Protonix uses and side effects. Protonix (Pantoprazole): Uses, Side Effects, Interactions, and Dosing Guide
What are the main uses of Protonix. How does Protonix work to treat acid-related conditions. What are the most common side effects of taking Protonix. How should Protonix be taken for maximum effectiveness. What drug and disease interactions are associated with Protonix.
Understanding Protonix: A Comprehensive Overview
Protonix, also known by its generic name pantoprazole, is a medication that belongs to a class of drugs called proton pump inhibitors (PPIs). It is primarily used to treat various acid-related conditions in the stomach and esophagus. As we delve deeper into this medication, we’ll explore its uses, mechanisms, side effects, and important considerations for patients and healthcare providers alike.
The Primary Uses of Protonix in Medical Treatment
Protonix is prescribed for several gastrointestinal conditions. Its main uses include:
- Treating gastroesophageal reflux disease (GERD)
- Healing erosive esophagitis
- Managing stomach ulcers
- Treating duodenal ulcers
- Addressing conditions related to excessive stomach acid production
- Managing Barrett’s esophagus
How does Protonix work to alleviate these conditions? It functions by reducing the amount of acid produced in the stomach. By inhibiting the proton pump in the stomach lining, Protonix effectively decreases acid secretion, allowing damaged tissues in the esophagus and stomach to heal and providing relief from acid-related symptoms.
Potential Side Effects and Safety Considerations
While Protonix is generally well-tolerated, it’s important to be aware of potential side effects. The most commonly reported side effects include:
- Headache
- Diarrhea
- Nausea
- Stomach pain
- Vomiting
- Gas
- Dizziness
- Joint pain
Is Protonix associated with any serious side effects? In rare cases, more severe side effects may occur, such as:
- Severe allergic reactions
- Kidney problems
- Low magnesium levels
- Increased risk of bone fractures with long-term use
- Increased risk of certain infections, including C. difficile
Patients should be vigilant and report any unusual or persistent side effects to their healthcare provider promptly.
Dosage and Administration Guidelines for Protonix
The appropriate dosage of Protonix can vary depending on the condition being treated and individual patient factors. Typically, the standard dose for adults is 40 mg once daily, though this may be adjusted based on the specific condition and severity.
Can Protonix be taken twice a day? In some cases, such as for certain severe conditions or under specific circumstances, a doctor may prescribe Protonix 40 mg twice daily. However, this should only be done under direct medical supervision and is not the standard dosing regimen.
How should Protonix be taken for maximum effectiveness? It’s generally recommended to take Protonix:
- At the same time each day
- With or without food
- Swallowed whole, not crushed or chewed
- For the full prescribed duration, even if symptoms improve
Patients should always follow their healthcare provider’s instructions regarding dosage and administration.
Drug Interactions and Precautions with Protonix
Protonix can interact with various medications, potentially altering their effectiveness or increasing the risk of side effects. According to the drug interaction checker, there are 163 known drug interactions with Protonix, categorized as follows:
- 16 major interactions
- 128 moderate interactions
- 19 minor interactions
What are some of the most significant drug interactions with Protonix? Some notable interactions include:
- Clopidogrel (Plavix)
- Methotrexate
- Warfarin
- Digoxin
- Certain HIV medications
Additionally, Protonix has 4 known disease interactions, including:
- C. difficile infection
- Liver disease
- Increased risk of bone fractures
- Hypomagnesemia (low magnesium levels)
It’s crucial for patients to inform their healthcare providers about all medications they’re taking, including over-the-counter drugs and supplements, to avoid potential interactions.
Long-Term Use of Protonix: Benefits and Risks
While Protonix can be highly effective in managing acid-related conditions, long-term use requires careful consideration. How long can one safely take Protonix? The duration of treatment depends on the condition being treated and individual patient factors. Some patients may require long-term therapy, while others may only need short-term treatment.
