What are the approved uses for Protonix. How does Protonix work to reduce stomach acid. What are the most common and serious side effects of taking Protonix. What important warnings should patients know before taking Protonix.

What is Protonix and How Does it Work?

Protonix (pantoprazole sodium) is a prescription medication classified as a proton pump inhibitor (PPI). PPIs are potent drugs that suppress stomach acid production by blocking proton pumps in the stomach lining. These pumps are responsible for secreting gastric acid.

Specifically, Protonix acts on the proton pumps to reduce the amount of acid they produce. This helps treat conditions related to excess stomach acid. Protonix is available only by prescription and can be prescribed to adults as well as children 5 years and older.

Who Manufactures Protonix?

Protonix is manufactured by Pfizer. However, generic versions of pantoprazole are also produced by several other pharmaceutical companies.

What are the Approved Uses for Protonix?

The FDA has approved Protonix for the following uses:

• Treatment of gastroesophageal reflux disease (GERD)
• Short-term treatment of erosive esophagitis (EE)
• Maintenance and healing of erosive esophagitis
• Treatment of hypersecretory conditions including Zollinger-Ellison syndrome

It’s important to note that Protonix is not intended for immediate heartburn relief. Rather, it’s designed for the treatment of chronic acid-related conditions.

How Long Can Protonix Be Taken?

For short-term treatment of conditions like erosive esophagitis, Protonix is typically prescribed for up to 8 weeks in both adults and children. In some adult cases, doctors may prescribe a second 8-week course. For long-term treatment of excess stomach acid, Protonix may be prescribed for longer periods. However, there is limited research on the effects of taking Protonix for more than 12 months continuously.

What are the Most Common Side Effects of Protonix?

While Protonix can be an effective treatment for acid-related conditions, it may cause some side effects. The most common side effects reported in both adults and children include:

• Headache
• Diarrhea
• Nausea
• Stomach pain
• Vomiting
• Gas
• Dizziness
• Joint pain

In children specifically, upper respiratory infection has also been reported as a common side effect.

What are the Potential Serious Side Effects of Protonix?

While less common, Protonix can potentially cause more serious side effects, especially with long-term use. These may include:

• Acute interstitial nephritis
• Chronic kidney damage or failure
• Bone fractures, particularly of the hip, wrist, and spine
• Increased risk of certain bacterial infections
• Vitamin B-12 deficiency
• Magnesium deficiency
• Increased risk of stomach cancer
• Increased risk of heart attack and stroke

If you experience any unusual symptoms while taking Protonix, it’s crucial to contact your healthcare provider immediately.

When Should You Call Your Doctor About Protonix Side Effects?

Contact your doctor immediately if you experience any of the following symptoms while taking Protonix:

• Coughing or choking
• Fast or uneven heartbeat
• Fainting
• Severe headache
• Hallucinations
• Muscle cramps or weakness
• Seizures
• Trouble breathing
• Watery or bloody diarrhea
• Memory problems or confusion

What Important Warnings Should Patients Know Before Taking Protonix?

The FDA has mandated several warnings for Protonix and other PPIs due to potential risks associated with their use. These warnings include:

1. Risk of gastric malignancy: Protonix may mask symptoms of gastric cancer.
2. Acute interstitial nephritis: This is a form of kidney inflammation that can occur with PPI use.
3. Clostridium difficile-associated diarrhea: PPIs may increase the risk of this serious intestinal infection.
4. Bone fracture risk: Long-term and high-dose PPI use may increase the risk of hip, wrist, and spine fractures.
5. Cutaneous and systemic lupus erythematosus: PPIs may trigger or exacerbate symptoms of lupus.
6. Vitamin B-12 deficiency: Long-term PPI use may lead to vitamin B-12 deficiency.
7. Magnesium deficiency: PPIs can cause low magnesium levels in the body.

It’s crucial to discuss these potential risks with your healthcare provider before starting Protonix treatment.

Are There Any Ongoing Legal Issues Related to Protonix?

Protonix, along with other PPIs, has been named in several lawsuits. These legal actions have been initiated by individuals who claim to have experienced serious side effects from using these medications. The lawsuits primarily focus on allegations that the manufacturers failed to adequately warn patients and healthcare providers about the potential risks associated with long-term PPI use.

Some of the key issues raised in these lawsuits include:

• Chronic kidney disease and kidney failure
• Acute kidney injury
• Bone fractures
• Increased risk of stomach cancer
• Heart attacks and other cardiovascular issues

It’s important to note that the existence of these lawsuits does not necessarily imply that Protonix is unsafe when used as directed. However, it underscores the importance of being fully informed about the potential risks and benefits of any medication.

How Should Patients Approach Protonix Treatment?

