pantoprazole 40 MG Delayed Release Oral Tablet
1 INDICATIONS AND USAGE Pantoprazole Sodium Delayed-Release Tablets, USP are indicated for: Pantoprazole is a proton pump inhibitor (PPI) 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 (ZE) Syndrome ( 1.3 ) 1.1 Short-Term Treatment of Erosive Esophagitis Associated With Gastroesophageal Reflux Disease (GERD) Pantoprazole is 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 (EE). For those adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of Pantoprazole 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 is indicated for maintenance of healing of EE 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 (ZE) Syndrome Pantoprazole is indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison (ZE) Syndrome.
Kremers Urban Pharmaceuticals Inc.
OVAL WHITE KU 181
KU 181 OVAL WHITE
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16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied
PANTOPRAZOLE SODIUM Delayed-Release Tablets, USP are supplied as 40 mg white to off-white, oval-shaped coated tablet, debossed with "17" on one side and are available as follows: NDC 62175-617-46, bottles of 90 NDC 62175-617-43, bottles of 1000
PANTOPRAZOLE SODIUM Delayed-Release Tablets, USP are supplied as 20 mg white to off-white, oval-shaped coated tablet, imprinted in black with “18” on one side and are available as follows: NDC 62175-618-46, bottles of 90 NDC 62175-618-43, bottles of 1000 Storage Store
PANTOPRAZOLE SODIUM Delayed-Release Tablets, USP at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature] .
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