What are the potential risks associated with long-term use of Protonix? Extended use of proton pump inhibitors like Protonix has been associated with:
- Increased risk of certain infections
- Potential vitamin and mineral deficiencies (e.g., vitamin B12, magnesium)
- Slightly increased risk of bone fractures
- Potential increased risk of kidney problems
Patients on long-term Protonix therapy should have regular follow-ups with their healthcare provider to monitor for potential side effects and assess the ongoing need for treatment.
Patient Experiences and Satisfaction with Protonix
Understanding patient experiences can provide valuable insights into the real-world effectiveness of Protonix. According to reviews on Drugs.com, Protonix has an average rating of 7.1 out of 10 based on 78 reviews. This suggests a generally positive reception among users.
How do patients rate Protonix for different conditions? Here’s a breakdown of average ratings for specific conditions:
- GERD: 7.3/10 (based on 50 reviews)
- Stomach Ulcer: 7.2/10 (based on 9 reviews)
- Barrett’s Esophagus: 9.1/10 (based on 7 reviews)
- Erosive Esophagitis: 6.0/10 (based on 6 reviews)
- Duodenal Ulcer: 6.7/10 (based on 3 reviews)
- Peptic Ulcer: 3.7/10 (based on 3 reviews)
It’s important to note that individual experiences can vary, and these ratings should be considered alongside professional medical advice.
Comparing Protonix to Other Proton Pump Inhibitors
Protonix is one of several proton pump inhibitors available for treating acid-related conditions. How does it compare to other PPIs like omeprazole? While all PPIs work in a similar manner, there are some differences in their specific properties and uses:
- Onset of action: Pantoprazole (Protonix) may have a slightly faster onset of action compared to omeprazole.
- Duration of effect: Both medications have similar durations of effect.
- Dosing frequency: Both are typically taken once daily, though specific dosing may vary.
- Food interactions: Pantoprazole can be taken with or without food, while omeprazole is usually taken before meals.
- Drug interactions: While both have potential drug interactions, the specific interactions may differ.
The choice between Protonix and other PPIs often depends on individual patient factors, specific condition being treated, and potential drug interactions. Healthcare providers will consider these factors when prescribing the most appropriate medication.
Protonix in Special Populations
Certain populations may require special considerations when using Protonix:
- Pregnancy: Protonix is classified as FDA pregnancy category B, meaning it should be used during pregnancy only if clearly needed.
- Breastfeeding: Protonix is excreted in human milk. The decision to continue or discontinue breastfeeding during treatment should be made considering the importance of the drug to the mother.
- Elderly patients: No dosage adjustment is necessary based on age alone, but elderly patients may be more sensitive to the effects of the drug.
- Patients with liver disease: In patients with severe liver impairment, the maximum recommended dose is 20 mg daily.
Healthcare providers will take these factors into account when prescribing Protonix to ensure safe and effective treatment.
Managing Potential Side Effects of Protonix
While Protonix is generally well-tolerated, some patients may experience side effects. Here are some strategies for managing common side effects:
- Headache: Over-the-counter pain relievers may help. If persistent, consult your healthcare provider.
- Diarrhea: Stay hydrated and consider using probiotics. If severe or persistent, seek medical advice.
- Nausea: Taking the medication with food may help. If nausea is severe or persistent, consult your doctor.
- Stomach pain: This often improves as your body adjusts to the medication. If it persists or worsens, inform your healthcare provider.
Always report any unusual or severe side effects to your healthcare provider promptly.
Lifestyle Modifications to Complement Protonix Treatment
While Protonix can effectively reduce stomach acid, certain lifestyle changes can complement medical treatment and improve overall outcomes:
- Dietary changes: Avoid trigger foods that exacerbate acid reflux, such as spicy or fatty foods, citrus, and chocolate.
- Weight management: Maintaining a healthy weight can reduce pressure on the stomach and lower esophageal sphincter.
- Elevating the head of the bed: This can help prevent nighttime reflux symptoms.
- Quitting smoking: Smoking can worsen GERD symptoms and increase the risk of complications.
- Limiting alcohol and caffeine: Both can increase acid production and worsen symptoms.
