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About PROTONIX®

on Wed, 04/10/2013 - 11:22

About PROTONIX

What is PROTONIX?
  • PROTONIX (pantoprazole sodium) is a prescription medicine called a proton pump inhibitor (PPI)
  • PROTONIX reduces the amount of acid in your stomach
    For Adults
    • PROTONIX is used for up to 8 weeks to heal acid-related damage to the lining of the esophagus (erosive esophagitis or EE) and to relieve symptoms caused by gastroesophageal reflux disease (GERD). If needed, your doctor may decide to prescribe another 8 weeks of PROTONIX
    • PROTONIX is used to maintain the healing of acid-related damage to the lining of the esophagus and help prevent return of heartburn symptoms caused by GERD. It is not known if PROTONIX is safe and effective if used longer than 12 months (1 year). GERD happens when acid in your stomach backs up into the tube (esophagus) that connects your mouth to your stomach. This may cause a burning feeling in your chest or throat, sour taste, or burping
      For Children
      • PROTONIX is used in children 5 years of age and older for up to 8 weeks to heal acid-related damage to the lining of the esophagus (erosive esophagitis or EE) caused by GERD
      • It is not known if PROTONIX is safe if used longer than 8 weeks in children. PROTONIX is not for use in children under 5 years of age
        Who should not take PROTONIX?
        • Do not take PROTONIX if you are:
          • allergic to pantoprazole sodium or any of the other ingredients in PROTONIX. A full list of ingredients can be found in the Medication Guide
          • allergic to any proton pump inhibitor (PPI) medicine
          Before you start taking PROTONIX, tell your doctor if you:
          • Have been told that you have low magnesium levels in your blood
          • Have liver problems
          • Have any other medical conditions
          • Are pregnant or plan to become pregnant. It is not known if PROTONIX will harm your unborn baby
          • Are breastfeeding or plan to breastfeed. PROTONIX may pass into your milk. You and your doctor should decide if you will take PROTONIX or breastfeed. You should not do both. Talk with your doctor about the best way to feed your baby if you take PROTONIX
          • Are taking any other medicines, including prescription and nonprescription drugs, vitamins, and herbal supplements. PROTONIX may affect how other medicines work, and other medicines may affect how PROTONIX works
            • Especially tell your doctor if you take atazanavir (Reyataz), nelfinavir (Viracept), warfarin (Coumadin, Jantoven), ketoconazole (Nizoral), a product that contains iron, an antibiotic that contains ampicillin, or methotrexate
            Important Safety Information
            • Patients who are allergic to PROTONIX or any ingredient 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.
            • 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.
            • 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 fever, rash, weight loss, feeling tired, and weakness as this may be a serious allergic reaction that affects your kidneys.
            • 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.
            • 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 if you are taking any drugs containing ampicillin esters, 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.

            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.

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            Scroll for Important Safety Information and Indications

            Important Safety Information
            • Patients who are allergic to PROTONIX (pantoprazole sodium) or any ingredient 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.
            • 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.
            • 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 fever, rash, weight loss, feeling tired, and weakness as this may be a serious allergic reaction that affects your kidneys.
            • 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.
            • 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 if you are taking any drugs containing ampicillin esters, 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.

            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.

            Please see full Prescribing Information, including Medication Guide.