Pantoprazole 40 mg Enteric Coated Tablets — Generic For Protonix — Aurobindo

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 DELAYED-RELEASE TABLETS.

PANTOPRAZOLE SODIUM delayed-release tablets, for oral use

Initial U.S. approval: 2000

Indications And Usage

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)

Dosage And Administration

See full prescribing information for administration instructions

Indication

Dose

Frequency

Short-Term Treatment of Erosive Esophagitis Associated With GERD (2.1)

Adults

40 mg

Once Daily for up to 8 wks

Children (5 years and older)

≥ 15 kg to < 40 kg

20 mg

Once Daily for up to 8 wks

≥ 40 kg

40 mg

Maintenance of Healing of Erosive Esophagitis (2.1)

Adults

40 mg

Once Daily*

Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome (2.1)

Adults

40 mg

Twice Daily

Dosage Forms And Strengths

Delayed-Release Tablets: 20 mg and 40 mg pantoprazole (3)

Contraindications

Patients with known hypersensitivity to any component of the formulation or to substituted benzimidazoles (4)

Patients receiving rilpivirine-containing products (4,7)

Warnings And Precautions

• Gastric Malignancy: In adults, symptomatic response does not preclude presence of gastric malignancy. Consider additional follow-up and diagnostic testing. (5.1)
• Acute Tubulointerstitial Nephritis: Discontinue treatment and evaluate patients. (5.2)
• Clostridium difficile-Associated Diarrhea: PPI therapy may be associated with increased risk of Clostridium difficile-associated diarrhea. (5.3)
• Bone Fracture: Long-term and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine. (5.4)
• Severe Cutaneous

• Gastric Malignancy: In adults, symptomatic response does not preclude presence of gastric malignancy. Consider additional follow-up and diagnostic testing. (5.1)
• Acute Tubulointerstitial Nephritis: Discontinue treatment and evaluate patients. (5.2)
• Clostridium difficile-Associated Diarrhea: PPI therapy may be associated with increased risk of Clostridium difficile-associated diarrhea. (5.3)
• Bone Fracture: Long-term and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine. (5.4)
• Severe Cutaneous

Gastric Malignancy: In adults, symptomatic response does not preclude presence of gastric malignancy. Consider additional follow-up and diagnostic testing. (5.1)

Acute Tubulointerstitial Nephritis: Discontinue treatment and evaluate patients. (5.2)

Clostridium difficile-Associated Diarrhea: PPI therapy may be associated with increased risk of Clostridium difficile-associated diarrhea. (5.3)

Bone Fracture: Long-term and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine. (5.4)

Severe Cutaneous Adverse Reactions: Discontinue at the first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation. (5.5)

Cutaneous and Systemic Lupus Erythematosus: Mostly cutaneous; new onset or exacerbation of existing disease; discontinue pantoprazole sodium and refer to specialist for evaluation. (5.6)

Cyanocobalamin (Vitamin B-12) Deficiency: Daily long-term use (e.g., longer than 3 years) may lead to malabsorption or a deficiency of cyanocobalamin. (5.7)

Hypomagnesemia and Mineral Metabolism: Reported rarely with prolonged treatment with PPIs. (5.8)

Fundic Gland Polyps: Risk increases with long-term use, especially beyond one year. Use the shortest duration of therapy. (5.10)

Adverse Reactions

Most common adverse reactions are:

For adult use (>2%): headache, diarrhea, nausea, abdominal pain, vomiting, flatulence, dizziness, and arthralgia. (6.1)

For pediatric use (>4%): URI, headache, fever, diarrhea, vomiting, rash, and abdominal pain. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Drug Interactions

See full prescribing information for a list of clinically important drug interactions (7)

Use In Specific Populations

Pregnancy: Based on animal data, may cause fetal harm. (8.1)

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 12/2025