Important Safety Information and Indications | Protonix.com

Important Safety Information and Indications

  • Do not take PROTONIX if you are:
    • allergic to pantoprazole sodium or any of the other ingredients of PROTONIX or other proton pump inhibitors (PPIs)
    • are taking a medicine that contains rilpivirine (Edurant®, Complera®, Odefsey®) used to treat HIV-1 (Human Immunodeficiency Virus)
  • You should take PROTONIX exactly as prescribed, at the lowest dose possible and for the shortest time needed
  • PROTONIX may help your acid-related symptoms, but you could still have serious stomach problems. 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
  • Protonix can cause serious side effects including:
    • 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 right away if you have a decrease in the amount that you urinate or if you have blood in your urine
    • Diarrhea caused by an infection (Clostridium difficile) in your intestines. Call your doctor right away if you have watery stools or stomach pain. You may or may not have fever
    • Bone fractures (hip, wrist, or spine). Bone fractures in the hip, wrist, or spine may happen in people who take multiple daily doses of PPI medicines, like PROTONIX, and for a long period of time (a year or longer)
    • Certain types of lupus erythematosus. Some people who take 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
    • Low vitamin B-12 levels in your body can happen in people who have taken PROTONIX for a long time (more than 3 years). Tell your doctor if you have symptoms of low vitamin B-12 levels, including shortness of breath, lightheadedness, irregular heartbeat, muscle weakness, pale skin, feeling tired, mood changes, and tingling or numbness in the arms and legs
    • Low magnesium levels can happen in patients who have taken PPIs, 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
    • Stomach growths (fundic gland polyps). People who take PPI medicines, like PROTONIX, for a long time have an increased risk of developing a certain type of stomach growths called fundic gland polyps, especially after taking PPI medicines for more than 1 year
  • The most common side effects for PROTONIX include:
    • headache, diarrhea, nausea, stomach-area (abdominal) pain, vomiting, gas, dizziness, and joint pain in adults
    • upper respiratory infections, headache, fever, diarrhea, vomiting, rash, and stomach-area (abdominal) pain in children
  • Before taking PROTONIX, tell your doctor if you are pregnant or plan to become pregnant. PROTONIX may harm your unborn baby
  • Before taking PROTONIX, tell your doctor about all of the medicines you take, especially if you take atazanavir, nelfinavir, warfarin, a product that contains iron, ketoconazole methotrexate, or mycophenolate mofetil. 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.

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