Pantoprazole – Uses

Background

Pantoprazole is a first-generation proton pump inhibitor (PPI) used for the management of gastroesophageal reflux disease (GERD), for gastric protection to prevent recurrence of stomach ulcers or gastric damage from chronic use of NSAIDs, and for the treatment of pathological hypersecretory conditions including Zollinger-Ellison (ZE) Syndrome. It can also be found in quadruple regimens for the treatment of H. pylori infections along with other antibiotics including amoxicillin, clarithromycin, and metronidazole, for example.1023 Its efficacy is considered similar to other medications within the PPI class including omeprazole, esomeprazole, lansoprazole, dexlansoprazole, and rabeprazole.

Properties and characteristics of Pantoprazole

Drug class	Proton pump inhibitor
Brand Names	Pantoprazole, Pantoloc Control, Somac Control, Tecta
Synonyms	Pantoprazol, Pantoprazole, Pantoprazolum
Molecular Formula	C16H15F2N3O4S
Molecular Weight	383.37 g/mol
IUPAC Names	6-(difluoromethoxy)-2-[(3,4-dimethoxypyridin-2-yl)methanesulfinyl]-1H-1,3-benzodiazole
Structural formula of main components
Pure active ingredient	Pantoprazole sodium
Appearance	White to off-white solid
Melting point	>130 °C
Solubility	Freely soluble in water
Excretion	Excreted in the urine
Available as	Tablets, oral suspension, powder for injection
Storage	Store at 20° to 25°C (68° to 77°F)
Prescription	Doctor prescription is required before consumption

What is pantoprazole oral tablet used for?

If you have problems with your esophagus or stomach, your doctor may prescribe pantoprazole for you.

It’s a prescription drug that’s used to:

• Treat erosive esophagitis related to gastroesophageal reflux disease (GERD). For this use, the drug is given to adults and children ages 5 years and older. Erosive esophagitis describes damage to your esophagus that’s caused by your body making too much stomach acid. GERD is described as having symptoms of acid reflux (heartburn) more than twice each week. Heartburn can feel like pain or burning in your chest that spreads up into your neck.

• Help heal damage to the esophagus that’s caused by erosive esophagitis. For this use, the drug is given to adults with GERD.
• Treat conditions that cause the body to produce large amounts of stomach acid. Zollinger-Ellison Syndrome is an example of these conditions. It’s caused by tumors that make the stomach produce large amounts of acid. For this use, pantoprazole is given to adults.

Pantoprazole side effects

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. 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)

Mechanism of action

Hydrochloric acid (HCl) secretion into the gastric lumen is a process regulated mainly by the H(+)/K(+)-ATPase of the proton pump, expressed in high quantities by the parietal cells of the stomach. ATPase is an enzyme on the parietal cell membrane that facilitates hydrogen and potassium exchange through the cell, which normally results in the extrusion of potassium and formation of HCl (gastric acid).

Proton pump inhibitors such as pantoprazole are substituted benzimidazole derivatives, weak bases, which accumulate in the acidic space of the parietal cell before being converted in the canaliculi (small canal) of the gastric parietal cell, an acidic environment, to active sulfenamide derivatives. This active form then makes disulfide bonds with important cysteines on the gastric acid pump, inhibiting its function.6 Specifically, pantoprazole binds to the sulfhydryl group of H+, K+-ATPase, which is an enzyme implicated in accelerating the final step in the acid secretion pathway. The enzyme is inactivated, inhibiting gastric acid secretion. The inhibition of gastric acid secretion is stronger with proton pump inhibitors such as pantoprazole and lasts longer than with the H(2) antagonists.

Drug Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.

A product that may interact with this drug is: methotrexate (especially high-dose treatment).

Some products need stomach acid so that the body can absorb them properly. Pantoprazole decreases stomach acid, so it may change how well these products work. Some affected products include ampicillin, atazanavir, erlotinib, levoketoconazole, nelfinavir, pazopanib, rilpivirine, sparsentan, certain azole antifungals (itraconazole, ketoconazole, posaconazole), among others.

This medication may interfere with certain laboratory tests (including urine test for tetrahydrocannabinol-THC, blood test to find certain tumors), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage forms (delayed-release tablets or suspension):

For erosive esophagitis:

• Adults—40 milligrams (mg) once a day for up to 8 weeks. Your doctor may want you to take pantoprazole for more than 8 weeks for certain conditions.
• Children 5 years of age and older weighing 40 kilograms (kg) or more—40 mg once a day for up to 8 weeks.
• Children 5 years of age and older weighing 15 to 39 kg—20 mg once a day for up to 8 weeks.
• Children younger than 5 years of age—Use and dose must be determined by your doctor.

For Zollinger-Ellison syndrome:

• Adults—At first, 40 milligrams (mg) 2 times a day. Your doctor may increase your dose as needed.
• Children—Use and dose must be determined by your doctor.

Oversdose

Experience in patients taking very high doses of PANTOPRAZOLE (greater than 240 mg) is limited. Spontaneous post-marketing reports of overdose are generally within the known safety profile of pantoprazole.

Pantoprazole is not removed by hemodialysis. In case of overdosage, treatment should be symptomatic and supportive.

Single oral doses of pantoprazole at 709 mg/kg, 798 mg/kg, and 887 mg/kg were lethal to mice, rats, and dogs, respectively. The symptoms of acute toxicity were hypoactivity, ataxia, hunched sitting, limb-splay, lateral position, segregation, absence of ear reflex, and tremor.

If overexposure to pantoprazole occurs, call your nearby Poison Control Center.

What special precautions should I follow?

Before taking pantoprazole,

• Tell your doctor and pharmacist if you are allergic to pantoprazole, dexlansoprazole (Dexilant), esomeprazole (Nexium, in Vimovo), lansoprazole (Prevacid), omeprazole (Prilosec, in Zegerid), rabeprazole (AcipHex), any other medications, or any of the ingredients in pantoprazole tablets or granules. Ask your pharmacist for a list of the ingredients.
• Tell your doctor if you are taking rilpivirine (Edurant, in Cabenuva, Complera, Juluca, Odefsey). Your doctor will probably tell you not to take pantoprazole if you are taking this medication.
• Tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: anticoagulants (blood thinners) such as warfarin (Jantoven), atazanavir (Reyataz, in Evotaz), dasatinib (Sprycel), digoxin (Lanoxin), diuretics (‘water pills’), erlotinib (Tarceva), iron supplements, itraconazole (Sporanox, Tolsura), ketoconazole, methotrexate (Trexall, Xatmep), mycophenolate mofetil (Cellcept, Myfortic), nelfinavir (Viracept), nilotinib (Tasigna), and saquinavir (Invirase). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• Tell your doctor if you have or have ever had a low level of magnesium, calcium, or potassium in your blood; hypoparathyroidism (condition in which the body does not produce enough parathyroid hormone [PTH; a natural substance needed to control the amount of calcium in the blood]); low levels of vitamin B12 in your body; osteoporosis (a condition in which the bones become thin and weak and break easily); or an autoimmune disease (condition in which the body attacks its own organs causing swelling and loss of function) such as systemic lupus erythematosus.
• Tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking pantoprazole, call your doctor.
• Talk to your doctor about the risks and benefits of taking pantoprazole if you are 70 years of age or older. Do not take this medication for a longer period of time than recommended by your doctor.

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.