Pantoprazole: medicine to lower stomach acid

1. About pantoprazole

Pantoprazole reduces the amount of acid your stomach makes.

It’s used for heartburn, acid reflux and gastro-oesophageal reflux disease (GORD) – GORD is when you keep getting acid reflux. It’s also taken to prevent and treat stomach ulcers.

Sometimes, pantoprazole is taken for a rare condition caused by a tumour in the pancreas or gut called Zollinger-Ellison syndrome.

Pantoprazole comes as tablets.

All types of pantoprazole are available on prescription. You can also buy lower-strength 20mg tablets from pharmacies for heartburn or acid reflux.

2. Key facts

• You’ll usually take pantoprazole once a day in the morning.
• The most common side effects are headaches and diarrhoea. These tend to be mild and go away when you stop taking the medicine.
• You should start to feel better in 2 to 3 days, but it may take up to 4 weeks for pantoprazole to fully control your symptoms.
• If you’ve bought pantoprazole without a prescription and your symptoms do not improve after 2 weeks, see a doctor before taking any more.
• Pantoprazole is not usually recommended during pregnancy.

3. Who can and cannot take pantoprazole

Adults and children aged 12 years and over can take pantoprazole.

Pantoprazole is not suitable for some people. To make sure it’s safe for you, tell your doctor if you:

• have ever had an allergic reaction to pantoprazole or any other medicine
• have liver problems
• are pregnant, trying to get pregnant or breastfeeding
• are due to have an endoscopy

If you’re going to have an endoscopy, ask your doctor if you should stop taking pantoprazole a few weeks before your procedure. This is because pantoprazole may hide some of the problems that would usually be spotted during an endoscopy.

4. How and when to take pantoprazole

You’ll usually take pantoprazole once a day, first thing in the morning.

If you take pantoprazole twice a day, take 1 dose in the morning and 1 dose in the evening.

Dosage and strength

Each tablet contains 20mg or 40mg of pantoprazole.

You can buy pantoprazole 20mg tablets from pharmacies. These are suitable for the short-term treatment of heartburn and acid reflux in adults.

The usual dose to treat:

• heartburn and acid reflux is 20mg a day
• gastro-oesophageal reflux disease is 20mg to 40mg a day
• stomach ulcers is 20mg to 40mg a day
• Zollinger-Ellison syndrome is 40mg to 80mg a day – this can increase to 160mg a day depending on how well it works for you

Doses are usually lower for people with liver problems.

How to take it

It’s best to take pantoprazole an hour before a meal. Swallow tablets whole with a drink of water.

Changes to your dose

Sometimes your doctor will increase your dose of pantoprazole if it’s not working well enough.

Depending on the reason you take pantoprazole, you may take a higher dose to begin with, usually for a month or 2. After this, your doctor may recommend that you take a lower dose.

How long to take it for

If you buy pantoprazole from a pharmacy, you can usually take it for up to 2 weeks.

After 2 weeks:

• if your symptoms have improved, you can take it for another 2 weeks
• if your symptoms have not improved or they are worse, speak to a doctor before taking any more pantoprazole

Do not take pantoprazole for more than 4 weeks without speaking to your doctor first. If your symptoms have not improved, you may need some tests to find out what’s causing them.

If you take pantoprazole on prescription, you may only need to take it for a few weeks or months, depending on your condition. Sometimes your doctor may advise you to take it for longer, even for many years.

Some people do not need to take pantoprazole every day and take it only when they have symptoms. Once you feel better (often after a few days or weeks), you can stop taking it.

Taking pantoprazole just on days when you have symptoms is not suitable for everyone. Speak to your doctor about what’s best for you.

If you forget to take it

If you usually take pantoprazole:

• once a day – take the missed dose as soon as you remember, unless your next dose is due in less than 12 hours in which case skip the missed dose and take the next one at the usual time
• twice a day – take the missed dose as soon as you remember, unless your next dose is due in less than 4 hours in which case skip the missed dose and take the next one at the usual time

Never take a double dose to make up for a forgotten one.

If you often forget doses, it may help to set an alarm to remind you. You could also ask your pharmacist for advice on other ways to remember to take your medicine.

If you take too much

It is very unlikely that taking extra doses of pantoprazole will cause any problems. But if you’re concerned, contact your doctor.

5. Side effects

Most people who take pantoprazole do not have any side effects. If you do get a side effect, it is usually mild and will go away when you stop taking pantoprazole.

These side effects happen in 1 in 100 people. Talk to your pharmacist or doctor if these side effects bother you or do not go away:

• headaches
• diarrhoea

Serious side effects

Serious side effects are rare and happen in less than 1 in 1,000 people.

Call a doctor or contact 111 straight away if you have:

• joint pain along with a red skin rash, especially on parts of your body exposed to the sun, such as your arms, cheeks and nose (this may be less noticeable on brown or black skin) – these can be signs of a rare condition called subacute cutaneous lupus erythematosus. This can happen even if you’ve been taking pantoprazole for a long time
• stomach pain that gets worse, the whites of your eyes turn yellow or your skin turns yellow (this may be less obvious on brown or black skin), or dark pee – these can be signs of liver problems
• pain when you pee, peeing less than usual, lower back pain, swollen ankles, and rash or a high temperature – these can be signs of a kidney problem
• severe or persistent diarrhoea – this can be a sign of an inflamed bowel

Go to 111. nhs.uk or call 111.

Serious allergic reaction

In rare cases, it’s possible to have a serious allergic reaction (anaphylaxis) to pantoprazole.

Immediate action required: Call 999 or go to A&E now if:

• you get a skin rash that may include itchy, red, swollen, blistered or peeling skin
• you’re wheezing
• you get tightness in the chest or throat
• you have trouble breathing or talking
• your mouth, face, lips, tongue or throat start swelling

You could be having a serious allergic reaction and may need immediate treatment in hospital.

These are not all the side effects of pantoprazole. For a full list see the leaflet inside your medicine packet.