Given the potential risks associated with Protonix and other PPIs, patients should approach treatment with caution and under close medical supervision. Here are some key points to consider:

1. Consult Your Healthcare Provider

Before starting Protonix, have a thorough discussion with your doctor about your medical history, current medications, and any concerns you may have. Your healthcare provider can help weigh the potential benefits against the risks based on your individual health situation.

2. Use as Directed

Always take Protonix exactly as prescribed by your doctor. Do not increase your dose or prolong your treatment without consulting your healthcare provider first.

3. Regular Monitoring

If you’re on long-term Protonix treatment, your doctor may recommend regular check-ups and tests to monitor for potential side effects, particularly those affecting kidney function and bone density.

4. Be Aware of Symptoms

Familiarize yourself with the potential side effects of Protonix. If you experience any unusual symptoms, report them to your doctor promptly.

5. Consider Alternatives

For some patients, lifestyle changes or alternative medications may be effective in managing acid-related conditions. Discuss these options with your healthcare provider.

6. Do Not Stop Abruptly

If you and your doctor decide to discontinue Protonix, follow their instructions carefully. Stopping PPIs suddenly can lead to rebound acid hypersecretion, potentially worsening your symptoms.

By taking these precautions and maintaining open communication with your healthcare provider, you can help ensure that your Protonix treatment is as safe and effective as possible.

What are Some Alternatives to Protonix?

While Protonix can be an effective treatment for acid-related conditions, some patients may prefer to explore alternatives, especially if they’re concerned about potential side effects or long-term use. Here are some options that may be considered:

1. Other Medications

• H2 Blockers: These medications, such as ranitidine or famotidine, also reduce stomach acid production, but are generally considered less potent than PPIs.
• Antacids: Over-the-counter antacids can provide quick relief for occasional heartburn, though they’re not typically used for long-term treatment of chronic conditions.
• Alginate drugs: These form a foam barrier that floats on top of the stomach contents, helping to prevent reflux.

2. Lifestyle Changes

For some patients, lifestyle modifications can significantly improve symptoms of acid reflux and related conditions:

• Dietary changes: Avoiding trigger foods, eating smaller meals, and not eating close to bedtime can help reduce symptoms.
• Weight loss: Excess weight can contribute to acid reflux, so losing weight may alleviate symptoms for some individuals.
• Elevating the head of the bed: This can help prevent stomach acid from flowing back into the esophagus during sleep.
• Quitting smoking: Smoking can worsen acid reflux symptoms.
• Limiting alcohol and caffeine: Both can increase acid production and relax the lower esophageal sphincter, leading to reflux.

3. Complementary and Alternative Therapies

Some patients find relief through alternative approaches, although scientific evidence for their effectiveness varies:

• Herbal remedies: Some herbs, like licorice root and chamomile, are thought to have anti-inflammatory properties that may help with acid reflux.
• Acupuncture: Some studies suggest acupuncture may help relieve GERD symptoms.
• Relaxation techniques: Stress can exacerbate acid reflux symptoms, so stress-reduction techniques like meditation or yoga may be beneficial for some patients.

It’s crucial to note that while these alternatives may be helpful for some patients, they may not be suitable or effective for everyone. Always consult with your healthcare provider before making any changes to your treatment plan or starting any new therapies.

How Does Protonix Compare to Other PPIs?

Protonix is one of several proton pump inhibitors available on the market. While all PPIs work in a similar manner to reduce stomach acid production, there are some differences in their specific properties, uses, and effectiveness for different conditions. Here’s a comparison of Protonix with some other common PPIs:

1. Omeprazole (Prilosec)

• One of the oldest and most widely used PPIs
• Available over-the-counter in some countries
• Generally considered equally effective as Protonix for most conditions
• May have more drug interactions compared to Protonix

2. Esomeprazole (Nexium)

• A newer PPI, chemically similar to omeprazole
• Some studies suggest it may be slightly more effective than other PPIs for certain conditions
• Like Protonix, it’s often used for GERD and erosive esophagitis

3. Lansoprazole (Prevacid)

• Similar efficacy to Protonix for most conditions
• May work slightly faster than some other PPIs
• Available over-the-counter in some formulations

4. Rabeprazole (Aciphex)

• Similar effectiveness to Protonix
• May have a slightly lower risk of certain drug interactions
• Often used for GERD and peptic ulcers

While these PPIs are generally considered equally effective for most conditions, individual patients may respond differently to each medication. Factors such as the specific condition being treated, potential drug interactions, cost, and individual patient characteristics may influence which PPI a doctor prescribes.

It’s worth noting that all PPIs, including Protonix, carry similar risks of long-term side effects. Therefore, the choice between different PPIs is often based on factors other than safety profile.

As with any medication, the best choice of PPI should be determined through a discussion between the patient and their healthcare provider, taking into account the individual’s specific medical history, current medications, and treatment goals.

