Pantoprazole Sodium in 0.9% Sodium Chloride

FDA Drug Profile — PANTOPRAZOLE SODIUM

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.