Information:

You can report any suspected side effect using the Yellow Card safety scheme.

Visit Yellow Card for further information.

6. How to cope with side effects of pantoprazole

What to do about:

• headaches – make sure you rest and drink plenty of fluids. It’s best not to drink too much alcohol. Ask your pharmacist to recommend a painkiller. Headaches usually go away after the first week of taking pantoprazole. Talk to your doctor if they last longer than a week or are severe.
• diarrhoea – drink plenty of water or squash by having small, frequent sips to avoid dehydration. Signs of dehydration include peeing less than usual or having dark, strong-smelling pee. Do not take any other medicines to treat diarrhoea without speaking to a pharmacist or doctor. If diarrhoea does not get better, talk to your doctor.

7. Pregnancy and breastfeeding

Pantoprazole and pregnancy

Pantoprazole is not usually recommended if you’re pregnant because there is little information about its use during pregnancy. Your doctor may recommend a similar medicine called omeprazole instead as there is more safety information available.

You may wish to try to treat your symptoms without taking medicine. You can try eating smaller meals more often, and avoiding fatty and spicy foods. Sit up straight when you eat, as this will take the pressure off your stomach.

If you get symptoms at night, you could prop your head and shoulders up when you go to bed. This helps to stop stomach acid coming up while you sleep.

Pantoprazole and breastfeeding

If your doctor or health visitor says your baby is healthy, it’s OK to take pantoprazole while you’re breastfeeding.

There is a little information available which shows that pantoprazole passes into breast milk in tiny amounts and your baby will not absorb a lot into their body from the breast milk.

It is unlikely that pantoprazole will cause any side effects in your baby.

Non-urgent advice: Tell your doctor if you’re:

• trying to get pregnant
• pregnant
• breastfeeding

8. Cautions with other medicines

Some medicines and pantoprazole can affect each other and make you more likely to have side effects or stop one of the medicines working as well.

Tell your doctor if you’re taking any of these medicines before you start pantoprazole treatment:

• antifungal medicines such as itraconazole, ketoconazole, posaconazole and voriconazole
• fluvoxamine, an antidepressant
• methotrexate, a medicine used to treat cancer, psoriasis and rheumatoid arthritis
• HIV medicines
• rifampicin, an antibiotic
• medicines that hep to prevent blood clots, such as warfarin

Mixing pantoprazole with herbal remedies and supplements

Do not take St John’s wort, the herbal remedy for depression, while you’re taking pantoprazole. St John’s wort may stop pantoprazole working as well as it should.

There’s not enough information to say that other complementary medicines and herbal remedies are safe to take with pantoprazole. They’re not tested in the same way as pharmacy and prescription medicines. They’re generally not tested for the effect they have on other medicines.

Important:
Medicine safety

Tell your doctor or pharmacist if you’re taking any other medicines, including herbal medicines, vitamins or supplements.

9. Common questions about pantoprazole

How does pantoprazole work?

Pantoprazole is a type of medicine called a proton pump inhibitor (PPI).

Proton pumps are enzymes in the lining of your stomach that help it make acid to digest your food.

Pantoprazole prevents proton pumps from working properly. This reduces the amount of acid the stomach makes.

When will I feel better?

You should start to feel better within 2 to 3 days. It may take up to 4 weeks for pantoprazole to work properly so you may still have some symptoms during this time.

If you bought pantoprazole without a prescription, and feel no better after 2 weeks, tell your doctor. They may want to do tests or change you to a different medicine.

Can I take pantoprazole for a long time?

If you’ve bought pantoprazole from a pharmacy without a prescription, do not take it for more than 4 weeks without speaking to your doctor.

If you take pantoprazole for more than 3 months, the levels of magnesium in your blood may fall.

Low magnesium can make you feel tired, confused and dizzy and cause muscle twitches, shakiness and an irregular heartbeat. If you get any of these symptoms, tell your doctor.

Taking pantoprazole for more than a year may increase your chances of certain side effects, including:

• bone fractures
• gut infections
• vitamin B12 deficiency – symptoms include feeling very tired, a sore and red tongue, mouth ulcers and pins and needles

If you take pantoprazole for longer than 1 year your doctor will regularly check your health to see if you should carry on taking it.

It’s not known if pantoprazole works less well the longer you take it. If you feel that it’s not working any more, talk to your doctor.

Does taking pantoprazole for a long time cause stomach cancer?

There is some information to suggest people taking medicines that reduce stomach acid, like proton pump inhibitors (PPIs) such as pantoprazole and h3 blockers, might have a very small increased chance of developing stomach cancer. It could be more likely in people taking them for longer than 3 years.

But studies involving more people need to be done to be sure that PPIs and h3 blockers cause stomach cancer, rather than something else causing it.

PPIs, like most medicines, can have side effects so it’s best to take them for the shortest time possible.

And it’s important to speak to your doctor if you notice any of these symptoms which can be signs of stomach cancer:

• having problems swallowing (dysphagia)
• feeling or being sick
• feeling full very quickly when eating
• losing weight without trying to

Speak to your doctor or pharmacist if you’re concerned.

How do I stop taking pantoprazole?

Usually, you can stop taking pantoprazole without reducing the dose first.

But if you’ve taken pantoprazole for a long time, speak to your doctor before you stop taking it. Stopping suddenly could make your stomach produce a lot more acid, and make your symptoms come back.

Reducing the dose gradually before stopping completely will prevent this happening.

Are there similar medicines?

There are 4 other medicines that are similar to pantoprazole:

• lansoprazole
• omeprazole
• esomeprazole
• rabeprazole

Like pantoprazole, these medicines are proton pump inhibitors. They work in the same way to reduce acid in your stomach. They generally work as well as pantoprazole and have similar side effects. However, they may be given in different doses to pantoprazole.

Sometimes, if pantoprazole is not working for you or you get side effects, your doctor may suggest that you try taking another proton pump inhibitor.

Are there other indigestion medicines?

There are other prescription medicines and ones you can buy that treat indigestion and heartburn.

