What should I tell my doctor about Protonix?
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Especially tell your doctor if you take methotrexate (Otrexup, Rasuvo, Trexall, XATMEP), digoxin (LANOXIN), or a water pill ( diuretic ). How should I take PROTONIX?
Are Protonix delayed-release tablets used in clinical trials?
PROTONIX Delayed-Release Tablets were used in the following clinical trials. A US multicenter, double-blind, placebo-controlled study of PROTONIX 10 mg, 20 mg, or 40 mg once daily was conducted in 603 patients with reflux symptoms and endoscopically diagnosed EE of grade 2 or above (Hetzel-Dent scale).
What are the guidelines for the treatment of Protonix?
Avoid administration of PPIs for longer than medically indicated. If signs or symptoms consistent with CLE or SLE are noted in patients receiving PROTONIX, discontinue the drug and refer the patient to the appropriate specialist for evaluation. Most patients improve with discontinuation of the PPI alone in 4 to 12 weeks.
What is Protonix used for?
PROTONIX is indicated in adults and pediatric patients five years of age and older for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis (EE).
What do you monitor on pantoprazole?
Check with your doctor immediately if you or your child has stomach cramps, bloated feeling, watery and severe diarrhea which may also be bloody sometimes, fever, nausea or vomiting, or unusual tiredness or weakness. Pantoprazole may increase your risk of having fractures of the hip, wrist, and spine.
What labs do you monitor with Protonix?
Increased INR and prothrombin time in patients receiving PPIs, including pantoprazole, and warfarin concomitantly. Increases in INR and prothrombin time may lead to abnormal bleeding and even death. Intervention: Monitor INR and prothrombin time.
What should I monitor before giving Protonix?
Monitor improvements in GI symptoms (gastritis, heartburn, and so forth) to help determine if drug therapy is successful. Monitor signs of hyperglycemia (drowsiness, fruity breath, increased urination, unusual thirst).
What should a nurse assess before giving Protonix?
Assess respiratory status, including respiratory rate and rhythm; note evidence of cough, hoarseness, and epistaxis, to monitor for potential adverse effects of the drugs.
Does pantoprazole affect blood work?
Proton pump inhibitors (PPIs), for example, omeprazole, lansoprazole, dexlansoprazole, rabeprazole, pantoprazole, and esomeprazole, can cause negatives laboratory test results in your urea breath test and the stool antigen test.
Can pantoprazole cause positive ANA?
Most patients improve with discontinuation of the PPI alone in 4 to 12 weeks. Serological testing (e.g., ANA) may be positive and elevated serological test results may take longer to resolve than clinical manifestations.
What is the most common side effect of Protonix?
The following are the most commonly reported Protonix side effects: Nausea or vomiting. Diarrhea or constipation. Stomach pain.
What are the side effects of taking Protonix?
Common Protonix Side EffectsHeadache.Diarrhea.Nausea.Stomach pain.Vomiting.Gas.Dizziness.Joint pain.
What are the most common side effects of pantoprazole?
Side EffectsBlurred vision.flushed, dry skin.fruit-like breath odor.increased hunger.increased thirst.increased urination.stomach pain.trouble breathing.More items...•
Which health complication will the nurse expect in a patient who is on proton pump inhibitor PPI therapy for a prolonged time?
Since 2010, the FDA has issued various safety warnings regarding the potential effects of long-term use of PPIs: risk of fractures, hypomagnesemia, Clostridium difficile–associated diarrhea, vitamin B12 deficiency, acute interstitial nephritis (AIN), and cutaneous and systemic lupus erythematosus events.
What should I assess after omeprazole?
Examination and Evaluation Monitor other CNS side effects (drowsiness, fatigue, weakness, headache), and report severe or prolonged effects. Monitor any chest pain and attempt to determine if pain is drug induced or caused by cardiovascular dysfunction (e.g., angina that occurs during exercise).
What are the contraindications of pantoprazole?
Who should not take PANTOPRAZOLE SODIUM?diarrhea from an infection with Clostridium difficile bacteria.inadequate vitamin B12.low amount of magnesium in the blood.a type of kidney inflammation called interstitial nephritis.subacute cutaneous lupus erythematosus.systemic lupus erythematosus, an autoimmune disease.More items...
What are the side effects of Protonix?
Common Protonix Side EffectsHeadache.Diarrhea.Nausea.Stomach pain.Vomiting.Gas.Dizziness.Joint pain.
What are the side effects of pantoprazole?