- Eating smaller, more frequent meals: This can help reduce the workload on your digestive system.
Implementing these lifestyle changes alongside Protonix treatment can lead to better symptom control and improved quality of life for many patients.
The Future of Acid-Suppression Therapy
As research in gastroenterology continues to advance, new treatments and approaches for acid-related conditions are being explored. While proton pump inhibitors like Protonix remain a cornerstone of treatment, future developments may include:
- More targeted therapies with fewer systemic effects
- Personalized treatment approaches based on genetic factors
- Novel drug delivery systems for improved efficacy and reduced side effects
- Combination therapies that address multiple aspects of acid-related disorders
Ongoing research aims to improve our understanding of these conditions and develop more effective and safer treatments. Patients should stay informed about new developments and discuss potential new treatment options with their healthcare providers.
The Role of Protonix in Comprehensive Gastrointestinal Care
While Protonix is an effective medication for many acid-related conditions, it’s important to view it as part of a comprehensive approach to gastrointestinal health. This approach may include:
- Regular check-ups and endoscopic examinations when necessary
- Dietary and lifestyle counseling
- Management of related conditions, such as anxiety or sleep disorders that may exacerbate GI symptoms
- Consideration of alternative or complementary therapies when appropriate
- Patient education on self-management strategies
By taking a holistic approach to treatment, healthcare providers can help patients achieve optimal outcomes and improved quality of life.
Navigating Insurance Coverage and Cost Considerations for Protonix
Access to medication is an important aspect of treatment success. Patients should be aware of the following considerations regarding Protonix:
- Insurance coverage: Many insurance plans cover Protonix, but coverage can vary. Check with your insurance provider for specific details.
- Generic alternatives: Pantoprazole, the generic version of Protonix, is available and may be more cost-effective.
- Patient assistance programs: Some pharmaceutical companies offer programs to help patients access medications at reduced costs.
- Comparison shopping: Prices can vary between pharmacies, so it may be worth comparing prices.
Patients should discuss any concerns about medication costs with their healthcare provider, as there may be alternative options or strategies to manage expenses.
In conclusion, Protonix (pantoprazole) is a valuable medication in the treatment of various acid-related gastrointestinal conditions. Its effectiveness, coupled with a generally favorable side effect profile, makes it a popular choice among healthcare providers. However, as with any medication, it’s crucial for patients to be well-informed about its uses, potential side effects, and important considerations for safe and effective use. By working closely with healthcare providers and staying informed, patients can maximize the benefits of Protonix while minimizing potential risks.
Protonix Interactions Checker – Drugs.com
Save
There are 163 drugs known to interact with
Protonix (pantoprazole), along with
4 disease interactions.
Of the total drug interactions,
16 are major, 128 are moderate, and 19 are minor.
Does Protonix interact with my other drugs?
Enter other medications to view a detailed report.
- View all 163 medications that may interact with Protonix
- View Protonix disease interactions (4)
Most frequently checked interactions
View interaction reports for Protonix (pantoprazole) and the medicines listed below.