Antacids

Antacids, like calcium carbonate (Tums), sodium bicarbonate, Maalox and Milk of Magnesia, relieve indigestion and heartburn by reducing the damage of acid in your stomach. They give quick relief that lasts for a few hours. They’re ideal for occasional stomach acid symptoms.

Some antacids, such as Gaviscon, have an extra ingredient called alginic acid. They work by lining your stomach so that juices from it do not splash up into your food pipe. They’re especially good for relieving acid reflux.

Antacids are available from pharmacies and supermarkets.

h3 blockers

Histamine antagonists (commonly called h3 blockers) reduce the amount of acid made in your stomach, but they do this in a different way to proton pump inhibitors.

They include famotidine (Pepcid), cimetidine (Tagamet) and nizatidine.

In general, proton pump inhibitors like pantoprazole are used first because they are better than h3 blockers at reducing stomach acid.

However, if a proton pump inhibitor does not suit you (for example, because of side effects), your doctor may prescribe an h3 blocker.

You can buy famotidine and nizatidine without a prescription from pharmacies.

Can I take pantoprazole with an antacid?

You can take pantoprazole with an antacid like Gaviscon.

Can I take painkillers with it?

Yes, it’s safe to take painkillers such as paracetamol or ibuprofen at the same time as pantoprazole.

It’s best to take ibuprofen with, or just after, a meal so it does not upset your stomach.

Will it affect my fertility?

There’s no evidence to suggest that taking pantoprazole will reduce fertility in either men or women.

However, speak to a pharmacist or your doctor if you’re trying to get pregnant as they may want to review your treatment.

Will it affect my contraception?

Pantoprazole does not affect any type of regular contraception, including the combined pill. But it may reduce the effectiveness of one type of emergency contraception called ellaOne (ulipristal), so a different form of emergency contraceptive may be recommended instead.

If pantoprazole gives you severe diarrhoea for more than 24 hours, your contraceptive pills may not protect you from pregnancy. Check the pill packet to find out what to do.

Find out what to do if you’re on the pill and have diarrhoea.

Can I drive or ride a bike?

Pantoprazole can make you feel dizzy or sleepy, or affect your vision. If this happens to you, do not drive, cycle or use machinery or tools until you feel better.

It’s an offence to drive a car if your ability to drive safely is affected. It’s your responsibility to decide if it’s safe to drive. If you’re in any doubt, do not drive.

Talk to your doctor or pharmacist if you’re unsure whether it’s safe for you to drive while taking pantoprazole. GOV.UK has more information on the law on drugs and driving.

Is there any food or drink I need to avoid?

You can eat and drink normally while taking pantoprazole, but it’s best to take it an hour before a meal.

It’s best to avoid foods that seem to make your symptoms worse, such as rich, spicy and fatty foods. It also helps to cut down on caffeinated drinks, such as tea, coffee and cola, as well as alcohol.

Can I drink alcohol with it?

Alcohol does not affect the way pantoprazole works. However, it’s best not to drink too much alcohol because drinking alcohol makes your stomach produce more acid than normal. This can irritate your stomach lining and make your symptoms worse.

Can lifestyle changes help?

It may be possible to ease symptoms caused by too much stomach acid by making a few changes to your diet and lifestyle.

• Maintain a healthy weight by eating healthily.
• Avoid foods that can make your symptoms worse, such as rich, spicy and fatty foods, and acidic foods like tomatoes, citrus fruits, salad dressings and fizzy drinks.
• Cut down on caffeinated drinks, such as tea, coffee and cola.
• Cut down on alcohol.
• Quit smoking if you can.
• Sit up straight when you eat. This will take the pressure off your stomach.
• If you have symptoms at night, try not to eat for at least 3 hours before you go to bed.
• Prop your head and shoulders up when you go to bed. This can stop stomach acid coming up while you sleep.

Side effects, dosage, uses, and more

1. Pantoprazole oral tablet is available as both a generic and a brand-name drug. Brand name: Protonix.
2. Pantoprazole comes in three forms: an oral tablet, an oral liquid suspension, and an intravenous (IV) form that’s injected into your vein by a healthcare professional.
3. Pantoprazole oral tablet is used to reduce the amount of stomach acid your body makes. It helps treat painful symptoms caused by conditions such as gastroesophageal reflux disease (GERD).

• Long-term use warning: Long-term use of pantoprazole can lead to an increased risk of certain side effects and complications. These include:
  • Increased risk of bone fracture in people taking higher, multiple daily doses for more than 1 year.
  • Vitamin B12 deficiency, which can lead to serious nerve damage and deteriorating brain functions. This has been seen in some people taking pantoprazole for longer than 3 years.
  • Chronic inflammation of the stomach’s lining (atrophic gastritis) when taking pantoprazole long term. People with H. pylori are particularly at risk.
  • Low blood magnesium (hypomagnesemia), which has been seen in some people taking pantoprazole for as few as 3 months. More often, it occurs after a year or more of treatment.
• Severe diarrhea warning: Severe diarrhea caused by Clostridium difficile bacteria can occur in some people treated with pantoprazole, especially hospitalized people.
• Allergy warning: Though it’s rare, pantoprazole can cause an allergic reaction. Symptoms could include rash, swelling, or breathing problems. This can progress to interstitial nephritis, a kidney disorder that can lead to kidney failure. Symptoms of this condition include:
  • nausea or vomiting
  • fever
  • rash
  • confusion
  • blood in your urine
  • bloating
  • elevated blood pressure
• Cutaneous lupus erythematosus and systemic lupus erythematosus warning: Pantoprazole can cause cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE). CLE and SLE are autoimmune diseases. Symptoms of CLE can range from a rash on the skin and nose, to a raised, scaly, red, or purple rash on certain parts of the body. Symptoms of SLE can include fever, tiredness, weight loss, blood clots, heartburn, and stomach pain. If you have any of these symptoms, call your doctor.
• Fundic gland polyps warning: Long-term use (especially over 1 year) of pantoprazole can cause fundic gland polyps. These polyps are growths on the lining of your stomach that can become cancerous. To help prevent these polyps, you should use this drug for as short a time as possible.

