How does Protonix affect pregnancy outcomes. What are the potential risks of using Protonix while pregnant. Is Protonix safe for treating GERD in pregnant women. How do Protonix and omeprazole compare for pregnancy use. What alternatives exist for managing GERD symptoms during pregnancy.

Understanding Protonix and Its Use in Pregnancy

Protonix, known generically as pantoprazole, is a proton pump inhibitor (PPI) medication commonly prescribed to treat gastroesophageal reflux disease (GERD) and other acid-related conditions. As many pregnant women experience GERD symptoms, the use of Protonix during pregnancy has become a topic of concern and scrutiny.

Is Protonix safe to use during pregnancy? The answer is not straightforward. While Protonix can effectively manage GERD symptoms, recent studies have raised concerns about potential risks to fetal development. Healthcare providers must carefully weigh the benefits of symptom relief against the possible risks when considering Protonix for pregnant patients.

How Does Protonix Work?

Protonix functions by reducing stomach acid production. It inhibits the proton pumps in the stomach lining, effectively decreasing the amount of acid secreted. This mechanism helps alleviate symptoms of GERD, such as heartburn and acid reflux, which can be particularly troublesome during pregnancy due to hormonal changes and physical pressure on the stomach.

Potential Risks of Protonix Use During Pregnancy

Recent studies have highlighted potential risks associated with Protonix use during pregnancy. These concerns have led to increased scrutiny and, in some cases, legal action.

• Birth Defects: Some research suggests a possible link between PPI use during pregnancy and certain birth defects.
• Bone Fractures: While not directly related to pregnancy, long-term PPI use has been associated with an increased risk of bone fractures.
• Nutrient Absorption: Reducing stomach acid may affect the absorption of certain nutrients, which could impact fetal development.

Are these risks significant enough to outweigh the benefits of GERD treatment? This question remains a subject of ongoing research and debate within the medical community.

Protonix Birth Defects: Emerging Concerns

Studies published in medical journals like Gastroenterology have indicated a potential connection between PPI use during early pregnancy and certain birth defects. These may include:

• Septal heart defects
• Limb malformations
• Anencephaly
• Hydroencephaly

It’s important to note that while these studies raise concerns, they do not definitively prove causation. More research is needed to fully understand the relationship between Protonix use and birth defects.

Legal Implications: The Protonix Lawsuit

The emerging concerns about Protonix birth defects have led to legal action. Some parents of children born with defects allegedly linked to Protonix use during pregnancy have filed lawsuits against the drug’s manufacturer.

What evidence is required for a Protonix lawsuit? Typically, these cases require:

1. Medical records showing Protonix prescription during pregnancy
2. Documentation of prescription filling and usage
3. Medical records of the pregnancy and birth
4. Expert medical opinions on the alleged birth defects
5. Records of medical care required for the affected child

These lawsuits aim to recover damages to cover medical expenses and other costs associated with caring for a child with birth defects. However, it’s crucial to remember that filing a lawsuit does not guarantee compensation, and the legal process can be complex and lengthy.

Comparing Protonix to Other GERD Treatments in Pregnancy

When considering GERD treatment during pregnancy, it’s essential to explore all available options. How does Protonix compare to other medications, particularly omeprazole (Prilosec)?

Protonix vs. Omeprazole: Key Differences

Both Protonix and omeprazole are proton pump inhibitors, but they have some notable differences:

• Availability: Protonix requires a prescription, while omeprazole is available over-the-counter.
• Age Range: Protonix is approved for use in patients 5 years and older, while omeprazole can be used in children as young as 1 year old.
• FDA Approvals: Omeprazole has additional FDA approvals for treating H. pylori infections and ulcers.

In terms of pregnancy safety, both medications are classified as Category C drugs by the FDA, meaning that risk cannot be ruled out. The choice between these medications should be made in consultation with a healthcare provider, considering individual patient factors and the latest research.

Managing GERD During Pregnancy: Alternative Approaches

Given the potential risks associated with PPI use during pregnancy, many healthcare providers and expectant mothers seek alternative methods for managing GERD symptoms. What non-pharmacological options are available?