- Major
- Moderate
- Minor
- Unknown
- albuterol
- amlodipine
- aspirin
- atorvastatin
- Cymbalta (duloxetine)
- folic acid
- gabapentin
- Lasix (furosemide)
- levothyroxine
- Lexapro (escitalopram)
- Lipitor (atorvastatin)
- lisinopril
- losartan
- Lyrica (pregabalin)
- metformin
- metoprolol
- Plavix (clopidogrel)
- potassium chloride
- prednisone
- Singulair (montelukast)
- Synthroid (levothyroxine)
- tramadol
- trazodone
- Tylenol (acetaminophen)
- Vitamin B12 (cyanocobalamin)
- Vitamin D3 (cholecalciferol)
- Xanax (alprazolam)
- Zofran (ondansetron)
- Zoloft (sertraline)
- Zyrtec (cetirizine)
Protonix disease interactions
There are 4 disease interactions with Protonix (pantoprazole) which include:
- C. diff
- liver disease
- bone fractures
- hypomagnesemia
Report options
Loading…
QR code containing a link to this page
More about Protonix (pantoprazole)
- Protonix consumer information
- Compare alternatives
- Pricing & coupons
- Reviews (80)
- Drug images
- Side effects
- Dosage information
- Patient tips
- During pregnancy
- Generic availability
- Support group
- Drug class: proton pump inhibitors
- Breastfeeding
- En español
Related treatment guides
- Erosive Esophagitis
- Barrett’s Esophagus
- Duodenal Ulcer
- GERD
Drug Interaction Classification
Major | Highly clinically significant. Avoid combinations; the risk of the interaction outweighs the benefit. |
---|---|
Moderate | Moderately clinically significant. Usually avoid combinations; use it only under special circumstances. |
Minor | Minimally clinically significant. Minimize risk; assess risk and consider an alternative drug, take steps to circumvent the interaction risk and/or institute a monitoring plan. |
Unknown | No interaction information available. |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medical Disclaimer
Protonix Reviews & Ratings – Drugs.com
Save
Protonix
has an average rating of 7.1 out of 10 from a total of 78 reviews
on Drugs. com.
64% of reviewers reported a positive experience, while 23% reported a negative experience.
Condition | Avg. Rating | Reviews | Compare |
---|---|---|---|
GERD | 50 reviews for GERD | 227 medications | |
Stomach Ulcer | 9 reviews for Stomach Ulcer | 100 medications | |
Barrett’s Esophagus | 7 reviews for Barrett’s Esophagus | 13 medications | |
Erosive Esophagitis | 6 reviews for Erosive Esophagitis | 103 medications | |
Duodenal Ulcer | 3 reviews for Duodenal Ulcer | 131 medications | |
Peptic Ulcer | 3 reviews for Peptic Ulcer | 47 medications | |
Add your review |
Reviews for Protonix
Frequently asked questions
- Pantoprazole vs. omeprazole: What’s the difference between them?
- Can you take pantoprazole 40 mg twice a day?
- What are the risks associated with heartburn medications?
- How long can I take pantoprazole?
Are you taking this medicine?
- Add your review
- Learn more about Protonix
More FAQ
- Does pantoprazole cause bloating?
Reviews may be edited to correct grammar/spelling or to remove inappropriate language and content. Reviews that appear to be created by parties with a vested interest are not published. This information is not intended to endorse any particular medication. While these reviews may be helpful, they are not a substitute for the expertise, knowledge, and judgement of healthcare professionals.
More about Protonix (pantoprazole)
- Check interactions
- Compare alternatives
- Pricing & coupons
- Drug images
- Side effects
- Dosage information
- Patient tips
- During pregnancy
- Generic availability
- Support group
- Drug class: proton pump inhibitors
- Breastfeeding
- En español
Patient resources
- Drug Information
- Protonix oral/injection
- Protonix (Pantoprazole Intravenous) (Advanced Reading)
- Protonix (Pantoprazole Oral) (Advanced Reading)
- Protonix (Pantoprazole Delayed-Release Granules)
- Protonix (Pantoprazole Delayed-Release Tablets)
Professional resources
- Prescribing Information
Other formulations
- Protonix IV
Related treatment guides
- Erosive Esophagitis
- Barrett’s Esophagus
- Duodenal Ulcer
- GERD
Protonix Tablet English – Product
Protonix Tablet English – Product – TabletWise. com
About Us
- About Us
- Privacy Policy
- Instructions for Use
- Overview
- Benefits
- Side Effects
- Precautions
- Contraindications
900 06 Interaction
Overview
Protonix Tablet is used for Gastroesophageal reflux disease and other conditions.
Protonix Tablet contains Pantoprazole Sodium as an active ingredient. Available in tablet form.
