Pantoprazole Sodium

Pantoprazole sodium for injection is indicated for treatment of: gastroesophageal reflux disease (GERD) and a history of erosive esophagitis (EE) for up to 10 days in adults. pathological hypersecretory conditions including Zollinger-Ellison (ZE) Syndrome in adults. Limitations of Use The safety and effectiveness of pantoprazole sodium for injection for the treatment of upper gastrointestinal bleeding have not been established in adult or pediatric patients.

Pediatric use information is approved for Pfizer Inc.’s PROTONIX ® I.V. (pantoprazole sodium) for Injection. However, due to Pfizer Inc.’s marketing exclusivity rights, this drug product is not labeled with that information. Pantoprazole sodium for injection is a proton pump inhibitor (PPI) indicated for treatment of: gastroesophageal reflux disease (GERD) and a history of erosive esophagitis (EE) for up to 10 days in adults.

( 1 ) pathological hypersecretion conditions including Zollinger-Ellison (ZE) Syndrome in adults. ( 1 ) Limitations of Use The safety and effectiveness of pantoprazole sodium for injection for the treatment of upper gastrointestinal bleeding have not been established in adult or pediatric patients. ( 1 )

Pantoprazole sodium for injection is contraindicated in patients with known hypersensitivity reactions including anaphylaxis to 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, 5.4), Adverse Reactions ( 6 ) ]. Proton pump inhibitors (PPIs), including pantoprazole sodium for injection, are contraindicated in patients receiving rilpivirine-containing products [ see Drug Interactions ( 7 ) ].

Known hypersensitivity to any component of the formulation or to substituted benzimidazoles. ( 4 ) Patients receiving rilpivirine-containing products. ( 4 , 7 )

Gastric Malignancy : In adults, symptomatic response to therapy with pantoprazole sodium for injection does no preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing. ( 5.1 ) Injection Site Reactions : Thrombophlebitis is associated with the administration of pantoprazole sodium for injection. Assess the patient and remove the catheter if clinically indicated. ( 5.2 ) Potential Exacerbation of Zinc Deficiency : Consider zinc supplementation in patients who are prone to zinc deficiency.