Label: PANTOPRAZOLE SODIUM- pantoprazole tablet, delayed release

  • NDC Code(s): 65162-636-03, 65162-636-09, 65162-637-03, 65162-637-09, view more
  • Packager: Amneal Pharmaceuticals LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated January 6, 2025

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for PANTOPRAZOLE SODIUM ...
  • Table of Contents
    Table of Contents
  • 1  INDICATIONS AND USAGE
    Pantoprazole sodium delayed-release tablets are indicated for: 1.1 Short-Term Treatment of Erosive Esophagitis Associated With Gastroesophageal Reflux Disease (GERD) Pantoprazole sodium ...
  • 2  DOSAGE AND ADMINISTRATION
    2.1 Recommended Dosing Schedule - Pantoprazole sodium delayed-release tablets are supplied as delayed-release tablets. The recommended dosages are outlined in Table 1. Table 1: Recommended ...
  • 3  DOSAGE FORMS AND STRENGTHS
    Delayed-Release Tablets: 20 mg, light yellow to yellow color, oval shaped, biconvex, delayed-release tablets imprinted “A6” with black ink on one side and plain on the other side. 40 mg, light ...
  • 4  CONTRAINDICATIONS
    Pantoprazole sodium delayed-release tablets are contraindicated in patients with known hypersensitivity to any component of the formulation or any substituted benzimidazole. Hypersensitivity ...
  • 5  WARNINGS AND PRECAUTIONS
    5.1 Presence of Gastric Malignancy - In adults, symptomatic response to therapy with pantoprazole sodium does not preclude the presence of gastric malignancy. Consider additional follow-up and ...
  • 6  ADVERSE REACTIONS
    The following serious adverse reactions are described below and elsewhere in labeling: Acute Tubulointerstitial Nephritis [see Warnings and Precautions (5.2)]. Clostridium difficile-Associated ...
  • 7  DRUG INTERACTIONS
    Table 4 includes drugs with clinically important drug interactions and interaction with diagnostics when administered concomitantly with pantoprazole sodium and instructions for preventing or ...
  • 8  USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - Available data from published observational studies did not demonstrate an association of major malformations or other adverse pregnancy outcomes with ...
  • 10  OVERDOSAGE
    Experience in patients taking very high doses of pantoprazole sodium (greater than 240 mg) is limited. Spontaneous post-marketing reports of overdose are generally within the known safety profile ...
  • 11  DESCRIPTION
    The active ingredient in pantoprazole sodium delayed-release tablets USP, a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl ...
  • 12  CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Pantoprazole is a PPI that suppresses the final step in gastric acid production by covalently binding to the (H+, K+)-ATPase enzyme system at the secretory surface of ...
  • 13  NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - In a 24-month carcinogenicity study, Sprague-Dawley rats were treated orally with doses of 0.5 to 200 mg/kg/day, about 0.1 to 40 times ...
  • 14  CLINICAL STUDIES
    Pantoprazole sodium delayed-release tablets were used in the following clinical trials. 14.1 Erosive Esophagitis (EE) Associated with Gastroesophageal Reflux Disease (GERD) Adult Patients - A ...
  • 16  HOW SUPPLIED/STORAGE AND HANDLING
    How Supplied - Pantoprazole sodium delayed-release tablets USP, 20 mg are supplied as light yellow to yellow color, oval shaped, biconvex, delayed-release tablets imprinted “A6” with black ink on ...
  • 17  PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling (Medication Guide). Gastric Malignancy - Advise patients to return to their healthcare provider if they have a suboptimal response or ...
  • MEDICATION GUIDE
    Dispense with Medication Guide available at: documents.amneal.com/mg/pantoprazole-sodium.pdf - Pantoprazole Sodium (pan toe’ pra zole soe’ dee um) Delayed-Release Tablets -  What is the most ...
  • PRINCIPAL DISPLAY PANEL
    NDC 65162-636-03 - Pantoprazole Sodium Delayed-release Tablets USP, 20 mg - Rx only - 30 Tablets - Amneal Pharmaceuticals LLC - NDC 65162-637-03 - Pantoprazole Sodium Delayed-release Tablets ...
  • INGREDIENTS AND APPEARANCE
    Product Information