Protonix – Uses, Side Effects, Dosage and Interactions

Protonix (pantoprazole sodium) is a drug in a class of powerful acid-suppressing medications called proton pump inhibitors (PPIs). These medicines can cause rare but life-threatening side effects. Protonix is one of several PPIs named in lawsuits over serious kidney conditions.

Protonix (pantoprazole sodium) is a proton pump inhibitor (PPI). PPIs are powerful medications that block the production of acid in the stomach. They treat acid-reflux and related conditions. Other PPIs include, among others, Nexium (esomeprazole) and Prilosec (omeprazole).

Protonix acts on proton pumps in the stomach. These tiny pumps secrete gastric acid. Protonix causes these pumps to produce less acid.

Protonix is a prescription-only medication. Doctors may prescribe it to adults or to children 5 years and older.

Pfizer manufactures Protonix. Several companies also manufacture generic versions of pantoprazole.

Protonix Uses

Protonix is for short-term treatment of acid-related esophagus damage. It may also treat other acid-related conditions. Protonix is not for immediate heartburn relief.

Approved Protonix Uses

• Gastroesophageal reflux disease (GERD)
• Hypersecretory conditions including Zollinger-Ellison syndrome
• Short-term treatment of erosive esophagitis (EE)
• Maintenance and healing of EE

Doctors prescribe Protonix to treat excess stomach acid.

Doctors may prescribe Protonix to treat erosive esophagitis in both adults and children. Short-term treatment lasts up to eight weeks. There is no safety information on longer use in children. But doctors may prescribe a second eight-week course in some adults with EE.

Doctors may also prescribe Protonix for long-term use to treat excess stomach acid. Long-term treatment is anything lasting more than eight weeks. There is no research on the effects of taking Protonix for more than 12 months.

Protonix Side Effects

Protonix side effects include rare but serious conditions. Serious PPI side effects most often result from long-term use.

Several 2022 studies have found links between PPIs and more than a dozen major side effects. Lawsuits also blame Protonix and other PPIs for life-altering problems.

Possible Serious Protonix Side Effects

• Acute interstitial nephritis
• 
  Artery damage
• 
  Bacterial infections
• 
  Bone fractures of the hip, wrist and spine
• 
  Childhood bone fractures
• 
  Chronic kidney damage
• 
  Esophageal (throat) cancer
• 
  Heart attack
• 
  Heart defects in children
• 
  Increased asthma and allergy risks in children
• 
  Kidney failure
• 
  Kidney injury
• 
  Stomach cancer
• 
  Stroke

Symptoms of Serious Protonix Side Effects

People should let their doctor know immediately if they experience Protonix side effects. These symptoms may indicate a serious problem.

When to Call Your Doctor About Protonix Side Effects

• Coughing or choking
• 
  Fainting
• 
  Fast or uneven heartbeat
• 
  Feeling jittery
• 
  Hallucinations
• 
  Headache
• 
  Jerking in muscles
• 
  Loss of appetite
• 
  Memory problems, confusion or trouble concentrating
• 
  Muscle cramps, weakness or other unusual muscle conditions
• 
  Seizures
• 
  Trouble breathing
• 
  Watery or bloody diarrhea

Always talk to your doctor before stopping Protonix. Stopping suddenly can cause other medical problems.

Some people may be able to manage their symptoms with alternatives to PPIs. These may include other medications or lifestyle changes.

Common Protonix Side Effects

Less serious Protonix side effects are more likely to occur than serious ones. The most common side effects of Protonix are the same for adults and children, but upper respiratory infection is only common in children who take Protonix.

Less Serious Side Effects of Protonix

• Headache
• 
  Diarrhea
• 
  Nausea
• 
  Stomach pain
• 
  Vomiting
• 
  Gas
• 
  Dizziness
• 
  Joint pain

Protonix Warnings

The U.S. Food and Drug Administration has ordered PPI makers to add specific warnings to their products. But the list does not include all potential Protonix side effects.

Protonix Side Effect Label Warnings

• Gastric malignancy
• Acute interstitial nephritis (AIN)
• Clostridium difficile (C. diff) associated diarrhea
• Bone fractures in hip, wrist and spine
• Cutaneous and systemic lupus erythematosus
• Vitamin B-12 deficiency
• Magnesium deficiency

Lawsuit Information

Multiple PPIs, including Protonix, have been named in lawsuits from people who say they suffered serious kidney problems after taking them. Learn more about currently pending litigation.

View Lawsuits

Studies dating back to the 1990s have linked PPIs like Protonix to kidney problems. Protonix kidney side effects may include kidney damage or injury.

• 2015 – Acute Kidney Injury:

  Researchers reviewed medical records of 290,000 people. They found that PPI users were more likely to suffer acute kidney injury.

• 2016 – CKD Progressing to Kidney Failure:

  Researchers found that long-term PPI use increased kidney failure risks by 95 percent. They also found that long-term PPI users were 28 percent more likely to suffer CKD.