Side EffectsBlurred vision.flushed, dry skin.fruit-like breath odor.increased hunger.increased thirst.increased urination.stomach pain.trouble breathing.More items...•
Does pantoprazole have a black box warning?
There are currently no black box warnings in the label of any PPI. This petition outlines the current state of evidence of the risks involved with short- and long-term use of PPIs and asks that the FDA make prescribers and consumers aware of these risks through the following labeling changes.
What are the contraindications of pantoprazole?
Who should not take PANTOPRAZOLE SODIUM?diarrhea from an infection with Clostridium difficile bacteria.inadequate vitamin B12.low amount of magnesium in the blood.a type of kidney inflammation called interstitial nephritis.subacute cutaneous lupus erythematosus.systemic lupus erythematosus, an autoimmune disease.More items...
How long does Protonix last?
PROTONIX is indicated in adults and pediatric patients five years of age and older for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis (EE).
How long does it take to swallow Protonix?
Sprinkle all of the granules in the packet on 1 teaspoon of applesauce. Swallow the granules and applesauce within 10 minutes of putting the granules on the teaspoon of applesauce. Take sips of water to make sure the granules are washed down into the stomach.
How long does it take for pantoprazole to increase ECL?
In 39 patients treated with oral pantoprazole 40 mg to 240 mg daily (majority receiving 40 mg to 80 mg) for up to 5 years, there was a moderate increase in ECL-cell density, starting after the first year of use, which appeared to plateau after 4 years.
How long after pantoprazole can you detect milk?
Pantoprazole was detectable in milk only 2 and 4 hours after the dose with milk levels of approximately 36 mcg/L and 24 mcg/L, respectively. A milk-to-plasma ratio of 0.022 was observed at 2 hours after drug administration. Pantoprazole was not detectable (<10 mcg/L) in milk at 6, 8 and 24 hours after the dose. The relative dose to the infant was estimated to be 7.3 mcg of pantoprazole, which is equivalent to 0.14% of the weight-adjusted maternal dose. No adverse events in the infant were reported by the mother.
Where is pantoprazole metabolized?
Pantoprazole is extensively metabolized in the liver through the cytochrome P450 (CYP) system. Pantoprazole metabolism is independent of the route of administration (intravenous or oral). The main metabolic pathway is demethylation, by CYP2C19, with subsequent sulfation; other metabolic pathways include oxidation by CYP3A4. There is no evidence that any of the pantoprazole metabolites have significant pharmacologic activity.
Does protonix cause gastric malignancy?
In adults, symptomatic response to therapy with PROTONIX does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing in adult patients who have a suboptimal response or an early symptomatic relapse after completing treatment with a PPI. In older patients, also consider an endoscopy.
Is Protonix contraindicated?
PROTONIX is contraindicated in patients with known hypersensitivity to any component of the formulation or any substituted benzimidazole. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute tubulointerstitial nephritis, and urticaria [see Warnings and Precautions (5.2), Adverse Reactions (6)].
What is the color of Protonix?
PROTONIX (pantoprazole sodium) Delayed-Release Tablets are supplied as yellow, oval biconvex delayed-release tablets imprinted with PROTONIX (brown ink) on one side containing 40 mg pantoprazole and are available as follows:
How long does Protonix last?
For those adult patients who have not healed after 8 weeks of treatment , an additional 8-week course of PROTONIX may be considered. Safety of treatment beyond 8 weeks in pediatric patients has not been established.
How long does it take for pantoprazole to be detected in milk?
Pantoprazole was detectable in milk only 2 and 4 hours after the dose with milk levels of approximately 36 mcg/L and 24 mcg/L, respectively. A milk-to-plasma ratio of 0.022 was observed at 2 hours after drug administration. Pantoprazole was not detectable (<10 mcg/L) in milk at 6, 8 and 24 hours after the dose.
What is the metabolite of pantoprazole?
Pantoprazole is metabolized mainly by CYP2C19 and to minor extents by CYPs 3A4, 2D6, and 2C9. In in vivo drug-drug interaction studies with CYP2C19 substrates (diazepam [also a CYP3A4 substrate] and phenytoin [also a CYP3A4 inducer] and clopidogrel), nifedipine, midazolam, and clarithromycin (CYP3A4 substrates), metoprolol (a CYP2D6 substrate), diclofenac, naproxen and piroxicam (CYP2C9 substrates), and theophylline (a CYP1A2 substrate) in healthy subjects, the pharmacokinetics of pantoprazole were not significantly altered.
What are the side effects of Protonix?
