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PROTONIX® (pantoprazole sodium) Safety Considerations

on Wed, 04/10/2013 - 11:51

Safety Considerations When Taking PROTONIX

The information below summarizes the most important things you need to know before you start PROTONIX and while you are taking it. Remember, nothing replaces the advice of your doctor.  If you have any concerns about your treatment, talk with your health care team.

How should I take PROTONIX?
  • Take PROTONIX exactly as prescribed by your doctor. For more detailed information, click here
What are the possible serious side effects of PROTONIX?
  • A type of kidney problem (acute interstitial nephritis). Some people who take proton pump inhibitor (PPI) medicines, including PROTONIX, may develop a kidney problem called acute interstitial nephritis that can happen at any time during treatment with PROTONIX. Call your doctor if you have a decrease in the amount that you urinate or if you have blood in your urine.
  • Diarrhea. PROTONIX may increase your risk of getting severe diarrhea. This diarrhea may be caused by an infection (Clostridium difficile) in your intestines. Call your doctor right away if you have watery stool, stomach pain, and fever that does not go away.
  • Bone fractures. People who take multiple daily doses of PPI medicines for a long period of time (a year or longer) may have an increased risk of fractures of the hip, wrist or spine. You should take PROTONIX exactly as prescribed, at the lowest dose possible for your treatment and for the shortest time needed. Talk to your doctor about your risk of bone fracture if you take PROTONIX.
  • Certain types of lupus erythematosus. Lupus erythematosus is an autoimmune disorder (the body's immune cells attack other cells or organs in the body). Some people who take PPI medicines, including PROTONIX, may develop certain types of lupus erythematosus or have worsening of the lupus they already have. Call your doctor right away if you have new or worsening joint pain or a rash on your cheeks or arms that gets worse in the sun.
    • Your doctor may check the level of magnesium in your body before you start taking PROTONIX or during      treatment, if you will be taking PROTONIX for a long period of time
What are the most common side effects of PROTONIX?
  • The most common side effects with PROTONIX in adults include: headache, diarrhea, nausea, stomach pain, vomiting, gas, dizziness, or pain in your joints
  • The most common side effects with PROTONIX in children include: upper respiratory infection, headache, fever, diarrhea, vomiting, rash, or stomach pain
  • Tell your doctor about any side effects that bother you
How should I store PROTONIX?
  • Store PROTONIX at room temperature between 68° to 77°F (20° to 25°C)
  • Keep PROTONIX and all medicines out of the reach of children
Important Safety Information
  • Patients who are allergic to pantoprazole sodium or any of the other ingredients of PROTONIX or other proton pump inhibitors (PPIs) should not take PROTONIX.
  • Relief of your symptoms while on PROTONIX does not exclude the possibility that serious stomach conditions may be present. Talk with your doctor.
  • A very serious allergic reaction to this drug is rare. Get medical help right away if you notice any symptoms of a serious allergic reaction, including throat tightness, fever, rash, difficult breathing, weight loss, feeling tired, and weakness as this may be a serious allergic reaction.
  • Some people who take proton pump inhibitor (PPI) medicines, including PROTONIX, may develop a kidney problem called acute interstitial nephritis that can happen at any time during treatment with PROTONIX. Call your doctor if you have a decrease in the amount that you urinate or if you have blood in your urine.
  • PROTONIX may increase the risk of getting severe diarrhea due to an intestinal infection caused by Clostridium difficile. Call your doctor right away if you have diarrhea, cramps, and fever that does not go away. Patients should use the lowest dose and shortest duration of PPI appropriate to the condition being treated.
  • PPI therapy, like PROTONIX, may be associated with an increased risk of bone fractures of the hip, wrist or spine. The risk of fracture increases in patients who are taking multiple daily doses and are on PPI therapy for a year or longer.
  • Some people who take proton pump inhibitors (PPIs), including PROTONIX, develop certain types of lupus erythematosus or have worsening of the lupus they already have. Call your doctor right away if you have joint pain or rash on your cheeks or arms that gets worse in the sun.
  • PROTONIX reduces the amount of acid in your stomach. Stomach acid is needed to absorb vitamin B-12 properly. Talk with your doctor about the possibility of vitamin B-12 deficiency if you have been on PROTONIX for a long time (more than 3 years).
  • Low magnesium levels can happen in some patients who take proton pump inhibitors, like PROTONIX, for at least 3 months. Tell your doctor right away if you have any of these symptoms of low magnesium: seizures, dizziness, irregular heartbeat, muscle spasms or cramps.
  • The most frequently reported side effects for PROTONIX in adults were headache, diarrhea, nausea, abdominal pain, vomiting, gas, dizziness, and joint pain.
  • The most frequently reported side effects for PROTONIX in children 1 to 16 years of age were upper respiratory infections, headache, fever, diarrhea, vomiting, rash, and abdominal pain.
  • Before taking PROTONIX, tell your doctor about all of the medicines you take, especially: an antibiotic that contains ampicillin, atazanavir, iron salts, ketoconazole, nelfinavir, erlotinib, mycophenolate mofetil (MMF), or warfarin. If you are taking PROTONIX with warfarin, you may need to have certain laboratory tests monitored as potential serious risks may occur.
  • Use of PROTONIX along with high doses of methotrexate may increase blood levels of methotrexate, possibly leading to methotrexate toxicity.
  • PROTONIX is a prescription drug for the short-­term treatment in the healing and relief of symptoms of acid-­related damage to the esophagus. This condition is known as erosive esophagitis or erosive gastroesophageal reflux disease (GERD) and is caused by back up of stomach acid into the esophagus.
  • PROTONIX can be used for adults and children 5 years of age and older for treatment up to 8 weeks. Adults can receive an additional 8 weeks of treatment if needed. Safety of treatment beyond 8 weeks has not been established in children. PROTONIX can be used to maintain healing of erosive GERD in adults. Studies did not go beyond 12 months.
  • PROTONIX is used in adults for the long-term treatment of conditions where your stomach makes too much acid. This includes a rare condition called Zollinger-Ellison syndrome.