• 2017 – Chronic Kidney Damage (CKD):

  Researchers looked at 125,000 PPI users over five years. Half who developed chronic kidney damage (CKD) never had kidney problems before PPIs. They also found PPI users had a 20 percent higher risk of CKD.

Protonix Lawsuits Over Kidney Damage

Lawsuits claim Protonix caused life-threatening kidney problems. The Protonix lawsuits are part of a multidistrict litigation (MDL). A judicial panel combined them in a New Jersey federal court. MDLs allow several similar lawsuits to move more quickly through the court process.

The New Jersey MDL includes lawsuits over several different PPI brands. As of July 2019, there were 12,775 PPI lawsuits in the MDL.

Injuries Claimed in Protonix Lawsuits

• Kidney disease
• 
  Kidney injury
• 
  Kidney failure
• 
  Acute interstitial nephritis

Protonix lawyers are still taking new cases. They expect to file thousands more PPI lawsuits before the first case goes to trial.

There have been no verdicts or settlements in the MDL. But Pfizer once paid a $55 million settlement to the U.S. Justice Department in a Protonix lawsuit. The government had claimed Pfizer promoted Protonix for unapproved uses.

Protonix Dosage and Interactions

The recommended adult Protonix dose is 40 mg once daily. Protonix is also available in 20 mg doses for children five to 16 years of age.

Doctors may also deliver Protonix as an IV drip or injection into a vein. Hospitals may prescribe Protonix to prevent stress ulcers during patients’ stay. Studies have suggested Protonix and other PPIs may be over-used in hospitals.

Protonix interactions can happen if people take other drugs while using Protonix. People should tell their doctors about medicines they are on before taking Protonix.

Protonix Drug Interactions Can Occur With:

• Coumadin, Jantoven (warfarin)
• Lanoxin, Digox, Digitek (digoxin)
• Hetacin (hetacillin) and other ampicillin esters
• Iron salts
• Nizoral, Xolegel, Extina (ketoconazole)
• Methotrexate
• Plavix (clopidogrel)
• Reyataz (atazanavir) or Viracept (nelfinavir) HIV antiretroviral drugs

Protonix can also cause false positives in drug tests for marijuana use.

People can suffer a Protonix overdose. In the U.S., people should call the Poison Help Line for Protonix overdose help. That number is 1-800-222-1212. It connects people to their local poison center.

Protonix Overdose Symptoms

• Hunched sitting
• 
  Tremor
• 
  Sluggishness
• 
  Splayed limbs
• 
  Loss of control of body movements

OTC Protonix and Generic Protonix

There is no Protonix over-the-counter (OTC) version available. Other OTC drugs may be similar to Protonix. Prilosec OTC, Nexium 24HR and Prevacid 24HR are available over the counter.

The generic name for Protonix is pantoprazole. Pfizer’s patent on pantoprazole ran out in 2010. The FDA approved the first generic versions of pantoprazole that same year.

The agency has approved several generic pantoprazole applications since then. All generic versions require a prescription.

Protonix Facts

Please seek the advice of a medical professional before making health care decisions.

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Protonix: 7 things you should know

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Medically reviewed by Carmen Fookes, BPharm. Last updated on April 5, 2022.

1. How it works

• Protonix is a brand (trade) name for pantoprazole.
• Pantoprazole works by reducing the production of stomach acid by irreversibly blocking the actions of an enzyme responsible for acid production, called H+/K+ ATPase (also known as the gastric proton pump). The proton pump is located in the parietal cells of the stomach wall. Both baseline gastric acid secretion and stimulated gastric acid secretion are affected; the degree which they are affected depends upon the dose of pantoprazole. This allows damaged tissue in the esophagus, stomach, and duodenum to heal.
• Protonix belongs to the class of medicines known as proton pump inhibitors (PPIs).

2. Upsides

• Effective at healing erosive esophagitis (a severe inflammation of the lining of the esophagus – the tube that carries food from the mouth to the stomach) and relieving symptoms of gastro-esophageal reflux disease (also known as heartburn).
• Useful in the treatment of hypersecretory conditions such as Zollinger-Ellison syndrome.
• Usually, only up to 8 weeks of treatment is required; although it may be used for up to 12 months to maintain the healing of erosive esophagitis.
• No dosage adjustment is needed in people with kidney or liver disease or the elderly.
• Available as oral tablets, an oral solution, and as an IV injection for infusion.
• Protonix IV injection should only be given by intravenous infusion for a maximum of 7 to 10 days. Discontinue the IV infusion as soon as the patient can swallow the tablets or receive the oral suspension.
• Protonix is available as a generic under the name pantoprazole.

