에스-판토프라졸나트륨삼수화물

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) and 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 not 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. Caution should be used when other EDTA containing products are also co-administered intravenously. ( 5.3 ) • Acute Tubulointerstitial Nephritis : Discontinue treatment and evaluate patients. ( 5.4 ) • Clostridioides difficile -Associated Diarrhea : PPI therapy may be associated with increased risk. ( 5.5 ) • 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. ( 5.6 ) • Severe Cutaneous Adverse Reactions : Discontinue at the first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation. ( 5.7 ) • Cutaneous and Systemic Lupus Erythematosus: Mostly cutaneous; new onset or exacerbation of existing disease; discontinue treatment and refer to specialist for evaluation. ( 5.8 ) • Hepatic Effects: Elevations of transaminases observed. ( 5.9 ) • Hypomagnesemia and Mineral …

8.1 Pregnancy Risk Summary Available data from published observational studies did not demonstrate an association of major malformations or other adverse pregnancy outcomes with pantoprazole. In animal reproduction studies, no evidence of adverse development outcomes was observed with pantoprazole sodium. Reproduction studies have been performed in rats at intravenous doses up to 20 mg/kg/day (4 times the recommended human dose) and rabbits at intravenous doses up to 15 mg/kg/day (6 times the recommended human dose) with administration of pantoprazole during organogenesis in pregnant animals and have revealed no evidence of harm to the fetus due to pantoprazole in this study (see Data). A …