• Dietary modifications: Avoiding trigger foods and eating smaller, more frequent meals
• Lifestyle changes: Elevating the head during sleep, avoiding lying down immediately after meals
• Natural remedies: Ginger tea, probiotics, or apple cider vinegar (under medical supervision)
• Other medications: Antacids or H2 blockers may be considered safer alternatives in some cases

These approaches may provide relief for mild to moderate GERD symptoms without the potential risks associated with PPI use. However, severe cases may still require medication, highlighting the importance of personalized medical advice.

The Role of Healthcare Providers in Protonix Decisions

Healthcare providers play a crucial role in guiding patients through the decision-making process regarding Protonix use during pregnancy. They must stay informed about the latest research, weigh individual patient factors, and communicate clearly about potential risks and benefits.

What questions should patients ask their healthcare providers about Protonix and pregnancy? Consider the following:

• Are there safer alternatives for my specific situation?
• What are the potential risks and benefits of Protonix use in my case?
• How can we monitor for potential side effects or complications?
• What lifestyle changes might help manage my GERD symptoms?

Open and honest communication between patients and healthcare providers is essential for making informed decisions about GERD treatment during pregnancy.

Future Research and Developments

The medical community continues to study the effects of Protonix and other PPIs on pregnancy outcomes. What areas of research are currently being explored?

• Long-term follow-up studies on children exposed to PPIs in utero
• Comparative studies of different GERD treatments during pregnancy
• Investigation of potential mechanisms linking PPI use to birth defects
• Development of new, potentially safer medications for GERD treatment in pregnancy

As new research emerges, guidelines for GERD treatment during pregnancy may evolve. Staying informed about these developments is crucial for both healthcare providers and patients.

Navigating GERD Treatment Decisions During Pregnancy

Managing GERD during pregnancy presents a complex challenge for both patients and healthcare providers. While Protonix can effectively alleviate symptoms, concerns about potential risks necessitate careful consideration and individualized decision-making.

How can expectant mothers make informed decisions about GERD treatment? Consider these steps:

1. Discuss all symptoms and concerns with a healthcare provider
2. Explore non-pharmacological management strategies
3. Understand the potential risks and benefits of medication options
4. Stay informed about the latest research and recommendations
5. Regularly reassess the treatment plan throughout pregnancy

By approaching GERD treatment thoughtfully and collaboratively, expectant mothers and their healthcare providers can work together to find the safest and most effective management strategies for each individual case.

Protonix Lawsuit | Protonix Birth Defects

Protonix is a gastrointestinal drug known as a proton pump inhibitor (PPI), which works by reducing the amount of acid produced by the stomach. Doctors prescribe Protonix (pantoprazole) for the short-term treatment of gastroesophageal reflux disease (GERD), because it may help ease the erosion and ulceration of the esophagus and to promote healing. It may also be used for long-term maintenance treatment of GERD, and for other acid-related conditions like Zollinger-Ellison syndrome and peptic ulcer disease.

Many pregnant women experience GERD during pregnancy, and therefore may be prescribed Protonix. Unfortunately, recent studies and reports indicate that Protonix and other PPI drugs may increase the risk for Protonix birth defects. Some parents who have had babies born with Protonix birth defects have gone on to file a Protonix lawsuit in the hopes of recovering damages to pay for medical expenses.

Protonix Lawsuit Requires Adequate Medical Records

Parents considering a potential Protonix lawsuit will want to gather medical records showing when the mother was prescribed Protonix, how often she filled the prescription, how long she took the medication, and what dosage she was prescribed. A Protonix lawyer may also require medical records of the pregnancy, and a doctor’s opinion on the alleged Protonix birth defects. Medical records and receipts of all medical care required for the newborn are also important in a Protonix lawsuit.

Drug Linked to Protonix Bone Fractures

PPI drugs like Protonix have been linked to serious side effects like Protonix bone fractures of the hip, wrist, and spine. The risk for these Protonix bone fractures is greatest in those patients who are 50 years and older. In 2010, the FDA warned the public and healthcare professionals thast certain antacid drugs like Protonix may increase the risk of these fractures. The FDA released this information after reviewing seven published studies, six of which reported an increased risk of fractures of the wrist, hip, and spine. The FDA also required manufacturers of these drugs to include warnings about bone fractures on the product labels.

