Pantoprazole 20 mg Enteric Coated Tablets — Generic For Protonix — Camber

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 delayed-release tablet is a proton pump inhibitor (PPI) indicated for the following:

(1.1)

1.2)

(1.3)

Dosage And Administration

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

See full prescribing information for administration instructions

Dosage Forms And Strengths

3)

Contraindications

4)

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

5.1)

5.2)

PPI therapy may be associated with increased risk of

Clostridium difficile-associated diarrhea.

(5.3)

5.4)

5.5)

5.6)

5.7)

5.8)

5.10)

Adverse Reactions

Most common adverse reactions are:

6.1)

(6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Hetero Labs Limited at 1-866-495-1995

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: 9/2023