Please see full Prescribing Information, including Medication Guide.

Patients should always ask their doctors for medical advice about adverse events.

You may report an adverse event related to Pfizer products by calling 1-800-438-1985 (US only). If you prefer, you may contact the U.S. Food and Drug Administration (FDA) directly. The FDA has established a reporting service known as MedWatch where health care professionals and consumers can report serious problems they suspect may be associated with the drugs and medical devices they prescribe, dispense, or use. Visit MedWatch or call 1-800-FDA-1088.

© 2017 Pfizer Inc.All rights reserved.PP-PRX-USA-0130-01

Scroll for Important Safety Information and Indications

Important Safety Information
  • Patients who are allergic to pantoprazole sodium or any of the other ingredients of PROTONIX or other proton pump inhibitors (PPIs) should not take PROTONIX.
  • Relief of your symptoms while on PROTONIX does not exclude the possibility that serious stomach conditions may be present. Talk with your doctor.
  • A very serious allergic reaction to this drug is rare. Get medical help right away if you notice any symptoms of a serious allergic reaction, including throat tightness, fever, rash, difficult breathing, weight loss, feeling tired, and weakness as this may be a serious allergic reaction.
  • Some people who take proton pump inhibitor (PPI) medicines, including PROTONIX, may develop a kidney problem called acute interstitial nephritis that can happen at any time during treatment with PROTONIX. Call your doctor if you have a decrease in the amount that you urinate or if you have blood in your urine.
  • PROTONIX may increase the risk of getting severe diarrhea due to an intestinal infection caused by Clostridium difficile. Call your doctor right away if you have diarrhea, cramps, and fever that does not go away. Patients should use the lowest dose and shortest duration of PPI appropriate to the condition being treated.
  • PPI therapy, like PROTONIX, may be associated with an increased risk of bone fractures of the hip, wrist or spine. The risk of fracture increases in patients who are taking multiple daily doses and are on PPI therapy for a year or longer.
  • Some people who take proton pump inhibitors (PPIs), including PROTONIX, develop certain types of lupus erythematosus or have worsening of the lupus they already have. Call your doctor right away if you have joint pain or rash on your cheeks or arms that gets worse in the sun.
  • PROTONIX reduces the amount of acid in your stomach. Stomach acid is needed to absorb vitamin B-12 properly. Talk with your doctor about the possibility of vitamin B-12 deficiency if you have been on PROTONIX for a long time (more than 3 years).
  • Low magnesium levels can happen in some patients who take proton pump inhibitors, like PROTONIX, for at least 3 months. Tell your doctor right away if you have any of these symptoms of low magnesium: seizures, dizziness, irregular heartbeat, muscle spasms or cramps.
  • The most frequently reported side effects for PROTONIX in adults were headache, diarrhea, nausea, abdominal pain, vomiting, gas, dizziness, and joint pain.
  • The most frequently reported side effects for PROTONIX in children 1 to 16 years of age were upper respiratory infections, headache, fever, diarrhea, vomiting, rash, and abdominal pain.
  • Before taking PROTONIX, tell your doctor about all of the medicines you take, especially: an antibiotic that contains ampicillin, atazanavir, iron salts, ketoconazole, nelfinavir, erlotinib, mycophenolate mofetil (MMF), or warfarin. If you are taking PROTONIX with warfarin, you may need to have certain laboratory tests monitored as potential serious risks may occur.
  • Use of PROTONIX along with high doses of methotrexate may increase blood levels of methotrexate, possibly leading to methotrexate toxicity.
INDICATIONS
  • PROTONIX is a prescription drug for the short-term treatment in the healing and relief of symptoms of acid-related damage to the esophagus. This condition is known as erosive esophagitis or erosive gastroesophageal reflux disease (GERD) and is caused by back up of stomach acid into the esophagus.
  • PROTONIX can be used for adults and children 5 years of age and older for treatment up to 8 weeks. Adults can receive an additional 8 weeks of treatment if needed. Safety of treatment beyond 8 weeks has not been established in children. PROTONIX can be used to maintain healing of erosive GERD in adults. Studies did not go beyond 12 months.
  • PROTONIX is used in adults for the long-term treatment of conditions where your stomach makes too much acid. This includes a rare condition called Zollinger-Ellison syndrome.

Please see full Prescribing Information, including Medication Guide.


Patients should always ask their doctors for medical advice about adverse events.

You may report an adverse event related to Pfizer products by calling 1-800-438-1985 (US only). If you prefer, you may contact the U.S. Food and Drug Administration (FDA) directly. The FDA has established a reporting service known as MedWatch where health care professionals and consumers can report serious problems they suspect may be associated with the drugs and medical devices they prescribe, dispense, or use. Visit MedWatch or call 1-800-FDA-1088.