3. Downsides

If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:

• A headache, fever, dizziness, nausea, diarrhea, cold-like symptoms (a sore throat, congested nose, sneezing), joint pain, and flatulence.
• May also interfere with some laboratory tests.
• May mask the symptoms of gastric malignancy. Further investigations should be carried out in people who have a suboptimal response to Nexium or an early symptomatic relapse once therapy has been discontinued. Endoscopy should be performed in seniors before administration of Protonix.
• PPIs (including Protonix) have been associated with an increased risk of osteoporosis-related fractures of the hip, wrist, or spine. People on high-dose or long-term therapy are more at risk.
• Has also been associated with other conditions such as lupus erythematosus and magnesium deficiency.
• Prolonged treatment (greater than 24-36 months) may cause vitamin B12 deficiency. The risk is greater in women, people aged less than 30, and with higher dosages.
• Administration of PPIs (such as Protonix), has been associated with acute interstitial nephritis, a severe inflammation of the kidneys. May occur on medication initiation or at any point of therapy. Symptoms include fever, rash, and generalized aches and pains. Discontinue Protonix and seek medical advice.
• Has been associated with a greater risk of Clostridium difficile-associated diarrhea. See your doctor if you develop diarrhea that does not improve.
• Will not provide instantaneous relief from heartburn symptoms. Antacids may be used to relieve these symptoms.
• Long-term use in animal studies has been associated with stomach cancer; it is not certain if Protonix has this effect in humans.
• Heartburn can cause similar symptoms to a heart attack. Seek urgent medical attention if you have chest pain, or pain that extends down your arm or up your neck, nausea, sweating and you feel unwell.
• Protonix may not be suitable for some people including those with severe liver disease, osteoporosis or low bone mineral density, or low levels of magnesium in their blood. May increase the risk of osteoporosis-related fracture of the hip, wrist, or spine. Not suitable for children under five.
• Protonix injection contains edetate disodium which can chelate metal ions, including zinc. Consider zinc supplementation in patients prone to zinc deficiency who are treated with Protonix IV.
• May interact with some other medications including antivirals used to treat HIV, methotrexate, and sometimes warfarin. Protonix can also reduce the absorption of drugs that are dependent on a certain gastric pH for their absorption.
• Data do not demonstrate an increased risk of major birth defects or adverse pregnancy outcomes with Protonix compared to the background risk present in pregnancies in general. Protonix has been detected in breast milk but its effects on a breastfeeding infant are unknown.

Note: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. View complete list of side effects

Protonix is used for the treatment of conditions associated with excessive acid production in the esophagus and stomach. Long-term use may be associated with magnesium and vitamin B12 deficiency and an increased risk of bone fracture. Use the lowest possible dose for the shortest possible time.

5. Tips

• Protonix tablets can be taken with or without food. Do not crush, break or chew the tablet, or swallow it whole. Protonix oral granules should be taken 30 minutes before a meal; sprinkle directly onto one teaspoonful of applesauce or apple juice, stir and swallow straight away. Swallow delayed-release tablets whole; do not crush or chew.
• Usually taken once a day. May be taken with or without food.
• If using delayed-release granules, sprinkle intact granules on applesauce ONLY (do not use any other type of liquid including water). Swallow whole without chewing granules 30 minutes before a meal.
• May cause a false positive result on a drug screening test.
• Seek urgent medical advice if you have severe stomach pain, nausea, vomiting, diarrhea, seizures, blood in the urine, urinating more frequently, or symptoms of low magnesium (confusion, dizziness, tremors, muscle spasms, abnormal heart rate).
• See your doctor if you develop any unexplained fever, rash (particularly one that gets worse after you have been in the sun), new or worsening joint pain, persistent diarrhea, or generalized aches and pains.

6. Response and effectiveness

• Peak effects happen within two and a half hours and start to decline after 12 hours although may last for over 24 hours.

7. Interactions

Medicines that interact with Protonix may either decrease its effect, affect how long it works, increase side effects, or have less of an effect when taken with Protonix. An interaction between two medications does not always mean that you must stop taking one of the medications; however, sometimes it does. Speak to your doctor about how drug interactions should be managed.

Common medications that may interact with Protonix include:

• aminophylline or theophylline
• ampicillin
• astemizole
• bisphosphonates, such as alendronate, etidronate, or risedronate
• clopidogrel
• delavirdine
• digoxin
• diuretics
• HIV medications (eg, atazanavir, indinavir, ritonavir, or saquinavir)
• iron supplements
• methotrexate
• medications that rely on a certain gastric pH for absorption, such as ampicillin, dasatinib, erlotinib, iron salts, ketoconazole/itraconazole, mycophenolate mofetil, or nilotinib
• medications that affect either CYP3A4 or CYP2C19 hepatic enzymes, such as erythromycin, fluconazole, fluvoxamine, itraconazole, ketoconazole, or voriconazole
• sucralfate
• tacrolimus
• warfarin.