Detailed information regarding the use, composition, dosage, side effects of Protonix Tablet / Protonix Tablet, as well as user reviews are provided below:
Uses
Protonix Tablet is used for the treatment, control, prevention, & improvement of the following diseases, conditions and symptoms: 4
Side-effects
The following is a list of possible side-effects that may occur from all constituents of Protonix Tablet. This list is not final. These side effects have been recorded previously, but are not always recorded when using the drug. Some of these side effects may be extremely rare, but have incredibly severe consequences. If you notice any side effects, contact your doctor immediately. Especially in the case of observing side effects for a long time.
- Constipation
- Headache
- Nausea
- Vomiting
- Gas
- Joint pain
- Constipation
90 003 If you experience side effects not listed above, contact your healthcare provider for advice. In addition, you can report side effects to your local Food and Drug Administration.
Precautions
Before starting this drug, tell your doctor about any medications you are taking, nutritional supplements (eg vitamins, natural supplements, etc.), allergies, existing medical conditions, and current health conditions (eg, pregnancy, upcoming surgery, etc. ). The side effects of the drug may be more pronounced depending on the condition of your body. Take this medicine as directed by your doctor, or follow the directions for use that come with your medicine. The dosage of the drug depends on your condition. Tell your doctor if there is no change or if your condition worsens. Important points to discuss with your healthcare provider are listed below.
- Breastfeeding
- Low blood magnesium
- Plan to get pregnant
- pregnant
Tablet / Protonix Tablet is subject to change. Tell your healthcare provider about all medications, vitamins, and supplements you use. Your doctor will be able to make the right plan for taking the drug, which will avoid negative interactions. Protonix Tablet may interact with the following drugs and products:
- Ampicillin
- Atazanavir
- Dexlansoprazole
- Digoxin
- Esomeprazole
- Ketoconazole
- Lansoprazole 90 008
- Methotrexate
- Nelfinavir
- Omeprazole
Hypersensitivity to Protonix Tablet is a contraindication. In addition, Protonix Tablet should not be used if you have the following conditions:
- Allergic reaction
Composition and active ingredients
Protonix Tablet is composed of the following active ingredients (salts)
- Pantoprazole Sodium attention to the fact that this drug is available with different strengths of intensity for each of the active ingredients listed above.
Packing Options and Strengths
Protonix Tablet is available in the following packages and strengths
Protonix Tablet packages available: EQ 40MG BASE, EQ 20MG BASE
FAQ
Is it safe to drive or operate heavy machinery while using this product?
If you experience drowsiness, dizziness, hypotension or a headache as side-effects when using Protonix Tablet medicine then it may not be safe to drive a vehicle or operate heavy machinery. You should stop driving if taking this medicine makes you drowsy, dizzy, or hypotensive. Doctors recommend that you stop drinking alcohol with such drugs, because. alcohol greatly increases the side effects and drowsiness. Please check for these effects on your body when using Protonix Tablet. Be sure to consult your doctor for advice based on the characteristics of your body and general health.
Is this drug (product) addictive or addictive?
Most drugs are not habit-forming or addictive. In most cases, the state classifies drugs that can be addictive as controlled dispensing drugs. For example, schedule H or X in India and schedule II-V in the USA. Please check the information on the drug packaging to make sure that this drug is not in the controlled category. Also, do not self-medicate or accustom your body to medications without consulting your doctor.
Can I stop using this product immediately or do I need to slowly stop using it?
Some medications need to be stopped gradually due to a rebound effect. Be sure to consult your healthcare provider for advice based on your body, general health, and other medications you may be taking.
Cite this page
Page URL
HTML Link
Protonix Tablet
APA Style Citation
- Protonix Tablet – Product – TabletWise.com. (n.d.). Retrieved May 03, 2023, from https://www.tabletwise.com/us-ru/protonix-tablet
MLA Style Citation
- “Protonix Tablet in English – Product – TabletWise.com” Tabletwise.com . N.p., n.d. Web. May 03 2023.
Chicago Style Citation
- “Protonix Tablet in English – Product – TabletWise.com” Tabletwise. Accessed May 03, 2023. https://www.tabletwise.com/us-ru/protonix-tablet.
More information about Protonix Tablet
- Uses of
- Reviews
- What are the uses of Protonix Tablet?
