pantoprazole 40 MG Delayed Release Oral Tablet

1 INDICATIONS AND USAGE Pantoprazole sodium delayed-release tablets are indicated for: Pantoprazole sodium 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 sodium 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 sodium 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 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 sodium is indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison (ZE) Syndrome.

Aurobindo Pharma Limited

FDA Reported Adverse Reactions
`[1] drug ineffective` `[2] fatigue` `[3] off label use` `[4] pain` `[5] nausea` `[6] adverse drug reaction` `[7] dyspnoea` `[8] headache` `[9] diarrhoea` `[10] pyrexia`

5 years ago

OVAL YELLOW I 52

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied

PANTOPRAZOLE SODIUM Delayed-Release Tablets USP, 20 mg are yellow colored, oval shaped, biconvex, enteric-coated tablets imprinted with ‘I’ and ‘51’ with brown ink on one side and plain on other side. Bottles of 90 NDC 65862-559-90 Bottles of 1,000 NDC 65862-559-99 Cartons of 100 (10 x 10) Unit-dose Tablets NDC 65862-559-10

PANTOPRAZOLE SODIUM Delayed-Release Tablets USP, 40 mg are yellow colored, oval shaped, biconvex, enteric-coated tablets imprinted with ‘I’ and ‘52’ with brown ink on one side and plain on other side. Bottles of 90 NDC 65862-560-90 Bottles of 1,000 NDC 65862-560-99 Cartons of 100 (10 x 10) Unit-dose Tablets NDC 65862-560-10 Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

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