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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PROTONIX NEWS HIGHLIGHTS
Published Studies Related to Protonix (Pantoprazole)
Clinical trial: intravenous pantoprazole vs. ranitidine for the prevention of peptic ulcer rebleeding: a multicentre, multinational, randomized trial. [2009.03.01]
BACKGROUND: Controlled pantoprazole [generic for Protonix] data in peptic ulcer bleeding are few. AIM: To compare intravenous (IV) pantoprazole with IV ranitidine for bleeding ulcers... CONCLUSIONS: Outcomes amongst pantoprazole and ranitidine-treated patients were similar; pantoprazole provided benefits in patients with arterial spurting and gastric ulcers.
Single-dose pharmacokinetics of oral and intravenous pantoprazole in children and adolescents. [2008.11]
The primary objective was to determine the pharmacokinetics of single oral and intravenous doses of pantoprazole [generic for Protonix] in children 2 to 16 years of age. The secondary objective was to assess the safety and tolerability of these doses... The doses used here were safe and well tolerated in this population.
Randomized placebo-controlled trial of pantoprazole for daytime sleepiness in GERD and obstructive sleep disordered breathing. [2008.08]
OBJECTIVE: To determine the efficacy of pantoprazole [generic for Protonix] therapy for daytime somnolence, psychomotor vigilance, and quality of life in patients with mild-moderate obstructive sleep disordered breathing (OSDB) and gastroesophageal reflux disease (GERD). STUDY DESIGN: Randomized, double-blind, placebo-controlled crossover trial... CONCLUSION: Patients with coexistent GERD and OSDB noted significant improvement in daytime sleepiness after treatment with pantoprazole over placebo likely related to a reduction in nocturnal reflux-related arousals.
A pilot study of efficacy and safety of continuous intravenous infusion of pantoprazole in the treatment of severe erosive esophagitis. [2008.06]
BACKGROUND AND OBJECTIVES: Reflux esophagitis is a common disease. Erosive reflux esophagitis is a more advanced stage of reflux esophagitis. Although death from reflux disease is uncommon, significant morbidity and mortality from complications, such as esophageal ulcer, stricture, and cancer, are not uncommon. Proton pump inhibitors are the popular medication for reflux esophagitis. The objective of this study was to determine the efficacy and safety of continuous intravenous infusion of pantoprazole [generic for Protonix] in the treatment of severe erosive esophagitis... CONCLUSIONS: Severe erosive esophagitis can be completely healed in a few days if pantoprazole is given intravenously and continuously for 72 h. It is safe to give pantoprazole intravenously and continuously for treatment of severe erosive esophagitis.
Intermittent intravenous pantoprazole and continuous cimetidine infusion: effect on gastric pH control in critically ill patients at risk of developing stress-related mucosal disease. [2008.05]
BACKGROUND: This study aimed to assess intermittent intravenous (IV) pantoprazole [generic for Protonix] for control of gastric acid and the possible prevention of upper gastrointestinal (UGI) bleeding in intensive care units (ICU) patients... CONCLUSIONS: This pilot study indicates that intermittent IV pantoprazole effectively controls gastric pH and may protect against UGI bleeding in high risk ICU patients without the development of tolerance.
Clinical Trials Related to Protonix (Pantoprazole)
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.
Long-Term Pantoprazole Trial in Patients With Symptoms of Chronic Acid Peptic Complaints (BY1023/VMG-708) [Active, not recruiting]
Gastroesophageal reflux disease (GERD) is a medical condition affecting the stomach and
esophagus. GERD might occur when the lower esophageal sphincter does not close properly and
stomach contents leaks back (refluxes) into the esophagus. GERD is one of the most common
medical disorders, with estimates of up to 50% of adults reporting reflux symptoms. One of
the main symptoms of GERD is heartburn. It occurs when the acidic content from the stomach
touches the lining of the esophagus, causing a burning sensation in the chest or throat.
Proton pump inhibitors such as pantoprazole can relieve symptoms of GERD and peptic ulcers in
a large proportion of patients.
Additionally, long-term treatment with proton pump inhibitors may be needed for patients with
chronic ulcer disease not caused by H. pylori (H. pylori is a stomach-dwelling bacteria which
is often associated with ulcers in the stomach or duodenum).
The aim of the study is to evaluate the long-term effect of pantoprazole in patients with
chronic gastric acid-related complaints. The study duration consists of a 5-year treatment
period. Pantoprazole will be administered once daily. The study will provide further data on
long-term safety, tolerability, and efficacy of pantoprazole.
On-Demand Use of Pantoprazole: Determinants for Chronic Use of Acid Suppressive Medication [Active, not recruiting]
Efficacy of Pantoprazole in Patients Older Than 18 Years Who Have Symptoms of Acid Reflux (Gastroesophageal Reflux Disease) (BY1023/M3-339) [Completed]
Gastroesophageal reflux disease (GERD) is a medical condition affecting the stomach and
esophagus. GERD occurs when the lower esophageal sphincter does not close properly and
stomach contents leaks back (refluxes) into the esophagus. GERD is one of the most common
medical disorders, with estimates of up to 50% of adults reporting symptoms related to
gastric reflux. Proton pump inhibitors (PPI) such as pantoprazole can relieve symptoms of
GERD in a large proportion of patients.
When refluxed stomach acidic content touches the lining of the esophagus, it causes a burning
sensation in the chest or throat. This sensation is often referred to as heartburn. Some
patients have symptoms of GERD without visible destruction of the tissue surface (no visible
changes by endoscopic examination).
The aim of the study is to evaluate the effect of pantoprazole on the complete remission of
GERD. Complete remission is defined as endoscopically confirmed healing and symptom relief
after a maximum of 12-week treatment period. Pantoprazole will be administered once daily in
the morning. Endoscopy will be performed at the start of the study, and then as required
after 4, 8, or 12 weeks. The study will provide further data on safety and tolerability of
pantoprazole.
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PROTONIX PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 11 ratings/reviews, Protonix has an overall score of 7.82. The effectiveness score is 8 and the side effect score is 8.73. 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 33 year old male patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | Acid Reflux |
| Dosage & duration: | | 20mg taken once/day for the period of 3yrs |
| Other conditions: | | High Blood Pressure, Sleep Apnea, Bronchial Asthma |
| Other drugs taken: | | Lisinopril | | |
Reported Results |
| Benefits: | | It has totally neutralized the effects of my reflux. |
| Side effects: | | No side effects encountered. |
| Comments: | | I started getting reflux after I had gall bladder surgery when I was 24. I had tried just about every reflux drug out there, but they either didn't work or had unacceptable side effects. When I first tried Protonix I couldn't believe how normal I felt within a couple days. It works so well for me, I forget I have reflux sometimes. I haven't noticed any issues with foods or coffee since taking it. |
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| | Protonix review by 70 year old male patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | acid reflux |
| Dosage & duration: | | 20 mg taken once a day for the period of 3 years |
| Other conditions: | | arthritis,shortness of breath |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | Effective in helping to control acid reflux |
| Side effects: | | none that i know of at the present time. But i do not know what damage it has done if any to any of my internal organs. |
| Comments: | | One tablet once a day |
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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: 2009-02-08
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