HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use PROTONIX safely and effectively. See full prescribing information for PROTONIX.
PROTONIX (pantoprazole sodium) delayed-release tablets, for oral use PROTONIX (pantoprazole sodium) for delayed-release oral suspension Initial U.S. approval: 2000 INDICATIONS AND USAGEPROTONIX 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 ADMINISTRATIONIndication | 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- •
- Delayed-Release Tablets: 20 mg and 40 mg pantoprazole (3)
- •
- For Delayed-Release Oral Suspension: 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 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 PROTONIX 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 REACTIONSMost 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 Pfizer Inc at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. DRUG INTERACTIONSSee full prescribing information for a list of clinically important drug interactions (7) USE IN SPECIFIC POPULATIONSPregnancy: Based on animal data, may cause fetal harm. (8.1) See 17 for PATIENT COUNSELING INFORMATION and Medication Guide. Revised: 6/2023 |