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Protonix (Pantoprazole Sodium) - 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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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.

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Clinical Trials Related to Protonix (Pantoprazole)

Effect of Digene Total Buffered Pantoprazole)on 24 Hour Gastric pH in Patients Suffering From Acid Peptic Disorder After Single and Repeated Dosing [Not yet recruiting]

Effect of Pantoprazole on the Symptoms of Acid Reflux Disease in Adult Patients (BY1023/M3-341) [Active, not recruiting]
The aim of the present study is to identify factors (such as symptom patterns and symptom scores) that influence the response to treatment with pantoprazole using different evaluation methods (e. g. ReQuest™ questionnaire, patient and investigator assessment). Pantoprazole will be administered once daily in the morning at one dose level. The study duration consists of a treatment period of 8 weeks. The study will provide further data on safety and tolerability of pantoprazole.

Efficacy of Pantoprazole in Patients Older Than 18 Years Who Have Symptoms of Non-Erosive Reflux or Gastroesophageal Reflux Disease (BY1023/DE-004) [Completed]
The aim of the study is to evaluate the effect of pantoprazole on fast symptom reduction in hospitalized patients with NERD (non-erosive reflux disease) or GERD (gastroesophageal reflux disease, Los Angeles [LA] Grade A-D). During the study, the patients will complete a patient-orientated, self-assessed reflux questionnaire (ReQuest™). The study duration consists of a treatment period of 7 days ± 3 days. Pantoprazole (tablet) will be administered once daily in the morning to patients with NERD or GERD at one dose level for each indication. The study will provide further data on the safety and tolerability of pantoprazole.

Intravenous (IV) Pantoprazole for Gastroesophageal Reflux Disease (GERD) in Neonates and Infants [Recruiting]
The purpose of this study is to determine how the body uses and eliminates pantoprazole, a drug used to treat GERD. This is a pharmacokinetic (PK) study. PK is a measure of how much drug is in the blood and how long it takes to leave the body. It is hypothesized that younger infants will need a lower dose than older children to achieve the same PK measurement.

The results of this study will be used to determine the best dose of the drug to use in each age group. Pantoprazole is a drug used to decrease acid production. The use of pantoprazole has not been approved for use in children. Pantoprazole is approved for use of acid-related and stomach disorders in adults.

Study Evaluating Pantoprazole With Doxorubicin for Advanced Cancer Patients With Extension Cohort of Patients With Solid Tumours [Recruiting]
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.

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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 >>


Based 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

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.


Protonix review by 29 year old male patient

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.


Protonix review by 66 year old female patient

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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