In addition, Protonix may affect some diagnostic tests, for example, those for neuroendocrine tumors or the secretin stimulation test. There have also been reports of false-positive urine screening tests for tetrahydrocannabinol (THC) in patients receiving PPIs, such as Protonix.

Note that this list is not all-inclusive and includes only common medications that may interact with Protonix. You should refer to the prescribing information for Protonix for a complete list of interactions.

More about Protonix (pantoprazole)

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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

• Barrett’s Esophagus
• GERD
• Erosive Esophagitis
• Duodenal Ulcer

References

• Protonix (pantoprazole) Revised 03/2022. Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. https://www.drugs.com/pro/protonix.html

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Protonix only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Copyright 1996-2023 Drugs.com. Revision date: April 5, 2022.

Medical Disclaimer

Protonix vs. Prilosec for GERD and Heartburn: Differences and Side Effects

Protonix

• Are Protonix and Prilosec the same thing?
• What are the possible side effects of Protonix?
• What are the possible side effects of Prilosec?
• What is Protonix?
• What is a Prilosec?
• What drugs interact with Protonix?
• What drugs interact with Prilosec?
• How should I take Protonix?
• How should I take Prilosec?

Are Protonix and Prilosec the same thing?

Protonix (pantoprazole sodium) and Prilosec (omeprazole) are proton pump inhibitors (PPIs) used to treat gastroesophageal reflux disease (GERD) and a history of erosive esophagitis.

Prilosec is also used to treat ulcers and frequent heartburn.

Protonix is ​​available by prescription, while Prilosec is available over-the-counter (OTC) and generic.

What are the possible side effects of Protonix?

Side effects of Protonix include:

• injection site reactions (redness, pain, swelling),
• Headache,
• nausea,
• vomiting,
• diarrhea,
• gas
• dizziness,
• joint pain,
• weight changes,
• drowsiness,
• feeling tired, or
• trouble sleeping (insomnia).

What are the possible side effects of Prilosec?

Common side effects of Prilosec include:

• Headache,
• nausea,
• vomiting,
• diarrhea,
• abdominal pain,
• gas 90 006
• constipation,
• fever, or
• cold symptoms nose, sneezing and sore throat).

What is a Prilosec?

What is a Prilosec?

Prilosec (omeprazole) is a proton pump inhibitor (PPI) used to treat conditions such as ulcers, gastroesophageal reflux disease (GERD) and Zollinger-Ellison syndrome, all of which are caused by stomach acid.

What drugs interact with Protonix?

Protonix may interact with atazanavir, blood thinners, digoxin, diuretics (water pills), ketoconazole, or methotrexate.

what meloxicam 7.5 is used for

Protonix may also interact with nelfinavir, ampicillin, or iron.

What medicines interact with Prilosec?

Prilosec may interact with digoxin, diuretics (water tablets), anticoagulants, antifungals such as ketoconazole, antibiotics such as ampicillin, iron or methotrexate, and HIV or AIDS medicines such as atazanavir and nelfinavir.

Prilosec may also interact with bosentan, cilostazol, clopidogrel, cyclosporine, diazepam, disulfiram, St. John’s wort, tacrolimus, or anticonvulsants.

How should I take Protonix?

The recommended adult dose of Protonix is ​​40 mg once daily.

• Protonix oral suspension should be taken 30 minutes before meals.
• Protonix Oral Suspension should only be taken with applesauce or apple juice 30 minutes before meals.
• Protonix oral suspension should not be taken with water or other liquids or with other foods.
• Protonix oral suspension must not be chewed or crushed.
• A packet of Protonix oral suspension should not be split to make a smaller dose.

How should I take Prilosec?

The recommended adult oral dose of Prilosec is 20 to 60 mg once daily, depending on the condition being treated. For maximum effectiveness, Prilosec tablets should be taken before meals, swallowed whole, not crushed, chewed or opened.

Disclaimer

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References Medical Editor: John P. Cunha, DO, FACOEP

SOURCE:

RxList. Protonix Medication Guide.

https://www.rxlist.com/protonix-drug.htm#medguide

RxList. Prilosec Side Effects Treatment Center.

https://www.rxlist.com/prilosec-side-effects-drug-center.htm

PPI equivalent dosages in the treatment of various acid-related diseases and H. pylori infection

00:00

Igor Veniaminovich Maev , professor:

– Now, dear colleagues, I would like to give the floor to Alexander Sergeevich Trukhmanov, who will make a presentation ton pump (IPP) at treatment of various acid-related diseases and H. pylori infection”.

Alexander Sergeyevich Trukhmanov , Professor:

– Thank you very much, Igor Veniaminovich.

First of all, I would like to substantiate the relevance of the topic under consideration. The previous two reports discussed, in particular, the comparison of various eradication therapy regimens with the inclusion of PPIs. As you have seen, the doses of PPIs used are different in each regimen. Various schemes are being explored. In the end, the result of the search will be an improvement in the final goal, the end point – the percentage of eradication.