- What are the side effects of Protonix Tablet?
- What other medicines does Protonix Tablet interact with?
- When should you not use Protonix Tablet?
- What precautions should you take while using Protonix Tablet?
Last updated date
This page was updated on 9/28/2020.
This page provides information for Protonix Tablet Product in English .
Share with friends, get 20% off
Invite your friends to TabletWise learning marketplace. For each purchase they make, you get 20% off (upto $10) on your next purchase.
Protonix I.V. – instructions for use, dosage, composition, analogs, side effects / Pillintrip
WARNINGS
Included as part of PRECAUTIONS section.
PRECAUTIONS
Sequelae of symptomatic response
Symptomatic response to pantoprazole therapy does
does not exclude the presence of malignant neoplasms of the stomach.Hypersensitivity and severe skin reactions
Anaphylaxis and other serious reactions such as erythema
multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis (TEN) have
reported with the use of intravenous pantoprazole. It may require an emergency
treatment .Injection site reactions
Thrombophlebitis has been associated with administration
intravenous pantoprazole.Potential for worsening zinc deficiency
PROTONIX contains disodium edetate (salt form
EDTA), a chelator of metal ions, including zinc. Therefore, zinc supplements
should be considered in patients treated with PROTONIX I.V. for injection who
susceptible to zinc deficiency. Caution should be exercised when using other EDTA-containing
products are also administered intravenously.Clostridium Difficile associated diarrhea
Published observational studies show that PPI therapy
how PROTONIX may be associated with increased risk Clostridium
difficile associated diarrhea, especially in hospitalized patients. This
the diagnosis should be considered in diarrhea that does not improve.Patients should use the lowest dose and shortest duration
PPI therapy appropriate to the condition being treated.Broken bones
Several published observational studies suggest this
proton pump inhibitor (PPI) therapy may be associated with an increased risk
with fractures of the hip, wrist or spine associated with osteoporosis. Risk
the fracture was enlarged in patients treated with a high dose, defined as multiple
daily doses and long-term PPI therapy (a year or more). Patients should use
lowest dose and shortest duration of PPI therapy consistent with
the condition is being treated. Patients at risk of fractures associated with osteoporosis
should be administered in accordance with established treatment guidelines.Hepatic effects
Mild, transient increases in transaminases have been
observed in clinical studies. The clinical significance of this discovery in
the large population of subjects receiving intravenous pantoprazole is unknown. .Hypomagnesemia
Hypomagnesemia, symptomatic and asymptomatic, was
rarely reported in patients treated with PPIs for at least three months, and in
most cases after a year of therapy. Serious adverse events include tetany
arrhythmias and seizures. In most patients, treatment of hypomagnesaemia
necessary replacement of magnesium and discontinuation of PPIFor patients who are expected to be on long-term treatment or who
take PPIs with drugs such as digoxin or drugs that can cause
hypomagnesemia (eg. , diuretics), healthcare professionals may consider
monitoring magnesium levels prior to initiating PPI treatment, and
periodically.THC Urine Screen Interference
Can produce THC false positive urinalysis
(tetrahydrocannabinol).
Simultaneous use of protonix with methotrexate
Literature suggests that concomitant use of PPIs with
methotrexate (mainly at high doses;Preclinical toxicology
Carcinogenesis, mutagenesis, impaired fertility
In a 24-month Sprague-Dawley rat carcinogenicity study
treated orally with doses of 0.5 to 200 mg/kg/day, about 0.1 to 40 times
an effect on the body surface area of a 50 kg human administered a dose of 40 mg/day.
