From the FDA Drug Label
4. Contraindications Pantoprazole sodium delayed-release tablets are contraindicated in patients with known hypersensitivity to any component of the formulation or any substituted benzimidazole. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute tubulointerstitial nephritis, and urticaria [see WARNINGS AND PRECAUTIONS (5.2), ADVERSE REACTIONS (6)]. Proton pump inhibitors (PPIs), including pantoprazole sodium, are contraindicated in patients receiving rilpivirine-containing products [see DRUG INTERACTIONS (7)]. The contraindications for Protonix (pantoprazole) are:
- Known hypersensitivity to any component of the formulation or any substituted benzimidazole
- Patients receiving rilpivirine-containing products 1
From the Research
Protonix (pantoprazole) is contraindicated in patients with known hypersensitivity to pantoprazole, any component of its formulation, or other proton pump inhibitors (PPIs). The most recent and highest quality study 2 provides evidence on the efficacy and safety of proton-pump inhibitors, but it does not directly address contraindications. However, based on the available evidence, it is clear that patients with known hypersensitivity to pantoprazole or other PPIs should avoid using Protonix. Some key points to consider when prescribing Protonix include:
- Concurrent use with rilpivirine-containing products is contraindicated due to significant decreases in rilpivirine exposure 3
- Patients with severe hepatic impairment should use Protonix with caution, as the drug is primarily metabolized in the liver
- While not absolutely contraindicated, Protonix should be used cautiously during pregnancy (especially first trimester) and breastfeeding due to limited safety data
- Long-term use may increase risks of vitamin B12 deficiency, bone fractures, Clostridium difficile infections, and hypomagnesemia
- Patients taking medications that depend on gastric pH for absorption (like ketoconazole, iron salts, erlotinib) may experience reduced efficacy when taking Protonix. It is essential to weigh the benefits and risks of using Protonix in each patient, considering their individual medical history and current medications.