Short-term Treatment of Erosive Esophagitis Associated With Gastroesophageal Reflux Disease (GERD)
These highlights do not include all the information needed to use PROTONIX safely and effectively.
See Full Prescribing Information for PROTONIX.
PROTONIX is contraindicated in patients with known hypersensitivity to any component of the formulation or to substituted benzimidazoles. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute interstitial nephritis, and urticaria.
Warnings and Precautions
- In adults, symptomatic response does not preclude presence of gastric malignancy. Consider additional follow-up and diagnostic testing
- Acute interstitial nephritis has been observed in patients taking PPIs
- PPI therapy may be associated with increased risk of Clostridium difficile-associated diarrhea
- Bone Fracture: Long-term and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine
- Cutaneous and Systemic Lupus Erythematosus: Mostly cutaneous; new onset or exacerbation of existing disease; discontinue PROTONIX and refer to specialist for evaluation
- Cyanocobalamin (Vitamin B-12) Deficiency: Daily long-term use (eg, longer than 3 years) may lead to malabsorption or a deficiency of cyanocobalamin
- Hypomagnesemia has been reported rarely with prolonged treatment with PPIs
- For adult use (>2%) are headache, diarrhea, nausea, abdominal pain, vomiting, flatulence, dizziness, and arthralgia
- For pediatric use (>4%) are URI, headache, fever, diarrhea, vomiting, rash, and abdominal pain
- Do not co-administer with atazanavir or nelfinavir
- Concomitant warfarin use may require monitoring
- May interfere with the absorption of drugs where gastric pH is important for bioavailability (eg, ketoconazole, ampicillin esters, atazanavir, iron salts, erlotinib and mycophenolate mofetil)
- May produce false-positive urine screen for THC
- Methotrexate: PROTONIX may increase serum level of methotrexate