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Pantoprazole (Oral route)

Pronunciation:

pan-TOE-pra-zole

Brand Names:

  • Protonix

Dosage Forms:

  • Tablet
  • Tablet, Enteric Coated
  • Packet

Classifications:

Therapeutic—

Gastric Acid Secretion Inhibitor

Pharmacologic—

Proton Pump Inhibitor

Uses of This Medicine:

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.

Before Using This Medicine:

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.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of pantoprazole in the pediatric population. Safety and efficacy have not been established.

Older adults—

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

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersBAnimal 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.

Breast-feeding—

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.

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. 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
  • Dasatinib
  • Erlotinib
  • Eslicarbazepine Acetate
  • Ketoconazole
  • Methotrexate
  • Mycophenolate Mofetil
  • Nelfinavir
  • Nilotinib
  • Pazopanib
  • Ponatinib
  • Saquinavir
  • 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
  • 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 of This Medicine:

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.

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

The delayed-release oral suspension granules should only be mixed with applesauce or apple juice. Do not mix the granules with water, other liquids, or food. Do not chew or crush the granules. Take the mixture at least 30 minutes before a meal. If you have a nasogastric feeding tube, make sure the tube is not clogged before you put this medicine in the tube with apple juice.

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—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 While Using This Medicine:

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

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. .

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. .

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". Stop using this medicine and 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.

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

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

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

Side Effects of This Medicine:

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
Abdominal or stomach pain
blurred vision
dry mouth
flushed, dry skin
fruit-like breath odor
increased hunger
increased thirst
increased urination
nausea
sweating
troubled breathing
unexplained weight loss
vomiting
Incidence not known
Absence of or decrease in body movements
blindness
blistering, peeling, or loosening of the skin
bloating
bloody or cloudy urine
bloody, black, or tarry stools
blurred vision
chills
clay-colored stools
constipation
continuous ringing or buzzing or other unexplained noise in the ears
cough
dark-colored urine
decreased vision
diarrhea
difficulty with speaking
difficulty with swallowing
dizziness or lightheadedness
drowsiness
fast heartbeat
feeling of constant movement of self or surroundings
fever
general feeling of tiredness or weakness
greatly decreased frequency of urination or amount of urine
headache
hearing loss
high fever
hives
indigestion
itching
joint pain
large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
light-colored stools
loss of appetite
mood or mental changes
muscle cramps
muscle pain or stiffness
muscle spasms (tetany) or twitching
pains in the stomach, side, or abdomen, possibly radiating to the back
pale skin
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
red skin lesions, often with a purple center
red, irritated eyes
seizures
sensation of spinning
shortness of breath
skin rash
sore throat
sores, ulcers, or white spots on the lips or in the mouth
stomach pain, continuing
swelling of the feet or lower legs
swollen glands
tightness in the chest
trembling
unexplained bleeding or bruising
unpleasant breath odor
unusual tiredness or weakness
vomiting of blood
wheezing
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
Belching
bloated or full feeling
excess air or gas in the stomach or intestines
passing gas
sleeplessness
trouble sleeping
unable to sleep
Incidence not known
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.


Last Updated: 4/4/2014

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