Protonix Information

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 PROTONIXPROTONIX 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 burpingPROTONIX 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. For ChildrenPROTONIX 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 GERDIt 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 ageWho 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) medicineBefore you start taking PROTONIX, tell your doctor if you:Have been told that you have low magnesium levels in your bloodHave liver problemsHave any other medical conditionsAre pregnant or plan to become pregnant. It is not known if PROTONIX will harm your unborn babyAre 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 PROTONIXAre 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, ormethotrexate, or mycophenolate mofetil (Cellcept)Important Safety InformationPatients 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.