What you need to know about Protonix (pantoprazole)

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Protonix (collectively known as pantoprazole) is a medicine called a proton pump inhibitor. This drug reduces the production of acid in the stomach. Protonix is used to treat certain conditions of the stomach and esophagus , such as acid reflux, gastroesophageal reflux disease (GERD) , and erosive esophagitis .

Protonix is approved for use in adults and children over 5 years of age. Most of the time it is given by mouth in tablet form, but there is also an oral liquid suspension and an intravenous form that is injected into a vein.

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Applications

Protonix is approved by the Food and Drug Administration (FDA) for the treatment of disorders of the stomach and esophagus. It is used for short-term treatment (usually eight weeks or less) for GERD. It can also be prescribed for a longer period of time as maintenance therapy for erosive esophagitis.

Protonix is also used to treat conditions in which the stomach produces too much acid, including Zollinger-Ellison syndrome .

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Erosive esophagitis

Erosive esophagitis is inflammation and irritation of the lining of the esophagus. This is a problem that can arise as a complication of GERD.

GERD is a condition that can cause signs and symptoms such as heartburn (a burning sensation in the chest), regurgitation, and nausea, which can be more severe after eating and at bedtime. Other symptoms may include a sore throat, hoarseness, chronic cough, wheezing, halitosis, chest pain, and a sensation of something in the throat.

Erosive esophagitis can cause symptoms of burning in the throat, difficulty swallowing, a sour or bitter taste in the mouth, a feeling that something is stuck in the throat, and blood in the vomit or stool (which may be black and tarry). If some symptoms are present, erosive esophagitis may be suspected.

This condition is usually diagnosed with an endoscopy procedure . During endoscopy, an instrument is inserted into the mouth and down the esophagus. The doctor can examine the inside of the esophagus and, if there is inflammation, also take a biopsy (small pieces of tissue) for analysis.

Erosive esophagitis can be a serious medical condition that, in rare cases, can lead to the development of cancer. Treatment for erosive esophagitis may include a proton pump inhibitor such as Protonix for a short cycle (eight weeks) or longer if necessary.

Zollinger-Ellison syndrome

Zollinger-Ellison syndrome is a rare condition that causes tumors to grow in the pancreas or duodenum (the first part of the small intestine ). These tumors produce a hormone that, in turn, causes the stomach to produce excess acid. Excess stomach acid can lead to ulcers.

Diagnosis can be made by endoscopy, ultrasound, or other imaging techniques. Surgery is required to remove the tumors. A proton pump inhibitor is also used to reduce the amount of acid produced .

Precautions and contraindications.

Taking Protonix with certain HIV medications is not recommended. Protonix can reduce the amount of antiretroviral drugs such as atazanavir and nelfinavir in the body. This can make HIV poorly controlled and it is recommended to avoid Protonix if you are taking these medications.

Use with rilpivirine is contraindicated. For other retroviral medications, check the prescribing information and consult your doctor.

Proton pump inhibitors like Protonix can cause an increase in serum levels of methotrexate . This means that for those taking higher doses of methotrexate, a proton pump inhibitor can increase the risk of methotrexate toxicity.

Studies have shown that proton pump inhibitors can cause an increase in the international normalized ratio (INR) and prothrombin time in people who also take the blood thinner warfarin . This means that it may take longer for the blood to clot, increasing the risk of heavy bleeding.

You may need to change your warfarin dose and / or have your healthcare provider monitor your INR and prothrombin time if you are prescribed Protonix.

Talk to your doctor about all the medications, supplements, and vitamins that you are currently taking. While some medications carry little risk of interactions, others may directly contraindicate their use or cause careful consideration of whether the benefits of treatment outweigh the disadvantages in your case.

Other proton pump inhibitors

Other brands of proton pump inhibitors include:

Dose

The manufacturer recommends the dosage for adults and children. However, the prescribing healthcare provider will indicate the dosage based on age, general health, and condition for which Protonix is being prescribed.

Protonix is a pill that you take by mouth. It comes in doses of 20 milligrams (mg) and 40 mg. Doses are indicated for the treatment of GERD and hyperactive acid production in adults. However, for children, a safe dose is indicated only for the treatment of GERD, as a safe dose for overactive acid production has not been established.

Usual dose for adults over 18 years:

  • With GERD: 40 mg once a day.
  • For overactive acid production (including Zollinger-Ellison syndrome) 40 mg twice daily.

Usual dose for children 5 to 17 years:

  • For children with GERD who weigh 15 to 40 kg, the dose is 20 mg once a day.
  • With GERD, children weighing 40 kg or more are prescribed 40 mg once a day.

All indicated doses are indicated by the manufacturer of the drug. Check your prescription and talk to your doctor to make sure you are taking the correct dose.

How to take and store

Protonix can be taken with or without food. It is recommended that you take it around the same time every day. It cannot be minced, cut or chewed. People taking Protonix can also take over-the-counter antacids.

If you miss an appointment, take it as soon as you remember. However, if it is almost time for the next dose, take the next one at the usual time. Do not double your doses or take more than one dose at a time.

Protonix should be stored between 20 and 25 ° C (68 to 77 F). It can be stored for a short period of time at a temperature lower than 15 ° C (59 F) to 30 ° C (86 F).

In the case of GERD, Protonix is only prescribed for eight weeks or less, so repeat doses are not common for this reason. If you need this drug for a long time to treat GERD or erosive esophagitis, talk to your doctor to get your supply replenished.

