Pantoprazole Sodium, Oral/Injection

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KEY POINTS

• This medicine is taken by mouth or given by injection to treat heartburn and to treat and prevent erosive esophagitis. Take it exactly as directed.
• If you develop severe diarrhea or diarrhea that lasts more than 2 or 3 days while taking this medicine, or for several weeks after you stop taking this medicine, contact your healthcare provider right away.
• This medicine may cause low levels of magnesium in your blood, which can increase your risk of serious side effects. Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: proton pump inhibitor (prevents acid production)

Generic and brand names: pantoprazole sodium, oral; pantoprazole sodium, injection; Protonix; Protonix I.V.

What is this medicine used for?

This medicine is used to treat heartburn related to gastroesophageal reflux disease (GERD) and to treat and prevent erosive esophagitis. It blocks the production of stomach acid.

It may also be used to treat a long-term condition where your stomach makes too much acid.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Liver disease
• Osteoporosis
• Problems with low levels of magnesium in the blood

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I take it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not stop taking this medicine without your healthcare provider's approval. Take it for as long as directed, even if you feel better. Do not take more or take it longer than prescribed.

Your healthcare provider may prescribe this medicine along with an antibiotic. Take all medicines each day as prescribed.

Check with your healthcare provider before using this medicine in children under age 5.

This medicine comes in tablet or granule form. You may take the tablets with or without food. Taking it with meals may lessen the chance the drug will upset your stomach. Take it at the same time each day. These are delayed-release tablets. Do not split, crush, or chew them. Swallow them whole.

If you have the granule form of this medicine, take the medicine 30 minutes before a meal. The granule form of this medicine is delayed-release. You may take the granules with applesauce or apple juice.

Injections of this medicine are given by your healthcare provider.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

Symptoms of an acute overdose have not been reported.

What should I watch out for?

This medicine may cause or worsen diarrhea. If you develop severe diarrhea or diarrhea that lasts more than 2 or 3 days while taking this medicine, or for several weeks after you stop taking this medicine, contact your healthcare provider right away. Do not take medicine to treat diarrhea without your provider's approval.

This medicine may cause low levels of magnesium in your blood. Talk with your provider about how often you should have blood tests while taking this medicine. This is very important if you take digoxin because low magnesium can increase your risk of serious side effects. Low magnesium can happen in some people who take this medicine for at least 3 months. If this happens, it is usually after a year of treatment. Tell your healthcare provider right away if you have any of these symptoms of low magnesium levels:

• Seizures
• Dizziness
• Irregular or fast heart beat
• Shaking
• Muscle weakness
• Spasms of the hands, feet, or voice box
• Cramps or muscle aches

This medicine reduces the amount of acid in your stomach. Stomach acid is needed to absorb vitamin B12 properly. If you have taken this medicine for more than 3 years, talk with your provider about vitamin B12 deficiency.

This medicine may increase your risk for fractures of the hip, wrist, and spine, especially if you take high doses or take this medicine for longer than 1 year. Follow your healthcare provider's instructions about diet and taking vitamin supplements.

Do not take this medicine for other conditions unless your healthcare provider approves.

Do not give this medicine to someone who has similar symptoms. It may make it hard to recognize other medical problems.

Drinking alcohol and smoking may increase acid in your stomach. Do not drink alcohol or smoke while you are taking this medicine.

It may take several days for your stomach pain to improve. If your condition does not improve or gets worse, contact your healthcare provider.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Serious (Report these to your healthcare provider right away.): Trouble breathing; blistering, peeling, or loosening of the skin; yellowing of your skin or eyes; unusual bruising or bleeding; unusual tiredness or weakness; seizures; severe dizziness or fainting; irregular or fast heart beat; shaking; muscle weakness, cramps, or spasms; severe diarrhea; changes in urination, blood in urine; unexplained weight gain or loss; unexplained swelling; fever; severe stomach pain, nausea, or vomiting; numbness or tingling in hands or feet; unusual tiredness or weakness; confusion; injection site redness, pain, or swelling.

Other: Headache, mild diarrhea, gas, mild stomach pain, mild nausea or vomiting, back or joint pain, runny nose, sinus problems, sore throat.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Antibiotics such as ampicillin, cefditoren (Spectracef), and rifampin (Rifadin)
• Antifungal medicines such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), and voriconazole (Vfend)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol) and phenytoin (Dilantin, Phenytek)
• Cancer medicines such as bosutinib (Bosulif), dabrafenib (Tafinlar), dasatinib (Sprycel), erlotinib (Tarceva), imatinib (Gleevec), nilotinib (Tasigna), pazopanib (Votrient), and vismodegib (Erivedge)
• Cholesterol-lowering medicines such as atorvastatin (Lipitor) and fluvastatin (Lescol)
• Digoxin (Lanoxin)
• Diuretics (water pills) such as bumetanide, chlorothiazide (Diuril), chlorthalidone, furosemide (Lasix), hydrochlorothiazide (Microzide), and torsemide (Demadex)
• HIV medicines such as abacavir (Ziagen), atazanavir (Reyataz), delavirdine (Rescriptor), efavirenz (Sustiva), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), nevirapine (Viramune), rilpivirine (Edurant), ritonavir (Norvir), saquinavir (Invirase), tenofovir (Viread), and zidovudine (Retrovir)
• Immunosuppressants such as cyclosporine (Gengraf, Neoral, Sandimmune) and mycophenolate (CellCept, Myfortic)
• Iron supplements or multivitamins that contain iron, and iron medicines such as ferric carboxymaltose (Injectafer), ferric gluconate (Ferrlecit), ferumoxytol (Feraheme), and iron sucrose (Venofer)
• Ledipasvir/sofosbuvir (Harvoni)
• Medicines to treat or prevent blood clots such as cilostazol (Pletal), clopidogrel (Plavix), and warfarin (Coumadin)
• Mesalamine (Apriso, Canasa)
• Methotrexate (Otrexup, Rasuvo, Rheumatrex, Trexall)
• Risedronate (Actonel, Atelvia)
• Sucralfate (Carafate) (Take this medicine at least 30 minutes before you take sucralfate.)

Do not drink alcohol while taking this medicine without your healthcare provider’s approval.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.