Evidence for Protonix Birth Defects

Though the FDA has not yet warned of Protonix birth defects, early studies indicate a connection between PPI drugs and Protonix birth defects like septal heart defects. A study published in Gastroenterology in 2010, for example, found that those mothers taking PPI drugs during the first trimester had an increased risk of giving birth to a baby with Protonix birth defects. Another 2010 study found that mothers taking PPI drugs before conception were also at an increased risk of Protonix birth defects.

A Protonix lawsuit may involve the review of these and other studies which have indicated a potential connection with Protonix birth defects like septal heart defects, limb malformations, anencephaly, and hydroencephaly.

A Protonix Birth Defects Lawyer May be Able to Help

Parents who have had a child with Protonix birth defects or Protonix birth defects may be eligible for a Protonix lawsuit. If you or a loved one has been injured by Protonix or have had a child with Protonix birth defects, contact Chaffin Luhana LLP today for a confidential case evaluation at 1-888-480-1123.

Differences, similarities and which is better

Pantoprazole and omeprazole are PPIs that treat heartburn symptoms from GERD and erosive esophagitis

Drug overview & main differences | Conditions treated | Efficacy | Insurance coverage and cost comparison | Side effects | Drug interactions | Warnings | FAQ

Pantoprazole and omeprazole are two proton pump inhibitors (PPIs) that are used to treat digestive conditions. Both drugs can be used for gastroesophageal reflux disease (GERD), a more chronic form of heartburn, and erosive esophagitis. They work by decreasing acid secretion in the stomach. While pantoprazole and omeprazole are similar medications, they also have some differences.

What are the main differences between pantoprazole and omeprazole?

Pantoprazole is the generic name for Protonix and can only be purchased with a prescription. It is FDA-approved to treat GERD in adults and children aged 5 years and older. Pantoprazole is supplied as a delayed-release tablet or liquid suspension. It can also be administered as an intravenous (IV) injection at a hospital or clinic. 

Omeprazole is known by its brand name, Prilosec, and can be purchased with a prescription or over-the-counter. Like pantoprazole, it works as a proton pump inhibitor to treat GERD. However, it is also FDA-approved to treat helicobacter pylori (H. pylori) infections, duodenal ulcers, and stomach ulcers. Omeprazole can treat GERD in adults and children aged 1 year and older. It comes as a delayed-release capsule, tablet, and liquid suspension. 

Conditions treated by pantoprazole and omeprazole

Pantoprazole and omeprazole are both FDA approved to treat heartburn symptoms from GERD and erosive esophagitis. PPIs like pantoprazole and omeprazole are more potent than regular antacids and histamine (h3) blockers. PPIs are usually prescribed as a short-term treatment that is taken for up to 8 weeks. 

Pantoprazole and omeprazole can also treat hypersecretory conditions that cause the stomach to produce too much acid. Zollinger-Ellison syndrome is a condition that involves tumors in the pancreas or duodenum (part of the small intestine). 

Pantoprazole and omeprazole can also help treat other conditions such as peptic ulcers, which include both duodenal ulcers and stomach ulcers. These ulcers are often caused by an infection from a bacteria called H. pylori. While omeprazole is FDA-approved to treat H. pylori in combination with other drugs, pantoprazole is used off-label for this infection.  

Other off-label uses for both drugs include Barrett’s esophagus and ulcers that stem from the use of nonsteroidal anti-inflammatory drugs (NSAIDs). 

Is pantoprazole or omeprazole more effective?

Pantoprazole and omeprazole have been shown to be effective for treating GERD. In a meta-analysis that pooled over 40 different studies, results found no significant differences in effectiveness between these PPIs. Pantoprazole was found to be equally as effective as omeprazole. Some double-blind clinical trials in the meta-analysis also compared other PPIs such as Nexium (esomeprazole), lansoprazole (Prevacid), and rabeprazole (Aciphex). 

