pantoprazole sodium injection
Drug Details
- Generic Name
- pantoprazole sodium injection
- Brand Names
- PANTOPRAZOLE SODIUM
- Application Number
- ANDA219230
- Sponsor
- Alembic Pharmaceuticals Limited
- NDC Codes
- 2
- Dosage Forms
- POWDER, FOR SOLUTION
- Routes
- INTRAVENOUS
- Active Ingredients
- PANTOPRAZOLE SODIUM
Indications and Usage
1 INDICATIONS AND USAGE 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 )