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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.

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.

 

Please see Full Prescribing Information, including Medication Guide.