Pantoprazole oral tablet is a prescription drug that’s available as the brand-name drug Protonix. It’s also available as a generic drug. Generic drugs usually cost less than the brand-name version. In some cases, they may not be available in all strengths or forms as the brand-name drug.

Pantoprazole comes in three forms: an oral tablet, an oral liquid suspension, and an intravenous (IV) form that’s injected into your vein by a healthcare professional.

Why it’s used

Pantoprazole oral tablet is used to reduce the amount of stomach acid your body makes. It helps treat painful symptoms caused by conditions such as gastroesophageal reflux disease (GERD). With GERD, gastric juices flow upward from your stomach and into the esophagus.

Pantoprazole oral tablet is also used to treat other conditions in which the stomach makes excess acid, such as Zollinger-Ellison syndrome.

How it works

Pantoprazole belongs to a class of drugs called proton pump inhibitors. It works to shut off the acid-pumping cells in your stomach. It reduces the amount of stomach acid and helps to reduce painful symptoms related to conditions such as GERD.

Pantoprazole oral tablet does not cause drowsiness. However, it can cause other side effects.

More common side effects

The more common side effects that can occur with pantoprazole include:

• headache
• diarrhea
• stomach pain
• nausea or vomiting
• gas
• dizziness
• joint pain

Serious side effects

Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life threatening or if you think you’re having a medical emergency. Serious side effects and their symptoms can include the following:

• Low magnesium levels. Using this drug for 3 months or longer can cause low magnesium levels. Symptoms can include:
  • seizures
  • abnormal or fast heart rate
  • tremors
  • jitteriness
  • muscle weakness
  • dizziness
  • spasms of your hands and feet
  • cramps or muscle aches
  • loss of taste

• Vitamin B12 deficiency. Using this drug for longer than 2 years can make it harder for your body to absorb vitamin B12. Symptoms can include:

• nervousness
  • neuritis (inflammation of a nerve)
  • numbness or tingling in your hands and feet
  • poor muscular coordination changes in menstruation
• Severe diarrhea. This may be caused by a Clostridium difficile infection in your intestines. Symptoms can include:
  • watery stool
  • stomach pain
  • fever that doesn’t go away
• Bone fractures
• Kidney damage. Symptoms can include:
  • flank pain (pain in your side and back)
  • changes in urination
• Cutaneous lupus erythematosus (CLE). Symptoms can include:
  • rash on the skin and nose
  • raised, scaly, red, or purple rash on your body
• Systemic lupus erythematosus (SLE). Symptoms can include:
  • fever
  • tiredness
  • weight loss
  • blood clots
  • heartburn
• Fundic gland polyps (typically asymptomatic, but may cause symptoms)

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this information includes all possible side effects. This information is not a substitute for medical advice. Always discuss possible side effects with a healthcare professional who knows your medical history.

Pantoprazole oral tablet can interact with other medications, herbs, or vitamins you might be taking. That’s why your doctor should manage all of your medications carefully. If you’re curious about how this drug might interact with something else you’re taking, talk with your doctor or pharmacist.

To help avoid interactions, your doctor should manage all of your medications carefully. Be sure to tell your doctor about all medications, vitamins, or herbs you’re taking. To find out how this drug might interact with something else you’re taking, talk with your doctor or pharmacist.

Examples of drugs that can cause interactions with pantoprazole are listed below.

HIV drugs

Taking certain HIV drugs with pantoprazole is not recommended. Pantoprazole may significantly decrease the amount of these drugs in your body. This can reduce their ability to control HIV infection. These drugs are:

• atazanavir
• nelfinavir

Anticoagulant

Some people taking warfarin with pantoprazole can experience increases in INR and prothrombin time (PT). This can lead to an increased risk of severe bleeding. If you take these drugs together, your doctor should monitor you for increases in INR and PT.

Drugs affected by stomach pH

Pantoprazole affects stomach acid levels. As a result, it can reduce your body’s absorption of certain drugs that are sensitive to the effects of decreased stomach acid. This effect can make these drugs less effective.

Examples of these drugs include:

• ketoconazole
• ampicillin
• atazanavir
• iron salts
• erlotinib
• mycophenolate mofetil

Cancer drug

Taking methotrexate with pantoprazole may increase the amount of methotrexate in your body. If you’re taking high doses of methotrexate, your doctor may have you stop taking pantoprazole during your methotrexate therapy.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs interact differently in each person, we cannot guarantee that this information includes all possible interactions. This information is not a substitute for medical advice. Always speak with your healthcare professional about possible interactions with all prescription drugs, vitamins, herbs and supplements, and over-the-counter drugs that you’re taking.

Pantoprazole oral tablet comes with several warnings.

Allergy warning

Though it’s rare, pantoprazole can cause an allergic reaction. Symptoms may include rash, swelling, or breathing problems.

This allergic reaction can progress to interstitial nephritis, a kidney disorder that can lead to kidney failure. Symptoms of this condition include:

• nausea or vomiting
• fever
• rash
• confusion
• blood in your urine
• bloating
• elevated blood pressure

If you experience any of these symptoms, call your doctor right away. If your symptoms seem severe or life threatening, go to an emergency room or call 911.

Warnings for people with certain health conditions

For people with osteoporosis: Pantoprazole can increase a person’s risk for osteoporosis, a condition that causes bones to become brittle. Tell your doctor if you have a history of osteoporosis.

For people with low blood magnesium (hypomagnesemia): Pantoprazole can decrease the amount of magnesium in your body. Tell your doctor if you have a history of hypomagnesemia.

For people being tested for neuroendocrine tumors: Pantoprazole can cause incorrect results in these tests. For this reason, your doctor will have you stop taking this drug at least 14 days before you have this testing. They may also have you repeat the testing if needed.

