PROTONIX SUMMARY
The active ingredient in PROTONIX® (pantoprazole sodium) Delayed-Release Tablets is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1
H
-benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F2N3NaO4S x 1.
PROTONIX® (pantoprazole sodium) Delayed-Release Tablets are indicated for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis. For those patients who have not healed after 8 weeks of treatment, an additional 8 week course of PROTONIX may be considered.
PROTONIX Delayed-Release Tablets are indicated for maintenance of healing of erosive esophagitis and reduction in relapse rates of daytime and nighttime heartburn symptoms in patients with gastroesophageal reflux disease (GERD). Controlled studies did not extend beyond 12 months.
PROTONIX Delayed-Release Tablets are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.
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NEWS HIGHLIGHTS
Published Studies Related to Protonix (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 (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
Reports of Suspected Protonix (Pantoprazole) Side Effects
Malaise (104),
Drug Ineffective (92),
Cerebrovascular Accident (70),
Nausea (54),
Gastrooesophageal Reflux Disease (53),
Pain (45),
Myocardial Infarction (43),
Gastric Disorder (40),
Hypertension (40),
Death (39), more >>
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 19 ratings/reviews, Protonix has an overall score of 8.21. The effectiveness score is 8.42 and the side effect score is 9.16. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
| | Protonix review by 52 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | Mild Side Effects | | |
Treatment Info |
| Condition / reason: | | GERD |
| Dosage & duration: | | 40mg taken once a day for the period of 3 months |
| Other conditions: | | hypertension, ulcer |
| Other drugs taken: | | Diovan HCT, Altace | | |
Reported Results |
| Benefits: | | Within two days, the severe burning pain of the GERD disappeared. At three months of treatment, the pain from the ulcer has receded considerably. Because of the ulcer, however, I still have to be careful not to eat anything too acidic--very fresh pasta sauce with chunks of tomato--or too spicy. |
| Side effects: | | Shortly after starting treatment, I developed diarrhea. It only lasted for a few days, but then I continue to have somewhat pasty stools, with occasional bouts of diarrhea again. |
| Comments: | | I went to the ER with severe burning in the chest. The doctors there suspected either cardiac problems or a blood clot in the lungs. Once they made certain there were no blood clots, and that the EKG and cardiac enzyme levels were normal, they started me on IV protonix. The next day I was switched to pill form of the protonix, and the improvement was amazing. Within thirty-six hours the pain was minimal, and by the third day of treatment, it was virtually gone. Since then, I haven't had any recurrence, and remain on the protonix only because of the ulcer, which is improving, even though at a slower pace. Overall, it's an excellent medication, and had worked wonders for me. |
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| | Protonix review by 29 year old male patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Considerably Effective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | Functional Dyspepsia |
| Dosage & duration: | | 40mg, once daily. taken once per day for the period of Four months, so far |
| Other conditions: | | IBS |
| Other drugs taken: | | Domperidone (for nausea/bloating) | | |
Reported Results |
| Benefits: | | I have/had an extremely easy to irritate stomach, over-sensitive to acid and food consumption. I spent most days feeling unbelievably bloated, even after only a few bites of food, sometimes. Protonix was prescribed to me in combination with Domperidone to reduce bloating, belching, and an acid-burning sensation in the stomach. |
| Side effects: | | None, really, that I can specifically blame on this drug. I had actually reacted fairly badly to other, similar drugs. The famous "purple pill" Nexium had actually given me a brutal headache, sore-throat, and even a racing heart-beat at times. I was somewhat anxious about taking another very similar medication, but Pantoprazole did not bother me at all (I have since read that Pantoprazole is one of the acid-reducers least likely to cause side-effects). |
| Comments: | | Treatment has been ongoing for several months and is set to continue. While still not quite "normal", I am feeling much better after several months of this therapy and will be discussing reducing my dosage and/or going off the drug completely in the next month or two. |
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| | Protonix review by 66 year old female patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Ineffective |
| Side effects: | | Extremely Severe Side Effects | | |
Treatment Info |
| Condition / reason: | | gastrointestinal disorder |
| Dosage & duration: | | dont remember (dosage frequency: once daily) for the period of on 2 occasions |
| Other conditions: | | high blood presure |
| Other drugs taken: | | hytrin premerin | | |
Reported Results |
| Benefits: | | none |
| Side effects: | | On the first occasion I took this drug, I experienced mild tingling and redness of my hands and feet and face. I became somewhat week and faint like . I did not, at the time tie these reactions to the medecation. When I took it on a seperate occasion I experienced extreme tingling, redness and diarea and had to be transported to the hospital where they treated me for toxic shock. passed out |
| Comments: | | Benadril, allegra and other intravenious medication I am not sure of. |
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Page last updated: 2014-11-30
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