What is the most important information I should know about pantoprazole?

Do not stop taking pantoprazole even if you begin to feel better. Your symptoms may improve before the condition is fully treated.

Do not crush, chew, or break a delayed-release (enteric-coated) tablet. It is specially made to release the medicine slowly into your body.

The oral granules should be mixed only with applesauce or apple juice to make swallowing easy. Do not use any other type of liquid or soft food. Pantoprazole granules may also be given with apple juice through a nasogastric (NG ) tube.

Some conditions must be treated long-term with pantoprazole. The chronic use of pantoprazole has caused stomach cancer in animal studies, but it is not known if this medication would have the same effects in humans. Talk with your doctor about your specific risk of developing stomach cancer.

Long-term treatment with pantoprazole may also make it harder for your body to absorb vitamin B-12, resulting in a deficiency of this vitamin. Talk with your doctor if you need long-term pantoprazole treatment and you have concerns about vitamin B-12 deficiency.

What is pantoprazole?

Pantoprazole is in a group of drugs called proton pump inhibitors. It decreases the amount of acid produced in the stomach.

Pantoprazole is used to treat erosive esophagitis (damage to the esophagus from stomach acid), and other conditions involving excess stomach acid such as Zollinger-Ellison syndrome.

Pantoprazole may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before taking pantoprazole?

Do not take this medication if you are allergic to pantoprazole. Before taking pantoprazole, tell your doctor if you are allergic to any drugs.

Some conditions must be treated long-term with pantoprazole. The chronic use of pantoprazole has caused stomach cancer in animal studies, but it is not known if this medication would have the same effects in humans. Talk with your doctor about your specific risk of developing stomach cancer.

Long-term treatment with pantoprazole may also make it harder for your body to absorb vitamin B-12, resulting in a deficiency of this vitamin. Symptoms of a vitamin B-12 deficiency may develop slowly and include pale skin, weakness, tired feeling, shortness of breath, and a fast heart rate. Talk with your doctor if you need long-term pantoprazole treatment and you have concerns about vitamin B-12 deficiency.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether pantoprazole passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take pantoprazole?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Pantoprazole can be taken with or without food.

Do not crush, chew, or break a delayed-release (enteric-coated) tablet. Swallow the pill whole. The enteric-coated pill has a special coating to protect your stomach. Breaking the pill could damage this coating, causing too much of the drug to be released at one time.

The oral granules should be mixed only with applesauce or apple juice to make swallowing easy. Do not use any other type of liquid or soft food. Sprinkle the granules directly onto a teaspoon of applesauce and swallow this mixture right away without chewing. Or pour the granules into a cup with 1 teaspoon of apple juice, stir for 5 seconds and swallow right away. To make sure you get the entire dose, add a little more apple juice to the same glass, swirl gently and drink right away. Do not save the granule mixture for later use.

To give pantoprazole granules through a nasogastric (NG) feeding tube:

• Attach a 60-milliliter syringe to the NG tube and remove the plunger. Hold the syringe high enough to prevent any bends in the tube.
• Sprinkle the pantoprazole granules into the syringe barrel and mix in 2 teaspoons of apple juice. Gently tap or shake the syringe as it empties into the tube.
• Add another 2 teaspoons of apple juice to the syringe to help rinse the granules through and to make sure the entire pantoprazole dose is given. Tap or shake the syringe as the juice empties into the tube.
• Repeat the rinse with 2 teaspoons of apple sauce at least twice more, gently shaking the syringe as it empties into the tube. Make sure there are no granules remaining in the syringe or NG tube.

Do not stop taking pantoprazole even if you begin to feel better. Your symptoms may improve before the condition is fully treated. Call your doctor if your condition does not improve after 8 weeks of treatment.

Store pantoprazole at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of pantoprazole is not expected to produce life-threatening symptoms.

What should I avoid while taking pantoprazole?

Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using pantoprazole.

What are the possible side effects of pantoprazole?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects are more likely to occur, such as:

• nausea, vomiting;
• gas, stomach pain;
• diarrhea; or
• headache.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect pantoprazole?

Before taking pantoprazole, tell your doctor if you are using any of the following drugs:

• atazanavir (Reyataz);
• a blood thinner such as warfarin (Coumadin);
• ampicillin (Omnipen, Principen);
• ketoconazole (Nizoral); or
• iron (Feosol, Mol-Iron, Fergon, Femiron, others).

This list is not complete and there may be other drugs that can interact with pantoprazole. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about pantoprazole.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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Copyright 1996-2003 Cerner Multum, Inc. Version: 3.04. Revision date: 05/07/2008.