Warnings for other groups

Pregnant people: If you’re pregnant or plan to become pregnant, speak with your doctor about this drug.

Studies of the drug in pregnant animals have shown risk to the fetus. There aren’t enough studies of pregnant people to show that the drug poses a risk to the fetus.

Those who are breastfeeding: Pantoprazole may pass through breast milk and could be passed to a breastfeeding baby. Talk with your healthcare professional about other treatment options while breastfeeding.

For children: Pantoprazole is sometimes used for short-term treatment of erosive esophagitis in children ages 5 and older. This condition is associated with GERD. It causes irritation and damage to the throat from stomach acid. Your child’s doctor will provide the correct dose.

This dosage information is for pantoprazole oral tablet. All possible dosages and forms may not be included here. Your dose, form, and how often you take it will depend on:

• your age
• the condition being treated
• the severity of your condition
• other medical conditions you have
• how you react to the first dose

Forms and strengths

Generic: Pantoprazole

• Form: oral tablet
• Strengths: 20 mg and 40 mg

Brand: Protonix

• Form: oral tablet
• Strengths: 20 mg and 40 mg

Dosage for gastroesophageal reflux disease (GERD)

Adult dosage (ages 18 years and older)

Typical dosage: 20 mg to 40 mg per day, taken once a day with or without food, depending on severity.

Child dosage (ages 5–17 years)

• Typical dosage: 1 mg to 2 mg per kilogram of body weight per day to a maximum of 40 mg per day.

Dosage for excess acid production, such as Zollinger-Ellison syndrome

Adult dosage (ages 18 years and older)

• Typical dosage: Initial dose of 80 mg twice daily, with or without food, up to a maximum of 240 mg per day.

Child dosage (ages 0–17 years)

A safe and effective dose hasn’t been established for children in this age range.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this list includes all possible dosages. This information is not a substitute for medical advice. Always speak with your doctor or pharmacist about dosages that are right for you.

Pantoprazole oral tablet may be prescribed for either short-term or long-term use. How long you take it will depend on the type and severity of your condition. It comes with serious risks if you don’t take it as prescribed.

If you don’t take it or stop taking it: If you don’t take the drug at all or stop taking it, you risk decreased ability to control your symptoms of GERD.

If you don’t take it on schedule: Not taking pantoprazole every day, skipping days, or taking doses at different times of day may also decrease your control of GERD.

What to do if you miss a dose: If you miss a dose, take the next dose as planned. Do not double your dose.

How to tell if the drug is working: You can tell that pantoprazole is working if it reduces your GERD symptoms, such as:

• heartburn
• nausea
• difficulty swallowing
• regurgitation
• sensation of a lump in your throat

Keep these considerations in mind if your doctor prescribes pantoprazole oral tablet for you.

General

• You can take this form with or without food. Take it at the same time every day for the best effects.
• Don’t cut, crush, or chew this medication.

Storage

• Store this drug at room temperature between 68°F and 77°F (20°C and 25°C).
• You can store it for a short time at temperatures as low as 59°F (15°C) and as high as 86°F (30°C).

Refills

A prescription for this medication is refillable. You should not need a new prescription for this medication to be refilled. Your doctor will write the number of refills authorized on your prescription.

Clinical monitoring

Pantoprazole can lower magnesium levels in certain people. Your doctor may suggest having your blood magnesium levels monitored if you’re treated with pantoprazole for 3 months or more.

Travel

When traveling with your medication:

• Always carry your medication with you. When flying, never put it into a checked bag. Keep it in your carry-on bag.
• Don’t worry about airport X-ray machines. They won’t damage your medication.
• You may need to show airport staff the pharmacy label for your medication. Always carry the original prescription-labeled container with you.
• Don’t put this medication in your car’s glove compartment or leave it in the car. Be sure to avoid doing this when the weather is very hot or very cold.

Possible alternatives to the oral tablet include:

• lansoprazole
• esomeprazole
• omeprazole
• rabeprazole
• dexlansoprazole

Talk with your doctor about other drug options that may work for you.

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.

Physical and chemical properties and control methods of pantoprazole sodium sesquihydrate (review) | Shelekhova

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Pantoprazole – official manufacturer’s instructions: how to take, dosage, composition

Composition

active substance : pantoprazole;

1 bottle contains pantoprazole sodium sesquihydrate equivalent to pantoprazole 40.0 mg;

excipients : sodium edetate, sodium hydroxide.

Dosage form

Lyophilisate for solution for injection.

Basic physical and chemical properties : Freeze-dried porous mass or powder from white to almost white.

Pharmacotherapeutic group

A drug for the treatment of acid-related diseases. proton pump inhibitors.

ATX code A02B C02.

Pharmacodynamics

Pantoprazole – replaced by benzimidazole, which inhibits the secretion of hydrochloric acid in the stomach by specific blockade of the proton pumps of parietal cells. Pantoprazole is transformed into an active form in an acidic environment in parietal cells, where it inhibits the enzyme H + -K + -AT phase, that is, it blocks the final stage of hydrochloric acid production in the stomach. The inhibition is dose dependent and inhibits both basal and stimulated acid secretion. These manifestations in most patients disappear within 2 weeks. The use of pantoprazole, like other proton pump inhibitors (PPIs) and h3 receptor inhibitors, reduces acidity in the stomach and thus increases gastrin secretion in proportion to the decrease in acidity. The increase in gastrin secretion is reversible. Since pantoprazole binds the enzyme distally to the cellular receptor, it can inhibit the secretion of hydrochloric acid, regardless of stimulation by other substances (acetylcholine, histamine, gastrin). The effect of oral and intravenous use is the same.

When using pantoprazole, the level of gastrin on an empty stomach increases. With short-term use of pantoprazole, the level of gastrin in most cases does not exceed the upper limit of normal. With long-term treatment, the level of gastrin in most cases doubles. An excessive increase in gastrin, however, is rare. As a consequence, sometimes with long-term treatment, there is a slight or moderate increase in the number of enterochromaffin-like cells (ECL cells) in the stomach (similar to adenomatoid hyperplasia). However, according to current studies, the formation of progenitor cells of neuroendocrine tumors (atypical hyperplasia) or neuroendocrine tumors of the stomach in humans has not been observed.