One study found that pantoprazole was more effective than omeprazole in the treatment of stomach ulcers. Effectiveness was determined based on how fast the ulcers healed. Pantoprazole was found to be more effective in the study, although a high dosage may have played a role in its effectiveness

Pantoprazole and omeprazole are both comparable drugs in terms of effectiveness. One may be preferred over the other depending on the condition being treated and the cost of the medication. Consult a doctor to determine which PPI may be better for you. 

Coverage and cost comparison of pantoprazole vs. omeprazole

Pantoprazole is a generic medication that is usually covered by Medicare and most insurance plans. The average retail cost of pantoprazole is around $522. You may be able to save more with a SingleCare pantoprazole coupon which can lower the cost to approximately $10.

Omeprazole is a generic medication that is usually covered by Medicare and most insurance plans. The average retail cost of omeprazole is around $67.99. With an omeprazole coupon you can expect to pay around $10 for a 30-day supply of 20 mg capsules. 

Common side effects of pantoprazole vs. omeprazole

Pantoprazole and omeprazole can cause side effects such as headache, dizziness, nausea, and vomiting. They can also cause other gastrointestinal side effects, such as diarrhea, constipation, abdominal pain, and gas. Other possible side effects may include joint pain, upper respiratory tract infections, and asthenia, or lack of energy. 

Omeprazole can also cause side effects such as back pain and coughing. Pantoprazole has not been found to cause these particular side effects as often as omeprazole.

*Consult a doctor or pharmacist for all possible side effects.

Source: DailyMed (pantoprazole), DailyMed (omeprazole)

Drug interactions of pantoprazole vs. omeprazole

Both pantoprazole and omeprazole can interact with the same drugs. They both can interact with antiretroviral medications such as rilpivirine, atazanavir, and saquinavir. Taking these medications together can alter the effectiveness of the antiretroviral drug and increase its toxicity. 

Some drugs that affect blood clotting should not be taken with certain PPIs. Taking pantoprazole or omeprazole with warfarin can increase the risk of bleeding. While clopidogrel, an antiplatelet drug, may not be affected by pantoprazole, it should be avoided with omeprazole.  

Pantoprazole and omeprazole can interact with methotrexate, an antimetabolite medication, and cause an increased risk of methotrexate toxicity. 

Pantoprazole and omeprazole should not be taken at the same time as iron salts and other drugs that depend on stomach acid for absorption. Other medications that depend on stomach acid for absorption include chemotherapy drugs, such as erlotinib and dasatinib, and antifungals, such as ketoconazole and itraconazole. 

Because both PPIs are metabolized in the liver, they may interact with other drugs that are processed by similar enzymes, including the CYP2C19 enzyme. However, according to the pantoprazole FDA label, some drugs that are metabolized in the liver, including phenytoin, citalopram, and diazepam, have not been shown to have significant interaction with pantoprazole. Still, it is important to discuss any medications you take with a doctor before taking a PPI. 

PPIs can also affect the results of certain lab tests. PPIs are known to cause false positives for THC urine tests. 

*This may not be a complete list of all possible drug interactions. Consult a doctor with all medications you may be taking. 

Warnings of pantoprazole and omeprazole

Pantoprazole and omeprazole are not recommended for long-term use since there may be an increased risk of bone fractures. Those with osteoporosis should monitor or avoid the use of PPIs.

Long-term use of pantoprazole and omeprazole can worsen or increase the risk of systemic lupus erythematosus, a rare autoimmune disease. 

Treatment with PPIs can increase the risk of diarrhea from Clostridium difficile infections. This risk may be higher in those who are hospitalized for a long time. 

PPIs can interfere with the absorption of vitamin B12 in the body, which can lead to vitamin B12 deficiency over time. PPIs can also affect the absorption of magnesium, which can lead to low levels of magnesium in the body (hypomagnesemia).

Both pantoprazole and omeprazole are in Pregnancy Category C and may cause harm to an unborn baby. Consult a doctor or healthcare provider if you are pregnant or breastfeeding before using a PPI. 

Frequently asked questions about pantoprazole vs. omeprazole

What is pantoprazole?

Pantoprazole (Protonix) is a proton pump inhibitor (PPI) medication prescribed to treat GERD and erosive esophagitis. It is often taken as a 40 mg delayed-release tablet for up to 8 weeks. It can be taken in adults and children 5 years and older. 

