Description and Brand Names

Drug information provided by: Micromedex

US Brand Name

  1. Protonix

Descriptions


Pantoprazole is used to treat certain conditions in which there is too much acid in the stomach. It is used to treat erosive esophagitis or "heartburn" caused by gastroesophageal reflux disease (GERD), a condition where the acid in the stomach washes back up into the esophagus. This medicine may also be used to treat Zollinger-Ellison syndrome, a condition where the stomach produces too much acid.

Pantoprazole is a proton pump inhibitor (PPI). It works by decreasing the amount of acid produced by the stomach.

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

  • Tablet
  • Tablet, Enteric Coated
  • Packet

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of pantoprazole to treat erosive esophagitis in children younger than 5 years of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of pantoprazole in the elderly.

Pregnancy

Information about this pantoprazole-oral-route
Pregnancy Category Explanation
All Trimesters B Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Rilpivirine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Atazanavir
  • Bosutinib
  • Citalopram
  • Dabrafenib
  • Dasabuvir
  • Dasatinib
  • Erlotinib
  • Eslicarbazepine Acetate
  • Ketoconazole
  • Ledipasvir
  • Methotrexate
  • Mycophenolate Mofetil
  • Nelfinavir
  • Nilotinib
  • Ombitasvir
  • Paritaprevir
  • Pazopanib
  • Saquinavir
  • Topotecan
  • Vismodegib

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Cranberry
  • Levothyroxine
  • Warfarin

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Diarrhea or
  • Hypomagnesemia (low magnesium in the blood), history of or
  • Osteoporosis (bone problem) or
  • Seizures, history of—Use with caution. May make these conditions worse.

Proper Use

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Swallow the delayed-release tablet whole. Do not split, crush, or chew it. You may take the tablet with or without food.

For delayed-release oral suspension granules:

  • Applesauce method:
    • 1. Open packet.
    • 2. Mix the packet contents with 1 teaspoonful of applesauce. Do not mix with water, other liquids, or food.
    • 3. Swallow the mixture at least 30 minutes before a meal. Take it within 10 minutes after you mix it.
    • 4. Sip some water after you swallow the mixture. This will make sure all of the granules get all the way to your stomach.
    • 5. Do not chew or crush the granules. Do not divide the packet contents to make smaller doses.
  • Apple juice method:
    • 1. Open packet.
    • 2. Mix the packet contents with 1 teaspoon of apple juice in a small cup or container.
    • 3. Stir for 5 seconds (granules will not dissolve) and swallow it immediately or take it at least 30 minutes before a meal.
    • 4. Rinse the container with apple juice to make sure you get all of the medicine. Swallow it immediately.
    • 5. Do not chew or crush the granules. Do not divide the packet contents to make smaller doses.
  • Feeding tube:
    • 1. Pour the packet contents in a 2-ounce (60 mL) catheter-tip syringe.
    • 2. Clear any clogs from the feeding tube before you put this medicine mixture into the tube.
    • 3. Add 10 mL of apple juice into the syringe. Gently tap or shake the barrel of the syringe to help rinse the syringe and tube.
    • 4. Repeat with an additional 10 mL of apple juice. No granules should remain in the syringe.
    • 5. Take this medicine at least 30 minutes before a meal.

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 and weighing 40 kilograms (kg) or more—40 mg once a day for up to 8 weeks.
      • Children 5 years of age and older and 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) two times a day. Your doctor may increase your dose if needed.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood, urine, and other laboratory tests may be needed to check for unwanted effects.

Atrophic gastritis (inflammation in the stomach) may occur, especially if you take this medicine for a long time. Talk with your doctor if you have concerns about this.

Check with your doctor right away if you have a fever, joint pain, skin rash, swelling of the body, feet, or ankles, or unusual weight gain after receiving this medicine. These could be symptoms of acute interstitial nephritis.

Taking this medicine for a long time may make it harder for your body to absorb vitamin B12. Tell your doctor if you have concerns about vitamin B12 deficiency.

Check with your doctor right away if you have watery stool that does not go away, stomach pain, and fever while taking this medicine.

Pantoprazole may increase your risk of having fractures of the hip, wrist, and spine. This is more likely if you are 50 years of age and older, if you receive high doses of this medicine, or use it for one year or more.

This medicine may cause hypomagnesemia (low magnesium in the blood). This is more likely to occur if you are taking this medicine for more than one year, or if you are taking this medicine together with digoxin (Lanoxin®) or certain diuretics or "water pills". Check with your doctor right away if you have convulsions (seizures), fast, racing, or uneven heartbeat, muscle spasms (tetany), tremors, or unusual tiredness or weakness.

Do not stop taking this medicine without first checking with your doctor, or unless told to do so by your doctor.

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription (eg, atazanavir, nelfinavir, Reyataz®, Viracept®) or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

  1. Abdominal or stomach pain
  2. blurred vision
  3. dry mouth
  4. flushed, dry skin
  5. fruit-like breath odor
  6. increased hunger
  7. increased thirst
  8. increased urination
  9. nausea
  10. sweating
  11. troubled breathing
  12. unexplained weight loss
  13. vomiting

Incidence not known

  1. Absence of or decrease in body movements
  2. blindness
  3. blistering, peeling, or loosening of the skin
  4. bloating
  5. bloody or cloudy urine
  6. bloody, black, or tarry stools
  7. blurred vision
  8. chills
  9. clay-colored stools
  10. constipation
  11. continuous ringing or buzzing or other unexplained noise in the ears
  12. cough
  13. dark-colored urine
  14. decreased vision
  15. diarrhea
  16. difficulty with speaking
  17. difficulty with swallowing
  18. dizziness or lightheadedness
  19. drowsiness
  20. fast heartbeat
  21. feeling of constant movement of self or surroundings
  22. fever
  23. general feeling of tiredness or weakness
  24. greatly decreased frequency of urination or amount of urine
  25. headache
  26. hearing loss
  27. high fever
  28. hives, itching, or skin rash
  29. indigestion
  30. joint pain
  31. large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  32. light-colored stools
  33. loss of appetite
  34. mood or mental changes
  35. muscle cramps
  36. muscle pain or stiffness
  37. muscle spasms (tetany) or twitching
  38. pains in the stomach, side, or abdomen, possibly radiating to the back
  39. pale skin
  40. puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  41. red skin lesions, often with a purple center
  42. red, irritated eyes
  43. seizures
  44. sensation of spinning
  45. sore throat
  46. sores, ulcers, or white spots on the lips or in the mouth
  47. stomach pain, continuing
  48. swelling of the feet or lower legs
  49. swollen glands
  50. tightness in the chest
  51. trembling
  52. unexplained bleeding or bruising
  53. unpleasant breath odor
  54. unusual tiredness or weakness
  55. vomiting of blood
  56. yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

  1. Belching
  2. bloated or full feeling
  3. excess air or gas in the stomach or intestines
  4. passing gas
  5. trouble sleeping

Incidence not known

  1. Increased watering of the mouth

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.