Given the results of animal studies, the effect of long-term (more than one year) treatment with pantoprazole on endocrine parameters of the thyroid gland cannot be completely excluded.

During treatment with antisecretory drugs, the level of gastrin in the blood serum increases in response to a decrease in acid secretion. In addition, chromogranin A (CgA) levels increase due to a decrease in stomach acidity. Elevated levels of CgA may affect the results of studies in the diagnosis of neuroendocrine tumors. Available published data suggest that treatment with proton pump inhibitors should be discontinued within a period of 5 days to 2 weeks before CgA levels are measured. This allows the CgA level, which may be incorrectly elevated after PPI treatment, to return to the normal range.

Pharmacokinetics

Suction . Pantoprazole is rapidly absorbed, and the maximum plasma concentration (C max) is reached after a single dose of 40 mg. On average, 2.5 hours after administration, the maximum serum concentration is reached at a level of about 2-3 μg / ml, the concentration remains stable after repeated administration. Pharmacokinetic properties do not change after a single or repeated administration. In the dose range from 10 to 80 mg, the pharmacokinetics of pantoprazole in blood plasma remains linear, both when administered orally and intravenously. It is established that the bioavailability of tablets is about 77%. Simultaneous ingestion of food does not affect the area under the concentration-time curve (AUC) or maximum concentration, and, accordingly, bioavailability. With the simultaneous intake of food, only the variability of the latent period increases.

Distribution. The binding of pantoprazole to plasma proteins is 98%. The volume of distribution is about 0.15 l/kg.

Metabolism. Pantoprazole is metabolized almost exclusively in the liver. The main metabolic pathway is demethylation by CYP2C19 followed by sulfur conjugation; in other metabolic pathways belongs to oxidation by CYP3A4.

Output . The terminal half-life is about 1 hour, and the clearance is 0.1 l / h / kg. Several cases of withdrawal delays have been noted. Due to the specific binding of pantoprazole to the parietal cell proton pump, the half-life does not correlate with a longer duration of action (inhibition of acid secretion).

The main part of pantoprazole metabolites is excreted in the urine (about 80%), the rest is excreted in the feces. The main metabolite in both serum and urine is desmethylpantoprazole conjugated with sulfate. The half-life of the main metabolite (about 1.5 hours) is not much longer than the half-life of pantoprazole.

Features of the use of certain groups of patients.

Slow metabolisers. 3% of Europeans have a low functional activity of the CYP2C19 enzyme; they are called slow metabolizers. In the organisms of such individuals, the metabolism of pantoprazole is probably mainly catalyzed by the CYP3A4 enzyme. After taking a single dose of 40 mg of pantoprazole, the mean area limited by the plasma concentration-time pharmacokinetic curve was approximately 6 times greater in slow metabolizers than in individuals with a functionally active CYP2C19 enzyme.(fast metabolizers). The maximum plasma concentration increased by about 60%. These results do not affect the dosage of pantoprazole.

Impaired kidney function. There are no dose reduction recommendations for pantoprazole in patients with impaired renal function (including dialysis patients). As in healthy volunteers, the half-life of pantoprazole is short. Only a very small amount of pantoprazole is dialyzed. Despite the fact that the main metabolite has a moderately long half-life (2-3 hours), the elimination is still fast, so cumulation does not occur.

Impaired liver function. Although in patients with liver cirrhosis (Child-Pugh A and B), the half-life is increased to 7-9 hours, and the AUC increases by 5-7 times, the maximum serum concentration increases only slightly – 1.5 times compared to healthy volunteers.

Elderly patients. The slight increase in AUC and Cmax in elderly volunteers compared to younger volunteers is also of no clinical significance.

Children. After a single dose of 20 or 40 mg of pantoprazole orally, AUC and Cmax at 5 to 16 years of age were within the corresponding values ​​in adults. After a single administration of pantoprazole at a dose of 0.8 or 1.6 mg/kg to children aged 2 to 16 years, there was no significant relationship between the clearance of pantoprazole and the age or body weight of the patient. AUC and volume of distribution with data from studies in adults.

Readings

1. Reflux esophagitis.

2. Duodenal ulcer.

3. Gastric ulcer.

4. Zollinger-Ellison syndrome and other hypersecretory pathological conditions.

Contraindications

Hypersensitivity to pantoprazole, benzimidazole derivatives or any other component of the drug.

Interaction with other medicinal products and other forms of interaction

Effect of pantoprazole on the absorption of other medicinal products. As a result of complete and prolonged inhibition of hydrochloric acid secretion, pantoprazole may reduce the absorption of drugs whose bioavailability depends on gastric pH (for example, some antifungal drugs such as ketoconazole, itraconazole, posaconazole or other drugs such as erlotinib).

HIV protease inhibitors . The combined use of pantoprazole with HIV protease inhibitors (such as atazanavir), the absorption of which depends on intragastric pH, is not recommended due to a significant decrease in their bioavailability (see section “Peculiarities of use”).

If co-administration of HIV protease inhibitors with proton pump inhibitors cannot be avoided, careful clinical monitoring (eg, viral load) is recommended. Do not exceed the daily dose of pantoprazole 20 mg. It may be necessary to adjust the dose of HIV protease inhibitors.

Indirect anticoagulants (phenprocoumon and warfarin) . Co-administration of pantoprazole with warfarin or phenprocoumon did not affect the pharmacokinetics of warfarin, phenprocoumon or PNI (international normalized index). However, an increase in MNI and a prolongation of prothrombin time have been reported in patients who co-administered PPIs with warfarin or phenprocoumon. An increase in MNI and a prolongation of prothrombin time can lead to the development of pathological bleeding and even death. In the case of such combined use, monitoring of PIM and PV is necessary.