In the gastric fund, treatment is performed at a dose of 0.5 to 200 mg / kg / day
enterochromaffin-like (ECL) cell hyperplasia and benign and malignant
neuroendocrine cell tumors in a dose-dependent manner. In the forest stomach
treatment at a dose of 50 and 200 mg / kg / day (about 10 and 40 times the recommended person
dose based on body surface area) caused benign squamous papillomas and
malignant squamous cell carcinomas. Rare gastrointestinal tumors are associated
with pantoprazole treatment included duodenal adenocarcinoma at age 50
mg / kg / day and benign polyps and adenocarcinomas of the gastric fund in 200
mg/kg/day. The liver is treated at a dose of 0.5 to 200 mg/kg/day
dose escalation for hepatocellular adenomas and related doses
carcinomas. In the thyroid gland, treatment at a dose of 200 mg / kg / day increased
frequency of follicular cell adenomas and carcinomas in both men and women
rats.In a 24-month Fischer rat carcinogenicity study 344
treated orally with doses of 5 to 50 mg/kg/day, about 1 to 10
multiply the recommended human dose based on body surface area. in the stomach
Fundus, treated at a dose of 5 to 50 mg/kg/day, produces enterochromaffin-like (ECL)
cell hyperplasia; and benign and malignant neuroendocrine cell tumors. Dose
selection for this study may not have been sufficient for a comprehensive assessment
carcinogenic potential of pantoprazole.In a 24-month carcinogenicity study in B6C3F1 mice,
orally treated with doses of 5 to 150 mg/kg/day, 0. 5 to 15 times more
recommended human dose based on body surface area. In the liver treatment at 150
mg/kg/day caused an increase in the frequency of hepatocellular adenomas and
carcinomas in female mice. Treatment of 5 to 150 mg/kg/day is also done
hyperplasia of ECL cells of the stomach.26-week Carcinogenicity Study in Transgenic Mice
was not positive.Pantoprazole was positive in in vitro people
lymphocyte chromosomal aberration assays in one of two mouse micronuclei
tests for clastogenic effects and in vitro Chinese hamster ovary
direct cell mutation/HGPRT assay for mutagenic effects. Equivalent results were
observed in an in vivo rat liver DNA covalent binding assay. Pantoprazole was
negative in in vitro Ames mutation assay in vitro unscheduled DNA
synthesis assay (UDS) with rat hepatocytes, in vitro AS52 / GPT mammal
gene mutation assay in cell direction in vitro thymidine kinase mutation test
with L5178Y mouse lymphoma cells and rat bone marrow cell in vivo
analysis of chromosomal aberration.No effect on fertility or reproduction
performance when taking pantoprazole at oral doses up to 500 mg/kg/day
male rats (98 times the recommended human dose based on body surface area) and
450 mg/kg/day in female rats (88 times the recommended human dose depending on the body
surface area).Use in certain populations
Pregnancy
Teratogenic effects – Pregnancy category B
Reproduction studies have been performed in rats in
intravenous doses up to 20 mg/kg/day (4 times the recommended human dose
on the body surface) and rabbits at intravenous doses up to 15 mg/kg/day (6
times the recommended human dose depending on body surface area) and identified
there is no evidence of impaired fertility or harm to the fetus due to pantoprazole. There
however, there are no adequate and well-controlled studies in pregnant women.
Because animal reproduction studies don’t always predict humans
In response, this medication should be used during pregnancy only if clearly needed.Nursing mothers
Pantoprazole and its metabolites are excreted in milk
rats. Excretion of pantoprazole in breast milk was found in a study a
single mother after a single dose of 40 mg. Clinical relevance
this find is unknown. Many drugs that are excreted in breast milk have
potential for serious adverse reactions in infants. Based
carcinogenic potential shown for pantoprazole in rodent carcinogenicity
research, a decision must be made whether to terminate care or
stop taking the drug, taking into account the benefits of the drug for
Mother.Pediatric use
Safety and efficacy of PROTONIX I.V. in pediatric
patients were not created.Geriatric use
No age difference in safety profile
intravenous pantoprazole has been seen in international trials involving 86 elderly people
(≥ 65 years) and 200 young (<65 years) patients with erosive esophagitis associated with GERD. The frequency of healing of esophagitis in 107 elderly patients (≥ 65 years) treated with oral pantoprazole in the US, clinical trials were similar to those found in patients under that age out of 65.