solid Tumours [Completed]
This is a single-centre, open label, dose finding, phase I study to determine the
recommended phase II dose (RP2D) for the combination of doxorubicin and pantoprazole in
patients with advanced tumours and no standard treatment options. A minimum of 3 patients
will be enrolled per dose level and intra-patient dose escalation is not permitted. Once the
RP2D has been identified, six additional patients with metastatic solid tumours will be
treated at the RP2D to confirm its tolerability.
Study of the Effects of Pantoprazole on Levels of Prescribed Psychiatric Medications [Enrolling by invitation]
The purpose of this 9-day study is to determine if:
1. Pantoprazole modifies the steady-state plasma concentrations of orally administered
psychotropic medications including valproic acid, lithium, and second-generation
antipsychotics (i. e., aripiprazole, asenapine, clozapine, lurasidone, olanzapine,
paliperidone, quetiapine, risperidone, ziprasidone)
2. Serum gastrin levels change within a week of starting or stopping pantoprazole
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Page last updated: 2014-11-30
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