Methotrexate . It has been reported that the simultaneous use of high doses of methotrexate (eg, 300 mg) and proton pump inhibitors increases the level of methotrexate in the blood in some patients. Patients taking high doses of methotrexate, such as patients with cancer or psoriasis, are advised to temporarily stop treatment with pantoprazole.

Medicinal products that inhibit or induce CYP2C19. CYP2C19 inhibitorssuch as fluvoxamine may increase the systemic exposure of pantoprazole. The need to reduce the dose of the drug should be considered for patients receiving long-term therapy with pantoprazole in high doses, and for patients with impaired liver function. Inducers of enzymes that affect CYP2C19 and CYP3A4, such as rifampicin and St. John’s wort (Hypericum perforatum), may reduce plasma concentrations of PPIs that are metabolized through these enzyme systems.

Other interactions. Pantoprazole is extensively metabolized in the liver via the cytochrome P450 enzyme system. The main metabolic pathway is demethylation by 2C19 and other metabolic pathways, including oxidation by the CYP3A4 enzyme. Studies with drugs that are also metabolized via these pathways, such as carbamazepine, diazepam, glibenclamide, nifedipine, and oral contraceptives containing levonorgestrel and ethinylestradiol, did not reveal clinically significant interactions.

An interaction of pantoprazole with other drugs that are metabolized through the same enzyme system cannot be ruled out.

It has been found that pantoprazole does not affect the metabolism of active substances that are metabolized by CYP1A2 (such as caffeine, theophylline), CYP2C9 (such as piroxicam, diclofenac, naproxen), CYP2D6 (such as metoprolol), CYP2E1 (such as ethanol), does not affect p-glycoprotein, which ensures the absorption of digoxin.

There was no interaction with concomitantly prescribed antacids.

It was reported that the interaction of pantoprazole with concomitantly prescribed certain antibiotics (clarithromycin, metronidazole, amoxicillin) did not reveal clinically significant interactions between these drugs.

Application features

Malignant neoplasms of the stomach . Symptomatic response to the use of pantoprazole may mask the symptoms of malignant neoplasms of the stomach and delay their diagnosis. If there are warning signs (eg, significant weight loss, intermittent vomiting, dysphagia, hematemesis, anemia, melena), or if a gastric ulcer is suspected or present, malignancy should be ruled out because treatment with pantoprazole may mask the symptoms of a malignant ulcer and delay establishing a diagnosis. If symptoms persist with further adequate treatment, an additional examination is necessary.

Liver dysfunction. Patients with severe hepatic impairment should have their liver enzyme levels monitored regularly. In the event of an increase in the level of liver enzymes, treatment must be discontinued.

HIV protease inhibitors . The combined use of pantoprazole with HIV protease inhibitors (such as atazanavir), the absorption of which depends on intragastric pH, is not recommended due to a significant decrease in their bioavailability (see section “Interaction with other drugs and other types of interactions”).

Vitamin B12 absorption . In patients with Zollinger-Ellison syndrome and other hypersecretory pathological conditions requiring long-term treatment, pantoprazole, like all drugs that block the production of hydrochloric acid, can reduce the absorption of vitamin B12 (cyanocobalamin) due to the occurrence of hypo- and achlorhydria. This should be considered if patients are underweight or have risk factors for reduced vitamin B12 absorption with long-term treatment, or if there are relevant clinical symptoms.

Infections of the digestive tract caused by bacteria. Treatment with pantoprazole may slightly increase the risk of gastrointestinal infections caused by bacteria such as Salmonella and Campylobacter or C. difficile.

Sodium. This medicinal product contains less than 1 mmol (23 mg)/dose (vial) sodium, i.e. practically free of sodium.

Hypomagnesemia. Severe hypomagnesaemia has been reported in patients treated with PPIs such as pantoprazole for at least 3 months and in most cases for a year. Serious manifestations of hypomagnesaemia such as fatigue, tetany, delirium, convulsions, dizziness, and ventricular arrhythmia may begin insidiously and may be missed. In most cases, patients improve after magnesium replacement therapy and discontinuation of PPI treatment.

For patients planning long-term therapy or taking PPIs concomitantly with digoxin or drugs that can cause hypomagnesaemia (eg, diuretics), it is recommended that magnesium levels be measured before initiating PPI treatment and periodically during therapy.

Bone fractures . Proton pump inhibitors, especially when used in high doses and for a long time (more than 1 year), may increase the risk of hip, wrist and spine fracture to a certain extent, mainly in elderly patients or in the presence of other existing risk factors. Studies have found that PPIs can increase the overall risk of fractures by 10-40%. Some of these may be due to other risk factors. Patients at risk of developing osteoporosis should be treated according to current clinical guidelines and receive adequate vitamin D and calcium.

Subacute cutaneous lupus erythematosus. The use of proton pump inhibitors has been associated with very rare cases of subacute cutaneous lupus erythematosus. If a lesion occurs, especially in areas exposed to sunlight, and this is accompanied by arthralgia, the patient should immediately consult a doctor who will consider the need to discontinue the drug. The occurrence of subacute cutaneous lupus erythematosus in patients during previous therapy with proton pump inhibitors may increase the risk of its development when using other proton pump inhibitors.

Effects on laboratory results. Elevated levels of chromogranin A (CgA) may interfere with test results in the diagnosis of neuroendocrine tumors. To avoid such an effect, the drug should be temporarily discontinued at least 5 days before the assessment of the level of CgA (see Section “Pharmacological”). If CgA and gastrin levels have not returned to the normal range after the initial measurement, repeat measurements should be taken 14 days after discontinuation of treatment with proton pump inhibitors.

The ability to influence the reaction rate when driving vehicles or operating machinery

Pantoprazole does not affect or has very little effect on the reaction rate when driving vehicles or operating other mechanisms. It is necessary to take into account the possible development of adverse reactions, such as dizziness and visual disturbances. In such cases, you should not drive vehicles or work with mechanisms.