Why do we stop at the question of equivalent dosage?

The fact is that recently, situations have become more frequent in which, in order to overcome resistance to ongoing therapy, to overcome refractoriness (for example, in the treatment of patients with gastroesophageal reflux disease), dosages of 2, sometimes even 3 times more than the standard ones are used.

Practitioners ask the question: “How do we decide on the effective dosage of PPIs so that we reach the end point and can evaluate the effectiveness of the use of these drugs?”.

Let me give you some definitions (they are clear and official) so that we finally understand how to evaluate various antisecretory drugs, various PPIs. This is due to the fact that their initial dosages are different.

02:31

Let’s look at these definitions.

Pharmaceutical equivalence contains two concepts.

Pharmaceutical equivalents are medicines that contain the same ingredient or active substance. Moreover, it is in the dosage and method of application that are indicated for this drug. Pharmaceutical equivalents may differ in the type of dosage form, type of tablet, color, name.

These are, for example, those aspirin preparations that have different names, but contain acetylsalicylic acid in the same dose.

Pharmaceutical alternatives are preparations that contain the same ingredient. However, for example, these identical components may be present as different salts or in different formulations of the drug.

(Slide show).

Here you see an example of tetracycline hydrochloride and tetracycline phosphate. Or quinidine sulfate, which can be contained in a dose of 200 mg in both tablets and capsules.

Thus, pharmaceutical equivalents and pharmaceutical alternatives are preparations containing the same active ingredient.

What is bioequivalence?

This is a very important concept that we must understand. Bioequivalent products are pharmaceutical products that are comparable in their effectiveness in terms of bioavailability when used in the same way.

I will remind you that bioavailability is that part of the drug that reaches the end point of application after being absorbed and metabolized in the liver.

When taking original and generic drugs, they can show the same bioequivalence. It can differ somewhere according to different standards up to 15%. This is the degree of absorption, distribution, bioavailability.

As a rule, bioequivalence is determined by experiment. This experiment allows us to say that the generic drug is comparable in its effectiveness to the original drug.

Of course, the identical parameters that are obtained in an experiment involving volunteers allow us to say that a particular generic is comparable in its effectiveness to the original drug.

05:27

(Slide show).

Let’s return to the comparison of different APIs. We can see that bioavailability, plasma protein binding, half-life of all the PPIs we currently have are roughly comparable.

How PPIs are metabolized is always of great importance to us. All of them are metabolized through the Cytochrome 450 system. PPIs such as “Pantoprazole” (“Pantoprazole”), in addition to the 2C19 isoenzyme, is also metabolized through the isoenzyme – isoform 3A4.

This gives some differences in the metabolism of “Pantoprazole”. In particular, in competition for metabolism through the 2C19 isoenzyme.

I ask you to pay your attention, dear colleagues, to the fact that all these data are given from the official instructions for the use of all these APIs.

You can see links below that allow us, when receiving this or that drug for use, to check the indications of bioavailability, metabolic pathways, and so on.

I urge, dear colleagues (this is where I want to draw your attention and call), that we very carefully return and analyze the information contained in the instructions for use. If we have the opportunity to use different APIs, we should be guided by these official documents.

Now we move on to the concept of therapeutic equivalence.

Therapeutic equivalents are drugs that have the same clinical effect and safety profile. Moreover, it is emphasized that this analysis is carried out under conditions that meet the instructions for use.

The fact is that the clinical effect can be assessed by different indicators. This is an effect on the symptoms, on some functional indicators.

However, it is very important for us to understand, be aware that comparisons of different drugs (in particular, one group) should be carried out under the conditions indicated in the instructions for use. This is primarily related to the dosages of drugs.

08:28

(Slide show).

Let’s take a look at the data released by the US Drug and Food Administration. They show that each of the IPPs has been analyzed in great detail.

These data indicate that a drug such as Pantoprazole has therapeutic equivalents. On the left side of the slide, it is underlined in red letters that Pantoprazole has equivalents. In the USA – “Protonix” (“Protonix”). In Russia – “Nolpaza” (“Nolpaza”).

Also listed here are the approved dosages for this drug. For Pantoprazole, the main standard dosage is 40 mg.

20 mg is a half dosage used in certain cases. All these cases are extremely strictly prescribed, indicated in the instructions for use.

If we look at “Omeprazole” it also shows that it has therapeutic equivalents. “Omeprazole” is used in a dosage of 20, 40 and 10 mg.

“Lansoprazole” (“Lansoprazole”). It has therapeutic equivalents. The doses at which this PPI is used are 15 and 30 mg. Moreover, 30 mg are the standard dosage (basic).

The drug “Rabeprazole” (“Rabeprazole”): in our country – “Pariet”, in the USA – “Aciphex”. It has no therapeutic equivalents, according to the FDA. The main dosage of Rabeprazole is 20 mg.