What are the possible side effects of Protonix? Protonix may cause serious side effects, including: severe stomach pain, diarrhea that is watery or has blood in it, sudden pain or difficulty moving your hip, wrist or back, bruising or swelling at the injection site, little or no urination, blood in the urine, swelling,
Does Protonix cause a rash?
Get medical help right away, if you have any of the symptoms listed above. The most common side effects of Protonix include: headache, dizziness,
How to report Prometrium side effects?
These are not all the possible side effects of Prometrium. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How does pantoprazole work?
Mechanism of Action: Pantoprazole is a substituted benzimidazole proton-pump inhibitor (PPI) that suppresses gastric acid secretion by inhibiting the gastric (H+,K+)-ATPase enzyme pump. Pantoprazole forms a covalent bond to two sites of the (H+,K+)-ATPase enzyme system at the secretory surface of the gastric parietal cell; this binding results in antisecretory effects that persists > 24 hours, which allows for once-daily dosing. A significant increase in gastric pH and decrease in basal acid output follow oral and IV administration of pantoprazole. Pantoprazole does not antagonize H2 or cholinergic receptors.
How long does it take to take 40 mg of pantoprazole?
40 mg PO once daily after the morning meal for 2 to 4 weeks. NOTE: The safe and effective use of pantoprazole for long-term maintenance therapy (e.g., more than 16 weeks) for duodenal ulcer disease has not been established.
How long does pantoprazole last?
20 mg PO once daily for up to 4 weeks. Per clinical practice guidelines, initiate empiric therapy based on a presumptive diagnosis of GERD in the setting of typical symptoms of heartburn and regurgitation. For patients with partial response to once daily therapy, consider pantoprazole 20 mg PO twice daily, or consider a one-time switch to a different PPI. Refer non-responders for further evaluation. Consider maintenance therapy for patients who continue to have symptoms after PPI discontinuation; the lowest effective dose, including on demand or intermittent therapy should be used with regular assessment of the need for continued PPI therapy. Alternatively, step-down maintenance therapy to an H2 blocker is acceptable.
Can pantoprazole be used in pregnancy?
There are no adequate and well-controlled studies of pantoprazole in pregnant women. Although data from published observational studies in humans failed to demonstrate an association of adverse pregnancy-related outcomes and pantoprazole use, methodological limitations of these observational studies cannot definitely establish or exclude any drug-associated risk during pregnancy. Animal reproductive studies have been conducted in rats and rabbits using doses up to 88 and 16 times, respectively, that of humans based on body surface area; there was no evidence of fetal harm. It is not known if pantoprazole crosses the human placenta, although another PPI with a similar molecular weight, omeprazole, is known to cross the human placenta. In one study, pregnancy outcomes were reported with exposure to omeprazole (n = 295), lansoprazole (n = 62), and pantoprazole (n = 53). Compared to non-exposed control groups, there was no difference in the rate of major malformations with the use of pantoprazole (RR 0.55, 95% CI 0.8 to 3.95). However, there is a possibility that the true risk of malformation was missed due to study design and/or sample size. In another study, there was no significant increase in major birth defects during analysis of first trimester exposure to pantoprazole in 549 live births. In addition, a meta-analysis that compared 1,530 pregnant women exposed to PPIs in at least the first trimester with 133,410 unexposed pregnant women showed no significant increases in risk for congenital malformations or spontaneous abortion with exposure to PPIs (for major malformations OR = 1.12 [95% CI 0.86 to 1.45] and for spontaneous abortions OR = 1.29 [95% CI 0.84 to 1.97]). Pantoprazole likely represents a low risk in pregnancy, but should be used during pregnancy only when clearly needed. In 2009, a population-based observational cohort study explored a possible link between gastric acid suppressive therapy (e.g., proton pump inhibitors) during pregnancy and a diagnosis of allergic disease or a prescription for asthma or allergy medications in the exposed child. Among the cohort (n = 585,716), 1% of children exposed to gastric acid suppressive drugs in pregnancy received a diagnosis of allergic diease. For developing allergy or asthma, an increased OR of 1.43 and 1.51, respectively, were observed regardless of drug used, time of exposure during pregnancy, and maternal history of disease. Proposed possible mechanisms for a link include: (1) exposure to increased amounts of allergens could cause sensitization to digestion-labile antigens in the fetus; (2) the maternal Th2 cytokine pattern could promote an allergy prone phenotype in the fetus; (3) maternal allergen specific immunoglobulin could cross the placenta and sensitize fetal immune cells to food and airborne allergens. Study limitations were present and confirmation of results are necessary before further conclusions can be drawn from this data. Risk versus benefit should be considered prior to use.