What is omeprazole?

Omeprazole (Prilosec) is a PPI medication prescribed to treat GERD and erosive esophagitis. It is also FDA approved for H. pylori infection and duodenal or gastric ulcers. It can be taken as a 20 mg delayed-release capsule for 4 to 8 weeks in adults and children 1 year and older. 

Are pantoprazole and omeprazole the same?

Pantoprazole and omeprazole are in the same class of medications. However, they have different approved uses and side effects. They also come in different dosages and formulations. 

Is pantoprazole or omeprazole better?

Pantoprazole and omeprazole are both effective for GERD and erosive esophagitis. One PPI drug may be preferred over the other depending on the condition being treated and the cost of the medication. 

Can I use pantoprazole or omeprazole while pregnant?

Pantoprazole and omeprazole are not recommended in pregnant women due to the risk of fetal harm. However, in some cases, the benefits may outweigh the risk. Consult a doctor if you are pregnant. 

Can I use pantoprazole or omeprazole with alcohol?

Consuming alcohol may increase certain side effects associated with pantoprazole or omeprazole. Alcohol may worsen PPI side effects, such as headache and nausea.

Is OTC omeprazole the same as the prescription?

Over-the-counter (OTC) omeprazole contains the same active ingredient found in prescription-strength omeprazole. OTC omeprazole can be found as OTC Prilosec in a 14-day supply of 20 mg tablets. This treatment course should not be taken more than once every 4 months. 

Should I take Pantoprazole and Omeprazole at the same time?

Since pantoprazole and omeprazole work in identical ways, they should not be taken at the same time. They both work as PPIs to reduce the production of acid in the stomach. Taking them together could increase the risk of adverse effects. 

Protonix Natural – instructions for use

Protonix Natural

Instruction:

• Release form
• Composition
• Application
• Contraindications
• Recommendations for use
• Special instructions
• Storage conditions
• Expiration date
• Terms of sale
• Classification

Presentation

Liquid in 120 ml vials.

Composition

Purified Water, Ginger Fruit Extract, Dill (Common Fennel) Seed Extract, Indian Cumin Seed Extract, Peppermint Leaf Extract, Dill Seed Extract, Anise Seed Extract, Lemon Flavor (Contains Carriers Triacetin, Propylene Glycol), Preservative sodium benzoate, carboxymethyl cellulose thickener sodium salt, acidity regulator citric acid, sweetener sucralose, color tartrazine.

Application

As a biologically active food supplement – a source of polyphenolic compounds.

Contraindications

Individual intolerance to the components, pregnancy, breast-feeding.

Directions for Use

Adults 1 tablespoon (15 ml) 3 times daily with meals, shake before use. The duration of admission is 2 weeks. If necessary, the reception can be repeated.

Special instructions

It is recommended to consult a physician before use.

Storage conditions

Store in a dry place out of the reach of children at a temperature not exceeding 30 °C.

Shelf life

3 years.

Terms of sale

Places of sale are determined by the national legislation of the Member States of the Eurasian Economic Union.

Classification

• Groups

  Dietary supplements – polyphenolic compounds

  Dietary supplements – products of plant, animal or mineral origin

Share this page

More on this topic

Find out more about Protonix Natural Dietary Supplement:

• Packing Forms (1)
• Reviews
• Questions

Information about the dietary supplement Protonix Natural is intended for medical and pharmaceutical professionals, for reference purposes only. The instructions are not intended to replace professional medical advice, diagnosis or treatment. The information contained here may change over time. The most accurate information is contained in the manufacturer’s instructions attached to the packaging of dietary supplements.

Protonix I.V. – instructions for use, dosage, composition, analogues, side effects / Pillintrip

WARNINGS

Included as part of PRECAUTIONS section.

PRECAUTIONS

Sequelae of symptomatic response

Symptomatic response to pantoprazole therapy makes
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 to exacerbate 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 an increased risk of 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 PPI

For 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, B6C3F1 mice were
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
analyzes of chromosomal aberration of lymphocytes 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.

There was 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 this age out of 65.