Use during pregnancy or lactation

Pregnancy. Available data on the use of pantoprazole in pregnant women indicate no fetal or feto/neonatal toxicity of the drug. Reproductive toxicity has been observed in animal studies. As a preventive measure, the use of the drug in pregnant women should be avoided.

Breastfeeding. Animal studies have shown excretion of pantoprazole into breast milk. There is insufficient data on the excretion of pantoprazole into breast milk, but such excretion has been reported. A risk to neonates/infants cannot be excluded. The decision to stop breastfeeding or stop/withhold treatment should be made taking into account the benefits of breastfeeding for the baby and the benefits of treatment for the woman.

Fertility. Pantoprazole did not interfere with fertility in animal studies.

Dosage and administration

The drug should be used by adults as directed and under the direct supervision of a physician.

Intravenous use of the drug is recommended only if it is impossible to use the oral form of pantoprazole. There are data on the duration of intravenous treatment up to 7 days. Therefore, when clinically possible, a transition from intravenous administration of pantoprazole to oral administration is carried out.

Reflux esophagitis, duodenal ulcer, gastric ulcer.

The recommended dose is 40 mg pantoprazole (1 vial) per day.

Treatment of Zollinger-Ellison syndrome and other hypersecretory pathological conditions.

For long-term treatment of Zollinger-Ellison syndrome and other hypersecretory pathological conditions, the recommended dose of pantoprazole is 80 mg per day. If necessary, the dose can be titrated, increasing or decreasing, depending on the indicators of acid secretion in the stomach. Doses exceeding 80 mg per day should be divided into two doses. It is possible to temporarily increase the dose of pantoprazole to more than 160 mg, but the duration of use should be limited only to the period necessary to adequately control acid secretion.

In the event that a rapid reduction in acidity is required, for most patients an initial dose of 2×80 mg is sufficient to achieve the desired level (<10 meq/h) within 1 hour.

Preparation for use.

Dissolve the powder in 10 ml of 0.9% sodium chloride solution, which is added to the vial. The solution can be administered directly or after mixing with 100 ml of 0.9% sodium chloride solution or 5% glucose solution in plastic or glass vials.

After dilution, the chemical and physical stability of the drug is maintained for 12 hours at a temperature of 25 ° C. From a microbiological point of view, the diluted drug must be used immediately.

Pantoprazole must not be prepared or mixed with other solvents than those mentioned above.

The introduction of the drug should be carried out within 2-15 minutes.

The bottle is for single use only. Before use, it is necessary to visually check the vials with the drug (in particular, for a change in color, the presence of sediment).

The diluted solution should have a clear yellowish color.

Liver failure . Patients with severely impaired liver function should not exceed a daily dose of 20 mg (½ bottle of pantoprazole, 40 mg powder).

Renal failure. Patients with impaired renal function do not require dose adjustment.

Elderly patients. No dose adjustment required.

Children

Pantoprazole is not recommended for use in children (under 18 years of age), as data on the safety and efficacy of the drug for this age group are limited. Currently available data are described in the Pharmacokinetics section, however dosing recommendations cannot be provided.

Overdose

Overdose symptoms are unknown.

Doses up to 240 mg given intravenously over 2 minutes were well tolerated. Since pantoprazole is extensively bound to blood proteins, it does not belong to drugs that can be easily removed by dialysis.

In case of overdose with the appearance of clinical signs of intoxication, symptomatic and supportive therapy should be used. There are no recommendations for specific therapy.

Adverse reactions

The occurrence of adverse reactions can be expected in about 5% of patients. A common side reaction is thrombophlebitis at the injection site. Diarrhea and pain occurred in about 1% of patients.

Manifestations of adverse reactions according to the frequency of occurrence are classified into the following categories: very often (≥ 1/10), often (≥ 1/100 and <1/10), infrequently (≥ 1/1000 and <1/100), rarely (≥ 1 / 10000 and <1/1000), very rare (<1/10000), unknown (frequency not determined from the available data).

For all adverse reactions reported during the post-marketing period, it is impossible to determine the frequency, therefore they are indicated with a frequency of “unknown”.

From the blood and lymphatic system.

Rare: agranulocytosis.

Very rare: leukopenia, thrombocytopenia, pancytopenia.

From the side of the immune system.

Rare: hypersensitivity reactions (including anaphylactic reactions, anaphylactic shock).

Metabolism and metabolic disorders.

Rare: hyperlipidemia and elevated lipid levels (triglycerides, cholesterol), changes in body weight.

Not known: hyponatremia, hypomagnesemia, hypocalcemia ¹ , hypokalemia.

Mental disorders.

Uncommon: sleep disorders.

Rare: depression (including exacerbations).

Very rare: disorientation (including exacerbations).

Not known: hallucinations, confusion (especially in patients with a predisposition to these disorders, and exacerbation of these symptoms, if any).

From the side of the nervous system.

Uncommon: headache, dizziness.

Rare: taste disturbances.

Not known: paresthesia.

From the side of the organs of vision.

Rare: blurred vision, blurred vision.

From the digestive tract.

Often: polyps from the fundic glands (benign).

Uncommon: diarrhea, nausea, vomiting, bloating, constipation, dry mouth, abdominal pain and discomfort.

Not known: microscopic colitis.

From the digestive system.

Infrequently: increased levels of liver enzymes (transaminases, g-HT).

Rare: increased bilirubin levels.

Not known: hepatocyte damage, jaundice, hepatocellular insufficiency.

From the skin and subcutaneous tissues.

Uncommon: skin rash, rash, itching.

Rare: urticaria, angioedema.

Not known: Stevens-Johnson syndrome, Lyell’s syndrome, erythema multiforme, photosensitivity, subacute cutaneous lupus erythematosus.

From the musculoskeletal system.

Infrequently: fractures of the hip, wrist, spine (see section “Peculiarities of use”).

Rare: arthralgia, myalgia.

Unknown: muscle spasm ² .

From the side of the kidneys and urinary system.

Not known: interstitial nephritis (with possible development of renal failure).