PANTOPRAZOLE (Systemic)

Some commonly used brand names are:

In the U.S.?

• Protonix

In Canada?

• Pantoloc

Category

• Gastric acid pump inhibitor
• antiulcer agent

Description

Pantoprazole (pan-TOE-pra-zole) is used to treat certain conditions inwhich there is too much acid in the stomach. It is used to treat duodenaland gastric ulcers and gastroesophageal reflux disease (GERD), a conditionin 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.)

Before Using This Medicine

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

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

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

Breast-feeding?It is not known whether pantoprazole passes intohuman breast milk. Since this medicine has been shown to cause unwanted effectsin animals, it may be necessary for you to take another medicine or to stopbreast-feeding during treatment. Be sure you have discussed the risks andbenefits of the medicine with your doctor.

Children? Studies on this medicine have been done only inadult patients, and there is no specific information comparing the use ofpantoprazole in children with use in other age groups.

Older adults?This medicine has been tested and has not beenshown to cause different side effects or problems in older people than itdoes in younger adults.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When youare taking pantoprazole, it is especially important that your doctor and pharmacistknow if you are taking any of the following:

• Warfarin (e.g., Coumadin)?May increase risk of abnormal bleeding

Other medical problems?The presence of other medicalproblems may affect the use of pantoprazole. Make sure you tell your doctorif you have any other medical problems, especially:

• Liver disease ?This condition may cause pantoprazole to buildup in the body

• Zinc deficiency, or prone to?May make your condition worse.

Proper Use of This Medicine

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

Swallow the tablet whole. Do not crush, break, orchew the tablet.

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

Tell your doctor if you have ever had problems with a lack of zinc in yourbody. Your doctor may have you take zinc supplements.

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

Dosing?The doseof pantoprazole will be different for different patients. Follow your doctor's orders or the directions on the label. The followinginformation includes only the average doses of pantoprazole. If your dose is different, do not change it unless your doctor tellsyou to do so.

• For oral dosage form (delayed-releasetablets):
  • To treat gastroesophageal reflux disease (GERD):
    • Adults?40 milligrams (mg) once a day, preferably in the morningfor up to eight weeks. Your doctor may advise you to continue taking the medicinefor an additional eight weeks if your condition does not improve after thefirst 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 fourweeks.
    • 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 twoweeks.
    • 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 tendays.
    • Children?Use and dose must be determined by your doctor.
• For injection dosage form:
  • To treat conditions in which the stomach produces too much acid:
    • Adults?80 mg injected into a vein twice a day. Your doctormay adjust your dose.
    • Children?Use and dose must be determined by your doctor.

Missed dose?If you miss a dose of this medicine, take itas soon as possible. However, if it is almost time for your next dose, skipthe missed dose and go back to your regular dosing schedule. Do not doubledoses.

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 otherdamp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be surethat any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

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

Side Effects of This Medicine

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

Check with your doctor as soon as possibleif 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-likerash on skin; changes in facial skin color; chest pain; diarrhea; difficulty in speaking; difficulty in urinating; discoloration, itching, numbness, pain, or redness at place ofinjection; 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/orstripping off of top layer of skin; loss of appetite; loss of vision (sudden); nausea; painful urination; pain in joints or muscles; puffiness or swellingof the eyelids or around the eyes; shortness of breath,troubled breathing, tightness in chest, and/or wheezing; skin rash, hives, and itching; skin tenderness withburning; unusual tiredness or weakness; unusual thirst; vomiting; yellow eyes or skin

Incidence not known

Blindness; bloody or cloudy urine; bloody, black or tarry stools; continuingvomiting; dark-colored urine; decreased vision; fever; general feeling of tiredness or weakness; greatlydecreased frequency of urination or amount of urine; high fever; light-colored stools; muscle cramps or spasms; muscle pain or stiffness; pale skin; sores, ulcers,or white spots on lips or in mouth; stomach pain; swelling of feet or lower legs; swollen glands; unexplained bleeding or bruising

Get emergency hep immediately if any of the following symptomsof overdose occur

Symptoms of overdose

Abdominal pain; blurred vision; confusion; fast, pounding, or irregularheartbeat or pulse; feeling faint, dizzy, or lightheaded; feeling of warmth or heat; flushing or redness of skin, especially on face and neck; headache; nausea and vomiting; sleepiness or unusual drowsiness; sweating

Otherside effects may occur that usually do not need medical attention. These sideeffects may go away during treatment as your body adjusts to the medicine.However, check with your doctor if any of the following side effects continueor 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; musclerigidness 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. Ifyou notice any other effects, check with your doctor.