Pantoprazole 20 mg Enteric Coated Tablets — Generic For Protonix — Dr Reddy

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

IndicationDoseFrequency

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

Adults40 mgOnce Daily for up to 8 wks

Children (5 years and older)

≥ 15 kg to < 40 kg20 mgOnce Daily for up to 8 wks

≥ 40 kg40 mg

Maintenance of Healing of Erosive Esophagitis (2.1)

Adults40 mgOnce Daily*

Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome (2.1)

Adults40 mgTwice Daily

See full prescribing information for administration instructions

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

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 Dr. Reddy’s Laboratories, Inc. at 1-888-375-3784 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: 8/2023