The drug “Esomeprazole” (“Esomeprazole”) – “Nexium” (“Nexium”). It is used in doses of 40 mg and 20 mg. It has no therapeutic equivalents yet.

10:38

How much does it matter?

Let’s turn to the standard of care for erosive esophagitis, that is, patients with gastroesophageal reflux disease, and look very closely at the doses that are recommended in the treatment of erosive esophagitis.

For Pantoprazole 40 mg per day. “Omeprazole” – 20 mg per day. “Rabeprazole” – 20 mg per day. Lansoprazole – 30 mg per day.

I draw your attention, dear colleagues. If we compare “Pantoprazole” and “Omeprazole”, then for “Pantoprazole” the main, standard, dosage is 40 mg. For Omeprazole, a 40mg dose would be a double dose. This certainly needs to be taken into account.

Naturally, each of us has every right to prescribe the dose of the drug, which, in our opinion, will have the maximum effective effect and will be most useful for our patient.

But we must at the same time be aware that when we prescribe a drug in a double dosage, we go beyond the instructions for use. If we prescribe this double dosage, we must definitely justify the need to prescribe a double dosage of this or that drug.

There is another classification of equivalent dosages. Particularly the IPP. This is the classification of the World Health Organization. Please note that the doses of these drugs are also given here. “Omeprazole” – 20 mg, “Pantoprazole” – 40 mg. “Esomeprazole” is listed here at a dose of 30 mg.

It is emphasized that this classification is not the basis for revising the standards of care. It is not a basis for comparing the effectiveness of drugs. It is purely reference data, which are based on comparative studies in terms of the pharmacokinetic properties of a particular PPI.

13:00

(Slide show).

Can we talk about the presence of equivalent dosages in the analysis of the antisecretory effect of PPIs?

Yes, absolutely.

If we set ourselves such a task and conduct an experiment that evaluates the antisecretory activity (for example, by increasing the pH level of gastric juice) when prescribing PPI preparations at various doses, we can finally say which PPI is effective in terms of increasing pH , for example, up to 4.

If, dear colleagues, you are interested in this topic, there is a link in the lower right corner of the slide. This is very meticulous work. It contains information on how PPIs at various doses increase pH by a certain amount. We are primarily interested in increasing the pH to 4.

An increase in pH is, of course, an important indicator in itself. It’s functional. We can compare drugs, but we are interested in clinical efficacy.

Now let me give you data from very serious studies (you see, these are double-blind, randomized clinical trials). They were devoted to comparing the effectiveness of various PPIs:

• in the treatment of patients with gastroesophageal reflux disease,

• in the treatment of peptic ulcer (healing of an ulcer),

• in relation to action in terms of eradication of H. pylori infection.

I would like to remind dear listeners and spectators that medicines are compared on such an indicator as relative risk. In the event that this indicator is equal to one, these drugs in a double-blind, randomized clinical trial are equivalent. If this indicator exceeds one, then the first drug, which is compared, exceeds the second drug in its effectiveness.

15:43

(Slide show).

Let’s look at this table.

You can see that when comparing “Pantoprazole” at a dose of 40 mg and “Omeprazole” at a dose of 20 mg (that is, the dosages indicated in the instructions for use), as a result, according to the analysis of studies that included 604 patients, it turned out that the relative the risk is close to unity. There was no significant difference in efficacy between the two PPIs.

Comparison of Lansoprazole and Omeprazole in standard dosages. When analyzing a cohort of more than 1800 people, there were also no significant differences in the effectiveness of these two PPIs in the treatment of gastroesophageal reflux disease within 4 weeks.

When analyzing randomized clinical trials involving more than 400 people, no difference was shown between Rabeprazole and Omeprazole.

When comparing two drugs – “Esomeprazole” and “Omeprazole”, it was demonstrated that “Esomeprazole” is slightly superior in its effectiveness to “Omeprazole” in the treatment of gastroesophageal reflux disease within 4 weeks.

Now we will review with you the results of randomized clinical trials on ulcer healing within 4 weeks.

Summarizing the data presented here, it can be understood that for this indicator, the IPI does not show a statistically significant difference. Similarly, in a study comparing Pantoprazole and Omeprazole, approximately the same results were demonstrated, but Pantoprazole turned out to be somewhat more effective.

Finally, comparing eradication regimens (as discussed in the first two lectures) using the same regimens – that is, using the same antibacterial agents and different PPIs – also showed the expected result.

The relative risk is approximately the same when prescribing, according to the study, Lansoprazole and Omeprazole, Rabeprazole and Lansoprazole, Rabeprazole and Omeprazole in the same comparable schemes.

Thus, dear colleagues, we can now imagine and know that there is such a concept – equivalent dosages. They lead to the achievement of the same therapeutic effect.