Modifications

The use of Protonix in pregnant women has not been widely studied. The FDA has not assigned Protonix a pregnancy category. Studies in pregnant rats treated with Protonix have not shown an increased risk of birth defects.

In humans, there is evidence from an observational study of 53 pregnant women in Europe that showed no increase in the incidence of serious birth defects. The manufacturer states that Protonix may 'harm' the fetus, and therefore people who are pregnant or planning to become pregnant should discuss potential risks with their doctor.

Protonix passes into breast milk and a small amount has been found in the breast milk of a nursing mother after taking a single 40 mg dose. The mother reported no side effects on the baby, but there is no research on the long-term effects of Protonix in nursing mothers or babies.

The benefits of Protonix must be weighed against the risks for breastfeeding patients.

Pediatric patients (under 18 years of age) have no data on the safety of using Protonix for more than eight weeks. Erosive esophagitis is rare in children, so studying the safety of a proton pump inhibitor over a long period in this age group is challenging.

There is no tablet formulation of Protonix suitable for children under 5 years of age. Protonix has been found to be ineffective in treating GERD in infants and therefore is not recommended for children under 1 year of age .

Side effects

general

Some of the common side effects of Protonix in adults include :

  • Diarrhea
  • Dizziness
  • Gas
  • Headache
  • Joint pain
  • Nausea
  • Pain in the abdomen (tummy)
  • Threw up

Common side effects of Protonix in children include :

  • Diarrhea
  • Hot
  • Headache
  • Rash
  • Pain in the abdomen (tummy)
  • Threw up
  • Upper respiratory tract infection

Warnings and interactions

Protonix is associated with some types of serious side effects and events. People taking Protonix should inform their doctor if they experience any of the signs and symptoms associated with these serious side effects.

Acute interstitial nephritis

Proton pump inhibitors have been linked to the risk of chronic kidney disease. Acute interstitial nephritis can occur at any time after you start taking Protonix. Signs and symptoms of kidney disease include less urination (urine) and blood in the urine. If these symptoms appear, they should be reported to the doctor immediately.

Clostridium difficile infection (C diff)

Taking proton pump inhibitors has been shown to be a risk factor for infection with a type of bacteria called C. difficile .

These bacteria are generally found in the human intestines, but when they grow, they can cause symptoms of diarrhea, fever, nausea, loss of appetite, and abdominal pain. If these symptoms occur, they should be reported to the doctor immediately.

Fractures

The risk of hip, wrist, or spine fractures has been shown to increase in people who take proton pump inhibitors for a year or more. The risk is multifactorial and may be associated with decreased absorption of certain vitamins and minerals while taking a proton pump inhibitor .

It is important to discuss the use of Protonix with your doctor in the event of a fracture.

lupus erythematosus

Lupus is an autoimmune disease in which a person's own immune cells attack the body. Several types of lupus are associated with the use of proton pump inhibitors. People with lupus have also reported a worsening of their condition after taking a proton pump inhibitor.

Symptoms of joint pain or a rash that is worse in the sun if it has just appeared (or worse in the case of established lupus) should be discussed with your doctor immediately.

Vitamin B12 levels

Taking Protonix for more than three years resulted in a decrease in vitamin B-12 levels . This is because proton pump inhibitors can interfere with the absorption of vitamin B12 .

Complications from low vitamin B12 levels can include anemia (causing shortness of breath, dizziness, irregular heartbeat, muscle weakness, pale skin, feeling tired), nerve problems (causing tingling or numbness in the hands and feet ), myelopathy (a disease of the spinal cord (the brain, causing numbness and tingling) and dementia (causing mood swings and cognitive problems).

Magnesium levels

Proton pump inhibitors have been shown to cause low magnesium levels, although the reason for this is not fully understood . Taking Protonix for three months resulted in a decrease in magnesium levels in the body.

Low magnesium levels can cause signs and symptoms, including seizures, dizziness, irregular heartbeats, nervousness, muscle pain or weakness, and spasms in the arms, legs, or voice.

Fundic gland polyps

The upper part of the stomach is called the fundus. A polyp is a type of abnormal growth. The use of proton pump inhibitors for more than a year has been linked to the growth of these polyps, which look like flat bumps .

Fundus polyps are rarely associated with cancer risk. However, if they develop, it may be advisable to stop taking the proton pump inhibitor.

Drug interactions

In addition to the precautions for the HIV medications, warfarin, and methotrexate listed above, Protonix may also interact with Cellcept (mycophenolate mofetil). Cellsept is an immunosuppressive drug used to prevent rejection after an organ transplant or to treat certain immune-mediated conditions, such as Crohn's disease.

Protonix may reduce the effectiveness of this Cellcept, but the level of this effect has not been established. Protonix recommends caution when taking Cellcept .

Diagnostic tests

There are two possible effects of proton pump inhibitors on blood and urine tests.

First, proton pump inhibitors can give false positive results on chromogranin A (CgA) tests, which are used to look for neuroendocrine tumors (which are a rare type of tumor). It is recommended that you stop taking your proton pump inhibitor two weeks before your CgA test .

Second, testing urine for tetrahydrocannabinol (THC), a substance found in marijuana that produces a high. Using proton pump inhibitors can cause a false positive THC test result. A different type of test may be required to confirm a positive THC result .

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