Can pantoprazole cause a false positive?
Gastric acid suppression may increase serum CgA. Increased CgA concentrations may cause false positive results in diagnostic investigations for neuroendocrine tumors. To prevent this interference, temporarily stop pantoprazole at least 14 days before assessing CgA concentrations and consider repeating the test if initial concentrations are high. If serial tests are performed, ensure the same commercial laboratory is used as reference ranges may vary. Reports have suggested use of proton pump inhibitors (PPIs) may cause false positive urine screening tests for THC. If a PPI-induced false positive urine screen is suspected, confirm the positive results using an alternative testing method. PPIs may also cause a hyper-response in gastrin secretion to the secretin stimulation test, falsely suggesting gastrinoma. Health care providers are advised to temporarily stop pantoprazole at least 14 days prior to performing a secretin stimulation test to allow gastrin concentrations to return to baseline. Preparations that combine PPIs with antimicrobials and bismuth are known to suppress H. pylori; thus, ingestion of these preparations within 4 weeks of performing diagnostic tests for H. pylori may lead to false negative results. At a minimum, instruct the patient to avoid the use of pantoprazole in the 1 to 2 weeks prior to the test and the use of antimicrobials and bismuth preparations in the 4 weeks prior to the test.
Is pantoprazole excreted in milk?
According to the manufacturer, pantoprazole and its metabolites are excreted in the milk of rats. Pantoprazole excretion in human milk has also been detected, but the clinical relevance of this finding is un known. Because of the potential for tumorigenicity and carcinogenicity found in animal studies, the manufacturer suggests that a decision should be made whether to discontinue nursing or pantoprazole, taking into account the benefit of the drug to the mother. In one study, a partially breast-feeding mother was 10 months postpartum and received a single 40 mg dose of oral pantoprazole. Although small quantities of the drug were present in breast milk at 2 and 4 hours after the dose (36 mcg/L and 24 mcg/L, respectively), the drug was undetectable in expressed milk 6, 8, and 24 hours after the dose. Using the above case, authors estimated that a fully breast fed infant would receive 0.14% of the maternal weight-adjusted dosage. Because of limited human data and the potential for serious adverse reactions from pantoprazole in the breast-fed infant (including suppression of gastric acid secretion), pantoprazole should be used with caution in breast-feeding women. Alternative therapies for consideration include antacids and H2 blockers.
Can pantoprazole cause vitamin B12 deficiency?
One large case-controlled study compared patients with and without an incident diagnosis of vitamin B12 deficiency. A correlation was demonstrated between vitamin B12 deficiency and gastric acid-suppression therapy of > 2 years duration [i.e., proton pump inhibitor (PPI), H2-receptor antagonist]. In addition, a dose-dependant relationship was evident, as larger daily PPI pill counts were more strongly associated with vitamin B12 deficiency. The possibility of cyanocobalamin deficiency should, therefore, be considered if clinical symptoms are observed.
What is Pfizer Rxpathways?
Pfizer RxPathways connects eligible patients to a range of assistance programs that offer insurance support, co-pay help, and medicines for free or at a savings. Patients and physicians can contact RxPathways at (866) 706-2400 or visit the website for more information on these programs www.pfizerrxpathways.com.
Can digoxin cause hypomagnesemia?
For patients expected to be on prolonged treatment or who take PPIs with medications such as digoxin or drugs that may cause hypomagnesemia (e.g., diuretics), health care professionals may consider monitoring magnesium levels prior to initiation of PPI treatment and periodically [see Adverse Reactions (6.2)].
Can PPI cause TIN?
Acute tubulointerstitial nephritis (TIN) has been observed in patients taking PPIs and may occur at any point during PPI therapy. Patients may present with varying signs and symptoms from symptomatic hypersensitivity reactions to non-specific symptoms of decreased renal function (e.g., malaise, nausea, anorexia). In reported case series, some patients were diagnosed on biopsy and in the absence of extra-renal manifestations (e.g., fever, rash or arthralgia). Discontinue PROTONIX and evaluate patients with suspected acute TIN [see Contraindications (4) ].
Does protonix cause gastric malignancy?
In adults, symptomatic response to therapy with PROTONIX does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing in adult patients who have a suboptimal response or an early symptomatic relapse after completing treatment with a PPI. In older patients, also consider an endoscopy.
Does PPI cause fundic gland polyps?
PPI use is associated with an increased risk of fundic gland polyps that increases with long-term use, especially beyond one year. Most PPI users who developed fundic gland polyps were asymptomatic and fundic gland polyps were identified incidentally on endoscopy.
