In the U.S.—

In Canada—

• Gastric acid pump inhibitor
• antiulcer agent

Pantoprazole ( pan-TOE-pra-zole) is used to treat certain conditions in which there is too much acid in the stomach. It is used to treat duodenal and gastric ulcers and gastroesophageal reflux disease (GERD), a condition in which the acid in the stomach washes back up into the esophagus.

Pantoprazole works by decreasing the amount of acid produced by the stomach.

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

Oral
• Delayed-release tablets (U.S. and Canada)

Parenteral
• Injection (U.S.)

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 pantoprazole, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to pantoprazole. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy— Pantoprazole has not been studied in pregnant women. However, studies in animals have shown that pantoprazole causes problems. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—It is not known whether pantoprazole passes into human breast milk. Since this medicine has been shown to cause unwanted effects in animals, it may be necessary for you to take another medicine or to stop breast-feeding during treatment. Be sure you have discussed the risks and benefits of the medicine with your doctor.

Children— Studies on this medicine have been done only in adult patients, and there is no specific information comparing the use of pantoprazole in children with use in other age groups.

Older adults—This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Other medicines—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. Tell your health care professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

• Liver disease —This condition may cause pantoprazole to build up in the body

Take pantoprazole tablets immediately before a meal, preferably in the morning. Pantoprazole tablets may be taken with food or on an empty stomach.

Swallow the tablet whole. Do not crush, break, or chew the tablet.

It may take several days before this medicine begins to relieve stomach pain. To help relieve this pain, antacids may be taken with pantoprazole, unless your doctor has told you not to use them.

Take this medicine for the full time of treatment, even if you begin to feel better. Also, keep your appointments with your doctor for check-ups so that your doctor will be better able to tell you when to stop taking this medicine.

Dosing—

The dose of pantoprazole 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 pantoprazole. If your dose is different, do not change it unless your doctor tells you to do so.

• For oral dosage form (delayed-release tablets):
  • To treat gastroesophageal reflux disease (GERD):
    • Adults—40 milligrams (mg) once a day, preferably in the morning for up to eight weeks. Your doctor may advise you to continue taking the medicine for an additional eight weeks if your condition does not improve after the first eight weeks.
    • Children—Use and dose must be determined by your doctor.
  • To treat gastric ulcers:
    • Adults—40 mg once a day, preferably in the morning for four weeks.
    • Children—Use and dose must be determined by your doctor.
  • To treat duodenal ulcers:
    • Adults—40 mg once a day, preferably in the morning for two weeks.
    • Children—Use and dose must be determined by your doctor.
• For injection dosage form:
  • To treat GERD:
    • Adults—40 mg injected into a vein once a day for seven to ten days.
    • 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—

To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

It is important that your doctor check your progress at regular visits. If your condition does not improve, or if it becomes worse, check with your doctor.

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 as soon as possible if any of the following side effects occur:

• Less common or rare
  • Abdominal or stomach pain;  blistering, loosening, peeling, or redness of skin;  bull's eye-like rash on skin;  changes in facial skin color;  chest pain;  diarrhea ;  difficulty in speaking;  difficulty in urinating;  discoloration, itching, numbness, pain, or redness at place of injection;  fast or irregular breathing;  increased frequency and volume of urination;  infection;  large, hive-like swellings on eyelids, face, lips, mouth, and/or tongue;  loosening and/or stripping off of top layer of skin;  loss of appetite;  loss of vision (sudden);  nausea;  painful urination;  pain in joints or muscles;  puffiness or swelling of the eyelids or around the eyes;  shortness of breath, troubled breathing, tightness in chest, and/or wheezing;  skin rash, hives, and itching;  skin tenderness with burning;  unusual tiredness or weakness;  unusual thirst;  vomiting;  yellow eyes or skin 
  
  

Other 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. However, check with your doctor if any of the following side effects continue or are bothersome.

• More common
  • Headache 
  
  

• Less common or rare
  • Aching, fullness, or tension in sinuses;  anxiety;  back pain;  belching ;  blurred vision;  chills ;  confusion;  constipation ;  cough;  difficulty in moving ;  dizziness;  drooling;  feeling of constant movement of self or surroundings;  flatulence;  hoarseness;  indigestion;  loss of energy or strength ;  migraine headache;  muscle rigidness or stiffness;  neck pain;  pain;  rectal problems;  ringing or buzzing in the ears;  runny or stuffy nose ;  sensation of spinning;  sneezing;  sore throat;  trouble in sleeping 
  
  

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