Pantoprazole Sodium in 0.9% Sodium Chloride
Drug Details
- Generic Name
- Pantoprazole Sodium in 0.9% Sodium Chloride
- Brand Names
- PANTOPRAZOLE SODIUM
- Application Number
- NDA217512
- Sponsor
- Baxter Healthcare Corporation
- NDC Codes
- 3
- Dosage Forms
- INJECTION, SOLUTION
- Routes
- INTRAVENOUS
- Active Ingredients
- PANTOPRAZOLE SODIUM
Indications and Usage
1 INDICATIONS AND USAGE Pantoprazole sodium is a proton pump inhibitor (PPI) indicated in adults for the following: • Short-term treatment (7 to 10 days) of gastroesophageal reflux disease (GERD) associated with a history of Erosive Esophagitis (EE). ( 1.1 ) • Pathological hypersecretion conditions including Zollinger-Ellison (ZE) Syndrome. ( 1.2 ) 1.1 Gastroesophageal Reflux Disease Associated with a History of Erosive Esophagitis Pantoprazole sodium in 0.9% sodium chloride injection is indicated for short-term treatment (7 to 10 days) of adult patients with gastroesophageal reflux disease (GERD) and a history of erosive esophagitis (EE). Safety and efficacy of pantoprazole sodium in 0.9% sodium chloride injection as a treatment of patients with GERD and a history of EE for more than 10 days have not been demonstrated. 1.2 Pathological Hypersecretion Including Zollinger-Ellison Syndrome Pantoprazole sodium in 0.9% sodium chloride injection is indicated for the treatment of pathological hypersecretory conditions including Zollinger-Ellison (ZE) Syndrome in adults.