Is pantoprazole carcinogenic?
Due to the chronic nature of GERD, there may be a potential for prolonged administration of PROTONIX. In long-term rodent studies, pantoprazole was carcinogenic and caused rare types of gastrointestinal tumors. The relevance of these findings to tumor development in humans is unknown [see Nonclinical Toxicology (13.1)].
Does Protonix cause diarrhea?
5.3 Clostridium difficile- Associated Diarrhea. Published observational studies suggest that PPI therapy like PROTONIX may be associated with an increased risk of Clostridium difficile associated diarrhea, especially in hospitalized patients.
What is Protonix?
Protonix has active ingredients of pantoprazole sodium. It is often used in gastroesophageal reflux disease. eHealthMe is studying from 121,179 Protonix users for its effectiveness, alternative drugs and more.
What is Laboratory test abnormal?
Laboratory test abnormal is found to be associated with 2,256 drugs and 1,288 conditions by eHealthMe.
How to use the study?
You can discuss the study with your doctor, to ensure that all drug risks and benefits are fully discussed and understood.
How the study uses the data?
The study uses data from the FDA. It is based on pantoprazole sodium (the active ingredients of Protonix) and Protonix (the brand name). Other drugs that have the same active ingredients (e.g. generic drugs) are not considered. Dosage of drugs is not considered in the study.
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With medical big data and proven AI algorithms, eHealthMe provides a platform for everyone to run phase IV clinical trials. We study millions of patients and 5,000 more each day. Results of our real-world drug study have been referenced on 600+ peer-reviewed medical publications, including The Lancet, Mayo Clinic Proceedings, and Nature.
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Proton Pump Inhibitors: Generic and Brand Names
Here is a table of the most commonly encountered proton pump inhibitor:
Disease spotlight: Gastroesophageal Reflux
Gastroesophageal reflux disease (GERD) occurs when stomach acid frequently flows back into the tube connecting the mouth and the stomach (esophagus).
What are Proton Pump Inhibitors?
Proton pump inhibitors suppress the secretion of hydrochloric acid into the lumen of the stomach.
Therapeutic actions
Blocks the final step of acid production, lowering the acid levels in the stomach.
Indication
Treatment and maintenance of erosive esophagitis, treatment of heartburn associated with GERD.
Pharmacokinetics
Esomeprazole, lansoprazole, and pantoprazole are available in delayed-release oral forms and as IV preparations; rabeprazole, dexlansoprazole, and omeprazole are available only in delayed-release oral forms.
Contraindications and Cautions
The following are contraindications and cautions when using proton pump inhibitors:
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What is Protonix used for?
Protonix is used to treat certain conditions in the stomach and esophagus, such as acid reflux, gastroesophageal reflux disease (GERD), and erosive esophagitis . Protonix is approved for use in adults and children over the age of 5 years. It is most often given orally as a pill, but there is also an oral liquid suspension form ...
How long can you use Protonix?
In pediatric patients (under the age of 18 years), there is no safety data on the use of Protonix for more than eight weeks. Erosive esophagitis is uncommon in children, so studying the safety of a proton pump inhibitor for longer periods of time in this age group is challenging.
What is the drug called that sups the production of acid in the stomach?
Side Effects. Warnings and Interactions. Protonix (generic name pantoprazole) is a type of drug that’s called a proton pump inhibitor. This drug works by lowering the production of acid in the stomach. Protonix is used to treat certain conditions in the stomach and esophagus, such as acid reflux, gastroesophageal reflux disease (GERD), ...
How long does Protonix last?
Protonix should be stored at 20 to 25 C (68 to 77 F). It may be stored for a brief period to a lower temperature of 15 C (59 F) or a high of 30 C (86 F). In the case of GERD, Protonix is only prescribed for eight weeks or less to start, so refills, for this reason, are not common.
Is Protonix a tablet?
However, the doctor that prescribes the drug will specify the dosage, while taking into account age, general health, and the condition for which Protonix is being prescribed. Protonix is a tablet that’s taken orally.
Does proton pump increase methotrexate?
Proton pump inhibitors such as Protonix may cause a serum increase of methotrexate. That means that for those who are taking higher doses of methotrexate, a proton pump inhibitor may increase the risk of methotrexate toxicity. 1 .
Can you take Protonix with HIV?
It’s not recommended that Protonix be taken with certain HIV medications. Protonix may lower the amount of antiretroviral medications, such as atazanavir and nelfinavir, in the body. This might result in HIV being less well controlled and it’s recommended that Protonix be avoided if these drugs are being taken.