pantoprazole sodium

FDA Drug Profile — Pantoprazole Sodium, pantoprazole sodium, Protonix I.V.

Drug Details

Generic Name
pantoprazole sodium
Brand Names
Pantoprazole Sodium, pantoprazole sodium, Protonix I.V.
Application Number
ANDA090970
Sponsor
Cardinal Health 107, LLC
NDC Codes
13
Dosage Forms
TABLET, DELAYED RELEASE, INJECTION, POWDER, FOR SOLUTION, POWDER
Routes
ORAL, INTRAVENOUS
Active Ingredients
PANTOPRAZOLE SODIUM

Indications and Usage

1 INDICATIONS AND USAGE Pantoprazole is a proton pump inhibitor indicated for the following: Short-Term Treatment of Erosive Esophagitis Associated with Gastroesophageal Reflux Disease (GERD) ( 1.1 ) Maintenance of Healing of Erosive Esophagitis ( 1.2 ) Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome ( 1.3 ) Pantoprazole sodium delayed-release tablets are indicated for: 1.1 Short-Term Treatment of Erosive Esophagitis Associated With Gastroesophageal Reflux Disease (GERD) Pantoprazole sodium delayed-release tablets are indicated in adults and pediatric patients five years of age and older for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis. For those adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium delayed-release tablets may be considered. Safety of treatment beyond 8 weeks in pediatric patients has not been established. 1.2 Maintenance of Healing of Erosive Esophagitis Pantoprazole sodium delayed-release tablets are indicated for maintenance of healing of erosive esophagitis and reduction in relapse rates of daytime and nighttime heartburn symptoms in adult patients with GERD. Controlled studies did not extend beyond 12 months. 1.3 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome Pantoprazole sodium delayed-release tablets are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.